Background Premature ventricular contraction （PVC） is one of the most common kinds of arrhythmias for which the treatment falls into dilemma. Previous clinical application showed that the traditional Chinese Medicin...Background Premature ventricular contraction （PVC） is one of the most common kinds of arrhythmias for which the treatment falls into dilemma. Previous clinical application showed that the traditional Chinese Medicine Shensongyangxin （SSYX） capsule is efficacious for the treatment of PVCs. This randomized clinical trial aimed to further evaluate the efficacy and safety of SSYX capsule on treating PVC. Methods The subjects who had frequent PVCs with or without organic heart disease and normal cardiac function were enrolled in the study. The primary endpoint was the change of PVC numbers after eight-week medication with SSYX capsule. The secondary endpoints included change of clinical symptoms related to PVCs and the safety evaluation of SSYX capsule. Totally 188 PVC patients were randomly enrolled in the non-organic heart disease PVCs trial and orally took either $SYX capsules or analogues （three times per day, 4 capsules one time）. A total of 671 PVCs patients were randomly enrolled in the organic heart disease PVCs trial, and orally took either SSYX capsules （three times per day, 4 capsules one time） or mexiletine tablet （three times per day, 150 mg one time）. The PVCs were monitored and calculated with 24-hour Holter electrocardiogram. Routine blood, liver and kidney function were tested before and after medication with SSYX capsule. Results SSYX capsules significantly decreased the PVCs numbers and alleviated the related symptoms in patients with or without organic heart disease. In non-organic heart disease group, SSYX capsules and the placebos decreased the PVCs from 12561.34±9777.93 to 4806.87±6507.17, and 12 605.69±8736.34 to 10364.94±9903.41, respectively. The total effective rate was 74.2% and 28.9% in SSYX and placebo groups （P〈0.001）. In organic heart disease group, SSYX capsule and mexiletine decreased the PVCs from 8641.01±8923.57 to 3853.68±7096.42, 8621.61±8367.74 to 5648.29±8667.38, respectively, The total effective rate was 65.8% and 50.7% in SSYX and mexiletine g展开更多
Objective： To assess the efficacy and safety of Moluodan （摩罗丹~） in treating dysplasia in chronic atrophic gastritis （CAG） patients. Methods： This was a multi-centered, double-blind, randomized controlled tria...Objective： To assess the efficacy and safety of Moluodan （摩罗丹~） in treating dysplasia in chronic atrophic gastritis （CAG） patients. Methods： This was a multi-centered, double-blind, randomized controlled trial. The total of 196 subjects were assigned to receive either Moluodan or folic acid in a 2：1 ratio by blocked randomization. Mucosa marking targeting biopsy （MTB） was used to insure the accuracy and consistency between baseline and after 6-month treatment. Primary outcomes were histological score, response rate of pathological lesions and dysplasia disappearance rate. Secondary endpoints included gastroscopic findings, clinical symptom and patient reported outcome （PRO） instrument. Results： Dysplasia score decreased in Moluodan group （P=0.002）, significance was found between groups （P=0.045）. Dysplasia disappearance rates were 24.6% and 15.2% in Moluodan and folic acid groups respectively, no significant differences were found （P=0.127）. The response rate of atrophy and intestinal metaplasia were 34.6% and 23.0% in Moluodan group, 24.3% and 13.6% in folic acid group. Moluodan could improve erythema （P=0.044）, and bile reflux （P=0.059）, no significance between groups. Moluodan was better than folic acid in improving epigastric pain, epigastric suffocation, belching and decreased appetite （P〈0.05）, with symptom disappearance rates of 37% to 83%. Conclusions： Moluodan improved dysplasia score in histopathology, and erythema and bile reflux score in endoscopy, and superior to folic acid in improving epigastric pain, epigastric suffocation, belching and decreased appetite.展开更多
Background The 2009 influenza A （H1N1） virus infection is associated with the high risk of severe complications and is spreading more rapidly throughout the world than other reported seasonal influenzas. This study ...Background The 2009 influenza A （H1N1） virus infection is associated with the high risk of severe complications and is spreading more rapidly throughout the world than other reported seasonal influenzas. This study aimed to evaluate the efficacy and safety of the nature herbal medicine Lianhuaqingwen capsule （LHC） in patients infected with influenza A （H1N1） virus. Methods A total of 244 patients aged 16-65 years confirmed with influenza A （H1N1） virus infection by the real time RT-PCR were randomized to one of two treatment groups of 122 patients each. Each group assigned to receive either LHC or Oseltamivir for five days and observation for seven days. The patients were enrolled within 36 hours of illness onset if they had an axillary temperature of ≥37.4℃ and with at least one of the following symptoms： nasal obstruction, runny nose, cough, sore throat, fatigue, headache, myalgia, chills and sweating. The primary end point was the duration of illness. Results Of 244 patients, 240 （98.36%） patients with a median age 21 years completed the study between October 24, 2009 and November 23, 2009. There were no significant overall differences between LHC treated and Oseltamivir treated patients in the median duration of illness （LHC 69 hours vs. Oseltamivir 85 hours P 〉0.05） or the median duration of viral shedding （LHC 103 hours vs. Oseltamivir 96 hours, P 〉0.05）. However, it was worthwhile to note that LHC significantly reduced the severity of illness and the duration of symptoms including fever, cough, sore throat, and fatigue （P〈0.05）. Both study medications were well tolerated. No drug related serious adverse events occurred during the study. Conclusions Compared with Oseltamivir, LHC achieved a similar therapeutic effectiveness reduction of the duration of illness and duration of viral shedding. Therefore, LHC might be an alternative therapeutic measure for influenza A （H1N1） virus infections.展开更多
AIM: To compare the clinical efficacies of two surgical procedures for hemorrhoid rectal prolapse with outlet obstruction-induced constipation.METHODS: One hundred eight inpatients who underwent surgery for outlet obs...AIM: To compare the clinical efficacies of two surgical procedures for hemorrhoid rectal prolapse with outlet obstruction-induced constipation.METHODS: One hundred eight inpatients who underwent surgery for outlet obstructive constipation caused by internal rectal prolapse and circumferential hemorrhoids at the First Affiliated Hospital of Xinjiang Medical University from June 2012 to June 2013 were prospectively included in the study.The patients with rectal prolapse hemorrhoids with outlet obstructioninduced constipation were randomly divided into two groups to undergo either a procedure for prolapse and hemorrhoids(PPH)(n = 54) or conventional surgery(n = 54; control group).Short-term(operative time,postoperative hospital stay,postoperative urinary retention,postoperative perianal edema,and postoperative pain) and long-term(postoperative anal stenosis,postoperative sensory anal incontinence,postoperative recurrence,and postoperative difficulty in defecation) clinical effects were compared between the two groups.The short- and long-term efficacies of the two procedures were determined.RESULTS: In terms of short-term clinical effects,operative time and postoperative hospital stay were significantly shorter in the PPH group than in the control group(24.36 ± 5.16 min vs 44.27 ± 6.57 min,2.1 ± 1.4 d vs 3.6 ± 2.3 d,both P < 0.01).The incidence of postoperative urinary retention was higher in the PPH group than in the control group,but the difference was not statistically significant(48.15% vs 37.04%).Theincidence of perianal edema was significantly lower in the PPH group(11.11% vs 42.60%,P < 0.05).The visual analogue scale scores at 24 h after surgery,first defecation,and one week after surgery were significantly lower in the PPH group(2.9 ± 0.9 vs 8.3 ± 1.1,2.0 ± 0.5 vs 6.5 ± 0.8,and 1.7 ± 0.5 vs 5.0 ± 0.7,respectively,all P < 0.01).With regard to long-term clinical effects,the incidence of anal stenosis was lower in the PPH group than in the control group,but the difference was not significant(1.85% vs 5展开更多
Many randomized clinical controlled trials have confirmed the efficacy and safety of calcium dobesilate in treating diabetic retinopathy(DR).This systematic review critically evaluated the evidence that links calcium ...Many randomized clinical controlled trials have confirmed the efficacy and safety of calcium dobesilate in treating diabetic retinopathy(DR).This systematic review critically evaluated the evidence that links calcium dobesilate to DR.In this fixed-effects meta-analysis,a total of 221 pertinent English-language articles published between January 1975 and October 2013 were identified.Systematic searches of PUBMED,Springer Link and the Cochrane Clinical Trials Database were conducted using the keywords "diabetic retinopathy" and "calcium dobesilate".The extracted information included the study design,inclusion and exclusion criteria,setting,sample size,participant mean age,treatment regime,mean change in best corrected visual acuity,laboratory parameters,capillary fragility,intraocular pressure and fundus manifestations based on the findings of fluorescent angiography.The summary statistics indicated that calcium dobesilate was significantly associated with improving retinal microaneurysms(RR: 0.62,95%CI: 0.42?0.90,P=0.01),retinalhemorrhages(RR: 0.39,95% CI: 0.17?0.88,P=0.02); exudates(RR: 0.31,95% CI: 0.12?0.81,P=0.02),reduction of whole blood viscosity(MD: ?0.57 CP,95% CI: ?0.75 to ?0.38,P<0.001),plasma viscosity(MD: ?0.36 CP,95% CI: ?0.63 to ?0.09,P=0.01) and blood cholesterol(MD: ?0.48 mg m L?1,95% CI: ?0.64?0.33,P<0.00001).Intraocular pressure was also significantly reduced(MD: ?5.59 mm Hg,95% CI: ?6.69 to ?4.50,P<0.00001).The results indicate that calcium dobesilate effectively treats DR at the systematic and local ocular levels.展开更多
BACKGROUND： Disease recurrence is a main challenge in treatment of hepatocellular carcinoma （HCC）. There is no generally accepted method for preventing recurrence of HCC after resection. OBJECTIVE： To compare the ...BACKGROUND： Disease recurrence is a main challenge in treatment of hepatocellular carcinoma （HCC）. There is no generally accepted method for preventing recurrence of HCC after resection. OBJECTIVE： To compare the efficacy of a traditional herbal medicine （THM） regimen and transarterial chemoembolization （TACE） in preventing recurrence in post-resection patients with small HCC. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS： This is a multicenter, open- label, randomized, controlled study, which was undertaken in five centers of China. A total of 379 patients who met the eligibility criteria and underwent randomization were enrolled in this trial. One hundred and eighty-eight patients were assigned to the THM group and received Cinobufacini injection and Jiedu Granule, and the other 191 patients were assigned to the TACE group and received one single course of TACE. MAIN OUTCOME MEASURES： Primary outcome measures were the annual recurrence rate and the time to recurrence. Incidence of adverse events was regarded as the secondary outcome measure. RESULTS： Among the 364 patients who were included in the intention-to-treat analysis, 67 patients of the THM group and 87 of the TACE group had recurrence, with a hazard ratio of 0.695 （P = 0.048）. Median recurrence-free survival of the patients in the THM and TACE groups was 46.89 and 34.49 months, respectively. Recurrence rates at 1, 2 and 3 years were 17.7%, 33.0% and 43.5% for the THM group, and 28.8%, 42.5% and 54.0% for the TACE group, respectively （P = 0.026）. Multivariate analysis indicated that the THM regimen had a big advantage for prolonging the recurrence-free survival. Adverse events were mild and abnormality of laboratory indices of the two groups were similar. CONCLUSION： In comparison with TACE therapy, the THM regimen was associated with diminished risk of recurrence of small-sized HCC after resection, with comparable adverse events. TRIAL REGISTRTION IDENTIFIER： This trial was registered in the Chinese Clinical Trial Re展开更多
INTRODUCTIONChronic hepatitis B virus (HBV) infection is a serious problem because of its world wide distribution and possible adverse sequelae ,such as cirrhosis and hepatocellular carcinoma .The World Health Organiz...INTRODUCTIONChronic hepatitis B virus (HBV) infection is a serious problem because of its world wide distribution and possible adverse sequelae ,such as cirrhosis and hepatocellular carcinoma .The World Health Organization estimates that HBV has infected mord than 350 million people worldwide ,and up to 20% of them will become chromic carricrs and will be at significant risk for cirrhosis and HCC .The ultimate goal of the therapy for chronic hepatitis B is to prevent progression to cirrhosis and to prevent development of HCC.展开更多
Dyssynergic defecation is one of the most common forms of functional constipation both in children and adults; it is defined by incomplete evacuation of fecal material from the rectum due to paradoxical contraction or...Dyssynergic defecation is one of the most common forms of functional constipation both in children and adults; it is defined by incomplete evacuation of fecal material from the rectum due to paradoxical contraction or failure to relax pelvic floor muscles when straining to defecate. This is believed to be a behavioral disorder because there.are no associated morphological or neurological abnormalities, and consequently biofeedback training has been recommended for treatment. Biofeedback involves the use of pressure measurements or averaged electromyographic activity within the anal canal to teach patients how to relax pelvic floor muscles when straining to defecate. This is often combined with teaching the patient more appropriate techniques for straining （increasing intra-abdominal pressure） and having the patient practice defecating a water filled balloon. Tn adults, randomized controlled trials show that this form of biofeedback is more effective than laxatives, general muscle relaxation exercises （described as sham biofeedback）, and drugs to relax skeletal muscles. Moreover, its effectiveness is specific to patients who have dyssynergic defecation and not slow transit constipation. However, in children, no clear superiority for biofeedback compared to laxatives has been demonstrated. Based on three randomized controlled studies in the last two years, biofeedback appears to be the preferred treatment for dyssynergic defecation in adults.展开更多
In recent years,as living standards have continued to improve,the number of diabetes patients in China,along with the incidence of complications associated with the disease,has been increasing.Among these complication...In recent years,as living standards have continued to improve,the number of diabetes patients in China,along with the incidence of complications associated with the disease,has been increasing.Among these complications,diabetic foot disease is one of the main causes of disability and death in diabetic patients.Due to the differences in economy,culture,religion and level of medical care available across different regions,preventive and treatment methods and curative results for diabetic foot vary greatly.In multidisciplinary models built around diabetic foot,the timely assessment and diagnosis of wounds and appropriate methods of prevention and treatment with internal and external surgery are key to clinical practice for this pathology.In 2019,under the leadership of the Jiangsu Medical Association and Chinese Diabetes Society,the writing group for the Guidelines on multidisciplinary approaches for the prevention and management of diabetic foot disease(2020 edition)was established with the participation of scholars from the specialist areas of endocrinology,burn injury,vascular surgery,orthopedics,foot and ankle surgery and cardiology.Drawing lessons from diabetic foot guidelines from other countries,this guide analyses clinical practices for diabetic foot,queries the theoretical basis and grades and gives recommendations based on the characteristics of the pathology in China.This paper begins with assessments and diagnoses of diabetic foot,then describes treatments for diabetic foot in detail,and ends with protections for high-risk feet and the prevention of ulcers.This manuscript covers the disciplines of internal medicine,surgical,nursing and rehabilitation and describes a total of 50 recommendations that we hope will provide procedures and protocols for clinicians dealing with diabetic foot.展开更多
Background Bell’s palsy involves acute facial paralysis due to inflammation of the facial nerve. Acupuncture and moxibustion (acu-moxi) is beneficial in treating facial palsy. In order to verify the efficacy of acu-...Background Bell’s palsy involves acute facial paralysis due to inflammation of the facial nerve. Acupuncture and moxibustion (acu-moxi) is beneficial in treating facial palsy. In order to verify the efficacy of acu-moxi on Bell’s palsy, a randomized single-blind, multicenter clinical trial was performed.Methods A total of 480 patients from four clinical centers were involved in this trial, of whom 439 completed the trial and 41 did not. All patients were randomly assigned to either the control group or to one of two treatment groups. The control group was treated with prednisone, vitamin B_1, vitamin B_ 12, and dibazole; the treatment groups were treated either with acu-moxi alone or in combination with prednisone, Vitamin B_1, vitamin B_ 12, and dibazole. Symptoms and signs, the House-Brackmann scale, and facial disability index (FDI) scores were assessed and determined both pre- and post-treatment to evaluate the effectiveness of the treatment methods.Results The characteristics of the control and two treatment groups were comparable without statistically significant differences before treatment. There were significant differences between the control and treatment groups after treatment (χ2=15.265, P=0.018). According to evaluations based on the House-Brackmann scale and FDI scores, the effectiveness of treatment in the two treatment groups was better than in the control group and was most effective in patients receiving acu-moxi treatment alone (Z=-2.827, P=0.005). Conclusion The efficacy of acu-moxi treatment for Bell’s palsy is verified scientifically.展开更多
Background Hemocoagulase Agkistrodon for injection is a single component thrombin which has passed phases I and II clinical trials. The purpose of this phase III clinical trial was to evaluate the effect of Hemocoagul...Background Hemocoagulase Agkistrodon for injection is a single component thrombin which has passed phases I and II clinical trials. The purpose of this phase III clinical trial was to evaluate the effect of Hemocoagulase Agkistrodon on hemostasis and coagulation in abdominal skin and subcutaneous incisions and to assess the safety of this agent in surgical patients. Methods This is a phase III, prospective, randomized, double-blind, and controlled multicenter clinical trial including 432 consecutive patients randomized into either a study group （injected with hemocoagulase Agkistrodon at 2 U, n=-324） or a control group （injected with hemocoagulase Atrox, n=108）. The hemostatic time, hemorrhagic volume, hemorrhagic volume per unit area, blood coagulation, and adverse events were measured and compared between the two groups. Results The mean hemostatic time in the study group was （36.8±18.7） seconds; the hemorrhagic volume was （3.77±3.93） g; and the hemorrhagic volume per unit area was （0.091±0.125） g/cm2. In the control group, the corresponding values were （38.1±19.7） seconds, （4.00±4.75） g, and （0.095±0.101） g/cm2, respectively. No significant difference in values existed between the two groups （P 〉0.05）. Blood coagulation results and hepatic and renal function were also similar between the two groups. Adverse events were reported in two cases, but were deemed non-drug-related. Conclusions Hemocoagulase Agkistrodon has good hemostatic and coagulative function and is safe for the use of arresting capillary hemorrhage that occurs while incising the abdomen during surgery.展开更多
OBJECTIVE：This meta-analysis was performed to systematically assess the efficacy and safety of the Chinese herbal medicine Huangqi Guizhi Wuwu Decoction（HGWWD） for treating diabetic peripheral neuropathy.DATA SOUR...OBJECTIVE：This meta-analysis was performed to systematically assess the efficacy and safety of the Chinese herbal medicine Huangqi Guizhi Wuwu Decoction（HGWWD） for treating diabetic peripheral neuropathy.DATA SOURCES：Six electronic databases,including the Cochrane Library,MEDLINE database,Chinese Biomedical Database,Chinese National Knowledge Infrastructure Database,Chinese Science and Technique Journals Database,and the Wanfang Database,were search ed on the internet for randomized controlled trials published up until 1 December 2015.The search terms included ＂Chinese herbal medicine＂,＂diabetic peripheral neuropathy＂ and ＂randomized controlled trials＂ in Chinese and in English.DATA SELECTION：We included randomized controlled trials using HGWWD/modified HGWWD for the treatment group,without restriction for the control group.We assessed literature quality in accordance with the Cochrane Review Handbook.A random or a fixed effects model was used to analyze outcomes using Rev Man 5.2 software.OUTCOME MEASURES：The primary outcomes were changes in symptoms and nerve conduction velocities.The secondary outcomeswere fasting blood glucose and hemorheological indexes.RESULTS：Sixteen randomized controlled trials,with a total of 1,173 patients,were included.Meta-analysis revealed that the efficacy of HGWWD for diabetic peripheral neuropathy was significantly superior compared with the control treatment（i.e.,control group）（risk ratio = 0.36,95% confidence interval（CI）：0.29–0.46,Z =8.33,P 〈 0.00001） Compared with the control group,there was an increase in median motor nerve conduction velocity（mean difference（MD） = 3.46,95%CI：1.88–5.04,Z = 4.30,P 〈 0.01） and median sensory nerve conduction velocity（MD = 3.30,95%CI：2.04–4.56,Z = 5.14,P 〈 0.01）.There was also an increase in peroneal motor nerve conduction velocity（MD = 3.22,95%CI：2.45–3.98,Z = 8.21,P 〈 0.01） and peroneal sensory nerve conduction velocity（MD = 3.05,95%CI：2.01–4.09,Z = 5.75,P 〈 展开更多
Background：Pharmacological therapy for congestive heart failure （CHF） with ventricular arrhythmia is limited.In the study,our aim was to evaluate the effects of Chinese traditional medicine Shensong Yangxin capsul...Background：Pharmacological therapy for congestive heart failure （CHF） with ventricular arrhythmia is limited.In the study,our aim was to evaluate the effects of Chinese traditional medicine Shensong Yangxin capsules （SSYX） on heart rhythm and function in CHF patients with frequent ventricular premature complexes （VPCs）.Methods：This double-blind,placebo-controlled,multicenter study randomized 465 CHF patients with frequent VPCs to the SSYX （n =232） and placebo groups （n =233） for 12 weeks of treatment.The primary endpoint was the VPCs monitored by a 24-h ambulatory electrocardiogram.The secondary endpoints included the left ventricular ejection fraction （LVEF）,left ventricular end-diastolic diameter,N-terminal pro-brain natriuretic peptide （NT-proBNP）,New York Heart Association （NYHA） classification,6-min walking distance （6MWD）,Minnesota Living with Heart Failure Questionnaire （MLHFQ） scores,and composite cardiac events （CCEs）.Results：The clinical characteristics were similar at baseline.SSYX caused a significantly greater decline in the total number of VPCs than the placebo did （-2145 ± 2848 vs.-841 ± 3411,P 〈 0.05）.The secondary endpoints of the LVEE NYHA classification,NT-proBNP,6MWD,and MLHFQ scores showed a greater improvements in the SSYX group than in the placebo group （ALVEF at 12th week：4.75 ± 7.13 vs.3.30 ± 6.53;NYHA improvement rate at the 8th and 12th week：32.6% vs.21.8%,40.5% vs.25.7%;mean level of NT-proBNP in patients with NT-proBNP 〉125 pg/ml at 12th week：-122 [Q1,Q3：-524,0] vs.-75 [Q1,Q3：-245,0];A6MWD at 12th week：35.1 ± 38.6 vs.17.2 ± 45.6;AMLHFQ at the 4th,8th,and 12th week：-4.24 ± 6.15 vs.-2.31 ± 6.96,-8.l 9 ± 8.41 vs.-3.25 ± 9.40,10.60 ± 9.41 vs.-4.83 ± 11.23,all P 〈 0.05）.CCEs were not different between the groups during the study period.Conclusions：In this 12-week pilot study,SSYX was demonstrated to have the benefits of VPCs suppression and cardiac function improvement with good compliance on a back展开更多
AIM To assess the efficacy and safety of a Chinese herbal medicine (CHM), Xiangsha Liujunzi granules, in the treatment of patients with functional dyspepsia (FD). METHODS We performed a randomized, double-blind, place...AIM To assess the efficacy and safety of a Chinese herbal medicine (CHM), Xiangsha Liujunzi granules, in the treatment of patients with functional dyspepsia (FD). METHODS We performed a randomized, double-blind, placebo-controlled trial with patients from three centers. Two hundred and sixteen subjects diagnosed with FD according to ROME. criteria and confirmed by upper gastrointestinal endoscopy and spleen-deficiency and Qi-stagnation syndrome were selected to receive Xiangsha Liujunzi granules or placebo for 4 wk in a 2: 1 ratio by blocked randomization. The subjects also received follow-up after the 4-wk intervention. Herbal or placebo granules were dissolved in 300 mL of water. Participants in both groups were administered 130 mL (45 degrees C) three times a day. Participants were evaluated prior to and following 4 wk of the intervention in terms of changes in the postprandial discomfort severity scale (PDSS) score, clinical global impression (CGI) scale score, hospital anxiety and depression scale (HADS) score, traditional Chinese medicine symptoms score (SS), scores of various domains of the 36-item short form health survey (SF-36), gastric emptying (GE) and any observed adverse effects. RESULTS Compared with the placebo group, patients in the CHM group showed significant improvements in the scores of PDSS, HADS, SS, SF-36 and CGI scale (P < 0.05 or P < 0.01). They also showed the amelioration in the GE rates of the proximal stomach and distal stomach (P < 0.05 or P < 0.01). CONCLUSION Xiangsha Liujunzi granules offered significant symptomatic improvement in patients with FD.展开更多
文摘Background Premature ventricular contraction （PVC） is one of the most common kinds of arrhythmias for which the treatment falls into dilemma. Previous clinical application showed that the traditional Chinese Medicine Shensongyangxin （SSYX） capsule is efficacious for the treatment of PVCs. This randomized clinical trial aimed to further evaluate the efficacy and safety of SSYX capsule on treating PVC. Methods The subjects who had frequent PVCs with or without organic heart disease and normal cardiac function were enrolled in the study. The primary endpoint was the change of PVC numbers after eight-week medication with SSYX capsule. The secondary endpoints included change of clinical symptoms related to PVCs and the safety evaluation of SSYX capsule. Totally 188 PVC patients were randomly enrolled in the non-organic heart disease PVCs trial and orally took either $SYX capsules or analogues （three times per day, 4 capsules one time）. A total of 671 PVCs patients were randomly enrolled in the organic heart disease PVCs trial, and orally took either SSYX capsules （three times per day, 4 capsules one time） or mexiletine tablet （three times per day, 150 mg one time）. The PVCs were monitored and calculated with 24-hour Holter electrocardiogram. Routine blood, liver and kidney function were tested before and after medication with SSYX capsule. Results SSYX capsules significantly decreased the PVCs numbers and alleviated the related symptoms in patients with or without organic heart disease. In non-organic heart disease group, SSYX capsules and the placebos decreased the PVCs from 12561.34±9777.93 to 4806.87±6507.17, and 12 605.69±8736.34 to 10364.94±9903.41, respectively. The total effective rate was 74.2% and 28.9% in SSYX and placebo groups （P〈0.001）. In organic heart disease group, SSYX capsule and mexiletine decreased the PVCs from 8641.01±8923.57 to 3853.68±7096.42, 8621.61±8367.74 to 5648.29±8667.38, respectively, The total effective rate was 65.8% and 50.7% in SSYX and mexiletine g
基金Supported by the 11th Five-Year Plan from Ministry of Sciences and Technology of China(No.2006BAI04A08)
文摘Objective： To assess the efficacy and safety of Moluodan （摩罗丹~） in treating dysplasia in chronic atrophic gastritis （CAG） patients. Methods： This was a multi-centered, double-blind, randomized controlled trial. The total of 196 subjects were assigned to receive either Moluodan or folic acid in a 2：1 ratio by blocked randomization. Mucosa marking targeting biopsy （MTB） was used to insure the accuracy and consistency between baseline and after 6-month treatment. Primary outcomes were histological score, response rate of pathological lesions and dysplasia disappearance rate. Secondary endpoints included gastroscopic findings, clinical symptom and patient reported outcome （PRO） instrument. Results： Dysplasia score decreased in Moluodan group （P=0.002）, significance was found between groups （P=0.045）. Dysplasia disappearance rates were 24.6% and 15.2% in Moluodan and folic acid groups respectively, no significant differences were found （P=0.127）. The response rate of atrophy and intestinal metaplasia were 34.6% and 23.0% in Moluodan group, 24.3% and 13.6% in folic acid group. Moluodan could improve erythema （P=0.044）, and bile reflux （P=0.059）, no significance between groups. Moluodan was better than folic acid in improving epigastric pain, epigastric suffocation, belching and decreased appetite （P〈0.05）, with symptom disappearance rates of 37% to 83%. Conclusions： Moluodan improved dysplasia score in histopathology, and erythema and bile reflux score in endoscopy, and superior to folic acid in improving epigastric pain, epigastric suffocation, belching and decreased appetite.
文摘Background The 2009 influenza A （H1N1） virus infection is associated with the high risk of severe complications and is spreading more rapidly throughout the world than other reported seasonal influenzas. This study aimed to evaluate the efficacy and safety of the nature herbal medicine Lianhuaqingwen capsule （LHC） in patients infected with influenza A （H1N1） virus. Methods A total of 244 patients aged 16-65 years confirmed with influenza A （H1N1） virus infection by the real time RT-PCR were randomized to one of two treatment groups of 122 patients each. Each group assigned to receive either LHC or Oseltamivir for five days and observation for seven days. The patients were enrolled within 36 hours of illness onset if they had an axillary temperature of ≥37.4℃ and with at least one of the following symptoms： nasal obstruction, runny nose, cough, sore throat, fatigue, headache, myalgia, chills and sweating. The primary end point was the duration of illness. Results Of 244 patients, 240 （98.36%） patients with a median age 21 years completed the study between October 24, 2009 and November 23, 2009. There were no significant overall differences between LHC treated and Oseltamivir treated patients in the median duration of illness （LHC 69 hours vs. Oseltamivir 85 hours P 〉0.05） or the median duration of viral shedding （LHC 103 hours vs. Oseltamivir 96 hours, P 〉0.05）. However, it was worthwhile to note that LHC significantly reduced the severity of illness and the duration of symptoms including fever, cough, sore throat, and fatigue （P〈0.05）. Both study medications were well tolerated. No drug related serious adverse events occurred during the study. Conclusions Compared with Oseltamivir, LHC achieved a similar therapeutic effectiveness reduction of the duration of illness and duration of viral shedding. Therefore, LHC might be an alternative therapeutic measure for influenza A （H1N1） virus infections.
文摘AIM: To compare the clinical efficacies of two surgical procedures for hemorrhoid rectal prolapse with outlet obstruction-induced constipation.METHODS: One hundred eight inpatients who underwent surgery for outlet obstructive constipation caused by internal rectal prolapse and circumferential hemorrhoids at the First Affiliated Hospital of Xinjiang Medical University from June 2012 to June 2013 were prospectively included in the study.The patients with rectal prolapse hemorrhoids with outlet obstructioninduced constipation were randomly divided into two groups to undergo either a procedure for prolapse and hemorrhoids(PPH)(n = 54) or conventional surgery(n = 54; control group).Short-term(operative time,postoperative hospital stay,postoperative urinary retention,postoperative perianal edema,and postoperative pain) and long-term(postoperative anal stenosis,postoperative sensory anal incontinence,postoperative recurrence,and postoperative difficulty in defecation) clinical effects were compared between the two groups.The short- and long-term efficacies of the two procedures were determined.RESULTS: In terms of short-term clinical effects,operative time and postoperative hospital stay were significantly shorter in the PPH group than in the control group(24.36 ± 5.16 min vs 44.27 ± 6.57 min,2.1 ± 1.4 d vs 3.6 ± 2.3 d,both P < 0.01).The incidence of postoperative urinary retention was higher in the PPH group than in the control group,but the difference was not statistically significant(48.15% vs 37.04%).Theincidence of perianal edema was significantly lower in the PPH group(11.11% vs 42.60%,P < 0.05).The visual analogue scale scores at 24 h after surgery,first defecation,and one week after surgery were significantly lower in the PPH group(2.9 ± 0.9 vs 8.3 ± 1.1,2.0 ± 0.5 vs 6.5 ± 0.8,and 1.7 ± 0.5 vs 5.0 ± 0.7,respectively,all P < 0.01).With regard to long-term clinical effects,the incidence of anal stenosis was lower in the PPH group than in the control group,but the difference was not significant(1.85% vs 5
基金supported by grant from the National Natural Science Foundation of China(81170859)Bejing Municipal Education Commission Key Project(KZ201210025027)Beijing Science and Technology New Star Project(2004B28)
文摘Many randomized clinical controlled trials have confirmed the efficacy and safety of calcium dobesilate in treating diabetic retinopathy(DR).This systematic review critically evaluated the evidence that links calcium dobesilate to DR.In this fixed-effects meta-analysis,a total of 221 pertinent English-language articles published between January 1975 and October 2013 were identified.Systematic searches of PUBMED,Springer Link and the Cochrane Clinical Trials Database were conducted using the keywords "diabetic retinopathy" and "calcium dobesilate".The extracted information included the study design,inclusion and exclusion criteria,setting,sample size,participant mean age,treatment regime,mean change in best corrected visual acuity,laboratory parameters,capillary fragility,intraocular pressure and fundus manifestations based on the findings of fluorescent angiography.The summary statistics indicated that calcium dobesilate was significantly associated with improving retinal microaneurysms(RR: 0.62,95%CI: 0.42?0.90,P=0.01),retinalhemorrhages(RR: 0.39,95% CI: 0.17?0.88,P=0.02); exudates(RR: 0.31,95% CI: 0.12?0.81,P=0.02),reduction of whole blood viscosity(MD: ?0.57 CP,95% CI: ?0.75 to ?0.38,P<0.001),plasma viscosity(MD: ?0.36 CP,95% CI: ?0.63 to ?0.09,P=0.01) and blood cholesterol(MD: ?0.48 mg m L?1,95% CI: ?0.64?0.33,P<0.00001).Intraocular pressure was also significantly reduced(MD: ?5.59 mm Hg,95% CI: ?6.69 to ?4.50,P<0.00001).The results indicate that calcium dobesilate effectively treats DR at the systematic and local ocular levels.
基金Supported by a grant from the Ministry of Science and Technology of China (National Key Technology Research & Development Program, No. 2006BAI 04A06)
文摘BACKGROUND： Disease recurrence is a main challenge in treatment of hepatocellular carcinoma （HCC）. There is no generally accepted method for preventing recurrence of HCC after resection. OBJECTIVE： To compare the efficacy of a traditional herbal medicine （THM） regimen and transarterial chemoembolization （TACE） in preventing recurrence in post-resection patients with small HCC. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS： This is a multicenter, open- label, randomized, controlled study, which was undertaken in five centers of China. A total of 379 patients who met the eligibility criteria and underwent randomization were enrolled in this trial. One hundred and eighty-eight patients were assigned to the THM group and received Cinobufacini injection and Jiedu Granule, and the other 191 patients were assigned to the TACE group and received one single course of TACE. MAIN OUTCOME MEASURES： Primary outcome measures were the annual recurrence rate and the time to recurrence. Incidence of adverse events was regarded as the secondary outcome measure. RESULTS： Among the 364 patients who were included in the intention-to-treat analysis, 67 patients of the THM group and 87 of the TACE group had recurrence, with a hazard ratio of 0.695 （P = 0.048）. Median recurrence-free survival of the patients in the THM and TACE groups was 46.89 and 34.49 months, respectively. Recurrence rates at 1, 2 and 3 years were 17.7%, 33.0% and 43.5% for the THM group, and 28.8%, 42.5% and 54.0% for the TACE group, respectively （P = 0.026）. Multivariate analysis indicated that the THM regimen had a big advantage for prolonging the recurrence-free survival. Adverse events were mild and abnormality of laboratory indices of the two groups were similar. CONCLUSION： In comparison with TACE therapy, the THM regimen was associated with diminished risk of recurrence of small-sized HCC after resection, with comparable adverse events. TRIAL REGISTRTION IDENTIFIER： This trial was registered in the Chinese Clinical Trial Re
文摘INTRODUCTIONChronic hepatitis B virus (HBV) infection is a serious problem because of its world wide distribution and possible adverse sequelae ,such as cirrhosis and hepatocellular carcinoma .The World Health Organization estimates that HBV has infected mord than 350 million people worldwide ,and up to 20% of them will become chromic carricrs and will be at significant risk for cirrhosis and HCC .The ultimate goal of the therapy for chronic hepatitis B is to prevent progression to cirrhosis and to prevent development of HCC.
文摘Dyssynergic defecation is one of the most common forms of functional constipation both in children and adults; it is defined by incomplete evacuation of fecal material from the rectum due to paradoxical contraction or failure to relax pelvic floor muscles when straining to defecate. This is believed to be a behavioral disorder because there.are no associated morphological or neurological abnormalities, and consequently biofeedback training has been recommended for treatment. Biofeedback involves the use of pressure measurements or averaged electromyographic activity within the anal canal to teach patients how to relax pelvic floor muscles when straining to defecate. This is often combined with teaching the patient more appropriate techniques for straining （increasing intra-abdominal pressure） and having the patient practice defecating a water filled balloon. Tn adults, randomized controlled trials show that this form of biofeedback is more effective than laxatives, general muscle relaxation exercises （described as sham biofeedback）, and drugs to relax skeletal muscles. Moreover, its effectiveness is specific to patients who have dyssynergic defecation and not slow transit constipation. However, in children, no clear superiority for biofeedback compared to laxatives has been demonstrated. Based on three randomized controlled studies in the last two years, biofeedback appears to be the preferred treatment for dyssynergic defecation in adults.
基金The National Natural Science Foundation of China(grant number:81770810)。
文摘In recent years,as living standards have continued to improve,the number of diabetes patients in China,along with the incidence of complications associated with the disease,has been increasing.Among these complications,diabetic foot disease is one of the main causes of disability and death in diabetic patients.Due to the differences in economy,culture,religion and level of medical care available across different regions,preventive and treatment methods and curative results for diabetic foot vary greatly.In multidisciplinary models built around diabetic foot,the timely assessment and diagnosis of wounds and appropriate methods of prevention and treatment with internal and external surgery are key to clinical practice for this pathology.In 2019,under the leadership of the Jiangsu Medical Association and Chinese Diabetes Society,the writing group for the Guidelines on multidisciplinary approaches for the prevention and management of diabetic foot disease(2020 edition)was established with the participation of scholars from the specialist areas of endocrinology,burn injury,vascular surgery,orthopedics,foot and ankle surgery and cardiology.Drawing lessons from diabetic foot guidelines from other countries,this guide analyses clinical practices for diabetic foot,queries the theoretical basis and grades and gives recommendations based on the characteristics of the pathology in China.This paper begins with assessments and diagnoses of diabetic foot,then describes treatments for diabetic foot in detail,and ends with protections for high-risk feet and the prevention of ulcers.This manuscript covers the disciplines of internal medicine,surgical,nursing and rehabilitation and describes a total of 50 recommendations that we hope will provide procedures and protocols for clinicians dealing with diabetic foot.
基金ThisstudywassupportedbytheClinicalFoundationoftheStateAdministrationofTCM (No 0 0 0 1LP5 0 )
文摘Background Bell’s palsy involves acute facial paralysis due to inflammation of the facial nerve. Acupuncture and moxibustion (acu-moxi) is beneficial in treating facial palsy. In order to verify the efficacy of acu-moxi on Bell’s palsy, a randomized single-blind, multicenter clinical trial was performed.Methods A total of 480 patients from four clinical centers were involved in this trial, of whom 439 completed the trial and 41 did not. All patients were randomly assigned to either the control group or to one of two treatment groups. The control group was treated with prednisone, vitamin B_1, vitamin B_ 12, and dibazole; the treatment groups were treated either with acu-moxi alone or in combination with prednisone, Vitamin B_1, vitamin B_ 12, and dibazole. Symptoms and signs, the House-Brackmann scale, and facial disability index (FDI) scores were assessed and determined both pre- and post-treatment to evaluate the effectiveness of the treatment methods.Results The characteristics of the control and two treatment groups were comparable without statistically significant differences before treatment. There were significant differences between the control and treatment groups after treatment (χ2=15.265, P=0.018). According to evaluations based on the House-Brackmann scale and FDI scores, the effectiveness of treatment in the two treatment groups was better than in the control group and was most effective in patients receiving acu-moxi treatment alone (Z=-2.827, P=0.005). Conclusion The efficacy of acu-moxi treatment for Bell’s palsy is verified scientifically.
文摘Background Hemocoagulase Agkistrodon for injection is a single component thrombin which has passed phases I and II clinical trials. The purpose of this phase III clinical trial was to evaluate the effect of Hemocoagulase Agkistrodon on hemostasis and coagulation in abdominal skin and subcutaneous incisions and to assess the safety of this agent in surgical patients. Methods This is a phase III, prospective, randomized, double-blind, and controlled multicenter clinical trial including 432 consecutive patients randomized into either a study group （injected with hemocoagulase Agkistrodon at 2 U, n=-324） or a control group （injected with hemocoagulase Atrox, n=108）. The hemostatic time, hemorrhagic volume, hemorrhagic volume per unit area, blood coagulation, and adverse events were measured and compared between the two groups. Results The mean hemostatic time in the study group was （36.8±18.7） seconds; the hemorrhagic volume was （3.77±3.93） g; and the hemorrhagic volume per unit area was （0.091±0.125） g/cm2. In the control group, the corresponding values were （38.1±19.7） seconds, （4.00±4.75） g, and （0.095±0.101） g/cm2, respectively. No significant difference in values existed between the two groups （P 〉0.05）. Blood coagulation results and hepatic and renal function were also similar between the two groups. Adverse events were reported in two cases, but were deemed non-drug-related. Conclusions Hemocoagulase Agkistrodon has good hemostatic and coagulative function and is safe for the use of arresting capillary hemorrhage that occurs while incising the abdomen during surgery.
基金supported by a grant from the National Basic Research Program of China(973 Program),No.2010CB530600Institutes Project from Guang’anmen Hospital of China Academy of Chinese Medical Sciences,No.2011261
文摘OBJECTIVE：This meta-analysis was performed to systematically assess the efficacy and safety of the Chinese herbal medicine Huangqi Guizhi Wuwu Decoction（HGWWD） for treating diabetic peripheral neuropathy.DATA SOURCES：Six electronic databases,including the Cochrane Library,MEDLINE database,Chinese Biomedical Database,Chinese National Knowledge Infrastructure Database,Chinese Science and Technique Journals Database,and the Wanfang Database,were search ed on the internet for randomized controlled trials published up until 1 December 2015.The search terms included ＂Chinese herbal medicine＂,＂diabetic peripheral neuropathy＂ and ＂randomized controlled trials＂ in Chinese and in English.DATA SELECTION：We included randomized controlled trials using HGWWD/modified HGWWD for the treatment group,without restriction for the control group.We assessed literature quality in accordance with the Cochrane Review Handbook.A random or a fixed effects model was used to analyze outcomes using Rev Man 5.2 software.OUTCOME MEASURES：The primary outcomes were changes in symptoms and nerve conduction velocities.The secondary outcomeswere fasting blood glucose and hemorheological indexes.RESULTS：Sixteen randomized controlled trials,with a total of 1,173 patients,were included.Meta-analysis revealed that the efficacy of HGWWD for diabetic peripheral neuropathy was significantly superior compared with the control treatment（i.e.,control group）（risk ratio = 0.36,95% confidence interval（CI）：0.29–0.46,Z =8.33,P 〈 0.00001） Compared with the control group,there was an increase in median motor nerve conduction velocity（mean difference（MD） = 3.46,95%CI：1.88–5.04,Z = 4.30,P 〈 0.01） and median sensory nerve conduction velocity（MD = 3.30,95%CI：2.04–4.56,Z = 5.14,P 〈 0.01）.There was also an increase in peroneal motor nerve conduction velocity（MD = 3.22,95%CI：2.45–3.98,Z = 8.21,P 〈 0.01） and peroneal sensory nerve conduction velocity（MD = 3.05,95%CI：2.01–4.09,Z = 5.75,P 〈
文摘Background：Pharmacological therapy for congestive heart failure （CHF） with ventricular arrhythmia is limited.In the study,our aim was to evaluate the effects of Chinese traditional medicine Shensong Yangxin capsules （SSYX） on heart rhythm and function in CHF patients with frequent ventricular premature complexes （VPCs）.Methods：This double-blind,placebo-controlled,multicenter study randomized 465 CHF patients with frequent VPCs to the SSYX （n =232） and placebo groups （n =233） for 12 weeks of treatment.The primary endpoint was the VPCs monitored by a 24-h ambulatory electrocardiogram.The secondary endpoints included the left ventricular ejection fraction （LVEF）,left ventricular end-diastolic diameter,N-terminal pro-brain natriuretic peptide （NT-proBNP）,New York Heart Association （NYHA） classification,6-min walking distance （6MWD）,Minnesota Living with Heart Failure Questionnaire （MLHFQ） scores,and composite cardiac events （CCEs）.Results：The clinical characteristics were similar at baseline.SSYX caused a significantly greater decline in the total number of VPCs than the placebo did （-2145 ± 2848 vs.-841 ± 3411,P 〈 0.05）.The secondary endpoints of the LVEE NYHA classification,NT-proBNP,6MWD,and MLHFQ scores showed a greater improvements in the SSYX group than in the placebo group （ALVEF at 12th week：4.75 ± 7.13 vs.3.30 ± 6.53;NYHA improvement rate at the 8th and 12th week：32.6% vs.21.8%,40.5% vs.25.7%;mean level of NT-proBNP in patients with NT-proBNP 〉125 pg/ml at 12th week：-122 [Q1,Q3：-524,0] vs.-75 [Q1,Q3：-245,0];A6MWD at 12th week：35.1 ± 38.6 vs.17.2 ± 45.6;AMLHFQ at the 4th,8th,and 12th week：-4.24 ± 6.15 vs.-2.31 ± 6.96,-8.l 9 ± 8.41 vs.-3.25 ± 9.40,10.60 ± 9.41 vs.-4.83 ± 11.23,all P 〈 0.05）.CCEs were not different between the groups during the study period.Conclusions：In this 12-week pilot study,SSYX was demonstrated to have the benefits of VPCs suppression and cardiac function improvement with good compliance on a back
基金Supported by the Major State Basic Research Development Program of China(973 Program)No.2013CB531703+1 种基金National Nature Science Foundation of China,No.81503567 and No.81673853the China Postdoctoral Science Foundation,No.2015M1227 and No.2016T90195
文摘AIM To assess the efficacy and safety of a Chinese herbal medicine (CHM), Xiangsha Liujunzi granules, in the treatment of patients with functional dyspepsia (FD). METHODS We performed a randomized, double-blind, placebo-controlled trial with patients from three centers. Two hundred and sixteen subjects diagnosed with FD according to ROME. criteria and confirmed by upper gastrointestinal endoscopy and spleen-deficiency and Qi-stagnation syndrome were selected to receive Xiangsha Liujunzi granules or placebo for 4 wk in a 2: 1 ratio by blocked randomization. The subjects also received follow-up after the 4-wk intervention. Herbal or placebo granules were dissolved in 300 mL of water. Participants in both groups were administered 130 mL (45 degrees C) three times a day. Participants were evaluated prior to and following 4 wk of the intervention in terms of changes in the postprandial discomfort severity scale (PDSS) score, clinical global impression (CGI) scale score, hospital anxiety and depression scale (HADS) score, traditional Chinese medicine symptoms score (SS), scores of various domains of the 36-item short form health survey (SF-36), gastric emptying (GE) and any observed adverse effects. RESULTS Compared with the placebo group, patients in the CHM group showed significant improvements in the scores of PDSS, HADS, SS, SF-36 and CGI scale (P < 0.05 or P < 0.01). They also showed the amelioration in the GE rates of the proximal stomach and distal stomach (P < 0.05 or P < 0.01). CONCLUSION Xiangsha Liujunzi granules offered significant symptomatic improvement in patients with FD.
