AIM: To evaluate if the administration of an enteral diet supplemented with glutamine, arginine and omega-3-fatty acids modulates inflammatory and immune responses after surgery. METHODS: A prospective randomized doub...AIM: To evaluate if the administration of an enteral diet supplemented with glutamine, arginine and omega-3-fatty acids modulates inflammatory and immune responses after surgery. METHODS: A prospective randomized double-blind, clinical trial was performed. Forty-eight patients with gastrointestinal cancer were randomized into two groups, one group was given an isocaloric and isonitrogenous standard diet and the other was fed with the supplemented diet with glutamine, arginine and omega-3-fatty acids. Feedings were started within 48 hours after operation, and continued until day 8. All variables were measured before operation and on postoperative day 1 and 8. Immune responses were determined by phagocytosis ability, respiratory burst of polymorphonuclear cells, total lymphocytes lymphocyte subsets, nitric oxide, cytokines concentration, and inflammatory responses by plasma levels of C-reactive protein, prostaglandin E2 level. RESULTS: Tolerance of both formula diets was excellent.There were significant differences in the immunological and inflammatory responses between the two groups. In supplemented group, phagocytosis and respiratory burst after surgery was higher and C-reactive protein level was lower (P【0.01) than in the standard group. The supplemented group had higher levels of nitric oxide, total lymphocytes, T lymphocytes, T-helper cells, and NK cells. Postoperative levels of IL-6 and TNF-alpha were lower in the supplemented group (P 【0.05). CONCLUSION: It was clearly established in this trial that early postoperative enteral feeding is safe in patients who have undergone major operations for gastrointestinal cancer. Supplementation of enteral nutrition with glutamine, arginine, and omega-3-fatty acids positively modulated postsurgical immunosuppressive and inflammatory responses.展开更多
OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Tot...OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Totally 304 RA patients were assigned to two groups:one group was administered Xinfeng capsule(XFC) plus the placebo of leflunomide and the other given leflunomide(LEF) plus the placebo of XFC for twelve weeks.The clinical and laboratory parameters were compared at baseline and fourth,eighth,and twelfth weeks.RESULTS:After twelve-week treatment,patients in two groups all showed some trend of effectiveness when compared in terms of American Rheumatism Association(ACR) recommended 20%,50%,70%improvement criteria,but it was insignificant.The validity in ameliorate modified disease activity score(DAS28) and laboratory indexes as erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF) were also found no difference.The score of health assessment questionnaire(HAQ),self-rating anxiety scale(SAS),self-rating depression scale(SDS) and quality of life questionnaire with rheumatoid arthritis(RAQOL)both lower than the first week and the changes showed no difference.However,the score of SDS dropped more in XFC group than in the other.A total of 147 adverse reaction cases were reported,which shows no difference between the two groups.The most common adverse reactions were hepatic impairment,anemia,leukocytopenia,epigastric discomfort and phalacrosis.CONCLUSION:XFC demonstrated better improvement in the scores of SDS and compared with those of LEF group.展开更多
OBJECTIVE: To evaluate the therapeutic effectiveness and safety of Jinying capsule on pelvic inflammatory disease(PID) in patients with symptoms identified as the pattern of damp and heat accumulation in terms of Trad...OBJECTIVE: To evaluate the therapeutic effectiveness and safety of Jinying capsule on pelvic inflammatory disease(PID) in patients with symptoms identified as the pattern of damp and heat accumulation in terms of Traditional Chinese Medicine(TCM).METHODS: We conducted a double-blinded, multicenter, randomized, placebo-controlled clinical trial which included 155 patients diagnosed with PID and identified as symptom pattern of damp and heat accumulation. They were randomly divided into experimental group(n = 78) and control group(n = 77) according to a random number table. The treatment lasted for a period of 28 d. The experimental group was given Jinying capsules and oral levofloxacin plus oral metronidazole for first 7 d.They continued with Jinying capsules and levofloxacin placebo and metronidazole placebo for another 7 d. For the remaining 14 d, they continued with Jinying capsules only. Whereas, the control group was treated with oral levofloxacin and metronidazole and Jinying capsule placebo for the first 14 d in the same way as the experimental group and then continued with Jinying capsule placebo only for the remaining 14 d. The clinical efficacy was assessed using McCormack scale, TCM symptom pattern scores, physicochemical indexes including white blood cell and erythrocyte sedimentation rate, C-reaction protein, smear of vaginal discharge,and pelvic ultrasound.RESULTS: Comparing McCormack scale between both groups after treatment, the difference in curative effect between both groups was significant (P = 0.0269). The cure rate of the experimental group and control group is 76.32% and 59.46% respectively at week 4. Comparing TCM symptom pattern scores between both groups before and after treatment, the differences in total effective rate were both significant(P < 0.05). The curative effect rate of experimental group is 2.63% and 13.70% of the control group at week 1(P = 0.0131), and73.33% of the experimental group and 56.94% of the control group at week 4(P = 0.0369). No significant differences were found展开更多
AIM: To evaluate the diagnostic efficiency of endoscopic ultrasound (EUS) as the main imaging modality in patients with moderate suspicion of common bile duct stones (CBDS).METHODS: 55 patients with moderate clinical ...AIM: To evaluate the diagnostic efficiency of endoscopic ultrasound (EUS) as the main imaging modality in patients with moderate suspicion of common bile duct stones (CBDS).METHODS: 55 patients with moderate clinical suspicion of CBDS were prospectively included to the study and evaluated with EUS. This study was done in single blind method in the clinical and biochemical data of patients. EUS was done with echo-endoscope Pentax FG 32-UA (f=5-7,5 MHz) and Hitachi EUB 405 ultrasound machine. Patients diagnosed with CBDS by EUS were excluded from this study and treated with ERC. All the other patients were included to the follow up study obtained by mail every 6 months for clinical evaluation (need of ERC or surgery).RESULTS: CBDS was found in 4 patients by EUS. Diagnosis was confirmed in all cases on ERC. The remaining 51 patients without CBDS on EUS were followed up for 6-26 months (meanly 13 months) There were: 40 women, 42cholecystectomized patients, aged: 55 (mean). Biochemical values (mean values) were as follows: bilirubin: 14,9 μmol.L-1,alkaline phosphatase: 95 IU.L-,1 γ-GTP: 131 IU.L-1, ALT: 50IU.L-1, AST: 49 IU.L-1, Only 1 patient was lost for follow up.In the remaining 50 patients with follow up, there was only 1 (2 %) patient with persistent biliary symptoms in whom CBDS was finally diagnosed by ERC with ES. All other patients remained symptoms free on follow up and did not require ERC or biliary surgery.CONCLUSION: Vast majority of patients with moderate suspicion of CBDS and no stones on EUS with linear array can avoid invasive evaluation of biliary tree with ERC.展开更多
OBJECTIVE: To evaluate the clinical efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder.METHODS: We conducted a double-blind,randomized,controlled trial involving 100...OBJECTIVE: To evaluate the clinical efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder.METHODS: We conducted a double-blind,randomized,controlled trial involving 100 patients with insomnia of Qi-deficiency of heart and gallbladder.Patients were randomly divided into the treatment group(n = 50) and the control group(n = 50) according to a random number table. The treatment group was given Zhenjingdingzhi decoction,while the control group was treated with Suanzaoren decoction. the pharmacological treatment lasted for 8weeks. The clinical efficacy was assessed by using Spiegel scale,Pittsburgh sleep quality index(PSQI)and Traditional Chinese Medicine(TCM) syndrome scores.RESULTS: Comparing Spiegel scores between the two groups at 4 and 8 weeks,the differences in curative effect between the two groups were both significant(both P < 0.05). The total effective rate was46% in the treatment group and 27.7% in the control group at 4 weeks,and 80% and 53.2% at 8weeks,respectively; After 8 weeks,PSQI scores showed that the total effective rates differed significantly between the two groups(P < 0.01): 84% in the treatment group and 59.6% in the control group; In improving sleep quality and sleep duration,the curative effect of the treatment group was better than that of the control group(P < 0.05).TCM syndrome,especially insomnia and palpitation,was improved better in the treatment group after 8 weeks as compared to that in the control group(P < 0.05). The total effective rate of the two groups was 84% and 66%,respectively.CONCLUSION: Zhenjingdingzhi decoction is effective and safe for the treatment of insomnia with Qi-deficiency of heart and gallbladder,especially for improving sleep quality and sleep duration.展开更多
OBJECTIVE: To evaluate the effect on acne vulgaris of pricking-bloodletting cupping at Dazhui(GV 14) under acupuncture anesthesia, and establish whether providing anesthesia to the treatment area by manipulating Hegu(...OBJECTIVE: To evaluate the effect on acne vulgaris of pricking-bloodletting cupping at Dazhui(GV 14) under acupuncture anesthesia, and establish whether providing anesthesia to the treatment area by manipulating Hegu(LI 4) and Quchi(LI 11) might have an additional therapeutic benefit. METHODS: Thirty-eight patients were recruited and randomized into a control group and an intervention group with a single-blind(observer-blind) method. The control group was treated by pricking-bloodletting cupping at Dazhui(GV 14) and the studied group by pricking-bloodletting cupping at Dazhui(GV 14) under acupuncture anesthesia at Hegu(LI 4) and Quchi(LI 11). Both groups were treated twice weekly for 6 weeks. The analgesic and therapeutic effects of acupuncture were evaluated on a visual analog scale(VAS) and global acne grading system(GAGS), respectively.RESULTS: There were differences in the VAS scores of pain on pricking and in the pricked area, and the duration of pain between the groups. After 12 treatments, there was a significant reduction in GAGS scores from baseline in both groups, but there was no significant difference between the groups. CONCLUSION: Acupuncture anesthesia at Hegu(LI 4) and Quchi(LI 11) is an effective means of alleviating the pain of pricking-bloodletting cupping and reducing the duration of pain in the treatment area. Pricking-bloodletting cupping at Dazhui(GV 14) improves the skin lesions of patients with moderate acne vulgaris, but acupuncture anesthesia does not appear to have an additional therapeutic effect.展开更多
文摘AIM: To evaluate if the administration of an enteral diet supplemented with glutamine, arginine and omega-3-fatty acids modulates inflammatory and immune responses after surgery. METHODS: A prospective randomized double-blind, clinical trial was performed. Forty-eight patients with gastrointestinal cancer were randomized into two groups, one group was given an isocaloric and isonitrogenous standard diet and the other was fed with the supplemented diet with glutamine, arginine and omega-3-fatty acids. Feedings were started within 48 hours after operation, and continued until day 8. All variables were measured before operation and on postoperative day 1 and 8. Immune responses were determined by phagocytosis ability, respiratory burst of polymorphonuclear cells, total lymphocytes lymphocyte subsets, nitric oxide, cytokines concentration, and inflammatory responses by plasma levels of C-reactive protein, prostaglandin E2 level. RESULTS: Tolerance of both formula diets was excellent.There were significant differences in the immunological and inflammatory responses between the two groups. In supplemented group, phagocytosis and respiratory burst after surgery was higher and C-reactive protein level was lower (P【0.01) than in the standard group. The supplemented group had higher levels of nitric oxide, total lymphocytes, T lymphocytes, T-helper cells, and NK cells. Postoperative levels of IL-6 and TNF-alpha were lower in the supplemented group (P 【0.05). CONCLUSION: It was clearly established in this trial that early postoperative enteral feeding is safe in patients who have undergone major operations for gastrointestinal cancer. Supplementation of enteral nutrition with glutamine, arginine, and omega-3-fatty acids positively modulated postsurgical immunosuppressive and inflammatory responses.
基金Supported by the Key Projects in the National Science&Technology Pillar Program in the Twelfth Five-Year Plan Period:Clinical Research on Xin'an Medicine Prevention and Treatment of Difficult Diseases of Chinese Medicine(No.2012BA126B02).ClinicalTrials.gov Identifier:NCT01774877
文摘OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Totally 304 RA patients were assigned to two groups:one group was administered Xinfeng capsule(XFC) plus the placebo of leflunomide and the other given leflunomide(LEF) plus the placebo of XFC for twelve weeks.The clinical and laboratory parameters were compared at baseline and fourth,eighth,and twelfth weeks.RESULTS:After twelve-week treatment,patients in two groups all showed some trend of effectiveness when compared in terms of American Rheumatism Association(ACR) recommended 20%,50%,70%improvement criteria,but it was insignificant.The validity in ameliorate modified disease activity score(DAS28) and laboratory indexes as erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF) were also found no difference.The score of health assessment questionnaire(HAQ),self-rating anxiety scale(SAS),self-rating depression scale(SDS) and quality of life questionnaire with rheumatoid arthritis(RAQOL)both lower than the first week and the changes showed no difference.However,the score of SDS dropped more in XFC group than in the other.A total of 147 adverse reaction cases were reported,which shows no difference between the two groups.The most common adverse reactions were hepatic impairment,anemia,leukocytopenia,epigastric discomfort and phalacrosis.CONCLUSION:XFC demonstrated better improvement in the scores of SDS and compared with those of LEF group.
文摘OBJECTIVE: To evaluate the therapeutic effectiveness and safety of Jinying capsule on pelvic inflammatory disease(PID) in patients with symptoms identified as the pattern of damp and heat accumulation in terms of Traditional Chinese Medicine(TCM).METHODS: We conducted a double-blinded, multicenter, randomized, placebo-controlled clinical trial which included 155 patients diagnosed with PID and identified as symptom pattern of damp and heat accumulation. They were randomly divided into experimental group(n = 78) and control group(n = 77) according to a random number table. The treatment lasted for a period of 28 d. The experimental group was given Jinying capsules and oral levofloxacin plus oral metronidazole for first 7 d.They continued with Jinying capsules and levofloxacin placebo and metronidazole placebo for another 7 d. For the remaining 14 d, they continued with Jinying capsules only. Whereas, the control group was treated with oral levofloxacin and metronidazole and Jinying capsule placebo for the first 14 d in the same way as the experimental group and then continued with Jinying capsule placebo only for the remaining 14 d. The clinical efficacy was assessed using McCormack scale, TCM symptom pattern scores, physicochemical indexes including white blood cell and erythrocyte sedimentation rate, C-reaction protein, smear of vaginal discharge,and pelvic ultrasound.RESULTS: Comparing McCormack scale between both groups after treatment, the difference in curative effect between both groups was significant (P = 0.0269). The cure rate of the experimental group and control group is 76.32% and 59.46% respectively at week 4. Comparing TCM symptom pattern scores between both groups before and after treatment, the differences in total effective rate were both significant(P < 0.05). The curative effect rate of experimental group is 2.63% and 13.70% of the control group at week 1(P = 0.0131), and73.33% of the experimental group and 56.94% of the control group at week 4(P = 0.0369). No significant differences were found
文摘AIM: To evaluate the diagnostic efficiency of endoscopic ultrasound (EUS) as the main imaging modality in patients with moderate suspicion of common bile duct stones (CBDS).METHODS: 55 patients with moderate clinical suspicion of CBDS were prospectively included to the study and evaluated with EUS. This study was done in single blind method in the clinical and biochemical data of patients. EUS was done with echo-endoscope Pentax FG 32-UA (f=5-7,5 MHz) and Hitachi EUB 405 ultrasound machine. Patients diagnosed with CBDS by EUS were excluded from this study and treated with ERC. All the other patients were included to the follow up study obtained by mail every 6 months for clinical evaluation (need of ERC or surgery).RESULTS: CBDS was found in 4 patients by EUS. Diagnosis was confirmed in all cases on ERC. The remaining 51 patients without CBDS on EUS were followed up for 6-26 months (meanly 13 months) There were: 40 women, 42cholecystectomized patients, aged: 55 (mean). Biochemical values (mean values) were as follows: bilirubin: 14,9 μmol.L-1,alkaline phosphatase: 95 IU.L-,1 γ-GTP: 131 IU.L-1, ALT: 50IU.L-1, AST: 49 IU.L-1, Only 1 patient was lost for follow up.In the remaining 50 patients with follow up, there was only 1 (2 %) patient with persistent biliary symptoms in whom CBDS was finally diagnosed by ERC with ES. All other patients remained symptoms free on follow up and did not require ERC or biliary surgery.CONCLUSION: Vast majority of patients with moderate suspicion of CBDS and no stones on EUS with linear array can avoid invasive evaluation of biliary tree with ERC.
基金Supported by Special Research Foundation of Selection and Cultivation for Outstanding Young Teacher of Shanghai University(Clinical Research on Zhenjingdingzhi Mixture for Insomnia,No.szy10046)the National Natural Science Foundation of China(Effect of Dopamine D1/D2 Receptor-MAPK/ERK Signal Transduction in PD Levodopa-induced Dyskinesias with Shudi Pingchan Tang,No.81302926)3-Year Action Plan for Shanghai Municipal Chinese Medicine Development Project(Clinical Succession Base of Ding's Medicine,No.ZYSNXD-CC-HPGC-JD-003)
文摘OBJECTIVE: To evaluate the clinical efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder.METHODS: We conducted a double-blind,randomized,controlled trial involving 100 patients with insomnia of Qi-deficiency of heart and gallbladder.Patients were randomly divided into the treatment group(n = 50) and the control group(n = 50) according to a random number table. The treatment group was given Zhenjingdingzhi decoction,while the control group was treated with Suanzaoren decoction. the pharmacological treatment lasted for 8weeks. The clinical efficacy was assessed by using Spiegel scale,Pittsburgh sleep quality index(PSQI)and Traditional Chinese Medicine(TCM) syndrome scores.RESULTS: Comparing Spiegel scores between the two groups at 4 and 8 weeks,the differences in curative effect between the two groups were both significant(both P < 0.05). The total effective rate was46% in the treatment group and 27.7% in the control group at 4 weeks,and 80% and 53.2% at 8weeks,respectively; After 8 weeks,PSQI scores showed that the total effective rates differed significantly between the two groups(P < 0.01): 84% in the treatment group and 59.6% in the control group; In improving sleep quality and sleep duration,the curative effect of the treatment group was better than that of the control group(P < 0.05).TCM syndrome,especially insomnia and palpitation,was improved better in the treatment group after 8 weeks as compared to that in the control group(P < 0.05). The total effective rate of the two groups was 84% and 66%,respectively.CONCLUSION: Zhenjingdingzhi decoction is effective and safe for the treatment of insomnia with Qi-deficiency of heart and gallbladder,especially for improving sleep quality and sleep duration.
基金Supported by the New Technique and Occupation Project of General Hospital of Ningxia Medical University(No.2011-2-20)
文摘OBJECTIVE: To evaluate the effect on acne vulgaris of pricking-bloodletting cupping at Dazhui(GV 14) under acupuncture anesthesia, and establish whether providing anesthesia to the treatment area by manipulating Hegu(LI 4) and Quchi(LI 11) might have an additional therapeutic benefit. METHODS: Thirty-eight patients were recruited and randomized into a control group and an intervention group with a single-blind(observer-blind) method. The control group was treated by pricking-bloodletting cupping at Dazhui(GV 14) and the studied group by pricking-bloodletting cupping at Dazhui(GV 14) under acupuncture anesthesia at Hegu(LI 4) and Quchi(LI 11). Both groups were treated twice weekly for 6 weeks. The analgesic and therapeutic effects of acupuncture were evaluated on a visual analog scale(VAS) and global acne grading system(GAGS), respectively.RESULTS: There were differences in the VAS scores of pain on pricking and in the pricked area, and the duration of pain between the groups. After 12 treatments, there was a significant reduction in GAGS scores from baseline in both groups, but there was no significant difference between the groups. CONCLUSION: Acupuncture anesthesia at Hegu(LI 4) and Quchi(LI 11) is an effective means of alleviating the pain of pricking-bloodletting cupping and reducing the duration of pain in the treatment area. Pricking-bloodletting cupping at Dazhui(GV 14) improves the skin lesions of patients with moderate acne vulgaris, but acupuncture anesthesia does not appear to have an additional therapeutic effect.