AIM:To determine the efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy.METHODS: A prospective, double-blind, randomized, placebo-controlled study was conduct...AIM:To determine the efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy.METHODS: A prospective, double-blind, randomized, placebo-controlled study was conducted on 70 patients who underwent elective laparoscopic cholecystectomy under general anesthesia at Siriraj Hospital, Bangkok, from January 2006 to December 2007. Patients were randomized to receive either 20 mg parecoxib infusion 30 min before induction of anesthesia and at 12 h after the first dose (treatment group), or normal saline infusion, in the same schedule, as a placebo (control group). The degree of the postoperative pain was assessed every 3 h in the first 24 h after surgery, and then every 12 h the following day, using a visual analog scale. The consumption of analgesics was also recorded.RESULTS:There were 40 patients in the treatment group, and 30 patients in the control group. The pain scores at each time point, and analgesic consumption did not differ between the two groups. However,there were fewer patients in the treatment group than placebo group who required opioid infusion within the first 24 h (60% vs 37%, P=0.053).CONCLUSION: Perioperative administration of parecoxib provided no significant effect on postoperative pain relief after laparoscopic cholecystectomy. However, preoperative infusion 20 mg parecoxib could significantly reduce the postoperative opioid consumption.展开更多
Background- Stopping the detrimental effects of the renin- angiotensin systemat the most upstream point of the cascade offers theoretical advantages for cardiovascular protection. This study compares the antihypertens...Background- Stopping the detrimental effects of the renin- angiotensin systemat the most upstream point of the cascade offers theoretical advantages for cardiovascular protection. This study compares the antihypertensive efficacy and safety of the novel oral renin inhibitor aliskiren with placebo and an active comparator. Methods and Results- The study was a randomized, multicenter, double- blind, placebo- controlled, active- comparator 8- week trial in patients with mild- to- moderate hypertension(mean sitting diastolic blood pressure ≥ 95 and< 110mm Hg). After a 2- week, single- blind placebo run- in, 652 patients were randomized to receive double- blind treatment with oncedaily oral doses of aliskiren(150, 300, or 600 mg), irbesartan 150 mg, or placebo. Aliskiren 150, 300, and 600 mg effectively lowered both trough mean sitting DBP and systolic blood pressure(SBP)(P< 0.001 versus placebo for both variables). The least- squares mean reductions in trough DBP were 9.3± 0.8, 11.8± 0.8, and 11.5± 0.8 mm Hg, respectively, versus 6.3± 0.8 mm Hg for placebo, and the least- squares mean reductions in trough SBP were 11.4± 1.3, 15.8± 1.2, and 15.7± 1.2 mm Hg, respectively, versus 5.3± 1.2 mm Hg for placebo. The antihypertensive effect of aliskiren 150 mg was comparable to that of irbesartan 150 mg(8.9± 0.7 and 12.5± 1.2 mmHg, least- squares reduction in mean sitting DBP and SBP, respectively, for irbesartan). Aliskiren 300 and 600 mg lowered mean sitting DBP significantly more than irbesartan 150 mg(P< 0.05). Aliskiren showed safety and tolerability comparable to those of placebo and irbesartan; the incidence of adverse events and number of patients discontinuing therapy were similar in all groups. Conclusions- Once- daily oral treatment with aliskiren lowers blood pressure effectively, with a safety and tolerability profile comparable to that of irbesartan and placebo, in patients with mild- to- moderate hypertension. Aliskiren 150 mg is as effective as irbesartan 150 mg in lowering blood pressure.展开更多
Background and Purpose - The effectiveness of functional electrical stimulation (FES) has been investigated in chronic hemiplegia. The present study examines whether FES, given during acute stroke, was more effective ...Background and Purpose - The effectiveness of functional electrical stimulation (FES) has been investigated in chronic hemiplegia. The present study examines whether FES, given during acute stroke, was more effective in promoting motor recovery of the lower extremity and walking ability than standard rehabilitation alone. Methods - Forty- six subjects, 70.9± 8.0 years old and 9.2± 4.1 days after stroke, were assigned randomly to 1 of 3 groups receiving standard rehabilitation with FES or placebo stimulation or alone (control). FES was applied 30 minutes and placebo stimulation 60 minutes, 5 days per week for 3 weeks. Outcome measurements included composite spasticity score, maximum isometric voluntary contraction of ankle dorsi- flexors and planter- flexors, and walking ability. They were recorded before treatment, weekly during the 3- week treatment, and at week 8 after stroke. Results - No significant differences were found in the baseline measurements. After 3 weeks of treatment, there was a significant reduction in the percentage of composite spasticity score, and a significant improvement in the ankle dorsiflexion torque, accompanied by an increase in agonist electromyogram and a reduction in electromyogram cocontraction ratio in the FES group, when compared with the other 2 groups (P < 0.05). All subjects in the FES group were able to walk after treatment, and 84.6% of them returned home, in comparison with the placebo (53.3% ) and control (46.2% , P < 0.05) groups. Conclusions - Fifteen sessions of FES, applied to subjects with acute stroke plus standard rehabilitation, improved their motor and walking ability to the degree that more subjects were able to return to home.展开更多
Chiglitazar(Carfloglitazar)is a novel non-thiazolidinedione(TZD)structured peroxisome proliferatoractivated receptor(PPAR)pan-agonist that has shown promising effects on glycemic control and lipid regulation in patien...Chiglitazar(Carfloglitazar)is a novel non-thiazolidinedione(TZD)structured peroxisome proliferatoractivated receptor(PPAR)pan-agonist that has shown promising effects on glycemic control and lipid regulation in patients with type 2 diabetes in previous clinical studies.This randomized phase 3 trial aimed to compare the efficacy and safety of chiglitazar with placebo in patients with type 2 diabetes with insufficient glycemic control by strict diet and exercise alone.Eligible patients were randomly assigned to receive chiglitazar 32 mg(n=167),chiglitazar 48 mg(n=166),or placebo(n=202)once daily.The primary endpoint was the change in glycosylated hemoglobin A_(1c)(HbA_(1c))at week 24 with superiority of chiglitazar over placebo.The results showed that both chiglitazar 32 and 48 mg resulted in significant and clinically meaningful reductions in HbA_(1c),and placebo-adjusted estimated treatment differences at week 24 for chiglitazar 32 and 48 mg were-0.87%(95%confidential interval(CI):-1.10 to-0.65;P<0.0001)and-1.05%(95%CI:-1.29 to-0.81;P<0.0001),respectively.Secondary efficacy parameters including glycemic control,insulin sensitivity and triglyceride reduction were also significantly improved in the chiglitazar groups.The overall frequency of adverse events and study discontinuation attributable to adverse events were similar among the groups.Low incidences of mild edema and body weight gain were reported in the chiglitazar dose groups.The results from this phase 3 trial demonstrated that the PPAR pan-agonist chiglitazar possesses an overall good efficacy and safety profile in patients with type 2 diabetes inadequately controlled with lifestyle interventions,thereby providing adequate supporting evidence for using this PPAR pan-agonist as a treatment option for type 2 diabetes.展开更多
基金Supported by Faculty of Medicine Siriraj Hospital Research Project Grant
文摘AIM:To determine the efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy.METHODS: A prospective, double-blind, randomized, placebo-controlled study was conducted on 70 patients who underwent elective laparoscopic cholecystectomy under general anesthesia at Siriraj Hospital, Bangkok, from January 2006 to December 2007. Patients were randomized to receive either 20 mg parecoxib infusion 30 min before induction of anesthesia and at 12 h after the first dose (treatment group), or normal saline infusion, in the same schedule, as a placebo (control group). The degree of the postoperative pain was assessed every 3 h in the first 24 h after surgery, and then every 12 h the following day, using a visual analog scale. The consumption of analgesics was also recorded.RESULTS:There were 40 patients in the treatment group, and 30 patients in the control group. The pain scores at each time point, and analgesic consumption did not differ between the two groups. However,there were fewer patients in the treatment group than placebo group who required opioid infusion within the first 24 h (60% vs 37%, P=0.053).CONCLUSION: Perioperative administration of parecoxib provided no significant effect on postoperative pain relief after laparoscopic cholecystectomy. However, preoperative infusion 20 mg parecoxib could significantly reduce the postoperative opioid consumption.
文摘Background- Stopping the detrimental effects of the renin- angiotensin systemat the most upstream point of the cascade offers theoretical advantages for cardiovascular protection. This study compares the antihypertensive efficacy and safety of the novel oral renin inhibitor aliskiren with placebo and an active comparator. Methods and Results- The study was a randomized, multicenter, double- blind, placebo- controlled, active- comparator 8- week trial in patients with mild- to- moderate hypertension(mean sitting diastolic blood pressure ≥ 95 and< 110mm Hg). After a 2- week, single- blind placebo run- in, 652 patients were randomized to receive double- blind treatment with oncedaily oral doses of aliskiren(150, 300, or 600 mg), irbesartan 150 mg, or placebo. Aliskiren 150, 300, and 600 mg effectively lowered both trough mean sitting DBP and systolic blood pressure(SBP)(P< 0.001 versus placebo for both variables). The least- squares mean reductions in trough DBP were 9.3± 0.8, 11.8± 0.8, and 11.5± 0.8 mm Hg, respectively, versus 6.3± 0.8 mm Hg for placebo, and the least- squares mean reductions in trough SBP were 11.4± 1.3, 15.8± 1.2, and 15.7± 1.2 mm Hg, respectively, versus 5.3± 1.2 mm Hg for placebo. The antihypertensive effect of aliskiren 150 mg was comparable to that of irbesartan 150 mg(8.9± 0.7 and 12.5± 1.2 mmHg, least- squares reduction in mean sitting DBP and SBP, respectively, for irbesartan). Aliskiren 300 and 600 mg lowered mean sitting DBP significantly more than irbesartan 150 mg(P< 0.05). Aliskiren showed safety and tolerability comparable to those of placebo and irbesartan; the incidence of adverse events and number of patients discontinuing therapy were similar in all groups. Conclusions- Once- daily oral treatment with aliskiren lowers blood pressure effectively, with a safety and tolerability profile comparable to that of irbesartan and placebo, in patients with mild- to- moderate hypertension. Aliskiren 150 mg is as effective as irbesartan 150 mg in lowering blood pressure.
文摘Background and Purpose - The effectiveness of functional electrical stimulation (FES) has been investigated in chronic hemiplegia. The present study examines whether FES, given during acute stroke, was more effective in promoting motor recovery of the lower extremity and walking ability than standard rehabilitation alone. Methods - Forty- six subjects, 70.9± 8.0 years old and 9.2± 4.1 days after stroke, were assigned randomly to 1 of 3 groups receiving standard rehabilitation with FES or placebo stimulation or alone (control). FES was applied 30 minutes and placebo stimulation 60 minutes, 5 days per week for 3 weeks. Outcome measurements included composite spasticity score, maximum isometric voluntary contraction of ankle dorsi- flexors and planter- flexors, and walking ability. They were recorded before treatment, weekly during the 3- week treatment, and at week 8 after stroke. Results - No significant differences were found in the baseline measurements. After 3 weeks of treatment, there was a significant reduction in the percentage of composite spasticity score, and a significant improvement in the ankle dorsiflexion torque, accompanied by an increase in agonist electromyogram and a reduction in electromyogram cocontraction ratio in the FES group, when compared with the other 2 groups (P < 0.05). All subjects in the FES group were able to walk after treatment, and 84.6% of them returned home, in comparison with the placebo (53.3% ) and control (46.2% , P < 0.05) groups. Conclusions - Fifteen sessions of FES, applied to subjects with acute stroke plus standard rehabilitation, improved their motor and walking ability to the degree that more subjects were able to return to home.
基金grants from Chinese National and Provincial Major Project for New Drug Innovation(National:2008ZX09101-002 and 2013ZX09401301Provincial:2011A080501010)Shenzhen Municipal Major Project(2010-1746)。
文摘Chiglitazar(Carfloglitazar)is a novel non-thiazolidinedione(TZD)structured peroxisome proliferatoractivated receptor(PPAR)pan-agonist that has shown promising effects on glycemic control and lipid regulation in patients with type 2 diabetes in previous clinical studies.This randomized phase 3 trial aimed to compare the efficacy and safety of chiglitazar with placebo in patients with type 2 diabetes with insufficient glycemic control by strict diet and exercise alone.Eligible patients were randomly assigned to receive chiglitazar 32 mg(n=167),chiglitazar 48 mg(n=166),or placebo(n=202)once daily.The primary endpoint was the change in glycosylated hemoglobin A_(1c)(HbA_(1c))at week 24 with superiority of chiglitazar over placebo.The results showed that both chiglitazar 32 and 48 mg resulted in significant and clinically meaningful reductions in HbA_(1c),and placebo-adjusted estimated treatment differences at week 24 for chiglitazar 32 and 48 mg were-0.87%(95%confidential interval(CI):-1.10 to-0.65;P<0.0001)and-1.05%(95%CI:-1.29 to-0.81;P<0.0001),respectively.Secondary efficacy parameters including glycemic control,insulin sensitivity and triglyceride reduction were also significantly improved in the chiglitazar groups.The overall frequency of adverse events and study discontinuation attributable to adverse events were similar among the groups.Low incidences of mild edema and body weight gain were reported in the chiglitazar dose groups.The results from this phase 3 trial demonstrated that the PPAR pan-agonist chiglitazar possesses an overall good efficacy and safety profile in patients with type 2 diabetes inadequately controlled with lifestyle interventions,thereby providing adequate supporting evidence for using this PPAR pan-agonist as a treatment option for type 2 diabetes.
