达立通颗粒治疗痞满证(功能性消化不良)的随机对照双盲试验

目的评价达立通颗粒治疗痞满证(功能性消化不良)的疗效和安全性.方法根据本研究的纳入与排出标准,选取痞满证(功能性消化不良)患者120例,按3:1随机分为达立通颗粒组(治疗组)90例和西沙必利组(对照组)30例,进行随机对照双盲双模拟试验.治疗组口服达立通颗粒,每日3次,每次6 g;对照组口服西沙必利片,每日3次,每次5 mg,疗程均为2周.结果对中医证候疗效而言,意向性治疗(intention-to-treat,ITT)分析结果显示,治疗组总显效率62.37%,总有效率99.55%;对照组总显效率58.08%,总有效率90.33%.符合方案数据分析(per-protocol population,PP)结果显示,治疗组总显效率为64.45%,总有效率96.67%;对照组总显效率为60.00%,总有效率为93.33%.两组中医证候疗效比较无统计学意义(P＞0.05).对痞满证候疗效而言,ITT分析显示,治疗组总显效率53.76%,总有效率86.02%;对照组的总显效率48.38%,总有效率80.64%.PP分析显示治疗组的总显效率55.56%,总有效率88.89%;对照组总显效率50.00%,总有效率为83.33%.两组痞满证疗效比较无统计学意义(P＞0.05).胃排空试验(PP人群)显示,治疗组总显效率72.42%,总有效率为79.32%;对照组显效率64.28%,总有效率64.28%.两组比较无统计学意义(P＞0.05).ITT分析与PP分析结果一致.临床观察中未发现明显不良反应.结论达立通颗粒疗效与西沙必利相当,未发现明显的毒副作用.

Double-Blind Randomized Controlled Trial of Dalitong Granule in the Treatment of Piman Syndrome (Functional Dyspepsia)

Objective To assess the effect and safety of Dalitong Granule in the treatment of the Piman syndrome(functional dyspepsia). Methods The double-blind,double-dummy and randomized controlled method was adopted. 120 patients were randomized to the treatment group (n=90,Dalitong Granule 6 g,tid) and the control group (n=30,treated with cisapride 5 mg,tid). The therapeutic course for both groups was 2 weeks. Results All the results were analyzed on the basis of intention-to-treat and per-protocol population. In the treatment group,the markedly effective rates were 62.37% and 64.45% respectively. The effective rates were 99.55% and 96.67% respectively. In the control group,the markedly effective rates were 58.08% and 60.00% respectively. The effective rates were 90.33% and 93.33% respectively. There was no significant difference between two groups (P>0.05). For effects on Piman syndrome,in the treatment group,the markedly effective rates were 53.76% and 55.56% respectively. The effective rates were 86.02% and 88.89% respectively. In the control group,the markedly effective rates were 48.38% and 50.00% respectively. The effective rates were 80.64% and 83.33% respectively. The results showed no statistical significance difference between two groups (P>0.05). For effects on gastric emptying function (PP population),in the treatment group,the markedly effective rate and effective rate were 72.42% and 79.32%. In the control group those were 64.28% and 64.28% .There was no significant difference between the two groups (P>0.05). ITT and PP analysis revealed similar results. No adverse effect was found in the observation. Conclusion Dalitong granule has the same clinical effect as cisapride with no obvious toxic-adverse effects.