达立通颗粒治疗功能性消化不良的临床研究

目的:评价达立通颗粒治疗功能性消化不良的有效性和安全性。方法:选取功能性消化不良患者130例,随机分为达立通颗粒组(治疗组)86例和西沙比利片组(对照组)44例,进行分层区组随机对照双盲模拟试验。治疗组口服达立通颗粒+西沙比利片模拟剂;对照组口服西沙比利片+达立通颗粒模拟剂:疗程均为2周。结果:对中医证候疗效,治疗组总显效率65.44%,总有效率97.29%;对照组分别为61.66%、95.41%。2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,治疗组总显效率56.09%,总有效率94.74%;对照组分别为50.00%、88.75%。2组痞满证疗效比较无统计学意义(P>0.05)。胃排空试验显示,治疗组总显效率64.65%,总有效率95.83%;对照组分别为63.15%、96.43%。2组胃排空疗效比较无统计学意义(P>0.05)。在试验过程中,未发现明显不良反应。结论:达立通颗粒疗效与西沙比利相当,未发现明显的毒副作用。

Clinical Research on Functional Dyspepsia treated by Dalitong Drug granule

Objective:To assess the effect and safety of Dalitong Granule in the Treatment of Functional Dyspepsia. Methods:The double-blind, double-dummy and randomized controlled method was adopted. 130 patients were randomized to the treatment group (n=86) and the control group (n=44). The therapeutic course for both groups was 2 weeks. Results: In the treatment group ,the markedly effective rates and effective rates were 65.44% and 97.29% respectively. In the control group were 61.66% and 95.41% 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 and effective rates were 56.09% and 94.74% respectively. In the control group were 50.00% and 88.75% respectively. The results showed no statistical significant difference between two groups(P >0.05).For effects on gastric emptying function, in the treatment group ,the markedly effective rates and effective rates were 64.65% and 95.83% respectively. In the control group were 63.15% and 96.43% respectively. There was no significant difference between two groups(P >0.05).No adverse effect was found in the observation.Conclusion: Dalitong granule has the same clinical effect as cisapride with no obvious toxic-adverse effects.