胃舒安颗粒治疗功能性消化不良的有效性和安全性多中心临床评价

目的：评价胃舒安颗粒治疗功能性消化不良的临床疗效和安全性。方法：试验采用分层区组、随机、双盲双模拟、阳性药平行对照、多中心临床研究方法，以西沙必利片作为对照药对比观察。共观察409例（3：1），其中试验组308例，对照组101例．其中脱落4例，剔除5例。结果：中医证候疗效：胃舒安颗粒组愈显率63．03％，总有效率95．70％；西沙必利片组愈显率62．38％，总有效率94．06％。痞满证候疗效：胃舒安颗粒组愈显率62．04％，总有效率92．07％；西沙必利片组愈显率54．45％，总有效率87．12％。胃排空试验胃舒安颗粒组愈显率60．78％，总有效率73．85％；西沙必利片组愈显率59．26％，总有效率70．37％。两组比较无统计学意义（P〉0．05）。结论：胃舒安颗粒治疗功能性消化不良疗效确切，未发现毒副作用。

Efficacy and safety of Weishuan pellets in treatment of patients with functional dyspepsia

AIM: To evaluate the clinical efficacy and safety of the Weishuan pellets in treatment of patients with functional dyspepsia. METHODS: 409 subjects were involved in a multi-center randomized, double-blinded, double-simulation, and positive drug parallel-controlled clinical trail. 308 patients were enrolled in the Weishuan-pellets group, while 101 cases were enrolled in the control group. RESULTS: The total effective rate and recovery and excellence rate in Weishuan pellets were 95.70 % and 63.03 %, respectively; In the control group, the total effective rate and recovery and excellence rate were 94.06 % and 62.38 %, respectively. For the effects on Piman synodrome, the total effective rate and recovery and excellence rate were 92.07 % and 62.04 %, respectively; In the control group, the total effective rate and recovery and excellence rate were 87.12 % and 54.45 %, respectively. For effects on gastric emptying function, in the treatment group, the total effective rate and recovery and excellence rate were 73.85 % and 60.78 %, respectively; In the control group, the total effective rate and recovery and excellence rate were 70.37 % and 59.26 %, respectively. There was no significant difference between the two groups (P> 0.05 ). CONCLUSION: Weishuan pellet is an effective and safe drug in treatment of patients with functional dyspepsia.