胃通颗粒治疗功能性消化不良临床研究

Multicentral clinical trial of weitong granules for functional dyspepsia

目的研究胃通颗粒对功能性消化不良(痞满证)属于脾胃气滞兼热证的临床疗效及安全性。方法对448例患者采用随机双盲双模拟和开放的临床试验。胃通颗粒组(甲)与木香顺气丸组、胃通颗粒组(乙)与多潘立酮组采用完全随机分组、双盲双模拟对照法(293例),开放组采用自身前后对照(155例)。各治疗组均按双盲双模拟对照法编号用药,而开放组则服用不编号的胃通颗粒,以上各组均每次1包,温水冲服,每日3次,疗程为7d。结果主症的总有效率治疗组、对照组、开放组三者相近;显效率治疗组、开放组优于对照组(P<0.01);对胃排空功能的总有效率、显效率,各组之间差异均无统计学意义(P>0.05);中医证候的总有效率、显效率,治疗组、开放组均明显优于对照组(P<0.05,P<0.01)。结论胃通颗粒治疗功能性消化不良具有安全、良好的临床疗效。

Objective To investigate the efficacy and safety of weitong granules in treatment of functional dyspepsia. Methods The randomized controlled-multicenter and open clinical trails was conducted in 448 patients with functional dyspepsia. Group weitong granules and muxin shunqi Pills,group weitong granules and domperidone were using completely randomized, double-blind double-dummy controlled method （293 patients）,open control group was using before and after of their own control method （155 patients）.The treatment groups were administrated by double- blind double-dummy controlled numbers,and open group was administrated the on marked number of granules. The above groups were administrated one package one time with warm water,three times a day.Duration of treatment was seven days. Results The treatment group,control group and open group were similar of main symptoms of total effective rate.Markedly effective rate of treatment group,open group were better than control group（P 〈 0.01）.The functional gastric emptying of total effective rate and markedly effective rate were no significant difference（P 〉 0.05）. The traditional chinese medicine （TCM） syndrome of total effective rate and markedly effectiverate, the treatment group and open group were better than control group（P 〈 0.05,P 〈 0.01）. Conclusion The weitong granules for functional dyspepsia treatment is safe and good clinical efficacy.