运肠胶囊治疗功能性便秘的多中心随机、双盲、阳性药对照Ⅲ期临床研究

Study of YunChang capsule on functional constipation: a multi center randomized, double blind, positive drug control phase III clinical research

目的:对运肠胶囊治疗功能性便秘(气阴两虚兼毒邪内蕴证)有效性及安全性的进一步评价。方法:采用多中心、随机双盲双模拟阳性药对照,两组均为胶囊剂型,试验组(运肠胶囊)2粒/次,每日3次,对照组(便通胶囊)3粒/次,每日2次,两组服药次数不同,故采用双盲双模拟法。观察大便质地、排便间隔时间、排便功能及中医证候气阴两虚兼毒邪内蕴证症状积分变化情况,以及舌象脉象变化情况。结果:共入组480例,试验组入组360例,完成336例,脱落9例,剔除15例;对照组入组120例,完成110例,脱落0例,剔除10例。在改善功能性便秘症状方面,全分析集(FAS)示试验组痊愈率67.8%,显效率19.1%,有效率11.3%;对照组痊愈率46.4%,显效率31.8%,有效率16.4%。符合方案集(PPS)示试验组痊愈率68.8%,显效率19.6%,有效率9.8%;对照组痊愈率46.4%,显效率31.8%,有效率16.4%。在改善中医证候方面,FAS试验组痊愈率61.2%,显效率24.4%,有效率12.8%;对照组痊愈率38.2%,显效率40.0%,有效率16.4%,两组具有明显差异。PPS试验组痊愈率61.9%,显效率25.0%,有效率11.3%;对照组痊愈率38.2%,显效率40.0%,有效率16.4%,两组具有明显差异。结论:运肠胶囊治疗功能性便秘在疗效方面优于便通胶囊。

Objective: To study the safety and effectiveness of YunChang capsule in the treatment of functional constipation(Qiyinliangxu and Duxieneiyun Symptom).Methods:The multi center and double blind randomized were used as positive control groups, both in capsule dosage form. Patientsin YunChang capsule group were given 2 capsules each time, three times a day, while those in the control group(BianTong capsule) were given 3 capsules each time, twice a day. Because of the difference between the two groups, double-blind double dummy technique was applied. The stool quality, defecation interval, defecation function, the changes of tongue and pulse and the symptom scores of TCM syndrome Qiyinliangxu and Duxieneiyun were observed.Results: 480 patients were selected and 360 cases were in YunChang capsule group. 336 cases were completed, 9 cases were removed and 15 cases were eliminated. 120 cases were selected in the control group, in which 110 cases were completed, 0 cases were removed and 10 cases were eliminated. In Full analysis set(FAS)YunChang capsule group, the recovery rate of functional constipation was 67.8%, the markedly effective rate was 19.1%, and the effective rate was 11.3%. In the control group, the recovery rate was 46.4%, the markedly effective rate was 31.8%, and the effective rate was 16.4%. Per-protocol population set(PPS) showed that the recovery rate in YunChang capsule group was 68.8%, the markedly effective rate was 19.6%, and the effective rate was 9.8%, while in the control group, the recovery rate was 46.4%, the markedly effective rate was 31.8%, and the effective rate was 16.4%. The improvement of TCM syndromes in FAS showed that in YunChang capsule group, the recovery rate was 61.2%, the markedly effective rate was 24.4%, and the effective rate was 2.8%, while in the control group the recovery rate was 38.2%, the markedly effective rate was 40%, and the effective rate was 16.4%. The difference between the two groups was statistically significant. PPS analysis showed that in YunChang capsule group the recovery rate was 61.9%, the markedly effective rate was 25%, and the effective rate was 11.3%, while in the control group the recovery rate was 38.2%,the markedly effective rate was 40%, and the effective rate was 16.4%. The difference between the two groups was statistically significant.Conclusion: YunChang capsule is better than BianTong capsule on functional constipation.