目的 观察芪黄通秘软胶囊治疗功能性便秘的临床疗效。方法 选取各研究中心2013年10月—2014年3月功能性便秘患者284例, 随机分为对照组(145例)和治疗组(139例)。对照组饭后30 min口服麻仁软胶囊, 1粒/次, 2次/d。治疗组饭后30 min口服芪黄通秘软胶囊, 3粒/次, 2次/d。两组均连续治疗3周。比较两组患者的临床疗效, 并对芪黄通秘软胶囊临床应用的安全性进行评价。结果 治疗后, 对照组愈显率、有效率分别为50.3%、84.8%;治疗组为59.7%、96.4%, 治疗组愈显率和有效率均显著高于对照组, 两组比较差异具有统计学意义(P<0.05、0.01)。治疗组治疗大便性状、排便次数、排便肠梗阻感症状的愈显率以及治疗排便不尽感和排便时肠梗阻感/阻塞感症状的有效率显著高于对照组(P<0.05, 0.01)。对于中医虚秘证的治疗, 治疗后, 对照组愈显率、有效率分别为52.4%、86.9%, 治疗组为57.6%、94.2%, 治疗组愈显率和有效率均显著高于对照组, 两组比较差异具有统计学意义(P<0.05、0.01)。治疗组对气短、头晕症状的愈显率以及对气短、舌淡苔薄、脉细无力症状的有效率显著优于对照组(P<0.05、0.01)。两组均未发生不良反应。结论 芪黄通秘软胶囊治疗功能性便秘疗效显著, 且无不良反应发生, 值得临床推广应用。

Objective To investigate the clinical effect of Qihuang Tongmi Soft Capsules in treatment of functional constipation. Methods The patients with functional constipation (284 cases) of research centers from October 2013 to March 2014 were randomly divided into control (145 cases) and treatment (139 cases) groups. The patients in the control group were po administered with Maren Soft Capsules 30 min after meals, 1 grain/time, twice daily. The patients in the treatment group were po administered with Qihuang Tongmi Soft Capsules 30 min after meals, 3 grains/time, twice daily. The patients in two groups were treated for 3 weeks. After treatment, the efficacies in two groups were evaluated, while the treatment safety of Qihuang Tongmi Soft Capsules was assessed. Results After treatment, the markedly effective rate and efficacy in the control group was 50.3% and 84.8%, respectively, while those in the treatment group were 59.7% and 96.4%, respectively. The markedly effective rate and efficacy in the treatment group was higher than those in the control group, and there were differences between two groups (P < 0.05, 0.01). The markedly effective rate of stool character, stool frequency, bowel obstruction symptom, and the efficacy of endless defecate feeling and sense of defecation/obstruction during defecation in the treatment group were significantly higher than those in the control group (P < 0.05, 0.01). For the treatment of deficiency constipation, the markedly effective rate and efficacies in the control group were 52.4% and 86.9%, respectively, while those in the treatment group were 57.6% and 94.2%, respectively. The markedly effective rate and efficacies in the treatment group were higher than those in the control group, and there were differences between the two groups (P < 0.05, 0.01). The markedly effective rate of breathe shortness, and dizziness, and the efficacies of breath shortness, pale tongue moss thin, and pulse weakness in the treatment group were significantly higher than those in the control group (P < 0.05, 0.01). There were no adverse reactions in two groups. Conclusion Qihuang Tongmi Soft Capsules has good clinical effect in treatment of functional constipation, and no adverse reaction occurred, which is worth clinical promotion.