目的 觀察芪黃通秘軟膠囊治療功能性便秘的臨床療效。方法 選取各研究中心2013年10月—2014年3月功能性便秘患者284例, 隨機分為對照組(145例)和治療組(139例)。對照組飯后30 min口服麻仁軟膠囊, 1粒/次, 2次/d。治療組飯后30 min口服芪黃通秘軟膠囊, 3粒/次, 2次/d。兩組均連續(xù)治療3周。比較兩組患者的臨床療效, 并對芪黃通秘軟膠囊臨床應(yīng)用的安全性進(jìn)行評價。結(jié)果 治療后, 對照組愈顯率、有效率分別為50.3%、84.8%;治療組為59.7%、96.4%, 治療組愈顯率和有效率均顯著高于對照組, 兩組比較差異具有統(tǒng)計學(xué)意義(P<0.05、0.01)。治療組治療大便性狀、排便次數(shù)、排便腸梗阻感癥狀的愈顯率以及治療排便不盡感和排便時腸梗阻感/阻塞感癥狀的有效率顯著高于對照組(P<0.05, 0.01)。對于中醫(yī)虛秘證的治療, 治療后, 對照組愈顯率、有效率分別為52.4%、86.9%, 治療組為57.6%、94.2%, 治療組愈顯率和有效率均顯著高于對照組, 兩組比較差異具有統(tǒng)計學(xué)意義(P<0.05、0.01)。治療組對氣短、頭暈癥狀的愈顯率以及對氣短、舌淡苔薄、脈細(xì)無力癥狀的有效率顯著優(yōu)于對照組(P<0.05、0.01)。兩組均未發(fā)生不良反應(yīng)。結(jié)論 芪黃通秘軟膠囊治療功能性便秘療效顯著, 且無不良反應(yīng)發(fā)生, 值得臨床推廣應(yīng)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.