胆石片治疗不伴有胆囊结石的慢性胆囊炎(肝胆气郁证)的随机双盲对照临床试验研究

Danshi Tablet in Treating Chronic Cholecystitis with Hepatobiliary- Qi Stagnation Syndrome without Gallbladder Stones: A Randomized Double-Blind Controlled Trial

目的评价胆石片治疗不伴有胆囊结石的慢性胆囊炎(肝胆气郁证)的有效性和安全性。方法采用随机、双盲、安慰剂平行对照、多中心临床试验设计。120例不伴有结石的慢性胆囊炎患者符合本试验纳入标准,试验组和对照组各60例。分别采用胆石片(6粒/次,3次/d)及胆石片安慰剂(6粒/次,3次/d)进行为期4周的治疗。以中医证候积分(包括右胁胀痛、口苦、咽干、嗳气、恶心、厌食油腻、纳食减少、胃脘痞满、上腹饱胀、右上腹部压痛和大便秘结)和腹部超声检查进行疗效评价。以血、尿、大便常规,肝功能(ALT、AST、TBIL、DBIL)、肾功能(Bun、Cr)和心电图检查结果作为安全性评价的依据。结果治疗4周后,经CMH卡方检验,两组主要疗效、次要疗效及影像学疗效中痊愈率、显效率、有效率、无效率及总有效率比较差异有统计学意义(P<0.01)。安全性:两组均无严重不良事件发生。结论胆石片能有效治疗不伴有胆囊结石的慢性胆囊炎,并有良好的安全性。

Objective To evaluate the efficacy and safety of Danshi tablet,a Chinese herbal medicine for smoothing liver,in treating chronic cholecystitis without gallbladder stones patients with hepatobiliary- qi stagnation syndrome. Methods A randomized,double- blind,and placebo control method was adopted. One hundred and twenty cases of chronic cholecystitis conforming to the inclusive criteria were randomly divided into treatment group( n = 60) and control group( n = 60). Patients in the treatment group were treated with Danshi tablet,six tablets each time and three times a day. Patients in the control group received Simulation agent,six tablets each time and three times a day. After 4 weeks of treatment,the efficacy of Danshi tablet was evaluated by the score of the syndromes of traditional Chinese Medicine and the examination of abdominal ultrasound. The safety of Danshi tablet was assessed by laboratory data and adverse events. Results After 4 weeks of treatment,the curative and markedly effective rate was 3. 45% in control group and 27. 12%in treatment group,and there was statistically significant difference between the two groups( P < 0. 01). The total effective rate was 27. 59% in control group and 66. 10% in treatment group,and there was statistically significant difference( P < 0. 01). Efficacy of TCM syndrome: the cure and markedly effective rate was 5.17% in control group and 40. 68% in treatment group,and the difference between the two groups was statistically significant( P < 0. 01). The total effective rate was 34. 48% in control group and 81. 36% in treatment group,and the difference between the two groups was statistically significant( P < 0. 01). Imaging Efficacy:the Cure and markedly effective rate was 16. 36% in control group and 45. 28% in treatment group,and the difference between the two groups was statistically significant( P < 0. 01). The total effective rate was 61. 82%in control group and 81. 13% in treatment group,and the difference between the two groups was statistically significant( P < 0. 05). Safety: no serious adverse events occurred in either groups. Conclusion Danshi tablet is effective and safe for treatment of chronic cholecystitis patients with chronic cholecystitis without gallbladder stones patients with hepatobiliary- qi stagnation syndrome.