胆宁片在胆囊切除术后应用的大样本、多中心临床研究  

Multi-center clinical evaluation of safety and efficacy of Danning Tablets in patients after cholecystectomy

作　　者：马恩伟[1] 顾宏刚[1] 阎良[2] 黄建平[2] 张静喆[1] 

机构地区：[1]上海中医药大学附属龙华医院,上海200032 [2]上海中医药大学附属曙光医院,上海200025

出　　处：《中成药》2013年第12期2606-2609,共4页Chinese Traditional Patent Medicine

基　　金：上海市科委课题;中药重点产品胆宁片的二次开发(10DZ1970200);上海市海派中医流派传承研究项目-顾氏外科流派建设(ZYSNXD-CC-APGC-JD002)

摘　　要：目的评估胆宁片用于因慢性胆道感染、胆石病行胆囊切除术后患者的安全性和临床疗效。方法采用多中心、开放、非随机自身对照的临床试验,对因慢性胆道感染、胆石病行胆囊切除术治疗的患者2 206例(男808例,女1 398例),术后口服胆宁片13周,观察药物的安全性;并对其中1 733例有程度不等胆囊切除术后综合征症状的患者,观察药物的有效性。结果在2 206例服用胆宁片患者中有108例患者出现不良反应(占总人数的4.9%),主要表现为腹泻和大便次数增多。这些患者的绝大部分经采用"减少试验用药剂量"的措施后仍能继续进行临床试验和随访。经Kruskal-Wallis Test分析,术后有胆囊切除术后综合征症状的患者在接受胆宁片治疗后5周、9周、13周,临床症状积分显著改善,有统计学差异(P<0.01),且这3个时间点两两比较均有显著差异(P<0.01),显示随治疗时间延长,临床症状进行性改善。结论胆宁片临床应用安全性高;胆宁片能有效改善胆囊切除术后患者临床症状,随着治疗时间延长,临床症状改善越显著。AIM To evaluate the safety and clinical efficacy of Danning Tablets in the treatment for patients with discomfort syndrome after the completion of cholecysteetomy. METHODS A multicenter, open, non-random and self-controlled clinical trial was conducted among 2 206 patients underwent cholecystectomy due to chronic bili- ary tract infection and cholelithiasis （male 808 and female 1 398） , all the patients for safety and 1 733patients for efficacy after surgery received thirteen weeks of Danning Tablets. RESULTS One hundred and eight patients a- mong 2 206 patients had some adverse events （4.9%） during the course of treatment, mainly appeared diarrhea and increased defecation frequency. The majority of patients with adverse reactions could peacefully sustain the clinical trial by modulate the dosage. Kruskal-Wallis Test showed that there was significant improvement in clinical symptoms scoring during treatment up to 5 weeks, 9 weeks, and 13 weeks （P 〈0.01 ）. There were also significant differences between three periods of treatment （P 〈 0. 01 ）, and the clinical symptoms relieved significantly with the prolongation of treatment. CONCLUSION Long-term oral medication of Danning Tablets is safe, and can effec- tively relieve discomfort symptoms of the post-cholecystectomy, and the clinical efficacy is associated with the time of treatment.

关 键 词：胆宁片 慢性胆道感染 胆石病 胆囊切除术后 临床疗效 安全性 

分 类 号：R287[医药卫生—中药学]