理气通便方治疗功能性便秘(肠道气滞证)的随机双盲安慰剂对照临床研究  

A Randomized Double-Blind Placebo-Controlled Clinical Study on the Treatment of Functional Constipation(Intestinal Qi Stagnation Syndrome)with Liqi Tongbian Decoction

作　　者：李玉锋[1] 姜巍[1] 刘阳 张鑫[2] 王垂杰[1] LI Yu-feng;JIANG Wei;LIU Yang;ZHANG Xin;WANG Chui-jie(Department of Spleen and Stomach Diseases,Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang Liaoning 110032;Graduate School of Liaoning University of Traditional Chinese Medicine,Shenyang Liaoning 110847)

机构地区：[1]辽宁中医药大学附属医院脾胃病科,辽宁沈阳110032 [2]辽宁中医药大学研究生学院,辽宁沈阳110847

出　　处：《世界中西医结合杂志》2021年第10期1900-1904,共5页World Journal of Integrated Traditional and Western Medicine

基　　金：辽宁省中医药管理局第六批全国老中医药专家学术经验继承工作项目(辽中医药函字[2017]118号)。

摘　　要：目的探讨理气通便方治疗功能性便秘(肠道气滞证)的有效性和安全性。方法选取2018年10月—2019年5月期间于辽宁中医药大学附属医院门诊就诊的60例患者为受试者,采用随机数字表法将患者分为治疗组和安慰剂组,每组各30例。治疗组应用理气通便方,安慰剂组采用理气通便方模拟剂治疗,冲服,2次/d。治疗7 d后,观察比较两组患者治疗前后排便次数变化、粪便性状、排便时间和排便困难分级变化情况和有效率;中医证候积分变化情况和有效率;服药24 h内第1次排便情况和安全性检测。结果治疗后两组患者1周排便次数均优于治疗前,差异有统计学意义(P<0.01);且治疗组治疗后1周排便次数明显高于安慰剂组,两组比较,差异有统计学意义(P<0.01)。治疗1周后,治疗组和安慰剂组粪便性状等级变化情况单项主症总有效率分别为90.0%、43.3%,两组比较,差异有统计学意义(P<0.01);治疗组和安慰剂组排便困难等级变化情况单项主症总有效率分别为90.0%、43.3%,两组比较,差异有统计学意义(P<0.01);治疗组和安慰剂组排便时间等级变化情况单项主症总有效率分别为86.7%、40.0%,两组比较,差异有统计学意义(P<0.01)。治疗后两组患者中医证候总积分均明显低于治疗前,差异有统计学意义(P<0.05);且治疗组治疗后中医证候总积分明显低于安慰剂组,两组比较,差异有统计学意义(P<0.05)。治疗后治疗组基本痊愈率、总显效率、总有效率分别为53.3%、73.3%、90.0%,安慰剂组基本痊愈率、总显效率、总有效率分别为6.7%、26.7%、53.3%,两组比较,差异有统计学意义(P<0.05)。治疗后治疗组第1次排便时间≤24 h的受试者比例为80%(24/30),安慰剂组第1次排便时间≤24 h的受试者比例为46.7%(14/30),两组比较,差异有统计学意义(P<0.01)。治疗期间,治疗组发生腹泻1例,安慰剂组无其他不良反应,安全性较高。结论理气通便方治疗�Objective To evaluate the efficacy and safety of Liqi Tongbian Decoction in the treatment of functional constipation intestinal Qi stagnation syndrome with placebo as a control.Methods Sixty patients who were treated in the outpatient clinic of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine from October 2018 to May 2019 were selected as subjects.The patients were divided into treatment group and placebo group by random number table method,with each group having each group.30 cases.The treatment group was treated with the Liqi Tongbian Decoction,and the placebo group was treated with the Liqi Tongbian Decoction Simulator,which was taken twice daily.After 7 days of treatment,observe and compare the changes in the number of bowel movements,stool characteristics,defecation time,and dysdefecation grading changes and effective rates of the two groups before and after treatment.The changes and effective rates of TCM syndrome scores and the safety test of the first bowel movement within 24 hours of taking the medicine were compared.Results After treatment,the number of bowel movements in the two groups was better than that before treatment,and the difference was statistically significant(P<0.01).And the number of bowel movements in the treatment group was significantly higher than that in the placebo group.There were differences between the two groups.Statistically significant(P<0.01).After 1 week of treatment,the total effective rate of the single main symptom in the treatment group and the placebo group was 90.0%and 43.3%respectively.The difference between the two groups was statistically significant(P<0.01);the treatment group and the placebo group.The total effective rates of changes in the grade of defecation difficulty in the group were 90.0%and 43.3%,respectively.The difference between the two groups was statistically significant(P<0.01);the changes in the grades of defecation time in the treatment group and the placebo group were 86.7%and 40.0%respectively,and the difference betwee

关 键 词：理气通便方 功能性便秘 肠道气滞证 双盲 随机对照试验 

分 类 号：R256.35[医药卫生—中医内科学]