消痞止痛方治疗脾虚气滞证功能性消化不良的随机、双盲、对照研究  

Randomized,double-blinded and controlled trial of Xiaopi Zhitong Decoction in the treatment of functional dyspepsia with syndrome of spleen deficiency and Qi stagnation

作　　者：李培菡 唐禹 温红珠[1] 火龙 卞慧[1] 费晓燕[1] 何文姬[3] 王勇军 章谙鸣 田芸 葛毅骏 魏智祥 黄烨 张伟 卢月婷 丁燕[11] 程芳 苏海 王炜妮 江雯雯 盛颖辉 杨滢[11] 缪佳[11] 苏雯华 林江[1] LI Peihan;TANG Yu;WEN Hongzhu;HUO Long;BIAN Hui;FEI Xiaoyan;HE Wenji;WANG Yongjun;ZHANG Anming;TIAN Yun;GE Yijun;WEI Zhixiang;HUANG Ye;ZHANG Wei;LU Yueting;DING Yan;CHENG Fang;SU Hai;WANG Weini;JIANG Wenwen;SHENG Yinghui;YANG Ying;MIU Jia;SU Wenhua;LIN Jiang(Department of Gastroenterology,Longhua Hospital,Affiliated with Shanghai University of Traditional Chinese Medicine,Shanghai,200032,China;School of Basic Medical Sciences,Fudan University;Department of Traditional Chinese Medicine,Shanghai Putuo District People's Hospital;Department of Gastroenterology,Shanghai Yangpu District Hospital of Traditional Chinese Medicine;department of Gastroenterology,Shanghai Putuo District Hospital of Traditional Chinese Medicine;Department of Gastroenterology,Shanghai Changning Tianshan Traditional Chinese Medieine Hospital;Department of Traditional Chinese Medicine,Shanghai Changzheng Town Community Health Service Center;Department of T raditional Chinese Medicine,Shanghai Changfeng Subdistrict Baiyu Community Health Service Center;Department of Traditional Chinese Medicine,Shanghai Taopu Town Community Health Service Center;Department of Traditional Chinese Medicine,Shanghai Yanji Community Health Service Center;Department of Traditional Chinese Medicine.Shanghai Shanggang Community Health Service Center;Department of Traditional Chinese Medicine.Shanghai Jinyang Community Health Service Center;Department of Traditional Chinese Medicine,Caohejing Community Health Service Center)

机构地区：[1]上海中医药大学附属龙华医院脾胃病科,上海200032 [2]复旦大学基础医学院 [3]上海市普陀区人民医院中医科 [4]上海市杨浦区中医医院脾胃病科 [5]上海市普陀区中医医院脾胃病科 [6]上海市长宁区天山中医医院脾胃病科 [7]上海市长征镇社区卫生服务中心中医科 [8]上海市长风街道白玉社区卫生服务中心中医科 [9]上海市桃浦镇社区卫生服务中心中医科 [10]上海市延吉社区卫生服务中心中医科 [11]上海市上钢社区卫生服务中心中医科 [12]上海市金杨社区卫生服务中心中医科 [13]上海市漕河泾街道社区卫生服务中心中医科

出　　处：《中国中西医结合消化杂志》2022年第4期245-249,254,共6页Chinese Journal of Integrated Traditional and Western Medicine on Digestion

基　　金：上海中医脾胃病专科联盟建设项目[No:ZY(2018-2020)-FWTX-4018]。

摘　　要：目的:评价消痞止痛方治疗功能性消化不良(脾虚气滞证)的临床疗效和安全性。方法:采用多中心、随机、双盲、阳性药物和安慰剂平行对照的方法,把117例功能性消化不良患者随机分为试验组、对照组和安慰剂组,分别予消痞止痛方、香砂六君子汤和安慰剂治疗4周。主要疗效指标为总体症状应答率,次要疗效指标为总体症状积分改善率和单项症状有效率。疗效分析分为全分析集(FAS)以及符合方案集(PPS)分析。结果:试验组、对照组和安慰剂组总体症状应答率的PPS集分析分别为76.9%,42.4%和27.8%(P<0.01),FAS集分析分别为75.6%.36.8%和26.3%(P<0.01);3组总体症状改善率的PPS集分析分别为41.1%.30.1%和.24.1%(P<0.05),FAS集分析分别为41.1%,25.5%和22.9%(P<0.05);试验组各单项症状有效率在FAS和PPS分析集中均显著优于安慰剂组,试验组的早饱感和上腹烧灼感的有效率在FAS分析集中显著优于对照组(P<0.05)。3组患者不良反应发生率比较差异无统计学意义(P>0.05)。结论:消痞止痛方能安全有效治疗脾虚气滞证功能性消化不良,其疗效优于香砂六君子汤。Objective: To evaluate the clinical effect and safety of Xiaopi Zhitong Decoction in the treatment of functional dyspepsia with syndrome of spleen deficiency and Qi stagnation. Methods: A total of 117 patients with functional dyspepsia were divided into three groups, the test group, control group and placebo group, and were given Xiaopi Zhitong Decoction, Xiangsha Liujunzi Decoction and the placebo respectively. This was a 4-week multicenter, randomized, double-blinded, positive and placebo parallel controlled, clinical trial. The primary efficacy indicators were the overall symptom response rate, and the secondary efficacy indicators were overall symtoms score improvement rate and individual symptom effective rate. Results: The overall clinical symptoms response rates of the test group, control group and placebo group were 76.9%, 42.4% and 27.8%(P<0.01) by PPS analysis, 75.6%, 36.8% and 26.3%(P<0.01) respectively by FAS analysis. The total symptom improvement rates of the three groups were 41.1%, 30.1% and 24.1%(P<0.05) respectively by PPS, 41.1%, 25.5% and 22.9%(P<0.05) respectively by FAS. The individual symptom effective rate in the test group was significantly better than that in the placebo group in both FAS and PPS analysis sets, and the efficiency of early satiety and epigastric burning in the test group was significantly higher than that in the control group in FAS analysis sets(P<0.05). There was no statistical difference in the incidence of adverse reactions among the three groups(P>0.05). Conclusion: Xiaopi Zhitong Decoction can safely and effectively improve the clinical symptoms of functional dyspepsia, and even more effective than Xiangsha Liujunzi Decoction.

关 键 词：消痞止痛方 香砂六君子汤 功能性消化不良 临床研究 

分 类 号：R256.3[医药卫生—中医内科学]