清热化湿方联合三联疗法治疗脾胃湿热型幽门螺杆菌感染的随机对照临床研究  

A Randomized Controlled Clinical Study of Qingre Huashi Decoction Combined with Triple Therapy in Treating Helicobacter Pylori Infection of Damp-Heat Type of Spleen and Stomach

作　　者：杨闪闪 叶晖[1] 黄秋月 邓鑫 肖惠霞 张学智[1] YANG Shan-shan;YE Hui;HUANG Qiu-yue;DENG Xin;XIAO Hui-xia;ZHANG Xue-zhi(Department of Traditional Chinese Medicine and Integrated Traditional Chinese and Western Medicine,Peking University First Hospital,Institute of Integrated Traditional Chinese and Western Medicine,Peking University,Beijing 100034)

机构地区：[1]北京大学第一医院中医、中西医结合科,北京大学中西医结合研究所,北京100034

出　　处：《世界中西医结合杂志》2020年第9期1734-1738,共5页World Journal of Integrated Traditional and Western Medicine

基　　金：首都卫生发展科研专项青年优才项目(2018-4-4078)。

摘　　要：目的评价清热化湿方联合三联疗法14 d方案根除幽门螺杆菌(Hp)的有效性和安全性。方法选取2019年1月—2019年12月期间于北京大学第一医院中西医结合科就诊的Hp感染患者102例。采用区组随机方法,根据生成的随机数字将入选患者随机分为两组,其中治疗组50例,对照组52例。治疗组(艾司奥美拉唑+阿莫西林+克拉霉素+清热化湿复方水煎剂)、对照组(艾司奥美拉唑+阿莫西林+克拉霉素+枸橼酸铋钾),疗程均为14 d,以Hp根除率、胃肠道症状改善情况为疗效指标,不良反应发生率为安全性指标评价其有效性和安全性。结果治疗组和对照组Hp根除率符合方案集分析(PP)分别为82.98%(39/47)、82.61%(38/46),意向性治疗分析(ITT)分别为81.63%(40/49)、82.35%(42/51),差异均无统计学意义(P>0.05)。症状评分方面,治疗组除恶心呕吐、大便干燥外,其余症状在治疗前后比较,差异均有统计学意义(P<0.05)。对照组除恶心呕吐、饮食减少、大便不畅、大便干燥外,其余症状在治疗前后比较,差异均有统计学意义(P<0.05)。两组间比较,除大便不畅外,其余症状在治疗前后比较,差异无统计学意义(P>0.05)。总体症状改善率治疗组为69.57%,高于对照组的61.41%。治疗组和对照组不良反应发生率分别为4.08%(2/49)、17.65%(9/51),两组比较差异有统计学意义(P<0.05)。结论清热化湿方联合三联疗法治疗幽门螺杆菌感染安全有效且具有不良反应少的优势。Objective To evaluate the efficacy and safety of Qingre Huashi Decoction combined with triple therapy in the eradication of Helicobacter pylori(Hp).Methods From January 2019 to December 2019,102 patients with Hp infection who attended the Department of Integrated Traditional Chinese and Western Medicine of Peking University First Hospital were selected.Using the block random method,the selected patients were randomly divided into two groups according to the generated random numbers,including 50 cases in the treatment group and 52 cases in the control group.Treatment group(esomeprazole+amoxicillin+clarithromycin+Qingre Huashi Decoction),control group(esomeprazole+amoxicillin+clarithromycin+bismuth potassium citrate),the course of treatment is 14 days,the Hp eradication rate and the improvement of gastrointestinal symptoms are used as the efficacy indicators,and the adverse reaction rate is the safety indicator to evaluate its effectiveness and safety.Results The Hp eradication rates in the treatment group and the control group were 82.98%(39/47)and 82.61%(38/46)in accordance with Per-Protocol analysis(PP),and the Intention-To-Treat analysis(ITT)was 81.63%(40/49)and 82.35%(42/51)respectively,and the difference was not statistically significant(P>0.05).In terms of symptom scores,except for nausea,vomiting and dry stool,the other symptoms of the treatment group were significantly different before and after treatment(P<0.05).Except for nausea and vomiting,reduced diet,poor bowel movements and dry stool,the other symptoms of the control group were significantly different before and after treatment(P<0.05).In the comparison between the groups,there was no significant difference in symptoms before and after treatment except for poor bowel movements(P>0.05).The overall symptom improvement rate in the treatment group was 69.57%,which was higher than 61.41%in the control group.The incidence of adverse reactions in the treatment group and the control group were 4.08%(2/49)and 17.65%(9/51)respectively,and the difference was s

关 键 词：清热化湿方 幽门螺杆菌 临床疗效 随机对照临床试验 

分 类 号：R714.255[医药卫生—妇产科学]