含铋剂四联方案联合荆花胃康胶丸治疗幽门螺杆菌感染的前瞻性多中心随机对照研究  

Jinghuaweikang capsules combined with Quadruple therapy in the treatment of Helicobacter pylori infection:a multicenter,randomized,controlled,clinical study

作　　者：杨琼[1] 尚琪[2] 魏国强 郭庆红[4] 卡世全 张志镒 李发旺[7] 申希平[8] 张德奎[2] Yang Qiong;Shang Qi;Wei Guoqiang;Guo Qinghong;Ka Shiquan;Zhang Zhiyi;Li Fawang;Shen Xiping;Zhang Dekui(Department of G

机构地区：[1]兰州大学第二医院西固医院消化科,兰州730000 [2]兰州大学第二医院消化科兰州大学第二医院消化系疾病重点实验室,兰州730000 [3]酒钢医院消化科,嘉峪关735100 [4]兰州大学第一医院消化科,兰州730000 [5]兰州市第一人民医院消化科,兰州730000 [6]武威肿瘤医院消化科,武威733000 [7]白银市第一人民医院消化科,白银730900 [8]兰州大学公共卫生学院流行病与卫生统计学研究所,兰州730000

出　　处：《中华医学杂志》2019年第4期295-300,共6页National Medical Journal of China

基　　金：国家自然科学基金(81770525);甘肃省青年科技基金计划(17JR5RA233,18JR3RA332);甘肃省自然科学基金(17JR5RA191).

摘　　要：摘要目的探讨甘肃地区荆花胃康胶丸联合四联疗法治疗幽门螺杆菌(H.pylori)感染的疗效。方法采用前瞻性简单随机分组研究,对象为甘肃地区7个中心H.pylori感染患者,通过简单随机分组将其分为4组。A1组:埃索美拉唑(20mg/次,2次/d)+果胶铋(200mg/次,3次/d)+阿莫西林(1000mg/次,2次/d)+克拉霉素(500mg/次,2次/d);A2组:在A1组基础上加用荆花胃康胶丸(160mg/次,3次/d);B1组:埃索美拉唑(20mg/次,2次/d)+果胶铋(200mg/次,3次/d)+阿莫西林(1000mg/次,2次/d)+呋喃唑酮(100mg/次,2次/d);B2组:在B1组基础上加用荆花胃康胶丸(160mg/次,3次/d);疗程均为14d。观察4组受试者治疗前、治疗14d、治疗后30d腹痛、反酸、腹胀、嗳气、呃逆等不适症状,同时在治疗结束后1个月所有受试者均接受13C或者14C检测H.pylori,判断根除结果。结果纳入2016年2月至2017年5月甘肃地区7个中心符合入选标准的455例H.pylori感染受试者,其中男189例,A1、A2、B1、B2组分别入组129例、96例、112例、118例。A1、A2、B1、B2组H.pylori根除率符合方案数据分析(PP)分别为46.9%(60/128)、63.8%(60/94)、60.7%(68/112)、68.6%(81/118)(P=0.004)。各组根除率结果比较显示,B1组与A2组较A1组H.pylori根治率高,差异有统计学意义(P<0.001,P=0.032),而B2与A2组、B1与B2组之间差异无统计学意义(P=0.208,P=0.461)。A1、A2、B1、B2组H.pylori根除率意向性分析(ITT)为46.5%(60/129)、62.5%(60/96)、60.7%(68/112)、68.6%(81/118)。A2组较A1组根治率高,差异有统计学意义(P=0.017),B2组较B1组根治率高,但差异无统计学意义(P=0.208);其余各组比较差异无统计学意义。在腹痛、腹胀、反酸、嗳气、呃逆的症状改善方面,含荆花胃康胶丸组较不含荆花胃康胶丸组效果好,差异有统计学意义(P<0.05)。各组均无严重不良反应发生。结论联合荆花胃康胶丸可提高H.pylori的根除率,改善患者不适症状。Objective To explore the efficacy of Jinghuaweikang capsules combined with Quadruple therapy in the treatment of Helicobacter pylori (H.pylori)infection. Methods Patients who were infected with H.pylori in 7 centers in Gansu Province were recruited in this prospective simple randomized study. All the patients are divided into four groups randomly: patients in Group A1 were treated with esomeprazole (20 mg, twice a day) + pectin bismuth (200 mg, three times a day) + amoxicillin (1 000 mg, twice a day) + clarithromycin (500 mg, twice a day), while Group A2 with Jinghuaweikang capsules(160 mg, three times a day) based on group A2, Group B1 with esomeprazole (20 mg, twice a day) + bismuth pectin (200 mg, three times a day) + amoxicillin (1 000 mg, twice a day) + furazolidone (100 mg, twice a day) and Group B2 with Jinghuaweikang capsules(160 mg, three times a day) based on group B2. The treatment time was 14 days for all 4 groups. In the course of treatment, abdominal pain, acid reflux, abdominal distension, belching, hiccups were observed at the time before treatment, 14 days and 30 days after treatment and were scored. Finally, all patients received 13C or 14C for H.pylori at the time of 30 days after the treatment. Result A total of 455 patients were included in 7 hospitals from February 2016 to May 2017 in Gansu province, and there were 189 male patients. Group A1 included 129 cases, group A2 96 cases, group B1 112 cases and group B2 118 cases. The eradication rates that accorded with program data analysis (PP) were A1[46.9%(60/128)], A2[63.8%(60/94)], B1[60.7%(68/112)], B2[68.6%(81/118)] (P<0.004). Compared with group A1, the eradication rate of H.pylori in group B1 and group A2 increased (P<0.001, P=0.032), there was no statistical difference between group B2 and group A2, group B1 and group B2 (P=0.208, P=0.461). According to intentional analysis (ITT), the eradication rates of H.pylori in group A1 were 46.5% (60/129),group A2 were 62.5% (60/96),group B1 were 60.7% (68/112),and group B2 were 68.6% (81/118).The

关 键 词：幽门螺杆菌 药物疗法 联合 中草药 

分 类 号：R573[医药卫生—消化系统]