荆花胃康胶丸联合三联疗法治疗幽门螺杆菌感染慢性胃炎疗效观察  

Jinghuaweikang Capsules combined with triple therapy in the treatment of Helicobacter pylori associated gastritis: a multicenter,randomized,controlled clinical study

作　　者：张月苗[1] 王婷婷[1] 叶晖[1] 张学智[1] 成虹[1] 李军祥[1] 韩海啸[1] 陈晓伟[1] 杨晋翔[1] 贾云飞[1] 刘永[1] 王慧英[1] 杨蓓[1] 

机构地区：[1]北京大学第一医院中西医结合科,北京100034

出　　处：《中国中西医结合消化杂志》2013年第11期587-590,共4页Chinese Journal of Integrated Traditional and Western Medicine on Digestion

基　　金：北京市中医药科技项目(No.KJTS201-5)

摘　　要：[目的]观察荆花胃康胶丸联合三联疗法治疗幽门螺杆菌(Hp)感染慢性胃炎的临床疗效及安全性。[方法]采用前瞻性多中心随机对照临床研究,将2012年9月至2013年8月于北京市5个中心医院就诊的150例符合入选标准的患者随机分为荆花胃康组(75例)和含铋四联组(75例)。荆花胃康组予兰索拉唑30mg+阿莫西林1 000mg+克拉霉素500mg+荆花胃康胶丸240mg,2次/d,疗程10d(d1-10),之后予荆花胃康胶丸240mg,2次/d,疗程14d(d11-24)治疗;含铋剂四联组予兰索拉唑30mg+阿莫西林1 000mg+克拉霉素500mg+枸橼酸铋钾220mg,2次/d,疗程10d(d1-10)治疗。记录治疗期间发生的不良反应,疗程结束至少4周后采用13 C-尿素呼气试验判断Hp根除情况。[结果]荆花胃康组、含铋四联组Hp根除率试验方案(PP)和意图治疗(ITT)分别为78.08%(57/73)、76.00%(57/75),83.10%(59/71)、78.67%(59/75),差异均无统计学意义(P>0.05)。荆花胃康组腹胀、嗳气症状改善情况均高于含铋四联组,其中以腹胀改善明显(P<0.05)。荆花胃康组1例患者出现不良反应退出治疗,含铋四联组4例患者出现不良反应,2例退出治疗。[结论]荆花胃康胶丸联合三联疗法治疗Hp感染慢性胃炎疗效与含铋四联疗法相近,但前者改善症状明显、不良反应少。[Objective]To explore the efficacy and safety of Jinghuaweikang Capsules plus triple therapy （LACJ）in treatment of Helicobacter pylori（Hp）associated gastritis.[Methods] A total of 150 patients with Hp infection were recruited from 5 hospitals from September 2012 to August 2013.They were divided randomly into LACJ therapy group and bismuth-containing quadruple therapy （LACB） therapy group.Group LACJ received lansoprazole 30 mg＋ amoxicillin 1000 mg＋clarithromycin 500 mg＋ Jinghuaweikang Capsules 240mg,twice a day for 10 days（dl-10）,then Jinghuaweikang Capsules 240mg twice a day for 14 days（d11-24）.Group LACB received lansoprazole 30 mg＋ amoxicillin 1000 mg＋clarithromycin 500 mg＋ bismuth potassium citrate 220mg,twice a day for 10 days（dl-10）.At least 4 weeks after the end of treatment,all patients underwent 13C urea breath test.The side effects were recorded.[Results]The perprotocol（PP）and intention-to-treat（ITT）eradication rates of patients in groups LACJ and LACB were as follows：78.08％ （57/73）,76.00％ （57/75）,83.10％ （59/71）,and 78.67％ （59/75）.No statistical differences existed between the two groups（all P＞0.05）.The symptomatic improvements of abdominal distension and belching were higher than those in group LACB.There was statistical difference in the improvement of abdominal distension between the two groups（P＜0.05）.There was only 1 patient complaining with side effects in group LACJ who quitted the treatment while there were 4 patients in group LACB with 2 of them abandoning the treatment.[Conclusion]The efficacy of LACJ for the treatment of Hp infection patients is similar to LACB,but it improves symptoms better and has relatively fewer side effects.

关 键 词：慢性胃炎 幽门螺杆菌 药物疗法 

分 类 号：R573.3[医药卫生—消化系统]