荆花胃康胶丸治疗幽门螺杆菌感染临床研究文献分析  

Literature analysis of clinical trials on Jinghua Weikang Capsule for the treatment of H. pylori Infection

作　　者：叶晖[1] 张学智[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：《北京中医药》2016年第11期1025-1029,共5页Beijing Journal of Traditional Chinese Medicine

基　　金：北京市中医药科技项目(KJTS2011-15)

摘　　要：目的分析近15年荆花胃康胶丸治疗幽门螺杆菌(H.pylori)感染的国内临床对照研究文献。方法检索2000年1月1日—2014年4月30日中国期刊全文数据库、万方数字化期刊全文数据库、维普中文期刊数据库、中国生物医学文献数据库发表的荆花胃康胶丸治疗H.pylori感染的临床对照研究文献,提取治疗组及对照组用药方案、H.pylori根除率,并从临床研究方法学角度进行评价。结果共纳入47篇文献,涉及病种最多为消化性溃疡33篇次,其次为胃炎23篇次;治疗组以荆花胃康胶丸+质子泵抑制剂+2种抗生素为最常见方案,平均根除率(87.97±7.37)%,对照组以传统三联方案最多见,平均根除率(75.27±9.19)%;文献在随机方法描述、盲法及安慰剂应用、脱落病例及意向性分析、长期随访方面均存在一定的不足。结论荆花胃康胶丸联合西药根除H.pylori具有较好的疗效,未来研究应严格遵循随机对照临床研究原则并于文中描述。Objective To analyze the literatures about the domestic clinical controlled trials on Jinghua Weikang Capsule for treating H. pylori infection in recent 15 years. Methods All the literatures about the clinical controlled trials on Jinghua Weikang Capsule for treating H. pylori infection from 1 January 2000 to 30 April 2014 in CJFD,Wanfang Digital Periodical Database,VIP China Journal Database and Chinese Biomedical Literature Database（ CBM） were retrieved. The therapeutic regimens and H. pylori eradication ratio were collected and these studies were evaluated from the aspect of clinical methodology. Results A total of 47 literatures were included,among which peptic ulcer involved most was researched in 33 articles and gastritis secondly in 23 ones. The most commonly seen regimen in the treatment group was Jinghua Weikang Capsule ＋ PPI ＋ 2 kinds of antibiotics of which the average H. pylori eradication ratio was（ 87. 97 ± 7. 37） %,while the classic triple regimen was mostly used in the control group with the average eradication ratio of（ 75. 27 ± 9. 19） %. Nevertheless,there were still some shortcomings in stochastic method description,blinding method and placebo application,off cases and ITT analysis as well as long-term follow-up found in these literatures. Conclusion Jinghua Weikang Capsule combined with western medicine can achieve preferable effect on eradicating H. pylori. The further researches should strictly abide by the principles of randomized controlled clinical trials and describe the related methods in the manuscripts.

关 键 词：荆花胃康胶丸 幽门螺杆菌 临床研究 文献评价 

分 类 号：R259[医药卫生—中西医结合]