国产醋酸奥曲肽治疗食管胃底静脉曲张破裂出血的系统评价

Efficacy and safety of China-made acetic octreotide in the treatment of bleeding from esophageal varices:a systematic review

目的:评价国产醋酸奥曲肽注射液治疗肝硬化门静脉高压食管胃底静脉曲张急性出血的疗效和安全性.方法:计算机检索Cochrane图书馆临床对照试验,Medline、PubMed及中国期刊全文数据库,中国生物医学文献数据库等中外文数据库.并辅以文献追溯、手工检索等方法收集查阅文献.凡评价国产醋酸奥曲肽注射液治疗肝硬化门静脉高压食管胃底静脉曲张急性出血的随机对照试验,无论语种、是否采用盲法均纳入,应用国际Cochrane协作网系统评价方法对其疗效和安全性进行Meta分析.结果:共纳试验5个包括患者557例.试验组285例,对照组272例.国产醋酸奥曲肽注射液组与善宁组比较,2组在疗效和安全性方面的差异无统计学意义,疗效合并OR=1.14,95%CI:0.64-2.05,P=0.62;不良反应的相对危险度RR=1.61,95%CI:0.57-4.50,P=0.93;对呕血和黑便病例的疗效Meta分析差异也无统计学意义.结论:国产醋酸奥曲肽注射液治疗食管胃底静脉曲张急性出血疗效与善宁相当,是安全有效的.

AIM：To evaluate the efficacy and safety of China-made acetic octreotide in the treatment of bleeding from esophageal varices by comparing with imported octreotide（Sandostatin）.METHODS：A computer-based search of the Cochrane library,Medline,PubMed,China Journal Full-text Database and CBM database,in combination with a manual search of relevant journals,was performed to identify relevant randomized controlled trials that evaluated the use of acetic octreotide in the treatment of bleeding from esophageal varices,regardless of language.A meta-analysis was conducted using the method for Cochrane systematic review.RESULTS：Five trials involving 557 patients,including 285 treated with China-made acetic octreotide and 272 treated with Sandostatin,were included in the systematic review.No significant differences were found in the efficacy（OR=1.14;95%CI：0.64-2.05;P=0.62） and safety（RR=1.61;95%CI：0.57-4.50;P=0.93） between the two groups.There were also no significant differences in the frequency and amount of hematemesis and black stools between the two groups.CONCLUSION：China-made acetic octreotide is effective and safe in the treatment of bleeding from esophageal varices in comparison with Sandostatin.