头孢克肟口服制剂生物等效性的Meta分析

Meta-analysis of Bioequivalence of Cefixime Oral Preparations

目的:系统评价头孢克肟口服制剂的生物等效性。方法:计算机检索中国学术期刊网络出版总库(CNKI)、万方数字化期刊全文数据库、中国生物医学文献数据库,检索时间范围均为建库至2017年8月,由2名评价者按照纳入标准与排除标准以及Cochrane协作网推荐的方法独立筛选文献、提取资料并评价纳入文献的方法学质量后,采用Rev Man5.3软件进行Meta分析。结果:共纳入26篇文献,670例受试者。Meta分析结果显示,头孢克肟口服制剂各亚组与参比制剂的AUC0-∞、AUC0-t、Cmax差异无统计学意义(P>0.05)。结论:本研究所纳入头孢克肟口服制剂与参比制剂生物等效性相当,但目前相关研究较少,年代较早且质量不高,尚需开展更多合理设计、严格执行的高质量RCT进一步补充和验证。

Objective ：To systematic evaluate the bioequivalence of Cefixime oral preparations. Methods ：CNKI,WanFang database,Chinese Biomedical Literature Database were electronically searched for relevant studies from inception to Mar.2017. According to the inclusion and exclusion criteria as well as the methods recommended by the Cochrane Collaboration,two reviewers independently screened literature to extract data and assess the methodological quality of the included studies. Then,Meta-analysis was performed by using RevMan5.3. Results ： A total of 26 studies were included,involving 670 cases. The result of Meta-analysis showed that there was no statistically significant difference in AUC 0-∞ 、AUC 0-t 、C max between Cefixime oral preparations and reference preparations（ P〉0.05）. Conclusion ：Cefixime oral preparations were bioequivalence with reference preparations in this Meta-analysis. It still need more reasonable design, strict implementation and high-quality randomized controlled trials to further confirmed.