TCu220C宫内节育器安全性和有效性的meta分析

A meta-analysis of the safety and effectiveness of TCu220C intrauterine device

目的：评价TCu220C宫内节育器（IUD）的安全性和有效性,比较TCu220C与其他含铜IUD的使用效果,为群众安全避孕提供科学依据.方法：基于PubMed、EMBASE、CENTRAL和POPLINE英文数据库检索,ClinicalTrials、Current Controlled metaRegister、FDA、WHO和相关企业网站检索,CBMDisc、CMCI、CNKI、VIP和Wanfang中文数据库检索,按照PICOS原则制定纳入和排除标准,所得题录导入EndNote X7软件进行文献管理并排除各数据库内重复的文献;采用EpiData 3.1软件进行信息录入,用RevMan 5.3.3和OpenMeta Anglyst软件进行meta分析,加权合并效应,计算率、RR及95％可信区间.采用＆quot;偏倚风险评估＆quot;标准进行文献方法学质量评价,采用GRADE系统进行证据质量的分级.结果：最终纳入28个涉及TCu220C IUD的随机对照临床试验和准随机对照临床试验,包括自1983～ 2014年正式发表的31篇文献,其中中文文献24篇和英文文献7篇.研究对象为43 239例,TCu220C组有15 794例,对照组（使用其他含铜IUD）共27 445例.国内合并研究效应与国外的合并研究效应比较,TCu220C国内外使用的总终止率及与IUD使用相关的终止率、因症终止率、副反应发生率存在显著差异,但尚未见国内外使用TCu220C在脱落率与妊娠率方面的差异.meta分析表明：人工流产术时放置可升高TCu220C脱落的风险;流产后即时/哺乳期放置的因症终止（主要因出血/疼痛终止）风险明显升高.结论：尽管其使用受到放置时期和使用对象的影响,目前仍可有选择地在适宜人群中使用.

Objective： To evaluate the safety and efficacy of TCu220C intrauterine device （IUD）, and to compare the effect of TCu220C with other copper bearing IUDs for providing scientific evidence for safe contraception. Method： Eng- lish databases including PubMed, EMBASE, CENTRAL, POPLINE, websites including Current Controlled metaReg- ister, FDA, WHO and related enterprises, and Chinese databases including CBMdisc, CMCI, CNKI, VIP and Wanfang were searched. The inclusion and exclusion criteria were set according to the PICOS principle. The literatures were im- ported into the endnote X7 software of document management, and repeat literatures in the database were excluded. The data was inputted by EpiData 3.1, and pool trial proportion with weight and derive RR and 95 % confidence interval of meta-analysis was conducted by RevMan 5.3.3 and OpenMeta Analyst. The criteria on assessing risk of bias were used for methodological quality of literatures. The GRADE system was used for grading of evidence quality. Search results; 7097 Chinese and 629 English literatures were preliminarily retrieved, 28 studies involving TCu220C IUD RCTs and quasi RCTs ultimately were recruited, including 31 literatures formally published from 1983 to 2014, which was 7 Eng- lish and 24 Chinese literatures. There were a total of 43239 women, including 15794 IUD users in TCu220C group and 27445 IUD users in control group （using other IUD）. Results： Comparing overall effect of domestic group with abroad group in TCu220C IUD users, there were significant differences of the total termination rate, using related discontinua- tion rate, termination rate for medical reason removal, side effects rate, while no significant differences of pregnancy rate and expulsion rate. Meta analysis results also showed that the risk of expulsion of TCu220C IUD inserted after arti- ficial abortion increased. The risk of medical removal of TCu220C IUD inserted after artificial abortion or lactation sig- nificantly increased （mainly for bleeding and pain）. Conclusions; Although the use of the TCu220C IUD is affected by the inserted periods and the different users, it is still selectively used among the appropriate women.