世界卫生组织、美国与欧盟复方口服避孕药使用标准和指南介绍及启示

Introduction and Enlightenment of Compound Oral Contraceptives Usage Criteria and Guideline Issued by WTO,US and Europe Union

目的:为修订和完善我国复方口服避孕药(COCs)的使用标准和指南提供参考。方法:对世界卫生组织(WHO)、美国与欧盟的COCs使用标准和指南进行介绍和比较。结果与结论:WHO曾先后制定了《避孕方法选用的医学标准》(MEC)、《避孕方法使用的选择性实用建议》(SPR)、《避孕节育知情选择咨询指南》和《计划生育服务提供者手册》等4部关于COCs的使用标准和指南。其中,MEC按照使用者的具体情况进行了适用、慎用、相对禁忌证、绝对禁忌证等分级;SPR主要介绍了如何安全、有效地使用各种避孕方法的具体内容;《避孕节育知情选择咨询指南》使用导读卡的模式,可快速查询避孕节育临床知情选择中的具体方法和步骤;《计划生育服务提供者手册》可为在一线工作的计划生育服务提供者进行实际的工作指导。美国在WHO MEC和WHO SPR的基础上,对个别项目进行了修改和补充,包括对母乳喂养者、COCs对复发深静脉血栓/肺栓塞风险的分级等。欧盟则早于WHO及美国制定了COCs的使用标准和指南,并不断根据最新的循证医学证据对COCs的关键风险点和特定品种进行了提示和更新,包括重新评估使用COCs后的血栓栓塞风险和对达英35®及其仿制药的特别安全提示等。我国应基于WHO、美国与欧盟的COCs使用的最佳证据,结合国情,为广大使用者和医护人员提供最新的、明确的COCs使用标准和指南。

OBJECTIVE：To provide the reference for verifying and improving the usage criteria and guidelines of compound oral contraceptives（COCs）in China. METHODS：The usage criteria and guidelines of COCs were introduced and compared issued by WHO,US and European Union（EU）. RESULTS CONCLUSIONS：WHO has established 4 standards and guidelines for COCs,i.e. Medical Eligibilitu Criteria for Contraceptive Use（MEC）,Selected Practice Recommendations for Contraceptive Use（SPR）,Decision-making Tool for Family Planning Clients and Providers,Family Planning：A Global Handbook for Providers. According to the specific circumstances of the user,MEC has been divided into 4 levels according to the situation of users,i.e. suitable for use,use cautiously,relative contraindication,absolute contraindication. SPR mainly describes the specific issues of how to use various contraception methods safely and effectively. The reading card mode for Decision-making Tool for Family Planning Clients and Providers can query specific methods and steps of contraceptive informed choice fast. Family Planning：A Global Handbook for Providers can provide practical guide for the family planning service providers in the first line. On the basis of WHO MEC and SPR,some projects are modified and added in the US MEC and SPR,including the classification of breast feeding,the risk grade of DVT/PE recurrence,etc. EU have formulated COCs criteria and guidelines earlier than WHO and US;the key points and specific varieties of COCs are prompted and updated based on the latest evidence- based medicine,including a new assessment of the risk of thrombosis after using the COCs,the special safety tips for the use of Diane 35#174;and its generics. Concerning the optimal evidences of current COCs usage of WHO,US and EU,combined with domestic situation,our country may provide the clear and up-to-date usage criteria and guidelines of COCs for its users and medical staff.