我国示范乡镇卫生院基本药物循证评价与遴选之二十:人工流产

Evidence-Based Evaluation and Selection of Essential Medicine for Township Health Centre in China: 20.Abortion

目的基于疾病负担,循证评价与遴选我国乡镇卫生院人工流产基本药物。方法应用本系列研究之二制定的基本药物循证评价与遴选标准、方法、流程,参考国内外循证或权威指南的推荐意见,结合国内相关临床研究证据,循证评价并推荐相关药物。主要采用RevMan 5.1、GRADEpro 3.6等软件处理数据、评价证据质量。结果①共纳入4个指南,含循证指南2个。②指南涉及人工流产基本药物8种及手术流产后所用抗生素4种。③药物流产基本药物遴选根据WHO EML(2011版)、NEML(2009版)、中国国家处方集(2010年版)、指南推荐及证据数量和质量,强推荐米非司酮、米索前列醇、缩宫素,不推荐前列腺素。④缩宫素、米非司酮、米索前列醇国内均有相关文献,并有相应剂型和规格上市。⑤国内研究表明:米非司酮配伍米索前列醇和缩宫素安全有效、简便易行、可接受性较好。结论人工流产推荐用药:①米非司酮配伍米索前列醇。米非司酮片25～50 mg,每日2次,连服2～3日,总量150 mg。米索前列醇0.6 mg,在服用米非司酮36～48小时后,空腹口服。②缩宫素,药流胎盘娩出后肌肉注射5～10 U,用于减少药流阴道出血量及缩短出血时间。建议统一规范判效标准,提高临床研究设计和实施质量。

Objective To evaluate and select essential medicine for abortion using evidence-based approaches based on the burden of disease.Methods By means of the approaches,criteria,and workflow set up in the second article of this series,we referred to the recommendations of evidence-based or authority guidelines from inside and outside China,collected relevant evidence from domestic clinical studies,and recommended essential medicine based on evidence-based evaluation.Data were analyzed by Review Manager（RevMan） 5.1 and GRADE profiler 3.6 to evaluate quality of evidence.Results （1） Four guidelines on medicine for abortion were included,two of which are based on evidence.（2） Included guidelines referred to eight essential medicines used in drug abortion and four antibiotics used after abortion surgery.（3） According to WHOEML（2011）,NEML（2009）,CNF（2010）,other guideline and the quantity and quality of evidence,we offered a strong recommendation for misoprostol,mifepristone,oxytocin except prostaglandins used in abortion.（4） Published literature on oxytocin,misoprostol and mifepristone were found.Oxytocin with the dosage form and specification corresponding to guidelines has been marketed in China.Oxytocin（in vial,10 U∶1 mL） cost 1.5 yuan/injection.Mifepristone（tablet,25 mg×1） cost 13.0 to 27.5 yuan/tablet.Misoprostol（0.2 mg×3） cost 2.8 to 3.7 yuan/ tablet.（5） Results of domestic studies indicated that mifepristone combined with misoprostol and oxytocin was safe,efficient,convenient and applicable to the treatment of abortion.Conclusion For abortion：（1） We make a recommendation for mifepristone plus misoprostol.Mifepristone（25 to 50 mg/tablet） is orally taken twice a day,continually for 2 to 3 days,the total dose of 150 mg for three days.Misoprostol（0.2 mg/ tablet） 0.6 mg is orally given on an empty stomach within 36 to 48 hours after the intake of mifepristone.（2） Oxytocin（5 to 10 U in vial） injected after delivering the placenta can reduce the volume and time of vaginal bleeding.In future,clinical study should be standardized in order to improve design and implementation quality.