在对抗风湿性药物对怀孕结果影响的观察性研究中使用行政索赔数据:一个范围审查协议
Shenthuraan Tharmarajah1, Sara Guilcher1,2, Araniy Santhireswaran1
1Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON, Canada.
JBI evidence synthesis
|September 21, 2023
概括
本综述综合了有关疾病修饰性抗风湿药物 (DMARDs) 和在怀孕期间用于风湿病的生物药物的现实数据. 它确定了在观察性研究中报告的不良妊娠结果及其相关代码.
科学领域:
- 类风湿病学 类风湿病学
- 药理学 药理学是指药理学的学科.
- 生殖健康 生殖健康
- 医疗保健服务研究 医疗服务研究
背景情况:
- 患有风湿性疾病的孕妇经常被排除在临床试验之外,导致有关抗风湿性药物安全性的知识差距.
- 尽管存在这些差距,但许多孕妇仍在继续服用抗风湿药物,因为他们认为益处超过风险.
- 现有的审查主要集中在随机试验上,需要从观察性研究中获得现实世界的证据.
研究的目的:
- 根据使用卫生行政数据的观察性研究报告,确定在患有风湿症的孕妇中使用的疾病修饰性抗风湿药物 (DMARD) 和生物药物.
- 描述这些研究中记录的不良妊娠结果 (母体和新生儿),包括它们的定义和相关的诊断/程序代码.
- 在怀孕期间产生关于抗风湿性药物治疗安全性的现实世界的证据.
主要方法:
- 使用基于人口的卫生行政数据进行的观察性研究的范围审查.
- 纳入标准:患有类风湿性关节炎,全身性红斑狼,性脊髓炎或牛皮性关节炎的孕妇接受DMARD或生物制剂.
- 排除标准:随机试验,评论,案例研究,意见稿和摘要. 数据来源包括MEDLINE,Embase,CINAHL和灰色文献.
主要成果:
- 对已识别的研究进行描述性分析,重点关注药物使用和报告的不良妊娠结果.
- 结果的表格呈现,详细说明药物类型,类风湿性疾病,结果定义和相关编码.
- 综合现实世界的数据,以告知临床实践和未来的研究.
结论:
- 来自卫生行政数据库的现实世界数据可以为怀孕期间的抗风湿药物安全性提供宝贵的见解.
- 本综述强调了使用的特定DMARD和生物药物以及相关的不良妊娠结果.
- 需要进行进一步的研究,以解决知识差距,并确保在孕妇中最佳地管理类风湿病.
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