A systematic review and Bayesian analysis of the adverse effects of dienogest

Rui-Rui Li, Qing Xi, Lei Tao, Wei Sheng, Cheng-Cheng Zhao, Yu-Jie Wu
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Abstract

Endometriosis and adenomyosis are two common diseases that impair women’s health, and dienogest is one of the pharmacologic treatments which is the first-line therapeutic option for patients with pelvic pain and individuals who have no desire for immediate pregnancy. The goal of this study was to summarize the current evidence of adverse events associated with dienogest as well as the prevalence of these adverse events during treatment with dienogest. Several databases (PubMed, Embase, Cochrane Central and Clinicaltrials.gov, etc.) and the US FDA Adverse Event Reporting System (FAERS) Public Dashboard were searched on May 31, 2023, using the topic words alongside free words of dienogest and “adverse reaction”. Studies were incorporated into this research if they reported or assessed safety issues or adverse reactions of dienogest during the period of endometriosis treatment or adenomyosis therapy. The extracted information comprised trial design, dienogest and control group demographics, as well as reported side effects. This systematic review comprehended 39 publications in total. The mean age of patients in the included studies was 34.43 years. The follow-up duration varied from 3 to 60 months. Most adverse reactions were common and not serious, and the most common adverse reactions during dienogest medication were abnormal uterine bleeding (55%, 95% CI 37–73%), amenorrhea (17%, 95% CI 2–42%) and swelling (13%, 95% CI 3–28%). Uncommon adverse reactions included dysmenorrhea (0.2%, n = 1), dyspepsia (0.4%, n = 1), and (lower) abdominal pain (1%, 95% CI 0–3%), urticaria (1%, 95% CI 0–3%) and peritonitis (1%, n = 1). Serious adverse reactions including decreased lumbar spine Bone Mineral Density (BMD), depression, peritonitis and so on have been reported. Heterogeneity assessment revealed that patient number and study design are influencing factors to adverse reaction prevalence. Moreover, abdominal pain, diarrhea, nausea and vomiting, back pain and anemia are side effects reported both in the FAERS database and in the systematic review. Dienogest’s most frequent side effects were not severe. Dienogest is generally safe for treating endometriosis and adenomyosis. Nevertheless, people should be aware of serious adverse reactions, such as decreased lumbar spine BMD and hemorrhagic shock.
对地诺孕酮不良反应的系统回顾和贝叶斯分析
子宫内膜异位症和子宫腺肌症是损害妇女健康的两种常见疾病,而地诺孕酮是其中一种药物治疗方法,是盆腔疼痛患者和无立即怀孕意愿者的一线治疗选择。本研究的目的是总结与地诺孕酮相关的不良事件的现有证据,以及使用地诺孕酮治疗期间这些不良事件的发生率。研究人员于 2023 年 5 月 31 日在多个数据库(PubMed、Embase、Cochrane Central、Clinicaltrials.gov 等)和美国 FDA 不良事件报告系统(FAERS)公共仪表板中使用主题词以及自由词 "地诺孕特 "和 "不良反应 "进行了检索。如果研究报告或评估了在子宫内膜异位症或子宫腺肌症治疗期间使用地诺孕酮的安全性问题或不良反应,则将其纳入本研究。提取的信息包括试验设计、地诺孕酮和对照组的人口统计学特征以及报告的副作用。本系统性综述共收录了 39 篇文献。纳入研究的患者平均年龄为 34.43 岁。随访时间从 3 个月到 60 个月不等。服用地诺孕酮期间最常见的不良反应是异常子宫出血(55%,95% CI 37-73%)、闭经(17%,95% CI 2-42%)和肿胀(13%,95% CI 3-28%)。不常见的不良反应包括痛经(0.2%,n = 1)、消化不良(0.4%,n = 1)、(下)腹痛(1%,95% CI 0-3%)、荨麻疹(1%,95% CI 0-3%)和腹膜炎(1%,n = 1)。严重不良反应包括腰椎骨矿密度(BMD)下降、抑郁、腹膜炎等。异质性评估显示,患者人数和研究设计是不良反应发生率的影响因素。此外,腹痛、腹泻、恶心和呕吐、背痛和贫血都是 FAERS 数据库和系统综述中报告的副作用。地诺孕酮最常见的副作用并不严重。戴诺司特治疗子宫内膜异位症和子宫腺肌症一般是安全的。不过,人们应注意严重的不良反应,如腰椎 BMD 减少和失血性休克。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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