Department of Pharmacy, Aviation General Hospital of China Medical University, Beijing, 100012, P.R. China.
Department of Gynaecology and Obstetrics, Aviation General Hospital of China Medical University, Beijing, 100012, P.R. China.
BMC Pharmacol Toxicol. 2024 Aug 1;25(1):43. doi: 10.1186/s40360-024-00767-1.
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.
子宫内膜异位症和子宫腺肌病是两种常见的影响女性健康的疾病，地诺孕素是一种药物治疗方法，是治疗盆腔疼痛和无生育要求患者的一线治疗选择。本研究旨在总结地诺孕素相关不良事件的现有证据，以及地诺孕素治疗期间这些不良事件的发生率。
于 2023 年 5 月 31 日，通过主题词与地诺孕素和“不良反应”的自由词相结合，检索了几个数据库（PubMed、Embase、Cochrane Central 和 Clinicaltrials.gov 等）和美国 FDA 不良事件报告系统（FAERS）公共仪表板。如果研究报告或评估了地诺孕素在子宫内膜异位症治疗或子宫腺肌病治疗期间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、地诺孕素和对照组的人口统计学资料以及报告的副作用。
本系统综述共纳入 39 篇文献。纳入研究中患者的平均年龄为 34.43 岁。随访时间从 3 个月到 60 个月不等。大多数不良反应较为常见但不严重，地诺孕素治疗期间最常见的不良反应为异常子宫出血（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）和（下）腹痛（1%，95%CI 0%-3%）、荨麻疹（1%，95%CI 0%-3%）和腹膜炎（1%，n=1）。已报告严重不良反应包括腰椎骨密度降低、抑郁、腹膜炎等。异质性评估显示，患者数量和研究设计是影响不良反应发生率的因素。此外，腹痛、腹泻、恶心、呕吐、背痛和贫血是 FAERS 数据库和系统综述中均报告的副作用。
地诺孕素最常见的副作用并不严重。地诺孕素治疗子宫内膜异位症和子宫腺肌病通常是安全的。然而，人们应该注意严重的不良反应，如腰椎骨密度降低和出血性休克。
