目的:子宫内膜异位症和子宫腺肌病是危害妇女健康的两种常见疾病,dienogest是药物治疗方法之一,是盆腔疼痛患者和不希望立即怀孕的人的一线治疗选择。这项研究的目的是总结与糖尿病相关的不良事件的当前证据以及在治疗期间这些不良事件的患病率。
方法:几个数据库(PubMed、Embase,CochraneCentralandClinicaltrials.gov,等。)和美国FDA不良事件报告系统(FAERS)公共仪表板于2023年5月31日进行了搜索,使用主题词以及dienogest和“不良反应”的自由词。如果研究报告或评估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,Dienogest和对照组人口统计学,以及报道的副作用。
结果:本系统综述共包括39篇出版物。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。大多数不良反应常见且不严重,最常见的不良反应是异常子宫出血(55%,95%CI37-73%),闭经(17%,95%CI2-42%)和肿胀(13%,95%CI3-28%)。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%CI0-3%),荨麻疹(1%,95%CI0-3%)和腹膜炎(1%,n=1)。严重的不良反应包括腰椎骨密度(BMD)降低,抑郁症,腹膜炎等均有报道。异质性评估显示,患者数量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,在FAERS数据库和系统评价中都报道了背痛和贫血的副作用.
结论:Dienogest最常见的副作用并不严重。Dienogest通常用于治疗子宫内膜异位症和子宫腺肌症是安全的。然而,人们应该意识到严重的不良反应,如腰椎骨密度下降和失血性休克。
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.