非那雄胺致后非那雄胺综合征风险：基于FAERS数据库的真实世界研究

Risk of Post-finasteride Syndrome Induced by Finasteride: A Real-world Study Based on the FAERS Database

关键词:  后非那雄胺综合征  非那雄胺  报告比值比  药物不良反应报告系统

Key words:  post-finasteride syndrome  finasteride  reporting odds ratio  FDA adverse event reporting system(FAERS)

摘要:

目的 评价非那雄胺致后非那雄胺综合征(post-finasteride syndrome，PFS)的风险，为非那雄胺的临床合理用药及安全风险提供参考。方法 选取FAERS数据库2015年第四季度—2021年第二季度与非那雄胺相关的所有数据进行研究，采用报告比值比(reporting odds ratio，ROR)法对非那雄胺引起PFS风险进行数据挖掘，并对剂量、年龄及诊断做进一步分析。同时探讨不同剂量非那雄胺对PFS事件临床结局的影响。结果 研究结果显示存在非那雄胺与PFS相关的风险信号(ROR 18.69；95%CI 17.05~20.49)。非那雄胺1 mg剂量组性功能障碍风险信号强度明显较其他组高(ROR 889.61；95%CI 746.94~1 059.52)。诊断为雄激素源性脱发组性功能障碍风险信号强度明显较其他组高(ROR 729.58；95%CI 629.09~846.14)。18~44岁的患者更容易发生PFS事件。不同非那雄胺剂量造成PFS事件结局的差异有统计学意义(P<0.05)；PFS事件严重不良反应发生率较高，依次为残疾率(19.07%)、住院率(14.53%)、死亡率(7.07%)。结论 非那雄胺可诱发PFS，且严重不良反应发生率较高。公众及医务工作者必须高度重视及判别非那雄胺引起的不良反应，以保证患者用药安全。

Abstract:

OBJECTIVE To evaluate the risk of post-finasteride syndrome(PFS) induced by finasteride, in order to provide more evidence for clinical rational and safe drug use. METHODS All data related to finasteride from the fourth quarter of 2015 to the second quarter of 2021 were extracted from FAERS database. Reporting odds ratio(ROR) method was used to data mining on the risk of PFS induced by finasteride. Furthermore, subgroup analyses were conducted by dosage, age and diagnosis. The effect of different finasteride dosages on the clinical outcome of PFS was investigated. RESULTS The results observed the risk signal of finasteride-related PFS(ROR 18.69; 95%CI 17.05-20.49). Sexual dysfunction signals for 1 mg finasteride group and diagnosis of androgenic alopecia group were stronger than others [(ROR 889.61; 95%CI 746.94-1 059.52) and (ROR 729.58; 95%CI 629.09-846.14), respectively]. Patients at the age range of 18 to 44 were more likely to have PFS. The outcome of PFS induced by different finasteride dosage had statistical significance(P<0.05). The serious outcome rate of PFS was high by a disability rate of 19.07%, hospitalization rate of 14.53% and death rate of 7.07%. CONCLUSION Finasteride can induce PFS with high incidence of serious adverse reactions. The public and clinicians should pay great attention and distinguish the adverse reactions caused by finasteride, so as to ensure the drug safety for patients.