伏立康唑片剂原研药与仿制药治疗侵袭性真菌感染的有效性与安全性比较

Comparison of Clinical Effectiveness and Safety Between Branded and Generic Voriconazole Tablets in the Treatment of Invasive Fungal Infections

目的 评价伏立康唑片剂原研药与仿制药在侵袭性真菌感染治疗中的有效性、安全性。方法 通过医院电子病历系统收集2014年12月~2020年9月入住某院接受伏立康唑治疗侵袭性真菌感染的患者的资料,比较仿制片剂与原研片剂治疗成人患者侵袭性真菌感染的临床有效率、微生物清除率、不良反应发生率。结果 根据纳排标准共纳入271例患者,仿制片剂组103例,原研片剂组168例;在倾向性评分匹配(PSM)后两组各87例。PSM后,仿制片剂组与原研片剂组的临床有效率为分别为57.47%(50/87)和65.52%(57/87),微生物清除率分别为60.94%(39/64)和67.69%(44/65),全因死亡率分别为4.60%(4/87)和6.90%(6/87),两组间临床有效率、微生物清除率和全因死亡率均无明显差异(P=0.275,P=0.423,P=0.515)。仿制组的不良反应发生率为5.75%(5/87),原研组的不良反应发生率为9.20%(8/87),P=0.387。结论 国产仿制伏立康唑片剂和原研片剂在治疗侵袭性真菌感染时疗效一致,安全性相似。

OBJECTIVE To evaluate the clinical effectiveness and safety of generic and branded voriconazole tablets in the treatment of invasive fungal infections(IFI),so as to provide references for clinical rational drug use and scientific management. METHODS The data of patients admitted to a hospital from December 2014 to September 2020 who received voriconazole for treatment of invasive fungal infection were collected through the hospital electronic medical record system.The clinical efficacy, microbial clearance rates and the incidence of adverse reactions between generic and branded tablets in targeted treatment of IFI in adults were compared. RESULTS A total of 271 patients were included, including 103 cases in the generic tablet group and 168 cases in the branded tablet group.After propensity score matching(PSM),there were 87 cases in each group.After PSM,the clinical effective rate of generic tablet group and branded tablet group were 57.47%(50/87) and 65.52%(57/87),the microbial clearance rates were 60.94%(39/64) and 67.69%(44/65),and the all-cause mortality were 4.60%(4/87) and 6.90%(6/87),respectively.There was no significant difference in clinical effective rate, microbial clearance rate and all-cause mortality between the two groups(P=0.275,P=0.423,P=0.515).The incidence of adverse reactions was 5.75%(5/87) in the generic tablet group and 9.20%(8/87) in the branded tablet group(P=0.387). CONCLUSION The generic voriconazole and the branded voriconazole have the same efficacy and similar safety in the treatment of invasive fungal infection.