莫西沙星仿制药与原研药用于非重症社区获得性肺炎的疗效及安全性回顾性对比研究

Retrospective Comparative Study of Efficacy and Safety Between Generic and Branded Moxifloxacin in Treatment of Non-Severe Community Acquired Pneumonia

目的:比较莫西沙星仿制药与原研药用于非重症社区获得性肺炎的疗效及安全性。方法:回顾性收集2016年1月至2018年12月复旦大学附属金山医院诊断为非重症社区获得性肺炎且使用莫西沙星的患者135例,根据用药情况,分为原研药组(使用原研莫西沙星抗感染治疗)64例、仿制药组(使用仿制莫西沙星抗感染治疗)71例,记录患者的基本信息及治疗情况。比较两组患者的临床疗效、住院时间、退热时间、治疗费用及不良反应发生情况的差异。结果:治疗72h,原研药组、仿制药组患者的总有效率分别为98.4%(63/64)、100.0%(71/71),差异无统计学意义(P>0.05);出院时,原研药组、仿制药组患者的总有效率分别为100.0%(64/64)、100.0%(71/71),差异无统计学意义(P>0.05)。治疗后,两组患者C反应蛋白水平明显优于治疗前,差异均有统计学意义(P<0.05),但组间的差异无统计学意义(P>0.05)。两组患者住院时间、退热时间的差异均无统计学意义(P>0.05),仿制药组患者的治疗费用明显低于原研药组,差异有统计学意义(P<0.05)。原研药组患者的不良反应发生率为12.5%(8/64),明显低于仿制药组的23.9%(17/71),差异有统计学意义(P<0.05)。结论:莫西沙星仿制药与原研药治疗成人非重症社区获得性肺炎的疗效相近,而仿制药的治疗费用较低,但不良反应发生风险较高。

OBJECTIVE:To compare the efficacy and safety between generic and branded moxifloxacin in treatment of non-severe community acquired pneumonia (CAP).METHODS:135 patients diagnosed non-severe CAP received moxifloxacin from Jan.2016 from Dec.2018 admitted into Jinshan Hospital of Fudan University were retrospectively selected and divided into branded group (64 cases,given branded moxifloxacin for anti-infective treatment) and generic group (71 cases,given generic moxifloxacin for anti-infective treatment) according to different medication,patients’ general information and treatment condition were recorded.Differences in clinical efficacy,hospital stays,relief times of fever,treatment expenses and incidences of adverse drug reactions between two groups were compared.RESULTS:After 72-hour treatment,the total effective rates of branded group and generic group were respectively 98.4%(63/64) and 100.0%(71/71),the difference had no statistical significance ( P >0.05);the total effective rates of branded group and generic group when discharge from hospital were respectively 100.0%(64/64) and 100.0%(71/71),the difference had no statistical significance ( P >0.05).After treatment,the CRP levels of both groups were significantly improved,with statistically significant difference ( P <0.05),but there was no significant difference between the two groups( P >0.05). There were no statistical significance in differences in hospital stays and relief times of fever between two groups ( P >0.05),the treatment expense of generic group was significantly lower than that of branded group,with statistically significant difference ( P <0.05).The incidence of adverse drug reactions of generic group was 12.5%(8/64),which was significantly lower than that of branded group (23.9%,17/71),with statistically significant difference ( P < 0.05).CONCLUSIONS:The efficacy of generic and branded moxifloxacin in treatment of non-severe CAP are similar,while generic moxifloxacin has lower treatment expense and higher risk in adverse drug reactions.