摘要
目的:通过真实世界研究探索替加环素原研药(商品名:泰阁)和仿制药(商品名:泽坦)的有效性、安全性。方法:回顾性收集某大型三甲医院中使用过泰阁或泽坦患者的真实世界数据,分为泰阁组和泽坦组进行研究,借助PSM方法调整组间差异,比较2组的有效性和安全性。结果:有效性分析显示:72 h有效率(77.5%vs.72.8%,P=0.325 5),出院时有效率(61.5%vs.59.2%,P=0.523 7),细菌清除率(24.9%vs.34.3%,P=0.144 7)在2组差异均无统计学意义;体温、CRP和PCT在2组差异也无统计学意义(P>0.05);安全性分析显示:泰阁组与泽坦组不良反应发生率差异有统计学意义(8.28%vs.26.04%,P<0.01),但不良事件发生率以及Cr、ALT、TbiL、Hb、PLT异常率差异均无统计学意义(P>0.05)。结论:泽坦和泰阁的有效性无明显差异,而泽坦的安全性低于泰阁。
OBJECTIVE To explore the safety, effectiveness of tigecycline original(tygacil)and generic drug(zetan)by real-world research.METHODS We can find those patients who had used tygacil or zetan in a large tertiary hospital, and then retrospectively collected their information on their clinical treatment.After that, we divided them into tygacil group and zetan group for research and adjusted the differences between groups with the help of PSM analysis method in order to ensure that the two sets of data are comparable.And then compared the efficacy and safety differences between tygacil and zetan group.RESULTS The effectiveness analysis shows: 72 h cure rate(77.5% vs.72.8%,P=0.325 5),cure rate at discharge(61.5% vs.59.2%,P=0.523 7),bacterial clearance rate(24.9% vs.34.3%,P=0.144 7)and there was no statistical difference in body temperature、CRP and PCT.The results of the safety analysis were as follows: the incidence of adverse reactions was statistically significant(8.28% vs.26.04%,P<0.01).The incidence of adverse events, abnormal rates of Cr, ALT,TbiL,Hb, and PLT were not statistically significant(P>0.05).CONCLUSION There is no significant difference between the effectiveness of zetan and tygacil, while the safety of zetan is lower than that of tygacil.
作者
刘雨蒙
熊堉
胡琪
龙恩武
王国俊
LIU Yu-meng;XIONG Yu;HU Qi;LONG En-wu;WANG Guo-Jun(School of Pharmacy of Southwest Medical University,Sichuan Luzhou 646000,China;Institute of Materia Medica,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100050 Chind;Personalized Drug Therapy Key Laboratory of Sichuan Province,Department of Pharmacy of Sichuan Academy of Medical Science&Sichuan Provincial People's Hospital,School of Medicine of University of Electronic Science and Technology of China,Sichuan Chengdu 610072,China)
出处
《中国医院药学杂志》
CAS
北大核心
2022年第22期2378-2382,共5页
Chinese Journal of Hospital Pharmacy
作者简介
刘雨蒙,男,硕士在读,初级药师,研究方向:临床药学;通讯作者:王国俊,女,硕士,主任药师,研究方向:临床药学。
