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目的:通过全国多中心协作观察异帕米星(依克沙)临床不良反应发生情况与发生类型,比较依克沙与其他常用抗菌药物不良反应发生情况,为临床安全用药提供依据。方法:前瞻性、平行对照观察依克沙与其他抗菌药物不良反应发生类型、发生率、相关因素、转归等。结果:36家医院,64个科室共观察依克沙2 100例、对照药物1 960例;其中有效病例依克沙组2 047例,对照组1 852例。依克沙组与对照组分别有51例与56例发生不良反应,与抗菌药物无关、可能无关分别为7例与6例;两组患者不良反应发生率分别为2.15%与2.70%,不具有统计学差异(P>0.05)。全部患者不良反应发生例次为148例次,与抗菌药物有关131例次,两组分别为59与72例次。两组患者不良反应严重程度、与药物相关性、转归等无显著性差异(P>0.05)。依克沙组实验室检查异常多于对照组,特别是尿素氮、肌酐的升高较多;患者异常症状以对照组为多,特别是胃肠道反应更是如此。依克沙组没有发现听力障碍患者。发生不良反应的44例依克沙应用患者与总体依克沙组用药方法、剂量、总量、疗程等均没有区别。依克沙组与对照组患者血尿常规、血生化检查结果没有差异。结论:依克沙不良反应发生率与其他非氨基糖苷类药物相似,主要不良反应为消化道、胃肠道反应,肾毒性少见,不良反应多属轻微。依克沙是一种安全性良好的氨基糖苷类抗菌药物。
OBJECTIVE: To compare the occurrence and types of clinical adverse reactions of ispamipexole (Eclipta) through the national multi-center collaborative study and compare the incidence of adverse reactions between Ezac and other commonly used antimicrobial agents to provide basis for clinical safe medication. Methods: A prospective, parallel controlled observation of the type, incidence, related factors, outcome and other factors of the adverse reactions of Ezac and other antibacterials. Results: In 36 hospitals and 64 departments, there were 100 cases of Ekasar and 1 960 cases of control drugs. There were 2 047 effective cases in Ekisha group and 1 852 cases in control group. There were 51 cases and 56 cases of eczema and control group, respectively. There were 7 cases and 6 cases unrelated to antibacterial drugs. The incidence of adverse reactions in both groups were 2.15% and 2.70% Statistical difference (P> 0.05). A total of 148 cases of adverse reactions occurred in all patients, with 131 cases of antimicrobial agents, the two groups were 59 and 72 cases. There was no significant difference between the two groups in the severity of adverse reactions, drug dependence and prognosis (P> 0.05). Ex ecus test more than the control group, especially urea nitrogen, creatinine increased more; abnormal symptoms in patients with more control group, especially gastrointestinal reactions more so. No patients with hearing impairment were found in the Iksac group. Adverse reactions occurred in 44 cases of patients according to Xisha and Xisha group overall drug use, dosage, total volume, duration of treatment are no different. There was no difference in the results of hematuria between hematuria group and control group according to the routine blood tests. Conclusion: The incidence of adverse drug reactions in Ixachas similar with other non-aminoglycoside drugs. The main adverse reactions are gastrointestinal tract, gastrointestinal tract reaction, rare renal toxicity and mild side effects. Iksac is a safe and good antimicrobial aminoglycoside.