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目的:调查比较使用头孢哌酮和头孢哌酮/舒巴坦患者不良反应的发生情况。方法:从解放军药品不良反应监测中心数据库中筛选2001年1月至2006年12月,应用头孢哌酮和头孢哌酮/舒巴坦静脉滴注发生不良反应的病例报告220例。分为2组:头孢哌酮组115例,头孢哌酮/舒巴坦组105例。分别给予头孢哌酮1.0g,头孢哌酮/舒巴坦2.0g(头孢哌酮:舒巴坦=1:1),均溶于5%葡萄糖或0.9%氯化钠注射液100～200ml中,2次/d静脉滴注,滴注时间30～60min。回顾性比较2组不良反应的类型、临床表现、严重程度、转归、对原患疾病的影响及发生时间等方面的差异。结果:2组的主要不良反应相同,均为皮肤及其附件损害、过敏反应及胃肠道反应,其发生率的差异无统计学意义(P>0.05)。2组不良反应转归和对原患疾病的影响不同,头孢哌酮组致死或严重(有后遗症)不良反应的构成比较头孢哌酮/舒巴坦组高,分别为0.9%、0和2.6%、0。头孢哌酮组不良反应出现时间为(1.9±2.1)d,头孢哌酮/舒巴坦组的出现时间较晚,为(2.9±4.1)d。头孢哌酮/舒巴坦组出现4例视觉异常、1例血糖升高和1例声音嘶哑患者。结论:头孢哌酮与头孢哌酮/舒巴坦的主要不良反应相似;头孢哌酮/舒巴坦的安全性更好,但应注意其引起的某些特殊不良反应。
OBJECTIVE: To investigate the incidence of adverse reactions in patients receiving cefoperazone and cefoperazone / sulbactam. Methods: From January 2001 to December 2006, 220 cases of adverse reactions were reported by using intravenous infusion of cefoperazone and cefoperazone / sulbactam from the database of People’s Liberation Army Drug Adverse Reaction Monitoring Center. Divided into two groups: 115 cases of cefoperazone group, cefoperazone / sulbactam group of 105 cases. Cefoperazone 1.0 g, cefoperazone / sulbactam 2.0 g (cefoperazone: sulbactam = 1: 1) were given respectively in 100-200 ml of 5% glucose or 0.9% sodium chloride injection, 2 times / d intravenous infusion, infusion time 30 ~ 60min. The types, clinical manifestations, severity, outcomes of the two groups of adverse reactions, the impact on the original disease and the occurrence time were retrospectively compared. Results: The main adverse reactions of the two groups were the same, which were the skin and its accessory damage, allergic reaction and gastrointestinal reaction. There was no significant difference in the incidence between the two groups (P> 0.05). The adverse effects of cefoperazone / cefoperazone / sulbactam vs cefoperazone / sulbactam were 0.9%, 0% and 2.6%, respectively, in the cefoperazone group. , 0. In cefoperazone group, the adverse reaction time was (1.9 ± 2.1) d, and cefoperazone / sulbactam group appeared later (2.9 ± 4.1) days. There were 4 cases of visual abnormalities in cefoperazone / sulbactam group, 1 case of hyperglycemia and 1 case of hoarse voice. Conclusions: The main side effects of cefoperazone and cefoperazone / sulbactam are similar; the safety of cefoperazone / sulbactam is better, but some special side effects should be noted.