头孢哌酮与头孢哌酮/舒巴坦不良反应的回顾性调查分析

Retrospective studies on adverse reactions induced by cefoperazone and cefoperazone/sulbactam

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 adverse reactions induced by cefoperazone （CPZ） and cefoperazone/sulbactam （ CPZ/ SB ）. Methods ： Two hundred and twenty case reports of adverse reactions induced by CPZ and CPZ/SB were collected from database of PLA ADRM Centre between January 2001 and December 2006. The 220 cases were divided into following two groups： the CPZ group （ 115 cases） and the CPZ/SB group （ 105 cases）. The patients in the CPZ and CPZ/SB groups were administered with CPZ 1 g and CPZ/SB （ CPZ：SB = 1：1 ） 2 g dissolved in 100-200 ml of glucose 5% or sodium chloride 0. 9% by intravenously two times daily, respectively, The time of infusion was 30 - 60 minutes, The clinical types and manifestations, severity, outcome, the effects on patients＇original diseases, and the time of onset to adverse reactions were compared between the CPZ group and＇the CPZ/SB group. Results： The main adverse reactions in the two groups were the same, ie, skin and appendages disorders, allergic reactions, gastrointestinal disorders, and their differences of incidence rate were no statistically significant （ P 〉 0. 05 ）. The incidence rate of the fatal or serious （sequelae occurring） adverse reactions was higher in the CPZ group than in the CPZ/SB group （0.9% vs. 0, 2.6% vs. 0）, The time of onset of adverse reactions was slower in the CPZ/SB group than in the CPZ group [ （2. 9± 4. 1 ） days vs. （ 1.9±2.1） days]. The vision abnormality （4 cases）, hyperglyeemia （1 case）, and aphasia （1 case） occurred in the CPZ/SB group. Conclusion： The cefoperazone/sulbatan is safer than cefoperazone, but it may induce some special adverse reactions, which should be paid more attention in clinical practice.