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目的探讨头孢哌酮钠舒巴坦钠致新生儿凝血功能异常的发生情况和相关因素。方法收集山东省枣庄市立医院2007年5月至2012年4月注射用头孢哌酮钠舒巴坦钠致凝血功能异常新生儿病例(不良反应组)的临床资料进行回顾性分析,记录患儿一般情况、用药情况、临床症状、凝血功能检查[血浆活化部分凝血酶时间(APTT),凝血酶原时间(PT),凝血酶时间(TT),纤维蛋白原(FIB)]结果和临床转归。用于对照的正常新生儿(正常对照组)凝血功能检查结果引自文献。采用Logistic回归分析方法分析不良反应相关因素。结果不良反应组共纳入新生儿36例(男19例,女17例),占同期应用该药新生儿768例的4.7%。正常对照组新生儿32例(男25例,女7例)。不良反应组APTT、PT、TT均明显长于正常对照组[(50.3±14.4)s比(42.5±6.4)s,P<0.05;(16.2±3.9)s比(13.4±2.6)s,P<0.01;(21.2±4.5)s比(16.3±3.7)s,P<0.01];而FIB明显低于正常对照组[(1.7±0.4)g/L比(2.0±0.6)g/L,P<0.05]。出生胎龄<34周、体重<2000 g、出生窒息史是头孢哌酮钠舒巴坦钠致新生儿凝血功能异常的高危因素。停药并给予维生素K_1等对症支持治疗后,34例(94.4%)凝血功能在7 d内恢复正常,2例(5.6%)因原发病恶化死亡。结论头孢哌酮钠舒巴坦钠致新生儿凝血功能异常的发生率为4.7%。早产、低体重、有窒息史是头孢哌酮钠舒巴坦钠致新生儿凝血功能异常的高危因素。
Objective To investigate the incidence of neonatal coagulation dysfunction caused by cefoperazone sodium and sulbactam sodium and related factors. Methods A retrospective analysis was conducted on the clinical data of neonatal cases of coagulation abnormalities caused by injection of cefoperazone sodium and sulbactam sodium (ADR) from May 2007 to April 2012 in Zaozhuang Municipal Hospital of Shandong Province. The clinical data of children were collected and recorded. The general condition and medication Clinical symptoms, coagulation tests [plasma activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT), fibrinogen (FIB)] results and clinical outcomes. Normal neonates used for control (normal control group) The results of coagulation tests were quoted from the literature. Logistic regression analysis was used to analyze the related factors of adverse reactions. Results A total of 36 newborns (19 males and 17 females) were enrolled in the ADR group, accounting for 4.7% of 768 newborns in the same period. The normal control group of 32 newborns (25 males and 7 females). APTT, PT and TT in the adverse reaction group were significantly longer than those in the control group [(50.3 ± 14.4) s vs (42.5 ± 6.4) s, P <0.05; (16.2 ± 3.9) s vs. (13.4 ± 2.6) s, P <0.01 ; (21.2 ± 4.5) s vs (16.3 ± 3.7) s, P <0.01], while the FIB was significantly lower than that of the control group [(1.7 ± 0.4) g / L ]. Birth gestational age <34 weeks, body weight <2000 g, history of birth asphyxia cefoperazone sodium and sulbactam sodium caused coagulation disorders in high risk factors. After stopping the treatment and giving symptomatic supportive treatment such as vitamin K_1, coagulation function returned to normal in 34 cases (94.4%) within 7 days and death in 2 cases (5.6%) due to deterioration of primary disease. Conclusion Cefoperazone sodium and sulbactam sodium caused coagulation abnormalities in neonates with a prevalence of 4.7%. Premature delivery, low birth weight and history of asphyxia are risk factors for coagulation dysfunction in neonates with cefoperazone sodium and sulbactam sodium.