头孢哌酮钠舒巴坦钠致新生儿凝血功能异常36例分析

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K1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。

Analysis of cefoperazone sodium and sulbactam sodium-induced blood coagulation dysfunction in 36 neonates

Objective To explore the occurrence and related factors of blood coagulation dysfunction due to cefoperazone sodium and sulbactam sodium in neonates. Methods Case records of the neonates who developed blood coagulation dysfunction due to cefoperazone sodium and sulbactam sodium for injection （ ADR group） in Zaozhuang Municipal Hospital of Shandong Province from May 2007 to April 2012 were collected and retrospectively analysed. The general situation, the situation of drug use, clinical symptoms, laboratory examinations activated partial thromboplastin time （APTT）, prothrombin time （PT）, thrombin time （TT）, and fibrinogen （FIB）], and clinical outcomes of the neonates were recorded. The results of coagulation function tests of normal neonates for the control （ the normal control group） were obtained from a literature. Related factors of adverse reactions were analysed in Logistic regression. Results There were 36 neonates （19 males and 17 females） in the ADR group, which accounted for 4.7% of 768 neonates. There were 32 neonates （25 males and 7 females） in the control group. The values of APTr, PT, and TT in the ADR group were longer markedly 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） svs. （16.3±3.7） s,P〈0.01]. The FIB level was lower markedly than that in the control group （ 1.7 ± 0.4 ） g/L vs. （2.0 ± 0.6） g/L, P 〈 0. 05 ]. Gestational age 〈 34 weeks, weighing 〈 2000 g, and birth asphyxia history were risk factors of blood coagulation dysfunction induced by sodium cefoperazone sodium and sulbactam. After the drug withdrawal, vitamin K1 and other supportive treatments were given, the blood coagulation function of 34 neonates （94.4%） returned to normal within 7 days and 2 neonates （5.6%） died of deterioration of their primary diseases. Conclusion The incidence of neonates＇blood coagulation dysfunction induced by sodium cefoperazone sodium and sulbactam is 4.7% and risk factors are preterm birth, low weight, and history of asphyxia.