甲氨蝶呤、阿糖胞苷鞘内注射严重不良反应分析

Analysis of Serious Adverse Reactions of the Nervous System Induced by Methotrexate and Cytarabine Intrathecal Injection

目的:了解鞘内化疗致严重不良事件的现状,为防范严重不良反应(SADRs)的发生、实施风险管理措施提供依据,探讨发生机制。方法:汇总国内近13年有关鞘内注射甲氨蝶呤(Methotrexate,MTX)和(或)阿糖胞苷(Cytarabine,Ara-C)注射液引起严重神经系统损伤70例以及我院4例,进行统计分析。结果:在74例中,由单独鞘注MTX引起者64.0%,单独鞘注ara-C引起者6.0%,两药合并鞘注引起者30.0%。SADRs的主要表现类型:急性化学性脊神经根炎(63.5%),急性化学脑膜炎(23.0%),白质脑病(2.7%)和视神经炎(4.1%)。81%患者出现SADRs症状在数小时或数天后消失,6.8%患者有后遗症状,12.2%预后差。结论:多种机制作用下发生不良事件。鞘内注射MTX或ara-C均可导致SADRs,以MTX致SADRs的发生率高,提倡规范操作,加强药品安全监管措施,可降低SADRs的发生率。

Objective： To understand the present situation of serious adverse events with intrathecal chemotherapy and provide some gists for preventing the occurrence of serious adverse reactions （SADRs） and implementing some risk management measures for this occurrence. This essay also tried to explore the mechanism of SARs. Method： 4 cases in our hospital and 70 other cases in China, which caused serious neurological damages during the last 13 year by injecting intrathecal methotrexate （MTX） and （or） cytarabine, were collected and statistically analyzed. Result： 64% of 74 eases were caused by injecting MTX alone, 6% was caused by injecting intrathecal Arac alone and 30% was caused by injecting these two drugs once. Here came the main types of performance of SADRs ： acute chemical inflammation of the spinal nerve root （63.5%） , acute chemical meningitis （23.0%） , leukoencephalopathy （2.7%） , and optic neuritis （4.1%）. Symptoms of SADRs in 81% of the patients disappeared in several hours or days following the injections, 6.8% of the patients had their sequels, and 12.2% had their poor prognosis. Conclusion： Many adverse events are caused by a variety of mechanisms. Injecting intrathecal methotrexate or ara-C can lead to SADRs, but the MTX injection has the highest rate of occurrence. Therefore, some standardized operations and drug safety monitoring measures should be promoted and strengthened. Only by doing these things could the occurrences of SADRs can be reduced.