白血病病人鞘内注射甲氨蝶呤不良反应文献分析

Analysis of adverse drug reactions after intrathecal injection of methotrexate for leukemia

目的探讨白血病病人鞘内注射甲氨蝶呤治疗白血病不良反应的发生规律,以期指导临床合理用药。方法1979—2007年间白血病病人鞘内注射甲氨蝶呤不良反应报告经检索"清华同方国内医药期刊数据库"及"维普医药期刊数据库"获得。对9篇不良反应病例报道涉及的15例个例报道,8篇临床治疗研究报道2514次鞘内注射相关不良反应进行分析。结果个例报道分析显示,鞘内注射后发生不良反应的男性占73%(11/15),年龄(22±s 14)a;女性占27%(4/15),年龄(28±17)a;ADR分布为双下肢麻木和软瘫占比例较大。从临床治疗研究白血病的文献报道分析,鞘内注射甲氨蝶呤后发生的ADR以头痛、头晕(13.44%,338/2 514),恶心、呕吐(9.98%,251/2 514)和发热(5.05%,271/2 514)为主,仅有0.12%的人发生软瘫、0.44%的人出现双下肢麻木,死亡率0.2%。结论鞘内注射甲氨蝶呤常发生头痛、头晕、恶心、呕吐和发热等ADR,偶见软瘫、双下肢麻木及死亡等严重ADR。

AIM To explore the characteristics of adverse drug reactions （ADR） after intrathecal injection of methotrexate for leukemia in order to conduct the proper clinical application. METHODS A statistical analysis was conducted on the 15 cases of ADR after intrathecal injection of methotrexate and 2 514 times intrathecal injections of methotrexate for leukemia from 1979 to 2007 records of two drug periodicals＇ data base. RESULTS After summarization of the cases＇ report showed that the ADR occurrences after intrathecal injection of methotrexate in male and female were 73 % （11/15） with age of （22 ± s 14） a and 27 % （4/15） with age of （28 ± 17） a, respectively. The main distribution of ADR included paraplegia and numbness of bilateral lower limbs. According to other clinical therapeutic literatures reports, the crucial symptoms of ADR were headache and dizziness 13.44 % （338/2 514）, nausea and vomiting 9.98 % （251/2 514）, and fever 5.05 % （271/ 2 514） ; but the occurrences of paraplegia and numbness of bilateral lower limbs were only 0.12 % and 0.44 % respectively; with 0.2 % mortality. CONCLUSION The ADRs after intrathecal injection of methotrexate for leukemia include the headache, dizziness, nausea, vomiting and fever, etc; but occasionally with paraplegia, numbness of bilateral lower limbs, or even death.