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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。
Objective To investigate the incidence of leukemia patients with leukemia intrathecal methotrexate treatment of leukemia adverse reactions, with a view to guiding clinical rational use of drugs. Methods The adverse reactions of intrathecal methotrexate in patients with leukemia during the period of 1979-2007 were obtained by searching “Database of Tsinghua Tongfang Domestic Medicine and Periodicals” and “Database of Medicine of Vip Pharm”. A total of 15 reports of 9 cases of adverse reactions were reported. 8 clinical trials reported 2514 cases of intrathecal injection-related adverse reactions. RESULTS: A case-control study showed that 73% (11/15) of men experienced adverse reactions after intrathecal injection, with a mean age of (22 ± s 14) a; women 27% (4/15) and age 28 ± 17 a; ADR distribution is a large proportion of numbness and soft-limbs in both lower extremities. From clinical reports of leukemia in clinical studies, ADR occurred after intrathecal methotrexate occurred in patients with headache, dizziness (13.44%, 338/2 514), nausea, vomiting (9.98%, 251/2 514) and fever 5.05%, 271/2 514). Only 0.12% had soft paralysis, and 0.44% had numbness of lower extremity with a mortality rate of 0.2%. Conclusion Intrathecal methotrexate often causes headache, dizziness, nausea, vomiting and fever and other ADR, occasionally soft paralysis, numbness and death of both lower extremities and other serious ADR.