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河南部分地区抗结核药物固定剂量组合重症不良反应调查

Research on adverse drug reactions of tuberculosis in Henan province

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【作者】 庄严马士文马丽萍刘占峰刘仁明赵富山高三友

【Author】 ZHUANG Yan;MA Shi-wen;MA Li-ping;LIU Zhan-feng;LIU Ren-ming;ZHAO Fu-shan;GAO San-you;Henan Center of Disease and Prenention Control;

【机构】 河南省疾病预防控制中心结核病预防控制所

【摘要】 目的了解结核病固定剂量组合药物治疗方式的重症不良反应发生情况及其对结核病控制策略的影响。方法随访观组合药物短程化疗方案的痰涂片阳性肺结核患者1394例,同时查阅病历,数据资料通过SPSS17.0软件进行统计分析。结果对使用2HRZE/4H3R3、2HRZES/6H3R3E3短程化疗方案的痰菌阳性肺结核患者进行了调查,结果不良反应发生比例为28.26%,主要临床表现有胃肠道反应25.05%,过敏反应20.24%,关节损害16.28%,中枢神经症状13.65%,肝损害2.68%等。各药物不良反应发生比例分别为Z 20.24%,R 19.12%,H 15.26%,E 12.63%,S 4.68%。患者年龄、性别、强化治疗时间等对不良反应的发生均有一定程度的影响。结论固定剂量组合药物短程治疗肺结核不良反应发生比例高于普通剂量,一定程度上影响了患者对化疗方案的接受性。因此,在临床治疗过程中可酌情调整化疗方案。

【Abstract】 Objective To reveal the incidence of Adverse Drug Reactions(ADRs) of fixed dosage drug at tuberculosis chemi-therapy. Methods A prospective cohort study of 1394 cases active tuberculosis(TB) treated with isoniazid(H),rifampicin(R) and pyrazinamide(Z) and were followed. To analyze the rate of ADRs by SPSS 17. 0. Results The incidence rate of ADRs was 28. 26%. Gastric-intestinal ADRs rate was 20. 05%. Anaphylactic reaction was 18. 22%. Knuckle reaction was 16. 28%. Neurological was 13. 65%. Hepatic damage was 2. 68%. And the rate of pyrazinamide ADR was 20. 24%,the rate of rifampicin ADR was 19. 12%,the rate of isoniazide ADR was 15. 26%,the rate of Ethambutol ADR was 12. 63%,The rate of Strepomycin ADR was 4. 68%. The gender,age and treatment time would effect on the ADRs incidence. Conclusion The ADRs rate of fixed dosage anti-tuberculosis drug were higher than flexible dosage. The acceptability of treatment plan was blocked at certain degree by tuberculosis. So it was rational that the changable treatment plan according to circumstances.

【关键词】 结核化疗固定剂量不良反应
【Key words】 TuberculosisChemi-therapyFixed dosageAdverse drug reaction
【基金】 卫生部世界银行贷款科研计划基金(20075167708)
  • 【文献出处】 医药论坛杂志 ,Journal of Medical Forum , 编辑部邮箱 ,2014年03期
  • 【分类号】R521
  • 【下载频次】26
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