抗结核固定复合剂药物不良反应观察

目的观察国产抗结核FDC在治疗初治涂阳肺结核疗程中的不良反应。为临床治疗和不良反应的处理提供一定参考资料。方法从全省的地理环境和经济状况抽取7个点,每个点共纳入120例初治涂阳肺结核病例,分3组:观察组、对照组1和对照组2,每组40例。对3组病人进行药物不良反应发生率及疗程中不良反应变化趋势观察。结果不良反应总发生率:神经系统20.7%。胃肠道系统19.4%。皮肤系统11.8%。肝功能异常37.3%。白细胞降低方面18.5%。结论以上各系统不良反应发生率与国内多家报道基本一致。从发病趋势来看,只有白细胞降低的发生率随着疗程有升高的趋势,其他不良反应发生率都呈下降趋势。

Observation on side effects of fixed-dose combination of anti-tuberculosis drug

Objective To observe side effects of domestic fixed-dose combination of anti-tuberculosis drug in the treatment for patients with new smear positive pulmonary tuberculosis and to provide reference data for clinical treatment and management of side effects.Method 7 points based on the geography and economic condition were selected,and 120 new smear positive TB cases were enrolled in every point and were divided into three groups： study group,control group 1 and group 2 with 40 cases,respectively.The rate of adverse reaction and the trend of adverse reaction were observed in each group.Results Overall,20.7% adverse reaction occured in nervous system,19.4% in gastrointestinal system,11.8% in skin system,37.3% in abnormal liver function,and 18.5% in leukopenia.Conclusion The rates of adverse reaction of the systems are in consistent with many domestic reports.From the trend of the adverse reaction,only the incidence of leukopenia increases with the treatment duration,other adverse reactions presents a downward trend.