资阳市抗结核药物固定剂量复合制剂每日疗法临床效果分析

Clinical Effect of Fixed-dose Combination Daily Therapy for Tuberculosis Patients in Ziyang

目的评价抗结核药物固定剂量复合制剂(FDC)每日疗法的临床应用效果,为结核病防治规划中FDC的推广应用提供参考依据。方法选取资阳市4个县(区)2011-07/2012-03期间,符合纳入"重大新药创制"科技重大专项结核病治疗新剂型研究课题条件的800例肺结核病患者,对其基本情况、依从性调查、不良反应监测记录、治疗和转归情况进行分析。结果纳入的800例患者,其中男性556例(69.5%;平均年龄42.16±21.082岁。初治涂阴肺结核占67%,初治涂阳肺结核占33%。用药后出现的不良反应(ADRs)为201例,ADRs发生率为25.12%,所有发生的不良反应中以胃肠道系统(41.22%)和神经系统(29.77%)最为常见。肝损害的发生率为7.63%。男性(23.02%)与女性(29.92%)ADRs发生率有统计学差异(χ2=4.29,P<0.05);<60岁组(17.21%)ADRs发生率明显低于≥60岁组(28.07%)(χ2=11.24,P<0.05)。治愈255例,完成治疗518例,结核死亡1例,非结核死亡5例,丢失3例。合计治疗完成773例,占96.63%,治愈率达到96.59%,完成治疗率是96.64%。结论服用FDC的患者ADRs总体发生率和肝功能损害发生率均与板式组合药相似,且能提高患者治愈率,可推广使用。

Objective To evaluate the clinical effect of anti- tuberculosis drug with fixed- dose combination（FDC） daily therapy and facilitate the development of promotion strategies on FDC. Methods A total 800 TB patients meet with the inclusion condition of ＂ significant new drug major science and technology research projects of new dosage forms of TB treatment＂ were selected in 4 counties /districts of Ziyang from July,2011 to March,2012. Basic situation,compliance investigations,monitoring and recording of adverse reactions,treatment and outcome were analyzed using EpiData3. 1 and SPSS19. 0. Results Of the 800 patients,556 were males（69. 5%）. The average age was 42. 16 ± 21. 08. Smear negative pulmonary tuberculosis accounted for 67% and smear positive pulmonary tuberculosis accounted for 33 %. Adverse drug reactions（ADRs）occurred in 201 cases,with an incidence of 25. 12%. Of all adverse reactions,the gastrointestinal system（41.22%） and neurological（29. 77%） were the most common ones. Liver damage rate was 7.63%.ADRs in males（23. 02%） and females（29. 92%） showed the statistically difference（ χ2= 4. 29,P〈0. 05）. The incidence of ADRs of those under 60 years（17. 21%） was significantly lower than those above60（28. 07%）（ χ2= 11. 24,P〈0. 05）. There were 255 cases cured and 518 cases completed the treatment. One patient died of TB,5 cases died of non- TB and 3 cases were lost. Altogether 773 cases（96. 63%） completed the treatment,with the cure rate was 96.59%. The completion rate of the treatment was 96. 64%. Conclusion The overall incidence of ADRs and incidence of liver dysfunction of people taking FDC are similar to those taking blister pack drug. FDC can improve the cure rate of patients and thus should be further expanded in future.