四川省抗结核固定剂量复合制剂与板式组合药治疗效果分析

Effect of Anti-tuberculosis Therapy between the Fixed-dose Combination and Blister Pack in Sichuan Province

目的评价抗结核固定复合制剂(FDC)与板式组合药(板式药)在四川省结核病防治规划中治疗肺结核患者的效果,为完善全省抗结核药品管理及为FDC在全省推广使用提供科学依据。方法以2014年在全省10个县区开展不良反应监测数据为基础,采用对照研究的方法,将使用FDC的5个县区与使用板式药的5个县区分组进行分析研究,对纳入的初治肺结核患者进行对比观察,按照《中国结核病防治规划实施工作指南》要求进行治疗管理,对两组患者的用药剂量、临床表现、治疗效果及不良反应进行分析比较,采用χ2检验,以P<0.05为差异有统计学意义。结果纳入患者1 261例,其中FDC组707例,板式药组554例。2个月和3个月末痰涂片阴转率,FDC组分别为92.38%和93.81%,板式药组分别为97.24%和98.62%。2组患者3个月末痰涂片阴转率差异有统计学意义(P<0.05)。治愈率,FDC组97.62%,板式药组97.24%,2组差异无统计学意义(P>0.05)。在不良反应发生病例数中,FDC组362例(51.20%);板式药组341例(61.55%),经统计学分析,使用板式药和FDC不良反应率差异有统计学意义(χ2=13.488,P<0.05),板式药不良反应率高于FDC。按照两种制剂用量方法计算患者口服药片数,1 261例初治肺结核患者全疗程下来FDC组比板式组减少了24.28%。结论 FDC与板式药的治疗效果相当,但FDC不良反应发生低于板式药,且用药剂量少,规模化推广应用FDC是可行的。

Objective To evaluate the drug effect of fixed- dose combination（ FDC） and the blister pack in tuberculosis（ TB） patient therapy in Sichuan province,provide evidence for policymakers to develop the FDC management and popularization in Sichuan. Methods Based on the data of drug adverse reactions and case- control study method,there were 5 counties using FDC as study group and 5 counties using the blister pack as control group. The drug doses,clinical symptom,treatment outcome and side-effect were compared with χ2 test,and the difference was significant when p 0. 0 5. Results There were 1261 patients separated 707 in study group and 554 in control group. In the end of 2nd and 3rd months,the conversion rate of study group were 92. 38% and 93. 81% respectively,corresponding in the conversion rate of control group were 97. 24% and 98. 62% respectively. In the end of 3rd months,the conversion rate was significantly different（ P〈0. 05） between the study and control group. There was no significant difference（ P〉0. 05） of the cure rate in study group（ 97. 62%）and control group（ 97. 24%）. There were 362 cases（ 51. 20%） of adverse reactions in study group,and 341cases（ 61. 55%） in control group,which was significant different（ χ2= 13. 488,P〈0. 05）. The number of drug tables used in FDC was 24. 28% decreased over the blister pack. Conclusion The effect of FDC and blister pack therapy were similar. The drug adverse reactions of FDC were less than the blister pack,even the dose of FDC was less. The FDC should be expanded further in Sichuan.