国产抗结核固定剂量复合剂与板式组合药的运用研究

目的比较国产抗结核固定四/二药复合剂(FDC)与板式组合药在抗结核治疗中的优劣。方法将湖州市吴兴、南浔区登记的初治痰涂片阳性(涂阳)肺结核病人随机分为研究(FDC)组和对照(板式组合药)组,每组100例,对两组病人的治疗效果、药物不良反应、病人对药物的抱怨度等进行比较。结果 (1)两组患者1月末相关临床症状的好转率,2月末及3月末痰菌阴转率,满疗程治愈率差异均无统计学意义;(2)研究组与对照组患者用药后严重不良反应率分别为4.2%和5.3%,总不良反应发生率分别为13.5%和22.1%,差异均无统计学意义;(3)病人对药物抱怨度,研究组小于对照组,分别为10.4%和21.1%,差异有统计学意义(P0.05)。结论 (1)国产FDC与板式组合药的治疗效果、不良反应率相近,病人的治愈率差异无统计学意义。(2)FDC用药简单,病人较愿意接受,且对不同体重的病人更能体现个体化的服药剂量。(3)在出现不良反应时,板式药较FDC更能鉴别是何药物引起。

Comparison of fixed-dose combination and co-packaged combination drug therapies in patients with tuberculosis

Objective To compare the antituberculosis efficacy of the fixed-dose combination（FDC）and the co-packaged combination drug therapies.Methods Two hundred new registered smear positive pulmonary tuberculosis（TB）patients were randomly and evenly divided into a study group（with FDC drugs）and a control group（with co-packaged combination drugs）in Huzhou city.The therapeutic efficacy and adverse events were compared between the two groups.Results There were no significant differences either in the improvement of related clinical symptoms,or in smear negative conversion rates,or in the cure rates between the two options of treatment.The adverse events and sever adverse events were reported in 13.5% and 4.2% of patients treated with FDC drugs,and in 22.1% and 5.3% of patients treated with co-packaged combination drugs,respectively.The differences were not significant.The complaints of patients were significantly lower in the FDC drug group than in the co-packaged combination drug group（10.4% vs 21.1%,P0.05）.Conclusion There were no significant differences in efficacy of therapy and adverse events between the drug treatments,although patients preferred to use FDC.The component responsible for adverse events can be easily identified if co-packaged combination drug treatment is used.