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目的评价国产固定剂量四/二药复合剂(4FDCs/2FDCs)治疗初治涂阳肺结核的疗效、不良反应、可接受性。方法选择成都市3个县(区)120例初治涂阳肺结核患者,随机分为研究(FDC)组和对照组,观察近期痰菌阴转、X线病灶改变、不良反应、可接受性。结果FDC组与对照组2月痰菌阴转率分别为88.68%、85.19%,6月后痰菌阴转率分别为100.00%、92.59%;胸部X线明显改善,FDC组与对照组分别为96.22%、92.59%,空洞缩小、闭合均为93.33%,;不良反应FDC组16例,对照组28例;服药片数FDC组较对照组强化期减少78.82%、继续期减少47.47%;治疗可接受性FDC组明显高于对照组。结论国产FDC治疗结核病高效、安全、用药片数少,易被患者接受,值得进一步推广应用。
Objective To evaluate the curative effect, side effects and acceptability of domestic fixed dose four / two drug combination (4FDCs / 2FDCs) in the treatment of newly diagnosed smear positive pulmonary tuberculosis. Methods A total of 120 newly diagnosed smear-positive pulmonary tuberculosis patients from 3 counties (districts) in Chengdu were randomly divided into study group (FDC) and control group. The sputum negative conversion, X-ray lesions, adverse reactions and acceptability were observed. Results The negative conversion rates of sputum in FDC group and control group were 88.68% and 85.19% respectively in February. The sputum negative conversion rates in June and June were 100.00% and 92.59% respectively. The chest X ray was significantly improved. The FDC and control groups were 96.22%, 92.59%, cavity shrinkage, closure were 93.33%; 16 cases of adverse reactions in FDC group, 28 cases in control group; FDC group compared with the control group decreased by 78.82%, 47.47% Accepted FDC group was significantly higher than the control group. Conclusion The domestic FDC is effective and safe in the treatment of tuberculosis. It is easy to be accepted by patients due to its small number of tablets. It is worth further promotion and application.