国产固定剂量四/二药复合剂治疗初治涂阳肺结核患者近期疗效观察

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。

Randomized Control Study on Domestic 4FDC/2FDC Combinations in Initial Treatment of Smear Positive Tuberculosis Patients

Objective To evaluate the treatment outcome,side-effects and acceptability of domestic 4 fixed-dose /2 fixed does combinations in treatment of smear positive tuberculosis patients.Methods 120 new bacteriological positive pulmonary tuberculosis patients from 3 counties were divided into FDCs group(60 cases) and control group(60 cases).The treatment outcome,side-effect and patient's acceptability were studied.Results The sputum negative conversion rates at the 2nd month in FDCs and the control group were 88.68% and 85.19% respectively.And the rates at the end of the chemotherapy(6 months after treatment) were 100.00% and 92.59% respectively.Chest radiography showed remarkable improvement.The resolution of pulmonary lesions in FDCs and the control group accounted for 96.22% and 92.59% respectively.The cavity closure rates were 93.33% in both FDCs and the control groups.The side-effect were 16 cases in FDCs group and 28 cases in the control group.The number of drug tablets used in FDCs group was fewer than that in control group.Acceptability was higher in FDCs group than in control group.Conclusion Domestic fixed-dose combinations show excellent therapeutic efficacy,safety,fewer tablets and easy to be accepted by the patients.The use of FDCs should be further expanded in next step.