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目的:评价国产注射用利福平灭菌粉末(维夫欣)治疗肺结核病的临床有效性和安全性,并与相同进口制剂比较。方法:121例初治菌阳肺结核患者采用1∶1随机分组方法分为试验组和对照组,前者采用国产制剂维夫欣,后者采用进口制剂尼福,其余治疗方案相同,评价2组治疗1、2月后痰菌阴转、X线检查结果和不良反应等。结果:完成疗程可评价疗效者共116例,2组各为58例,治疗2个月后试验组和对照组痰涂片阴转率分别为86·21%、91·38%(X2=0·780,P=0·377),痰结核分枝杆菌培养的转阴率分别为91·38%和93·10%(X2=0·120,P=0·729);2组X线检查显效率分别为82·76%和70·69%(X2=2·365,P=0·124),有效率均为96·55%;2组不良事件发生率分别为8·20%和11·67%;各指标比较均无显著性差异。结论:2种制剂治疗肺结核病的疗效、安全性及耐受性相似。
OBJECTIVE: To evaluate the clinical efficacy and safety of domestic rifampicin-sterilized powder for injection (Wiefuxin) in the treatment of pulmonary tuberculosis and to compare with the same imported preparations. Methods: One hundred and twelve newly diagnosed bacillary positive pulmonary tuberculosis patients were divided into experimental group and control group by 1: 1 randomized method. The former was treated with domestic drug Vivexin and the latter with Nifu imported. The rest of the treatment regimens were the same, 1, 2 months after sputum negative conversion, X-ray examination results and adverse reactions. Results: The complete course of treatment evaluable efficacy of a total of 116 cases, two groups of 58 cases, two months after treatment, the sputum smear negative conversion rates of the experimental group and the control group were 86.21%, 91.38% (X2 = 0 · 780, P = 0.377). The negative conversion rates of Mycobacterium tuberculosis were 91.38% and 93.10% respectively (X2 = 0.122, P = 0.729) The effective rates were 82.76% and 70.69% respectively (X2 = 2.365, P = 0.124), the effective rates were 96.55%. The incidences of adverse events were 8.2% and 11.2% in the two groups · 67%; There was no significant difference between each index. Conclusion: The efficacy, safety and tolerability of the two preparations in the treatment of pulmonary tuberculosis are similar.