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目的:评估左氧氟沙星、加替沙星及莫西沙星等新氟喹诺酮类药物对肺结核患者的早期杀菌活性及延长早期杀菌活性。设计:随机开放临床试验。40例成年新诊断的涂阳肺结核患者(每组10例)分别每日单一接受异烟肼300mg,或左氧氟沙星1000mg,或加替沙星400mg,或莫西沙星400mg的7天治疗。治疗前2天及单药治疗7天期间,每日收集痰液进行定量培养。计量单药治疗开始的头2天(0-2天)及治疗后5天(2-7天)的菌量下降情况,以评估各药的早期及延长早期杀菌活性。对实验室工作人员关于病人治疗分组信息采用单盲法。结果:异烟肼的早期杀菌活性为0.67log10cfu/毫升/天,高于莫西沙星(0.33log10cfu/毫升/天)及加替沙星(0.35log10cfu/毫升/天)。与每日1000mg左氧氟沙星的早期杀菌活性(0.45log10cfu/毫升/天)相比,无统计学差异(P=0.14)。3种氟喹诺酮类药物的早期杀菌活性(0-2天)与延长早期杀菌活性(2-7天)相似。总体说来,氟喹诺酮类药物的延长早期杀菌活性高于异烟肼。结论:莫西沙星、加替沙星及高剂量左氧氟沙星,虽然略低于异烟肼,但均有良好的早期杀菌活性,并具有较高的延长早期杀菌活性。有理由对这些药物敏感的结核病人进行进一步的治疗研究。
Objective: To evaluate the early bactericidal activity and prolong the early bactericidal activity of new fluoroquinolones such as levofloxacin, gatifloxacin and moxifloxacin in patients with pulmonary tuberculosis. Design: Randomly open clinical trials. Forty adult patients with newly diagnosed smear-positive pulmonary tuberculosis (10 in each group) received a single daily dose of isoniazid 300 mg, levofloxacin 1000 mg, gatifloxacin 400 mg, or moxifloxacin 400 mg for 7 days. Sputum was collected daily for quantitative 2 days before treatment and during 7 days of monotherapy. Measure the decrease in the first two days (0-2 days) and the fifth day (2-7 days) after the initiation of monotherapy to assess the early and extended early bactericidal activity of each drug. The laboratory staff on the patient treatment grouping information using single-blind method. Results: The early bactericidal activity of isoniazid was 0.67 log 10 cfu / ml / day, higher than moxifloxacin (0.33 log 10 cfu / ml / day) and gatifloxacin (0.35 log 10 cfu / ml / day). There was no significant difference (P = 0.14) from the early bactericidal activity of levofloxacin 1000 mg daily (0.45 log 10 cfu / ml / day). Three fluoroquinolones early bactericidal activity (0-2 days) and extend the early bactericidal activity (2-7 days) similar. In general, fluoroquinolones extended the early bactericidal activity than isoniazid. Conclusion: Moxifloxacin, gatifloxacin and high-dose levofloxacin, although slightly lower than isoniazid, have good early bactericidal activity, and has a high early-stage bactericidal activity. It is reasonable to conduct further therapeutic studies on these drug-sensitive TB patients.