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背景:利福喷丁在香港的临床研究。目的:评价研究中所使用的中国利福喷丁的生物利用度。设计:通过微生物学试验测定给予四批药物的287名病人血清标本中利福喷丁的含量结果:从40名病人中随机分配给西方或中国的利福喷丁所获得的首批曲线区域图对比显示:中国利福喷丁生物利用度是西方药物的74％。第二批药的生物利用度发现是西方的66％,最后二批利福喷丁的剂量由计划的600mg增至750mg或短时增至900mg,则血清中浓度同西方药获得的相类似,在每批药使用期间生物利用度没有变化。结论:通过比较开始二批和最后二批试验的结果将估价利福喷丁剂量对疗效和毒性的作用。
Background: Clinical study of rifapentine in Hong Kong. Objectives: To evaluate the bioavailability of Chinese rifapentine used in the study. Design: Determination of rifapentine levels in serum samples from 287 patients given four batches of drugs by microbiology test Results: First series of curve maps obtained from 40 patients randomly assigned to either western or Chinese rifapentine The comparison shows that Chinese bioavailability of rifapentin is 74% of that of western drugs. The bioavailability of the second drug was found to be 66% in the West and the final dose of rifapentine was increased from 600 mg to 750 mg or short-term to 900 mg in the second batch. The serum concentrations were similar to those obtained with Western drugs, There was no change in bioavailability during each batch of drug use. Conclusion: The effect of rifapentine doses on efficacy and toxicity will be assessed by comparing the results of the two and the last two batches of trials.