中华人民共和国江苏省启东市Oltipraz化学预防试验

B C Zhang, Y R Zhu, J B Wang, Y Wu, Q N Zhang, G S Qian, S Y Kuang, Y F Li, X Fang, L Y Yu, S De Flora, L P Jacobson, A Zarba, P A Egner, X He, J S Wang, B Chen, C L Enger, N E Davidson, G B Gordon, M B Gorman, H J Prochaska, J D Groopman, A Muñoz, T W Kensler
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引用次数: 0

摘要

Oltipraz已在世界许多地区作为抗血吸虫剂在临床上使用,并且是黄曲霉毒素在大鼠肝癌发生的有效抑制剂。oltipraz的这种化学预防作用主要是由于黄曲霉毒素代谢激活和解毒平衡的改变。1995年,对中华人民共和国启东市黄曲霉毒素暴露和肝癌发生的高危人群进行了随机、安慰剂对照、双盲干预。主要研究目标是确定oltipraz的剂量和时间表,以降低参与者生物体液中黄曲霉毒素生物标志物的水平,并进一步表征剂量限制性副作用。234名健康的符合条件的个体,包括HBV感染者,被随机分为每日125 mg奥替普拉、每周500 mg奥替普拉或安慰剂。在为期8周的干预和随后的8周随访期间,收集血液和尿液标本以监测潜在的毒性并评估生物标志物。总体而言,干预的依从性非常好;大约85%的参与者完成了这项研究。在研究设计中纳入安慰剂组极大地促进了不良事件的客观评价。与安慰剂组(3%)相比,活跃组(每日125毫克组和每周500毫克组分别为18%和14%)中唯一发生频率更高的事件是指尖麻木、刺痛和疼痛。这些症状是可逆的,可以用非甾体类抗炎药缓解。oltipraz在调节黄曲霉毒素生物标志物水平方面的功效评估有待完成,对oltipraz化学预防效用的更全面了解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Oltipraz chemoprevention trial in Qidong, Jiangsu Province, People's Republic of China.

Oltipraz has been used clinically in many regions of the world as an antischistosomal agent and is an effective inhibitor of aflatoxin hepatocarcinogenesis in rats. This chemopreventive action of oltipraz results primarily from an altered balance in aflatoxin metabolic activation and detoxication. In 1995, a randomized, placebo-controlled, double-blind intervention was conducted in residents of Qidong, People's Republic of China, who are at high risk for exposure to aflatoxin and development of hepatocellular carcinoma. The major study objectives were to define a dose and schedule for oltipraz that would reduce levels of aflatoxin biomarkers in biofluids of the participants, and to further characterize dose-limiting side effects. Two hundred thirty-four healthy eligible individuals, including those infected with HBV, were randomized to receive either 125 mg oltipraz daily, 500 mg oltipraz weekly, or placebo. Blood and urine specimens were collected to monitor potential toxicities and evaluate biomarkers over the 8-week intervention and subsequent 8-week follow-up periods. Overall, compliance in the intervention was excellent; approximately 85% of the participants completed the study. Objective evaluation of adverse events was greatly facilitated by inclusion of a placebo arm in the study design. A syndrome involving numbness, tingling, and pain in the fingertips was the only event that occurred more frequently among the active groups (18 and 14% of the daily 125 mg and weekly 500 mg arms, respectively) compared to placebo (3%). These symptoms were reversible and could be relieved with non-steroidal antiinflammatory agents. A more complete understanding of the chemopreventive utility of oltipraz awaits completion of an assessment of the efficacy of oltipraz in modulating levels of aflatoxin biomarkers.

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