Oltipraz chemoprevention trial in Qidong, Jiangsu province, People's Republic of China

Bao Chu Zhang, Yuan Rong Zhu, Jin Bing Wang, Yan Wu, Qi Nan Zhang, Geng Sun Qian, Shuang Yuan Kuang, Yan Feng Li, Xi Fang, Lu Yi Yu, Silvio De Flora, Lisa P. Jacobson, Audrey Zarba, Patricia A. Egner, Xia He, Jia Sheng Wang, Baibai Chen, Cheryl L. Enger, Nancy E. Davidson, Gary B. GordonMary B. Gorman, Hans J. Prochaska, John D. Groopman, Alvaro Muñoz, Kathy J. Helzlsouer, Thomas W. Kensler

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)166-173
Number of pages8
JournalJournal of cellular biochemistry
Volume67
Issue numberSUPPL. 28/29
DOIs
StatePublished - 1997

Keywords

  • Aflatoxin B
  • Aflatoxin albumin adducts
  • Biomarkers
  • Enzyme induction
  • Glutathione S-transferases
  • Hepatocellular carcinoma

ASJC Scopus subject areas

  • Biochemistry
  • Molecular Biology
  • Cell Biology

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