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

摘要: Oltipraz has been used clinically in many regions of the world as an antischistosomal agent and is effective inhibitor aflatoxin hepatocarcinogenesis rats. This chemopreventive action oltipraz results primarily from altered balance metabolic activation detoxication. In 1995, a randomized, placebo-controlled, double-blind intervention was conducted residents Qidong, People's Republic China, who are at high risk for exposure to development hepatocellular carcinoma. The major study objectives were define dose schedule that would reduce levels biomarkers biofluids participants, further characterize dose-limiting side effects. Two hundred thirty-four healthy eligible individuals, including those infected with HBV, randomized receive either 125 mg daily, 500 weekly, or placebo. Blood urine specimens collected monitor potential toxicities evaluate over 8-week subsequent follow-up periods. Overall, compliance excellent; approximately 85% participants completed study. Objective evaluation adverse events greatly facilitated by inclusion placebo arm design. A syndrome involving numbness, tingling, pain fingertips only event occurred more frequently among active groups (18 14% daily weekly arms, respectively) compared (3%). These symptoms reversible could be relieved non-steroidal antiinflammatory agents. complete understanding utility awaits completion assessment efficacy modulating biomarkers. J. Cell. Biochem. Suppls. 28/29:166–173. © 1998 Wiley-Liss, Inc.