摘要
瞄准:为长期的丙肝的治疗在高病毒的负担的肝炎病毒遗传型 1b 被表明了的干扰素的功效上的锌补充的有益的效果。这研究与遗传型 2 集中于病人,它比遗传型 1b 对干扰素更敏感,并且使用了一致干扰素(CIFN ) 与或没有锌。方法:我们使随机化有到在 18 MIU 的 CIFN 的长期的丙肝的 83 个病人为 4 wk 的六 times/wk,在 18 MIU 由 CIFN 列在后面为另一 20 wk 的六 times/wk,在有 polaprezinc 的联合 300 mg (政体 A, n=41 ) 或同样单音的治疗(政体 B, n=42 ) 。在政体 A 的 31 个病人和在政体 B 的 33 个病人完成了临床的试用;因为副作用或转移,留下的病人撤退了到另一所医院。结果:支撑了生物化学的反应,作为正常定义 aminotransferase 在 6 瞬间的结束铺平处理以后的观察,是 68% 和 69% ,并且支撑了 virological 反应,在 6 瞬间的结束定义为无法发现的 HCV-RNA 处理以后的观察,分别地为政体 A 和 B 是 54% 和 67% 。结论:与锌相结合的 CIFN 治疗没提高出现由的 CIFN 的效果生物化学, virological 标准。与 polaprezinc 有关的副作用都没被注意。
AIM: The beneficial effect of zinc supplementation on the efficacy of interferon as a treatment for chronic hepatitis C had been demonstrated in hepatitis virus genotype lb of high viral load. This study focused on patients with genotype 2, which is more sensitive to interferon than genotype lb, and used consensus interferon (CIFN) with or without zinc.
METHODS: We randomized 83 patients with chronic hepatitis C to CIFN at 18 MIU six times/wk for 4 wk, followed by CIFN at 18 MIU six times/wk for another 20 wk, in combination with polaprezinc 300 mg (regimen A, n = 41) or as monotherapy (regimen B, n = 42). Thirtyone patients in regimen A and 33 patients in regimen B completed the clinical trial; the remaining patients withdrew because of side effects or a transfer to another hospital.
RESULTS: Sustained biochemical response, defined as a normal aminotransferase level at the end of the 6-too post-treatment observation, was 68% and 69%, and sustained virological response, defined as undetectable HCV-RNA at the end of the 6-too post-treatment observation, was 54% and 67% for regimens A and B, respectively.
CONCLUSION: CIFN treatment combined with zinc did not enhance the effect of CIFN as shown by biochemical, virological criteria. No side effects related to polaprezinc were noted.
基金
Supported by the grant center of Excellence,Biomedical research using accelerator technology,Gunma,Japan
关键词
干扰素
锌元素
慢性丙型肝炎
病理机制
Randomized controlled trial
Consensus interferon
Zinc
Chronic hepatitis C
Genotype 2