Meta‐analysis of interferon randomized trials in the treatment of viral hepatitis C: Effects of dose and duration
Meta‐analysis of interferon randomized trials in the treatment of viral hepatitis C: Effects of dose and duration
复制标题
干扰素随机试验治疗丙型病毒性肝炎的荟萃分析：剂量和持续时间的影响
作者：
T. Poynard;V. Leroy;M. Cohard;T. Thévenot;P. Mathurin;P. Opolon;J. Zarski
本研究的目的是评估与标准干扰素治疗方案（3 MU，每周 3 次，持续 6 个月）相比，更高剂量或更长持续时间对慢性丙型肝炎的益处，并评估干扰素对急性丙型肝炎的疗效。荟萃分析利用了 Peto 等人的研究。以及 Der Simonian 和 Laird 方法，进行异质性和敏感性分析。在慢性肝炎方面，总共纳入了 17 项与对照组相比的试验以及 16 项比较不同干扰素治疗方案的试验。标准方案（3 MU，每周 3 次，持续 6 个月）与丙氨酸转氨酶 (ALT) 完全缓解率和持续 (ALT) 缓解率分别增加 45%（95% 置信区间：35% 至 55%；P < .001）和 21%（13% 至 28%；P < .001）相关，自然病程低于自发反应的 2%。 12 个月时的持续缓解率存在显着的剂量效应（6 与 3 MU 每周 3 次），平均增加 17%（7% 至 28%；P < .001），但 6 个月时则不然。在 3 MU 剂量下，平均为 16%（9% 至 23%；P < .001），和每周 3 次 6 MU 剂量下，平均为 20%（7% 至 33%；P = .003），对持续缓解率有显着的持续反应率（12 个月与 6 个月）。在急性丙型肝炎中，在完全 ALT 缓解（69% vs. 29%；P < .001）、治疗后 12 个月期间的持续缓解率（53% vs. 32%；P = .02）以及丙型肝炎病毒 (HCV)-RNA 清除率（41% vs. 4%；P < .001）方面，3 个月的干扰素治疗显示出与对照相比显着的疗效（4 项试验）。对于从未接受过干扰素治疗的慢性丙型肝炎患者，最佳疗效/风险比是每周 3 次 3 MU，持续至少 12 个月。急性肝炎患者应至少每周 3 次 3 MU 治疗，持续 3 个月。
The aims of this study were to evaluate the benefits of higher doses or of longer duration in comparison with a standard interferon regimen (3 MU three times per week for 6 months) in chronic hepatitis C, and to assess the efficacy of interferon in acute hepatitis C. Meta‐analysis made use of the Peto et al. and the Der Simonian and Laird methods, with heterogeneity and sensitivity analyses. In chronic hepatitis, a total of 17 trials versus controls and of 16 trials comparing different interferon regimens were included. Standard regimen, 3 MU three times per week for 6 months, was associated with an increase of the complete alanine transaminase (ALT) response rate and sustained (ALT) response rate by 45% (95% confidence interval: 35% to 55%; P < .001) and 21% (13% to 28%; P < .001), respectively, with the natural course being less than 2% of spontaneous responses. There was a significant dose effect (6 vs. 3 MU three times per week) upon the sustained response rate at 12 months, with a mean 17% increase (7% to 28%; P < .001), but not at 6 months. There was a significant duration effect (12 vs. 6 months) upon the sustained response rate both at the dose of 3 MU with a mean of 16% (9% to 23%; P < .001), and at the dose of 6 MU three times per week with a mean of 20% (7% to 33%; P = .003). In acute hepatitis C, 3 months of interferon treatment showed significant efficacy versus controls (4 trials), upon the complete ALT response (69% vs. 29%; P < .001), the sustained response rate during the 12 months following treatment (53% vs. 32%; P = .02), and hepatitis C virus (HCV)‐RNA clearance (41% vs. 4%; P < .001). The best efficacy/risk ratio was in favor of 3 MU three times per week for at least 12 months in patients with chronic hepatitis C who had never been treated with interferon. Patients with acute hepatitis should be treated with at least 3 MU three times per week for 3 months.
影响因子：
2
作者：
DEMETS, DL
通讯作者：
DEMETS, DL