干扰素α治疗肝炎的序贯设计

Sequential design of interferon-alfa in treating hepatitis

干扰素α是人α１型基因工程干扰素，由上海生物制品研究所研制。临床验证，与同类产品比较具有疗效好、副作用少的优点。本文用序贯分析检验干扰素α对慢性乙型肝炎的疗效。２种设计，双向及单向序贯试验的试验标准分别为θ＝０．８，２α＝０．０１，β＝０．０５及Ｐ１＝０．６，Ｐ０＝０．２，α＝β＝０．０１。序贯图显示实验线触及上界，结论为干扰素α治疗慢性乙型肝炎有效。

Interferon α,the recombinant human interferon α-1,was developed by Shanghai Institute of Biological Products.It showed better efficacy and milder side effects during clinical trials in comparison with similar products. Sequential trials were designed to detect the advantage of interferon α over the placbo in treatment of chronic hepatitis B.Two types of sequential trials,one-and two-sided designs,were adopted.The criteria of the two designs were θ=0.8,2α=0.01,β=0.05 and P1=0.6,P0=0.2,α=β=0.01respectively.As the sequential charts showed, the sample paths of interferon α crossed the upper boundaries with the conclusion that interferon α was preferred over the placebo.