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采用概率单位平行线法对7个厂家7年间生产的血源乙型肝炎疫苗的效力试验结果进行统计分析,并与现行规程的Reed-Muench法计算结果比较,前法可进行线性、平行性检验及可信限率等分析,有效地区分试验误差,准确客观地评价疫苗效力。用此法时,剂量应不少于4组;各剂量反应率应落在经验区间内;EDS50可信限率应≤60%,相对效价可信限率应≤150%;可用合格、不合格或复试三个标准予以评价。本文对疫苗效力的稳定性及试验的一致性进行了质量分析,计得共同回归系数为1.5896、总体相对效价为2.31(2.20,2.42)。上述方法已用BASIC语言编制了程序,可用于常规检定。
The parallel test of probability units was used to analyze the efficacy of blood-borne Hepatitis B vaccine produced by seven factories for seven years. Compared with the results of Reed-Muench method, the former method can be used for linearity and parallelism test And credible limit rate analysis, effectively distinguish the test error, accurately and objectively evaluate the effectiveness of the vaccine. With this method, the dose should not be less than 4 groups; the dose response rate should fall within the empirical range; EDS50 credible rate should be ≤ 60%, relative potency credible rate should be ≤ 150%; available qualified, not Pass or retest three criteria to be evaluated. In this paper, the stability of the vaccine efficacy and consistency of the test were analyzed, the common regression coefficient was 1.5896, the overall relative potency was 2.31 (2.20,2.42). The above method has been programmed in BASIC language and can be used for routine verification.