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卡介苗自从1921年以来用于预防结核病,60年代以来又用于肿瘤的免疫刺激。预防性和免疫刺激性两种作用都曾有人对之作出评价并加以报道,但却得出互相矛盾的正反两方面结论。为了客观地评价并解释卡介苗保护作用的功效、有效性和效率,必须考虑以下事实:(1)一些从事生产的实验室业已开发了数种卡介苗次代株,它们的残余毒力各不相同,而后者对免疫原性和反应原性起着决定作用;(2)用了各种液体的和冷冻干燥的卡介苗生产方法,结果使一次剂量所含卡介苗活菌单位各异(3)定量的生物测定方法尚未被用于本疫苗的统计学的质量控制;(4)卡介苗产品被用于各种人口统计的、流行病学的、以及社会经济的情况,其接种制度均不相同;(5)不适当的生物统计学模式常被用于效能、有效性和不良反应的分析。同样的情况也影响对卡介苗在肿瘤形成中免疫刺激作用的准确评价。重组DNA技术将会改进生产方法,并在分子水平上解释卡介苗在结核病中起到的保护作用,和在肿瘤形成中产生免疫刺激的机理。建立在概率逻辑和归纳推理基础上的高水平实验室技术和生物统计学方法,使适当实验设计的制订和实验资料与接种制度所得结果的正确分析得到保证。这些将会导致对卡介苗保护作用的评价,以减少在卡介苗问题上的意见分歧。
BCG has been used to prevent tuberculosis since 1921 and has been used to immunostimulate tumors since the 1960s. Preventive and immunostimulatory effects have both been evaluated and reported, but contradictory conclusions have been drawn both positive and negative. In order to objectively evaluate and explain the efficacy, effectiveness and efficiency of BCG protection, the following facts must be taken into consideration: (1) In some laboratories engaged in production, several BCG secondary strains have been developed with different residue virulence, and then (2) a variety of liquid and freeze-dried BCG production methods, the results of a dose of BCG live bacteria contained units (3) quantitative bioassay Methods have not been used for the statistical quality control of this vaccine; (4) BCG products are used in a variety of demographic, epidemiological and socioeconomic situations with varying degrees of vaccination; Proper biometric models are often used for analysis of potency, efficacy and adverse reactions. The same situation also affects the accurate assessment of the immunostimulatory effects of BCG in tumor formation. Recombinant DNA technology will improve production methods and explain at the molecular level the protective role of BCG in tuberculosis and the mechanism by which immunostimulation occurs in tumorigenesis. High-level laboratory techniques and biostatistics based on probabilistic logic and inductive reasoning ensure that the proper analysis of experimental design and experimental data and inoculations results are warranted. These will lead to the evaluation of the protective effect of BCG in order to reduce the disagreement on the BCG issue.