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卡介苗是一种非特异性免疫刺激剂,也是美国临床上针对浅表型膀胱癌的免疫疗法的主要形式。以往靠检测疫苗在营养介质中生长的集落形成单位的数量决定疫苗的剂量,但这个剂量和活性检测方法是有误导的。细胞活性应根据残留ATP水平确定。本文回顾了卡介苗抗膀胱癌作用的方式,并着重讨论了在疫苗的生产制备和后续质量控制中需要注意的因素。这包括形态学、ATP含量和颗粒大小分布等的测定与评价。
Bacillus Calmette-Guérin (BCG) is a nonspecific immunostimulant and is the leading form of immunotherapy in the United States for superficial bladder cancer. In the past, the amount of colony-forming units that grow in the nutrient medium by the test vaccine determines the dose of the vaccine, but this test of dose and activity is misleading. Cell viability should be based on residual ATP levels. This article reviews the ways in which BCG plays a role in preventing bladder cancer and highlights the factors that need attention in vaccine preparation and subsequent quality control. This includes the determination and evaluation of morphology, ATP content and particle size distribution.