热原检查法结果判断新模式的验证

Verification of the New Proposed Version of Pyrogen Result Judgment Algorithm

目的对热原检查法结果判断新模式(NPRJA)进行验证,以进一步判断该模式的实用性、准确性和可靠性,为推进该模式的耐用性提供理论依据。方法使用本实验室近3年的654批(1 962只)热原实验初试数据进行验证;对3 648只预检温合格家兔体温波动情况进行统计分析,论证使用单只升温作为判断热原合格与否的优劣性;使用逻辑分析的方法对热原检查法结果判断新模式进行论证。结果与2010年版《中国药典》三部热原结果判断模式的可疑率为28.0%相比,热原检查法结果判断新模式可疑率仅为10.4%,可减少目前重复检测次数的60%以上,同时对不合格供试品仍可全部检测出。预检温合格的家兔中,前3 h内有8%以上体温波动达到0.4℃。结论热原检查中因家兔自身体温波动较大,以单只家兔升温≥0.6℃作为判定供试品复试的标准之一,会导致检测结果复试率升高。热原结果判断新模式所采用的升温总和阈值法不仅可保证现有热原检测结果的准确性不变,而且还可显著减少动物使用量和实验重复次数,从而降低实验成本和劳动量。同时,它简便实用、科学可靠,是一个值得采用与推广的热原结果判断模式。

OBJECTIVE To verify the new proposd version of pyrogen result judgment algorithm （NPRJA） and validate practicality, accuracy and reliability. METHODS Six hundred and fifty-four batches of pyrogen test data from our laboratory in near three years were used; 3 648 rabbit body temperature fluctuations qualified in preview were statistically analyzed. Only single rabbit having fever was used to judge the pyrogen qualified or not; using logic anlysis method determined the NPRJA. RESULTS According to the existing Chinese Pharmacopoeia volume III, suspicious rate of pyrogenic results was 28. 0% , but the suspicious rate was only 10. 4% in NPRJA. The new model can reduce over 60% of the repeat test. However, all failed samples were not leaked in new determiner. In preflight warm qualified rabbits, the temperature fluctuations were rather more than reach 0. 4 ℃ within the first 3 h, they had more than 8% in whole rabbits. CONCLUSION In pyrogen test rabbit own body temperature appears fluctuation, single rabbit warming≥ 0. 6℃ serves as one of the criteria for re-examination of the sample, its results will lead to raising re-examination rate! The new proposed version of pyrogen result judgment algorithm was used to threshold of the sum of temperature rise of all tested rabbits, that not only guarantees the no changing of accuracy in existing present pyrogen test results, also significantly reduces the amount of animals and experimental repetitions. Thereby reducing the amount of experimental and labor costs. Meanwhile, it might be convenient and practical, as will as a worthy utilization and promoting patterns.