批质量保证二次抽样法在抗疟药治疗恶性疟疗效监测中的适用性研究

STUDY ON THE SUITABILITY OF DOUBLE LOT QUALITY ASSURANCE SAMPLING IN THE MONITORING OF EFFICACY OF ANTIMALARIALS AGAINST FALCIPARUM MALARIA

目的 探索批质量保证二次抽样法 (DLQAS)在抗疟药对恶性疟疗效监测中应用的可能性。 方法 在现场按WHO推荐的 2 8d体内法氯喹疗效评估方案收集病例 ,给予氯喹治疗 ,判定治疗失败与否 ,比较传统的流行病学方法与DLQAS法对疗效判定的结果 ,评估和比较对样本量的需求。 结果 传统方法调查到治疗失败率为 40 .7% ,DLQAS法第一阶段和第二阶段调查到治疗失败率均大于WHO推荐换用药物治疗失败率上限 2 5 % ;DLQAS法的样本量比传统的流行病学横断面抽样方法少。 结论 DLQAS的现场调查治疗失败判定结果同传统流行病学方法 ,且样本量小、快速 ,适用于对抗疟药治疗恶性疟疗效监测的现场评估。

Objective To explore the possibility of Double Lot Quality Assurance Sampling (DLQAS) in application to monitoring of efficacy of antimalarial drugs against falciparum malaria. Methods Collect and treat patients of falciparum malaria following the WHO 28 days' assessment of chloroquine efficacy, and identify treatment failure or success. Compare the justification results and sample size of traditional epidemiological methods with DLQAS. Results The treatment failure rate of traditional method is 40.7 %, and the treatment failure rates of first and second stage of DLQAS were higher than 25% which was recommended by WHO for change of drugs. The sample sizes of DLQAS were smaller than traditional method of epidemiological cross-section survey. Conclusion The justification of treatment efficacy of traditional methods and DLQAS was the same. DLQAS requested smaller sample sizes, was quicker and suitable for field monitoring of the efficacy of antimalarial drugs against falciparum malaria.