摘要
回顾了近40a来云南省对治疗恶性疟研究的疗效判定标准、抗性判定标准、病例入选标准和排除标准、病例观察方法以及实验室血液和生化指标选择,描述了5个单方和15个联合用药的效果观察结果,认为近年来云南的恶性疟原虫对氯喹的抗性仍然维持较高的水平;萘酚喹的治愈率高但是其临床即时效果不明显;蒿甲醚与本芴醇联用的效果最好;复方蒿甲醚和青蒿琥酯+萘酚喹两配伍的治愈率、平均退热时间和平均无性体原虫清除时间均相似,是复方中较好的;青蒿素栓可首选与甲氟喹500mg伍用;青蒿琥酯与苯勿醇伍用的治愈率高达100%但是平均退热时间较长(仅次于苯勿醇单用).对方法学按照目前国际流行的GCP进行了初步评价,针对存在的问题建议即按照GCP的要求建立云南省的恶性疟治疗效果评价标准方案和监查的标准规程(SOP),建立必要的抗疟药临床实验基地,对常用的药物开展纵向敏感性观察、应用现代成熟的分子生物学方法为效果判断提供准确的数据.
This paper reviewes the important aspects of researches in the treatment efficacy of falciparum malaria in Yunnan, including criteria for identification of efficacy, criteria of resistance, patients＇ inclusion and exclusion criteria, methods for clinical observation, biochemical and blood tests. It also describes the efficacy of 5 monotherapy regimens and 15 combinations of different antimalarial drugs. It concludes that the resistance of P. falciparum remains high, the clinical cure rates of naphthoquine during 28-day follow-up were high but had not prompt efficacy, the combination of artemether and benflumetol （Lumefantrine） held the best treatment effect, artemether compound had similar cure rate, mean fever clearance time and mean parasite clearance time, compared with artesunate plus naphthoquine （both were the best in all the combinations） , the priority drug for combining with artemisinin suppository was mafloquine 500 mg, the cure rate of artesunate plus benflometol reached 100% but with a longer fever clearance time （only shorter than benflometol alone）. The paper also reviewes and preliminarily assesses the methodology based on the internationally prevalent GCP and against the problems found, it suggested establishment of standards and SOP for evaluation of treatment efficacy of falciparum malaria in Yunnan, setup of clinical base for efficacy evaluation, conduct of longitudinal observation of parasite sen itivity to antimalarial drugs, and application of robust molecular methods in providing accurate data for efficacy judgment.
出处
《昆明医学院学报》
2009年第8期26-34,共9页
Journal of Kunming Medical College
关键词
恶性疟
治疗
研究
云南
Falciparum malaria
Treatment
Research
Yunnan
