青蒿琥酯预防日本血吸虫病临床试验

Clinical Trials on Preventive Effect of Artesunate on Schistosomiasis Japonica

目的 客观、正确评价青蒿琥酯预防日本血吸虫病的现场应用效果及其影响因素和毒副反应 ,为拟定规范的服药方案提供科学依据。方法 在江西、安徽和湖北三省血吸虫病流行区的志愿者中 ,采用双盲试验法将受试居民随机分成实验和对照两组 ,先服单剂吡喹酮 ( 4 0～ 5 0mg/kg)清虫 ,随后实验组于接触疫水后每隔 7天和 15天口服青蒿琥酯 ( 6mg/kg) 1次 ,对照组口服与青蒿琥酯剂型相同的安慰剂。末次给药后 3 0天用孵化法和改良Kato法作粪便检查。在服药过程中和中止服药后不同时期观察毒副反应。结果 在江西省所有 467例实验组“7天间隔服药”粪检阳性率为 0 ,保护率为 10 0 % ;在对照组 3 97例居民粪检平均阳性率为 10 .3 %。湖北省的上述剂量预防作用与江西的相同。而“15天间隔服药”受试志愿者保护率为 3 7.7%～ 10 0 % ,实验组保护率与对照组感染率和暴露率存在明显负相关。青蒿琥酯的副作用轻 ,血和尿常规、心电图、肝、肾功能治疗前后无明显改变。结论 通过上述研究 ,阐明了青蒿琥酯的预防效果及其影响因素 ,并据此提出了获得最佳保护率的服药方案。

Objective To examine the preventive effect and adverse reaction of Artesunate on Schistosomiasis japonica,and to provide scientific basis for drawing up standard dosing scheme.Method 3461 residents in eleven endemic villages of schistosomiasis japonica in Jiangxi, Anhui and Hubei provinces were selected for this study.The trial volunteers were divided into two groups by double blind test.Group Ⅰ(Artesunate group) received Artesunate 6mg/kg once every 7 days and 15days respectively after contacting infected water during the period from 1993～1998.Group Ⅱ(control group ) received the placebo with same dose schedule in the transmission season for schistosomiasis japonica.Thirty days after the last dosing,fecal examinations for schistosomiasis japonicon ova and miracidia were carried out to evaluate the final effect.The adverse reactions were recorded or examined in whole procedure of administration.Results All of the 467 residents in Artesunate group of '7 days interval' in Jiangxi province were free from ova or miracidia upon stool examination,the protective rate was 100.0%;and in 397 residents of control group,the average positive rate of stool examination was 10.3%;the preventive effect of same dosage schedule mentioned above in Hubei province was similar to that of Jiangxi.In Artesunate group of “15 days interval”,the protective rate of trial voluteers was 37.7%～100.0%,and there was a significant negative correlation between protective rate in Artesunate group and infection or exposure rate in control group.The side effects of Artesunate were mild,there were no significant changes in routine blood and urine tests,ECG,hepatic and renal functions before and after administration.Conclusions According to the results of clinical trials with other experimental studies,the influential factors of preventive effect of Artesunate have been determined.Based on them,dosing scheme can be put forward to achieve the best protective rate.