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青蒿素哌喹片治疗无并发症恶性疟的剂量探索试验
引用本文:宋健平,谈博,DUONG Socheat,SUOU Seila,徐颖,欧凤珍,李国桥,SRENG Sokunthea,LEAP Sophorn. 青蒿素哌喹片治疗无并发症恶性疟的剂量探索试验[J]. 中国新药与临床杂志, 2008, 27(12)
作者姓名:宋健平  谈博  DUONG Socheat  SUOU Seila  徐颖  欧凤珍  李国桥  SRENG Sokunthea  LEAP Sophorn
作者单位:1. 广州中医药大学青蒿研究中心,广东,广州,510405
2. 柬埔寨国家疟疾控制中心,柬埔寨金边
3. 柬埔寨实居省医院,柬埔寨实居省
摘    要:
目的探索青蒿素哌喹片治疗无并发症恶性疟的安全有效的适宜剂量。方法收治7~65岁男性和女性病人共100例,按区组随机化方案分成2组,成人总量1400 mg组年龄(22±s12)岁,1750 mg组年龄(21±12)岁。分别于0h和24h给药一次,比较2组的平均原虫转阴和退热时间、28d治愈率及原虫复燃率。结果2组的平均原虫转阴时间分别是(61±19)h和(57±21)h,平均退热时间为(20±15)h和(18±10)h,P>0.05;28 d治愈率是80%和96%,原虫复燃率为20%和4%,总量1750 mg组显著优于1400 mg组(P<0.05)。2组耐受性均良好,未发现明显的不良反应。结论推荐青蒿素哌喹片的临床治疗剂量为总量1750 mg,每日1次,分2d服完为1个疗程。

关 键 词:疟原虫  恶性  疟疾  青蒿素  抗疟药  药物疗法  哌喹

Dosage exploring of artemisinin-piperaquine in treatment of uncomplicated falciparum malaria
SONG Jian-ping,TAN Bo,DUONG Socheat,SUOU Seila,XU Ying,OU Feng-zhen,SRENG Sokunthea,SRENG Sokunthea,LEAP Sophorn. Dosage exploring of artemisinin-piperaquine in treatment of uncomplicated falciparum malaria[J]. Chinese Journal of New Drugs and Clinical Remedies, 2008, 27(12)
Authors:SONG Jian-ping  TAN Bo  DUONG Socheat  SUOU Seila  XU Ying  OU Feng-zhen  SRENG Sokunthea  SRENG Sokunthea  LEAP Sophorn
Affiliation:SONG Jian-ping~1,TAN Bo~1,DUONG Socheat~2,SUOU Seila~2,XU Ying~1,OU Feng-zhen~1,SRENG Sokunthea~2,LEAP Sophorn~3,LI Guo-qiao~1 (1.Research Center for Qinghao,Guangzhou University of Chinese Traditional Medicine,Guangzhou GUANGDONG 510405,China,2.National Malaria Center,Ministry of Health,PHNOM PRNH,Cambodia,3.Kampong Spue Referral Hospital,KAMPONG SPUE,Cambodia)
Abstract:
AIM To explore the effective and safe dosage of artemisinin-piperaquine for uncomplicated falciparum malaria.METHODS One hundred uncomplicated falciparum malaria male and female patients aged from 7 to 65 years old were enrolled in the trial according to randomized block design;equally distributed into 2 dosage groups,the adult total dose 1 400 mg group(mean age(22±s 12) years) and the 1 750 mg group (mean age(21±12) years).Once-daily administration respectively at 0 h and 24 h,comparison were made including the mean parasite clearance time,mean fever clearance time,28-day cure rates,and parasite recrudescence rates in two groups.RESULTS The mean parasite clearance time were(61±19) h and(57±21) h,the mean fever clearance time were(20±15) h and(18±10) h,P> 0.05;28-day cure rates were 80%and 96%,and parasite recrudescence rates were 20%and 4%,respectively.The efficacy of total dose 1 750 mg group is superior to that of the 1 400 mg group(P < 0.05).Patients in both groups showed good tolerance and no obvious adverse reactions.CONCLUSION The recommended total clinical therapeutic dose of artemisinin-piperaquine is 1 750 mg,once daily,taking all together 2 d,as a course.
Keywords:Plasmodium falciparum  malaria  artemisinin  antimalarials  drug therapy  piperaquine  
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