Adam I, A-Elbasit I E, Idris S M, Malik E M, Elbashir M I
New Halfa Teaching Hospital, Sudan.
Ann Trop Med Parasitol. 2005 Jul;99(5):449-55. doi: 10.1179/136485905X36299.
In an open, randomized, clinical trial, conducted in New Halfa, eastern Sudan, in September-October 2004, the efficacies and adverse effects of artesunate plus sulfadoxine-pyrimethamine (SP), in the treatment of uncomplicated, Plasmodium falciparum malaria, were compared with those of SP alone. Patients were randomized to receive either artesunate (4 mg/kg. day) on days 0-2 plus SP (25 mg sulfadoxine/kg) on day 0 or the SP alone, and then followed-up for 28 days. Sixty patients completed follow-up. Compared with the 30 given artesunate plus SP (ASP), the 30 given SP alone were much more likely to be febrile (30% v. 3.3%; P=0.006) and parasitaemic (50% v. 6.7%; P<00001) on day 1. By day 3, 16.7% of the patients given SP alone were still febrile and 6.7% of them were still parasitaemic, although all the patients given ASP were then afebrile (P=0.02) and aparasitaemic (P=0.1). Five (16.7%) of the patients treated with SP alone but none of those given ASP appeared to be treatment failures (P<0.05). Parasite genotyping revealed that four of the five apparent treatment failures were true recrudescences but the other represented a re-infection detected on day 28. The true frequencies of cure by day 28 were therefore 100% for ASP and 86.7% for SP alone (P=0.02). Adverse effects of treatment (nausea, itching and giddiness) were observed with similar frequencies in the two treatment arms (10.0% of the patients given ASP v. 13.3% of the patients given SP alone; P>0.05). The frequencies of gametocytaemia during follow-up were, however, much lower in the ASP arm than in the SP-only (0.0% v. 23.3%; P=0.005).Thus, although the problems posed by adverse effects were similar in the two treatment arms, ASP appeared markedly better, in terms of fever- and parasite-clearance times and the prevalence of post-treatment gametocytaemia, than SP alone.
2004年9月至10月在苏丹东部的新哈尔法进行了一项开放性随机临床试验，比较了青蒿琥酯加周效磺胺 - 乙胺嘧啶（SP）与单用SP治疗非复杂性恶性疟原虫疟疾的疗效和不良反应。患者被随机分为两组，一组在第0 - 2天接受青蒿琥酯（4mg/kg·天）加第0天的SP（25mg磺胺多辛/kg），另一组仅接受SP，然后随访28天。60名患者完成了随访。与30名接受青蒿琥酯加SP（ASP）治疗的患者相比，30名单用SP治疗的患者在第1天发热（30%对3.3%；P = 0.006）和寄生虫血症（50%对6.7%；P<0.0001）的可能性要大得多。到第3天，单用SP治疗的患者中有16.7%仍发热，6.7%仍有寄生虫血症，而所有接受ASP治疗的患者此时已退热（P = 0.02）且无寄生虫血症（P = 0.1）。单用SP治疗的患者中有5例（16.7%）似乎治疗失败，而接受ASP治疗的患者中无一例出现治疗失败（P<0.05）。寄生虫基因分型显示，5例明显治疗失败的患者中有4例是真正的复发，但另一例代表在第28天检测到的再感染。因此，到第28天ASP的真正治愈率为100%，单用SP为86.7%（P = 0.02）。两个治疗组中观察到的治疗不良反应（恶心、瘙痒和头晕）频率相似（接受ASP治疗的患者中有10.0%，单用SP治疗的患者中有13.3%；P>0.05）。然而，随访期间ASP组的配子体血症频率远低于单用SP组（0.0%对23.3%；P = 0.005）。因此，尽管两个治疗组中不良反应带来的问题相似，但就退热和清除寄生虫时间以及治疗后配子体血症的患病率而言，ASP明显优于单用SP。
