Medical Research Unit, Albert Schweitzer Hospital, Lambaréné, Gabon.
Lancet Infect Dis. 2010 Feb;10(2):125-32. doi: 10.1016/S1473-3099(09)70327-5.
Paediatric formulations of artemisinin combination therapies (ACTs) have recently been developed for the treatment of children with falciparum malaria. Compared with conventional tablet formulations, the new non-tablet preparations have shown equivalent efficacy, safety, and tolerability in individual trials. We aimed to investigate whether objective evidence supports the development and use of paediatric ACTs. A systematic review identified seven studies involving 2515 children that were eligible for meta-analysis. Similar efficacy and safety were seen in pooled analyses of paediatric and conventional formulations. 23 (2.0%) of 1154 patients in the paediatric formulation groups and 19 (1.7%) of 1137 in the tablet formulation groups were not cured (RR 1.27, 95% CI 0.66-2.44). Despite similar overall tolerability, the tolerability of drug administration was improved for paediatric formulations as shown by significantly fewer patients with drug-induced vomiting (93 of 1018 and 114 of 837 patients; risk ratio [RR] 0.78, 95% CI 0.61-0.99), and drug-related gastrointestinal disorders (8 of 545 and 15 of 358 patients; RR 0.36, 95% CI 0.15-0.85). These data provide, for the first time, evidence for improved management of children by use of paediatric formulations, and support the further development and use of paediatric ACTs.
儿童青蒿素复方疗法制剂最近已被开发用于治疗儿童疟疾。与传统片剂制剂相比，新的非片剂制剂在个别试验中显示出同等的疗效、安全性和耐受性。我们旨在研究客观证据是否支持儿童青蒿素复方疗法制剂的开发和使用。系统评价确定了七项涉及 2515 名儿童的研究，这些研究符合荟萃分析的条件。在对儿科和传统制剂的汇总分析中，观察到了相似的疗效和安全性。在儿科制剂组的 1154 名患者中，有 23 名（2.0%）未治愈，在片剂制剂组的 1137 名患者中，有 19 名（1.7%）未治愈（RR 1.27，95%CI 0.66-2.44）。尽管总体耐受性相似，但儿科制剂的药物给药耐受性得到改善，表现为药物引起的呕吐的患者明显减少（1018 名患者中有 93 名，837 名患者中有 114 名；风险比[RR]0.78，95%CI 0.61-0.99），以及与药物相关的胃肠道疾病（545 名患者中有 8 名，358 名患者中有 15 名；RR 0.36，95%CI 0.15-0.85）。这些数据首次提供了使用儿科制剂改善儿童管理的证据，并支持进一步开发和使用儿科青蒿素复方疗法制剂。
