Department of Pharmacology and Clinical Pharmacy, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
BMC Infect Dis. 2021 Apr 7;21(1):326. doi: 10.1186/s12879-021-06018-6.
Malaria is a major cause of morbidity and mortality in pediatrics in malaria endemic areas. Artemisinin-based combination therapies (ACTs) are the drugs of choice for malaria management particularly across malaria-endemic countries. This systematic review and meta-analysis was performed to assess efficacy and safety of ACTs for uncomplicated malaria in pediatric populations.
A body of evidence was searched for published ACT trials until March 06, 2020. The search was focused on efficacy and safety studies of ACTs for uncomplicated malaria in pediatrics. PubMed library was searched using best adapted search terms after multiple trials. References were exported to the endnote library and then to Covidence for screening. Data was extracted using the Covidence platform. The per-protocol analysis report for the efficacy and the intention-to-treat analysis for the safety were synthesized. Met-analysis was carried using Open Meta-Analyst software. Random effects model was applied and the heterogeneity of studies was evaluated using I statistic.
Nineteen studies were included in the final analysis. Overall, crude, PCR-corrected P. falciparum malaria treatment success rate was 96.3 and 93.9% for day 28 and 42, respectively. In the subgroup analysis, PCR-corrected adequate clinical and parasitological response (ACPR) of dihydroartemisinin-piperaquine (DP) was 99.6% (95% CI: 99.1 to 100%, I = 0%; 4 studies) at day 28 and 99.6% (95% CI of 99 to 100%, I = 0%; 3 studies) at day 42. Nine studies reported ACT related adverse drug reactions (ADR) (8.3%, 356/4304). The reported drug related adverse reactions ranged from 1.8% in DP (two studies) to 23.3% in artesunate-pyronaridine (AP). Gastrointestinal symptoms were the most common ACT related adverse effects, and all ADRs were reported to resolve spontaneously.
ACTs demonstrated a high crude efficacy and tolerability against P. falciparum. The high treatment success and tolerability with low heterogeneity conferred by DP has implication for policy makers who plan the use of ACTs for uncomplicated falciparum malaria treatment in pediatrics.
疟疾是疟疾流行地区儿科发病率和死亡率的主要原因。青蒿素为基础的联合疗法（ACTs）是治疗疟疾的首选药物，特别是在疟疾流行国家。本系统评价和荟萃分析旨在评估 ACTs 治疗儿科无并发症疟疾的疗效和安全性。
检索了截至 2020 年 3 月 6 日发表的 ACT 试验证据。该研究重点关注儿科无并发症疟疾的 ACTs 疗效和安全性研究。在经过多次试验后，使用最佳适应搜索词搜索 PubMed 库。将参考文献导出到 endnote 库，然后导入 Covidence 进行筛选。使用 Covidence 平台提取数据。报告疗效的意向治疗分析和安全性的按方案分析报告被综合。使用 Open Meta-Analyst 软件进行荟萃分析。应用随机效应模型，并使用 I 统计量评估研究的异质性。
最终分析纳入了 19 项研究。总的来说，第 28 天和第 42 天未校正的、聚合酶链反应（PCR）校正的恶性疟原虫疟疾治疗成功率分别为 96.3%和 93.9%。在亚组分析中，二氢青蒿素-哌喹（DP）的 PCR 校正适当临床和寄生虫学反应（ACPR）为 99.6%（95%置信区间：99.1%至 100%，I=0%；4 项研究），第 28 天为 99.6%（95%置信区间：99%至 100%，I=0%；3 项研究）。9 项研究报告了与 ACT 相关的药物不良反应（ADR）（8.3%，356/4304）。报告的药物相关不良反应的范围从 DP 的 1.8%（两项研究）到青蒿琥酯-咯萘啶（AP）的 23.3%。胃肠道症状是最常见的与 ACT 相关的不良反应，所有的 ADR 都被报告为自发缓解。
ACTs 对恶性疟原虫表现出高的粗疗效和耐受性。DP 具有高的治疗成功率和低的异质性，这对计划在儿科无并发症恶性疟治疗中使用 ACTs 的决策者具有重要意义。
