Toure Offianan Andre, Valecha Neena, Tshefu Antoinette K, Thompson Ricardo, Krudsood Srivicha, Gaye Oumar, Rao Bappanaidu Hoigegudde Krishnamurthy, Sagara Issaka, Bose Tarit Kumar, Mohanty Sanjib, Rao Ballamudi Srinivas, Anvikar Anupkumar R, Mwapasa Victor, Noedl Harald, Arora Sudershan, Roy Arjun, Iyer Sunil S, Sharma Pradeep, Saha Nilanjan, Jalali Rajinder K, Tiacoh Landry, Enosse Sonia, Tangpukdee Noppadon, Kokolomami Jack, Ndiaye Jean-Louis, Rao Deepak, Yumva Ntamabyaliro Nsengi, Sidibe Bouran, Mohanty Rajesh, Jha A C, Nyirenda Mulinda, Starzengruber Peter, Swoboda Paul
Malariology Department, Institut Pasteur Côte d'Ivoire, Abidjan.
Epidemiology and Clinical Research Division, National Institute of Malaria Research, New Delhi, India.
Clin Infect Dis. 2016 Apr 15;62(8):964-971. doi: 10.1093/cid/ciw029. Epub 2016 Feb 21.
Artemisinins, which are derived from plants, are subject to risk of supply interruption due to climatic changes. Consequently, an effort to identify a new synthetic antimalarial was initiated. A fixed-dose combination of arterolane maleate (AM), a new synthetic trioxolane, with piperaquine phosphate (PQP), a long half-life bisquinoline, was evaluated in patients with uncomplicatedPlasmodium falciparummalaria.
In this multicenter, randomized, double-blind, comparative, parallel-group trial, 1072 patients aged 12-65 years withP. falciparummonoinfection received either AM-PQP (714 patients) once daily or artemether-lumefantrine (A-L; 358 patients) twice daily for 3 days. All patients were followed up until day 42.
Of the 714 patients in the AM-PQP group, 638 (89.4%) completed the study; of the 358 patients in the A-L group, 301(84.1%) completed the study. In both groups, the polymerase chain reaction corrected adequate clinical and parasitological response (PCR-corrected ACPR) on day 28 in intent-to-treat (ITT) and per-protocol (PP) populations was 92.86% and 92.46% and 99.25% and 99.07%, respectively. The corresponding figures on day 42 in the ITT and PP populations were 90.48% and 91.34%, respectively. After adjusting for survival ITT, the PCR-corrected ACPR on day 42 was >98% in both groups. The overall incidence of adverse events was comparable.
AM-PQP showed comparable efficacy and safety to A-L in the treatment of uncomplicatedP. falciparummalaria in adolescent and adult patients. AM-PQP demonstrated high clinical and parasitological response rates as well as rapid parasite clearance.
India. CTRI/2009/091/000101.
源自植物的青蒿素因气候变化存在供应中断风险。因此，启动了一项寻找新型合成抗疟药物的工作。对一种新型合成三氧烷马来酸蒿甲醚（AM）与一种半衰期长的双喹啉磷酸哌喹（PQP）的固定剂量复方制剂，在非复杂性恶性疟原虫疟疾患者中进行了评估。
在这项多中心、随机、双盲、对照、平行组试验中，1072例年龄在12至65岁的恶性疟原虫单重感染患者，其中714例患者每日一次接受AM-PQP治疗，358例患者每日两次接受蒿甲醚-本芴醇（A-L）治疗，疗程均为3天。所有患者随访至第42天。
AM-PQP组714例患者中，638例（89.4%）完成研究；A-L组358例患者中，301例（84.1%）完成研究。在两组中，在意向性治疗（ITT）人群和符合方案（PP）人群中，第28天的聚合酶链反应校正的充分临床和寄生虫学反应（PCR校正的ACPR）分别为92.86%和92.46%以及99.25%和99.07%。ITT人群和PP人群中第42天的相应数字分别为90.48%和91.34%。在对ITT生存情况进行校正后，两组在第42天的PCR校正的ACPR均>98%。不良事件的总体发生率相当。
在青少年和成年患者的非复杂性恶性疟原虫疟疾治疗中，AM-PQP显示出与A-L相当的疗效和安全性。AM-PQP表现出高临床和寄生虫学反应率以及快速的寄生虫清除率。
印度。CTRI/2009/091/000101。
