Ifakara Health Institute, P,O, Box 78373, Kiko Avenue, Old Bagamoyo Road, Mikocheni, Dar es Salaam, Tanzania.
Malar J. 2010 Feb 11;9:48. doi: 10.1186/1475-2875-9-48.
Controlled clinical trials have shown that a six-dose regimen of artemether-lumefantrine (AL) therapy for uncomplicated Plasmodium falciparum malaria results in cure rates >95% with good tolerability.
A prospective study was carried out to document the adherence to and acceptability of AL administration. This was undertaken in the context of the ALIVE study, a prospective, community-based, observational study in a rural, malaria-endemic area of Tanzania. Following microscopic confirmation of P. falciparum infection, the first AL dose was taken under supervision, with the subsequent five doses taken unsupervised at home. Patients were randomized to receive a home-based assessment close to the scheduled time for one of the unsupervised doses, but were blinded to which follow-up visit they had been allocated. A structured questionnaire was administered by trained staff and AL consumption was confirmed by inspection of blister packs.
A total of 552 patients were recruited of whom 352 (63.8%) were <13 years old. The randomization process allocated 112, 109, 110, 100 and 111 patients to a follow-up visit after doses 2, 3, 4, 5 and 6, respectively. For dose 2, 92.0% of patients (103/112) correctly took AL at 8 +/- 1 hours after dose 1. The remaining doses were taken within four hours of the correct time in 87-95% of cases. Nine patients (1.7%) missed one dose. Blister packs were available for inspection in 548 of cases (99.3%) and confirmed patient-reported data that the previous dose had been administered. Nearly all patients took AL with water (549/552 [99.5%]). Two patients (0.4%) took the drug with food. The dosing pictogram and clustering of tablets within the blister packs was considered helpful by 91.8% and 100.0% of patients, respectively. Overall, 87.1% of patients (481/552) found AL easier to take/administer than sulphadoxine-pyrimethamine (SP) and 87.7% (484/552) believed that AL was more effective than SP.
Factors contributing to adherence were likely to be helpful packaging, pictorial dosing instructions and patients' conviction that AL is effective.
Adherence to the dosing regimen and timing of AL administration was very good.
对照临床试验表明，六剂青蒿琥酯-咯萘啶（AL）疗法治疗无并发症恶性疟原虫疟疾，治愈率超过 95%，且耐受性良好。
本前瞻性研究旨在记录 AL 给药的依从性和可接受性。这是在 ALIVE 研究的背景下进行的，这是一项在坦桑尼亚农村疟疾流行地区进行的前瞻性、基于社区的观察性研究。在镜检确认疟原虫感染后，首次 AL 剂量在监督下服用，随后五次剂量在家中无人监督下服用。根据预定时间，患者随机接受一次未监督剂量的家庭评估，但对随访分配情况不知情。经过培训的工作人员进行了结构化问卷调查，通过检查泡罩包装确认 AL 消耗情况。
共招募了 552 名患者，其中 352 名（63.8%）年龄<13 岁。随机化过程将 112、109、110、100 和 111 名患者分配到剂量 2、3、4、5 和 6 后的随访中。对于剂量 2，92.0%（103/112）的患者在剂量 1 后 8 +/- 1 小时正确服用 AL。其余剂量在 87-95%的情况下在正确时间的四个小时内服用。9 名患者（1.7%）漏服一剂。548 例（99.3%）可检查泡罩包装，证实了患者报告的前一剂已给药的数据。几乎所有患者都用水服用 AL（552/552 [99.5%]）。2 名患者（0.4%）用食物服药。91.8%和 100.0%的患者分别认为剂量图和泡罩包装中片剂的聚类有助于用药。总的来说，87.1%（481/552）的患者认为 AL 比磺胺多辛-乙胺嘧啶（SP）更容易服用/管理，87.7%（484/552）的患者认为 AL 比 SP 更有效。
有助于依从性的因素可能是有助于包装、图片剂量说明以及患者对 AL 有效性的信念。
AL 给药方案和时间的依从性非常好。
