Swiss Tropical and Public Health Institute, Basel, Switzerland.
University of Basel, Basel, Switzerland.
PLoS Negl Trop Dis. 2020 Jan 27;14(1):e0008028. doi: 10.1371/journal.pntd.0008028. eCollection 2020 Jan.
Nifurtimox eflornithine combination therapy (NECT) to treat human African trypanosomiasis (HAT), commonly called sleeping sickness, was added to the World Health Organisation's (WHO) Essential Medicines List in 2009 and to the Paediatric List in 2012. NECT was further tested and documented in a phase IIIb clinical trial in the Democratic Republic of Congo (DRC) assessing the safety, effectiveness, and feasibility of implementation under field conditions (NECT-FIELD study). This trial brought a unique possibility to examine concomitant drug management.
METHODOLOGY/PRINCIPAL FINDINGS: This is a secondary analysis of the NECT-FIELD study where 629 second stage gambiense HAT patients were treated with NECT, including children and pregnant and breastfeeding women in six general reference hospitals located in two provinces. Concomitant drugs were prescribed by the local investigators as needed. Patients underwent daily evaluations, including vital signs, physical examination, and adverse event monitoring. Concomitant medication was documented from admission to discharge. Patients' clinical profiles on admission and safety profile during specific HAT treatment were similar to previously published reports. Prescribed concomitant medications administered during the hospitalization period, before, during, and immediately after NECT treatment, were mainly analgesics/antipyretics, anthelmintics, antimalarials, antiemetics, and sedatives. Use of antibiotics was reasonable and antibiotics were often prescribed to treat cellulitis and respiratory tract infections. Prevention and treatment of neurological conditions such as convulsions, loss of consciousness, and coma was used in approximately 5% of patients.
CONCLUSIONS/SIGNIFICANCE: The prescription of concomitant treatments was coherent with the clinical and safety profile of the patients. However, some prescription habits would need to be adapted in the future to the evolving available pharmacopoeia. A list of minimal essential medication that should be available at no cost to patients in treatment wards is proposed to help the different actors to plan, manage, and adequately fund drug supplies for advanced HAT infected patients.
The initial study was registered at ClinicalTrials.gov, number NCT00906880.
硝呋替莫-依氟鸟氨酸联合疗法（NECT）用于治疗非洲人类锥虫病（HAT），俗称昏睡病，于 2009 年被世界卫生组织（WHO）列入基本药物清单，并于 2012 年列入儿科药物清单。NECT 在刚果民主共和国（DRC）的一项 IIIb 期临床试验中进行了进一步测试和记录，评估了在现场条件下实施的安全性、有效性和可行性（NECT-FIELD 研究）。这项试验为检查伴随药物管理提供了一个独特的机会。
方法/主要发现：这是对 NECT-FIELD 研究的二次分析，该研究纳入了 629 例第二阶段冈比亚锥虫病 HAT 患者，这些患者在位于两个省的六家综合参考医院接受了 NECT 治疗，包括儿童、孕妇和哺乳期妇女。当地研究人员根据需要开出了伴随药物。患者每天接受评估，包括生命体征、体检和不良事件监测。从入院到出院，记录了伴随药物的使用情况。患者入院时的临床特征和特定 HAT 治疗期间的安全性概况与之前发表的报告相似。在住院期间、NECT 治疗前、治疗中和治疗后开具的伴随药物主要是镇痛药/退烧药、驱虫药、抗疟药、止吐药和镇静剂。抗生素的使用是合理的，抗生素经常用于治疗蜂窝织炎和呼吸道感染。大约 5%的患者使用了预防和治疗神经疾病的药物，如癫痫发作、意识丧失和昏迷。
结论/意义：伴随治疗的处方与患者的临床和安全性概况相符。然而，未来需要根据不断发展的药物手册调整一些处方习惯。提出了一份基本药物清单，清单上的药物应免费提供给治疗病房的患者，以帮助不同的参与者规划、管理和充分资助晚期 HAT 感染患者的药物供应。
最初的研究在 ClinicalTrials.gov 上注册，编号为 NCT00906880。
