Jha Tara K, Sundar Shyam, Thakur Chandreshwar P, Felton J Mark, Sabin Antony J, Horton John
Kala-azar Research Center, Muzaffarpur, India.
Am J Trop Med Hyg. 2005 Dec;73(6):1005-11.
This randomized, open label, multicenter study assessed the dose-response and safety profile for oral sitamaquine in 120 Indian subjects with visceral leishmaniasis (VL). Patients aged 5-64 years (mean age 21.2 years) received one of four sitamaquine doses (1.5, 1.75, 2.0, or 2.5 mg kg(-1) day(-1)) daily for 28 days. At Day 180 in the intent-to-treat population, final cure (primary efficacy outcome) was achieved in 92 of 106 (87%) patients overall and 25 of 31 (81%), 24 of 27 (89%), 23 of 23 (100%), and 20 of 25 (80%) patients at doses of 1.5, 1.75, 2.0, or 2.5 mg kg(-1) day(-1) sitamaquine, respectively. Sitamaquine was generally well tolerated. The most common adverse events during the active treatment phase were vomiting (8% [10 of 120]), dyspepsia (8% [9 of 120]) and cyanosis (3% [4 of 120]). Nephrotic syndrome (3% [3 of 120]) and glomerulonephritis (2% [2 of 120]) were also reported and require further investigation. Oral sitamaquine demonstrated efficacy in Indian VL and was well tolerated.
这项随机、开放标签、多中心研究评估了口服硝唑尼特对120名患有内脏利什曼病（VL）的印度受试者的剂量反应和安全性。年龄在5至64岁（平均年龄21.2岁）的患者接受四种硝唑尼特剂量（1.5、1.75、2.0或2.5 mg kg⁻¹ 天⁻¹）之一，每日服用28天。在意向性治疗人群中，在第180天时，总体106名患者中有92名（87%）实现了最终治愈（主要疗效结果），硝唑尼特剂量为1.5、1.75、2.0或2.5 mg kg⁻¹ 天⁻¹时，分别有31名患者中的25名（81%）、27名患者中的24名（89%）、23名患者中的23名（100%）以及25名患者中的20名（80%）实现了最终治愈。硝唑尼特总体耐受性良好。积极治疗阶段最常见的不良事件为呕吐（8% [120例中的10例]）、消化不良（8% [120例中的9例]）和发绀（3% [120例中的4例]）。还报告了肾病综合征（3% [120例中的3例]）和肾小球肾炎（2% [120例中的2例]），需要进一步调查。口服硝唑尼特在印度VL患者中显示出疗效且耐受性良好。
