Sundar Shyam, Agrawal Neha, Arora Rakesh, Agarwal Dipti, Rai Madhukar, Chakravarty Jaya
Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.
Clin Infect Dis. 2009 Sep 15;49(6):914-8. doi: 10.1086/605438.
Treatment of visceral leishmaniasis (VL) is far from satisfactory. There is an urgent need for a therapy that is efficacious, safe, affordable, and of short duration.
A randomized open-label study was conducted to assess the efficacy and safety of 2 regimens of paromomycin administered intramuscularly. Group A received 11 mg/kg/day for 14 days (n = 217) and group B received 11 mg/kg/day for 21 days (n = 112) for the treatment of VL in India.
Mild grade injection site pain was the most common adverse event. There was no nephrotoxicity, but 4 patients in group A had to discontinue treatment because of grade 3 elevation of hepatic enzymes. Initial cure was observed in 91.2% and 96.4% of patients in group A and group B, respectively. Definitive cure at 6 months of follow up was seen in 82% of patients in group A and 92% of patients in group B by intention-to-treat analysis and in 84.3% of patients in group A and 92.8% of patients in group B by per protocol analysis.
Although the cure rate in the group of patients who received the 14-day regimen was not optimal, the results with respect to initial cure were encouraging. Further studies that combine a short course of paromomycin with treatment with another antileishmanial agent are warranted. ( ClinicalTrials.gov identifier: NCT00629031).
内脏利什曼病（VL）的治疗效果远不尽人意。迫切需要一种有效、安全、可负担且疗程短的治疗方法。
开展了一项随机开放标签研究，以评估两种肌肉注射巴龙霉素方案的疗效和安全性。在印度，A组接受11mg/kg/天，共14天（n = 217），B组接受11mg/kg/天，共21天（n = 112）用于治疗VL。
轻度注射部位疼痛是最常见的不良事件。未出现肾毒性，但A组有4名患者因3级肝酶升高而不得不停止治疗。A组和B组分别有91.2%和96.4%的患者实现初始治愈。通过意向性分析，A组82%的患者和B组92%的患者在随访6个月时实现最终治愈；通过符合方案分析，A组84.3%的患者和B组92.8%的患者实现最终治愈。
尽管接受14天方案的患者治愈率并不理想，但初始治愈结果令人鼓舞。有必要开展进一步研究，将短疗程巴龙霉素与另一种抗利什曼原虫药物联合使用。（ClinicalTrials.gov标识符：NCT00629031）
