Rajendra Memorial Research Institute of Medical Science, Patna, Bihar, India.
Am J Trop Med Hyg. 2010 Aug;83(2):357-64. doi: 10.4269/ajtmh.2010.10-0156.
We evaluated, through the prospective monitoring of 251 patients at Sadar Hospital in Bihar, India, the effectiveness and safety of 20 mg/kg body weight of liposomal amphotericin B for the treatment of visceral leishmaniasis. The treatment success rates for the intention-to-treat, per protocol, and intention-to-treat worse-case scenario analyses were 98.8%, 99.6%, and 81.3%, respectively. Nearly one-half of patients experienced mild adverse events, but only 1% developed serious but non-life-threatening lips swelling. The lost to follow-up rate was 17.5%. Our findings indicate that the 20 mg/kg body weight treatment dosage is effective and safe under routine program conditions. Given that the exorbitant cost of liposomal amphotericin B is a barrier to its widespread use, we recommend further study to monitor and evaluate a lowered dosage and a shorter treatment course.
我们通过对印度比哈尔邦萨达尔医院的 251 名患者进行前瞻性监测,评估了 20 毫克/公斤体重的脂质体两性霉素 B 治疗内脏利什曼病的疗效和安全性。意向治疗、符合方案和意向治疗最差情况分析的治疗成功率分别为 98.8%、99.6%和 81.3%。近一半的患者出现轻度不良反应,但只有 1%的患者出现严重但无生命威胁的嘴唇肿胀。失访率为 17.5%。我们的研究结果表明,在常规项目条件下,20 毫克/公斤体重的治疗剂量是有效和安全的。鉴于脂质体两性霉素 B 的高昂成本是其广泛使用的障碍,我们建议进一步研究以监测和评估较低的剂量和较短的疗程。
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