Pandey Krishna, Ravidas Vidyanand, Siddiqui Niyamat A, Sinha Sanjay K, Verma Rakesh B, Singh Tripurari P, Dhariwal A C, Das Gupta R K, Das Pradeep
Rajendra Memorial Research Institute of Medical Sciences, Indian Council of Medical Research, Patna, India.
Sadar Hospital, East Champaran, Bihar, India.
Am J Trop Med Hyg. 2016 Nov 2;95(5):1100-1105. doi: 10.4269/ajtmh.16-0242. Epub 2016 Sep 19.
Miltefosine, the only oral drug for visceral leishmaniasis (VL), is being used as the first-line drug under the VL elimination program in the Indian subcontinent. Miltefosine is an oral drug which was used as a topical application for skin metastasis of breast cancer. It was found to be effective against Leishmania donovani The main adverse events (AE) reported previously with miltefosine use includes diarrhea, vomiting, and dehydration. Other AEs include, raised serum alanine transaminase/aspartate aminotransferase and renal parameters such as creatinine. In this study, we report AEs in a large patient cohort of VL treated with miltefosine. The purpose of this pharmacovigilance study was to assess adverse drug reactions (ADRs)/AE of miltefosine treatment under unrestricted condition in the field setup. Patients were followed up to 6 months for therapeutic effectiveness. Outcomes of a larger data set of patients treated with this regimen from April 2012 to March 2015 were recorded. In the present study, 646 patients of VL were given miltefosine. Majority of the study subjects (58%) were male. Relapse occurred in 7% during follow-up period. Main causes of death were VL-pulmonary tuberculosis coinfection, extreme diarrhea, and acute pancreatitis which were reported in 1.7% subjects. Of 553 (85.6%) patients completing full course of treatment, 463 (83.7%) showed ADR with miltefosine during the study period. About 2.3% were suffering severe ADR, 51% from moderate, and the rest had mild ADR. The initial and final cure rate was 97.4% and 85.6%, respectively.
米替福新是治疗内脏利什曼病（VL）的唯一口服药物，在印度次大陆的VL消除计划中被用作一线药物。米替福新是一种口服药物，曾被用于乳腺癌皮肤转移的局部治疗。后来发现它对杜氏利什曼原虫有效。先前报告的使用米替福新的主要不良事件（AE）包括腹泻、呕吐和脱水。其他不良事件包括血清丙氨酸转氨酶/天冬氨酸转氨酶升高以及肌酐等肾脏指标异常。在本研究中，我们报告了一大组接受米替福新治疗的VL患者的不良事件。这项药物警戒研究的目的是在现场不受限制的条件下评估米替福新治疗的药物不良反应（ADR）/不良事件。对患者进行了长达6个月的随访以评估治疗效果。记录了2012年4月至2015年3月接受该治疗方案的更大数据集患者的治疗结果。在本研究中，646例VL患者接受了米替福新治疗。大多数研究对象（58%）为男性。随访期间7%的患者出现复发。主要死亡原因是VL-肺结核合并感染、严重腹泻和急性胰腺炎，1.7%的患者报告了这些情况。在完成全部疗程的553例（85.6%）患者中，463例（83.7%）在研究期间出现了米替福新相关的药物不良反应。约2.3%的患者出现严重不良反应，51%为中度，其余为轻度不良反应。初始治愈率和最终治愈率分别为97.4%和85.6%。
