Musa A M, Khalil E A G, Mahgoub F A, Hamad S, Elkadaru A M Y, El Hassan A M
Department of Clinical Pathology and Immunology, Institute of Endemic Diseases, University of Khartoum, Sudan.
Ann Trop Med Parasitol. 2005 Sep;99(6):563-9. doi: 10.1179/136485905X514127.
A dermatosis commonly known as post-kala-azar dermal leishmaniasis (PKDL) may develop following the treatment of human visceral leishmaniasis (VL). In about 15% of PKDL cases the disfiguring lesions persist, sometimes for many years. Such persistent lesions currently require daily injections of sodium stibogluconate (SSG) for 2-4 months and even then treatment may not be successful. Alternative, quicker and cheaper treatment options that cause less toxicity are being explored. Immuno-chemotherapeutic regimens (based on leishmaniasis candidate vaccines/BCG with SSG) are still experimental but treatment with liposomal amphotericin B (AmBisome) has already been found effective, albeit in a small number of patients. AmBisome is considered less nephrotoxic than non-liposomal amphotericin B because it specifically targets the macrophages in which the Leishmania parasites develop. The aim of the present study was to evaluate further the usefulness of AmBisome in the treatment of persistent PKDL, in Sudan. The 12 subjects, all of whom gave their informed consent, had each had PKDL lesions for >6 months and shown no improvement after repeated injections of SSG. During the study period, they were hospitalized and regularly screened, haematologically and biochemically, for adverse effects. The AmBisome, given intravenously at 2.5 mg/kg.day for 20 days, completely cleared the skin rash of 10 (83%) of the patients and caused no detectable adverse effects. In the 10 patients who responded well to the treatment, the papular lesions regressed and became flat while the hypopigmented lesions darkened (continuing to do so even after the last AmBisome injections). Treatment outcome appeared to be unaffected by the age or gender of the patient (P = 0.7 for each) but the time taken for the PKDL lesions to heal was correlated with the age of the lesions (P = 0.009). The macular lesions healed more slowly than the papular (P = 0.02). In conclusion, Ambisome appears suitable for the treatment of persistent PKDL lesions in Sudan. Once certain favourable clinical signs (the regression and/or darkening of the PKDL lesions) have been noted, the lesions will probably continue to clear without the need for more injections.
一种通常被称为黑热病后皮肤利什曼病（PKDL）的皮肤病可能在人类内脏利什曼病（VL）治疗后出现。在大约15%的PKDL病例中，毁容性病变会持续存在，有时长达数年。目前，这种持续性病变需要每日注射葡萄糖酸锑钠（SSG）2至4个月，即便如此，治疗也可能不成功。人们正在探索毒性更小、更快且更便宜的替代治疗方案。免疫化疗方案（基于利什曼病候选疫苗/卡介苗联合SSG）仍处于试验阶段，但脂质体两性霉素B（安必素）治疗已被发现有效，尽管仅在少数患者中。安必素被认为比非脂质体两性霉素B的肾毒性更小，因为它特异性靶向利什曼原虫寄生的巨噬细胞。本研究的目的是进一步评估安必素在苏丹治疗持续性PKDL中的效用。12名受试者均已签署知情同意书，他们的PKDL病变均已超过6个月，且在反复注射SSG后无改善。在研究期间，他们住院并定期进行血液学和生化检查以筛查不良反应。以2.5mg/kg·天的剂量静脉注射安必素，持续20天，10名（83%）患者的皮疹完全消退，且未出现可检测到的不良反应。在对治疗反应良好的10名患者中，丘疹性病变消退并变平，而色素减退性病变颜色变深（即使在最后一次注射安必素后仍继续变深）。治疗结果似乎不受患者年龄或性别的影响（两者P值均为0.7），但PKDL病变愈合所需时间与病变时长相关（P = 0.009）。斑疹性病变比丘疹性病变愈合得更慢（P = 0.02）。总之，安必素似乎适用于苏丹持续性PKDL病变的治疗。一旦发现某些有利的临床体征（PKDL病变消退和/或颜色变深），病变可能会继续消退，无需更多注射。
