Gadelha Ellen Priscilla Nunes, Talhari Sinésio, Guerra Jorge Augusto de Oliveira, Neves Leandro Ourives, Talhari Carolina, Gontijo Bernardo, Silva Junior Roberto Moreira da, Talhari Anette Chrusciak
Fundação de Medicina Tropical do Amazonas Dr. Heitor Vieira Dourado, Manaus, AM, Brazil.
An Bras Dermatol. 2015 Nov-Dec;90(6):807-13. doi: 10.1590/abd1806-4841.20153956.
There have been few studies on pentamidine in the Americas; and there is no consensus regarding the dose that should be applied.
To evaluate the use of pentamidine in a single dose to treat cutaneous leishmaniasis.
Clinical trial of phase II pilot study with 20 patients. Pentamidine was used at a dose of 7 mg/kg, in a single dose. Safety and adverse effects were also assessed. Patients were reviewed one, two, and six months after the end of treatments.
there was no difference between the treatment groups in relation to gender, age, number or location of the lesions. Pentamidine, applied in a single dose, obtained an effectiveness of 55%. Mild adverse events were reported by 17 (85%) patients, mainly transient pain at the site of applications (85%), while nausea (5%), malaise (5%) and dizziness (5%) were reported in one patient. No patient had sterile abscess after taking medication at a single dose of 7mg/kg.
Clinical studies with larger samples of patients would enable a better clinical response of pent amidine at a single dose of 7mg, allowing the application of more powerful statistical tests, thus providing more evidences of the decrease in the effectiveness of that medication. Hence, it is important to have larger studies with new diagrams and/or new medications.
在美洲，关于喷他脒的研究较少；对于应使用的剂量也没有达成共识。
评估单剂量喷他脒治疗皮肤利什曼病的效果。
对20名患者进行II期试点研究的临床试验。喷他脒的使用剂量为7mg/kg，单次给药。同时评估安全性和不良反应。在治疗结束后1个月、2个月和6个月对患者进行复查。
治疗组在性别、年龄、病变数量或部位方面没有差异。单次给药的喷他脒有效率为55%。17名（85%）患者报告了轻度不良事件，主要是用药部位的短暂疼痛（85%），而1名患者报告了恶心（5%）、不适（5%）和头晕（5%）。在单次服用7mg/kg药物后，没有患者出现无菌性脓肿。
对更多患者样本进行临床研究将能更好地了解7mg单剂量喷他脒的临床反应，从而可以应用更强大的统计测试，进而提供更多关于该药物有效性下降的证据。因此，开展涉及新方案和/或新药物的更大规模研究很重要。
