Cruz Rossilene Conceição da Silva, Bührer-Sékula Samira, Penna Gerson Oliveira, Moraes Maria Elisabete Amaral de, Gonçalves Heitor de Sá, Stefani Mariane Martins de Araújo, Penna Maria Lúcia Fernandes, Pontes Maria Araci de Andrade, Talhari Sinésio
Fundação de Dermatologia Tropical e Venereologia "Alfredo da Matta", Manaus, AM, Brazil.
Program of Post-graduation in Tropical Medicine, Instituto de Patologia Tropical e Saúde Pública, Universidade Federal de Goiás, Goiânia, GO, Brazil.
An Bras Dermatol. 2018 Jun;93(3):377-384. doi: 10.1590/abd1806-4841.20186709.
The Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR), designed to evaluate the effectiveness of a six-months regimen, assessed the adverse effects caused by the drugs.
Describe adverse effects due to MDT in U-MDT/CT-BR, comparing the uniform regimen (U-MDT) to the current WHO regimen (R-MDT).
After operational classification, patients were randomly allocated to the study groups. U-MDT PB and U-MDT MB groups, received the U-MDT regimen, six doses of MB-MDT (rifampicin, dapsone and clofazimine). R-MDT PB and R-MDT MB groups, received the WHO regimens: six doses (rifampicin and dapsone) for PB and 12 doses (rifampicin, dapsone and clofazimine) for MB. During treatment, patients returned monthly for clinical and laboratorial evaluation. Patients with single lesion were not included in this trial.
Skin pigmentation (21.7%) and xerosis (16.9%) were the most frequent complaints among 753 patients. Laboratory exams showed hemoglobin concentration lower than 10g/dL in 23.3% of the patients, glutamic oxaloacetic transaminase (GOT) above 40U/L in 29.5% and glutamic pyruvic transaminase (GPT) above 40U/L in 28.5%. Twenty-four patients (3.2%) stopped dapsone intake due to adverse effects, of whom 16.6% due to severe anemia. One case of sulfone syndrome was reported.
Loss of some monthly laboratory sample collection.
There was no statistical difference regarding adverse effects in the R-MDT and U-MDT groups but anemia was greater in patients from R-MDT/MB group, therefore adverse effects do not represent a constraint to recommend the six-month uniform regimen of treatment for all leprosy patients.
巴西麻风病人统一多药疗法临床试验（U-MDT/CT-BR）旨在评估六个月治疗方案的有效性，并对药物引起的不良反应进行评估。
描述U-MDT/CT-BR中多药疗法引起的不良反应，将统一治疗方案（U-MDT）与世界卫生组织现行治疗方案（R-MDT）进行比较。
在进行操作分类后，将患者随机分配到各研究组。U-MDT PB组和U-MDT MB组接受U-MDT方案，即六剂MB-MDT（利福平、氨苯砜和氯法齐明）。R-MDT PB组和R-MDT MB组接受世界卫生组织的治疗方案：PB患者接受六剂（利福平和氨苯砜），MB患者接受12剂（利福平、氨苯砜和氯法齐明）。在治疗期间，患者每月返回进行临床和实验室评估。单病灶患者不纳入本试验。
在753例患者中，皮肤色素沉着（21.7%）和皮肤干燥（16.9%）是最常见的主诉。实验室检查显示，23.3%的患者血红蛋白浓度低于10g/dL，29.5%的患者谷草转氨酶（GOT）高于40U/L，28.5%的患者谷丙转氨酶（GPT）高于40U/L。24例患者（3.2%）因不良反应停止服用氨苯砜，其中16.6%是由于严重贫血。报告了1例砜综合征病例。
部分月度实验室样本采集缺失。
R-MDT组和U-MDT组在不良反应方面无统计学差异，但R-MDT/MB组患者的贫血情况更严重，因此不良反应并不构成推荐为所有麻风患者采用六个月统一治疗方案的限制因素。
