Frade Marco Andrey Cipriani, Albertino Gustavo Sartori, Lima Filipe Rocha, de Paula Natália Aparecida, Cinto Fabiana Aparecida Correa, Perecin Fernanda Cruz, Westin Andrezza, Junior Wilson Marques, Lugão Helena Barbosa
Universidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Divisão de Dermatologia, Departamento de Medicina Interna, São Paulo, SP, Brazil; Universidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Hospital das Clínicas, Centro Nacional de Referência em Dermatologia Sanitária e H.D., São Paulo, SP, Brazil.
Universidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Divisão de Dermatologia, Departamento de Medicina Interna, São Paulo, SP, Brazil; Universidade de São Paulo (USP), Faculdade de Medicina de Ribeirão Preto (FMRP), Hospital das Clínicas, Centro Nacional de Referência em Dermatologia Sanitária e H.D., São Paulo, SP, Brazil.
Braz J Infect Dis. 2025 May 14;29(4):104539. doi: 10.1016/j.bjid.2025.104539.
World Health Organization (WHO) has recommended Multidrug Therapy (MDT/WHO) for Hansen's Disease (HD) since 1982; nevertheless, relapse, antimicrobial resistance, and adverse reactions indicate the need for new therapeutic regimens. We evaluated the efficacy and safety of the new anti-HD regimen RIMOXCLAMIN (Rifampicin, Moxifloxacin, Clarithromycin, and Minocycline) compared with standard Multidrug Therapy provided by WHO (MDT/WHO).
METHODOLOGY/PRINCIPAL FINDINGS: 66 multibacillary HD new cases (46: RIMOXCLAMIN / 20: MDT/WHO) were evaluated between 2015 and 2023. Patients were followed up at least bimonthly by hansenologists for neurological and cutaneous findings and side effects of treatments. Hands/feet tactile sensitivity tests by Semmes Weinstein Monofilaments (SWM) and Physical Disability Grade (PDG) were carried out on the diagnosis, 3rd, 6th, and 12th months. 84.8 % and 80 % of the patients were classified as Borderline-Borderline (BB) in RIMOXCLAMIN and MDT/WHO groups, respectively, with no significant difference between them (p = 0.12). Nerve thickening was reduced by palpation in both groups: in RIMOXCLAMIN, reduction occurred early (65 % to 28 % at 6-months, p = 0.03; 9 % at 12-months, p = 0.03), while in MDT/WHO, it was later (95 % to 40 % at 12-months, p = 0.002). The greatest difference was at 6 months (p < 0.0001). A significant reduction was observed in pain scales on the 3rd month of treatment only with RIMOXCLAMIN; in the end, both groups showed significant reductions in pain scales, being greater in RIMOXCLAMIN group. 0.5 % reduction in the number of abnormal SWM points on the hands compared to baseline, while in the MDT/WHO group, there was an increase of abnormal points of 5.4 %. On the feet, RIMOXCLAMIN showed a reduction of 17.9 %, while in the MDT/WHO, it was 10.3 %. During follow-up, the RIMOXCLAMIN showed a significant decrease in the sum of altered SWM points compared to MDT/WHO (p < 0.05). Only RIMOXCLAMIN improved PDG monitoring. Both groups reported mild adverse effects.
CONCLUSIONS/SIGNIFICANCE: The results indicate that RIMOXCLAMIN was superior to MDT/WHO in terms of quick recovery of neurological damage, evidenced by the improvement of symptoms and sensitivity in hands and feet as early as the third month, with a progressive improvement, maintained after the end of treatment, including a reduce of patients with PDG.
自1982年以来，世界卫生组织（WHO）推荐采用多药疗法（MDT/WHO）治疗麻风病（HD）；然而，复发、抗菌药物耐药性和不良反应表明需要新的治疗方案。我们评估了新型抗HD方案RIMOXCLAMIN（利福平、莫西沙星、克拉霉素和米诺环素）与WHO提供的标准多药疗法（MDT/WHO）相比的疗效和安全性。
方法/主要发现：2015年至2023年期间对66例多菌型HD新病例进行了评估（46例：RIMOXCLAMIN / 20例：MDT/WHO）。麻风病专家至少每两个月对患者进行一次随访，以检查神经和皮肤方面的情况以及治疗的副作用。在诊断时、第3、6和12个月，使用Semmes Weinstein单丝（SWM）进行手足触觉敏感性测试和身体残疾分级（PDG）。RIMOXCLAMIN组和MDT/WHO组分别有84.8%和80%的患者被分类为边缘-边缘型（BB），两组之间无显著差异（p = 0.12）。两组通过触诊发现神经增粗均有所减轻：在RIMOXCLAMIN组，减轻出现得较早（6个月时从65%降至28%，p = 0.03；12个月时为9%，p = 0.03），而在MDT/WHO组则较晚（12个月时从95%降至40%，p = 0.002）。最大差异出现在6个月时（p < 0.0001）。仅在使用RIMOXCLAMIN治疗的第3个月观察到疼痛量表有显著降低；最终，两组的疼痛量表均显著降低，RIMOXCLAMIN组降低幅度更大。与基线相比，RIMOXCLAMIN组手部异常SWM点数量减少了0.5%，而MDT/WHO组异常点数量增加了5.4%。在足部，RIMOXCLAMIN组减少了17.9%，而MDT/WHO组为10.3%。在随访期间，与MDT/WHO相比，RIMOXCLAMIN组SWM改变点的总和显著降低（p < 0.05）。只有RIMOXCLAMIN改善了PDG监测。两组均报告有轻度不良反应。
结论/意义：结果表明，RIMOXCLAMIN在神经损伤的快速恢复方面优于MDT/WHO，早在第三个月就表现为手足症状和敏感性的改善，并持续进行性改善，治疗结束后仍保持，包括PDG患者数量的减少。
