Marco Andrey Cipriani Frade , Gustavo Sartori Albertino , Filipe Rocha Lima , Natália Aparecida de Paula , Fabiana Aparecida Correa Cinto , Fernanda Cruz Perecin , Andrezza Westin , Wilson Marques Junior , Helena Barbosa Lugão
{"title":"利莫霉素:基于有效敏感性恢复治疗汉森氏病的新治疗方案","authors":"Marco Andrey Cipriani Frade , Gustavo Sartori Albertino , Filipe Rocha Lima , Natália Aparecida de Paula , Fabiana Aparecida Correa Cinto , Fernanda Cruz Perecin , Andrezza Westin , Wilson Marques Junior , Helena Barbosa Lugão","doi":"10.1016/j.bjid.2025.104539","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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).</div></div><div><h3>Methodology/principal findings</h3><div>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 (<em>p</em> = 0.12). Nerve thickening was reduced by palpation in both groups: in RIMOXCLAMIN, reduction occurred early (65 % to 28 % at 6-months, <em>p</em> = 0.03; 9 % at 12-months, <em>p</em> = 0.03), while in MDT/WHO, it was later (95 % to 40 % at 12-months, <em>p</em> = 0.002). The greatest difference was at 6 months (<em>p</em> < 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 (<em>p</em> < 0.05). Only RIMOXCLAMIN improved PDG monitoring. Both groups reported mild adverse effects.</div></div><div><h3>Conclusions/significance</h3><div>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.</div></div>","PeriodicalId":56327,"journal":{"name":"Brazilian Journal of Infectious Diseases","volume":"29 4","pages":"Article 104539"},"PeriodicalIF":3.0000,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"RIMOXCLAMIN: New therapeutic regimen for Hansen’s Disease cure based on effective sensitivity recovery\",\"authors\":\"Marco Andrey Cipriani Frade , Gustavo Sartori Albertino , Filipe Rocha Lima , Natália Aparecida de Paula , Fabiana Aparecida Correa Cinto , Fernanda Cruz Perecin , Andrezza Westin , Wilson Marques Junior , Helena Barbosa Lugão\",\"doi\":\"10.1016/j.bjid.2025.104539\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>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).</div></div><div><h3>Methodology/principal findings</h3><div>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 (<em>p</em> = 0.12). Nerve thickening was reduced by palpation in both groups: in RIMOXCLAMIN, reduction occurred early (65 % to 28 % at 6-months, <em>p</em> = 0.03; 9 % at 12-months, <em>p</em> = 0.03), while in MDT/WHO, it was later (95 % to 40 % at 12-months, <em>p</em> = 0.002). The greatest difference was at 6 months (<em>p</em> < 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 (<em>p</em> < 0.05). Only RIMOXCLAMIN improved PDG monitoring. Both groups reported mild adverse effects.</div></div><div><h3>Conclusions/significance</h3><div>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.</div></div>\",\"PeriodicalId\":56327,\"journal\":{\"name\":\"Brazilian Journal of Infectious Diseases\",\"volume\":\"29 4\",\"pages\":\"Article 104539\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-05-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Brazilian Journal of Infectious Diseases\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S141386702500042X\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Brazilian Journal of Infectious Diseases","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S141386702500042X","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
RIMOXCLAMIN: New therapeutic regimen for Hansen’s Disease cure based on effective sensitivity recovery
Background
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.
期刊介绍:
The Brazilian Journal of Infectious Diseases is the official publication of the Brazilian Society of Infectious Diseases (SBI). It aims to publish relevant articles in the broadest sense on all aspects of microbiology, infectious diseases and immune response to infectious agents.
The BJID is a bimonthly publication and one of the most influential journals in its field in Brazil and Latin America with a high impact factor, since its inception it has garnered a growing share of the publishing market.