Adverse effects of alternative therapy (minocycline, ofloxacin, and clofazimine) in multibacillary leprosy patients in a recognized health care unit in Manaus, Amazonas, Brazil
Adverse effects of alternative therapy (minocycline, ofloxacin, and clofazimine) in multibacillary leprosy patients in a recognized health care unit in Manaus, Amazonas, Brazil
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DOI：
10.1590/s0365-05962013000200003
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发表时间：
2013-04-01
影响因子：
1.7
通讯作者：
Cunha, Carolina Souza
中科院分区：
文献类型：
--
作者：
Maia, Marina Valente;Cunha, Maria da Graça Souza;Cunha, Carolina Souza
背景技术背景：在采用多种药物疗法之后，麻风病的流行率和新病例的发现率都有所下降。然而，麻风的耐药性和复发记录是麻风控制的威胁因素。因此，新的替代方案和监测的不良反应，以避免治疗放弃是重要的consideration.Objective：描述的副作用的多药治疗方案，包括米诺环素，氧氟沙星，氯法齐明在multibacillary leprosy patients.METHODS：我们进行了一项前瞻性，描述性和观察性研究与multibacillary患者，包括不耐受的情况下，标准MDT和复发。该研究于2010年4月至2012年1月在亚马孙州马瑙斯的Alfredo da Matta基金会进行。患者接受替代治疗，包括每日自我给药100 mg米诺环素、400 mg氧氟沙星和50 mg氯法齐明，以及每月监督剂量300 mg氯法齐明，持续6个月，随后是18个月每日剂量氧氟沙星400 mg、氯法齐明50 mg和每月监督剂量300 mg氯法齐明。结果：共纳入21例。33.3%的患者发生轻度和一过性副作用。在所有事件中，45.9%归因于氧氟沙星，包括腹痛、恶心、呕吐、头痛和失眠; 21.6%归因于氯法齐明，100%的患者出现皮肤色素沉着。不良反应发生的平均时间为15.2天。结论：所有患者耐受性良好，依从性满意，无严重不良事件发生。与其他标准MDT研究不同，没有因副作用而停止治疗。然而，患者随访和更大样本的研究是必要的，以保证替代方案作为多药治疗的二线方案的有效性和安全性。
BACKGROUND: After the introduction of the multidrug therapy, there was a decline in the coefficients of prevalence and detection of new cases of leprosy. However, the records of drug resistance and relapses are threatening factors in leprosy control. Hence, new alternative schemes and monitoring of adverse effects to avoid treatment abandonment are important considerations.OBJECTIVE: Describe the side effects of a multidrug regimen containing minocycline, ofloxacin, and clofazimine in multibacillary leprosy patients.METHODS: We conducted a prospective, descriptive, and observational study with multibacillary patients, including cases of intolerance to standard MDT and relapses. The study was carried out at Fundacao Alfredo da Matta (Alfredo da Matta Foundation), in Manaus, Amazonas, from April 2010 to January 2012. The patients received alternative therapy, which consisted of daily self-administered doses of 100mg of minocycline, 400 mg of ofloxacin, and 50mg of clofazimine and a supervised monthly dose of 300mg of clofazimine for six months, followed by eighteen months of daily doses of ofloxacin 400mg, clofazimine 50mg, and a supervised monthly dose of clofazimine 300mg. Results: Twenty-one cases were included. Mild and transitory side effects occurred in 33.3% of patients. Of the total episodes, 45.9% were attributed to ofloxacin and they included abdominal pain, nausea, vomiting, headache, and insomnia; 21.6% were due to clofazimine, with 100% of patients presenting skin pigmentation. The mean time for the development of adverse effects after beginning the therapy was 15.2 days.CONCLUSION: All patients tolerated the drugs well, and compliance was satisfactory, with no serious events. Unlike other standard MDT studies had shown, no treatment was stopped due to side effects. Nevertheless, patient follow-up and studies with bigger samples are necessary to guarantee the efficacy and safety of the alternative regimen as a second-line scheme in multidrug therapy.