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一项针对多菌型麻风病的比较临床试验,涉及四种不同多药联合治疗方案的长期复发率。

A comparative clinical trial in multibacillary leprosy with long-term relapse rates of four different multidrug regimens.

作者信息

Fajardo Tranquilino T, Villahermosa Laarni, Pardillo Fe Eleanor F, Abalos Rodolfo M, Burgos Jasmin, Dela Cruz Eduardo, Gelber Robert H

机构信息

Leonard Wood Memorial Center for Leprosy Research, Cebu City, Philippines.

出版信息

Am J Trop Med Hyg. 2009 Aug;81(2):330-4.

PMID:19635893
Abstract

As a participant in a multicenter trial, we evaluated the relapse rate in 189 multibacillary (MB) leprosy patients treated with four different regimens and followed-up for as many as 12 years after the initiation of treatment. Treatment regimens included 1 year of WHO MDT (a regimen including dapsone, clofazimine, and rifampin), 2 years of WHO MDT, 1 month of daily rifampin and daily ofloxacin, and 1 year of WHO MDT plus an initial 1 month of daily rifampin and daily ofloxacin. Relapse rates after 9 and 12 years from the initiation of therapy in the three regimens that included WHO MDT were 0-3%, whereas relapses occurred in those treated with the 1-month regimen alone at a significantly greater rate (P < 0.05): 11% at 9 years and 25% at 12 years. Relapses occurred late, beginning at 5 years after the initiation of therapy, and were confined to those patients histopathologically borderline lepromatous and polar lepromatous having a high bacterial burden. Prospects for an alternative effective short-course therapy of leprosy are presented.

摘要

作为一项多中心试验的参与者,我们评估了189例多菌型(MB)麻风病患者采用四种不同治疗方案治疗后的复发率,并在治疗开始后进行了长达12年的随访。治疗方案包括1年的世界卫生组织麻风病联合化疗方案(一种包括氨苯砜、氯法齐明和利福平的方案)、2年的世界卫生组织麻风病联合化疗方案、每日服用利福平及氧氟沙星1个月,以及1年的世界卫生组织麻风病联合化疗方案加最初每日服用利福平及氧氟沙星1个月。在包括世界卫生组织麻风病联合化疗方案的三种治疗方案中,治疗开始后9年和12年的复发率为0%-3%,而仅采用1个月治疗方案的患者复发率明显更高(P<0.05):9年时为11%,12年时为25%。复发出现较晚,始于治疗开始后5年,且仅限于那些组织病理学上为中间界线类偏瘤型和极重型偏瘤型且细菌载量高的患者。文中还介绍了麻风病替代有效短程治疗方案的前景。

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引用本文的文献

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World Health Organization (WHO) antibiotic regimen against other regimens for the treatment of leprosy: a systematic review and meta-analysis.世界卫生组织(WHO)抗麻风病抗生素方案与其他方案的比较:系统评价和荟萃分析。
BMC Infect Dis. 2020 Jan 20;20(1):62. doi: 10.1186/s12879-019-4665-0.
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Leprosy.
麻风病
BMJ Clin Evid. 2010 Jun 28;2010:0915.