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Abstract：
BACKGROUND: Leprosy is a neglected dermato-neurologic, infectious disease caused by Mycobacterium leprae or M. lepromatosis. Leprosy is treatable and curable by multidrug therapy/MDT, consisting of 12 months rifampicin, dapsone and clofazimine for multibacillary/MB patients and for 6 months for paucibacillary/PB patients. The relapse rate is considered a crucial treatment outcome. A randomized Controlled Clinical Trial (U-MDT/CT-BR) conducted from 2007‒2012 compared clinical outcomes in MB patients after 12 months regular MDT/R-MDT and 6 months uniform MDT/U-MDT in two highly endemic Brazilian areas.
OBJECTIVE: To estimate the 10 years relapse rate of MB patients treated with 6 months U-MDT.
METHODS: The statistical analyses treated the data as a case-control study, sampled from the cohort generated for the randomized trial. Analyses estimated univariate odds ratio and applied logistic regression for multivariate analysis, controlling the confounding variables.
RESULTS: The overall relapse rate was 4.08 %: 4.95 % (16 out of 323) in the U-MDT group and 3.10 % (9 out of 290) in the regular/R-MDT group. The difference in relapse proportion between U-MDT and R-MDT groups was 1.85 %, not statistically significant (Odds Ratio = 1.63, 95 % CI 0.71 to 3.74). However, misdiagnosis of relapses, may have introduced bias, underestimating the force of the association represented by the odds ratio.
CONCLUSIONS: The relapse estimate of 10 years follow-up study of the first randomized, controlled study on U-MDT/CT-BR was similar to the R-MDT group, supporting strong evidence that 6 months U-MDT for MB patients is an acceptable option to be adopted by leprosy endemic countries worldwide.
BACKGROUND: ClinicalTrials.gov: NCT00669643.
OBJECTIVE: To estimate the 10 years relapse rate of MB patients treated with 6 months U-MDT.
METHODS: The statistical analyses treated the data as a case-control study, sampled from the cohort generated for the randomized trial. Analyses estimated univariate odds ratio and applied logistic regression for multivariate analysis, controlling the confounding variables.
RESULTS: The overall relapse rate was 4.08 %: 4.95 % (16 out of 323) in the U-MDT group and 3.10 % (9 out of 290) in the regular/R-MDT group. The difference in relapse proportion between U-MDT and R-MDT groups was 1.85 %, not statistically significant (Odds Ratio = 1.63, 95 % CI 0.71 to 3.74). However, misdiagnosis of relapses, may have introduced bias, underestimating the force of the association represented by the odds ratio.
CONCLUSIONS: The relapse estimate of 10 years follow-up study of the first randomized, controlled study on U-MDT/CT-BR was similar to the R-MDT group, supporting strong evidence that 6 months U-MDT for MB patients is an acceptable option to be adopted by leprosy endemic countries worldwide.
BACKGROUND: ClinicalTrials.gov: NCT00669643.
摘要：
背景：麻风病是一种被忽视的皮肤神经，麻风分枝杆菌或麻风分枝杆菌引起的传染病。麻风病可以通过多种药物治疗/MDT治疗和治愈，由12个月的利福平组成，氨苯砜和氯法齐明用于多杆菌/MB患者和6个月用于少杆菌/PB患者。复发率被认为是关键的治疗结果。2007-2012年进行的一项随机对照试验（U-MDT/CT-BR）比较了在两个高度流行的巴西地区，经过12个月的常规MDT/R-MDT和6个月的均匀MDT/U-MDT后，MB患者的临床结果。
目的：评估接受6个月U-MDT治疗的MB患者10年复发率。
方法：统计分析将数据视为病例对照研究，从随机试验产生的队列中取样。分析估计的单变量比值比，并应用逻辑回归进行多变量分析，控制混杂变量。
结果：U-MDT组的总复发率为4.08％：4.95％（323个中的16个），常规/R-MDT组为3.10％（290个中的9个）。U-MDT和R-MDT组的复发比例差异为1.85%,无统计学意义(赔率=1.63，95%CI0.71至3.74)。然而,复发的误诊，可能引入了偏见，低估了赔率比所代表的联想的力量。
结论：首次随机，U-MDT/CT-BR的对照研究与R-MDT组相似,支持强有力的证据表明,MB患者6个月U-MDT是全世界麻风病流行国家采用的可接受选择.
背景：ClinicalTrials.gov：NCT00669643。
目的：评估接受6个月U-MDT治疗的MB患者10年复发率。
方法：统计分析将数据视为病例对照研究，从随机试验产生的队列中取样。分析估计的单变量比值比，并应用逻辑回归进行多变量分析，控制混杂变量。
结果：U-MDT组的总复发率为4.08％：4.95％（323个中的16个），常规/R-MDT组为3.10％（290个中的9个）。U-MDT和R-MDT组的复发比例差异为1.85%,无统计学意义(赔率=1.63，95%CI0.71至3.74)。然而,复发的误诊，可能引入了偏见，低估了赔率比所代表的联想的力量。
结论：首次随机，U-MDT/CT-BR的对照研究与R-MDT组相似,支持强有力的证据表明,MB患者6个月U-MDT是全世界麻风病流行国家采用的可接受选择.
背景：ClinicalTrials.gov：NCT00669643。
