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.
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。