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巴西麻风病人统一多药疗法临床试验(U-MDT/CT-BR)结果:细菌学指数下降。

Results from the clinical trial of uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): decrease in bacteriological index.

作者信息

Penna Maria Lucia Fernandes, Bűhrer-Sékula Samira, Pontes Maria Araci de Andrade, Cruz Rossilene, Gonçalves Heitor de SáOliveira, Penna Gerson Oliveira

出版信息

Lepr Rev. 2014 Dec;85(4):262-6.

Abstract

BACKGROUND

Many believe that the regular treatment for multibacillary (MB) leprosy cases could be shortened. A shorter treatment allowing uniformity in treatment for all cases renders case classification superfluous and therefore simplifies leprosy control.

OBJECTIVE

To evaluate the association between treatment duration and the trend in bacteriological index (BI) decrease over time among patients given Uniform MDT (UMDT) compared to those given regular MDT (RMDT).

METHODS

An open-label randomised clinical trial to compare the present routine treatment with one lasting six month. Patient intake was from March 2007 to February 2012. To evaluate the trend of BI as a function of time, a multilevel linear with mixed effects model was fixed to the two study groups and also four groups after stratification by BI, less than 3 and 3 or more.

RESULTS

The BI fall was higher among those taking RMDT, this difference however was not statistically significant.

CONCLUSION

The results presented here support the possibility of use of UMDT in the field, but further follow up is still needed for a final conclusion.

摘要

背景

许多人认为多菌型麻风病例的常规治疗疗程可以缩短。缩短治疗疗程可使所有病例的治疗趋于统一,使病例分类变得多余,从而简化麻风病防治工作。

目的

评估与接受常规联合化疗(RMDT)的患者相比,接受统一多药联合化疗(UMDT)的患者治疗持续时间与细菌学指数(BI)随时间下降趋势之间的关联。

方法

一项开放标签随机临床试验,比较现行常规治疗与为期6个月的治疗。患者纳入时间为2007年3月至2012年2月。为评估BI随时间变化的趋势,对两个研究组以及按BI分层(小于3和3及以上)后的四个组采用了具有混合效应的多水平线性模型。

结果

接受RMDT的患者BI下降幅度更大,但这种差异无统计学意义。

结论

此处呈现的结果支持在现场使用UMDT的可能性,但仍需进一步随访才能得出最终结论。

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