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预测利福平化学预防对接触者有效性的患者相关因素:孟加拉国COLEP队列的6年随访

Patient-related factors predicting the effectiveness of rifampicin chemoprophylaxis in contacts: 6 year follow up of the COLEP cohort in Bangladesh.

作者信息

Feenstra Sabiena G, Pahan David, Moet F Johannes, Oskam Linda, Richardus Jan Hendrik

机构信息

Department of Public Health, Erasmus MC, University Medical Center Rotterdam, The Netherlands.

出版信息

Lepr Rev. 2012 Sep;83(3):292-304.

Abstract

OBJECTIVES

The COLEP trial in Bangladesh showed a 57% reduction in leprosy incidence among contacts of newly diagnosed patients in the first 2 years after chemoprophylaxis with single dose rifampicin (SDR). We assessed the impact of this intervention after 6 years and identified characteristics of the leprosy index patients predicting the effectiveness of this intervention.

DESIGN

The cohort of 1037 patients and their 28 092 contacts that participated in the randomised placebo controlled field trial with single dose rifampicin was followed for 6 years. The leprosy status of contacts was established at 2, 4 and 6 years after the intervention. We assessed the association between characteristics of the index leprosy patients and the development of clinical leprosy among their contacts using logistic regression.

RESULTS

The protective effect of SDR was seen only in the first 2 years, with no additional effect after 4 and 6 years. However, the total impact of the intervention was still statistically significant (P = 0.025) after 6 years and no excess cases were observed in the SDR arm at a later stage. The intervention prevented leprosy in contacts that actually received SDR, but did not offer protection to members of the same contact group who did not take chemoprophylaxis. The intervention was most effective in contact groups of female index patients, an enhanced effect was also observed in contact groups of patients belonging to a cluster of two or more leprosy patients at intake as well.

CONCLUSION

These easy to recognise patient characteristics indicate a possible enhanced risk of transmission of Mycobacterium leprae to contacts in the vicinity of patients and are useful for deciding about preventive measures, such as early detection or chemoprophylaxis.

摘要

目的

孟加拉国的COLEP试验表明,在采用单剂量利福平(SDR)进行化学预防后的头两年,新诊断患者的接触者中麻风发病率降低了57%。我们评估了6年后该干预措施的影响,并确定了预测该干预措施有效性的麻风指数患者的特征。

设计

对参与单剂量利福平随机安慰剂对照现场试验的1037例患者及其28092名接触者进行了6年的随访。在干预后2年、4年和6年确定接触者的麻风状况。我们使用逻辑回归评估指数麻风患者的特征与他们接触者中临床麻风病发生之间的关联。

结果

SDR的保护作用仅在头两年出现,4年和6年后没有额外效果。然而,干预的总体影响在6年后仍具有统计学意义(P = 0.025),并且在后期SDR组未观察到过多病例。该干预措施预防了实际接受SDR的接触者患麻风病,但对未进行化学预防的同一接触组成员没有提供保护。该干预措施在女性指数患者的接触组中最有效,在入组时属于两个或更多麻风患者聚集群的患者接触组中也观察到增强效果。

结论

这些易于识别的患者特征表明,麻风分枝杆菌在患者附近向接触者传播的风险可能增加,并且有助于决定采取诸如早期检测或化学预防等预防措施。

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