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利福平化学预防在预防麻风病患者接触者感染方面的有效性:对定量和定性证据的系统评价

Effectiveness of rifampicin chemoprophylaxis in preventing leprosy in patient contacts: a systematic review of quantitative and qualitative evidence.

作者信息

Ferreira Silvana Margarida Benevides, Yonekura Tatiana, Ignotti Eliane, Oliveira Larissa Bertacchini de, Takahashi Juliana, Soares Cassia Baldini

机构信息

1The University of Cuiabá, and Graduate Program, Federal University of Mato Grosso/School of Nursing, Mato Grosso, Brazil 2School of Nursing, University of São Paulo, São Paulo, Brazil 3Mato Grosso State University, Mato Grosso, Brazil 4The Brazilian Centre for Evidence-based Healthcare: a Joanna Briggs Institute Centre of Excellence.

出版信息

JBI Database System Rev Implement Rep. 2017 Oct;15(10):2555-2584. doi: 10.11124/JBISRIR-2016-003301.

Abstract

BACKGROUND

Individuals in contact with patients who have leprosy have an increased risk of disease exposure, which reinforces the need for chemoprophylactic measures, such as the use of rifampicin.

OBJECTIVES

The objective of the review was to synthesize the best available evidence regarding the effectiveness of rifampicin chemoprophylaxis for contacts with patients with leprosy, and to synthesize the best available evidence on the experience and acceptability of rifampicin chemoprophylaxis as reported by the contacts and health professionals involved in the treatment of leprosy or Hansen's disease.

INCLUSION CRITERIA TYPES OF PARTICIPANTS

In the quantitative component, individuals in contact with leprosy patients were included. In the qualitative component, in addition to contacts, health professionals who were in the practice of treating leprosy were included.

TYPES OF INTERVENTION(S)/PHENOMENA OF INTEREST: The quantitative component considered as an intervention rifampicin at any dose, frequency and mode of administration, and rifampicin combination regimens.The qualitative component considered as phenomena of interest the experience and acceptability of rifampicin chemoprophylaxis.

TYPES OF STUDIES

The quantitative component considered experimental and observational studies whereas the qualitative component considered studies that focused on qualitative data, including but not limited to, designs such as phenomenology, grounded theory, ethnography and action-research.

OUTCOMES

The quantitative component considered studies that reported on outcomes such as the development of clinical leprosy in the contacts of patients who had leprosy, incidence rates, adverse effects and safety/harmful effects of the intervention.

SEARCH STRATEGY

A three-step strategy for published and unpublished literature was used. The search for published studies included: PubMed, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Scopus, Web of Science, National Institute for Health and Clinical Excellence, Latin American and Caribbean Health Sciences Literature; and Google Scholar and EVIPnet for unpublished studies. Studies published from the time of the respective database inception to January 2016 in English, Spanish, Portuguese, Japanese and Chinese were considered.

METHODOLOGICAL QUALITY

Two reviewers independently assessed the studies for methodological quality using standardized critical appraisal instruments from the Joanna Briggs Institute.

DATA EXTRACTION

Standardized data extraction tools developed by the Joanna Briggs Institute were used to extract quantitative and qualitative data from papers included in the review.

DATA SYNTHESIS

Due to clinical and methodological heterogeneity in the interventions of the included studies, no statistical meta-analysis was possible. Quantitative and qualitative research findings are presented in narrative form.

RESULTS

Following critical appraisal, eight studies were included in this review, seven quantitative and one qualitative. The reduction in incidence of leprosy, using one dose of rifampicin in the first two years, was 56.5%; in the follow up period of one to four years, the reduction was 34.9%. The combination of rifampicin and the Bacillus Calmette-Guérin vaccine showed a preventative effect of 80% against the disease. The only controlled clinical trial using two doses of rifampicin was community-based and did not indicate effectiveness of the intervention. The qualitative findings showed social acceptability of rifampicin.

CONCLUSIONS

Chemoprophylaxis with one dose of rifampicin is found to be effective in preventing contacts of leprosy patients from contracting the disease. Also, there is indication that this strategy is socially accepted.

摘要

背景

与麻风病患者接触的个体面临更高的疾病暴露风险,这强化了采取化学预防措施的必要性,如使用利福平。

目的

本综述的目的是综合关于利福平化学预防对麻风病患者接触者有效性的最佳现有证据,并综合接触者以及参与麻风病或汉森病治疗的卫生专业人员所报告的利福平化学预防的经验和可接受性方面的最佳现有证据。

纳入标准 参与者类型:在定量研究部分,纳入与麻风病患者接触的个体。在定性研究部分,除了接触者外,还纳入从事麻风病治疗工作的卫生专业人员。

干预类型/感兴趣的现象:定量研究部分将任何剂量、频率和给药方式的利福平以及利福平联合用药方案视为干预措施。定性研究部分将利福平化学预防的经验和可接受性视为感兴趣的现象。

研究类型

定量研究部分考虑实验性和观察性研究,而定性研究部分考虑专注于定性数据的研究,包括但不限于现象学、扎根理论、民族志和行动研究等设计。

结局

定量研究部分考虑报告如下结局的研究:麻风病患者接触者中临床麻风病的发生情况、发病率、干预措施的不良反应以及安全性/有害效应。

检索策略

采用三步策略检索已发表和未发表的文献。检索已发表研究包括:PubMed、护理及相关健康文献累积索引、考克兰图书馆、Scopus、科学引文索引、英国国家卫生与临床优化研究所、拉丁美洲和加勒比卫生科学文献库;以及检索未发表研究的谷歌学术和EVIPnet。考虑了从各数据库创建之时至2016年1月以英文、西班牙文葡萄牙文、日文和中文发表的研究。

方法学质量

两名评审员使用乔安娜·布里格斯研究所的标准化批判性评价工具独立评估研究的方法学质量。

数据提取

使用乔安娜·布里格斯研究所开发的标准化数据提取工具从纳入综述的论文中提取定量和定性数据。

数据综合

由于纳入研究的干预措施存在临床和方法学异质性,无法进行统计荟萃分析。定量和定性研究结果以叙述形式呈现。

结果

经过批判性评价,本综述纳入八项研究,七项定量研究和一项定性研究。在前两年使用一剂利福平,麻风病发病率降低了56.5%;在一至四年的随访期内,降低了34.9%。利福平和卡介苗联合使用对该病显示出80%的预防效果。唯一一项使用两剂利福平的对照临床试验是以社区为基础的,未显示该干预措施有效。定性研究结果表明利福平具有社会可接受性。

结论

发现一剂利福平化学预防对预防麻风病患者接触者感染该病有效。此外,有迹象表明该策略在社会上是可接受的。

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