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结核病高流行国家中感染艾滋病毒的孕妇和产后妇女的异烟肼预防性治疗:一项系统评价方案

Isoniazid preventive therapy in HIV-infected pregnant and postpartum women in high prevalence of tuberculosis countries: A protocol for systematic review.

作者信息

Wang Xiaozhuan, Zhang Yun, Lin Xiaojuan, Fu Yu, Sun Qingmei, Li Jing, Liu Xiaoling, Bai Jing

机构信息

Gansu Provincial Maternity and Child-care Hospital, Lanzhou, Gansu Province, China.

出版信息

Medicine (Baltimore). 2020 Nov 20;99(47):e23089. doi: 10.1097/MD.0000000000023089.

Abstract

BACKGROUND

Tuberculosis (TB) is the leading cause of health complications and death among human with immunodeficiency virus (HIV) infection. When TB develops during pregnancy or the early postpartum period, it is associated with negative maternal, pregnancy, and fetus and infant outcome, including premature birth, low birth weight, and congenital or neonatal TB infection or disease. The objective of this systematic review is to investigate the effective and safe of isoniazid for preventing TB for HIV-infected pregnant women in counties with high prevalence of TB.

METHODS

Pubmed, Embase, and Cochrane library will be searched to include randomized control trials which compared isoniazid preventive therapy with placebo for preventing TB in HIV-infected pregnant and postpartum women. RevMan version 5.3 will be used to perform all calculations related to the meta-analysis. Dichotomous data will be calculated in terms of a fixed or random effect model and expressed by the relative risk (RR) with 95% confidence interval (CI). The Cochrane collaboration's tool in the following aspects was used to assess the risk of bias (ROB) in included studies. The inconsistency index (I2) and Chi-squared will be applied for heterogeneity detection between clinical trials. A value of P < 0.05 will be considered statistically significant.

RESULTS

The main outcomes of pooled evidence synthesis will be presented including the incidence of TB and adverse events.

CONCLUSION

This study will provide the evidence of whether isoniazid is an effective and safe intervention for preventing TB for HIV-infected pregnant women.

REGISTRATION NUMBER

INPLASY202070011.

摘要

背景

结核病是人类免疫缺陷病毒(HIV)感染者健康并发症和死亡的主要原因。当结核病在孕期或产后早期发生时,会对母亲、妊娠以及胎儿和婴儿产生不良影响,包括早产、低出生体重以及先天性或新生儿结核感染或疾病。本系统评价的目的是调查在结核病高流行县,异烟肼预防HIV感染孕妇患结核病的有效性和安全性。

方法

检索PubMed、Embase和Cochrane图书馆,纳入比较异烟肼预防性治疗与安慰剂预防HIV感染孕妇和产后妇女结核病的随机对照试验。将使用RevMan 5.3版进行所有与荟萃分析相关的计算。二分数据将根据固定效应模型或随机效应模型进行计算,并以相对风险(RR)及95%置信区间(CI)表示。采用Cochrane协作网的工具从以下方面评估纳入研究的偏倚风险(ROB)。将应用不一致性指数(I2)和卡方检验检测临床试验之间的异质性。P<0.05的值将被视为具有统计学意义。

结果

将呈现汇总证据合成的主要结果,包括结核病发病率和不良事件。

结论

本研究将提供证据,证明异烟肼对预防HIV感染孕妇患结核病是否为有效且安全的干预措施。

注册号

INPLASY202070011。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4917/7676523/2ddc7972b149/medi-99-e23089-g001.jpg

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