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拉坦前列素对原发性开角型青光眼的治疗效果:一项随机对照试验系统评价的方案

Therapeutic efficacy of latanoprost on primary open angle glaucoma: A protocol for a systematic review of randomized controlled trial.

作者信息

Dai Hai-Yan, Wang Jia-Ying, Li Yan-Qing, Diao Hui-Jie, Zhang Li

机构信息

Second Ward of Ophthalmology Department.

First Ward of Ophthalmology Department.

出版信息

Medicine (Baltimore). 2018 Dec;97(51):e13833. doi: 10.1097/MD.0000000000013833.

Abstract

BACKGROUND

Latanoprost is quiet new formulation that is approved for the treatment of primary open angle glaucoma (POAG). However, no updated systematic review has addressed its efficacy for POAG. This systematic review of randomized controlled trials (RCTs) aims to assess its efficacy and safety for the treatment of patients with POAG.

METHODS

This study will search the databases of CENTRAL, EMBASE, MEDILINE, CINAHL, AMED and Chinese databases without language restrictions from their inception to the present. It will only include RCTs of latanoprost for POAG. The quality of the included RCTs will be evaluated by the tool of Cochrane risk of bias. The primary outcomes will be measured by the mean IOP reduction from baseline to the endpoint. The secondary outcomes will be assessed by the mean IOP, adjusted mean IOP reduction at each time point, quality of life, and adverse events. The RevMan V.5.3 software will be used to compute the data synthesis carefully if the meta-analysis is allowed. The summary results of the included RCTs will be conducted by using the models of random-effects or fixed-effects based.

RESULTS

The results of this study will be published at the peer-reviewed journals. It will provide evidence to determine the efficacy and safety of latanoprost for POAG.

CONCLUSION

The results of this study will provide helpful evidence for both clinicians and patients, and for the health policy makers to refer for the policy or guideline making.

SYSTEMATIC REVIEW REGISTRATION

PROSPERO CRD42018115416.

摘要

背景

拉坦前列素是一种新获批用于治疗原发性开角型青光眼(POAG)的制剂。然而,尚无更新的系统评价探讨其对POAG的疗效。本随机对照试验(RCT)的系统评价旨在评估其治疗POAG患者的疗效和安全性。

方法

本研究将检索CENTRAL、EMBASE、MEDILINE、CINAHL、AMED数据库以及中文数据库,检索时间从建库至当前,无语言限制。仅纳入拉坦前列素治疗POAG的RCT。采用Cochrane偏倚风险工具评估纳入RCT的质量。主要结局指标为从基线至终点的平均眼压降低值。次要结局指标将通过平均眼压、各时间点的调整后平均眼压降低值、生活质量和不良事件进行评估。若允许进行Meta分析,将使用RevMan V.5.3软件仔细计算数据合成。纳入RCT的总结结果将采用随机效应模型或固定效应模型进行分析。

结果

本研究结果将在同行评审期刊上发表。它将为确定拉坦前列素治疗POAG的疗效和安全性提供证据。

结论

本研究结果将为临床医生、患者以及卫生政策制定者在制定政策或指南时提供有益的参考依据。

系统评价注册

PROSPERO CRD42018115416

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8caf/6320140/d657f7d284e8/medi-97-e13833-g002.jpg

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