Li Shu-Min, Lin Yang, Liang Shan-Shan
Department of Respiratory Medicine, First Affiliated Hospital of Jiamusi University, Jiamusi, China.
Medicine (Baltimore). 2019 Apr;98(17):e15407. doi: 10.1097/MD.0000000000015407.
This study will systematically assess the efficacy and safety of pirfenidone for the treatment of patients with pulmonary fibrosis (PF).
We will search potential records from following literature sources from their inceptions to the present without language, and publication status limitations: Cochrane Library, EMBASE, PUBMED, the Cumulative Index to Nursing and Allied Health Literature, the Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. In addition, we also search grey literature sources, such as dissertations, conference proceedings, as well as the reference lists of included studies. All randomized controlled trials related to the pirfenidone for treating PF will be included. All the process of study selection, data extraction, and methodological evaluation will be carried out by 2 authors independently. The primary outcome comprises of all-cause-mortality, and lung function status, as measured by forced vital capacity. The secondary outcomes consist of 6-minute walk distance, progression-free survival, dyspnea, acute exacerbation, quality of life, and adverse events. Whenever possible, all results data will be pooled and meta-analysis will be performed.
This study will systematically assess the efficacy and safety of pirfenidone for the treatment of patients with PF.
The findings of the present study will summarize most recent evidence of pirfenidone for PF.
No individual data will be analyzed in this study, thus, no research ethics approval is required in this study. The findings of this study are expected to be disseminated in a peer-reviewed journal or conference presentations.
PROSPERO CRD42019126958.
本研究将系统评估吡非尼酮治疗肺纤维化（PF）患者的疗效和安全性。
我们将检索以下文献来源从创刊至今的潜在记录，不受语言和出版状态限制：Cochrane图书馆、EMBASE、PUBMED、护理及相关健康文献累积索引、补充与替代医学数据库、中国生物医学文献数据库和中国知网。此外，我们还检索灰色文献来源，如学位论文、会议论文集以及纳入研究的参考文献列表。所有与吡非尼酮治疗PF相关的随机对照试验都将被纳入。研究选择、数据提取和方法学评估的所有过程将由两位作者独立进行。主要结局包括全因死亡率和用力肺活量测量的肺功能状态。次要结局包括6分钟步行距离、无进展生存期、呼吸困难、急性加重、生活质量和不良事件。只要有可能，所有结果数据将进行汇总并进行荟萃分析。
本研究将系统评估吡非尼酮治疗PF患者的疗效和安全性。
本研究结果将总结吡非尼酮治疗PF的最新证据。
本研究不会分析个体数据，因此，本研究无需研究伦理批准。本研究结果预计将在同行评审期刊或会议报告中发表。
PROSPERO注册号：PROSPERO CRD42019126958。
