类固醇和非甾体抗炎药在类风湿性关节炎治疗中的应用：系统评价方案。
Use of steroid and nonsteroidal anti-inflammatories in the treatment of rheumatoid arthritis: Systematic review protocol.
作者信息
Del Grossi Moura Mariana, Cruz Lopes Luciane, Silva Marcus Tolentino, Barberato-Filho Sílvio, Motta Rogério Heládio Lopes, Bergamaschi Cristiane de Cássia
机构信息
Department of Pharmaceutical Sciences, University of Sorocaba, Sorocaba, São Paulo.
Faculty of Medicine, Federal University of Amazonas, Manaus, Amazonas.
出版信息
Medicine (Baltimore). 2018 Oct;97(41):e12658. doi: 10.1097/MD.0000000000012658.
BACKGROUND
Rheumatoid arthritis affects 1% of the world's population and its current treatment options are costly. There are not enough studies that evaluated the efficacy and safety of anti-inflammatory drugs medications used to reduce rheumatoid arthritis's symptoms. This study will evaluate the effectiveness and the safety of steroid and nonsteroidal anti-inflammatory drugs for the treatment of patients with rheumatoid arthritis.
METHODS
Randomized clinical trials eligible for our systematic review will enroll adults with rheumatoid arthritis treated with anti-inflammatory drugs compared with a control group (placebo or active control) at any dose, duration, and route of administration and double blind studies. In order to include all forms of rheumatoid arthritis and anti-inflammatory drugs, we will search the following electronic databases: Cochrane Central Register of Controlled Trials, MEDLINE (via Ovid); ExcerptaMedica Database (via Ovid); Cumulative Index to Nursing and Allied Health Literature (via Ovid); Web of Science; ClinicalTrial.gov; and WHO International Clinical Trials Registry Platform. We will not impose any language restrictions or publication status. Outcomes of interest include are pain, physical function, swelling, stiffness, grip force, radiological image of the joint, quality of life, adverse events, discontinuation due to adverse events, satisfaction with the treatment, and rescue medication for pain. A team of reviewers will independently screen search results, extract data from eligible trials, and assess risk of bias. We will use the Grading of Recommendations Assessment, Development and Evaluation approach to rate overall certainty of the evidence by outcome. Dichotomous data will be summarized as risk ratios; continuous data will be given as standard average differences with 95% confidence intervals.
RESULTS
The evidence derived by this study will increase awareness of the effectiveness and safety of steroid and nonsteroidal anti-inflammatory drugs for the treatment of rheumatoid arthritis.
CONCLUSION
The results could guide patients and healthcare practitioners and help facilitate evidence-based shared care decision making.
背景
类风湿关节炎影响着全球1%的人口，目前的治疗方案成本高昂。评估用于减轻类风湿关节炎症状的抗炎药物疗效和安全性的研究尚不充分。本研究将评估类固醇和非甾体抗炎药治疗类风湿关节炎患者的有效性和安全性。
方法
符合我们系统评价的随机临床试验将纳入使用抗炎药物治疗的类风湿关节炎成人患者，并与任何剂量、疗程和给药途径的对照组（安慰剂或活性对照）进行比较，且为双盲研究。为了纳入所有形式的类风湿关节炎和抗炎药物，我们将检索以下电子数据库：Cochrane对照试验中心注册库、MEDLINE（通过Ovid）；医学文摘数据库（通过Ovid）；护理学与健康相关文献累积索引（通过Ovid）；科学引文索引；ClinicalTrial.gov；以及世界卫生组织国际临床试验注册平台。我们不会施加任何语言限制或出版状态限制。感兴趣的结局包括疼痛、身体功能、肿胀、僵硬、握力、关节的放射影像、生活质量、不良事件、因不良事件停药、对治疗的满意度以及疼痛的解救药物。一组评审员将独立筛选检索结果，从符合条件的试验中提取数据，并评估偏倚风险。我们将使用推荐分级评估、制定与评价方法按结局对证据的总体确定性进行评级。二分数据将汇总为风险比；连续数据将以95%置信区间的标准平均差给出。
结果
本研究得出的证据将提高对类固醇和非甾体抗炎药治疗类风湿关节炎有效性和安全性的认识。
结论
研究结果可为患者和医疗从业者提供指导，并有助于促进基于证据的共同护理决策。
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