按CONSORT声明要求报告随机对照试验.pptVIP

 按CONSORT声明要求报告随机对照试验 中华医学杂志英文版 汪谋岳 何谓CONSORT声明 Consolidated standards of reporting trials CONSORT小组发布的写作指南 专门针对两组的RCT 1995年初次发布，2000年修订，随后有补充 目前国际许多主流医学期刊使用 何谓CONSORT声明 CONSORT小组 临床试验学家 统计学家 流行病学家 生物医学编辑 CONSORT声明主要内容 一个流程图：介绍病例入组到进入分析各阶段的动态变化 一个核查表：22个项目，从文题到讨论都有要求 CONSORT声明核查表 CONSORT声明核查表 CONSORT声明核查表 CONSORT声明 CONSORT声明的内容 文题举例 Efficacy and Safety of Benazepril for Advanced Chronic Renal Insufficiency (贝那普利) Efficacy and Safety of Benazepril for Advanced Chronic Renal Insufficiency：a randomized, double-blind study 文题举例 Actinomycin D Versus Methotrexate-Folinic Acid as the Treatment of Stage I, Low-Risk Gestational Trophoblastic Neoplasia: A Randomized Controlled Trial Immunogenicity, Reactogenicity, and Safety of Human Papillomavirus 16/18 AS04-Adjuvanted Vaccine in Japanese Women: Interim Analysis of a Phase II, Double-blind, Randomized Controlled Trial at Month 7 摘要举例 Background Angiotensin-converting–enzyme inhibitors provide renal protection in patients with mild-to-moderate renal insufficiency (serum creatinine level, 3.0 mg per deciliter or less). We assessed the efficacy and safety of benazepril in patients without diabetes who had advanced renal insufficiency. 摘要举例 Methods We enrolled 422 patients in a randomized, double-blind study. After an eight-week run-in period, 104 patients with serum creatinine levels of 1.5 to 3.0 mg per deciliter (group 1) received 20 mg of benazepril per day, whereas 224 patients with serum creatinine levels of 3.1 to 5.0 mg per deciliter (group 2) were randomly assigned to receive 20 mg of benazepril per day (112 摘要举例 patients) or placebo (112 patients) and then followed for a mean of 3.4 years. All patients received conventional antihypertensive therapy. The primary outcome was the composite of a doubling of the serum creati