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Aim To investigate the effect of dipeptidyl peptidase-4 inhibitor (DPP-4i) on serum creatinine (Cr) in patients with type 2 diabetes mellitus (T2DM). Methods A systematic search was performed across databases of PubMed, Embase, Cochrane Library and Web of Science, and randomized controlled trials (RCT) of DPP-4i therapy for regulating Cr in T2DM patients was included. A fixed-effect or random-effect model was used for data fitting, heterogeneity was quantitatively evaluated according to the index of I², and sensitivity analysis and publication bias testing were performed by using the standard methods. Results After searching the database through the system, 12 RCTs were included, with a total of 2 276 participants. Due to the potential heterogeneity, a random effect model was used for data fitting. DPP-4i treatment could mildly increase Cr levels in T2DM patients (WMD: 0. 15 mg / L, 95% CI: 0. 03 ~ 0. 27, I² = 18%, P= 0. 02), and the results showed statistical differences. According to sensitivity testing, the results of Meta-analysis were relatively reliable. No publication bias was observed according to Begg’ s and Egger’ s tests. Conclusions The use of DPP-4i for hypoglycemic treatment in T2DM patients may result in mild elevation of blood Cr levels. Further multicenter studies with larger samples are needed in the future to explore the clinical significance of DPP-4i treatment induced changes in Cr levels. [ABSTRACT FROM AUTHOR]

非劣效性设计临床试验是一类检验试验组治疗手段是否不劣于对照组治疗手段的随机对照临床试验。本文简要介绍非劣效性设计临床试验的基本概念、设计要点及其与等效性和优效性设计临床试验的差异，并通过具体案例解读，帮助读者全面了解、实施和评价非劣效性设计方法。 【Abstract】 A noninferiority design clinical trial is a type of randomized controlled clinical trials that examines whether the treatment of the experimental group is not inferior to the treatment of the control group. This paper introduces the basic concept, design points,comparison with equivalence and superiority trials, and case analysis to help readers fully understand, implement and evaluate noninferiority design clinical trials.

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基于登记/注册研究的随机对照试验是一种利用现有的高质量登记/注册平台进行病例记录、数据收集、随机化应用以及随访的临床试验。本文简要介绍基于登记/注册研究的随机对照试验的基本概念、历史渊源、设计思路与传统随机对照试验的比较、适用场景、案例解读、统计方法及报告规范等内容，以期帮助临床研究者认识了解、掌握此类研究设计。 Abstract: A registry-based randomized controlled trial (RCT) is a clinical trial utilizing the existing high-quality registry platform for case records, data collection, randomized utilization, and follow-up. This article introduced the basic concept, historical origin, design ideas of registry-based RCT, comparison with traditional RCTs, applicable scenarios, cases analysis, statistical methods, report standards and so on.

Objective • To systematically review the efficacy of cryotherapy in head and neck cancer patients with radiation-induced oral stomatitis. Methods • >ubMed, EMbase, Cochrane Library, Web of Science, CNKI, WanFang, VIP and CBM databases were searched to collect randomized controlled trials (RCTs) of cryotherapy in head and neck cancer patients with ration-induced stomatitis from inception to January 31th, 2022. Literature screening, data extraction, and quality evaluation were performed independently by two researchers. Meta-analysis was then performed by using RevMan 5.4 and Stata 16.0 software. Results • A total of 36 RCTs were included. The results of meta-analysis showed that compared to control group, cryotherapy group had a lower total incidence of radiation-induced stomatitis [adds ratio (OR)=0.30, 95% confidence interval (CI) 0.23-0.39, P=0.000] and a lower incidence of severe radiation-induced stomatitis (OR=0.17, 95%CI 0.14-0.21, P=0.000). Conclusion • Cryotherapy may contribute to reducing the incidence of radiation-induced stomatitis and the incidence of severe radiation-induced stomatitis. [ABSTRACT FROM AUTHOR]