ON SAMPLE SIZE CALCULATION BASED ON ODDS RATIO IN CLINICAL TRIALS

Sample size calculation formulas for testing equality, noninferiority, superiority, and equivalence based on odds ratio were derived under both parallel and one-arm crossover designs. An example concerning the study of odds ratio between a test compound (treatment) and a standard therapy (control) for prevention of relapse in subjects with schizophrenia and schizoaffective disorder is presented to illustrate the derived formulas for sample size calculation for various hypotheses under both a parallel design and a crossover design. Simulations were performed to assess the adequacy of the sample size calculation formulas. Simulation results were given at the end of the paper.     

民营医院集团化发展SWOT分析及策略选择

运用态势分析法（SWOT）分析民营医院集团化发展策略,掌握民营医院所处环境,探讨民营医院集团化的优劣势,积极把握新医改背景下民营医院发展的机遇,提出民营医院集团化管理策略、人才队伍建设策略和资本引入策略。     

如何正确运用t检验——两算术均值比较优效性t检验及SAS实现

本文主要介绍临床试验中优效性检验的概念、假设检验、界值设定和样本量的估计以及成组设计一元定量资料优效性t检验的SAS实现。通过实例展示SAS在优效性t检验中的应用,分别基于两种数据结构(原始定量数据和样本含量、均值、标准差数据)进行操作,对结果进行解释并作出结论。     

激痛点特种针法治疗颈肩肌筋膜疼痛综合征的临床研究进展

随着现代颈肩疾病的频繁发生,颈肩肌筋膜疼痛综合征(Myofascial Pain Symdrome, MPS)已逐渐成为困扰人们生活和工作的因素。针刺治疗软组织损伤引起的疼痛,因疗效确切、安全、无不良反应等优势在临床上被广泛应用。在国家知识基础设施数据库、中文科技期刊数据库、中国学术期刊数据库、PubMed数据库中,对2009—2019年间有关针刺治疗肌筋膜疼痛综合征、针刺治疗肌筋膜炎、激痛点的相关资料进行查阅和筛选,从激痛点特种针刺手法运用,特种针具使用以及复合其他温热电等针刺疗法临床运用3个方面来对激痛点针刺治疗颈肩MPS临床文献进行总结,结果发现颈肩MPS在激痛点行特种针刺疗法有显著的疗效。     

大学附属口腔医院管理模式初探

口腔医疗市场近十年的巨大变化,给大学口腔医院带来了压力和冲击,但同时也面临机遇和挑战。如何充分发挥大学口腔医院人才优势,更新口腔医疗市场管理理念,建立现代管理模式,是决定大学口腔医院未来发展的关键。     

射频凝血器辅助下肝切除术临床分析

目的探讨射频凝血器在肝脏切除手术中应用的可行性及优越性。方法回顾性分析2012年1月-2013年3月施肝切除手术的临床效果,所有患者分为射频凝血器组(58例),百克钳组(58例)。对两组患者临床资料对比分析,评价射频凝血器在肝切除术中的优越性。结果射频凝血器组的平均手术时间,出血量等明显少于百克钳组,术后并发症、平均住院时间差异无统计学意义。结论应用射频凝血器进行预处理后行肝切除手术无需阻断肝脏血流情况下可以达到明显减少术中出血及缩短手术时间的效果,使肝切除手术更加安全、快捷。     

Exact and Approximate Power and Sample Size Calculations for Analysis of Covariance in Randomized Clinical Trials With or Without Stratification

ABSTRACT

Analysis of covariance (ANCOVA) is commonly used in the analysis of randomized clinical trials to adjust for baseline covariates and improve the precision of the treatment effect estimate. We derive the exact power formulas for testing a homogeneous treatment effect in superiority, noninferiority, and equivalence trials under both unstratified and stratified randomizations, and for testing the overall treatment effect and treatment × stratum interaction in the presence of heterogeneous treatment effects when the covariates excluding the intercept, treatment, and prestratification factors are normally distributed. These formulas also work very well for nonnormal covariates. The sample size methods based on the normal approximation or the asymptotic variance generally underestimate the required size. We adapt the recently developed noniterative and two-step sample size procedures to the above tests. Both methods take into account the nonnormality of the t statistic, and the lower order variance term commonly ignored in the sample size estimation. Numerical examples demonstrate the excellent performance of the proposed methods particularly in small samples. We revisit the topic on the prestratification versus post-stratification by comparing their relative efficiency and power. Supplementary materials for this article are available online.     

分子筛制氧设备在医院的应用

本文通过对医院应用供氧方式的对比，说明分子筛制氧设备应用于医院供氧的优越性，并对目前国内采用医用分子筛制氧设备性能不稳定问题，进行了总结分析，提出了改进技术。     

Simplification to single-tablet regimen of elvitegravir,cobicistat, emtricitabine,tenofovir DF from multi-tablet ritonavir-boosted protease inhibitor plus coformulated emtricitabine and tenofovir DF regimens: week 96 results of STRATEGY-PI

Background: Antiretroviral therapy (ART) simplification to a single-tablet regimen can benefit HIV-1-infected, virologically suppressed, individuals on ART composed of multiple pills.

Objective: We assessed long-term efficacy and safety of switching to co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF) from multi-tablet ritonavir-boosted protease inhibitor (PI + RTV) plus F/TDF (TVD) regimens.

Methods: STRATEGY-PI was a 96-week, phase 3b, randomized (2:1), open-label, non-inferiority study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF from PI + RTV + TVD regimens in virologically suppressed individuals (HIV-1 RNA <50 copies/mL). Participants were randomized to switch to E/C/F/TDF (switch group) or to continue their PI + RTV + TVD regimens (no-switch group). Eligibility criteria included no resistance to F/TDF or history of virologic failure, and estimated creatinine clearance ≥70 mL/min.

Results: At week 96, 87% (252/290) of switch and 70% (97/139) of no-switch participants maintained HIV-1 RNA <50 copies/mL (difference: 17%, 95% CI 8.7–26.0%, p < 0.001). Superiority of the switch to E/C/F/TDF vs. no-switch was due to a smaller proportion of both virologic failures (switch, 1% [3/290]; no-switch, 6% [8/139]) and discontinuations for non-virologic reasons (switch, 11% [31/290]; no-switch, 24% [33/139]). No treatment-emergent resistance was observed in switch subjects with virologic failure. Discontinuation rates from adverse events were 3% in both groups (9/293, switch; 4/140, no-switch). Switching from PI + RTV + TVD to E/C/F/TDF was associated with significant improvements in patient-reported outcomes related to gastrointestinal symptoms (nausea and bloating).

Conclusion: E/C/F/TDF is a safe, effective long-term alternative to multi-tablet PI + RTV + TVD-based regimens in virologically suppressed, HIV-1-infected adults, and improves patient-reported gastrointestinal symptoms.     

基层中医院发挥中医特色优势的思路与方法

当前,基层中医医院规模数量不断下降,中医特色日趋淡化,生存发展困难。基层中医医院急需亮出中医招牌,采取多种措施,内强素质,外树形象,发展中医特色并将其转化为中医优势,通过为患者提供多样化的医疗选择和高水平的医疗服务,突破目前困境,为自身发展开发新的经济增长点,为中医药的发展做出历史性的贡献。