角膜塑形镜控制中小学生近视有效性和安全性Meta分析

目的 系统评价角膜塑形镜对中小学生轻中度近视延缓的有效性和安全性。方法 检索The Cochrane Library、PubMed、EMbase、CBM、CNKI、WanFang Data和VIP等数据库,语言限定为中英文。采用Cochrane手册提供的偏倚风险评价工具和改良JADAD评分量表评价纳入文献质量;采用漏斗图检测纳入文献的发表偏倚;采用RevMan5.4软件进行Meta分析。结果 共有12篇文献符合纳入排除标准,包含1 908例研究对象。Meta分析结果显示: 佩戴角膜塑形镜后,裸眼视力有所提高[1年:MD=0.40,95%CI(0.05～0.74),P=0.02];角膜曲率有所下降[1年:MD=-3.21,95%CI=(-3.64～-2.79),P＜0.01];屈光度增长得到了有效控制[1年:MD=-3.19,95%CI=(-4.42～-1.95),P＜0.01;2年:MD=-3.61,95%CI=(-5.78～-1.43),P＜0.01];眼轴增长有所控制[1年:MD=-0.73,95%CI=(-1.43～-0.03),P=0.04;2年:MD=-1.15,95%CI=(-2.25～-0.06),P=0.04];眼轴变化量有所下降[1年:MD=-0.42,95%CI=(-0.64～-0.21),P＜0.01;2年:MD=-0.53,95%CI=(-0.96～-0.11),P=0.01]。结论 角膜塑形镜能够延缓中小学生轻中度近视的进展,且较为安全。     

中医药随机对照试验中采用真实世界数据作为对照组的研究设计及挑战

在设计随机对照试验（RCT）时,如果对照组存在患者招募和入组困难的情况,就会影响试验整体实施。近年来,真实世界数据（RWD）作为除RCT之外的数据来源,在医疗领域中发挥着越来越重要的作用。中医药RCT中可以尝试采用将RWD作为对照组的研究设计,不仅可以有效解决中医药RCT西医对照组患者入组困难的问题,同时能提供有力证据来评价中医药的疗效。倾向评分法目前已广泛应用于真实世界研究中混杂因素的处理,该文对RCT采用RWD作为对照组的这类设计中,基于倾向评分法常见的4种研究设计形式以实例分别进行了介绍,包括不对称随机分配、基于倾向评分分层法的两阶段设计、倾向评分联合复合似然法及倾向评分多种方法的联合。同时,这种设计类型也存在着方法学的挑战,包括RWD数据源必须是高质量且关键信息需要规范收集、RCT和RWD患者基线特征应该具有可比性、协变量选择时需要把所有已知与干预措施和结局相关的协变量都纳入进行分析等。在中医药领域采用这种设计时,还存在着有些RWD中医证型信息缺失、中医结局指标缺失等问题,在使用RWD时,需要根据数据实际情况决定如何分析。该文对以RWD作为RCT对照组的设计类型及面临的方法学挑战进行了介绍,期望能为研究者今后使用这类设计提供方法学借鉴。     

中药治疗糖尿病肾脏疾病随机对照试验结局指标的现状分析

目的 分析中药治疗糖尿病肾脏疾病（DKD）随机对照试验中结局指标的使用情况和其他试验设计要素,为中药治疗DKD临床试验的设计及核心指标集的构建提供依据。方法 计算机检索知网、万方、维普、中国生物医学等7个医学数据库及2个临床试验注册中心（clinicaltrials.gov、chinadrugtrials.org.cn）近5年收录的中药治疗DKD随机对照试验,运用Cochrance手册对纳入的文献进行偏倚风险评估,对结局指标及其他试验设计要素进行统计与分析。结果 共纳入97项随机对照试验（RCTs）,包含5项试验注册方案,研究发现,97项研究总体偏倚风险较高;DKD Ⅲ期（36项,41.38%）和气阴两虚兼血瘀证（16次,26.23%）为应用最多的DKD分期及中医证型;92项RCTs的疗程最多96周,最少2周,其中52项（56.52%）研究疗程为12周;92项RCTs及5项注册试验共采用152种结局指标,使用1 040次,共分为8大类,实验室检查（血液）、实验室检查（尿液）、临床疗效、中医证候积分、生活质量量表、生命体征、其他指标及其他事件,应用频率较高的依次是血肌酐（68次,70.10%）、临床有效率（55次,56.70%）、空腹血糖（51次,52.58%）、尿素氮（48次,49.48%）、总胆固醇（47次,48.45%）、24 h尿蛋白定量（43次,44.33%）等;56项RCTs及2项注册试验共采用安全性指标53种,频数227次,使用频率较高的依次是,不良反应（49次,84.48%）、肝功能（28次,48.28%）、血常规（24次,41.38%）、心电图（17次,29.31%）、尿常规（14次,24.14%）;10项RCTs及5项注册试验报告了主要结局指标;54项RCTs报告了临床有效率指标。结论 目前中药治疗DKD的RCTs结局指标设计尚不规范,未来应积极构建突显出中医药特色的核心结局指标集,提升临床研究的质量,提高试验结果的应用价值。     

Assessing the Effectiveness of Front of Pack Labels: Findings from an Online Randomised-Controlled Experiment in a Representative British Sample

Front of pack food labels (FOPLs) provide accessible nutritional information to guide consumer choice. Using an online experiment with a large representative British sample, we aimed to examine whether FOPLs improve participants’ ability to identify the healthiness of foods and drinks. The primary aim was to compare ability to rank between FOPL groups and a no label control. Adults (≥18 years), recruited from the NatCen panel, were randomised to one of five experimental groups (Multiple Traffic Light, MTL; Nutri-Score, N-S; Warning Label, WL; Positive Choice tick, PC; no label control). Stratification variables were year of recruitment to panel, sex, age, government office region, and household income. Packaging images were created for three versions, varying in healthiness, of six food and drink products (pizza, drinks, cakes, crisps, yoghurts, breakfast cereals). Participants were asked to rank the three product images in order of healthiness. Ranking was completed on a single occasion and comprised a baseline measure (with no FOPL), and a follow-up measure including the FOPL as per each participant’s experimental group. The primary outcome was the ability to accurately rank product healthiness (all products ranked correctly vs. any incorrect). In 2020, 4504 participants had complete data and were included in the analysis. The probability of correct ranking at follow-up, and improving between baseline and follow-up, was significantly greater across all products for the N-S, MTL and WL groups, compared to control. This was seen for only some of the products for the PC group. The largest effects were seen for N-S, followed by MTL. These analyses were adjusted for stratification variables, ethnicity, education, household composition, food shopping responsibility, and current FOPL use. Exploratory analyses showed a tendency for participants with higher compared to lower education to rank products more accurately. Conclusions: All FOPLs were effective at improving participants’ ability to correctly rank products according to healthiness in this large representative British sample, with the largest effects seen for N-S, followed by MTL.     

Effects of Staff Training on Nursing Home Residents’ End-Of-Life Care: A Randomized Controlled Trial

ObjectivesThis trial examines the effects of end-of-life training on long-term care facility (LTCF) residents' health-related quality of life (HRQoL) and use and costs of hospital services.DesignA single-blind, cluster randomized (at facility level) controlled trial (RCT). Our training intervention included 4 small-group 4-hour educational sessions on the principles of palliative and end-of-life care (advance care planning, adverse effects of hospitalizations, symptom management, communication, supporting proxies, challenging situations). Training was provided to all members of staff. Education was based on constructive learning methods and included resident cases, role-plays, and small-group discussions.Setting and participantsWe recruited 324 residents with possible need for end-of-life care due to advanced illness from 20 LTCF wards in Helsinki.MethodsPrimary outcome measures were HRQoL and hospital inpatient days per person-year during a 2-year follow-up. Secondary outcomes were number of emergency department visits and cost of all hospital services.ResultsHRQoL according to the 15-Dimensional Health-Related Quality-of-Life Instrument declined in both groups, and no difference was present in the changes between the groups (P for group .75, adjusted for age, sex, do-not-resuscitate orders, need for help, and clustering). Neither the number of hospital inpatient days (1.87 vs 0.81 per person-year) nor the number of emergency department visits differed significantly between intervention and control groups (P for group .41). The total hospital costs were similar in the intervention and control groups.Conclusions and ImplicationsOur rigorous RCT on end-of-life care training intervention demonstrated no effects on residents’ HRQoL or their use of hospitals. Unsupported training interventions alone might be insufficient to produce meaningful care quality improvements.     

The Effect of Medication Reconciliation via a Patient Portal on Medication Discrepancies: A Randomized Noninferiority Study

BackgroundMedication reconciliation has become standard care to prevent medication transfer errors. However, this process is time-consuming but could be more efficient when patients are engaged in medication reconciliation via a patient portal.ObjectivesTo explore whether medication reconciliation by the patient via a patient portal is noninferior to medication reconciliation by a pharmacy technician.Design (including intervention)Open randomized controlled noninferiority trial. Patients were randomized between medication reconciliation via a patient portal (intervention) or medication reconciliation by a pharmacy technician at the preoperative screening (usual care).Setting and ParticipantsPatients scheduled for elective surgery using at least 1 chronic medication were included.MeasuresThe primary endpoint was the number of medication discrepancies compared to the electronic nationwide medication record system (NMRS). For the secondary endpoint, time investment of the pharmacy technician for the medication reconciliation interview and patient satisfaction were studied. Noninferiority was analyzed with an independent t test, and the margin was set at 20%.ResultsA total of 499 patients were included. The patient portal group contained 241 patients; the usual care group contained 258 patients. The number of medication discrepancies was 2.6 ± 2.5 in the patient portal group and 2.8 ± 2.7 in the usual care group. This was not statistically different and within the predefined noninferiority margin. Patients were satisfied with the use of the patient portal tool. Also, the use of the portal can save on average 6.8 minutes per patient compared with usual care.Conclusions and ImplicationsMedication reconciliation using a patient portal is noninferior to medication reconciliation by a pharmacy technician with respect to medication discrepancies, and saves time in the medication reconciliation process. Future studies should focus on identifying patient characteristics for successful implementation of patient portal medication reconciliation.     

曲美他嗪对陈旧性心肌梗死后室性心律失常影响的随机配对、交叉研究

目的：研究曲美他嗪（Trimetazidine）对于处于常规治疗中的心肌梗死后的心 律失常的作用。方法：冠心病陈旧心肌梗死病例（OMI）,共29对（58例）;男性27对,女性2对;配对主要条件：性别、年龄、梗死部位、梗死后时间、高血压病史及分级;糖尿病史;采用病例配对、随机进入试验、交叉、单盲的试验设计;结果分析采用方差分析（ANOV／F检验）。结果：综合交叉试验结果,Trimetazidine处理组室性心律失常的发生低于对照组（F＝4．20,P＜0．05）;对于清醒时间段即活动时间段的室性心律失常的分析显示：Trimetazidine也具有显著的抑制作用（F＝5．87,P＜0．05）;对于Lown3级以上室性心律失常的单独分析,也显示出其较明显的抑制作用（F＝7．61,P≈0．01）;对于OMI后LVEF≤40％患者组的室性心律失常,Trimetazidine也表现出明确的抑制作用（F＝5．43,P＜0．05）。结论：对于陈旧性心肌梗死所伴发的室性心律失常,除基础药物的处理外,应用曲美他嗪可对其产生显著地抑制作用,并减少抗心律失常药物的应用;改善缺血心肌的能量代谢可能是此作用的主要基础。     

尼卡地平和硝普钠用于颅内血管术中控制性降压的比较观察

目的：探寻颅脑术中控制性降压的理想药物。方法：选用20例22－52岁颅内动脉瘤及动静脉畸形手术病人,随机分为尼卡地平（N）组和硝普钠（S）组。观察两组降压前和降压10、20、30min及停药10、20min时的平均动脉压（MAP）,心率（HR）,颅内压（ICP）,中心静脉压（CVP）的变化,同步监测动脉及颅内静脉血气值,计算动脉氧含量（CaO2)与颈内静脉氧含量（CjO2)的差,即动静脉氧含量差值（AJDO2）和收缩压与心率乘积（RPP）。结果：两组降压均有效,与降压前比较,MAP明显下降。在控制性降压及复压过程中,N组血压变化平稳,HR、ICP和JADO2无显著变化,RPP明显下降（P＜0．01）。S组有一过性心动过速（P＜0．05）,ICP和AJDO2明显升高（P＜0．01或P＜0．05）,停药后,血压反跳（P＜0．01或P＜0．05）。结论：尼卡地平用于颅脑术中控制性降压安全有效,其临床价值优于硝普钠。