Comparison of an SMS text messaging and phone reminder to improve attendance at a health promotion center:A randomized controlled trial

Objective: To compare the efficacy of a short messaging service (SMS) text messaging and phone reminder to im-prove attendance rates at a health promotion center. Methods: A total of 1 859 participants who had scheduled appointments in the health promotion center of our hospital from April 2007 to May 2007 were enrolled in the study and randomly assigned into 3 groups: control (no reminder) group,SMS text messaging reminder group and telephone reminder group. Attendance rates and costs of interventions were collected. Results: A total of 1848 participants were eligible for analysis. Attendance rates of control,SMS and telephone groups were 80.5%,87.5% and 88.3%,respectively. The attendance rates were significantly higher in SMS and telephone groups than that in the control group,with odds ratio 1.698,95% confidence interval 1.224 to 2.316,P=0.001 in the SMS group,and odds ratio 1.829,95% confidence interval 1.333 to 2.509,P<0.001 in the telephone group. However,there was no difference between the SMS group and the telephone group (P=0.670). The cost effectiveness analysis showed that the cost per attendance for the SMS group (0.31 Yuan) was significantly lower than that for the telephone group (0.48 Yuan). Conclusion: SMS and telephone are effective reminders for improving attendance rate at a health promotion center. SMS reminder may be more cost-effective compared with the telephone reminder.

Ginkgo biloba Extract EGb 761® Improves Central Vestibular Vertigo in Patients Undergoing Vestibular Exercises: A Randomised Placebo-Controlled Trial

Background: Ginkgo biloba extract EGb 761® is widely used to treat various types of vertigo. Aims: An exploratory trial was conducted to evaluate the efficacy of EGb 761® in addition to vestibular exercises in central vestibular vertigo caused by vertebro-basilar ischaemia. Subjects and Methods: In this randomised, placebo-controlled, double-blind trial, 40 patients were enrolled in the vertigo clinic of a neurological university hospital and treated with daily doses of 240 mg EGb 761® or placebo for a period of 180 days. All patients regularly performed vestibular exercises in addition. Efficacy was assessed using: a visual analogue scale for the patients to rate the overall intensity of vertigo;a numeric scale for physician-rated change;a vertigo score based on intensity, duration, and frequency of vertigo;and electronystagmography. Results: Until day 180, the mean patient-rated intensity of vertigo decreased by 46% during EGb 761® treatment and by 19% with placebo (p ® group compared to the placebo group. Nystagmus or other eye movement disorders were present only in small subgroups of patients without sufficient statistical power to detect differences between treatment groups. Conclusions: EGb 761® alleviated vertigo caused by ischaemic lesions in the brainstem or cerebellum in patients undergoing vestibular exercises.

Research trends of worldwide ophthalmologic randomized controlled trials in the 21st century:A bibliometric study

Background:Randomized controlled trials(RCTs)are often considered the gold standard and the cornerstone for clinical practice.However,bibliometric studies on worldwide RCTs of ophthalmology published in the 21st century have not been reported in detail yet.This study aims to perform a bibliometric study and visualization analysis of worldwide ophthalmologic RCTs in the 21st century.Methods:Global ophthalmologic RCTs from 2000 to 2022 were searched in the Web of Science Core Collection.The number of publications,country/region,institution,author,journal,and research hotspots of RCTs were analyzed using HistCite,VOSviewer,CiteSpace,and Excel software.Results:2366 institutions and 90 journals from 83 countries/regions participated in the publication of 1769 global ophthalmologic RCTs,with the United States leading in the number of volumes and research field,and the Moorfields Eye Hospital contributing to the most publications.Ophthalmology received the greatest number of publications and co-citations.Jeffrey S.Heier owned the most publications and Jost B.Jonas owned the most cocitations.The knowledge foundations of global ophthalmologic RCTs were mainly retinopathy,glaucoma,dry eye disease(DED),and cataracts,and anti-vascular endothelial growth factor(VEGF)therapy(ranibizumab),topical ocular hypotensive medication,laser trabeculoplasty.Anti-VEGF therapy for age-related macular degeneration(AMD),DME(diabetic macular edema),and DED,the use of new diagnostic tools,and myopia were the hottest research highlights.Anti-VEGF therapy,prompt laser,triamcinolone,and verteporfin photodynamic therapy for AMD,DME,and CNV(choroidal neovascularization),DED,myopia,and open-angle glaucoma were the research hotspots with the longest duration.The future research hotspots might be DED and the prevention and control of myopia.Conclusions:Overall,the number of global ophthalmologic RCTs in the 21st century was keeping growing,there was an imbalance between the regions and institutions,and more efforts are required to raise the quantity,quality,and global impact of high-quality clinical evidence in developing countries/regions.

正念减压疗法和正念认知疗法安全性的meta分析

目的:探讨正念减压疗法(MBSR)和正念认知疗法(MBCT)相关不良事件及影响因素。方法:检索PubMed、CINAHL、Embase、WebofScience、Scopus、Proquest、ScienceDirect、PsycINFO数据库及未发表的研究报告和灰色文献中有关MBSR和MBCT不良事件或不良反应的随机对照试验,并追溯纳入文献的参考文献和相关期刊,检索时限截止到2022年6月1日。采用RevMan5.4软件进行meta分析,计算合并OR(95%CI)值。结果:共纳入15篇文献,包含2841名研究对象。Meta分析结果显示,MBSR或MBCT干预组和对照组发生不良事件或不良反应的差异有统计学意义(0R=2.48,95%CI=1.09~1.61;P<0.05);使用的正念干预方法(单独使用MBSR,OR=9.04,95%CI=5.34~15.30)、参与者合并基础疾病(合并精神疾病,OR=1.49,95%CI=1.12~1.97;合并躯体疾病,OR=8.65,95%CI=5.17~14.45)、练习强度(每次>2h,OR=1.43,95%CI=1.04~1.96)及正念师资水平(未经过规范培训,OR=1.96,95%CI=1.20~3.23)是影响MBSR和MBCT治疗过程中可能会出现相关不良事件或不良反应的因素。结论:正念减压治疗或正念认知治疗过程中可能会出现不良事件或不良反应。

泡沫敷料与纱布敷料对气管切开患者伤口换药效果的Meta分析

目的系统评价泡沫敷料与纱布敷料对气管切开患者的伤口换药效果。方法全面检索自建库至2023年6月14日在CBM、PubMed、EMBASE等国内外权威数据库的相关临床研究,按纳排标准筛选文献并提取数据,采用RevMan软件进行Meta分析。结果纳入50项研究,共计2496例患者。Meta分析结果显示:气管切开患者泡沫敷料组的切口感染发生率(OR=0.17,95%CI:0.13~0.22,P<0.00001)、肺部感染发生率(OR=0.25,95%CI:0.14~0.45,P<0.00001)、切口周围皮肤并发症发生率(OR=0.23,95%CI:0.19~0.28,P<0.00001)、更换敷料频率(MD=-2.61次/d,95%CI:-3.33~-1.88,P<0.00001)、拔管时间(MD=-4.90 d,95%CI:-5.99~-3.80,P<0.00001)和切口愈合时间(MD=-4.16 d,95%CI:-5.62~-2.71,P<0.00001)均显著低于纱布敷料组,但换药间隔时间(MD=13.17 h,95%CI:10.69~15.65,P<0.00001)明显长于纱布敷料组。结论与传统无菌纱布敷料相比,泡沫敷料可显著降低气管切开患者的切口感染和肺部感染、减少切口周围皮肤并发症发生率,延长换药间隔时间,缩短更换敷料频率、缩短拔管时间,促进切口愈合。

穴位治疗对子宫内膜异位症疗效的网状Meta分析

目的系统评估穴位治疗对子宫内膜异位症(EMT)的疗效。方法在PubMed、the Cochrane Library、Embase、中国知网等数据库检索以穴位治疗为代表的不同中医外治法治疗EMT的相关文献,检索时间为各数据库建库至2023年6月1日。最终纳入66篇文献,均为随机对照试验(RCT)研究,包括6种治疗组合:单纯中药治疗,单纯西药治疗,单纯穴位治疗,中药联合穴位治疗,西药联合穴位治疗,西药、中药联合穴位治疗。采用网状Meta分析评估治疗方法对主要结局指标癌抗原125(CA125)、雌二醇(E_(2))、促卵泡激素(FSH)、黄体生成素(LH)、前列腺素F_(2α)(PGF_(2α))、视觉模拟量表(VAS)评分的影响。结果一致性模型分析结果显示,在CA125水平的改善方面,西药联合穴位治疗的效果显著优于单纯中药治疗、单纯西药治疗(P<0.05),其余治疗组比较差异无统计学意义(P>0.05)。在LH水平的改善方面,西药、中药联合穴位治疗的效果显著优于单纯西药治疗(P<0.05),其余治疗组比较差异无统计学意义(P>0.05)。在PGF2α水平的改善方面,西药联合穴位治疗的效果显著优于单纯中药治疗、单纯西药治疗、单纯穴位治疗、中药联合穴位治疗以及西药、中药联合穴位治疗(P<0.05),中药联合穴位治疗及西药、中药联合穴位治疗的效果显著优于单纯西药治疗(P<0.05),其余治疗组比较差异无统计学意义(P>0.05)。在E2、FSH水平及VAS评分的改善方面,各治疗组效果差异无统计学意义(P>0.05)。结论穴位治疗作为辅助疗法,可有效促进EMT关键指标的改善。

真实世界证据与随机对照试验:RCT DUPLICATE项目方法学介绍

传统随机对照试验(RCT)之外基于真实世界数据(RWD)分析产生的证据,即真实世界证据(RWE),在医学研究领域受到越来越多的关注。哈佛大学的研究团队于2018年率先发起了RCT DUPLICATE项目,旨在利用RWD开展非随机的研究,来重复或预测RCT的结果,探索RWD产生RWE涉及的理论方法,进一步推广RWE的应用。本文简要介绍了该项目的产生背景、待重复或待预测的RCT的遴选标准,并对开展RWD研究过程中存在的偏倚及实际应用中的应对策略进行了重点讨论。本文进一步总结归纳了研究者在设计、实施和评估这类研究时需要关注的关键问题,并整理了该项目组提出的RWD研究的结构化流程框架,以期帮助国内学者更好地理解RWD研究的应用价值及其局限性,为相关领域的学者今后开展更深入的研究工作提供参考,为医疗监管机构进行决策提供证据支撑。

真实世界证据与随机对照试验:RCT DUPLICATE项目成果

随着医疗大数据的推广和使用,政策制定者和研究者逐渐聚焦于利用真实世界数据(RWD)产生真实世界证据(RWE)及其相关研究上。哈佛的研究团队于2018年率先发起了RCT DUPLICATE项目,通过利用RWD构建非随机的观察性研究,来重复随机对照试验(RCT)的结果,以期充分评估RWD产生RWE后达成的初期理论及进一步推广应用。本文在简要介绍了RCT DUPLICATE项目的背景和两个基于RWD形成的RWE并在此基础上获得审批的药物实例之后,对该项目的四个子项目的研究过程、研究进展及研究成果进行了重点阐述,希望对国内学者理解RWE的应用价值和日后深入地开展研究有所裨益。

真实世界证据与随机对照试验:RCT DUPLICATE项目概述

近年来,利用真实世界数据(real-world data,RWD)通过恰当的设计和分析产生真实世界证据(real-world evidence,RWE),已经成为学术界、工业界和监管机构共同关注的话题。但RWE能否代替来自严格受控的随机对照试验(RCT)产生的证据仍不确定。为此,2018年美国启动了RCT DUPLICATE项目,旨在利用真实世界证据,通过非随机的观察性研究来重复RCT的结果。本文回顾了RCT DUPLICATE产生的背景,重点介绍了该项目的研究团队、研究目的、研究内容及项目意义,以期促进国内学者更好地理解RWE的适用范围和应用价值。

Meta-analysis and Trial Sequential Analysis of Compound Qingdai Capsule in the Treatment of Psoriasis

[Objectives]To analyze the efficacy of Compound Qingdai Capsule in the treatment of psoriasis and conduct a systematic evaluation.[Methods]The clinical total effective rate,PASI index score,IL-17 level,IL-23 level,TNF-level,and adverse reactions were analyzed.TSA 0.9 software was used to conduct sequential analysis of the total effective rate,and subgroup analysis was performed according to the average age of the experimental group.[Results]Single application of Compound Qingdai Capsule or in combination with other methods in the treatment of psoriasis was superior to non-Compound Qingdai Capsule group,and the side effects were less than non-Compound Qingdai Capsule group;the n≥40 year-old group had certain heterogeneity,suggesting that the difference was statistically significant,and the effective rate was higher than that of the control group.The funnel plot showed that the graph was asymmetrical,and there may be publication bias or the possibility of low-quality literature.The TSA results indicated that the actual sample size was far lower than the expected sample size,and the cumulative Z value did not reach the TSA cut-off value and more trials need to be included to confirm the efficacy.[Conclusions]Compound Qingdai Capsule has a clear curative effect on psoriasis,and its safety is high.This study can provide relevant evidence for the effectiveness of Chinese patent drugs(CPD)in treating psoriasis.

中国传统音乐疗法对肿瘤相关抑郁状态的影响——系统评价和荟萃分析

目的评价中国传统音乐疗法对肿瘤相关抑郁状态的影响。方法2021年10月两名研究者在中国分别采用计算机检索4个中文数据库中国知网、万方数据库、维普数据库、中国生物医学文献数据库、另一名研究者在加拿大阿尔伯塔大学图书馆负责检索MEDLINE、PubMed、CINAHL、EBSCO、Natural Medicine。按纳入与排除标准选择文献,文献质量采用Cochrane协作网推荐的偏倚风险评估方法进行定性描述和Meta分析。结果使用随机效应模型对22个随机对照试验(RCTs),共1809肿瘤患者进行荟萃分析。Meta分析显示,与常规护理相比,中国传统音乐疗对缓解肿瘤相关抑郁状态有显著疗效(SMD=-2.09,95%CI:-2.97至-1.20,P<0.00001),中国传统音乐疗法对肿瘤相关抑郁状态果有显著效果,综合焦虑抑郁量表(HADS)评分(MD=-1.67,95%CI:-2.60至0.73,P=0.0005);抑郁自评量表(SDS)评分(MD=-9.26,95%CI:-11.71至-7.53,P<0.00001);汉密尔顿抑郁量表(HAMD)评分(MD=-5.27,95%CI:-7.86至-2.68,P<0.0001);Meta分析异质性高,存在发表偏倚。结论通过HADS、SDS、HAMD量表评价证实中国传统音乐疗法对缓解肿瘤相关抑郁状态有积极作用,未来的研究人员需要优化研究方案,开展更高质量、大样本、多中心随机对照研究。

Acupuncture and moxibustion for incomplete adhesive intestinal obstruction:A randomized controlled trial

Objective:To investigate the clinical efficacy of acupuncture and moxibustion for incomplete adhesive intestinal obstruction.Methods:A total of 100 patients with incomplete adhesive intestinal obstruction were randomly divided into an observation group and a control group,and there were 50 patients in each group.The control group was treated with routine western medicine treatment,while the observation group was treated with acupuncture and moxibustion therapy on the foundation of the routine western medicine treatment of the control group.Zhongwan(中脘CV12),Tianshu(天枢ST25),Zusanli(足三里ST36),Shangjiuxu(上巨虚ST37),Zhigou(支沟TE6),Dachangshu(大肠俞BL25),and Xiaochangshu(小肠俞BL27)were taken when acupuncture was performed.Moxibustion was performed with moxibustion box on abdomen after acupuncture.The time of abdominal pain relief,the first anal exhausting,the first defecation and intestines sound recovery,surgery conversion rate and clinical efficacy were observed in the two groups.Results:The time of abdominal pain relief,the first anal exhausting,the first defecation and intestines sound recovery in the observation group were all shorter than those of the control group.There were statistically significant differences between the two groups(all P<0.01).The surgery conversion rate of the observation group was lower than that of the control group,there was statistically significant difference between the two groups(P<0.01).The clinical efficacy of the observation group was superior to that of the control group,the difference between the two groups was statistically significant(P<0.05).Conclusions:Acupuncture and moxibustion therapy on the foundation of the routine western medicine treatment,which can reduce the surgical conversion rate and cut down the time of treatment,was superior to routine western medicine treatment on the clinical efficacy of incomplete adhesive intestinal obstruction.

不同饮食模式对妊娠期糖尿病血糖及妊娠结局影响的网状Meta分析

目的:运用网状Meta分析评价7种不同饮食模式对妊娠期糖尿病血糖及妊娠结局的影响。方法:对中国知网(CNKI)、万方、维普网(VIP)、SinoMed、PubMed、Embase、Web of Science、Cochrane Library等中英文数据库进行系统检索,检索时间为建库至2023年3月。由2名研究者独自进行文献的筛选与资料的提取,采用Cochrane偏倚风险评估工具进行质量评价,运用Review Manager5.4.1、Stata15.1软件进行数据分析。结果:共纳入25项研究,从空腹血糖方面看,网状Meta分析排序结果从优到劣依次为:低血糖指数饮食>低血糖指数饮食联合常规饮食>终止高血糖饮食(DASH)>低血糖负荷饮食>低碳水化合物饮食>低碳水化合物饮食联合DASH>常规饮食;从餐后2h血糖方面看,网状Meta分析排序结果从优到劣依次为:低血糖指数饮食>低血糖指数饮食联合常规饮食>低血糖负荷饮食>低碳水化合物饮食>常规饮食;从胰岛素抵抗方面看,网状Meta分析排序结果从优到劣依次为:DASH>低血糖指数饮食联合常规饮食>低血糖指数饮食>常规饮食;从不良妊娠结局发生率方面看,网状Meta排序结果从优到劣依次为:低血糖指数饮食>DASH>低血糖指数饮食联合常规饮食>低碳水化合物饮食>低血糖负荷饮食>常规饮食>低碳水化合物饮食联合DASH。结论:从空腹血糖、餐后2h血糖、不良妊娠结局发生率方面来看,低血糖指数饮食可达到良好的效果,在7种方法中概率排名第一。胰岛素抵抗方面,DASH排名第一。但是,还需更多有质量的随机对照试验予以进一步验证。

Pestle needling at Yāoyángguān-Bāzhèn points for intractable lumbodynia after lumbar disc herniation surgery: A randomized controlled trial

Objective:To observe the differences of clinical efficacy of intractable lumbodynia after lumbar disc herniation surgery treated by pestle needling at Yāoyángguān Bāzhèn points,electroacupuncture and western medication.Methods:A total of 210 patients with intractable lumbodynia after lumbar disc herniation were randomly divided into pestle needle group,electroacupuncture group and western medication group,with 70 cases in each group.The pestle needle group was treated with pestle needle poking Yāoyángguān-Bāzhèn(GV3-Bāzhèn)points.The electroacupuncture group was treated with conventional electroacupuncture,and the western medication group was treated with oral diclofenac sodium dual release enteric-coated capsules(Difene).The pestle needle group and the electroacupuncture group were treated once a day,and there was 1 day of rest after 6 days of treatment,and a course of treatment included 7 days,and a total of 3 courses of treatment were performed.The western medication group took 1 Difene capsule(75 mg)at a time,with once a day continuing for 21 days.Visual Analog Scale(VAS),Pain Rating Index(PRI)and Present Pain Intensity(PPI)were used to observe the improvement of pain before and after treatment,and the waist muscle tone was examined and the clinical efficacy was observed.Results:The post-treatment VAS,PRI,and PPI scores of the three groups were all lower than pretreatment,and the differences were statistically significant(all P<0.05).There were no statistically significant differences in VAS,PRI and PPI scores between pestle needle group and western medication group(all P>0.05).Meanwhile,they were all lower than the electroacupuncture group,and the differences were statistically significant(both P<0.05).After treatment,the waist muscle tone of the three groups was higher than that pre-treatment,and the differences were statistically significant(all P<0.05).After treatment,the waist muscle tone of the pestle needle group was higher than the electroacupuncture group,and the electroacupuncture group was higher than the western medication group,and the differences were statistically significant(both P<0.05).The total effective rate was 88.57%in the pestle needle group,80%in the electroacupuncture group,and 77.14%in the western medication group,and there were no statistically significant differences among the groups(P>0.05).Conclusions:Pestle needle poking GV3-Bāzhèn points can effectively relieve intractable lumbodynia after lumbar disc herniation surgery,decrease VAS,PRI,PPI scores and relieve waist muscle tone,and the effect was remarkable.

Conducting qi and regulating the spirit needling method for insomnia: A randomized controlled trial

Objective:To evaluate the clinical effect differences between conducting qi and regulating the spirit needling method and regular needling method.Methods:Sixty-nine patients of insomnia were randomly divided into an observation group(35 cases)and a control group(34 cases).Bǎihuì(百会GV20),Sìshéncōng(四神聪EX-HN1),Hégǔ(合谷LI4),Tàichōng(太冲LR3),Zúsānlǐ(足三里ST36)and Sānyīnjiāo(三阴交SP6)were selected in the two groups.The patients in the observation group were treated with needling method for conducting qi and regulating the spirit.The patients in the control group were treated with the regular needling method.The treatment was given once every other day,both groups were treated for 12 times.Pittsburgh Sleep Quality Index(PSQI)and Epworth Sleepiness Scale(ESS)were observed before and after the treatment and the clinical effect was evaluated.Results:After treatment,the total score and the score of each item of PSQI as well as the result of ESS were all improved after the treatment in the two groups(all P<0.05).The improvements in the total score of PSQI and the result of ESS in the observation group were better than the control group(both P<0.05).The total effective rate was 88.57%(31/35)in the observation group,significantly superior to 76.47%(26/34)in the control group(P<0.05).Conclusion:The conducting qi and regulating the spirit needling method achieves a better effect on insomnia as compared with the regular needling method.This method achieves a remarkable improvement in sleep latency,sleep quality and daytime sleepiness.

天枢穴主治病症及配伍规律探析:基于随机临床对照试验

目的:运用数据挖掘技术深入总结天枢穴现代主治病症及腧穴配伍规律。方法:检索自建库至2022年6月2日中国期刊全文数据库(CNKI)、万方数据知识服务平台(Wanfang)、维普资讯中文期刊服务平台(VIP)、中国生物医学文献数据库(SinoMed)、PubMed及Web of Science等数据库相关文献资料,建立天枢单穴、配伍主治病症和配伍腧穴等数据库。运用SPSS Modeler 18.0和Gephi 0.9.2等软件对纳入文献进行复杂网络分析、关联分析、聚类分析。结果:共纳入随机对照试验文献622篇,毫针刺、电针、穴位敷贴以及艾灸是天枢穴常用的干预措施。单穴主治病症12种,优势病症为便秘、腹泻等2种;配伍主治病症85种,优势病症为便秘、胃肠功能障碍、肠易激综合征、肥胖、腹泻、消化不良、溃疡性结肠炎等14种。高频配伍腧穴为足三里、中脘、上巨虚、关元等22穴,聚类分析得到4系6类天枢配伍组合,配伍经脉以任脉频次最高,阳经腧穴多于阴经。结论:天枢穴主治范围广泛,以消化系统疾病为主,便秘为核心优势病症,其高频配穴为足三里、中脘、上巨虚、关元。

Efficacy and safety of acupuncture on the treatment of functional constipation: Study protocol for a randomized controlled trial

Objective:This trial is aimed at evaluating the efficacy and safety of acupuncture on treating FC.Methods:We describe the protocol for a randomized,patient-assessor-blinded,sham controlled trial.Seventy-two eligible patients will be randomly assigned to the intervention group(acupuncture)or the control group(sham acupuncture).All treatment will be given 26 sessions of acupuncture or sham acupuncture over 8 weeks(5 times per week in the first 2 weeks,3 times per week during weeks 3-6,and 2 times per week during weeks 7 and 8).Each treatment will last for 20 min.The primary outcome is the change in mean complete spontaneous bowel movements(CSBMs)per week.The secondary out?comes are patient assessment of constipation quality of life questionnaire(PAC-QOL),self-rating anxiety scale(SAS),and the dosage of the medication.All adverse events will be recorded in detail and managed by corresponding researchers as quickly as possible.Outcomes will be evaluated at baseline(1 week before treatment),2 weeks after intervention begins,6 weeks after intervention begins,8 weeks after intervention begins,4 weeks follow-up,and 12 weeks follow-up.Discussion:The results of this study will provide the evidence of the efficacy and safety of acupuncture as a traditional treatment methods for functional constipation.Trial registration:Chinese Clinical Trial Registry,ChiCTR-INR-17011472.Registered on 23 May 2017.

晚期食管癌PD-1/PD-L1免疫检查点抑制剂疗法的Cochrane Meta分析

目的评价现有免疫检查点抑制剂疗法对接受手术、放疗或化疗的食管癌患者的疗效和安全性,比较使用与不使用免疫检查点抑制剂治疗方案的疗效。方法计算机检索Cochrane Library、PubMed、Embase等数据库,查询食管癌免疫疗法的相关研究,采用RevMan5.4软件进行Meta分析。纳入的研究为临床Ⅱ期或Ⅲ期的双盲随机对照试验(randomized controlled trials,RSTs)。结果共纳入10项RSTs,包含6497例晚期食管癌患者。Meta分析结果显示,使用PD-1/PD-L1抑制剂干预的免疫检查点抑制剂疗法和/或联合手术、放化疗,能有效提高食管癌患者的总体生存率(overall survival,OS)(HR=0.75,95%CI:0.71~0.80,P<0.0001;异质性:I^(2)=48%,P=0.05)、无进展生存期(progression-free survival,PFS)(HR=0.77,95%CI:0.66~0.90,P=0.0008;异质性:I^(2)=90%,P<0.001)、客观缓解率(objective response rate,ORR)(RR=1.28,95%CI:1.20~1.36,P<0.0001;异质性:I^(2)=49%,P=0.06)和疾病控制率(disease control rate,DCR)(RR=1.07,95%CI:1.02~1.12,P=0.003;异质性:I^(2)=28%,P=0.24),且具有可管理的安全性。结论基于PD-1/PD-L1抑制剂的免疫检查点抑制剂疗法和/或联合传统疗法可以提高食管癌的总体生存水平和疗效,显示出优于传统放化疗的安全性。

益肾升白贴联合穴位注射治疗放化疗所致骨髓抑制的疗效观察

目的观察益肾升白贴联合穴位注射地塞米松治疗恶性肿瘤放化疗所致骨髓抑制的疗效及副作用。方法将101例恶性肿瘤放化疗后发生骨髓抑制的病人随机分成3组,35例采用益肾升白贴联合穴位注射地塞米松治疗,35例仅采用穴位注射地塞米松治疗作为对照组1组,31例以重组人粒细胞集落刺激因子皮下注射治疗作为对照组2组。观察骨髓功能恢复情况及用药的不良反应。结果3组病人骨髓功能恢复时间及总有效率无统计学差异(P>0.05),3组病人经治疗后再程放化疗,骨髓功能分级有统计学意义(P<0.05),益肾升白贴联合穴位注射地塞米松治疗组再程放化期间,仍对骨髓功能有显著保护作用。3组病人均无特殊不良反应。结论益肾升白贴联合穴位注射地塞米松治疗恶性肿瘤放化疗后骨髓抑制安全、有效,且对骨髓功能保护时间长,无明显不良反应,值得临床推广使用。

基于真实世界数据的随机对照试验模拟研究设计、评价与实例分析

目前开展的真实世界研究(real world study,RWS)仍存在诸多局限性,而未能在卫生技术评估方面充分发挥应有的作用。因此,有必要改进传统RWS设计,以产生高质量的医学证据。策略之一是仿照随机对照试验(randomized controlled trial,RCT)开展观察性研究(又称RCT仿真或模拟研究),既借鉴了RCT设计优势,增强了因果推断的强度,又保留了RWS的代表性,可以作为打通药品上市前与上市后证据链的桥梁,以期为医疗决策提供合理的证据支撑。仿照RCT开展观察性研究分为两步:第一步,基于临床问题构建一个目标试验,参照目标试验关键特征构建相应的RWS方案(包括纳排标准、治疗策略、分配程序、随访、结局定义、因果对比和统计分析策略),特别注意减小模拟差异和控制相关偏倚;第二步,使用真实世界数据(real world data,RWD)按照既定研究方案进行数据分析,得到相应结果。