Exercise-based rehabilitation programmes for pulmonary hypertension:a systematic review and meta-analysis of randomized controlled trails

Objective Individuals with pulmonary hypertension(PH)have reduced exercise capacity and quality of life.Exercise-based rehabilitation may have beneficial effects to improve the exercise capacity and quality of life in patients with PH.We aim to assess the efficacy and safety of exercised-based rehabilitation for people eith PH by performing a randomized controlled trails(RCTs)meta-analysis of exercised-based rehabilitation for people with PH by performing a randomized controlled trails meta-analysis.

Efficacy of intraorbital electroacupuncture for diabetic abducens nerve palsy： study protocol for a prospective single-center randomized controlled trial

Abducens nerve palsy（ANP） is commonly seen in patients with diabetes mellitus. The validity of acupuncture as a traditional Chinese medicine method in peripheral nerve repair is well established. However, its efficacy in randomized controlled trials remains unclear. Herein, we designed a protocol for a prospective, single-center, randomized controlled trial to investigate the effect of intraorbital electroacupuncture on diabetic ANP. We plan to recruit 60 patients with diabetic ANP, and randomly divide them into treatment and control groups. Patients in both groups will continue their glucose-lowering therapy. A neural nutrition drug will be given to both groups for six weeks. The treatment group will also receive intraorbital electroacupuncture therapy. We will assess efficacy of treatment, eyeball movement, diplopia deviation and the levels of fasting blood-glucose and glycosylated hemoglobin before treatment at 2, 4, and 6 weeks after treatment. The efficacy and recurrence will be investigated during follow-up（1 month after intervention）. This protocol was registered at Chinese Clinical Trial Registry on 16 January 2015（Chi CTR-IPR-15005836）. This study was approved by the Ethics Committee of First Affiliated Hospital of Harbin Medical University of China（approval number： 201452）. All protocols will be in accordance with Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be provided by participants. We envisage that the results of this clinical trial will provide evidence for promoting clinical use of this new therapy for management of ANP.

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.

Effects of combination pharmacotherapy and social skills training for schizophrenia: A randomized controlled trial

Pharmaco-psychosocial treatment (PPST) refers to a treatment paradigm combining pharmacotherapy with psychosocial therapy. We conducted an 18-month randomized controlled tracking study to evaluate the efficacy of social skills training (SST) in 11 individuals with schizophrenia on risperidone monotherapy. They were randomized to either SST or non-SST group, and Global Assessment Functioning (GAF) and Brief Psychiatric Rating Scale (BPRS) scores in the 2 groups showed gradual improvement. In the SST group, Digit Span Distraction Test (DSDT) at 12 and 18 months showed significant improvement. The Subjective Deficit Syndrome Scale (SDSS) scores in the SST group showed significant improvement after 6 months and showed a significant difference in comparison between the groups. After the subjective feeling of health was recovered, the items of motivation were recovered as a direct effect of SST. Some items of the Life Assessment Scale for the Mentally Ill (LASMI) score showed significant improvement (or significant trend) in only the SST group after 6 months. Items of daily life, work skills, and self-recognition were continuously improved. We report 2 cases in the SST group that had DSDT improvement in parallel with change of action and communication as a change of social function. This study is only exploratory due to the small number of cases. However, we have demonstrated potential improvement in cognitive function due to learning experiences that required working memory and attention, thus providing improvement in social life.

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.

Curative effect of Dingqi analgesic patch on cancer pain:a single-blind randomized controlled trail

OBJECTIVE:To observe the curative effect of an acupoint application with a Dingqi analgesic patch on moderate to severe pain caused by liver cancer.METHODS:Forty patients with moderate to severe pain caused by liver cancer were randomly divided intoatreatmentgroup(TG)andacontrolgroup(CG).Patients with moderate pain were given 100 mg qd of a sustainably released tablet of tramadol hydrochloride;patientswithseverepainweregiven4.2mg q3d of the fentanyl transdermal system.The ashi points Ganshu(BL 18),Danshu(BL 19) and Qimen(LR 14) were chosen for the acupoint application intervention.CG patients were given a sham patch and TG patients were given a Dingqi analgesic patch.A visual analogue scale(VAS) was used before treatment and after 1,3,6,9 and 12 days of treatment.The Karnofsky score was measured before treatment and after 12 days of treatment.Any main adverse reactions(e.g.nausea,constipation,dizziness and headache) were recorded after 6 and 12 days of treatment.Any skin side effects(i.e.skin irritation and allergic reactions) were recorded.RESULTS:The VAS in TG was significantly lower than that in CG after 3,6,9 and 12 days of treatment(P<0.05).There was no significant difference in the Karnofsky score before treatment and after 12 days of treatment between CG and TG.There were also no significant differences in the main adverse reactions or skin side effects after 6 and 12 days of treatment between CG andTG(P>0.05).CONCLUSION:The Dingqi analgesic patch can enhance the analgesic effect of tramadol and fentanyl.

Immediate analgesic effect of needling acupoints(bilateral De Qi vs unilateral De Qi)on primary dysmenorrhea:a multi-center,randomized,controlled trail

OBJECTIVE: To analyze the effect of needling acupoints(bilateral vs unilateral) with De Qi using data collected from 501 primary dysmenorrhea(PD) patients participating in multi-center, randomized,controlled trail.METHODS: De Qi was defined as at least one of the feelings in soreness, numbness, fullness or heaviness at the acupoints when stimulated with needles. The 501 patients were grouped in 3 groups in terms of De Qi or not De Qi in one side(unilateral)or both sides(bilateral) of the body: bilateral De Qi group, unilateral De Qi group, and non-De Qi group. The abdominal pains were measured using visual analog scale(VAS).RESULTS: In 501 patients, 472 acquired De Qi at unilateral acupoints, 24 De Qi at bilateral acupoint,and 5 had no De Qi at any acupoint. The data of non-De Qi group was excluded as the sample was less than 5% of that in the bilateral De Qi group.There was significant difference in the VAS before and after treatment between unilateral and bilateral De Qi group(P < 0.01). After stratified by acupoints, for the patients needled at Sanyinjiao(SP 6)and Xuanzhong(GB 39), VAS scores in the bilateral De Qi group were larger than those in the unilateral De Qi group(P < 0.05).CONCLUSION: Bilateral De Qi was possibly superior to unilateral De Qi in enhancing the immediate analgesic effect of needling the acupoints, but no statistical significance was observed on the pa-tients of needling at non acupoint, which preliminarily suggested this immediate analgesic effect was perhaps along meridians.

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。

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.

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.

近5年针灸治疗围绝经期失眠随机对照试验的特征分析及质量评价

目的:总结分析针灸治疗围绝经期失眠的随机对照临床试验研究特征,评价其方法学质量与针刺干预措施的报告质量,为今后开展相关研究提供参考。方法:通过计算机检索6个中英文数据库,筛选以针灸疗法为主治疗围绝经期失眠的随机对照试验,提取其研究特征,运用Cochrane偏倚风险评估工具及针刺临床试验干预措施报告规范(STRICTA)对照检查清单进行评价。结果:共纳入文献92篇,其中针刺研究57篇(64.1%),耳穴疗法研究20篇(21.7%)。其诊断标准以教材和指南为主,结局指标以量表为主,研究多聚焦于针灸与其他疗法的优势比较。Cochrane偏倚风险评估结果发现,大部分研究在随机序列的生成(64.1%)、分配隐藏(19.6%)、受试者和干预提供者盲法(0%)、结局评价者盲法(15.2%)方面报告率较低。对照STRICTA条目发现,报告完整度分别为用针数量0篇、进针深度39篇(50.6%)、针具类型42篇(54.5%)、治疗场所信息0篇,治疗师背景4篇(5.2%)。结论:目前针灸治疗围绝经期失眠的随机对照试验的报道多见于国内,其方法学质量与针刺相关报告质量偏低,提示未来相关临床试验需进一步完善和规范试验设计与报告。

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.

温针灸联合盆底肌训练治疗压力性尿失禁临床疗效的Meta分析

目的:对温针灸联合盆底肌训练治疗压力性尿失禁(stress urinary incontinence,SUI)相关文献进行Meta分析,为温针灸联合盆底肌训练治疗压力性尿失禁提供循证医学依据。方法:以温针灸、尿失禁、压力性尿失禁等为主题词,检索PubMed、Cochrane图书馆中心数据库、Embase、中国生物医学文献数据库(CBM)、中国知网数据库(CNKI)、万方数据知识服务平台(Wanfang Data)、维普期刊全文数据库(VIP),检索时限均为自建库至2022年11月。参照Cochrane系统评价的要求,对选择纳入的临床试验进行方法学质量评估、数据提取和数据分析。结果:共纳入11个研究,774例患者,与常规只进行单一的盆底肌训练治疗相比,Meta结果分析显示,温针灸联合盆底肌训练组治疗SUI总有效率高于对照组[OR=4.02,95%CI(2.58,6.26),P<0.00001];ICI-Q-SF评分[MD=-1.17,95%CI(-1.63,-0.7),P<0.00001];1 h尿垫试验[MD=-1.65,95%CI(-2.07,-1.23),P<0.00001],差异具有统计学意义;纳入文献均未报告不良反应。结论:温针灸联合盆底肌训练治疗压力性尿失禁,对提高患者的生活质量、减少漏尿量有较好的疗效。

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。

四君子汤加减联合西医常规疗法治疗胃癌的有效性及安全性Meta分析

目的:系统评价四君子汤加减联合西医常规疗法治疗胃癌的疗效及安全性。方法:检索中国知网、万方数据库、维普数据库、中国生物医学文献数据库以及PubMed、Embase、Cochrane Library、Web of Science等数据库,检索时间均从建库至2022年2月17日,纳入四君子汤加减联合西医常规疗法治疗胃癌的随机对照试验,根据Cochrane协作网偏倚风险评价标准对纳入研究进行方法学质量评价并采用RevMan 5.4软件进行Meta分析,得出结论。结果:共纳入17篇文献,1 338例患者。分析结果显示,四君子汤加减联合西医常规疗法治疗胃癌在提高临床总有效率、Karnofsky功能状态评分量表(Karnofsky Performance Status,KPS)评分,改善免疫功能指标T淋巴细胞亚群(CD3^(+)、CD4^(+)、CD8^(+)、CD4^(+)/CD8^(+))水平、患者生活质量、术后恢复,降低肿瘤标志物(糖类抗原-199)水平以及焦虑自评量表(Self-Rating Anxiety Scale,SAS)评分、抑郁自评量表(Self-rating Depression Scale,SDS)评分,减少不良反应方面等均优于西医常规疗法。结论:四君子汤加减联合西医常规疗法治疗胃癌疗效优于西医常规治疗,且安全性较高。但受纳入文献质量和数量的影响,上述结论仍需有更多大样本、多中心随机对照试验进一步验证。

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。

Wrist–ankle acupuncture combined with pinching along the spine for children allergic rhinitis: A randomized controlled trial

Objective:To investigate the clinical effect of wrist–ankle acupuncture combined with pinching along the spine on allergic rhinitis(AR)in children.Methods:A total of 65 children with AR were collected from February 2017 through to December 2018 and they were randomly divided into a combined treatment group with wrist–ankle acupuncture,pinching along the spine and western medication(combined treatment group,32 cases)and a western medication group(33 cases).In the western medication group,loratadine was prescribed for oral administration.In the combined treatment group,on the base of the medication as the western medication group,the wrist–ankle acupuncture was adopted in combination with pinching along the spine.Before and after treatment,the symptoms and physical signs were scored and the clinical effect was observed in the children of the two groups.Results:After the treatment and in the follow-up,the scores of the symptoms and physical signs in the combined treatment group were lower than those of the western medication group,indicating a statistical significance(all P<0.05).The total effective rate was 93.7%in the combined treatment group,which was higher than 63.63%in the western medication group,indicating a statistical significance(P<0.05).Conclusion:The combined treatment of wrist–ankle acupuncture combined with pinching along the spine and loratadine effectively relieves the clinical symptoms and the physical signs in AR children.The clinical effect of this combined treatment is better than the simple use of loratadine.

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。