Effect of Xingnao-Jianshen granules in treating AIS patients:study protocol for a non-randomized controlled intervention trial

Objective:Acute ischemic stroke(AIS)is characterized by high morbidity and high mortality.In recent years,complementary and alternative medicine has gradually been widely accepted and applied.At present,traditional Chinese medicine therapy and standard treatments are used for the treatment of AIS.Xingnao-Jianshen prescriptions(XNJS)is an effective prescription for the clinical treatment of AIS,but there is a lack of large-scale clinical evidence to confirm its clinical efficacy.Therefore,our team designed this protocol to evaluate the initial therapeutic effect of XNJS.Methods:The protocol for a non-randomized controlled trial is designed in which 72 eligible patients will be allocated to one of two groups.The control group(n=36)will receive standard treatment for AIS,the test group(n=36)will receive XNJS and standard treatment.Patients will be recruited after stroke onset and will receive the intervention continuously over 10±1 days,with a follow-up period of 90 days.The primary outcome will be the change in the NIHSS,BI,mRS scores.All outcome measures will be assessed at inception,after the intervention(10±1 days),and at the follow-up(90 days).The results will be disseminated to the public through peerreviewed journals and academic conferences.Discussion:The study will provide evidence of the preliminary effects.

Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis:study protocol of a multicenter randomized controlled trial

BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.

Randomized Controlled Trials and Ph.D. Level Training in Educational Research

This invited paper reviews recent initiatives in teaching about randomized field trials at the graduate level in education research. Reports in a book on randomized trials by Mosteller and Boruch are used as a benchmark. The initiatives have been driven heavily by recent governmental emphasis on ＂evidence based policy＂ in education, criminology, welfare and other sectors. This policy has been backed, in the US at least, by substantial investments in mounting randomized controlled trials to evaluate curriculum packages and programs in grades K-12, crime prevention programs, welfare, and other work. Accelerated growth in randomized trials has entailed cross discipline pre-doctoral and post-doctoral institutes and graduate education programs aimed at enhancing the quality in trial design, execution, and analysis of results. Specific illustrations of graduate education in this area of statistics are taken mainly from experience at the University of Pennsylvania＇s Graduate School of Education and selected other institutions.

Effectiveness and safety of Jiawei Xiaoyao pill(加味逍遥丸)in the treatment of premenstrual syndrome(liver depression,spleen deficiency,and blood-heat syndrome):a multi-center,randomized,placebo-controlled trial

OBJECTIVE:To investigate the effectiveness and safety of Jiawei Xiaoyao pill(加味逍遥丸,JXP)in the treatment of symptoms associated with premenstrual syndrome(PMS).METHODS:A total of 144 regularly menstruating women with PMS were recruited at 8 sites in China from August 2017 to December 2018,and randomized to receive either a JXP or a matching placebo(12 g/d,6 g twice a day)for 3 menstrual cycles.The primary indicator was the reduced Daily Record of Severity of Problems(DRSP)scores in the luteal phase after 3 months of treatment.The safety outcomes included clinical adverse events(AEs),adverse reactions(ARs),changes in vital signs,and laboratory tests.RESULTS:JXP surpassed the placebo in reducing DRSP scores(psychological/somatic dysfunction)in the luteal phase over 3 menstrual cycles of treatment(PFAS=0.002,PPPS=0.001).Additionally,there were no significant differences in the incidence of AEs,severe AEs,withdrawal due to AEs and ARs between the two groups(all P>0.05),and no clinically significant adverse medical events related to the test drug observed.CONCLUSIONS:JXP was superior to the placebo in relieving the symptoms associated with PMS,which signified that JXP may be effective,safe,and welltolerated as an alternative therapy.

Digital blinding of radiographs to mask allocation in a randomized control trial

AIM To demonstrate the effectiveness of a digital radiographic altering technique in concealing treatment allocation to blind outcome assessment of distal femur fracture fixation.METHODS Digital postoperative anteroposterior and lateral radiographs from a sample of 33 randomly-selected patients with extra-articular distal femur fractures treated by surgical fixation at a Level 1 trauma center were included. Using commercially available digital altering software, we devised a technique to blind the radiographs by overlaying black boxes over the implant hardware while preserving an exposed fracture site for assessment of fracture healing. Three fellowship-trained surgeons evaluated a set of blinded radiographs twice and a control set of unblinded radiographs once. Each set of radiographs were reviewed independently and in a randomly-assigned order. The degrees of agreement and disagreement among evaluators in identifying implant type while reviewing both blinded and unblinded radiographs were assessed using the Bang Blinding Index and James Blinding Index. The degree of agreement in fracture union was assessed using kappa statistics.RESULTS The assessment of blinded radiographs with both the Bang Blinding Index(BBI) and James Blinding Index(JBI) demonstrated a low degree of evaluator success at identifying implant type(Mean BBI, far cortical locking:-0.03, SD: 0.04; Mean BBI, standard screw: 0, SD: 0; JBI: 0.98, SD: 0), suggesting near perfect blinding. The assessment of unblinded radiographs with both blinding indices demonstrated a high degree of evaluator success at identifying implant type(Mean BBI, far cortical locking: 0.89, SD: 0.19; Mean BBI, standard screw: 0.87, SD: 0.04; JBI: 0.26, SD: 0.12), as expected. There was moderate agreement with regard to assessment of fracture union among the evaluators in both the blinded(Kappa: 0.38, 95%CI: 0.25-0.52) and unblinded(Kappa: 0.35, 95%CI: 0.25-0.45) arms of the study. There was no statistically significant difference in fracture union agreement between the blinded and unblinded groups.CONCLUSION The digital blinding technique successfully masked the surgeons to the type of implant used for surgical treatment of distal femur fractures but did not interfere with the surgeons' ability to reliably evaluate radiographic healing at the fracture site.

基于组合赋权云模型的塔台管制系统运行安全评估

随着我国民航业的迅猛发展,空中交通流量不断攀升,机场塔台管制系统的运行安全面临严峻考验,因此,正确识别和评估风险成为有效提高塔台管制系统运行安全水平的重要前提。为精准且有效地完成对塔台管制系统运行的安全评估,构建了基于模糊决策实验室分析法(Decision-Making Trial and Evaluation Laboratory,DEMATEL)网络层次分析法(Analytic Network Process,ANP)熵权法云模型的塔台管制系统运行安全评估模型。首先,通过流程图法并结合人机环管的思想建立塔台管制系统运行安全评估指标体系,并采用模糊DEMATEL法确定评估指标间的相互影响关系,绘制评估指标之间的网络结构图;然后,通过ANP法确定各评估指标的主观权重,采用熵权法确定各评估指标的客观权重,并通过博弈论方法计算评估指标的综合权重;最后,将权重结果与评语层云模型结合使用对各级安全评估指标进行安全评估,通过MATLAB软件完成算例的仿真分析。结果表明:该塔台管制系统运行安全等级在一般和良好之间,仍需采取有效措施对某些风险因素进行控制;同时验证了该模型在塔台管制系统运行安全评估中具有可行性和准确性,对塔台管制系统安全评估具有指导意义。

Acupuncture for Moderate to Severe Allergic Rhinitis:A Non-randomized Controlled Trial

Objective： To evaluate the effect and safety of acupuncture therapy on patients with moderate to severe allergic rhinitis. Methods： A non-randomized controlled design was used to compare between the acupuncture group and the medication group. The acupuncture group received 8-week acupuncture therapy, and the medication group received budesonide nasal spray with cetirizine tablets for 8 weeks. The clinical symptoms and signs were analyzed before treatment, at 4 and 8 weeks after the start of treatment, and at 12 weeks after the end of treatment. Furthermore, the clinical efficacy and safety indicators were compared between the two groups. Results： A total of 76 participants consisting of 38 in each of the two groups were enrolled. The scores of each clinical symptom and sign, including sneezing, runny nose, stuffy nose, nasal itching, and turbinate edema, and the total scores decreased over time in both groups （all P〈0.05）; and no difference was found in the scores between the two groups （P〉0.05）. There was no statistically significant difference in the effective rates of the acupuncture group at 4 and 8 weeks after the start of treatment as well as at 12-week follow-up compared with those of the medication group （83.3% vs. 91.2%, and 94.4 % vs. 85.3%; and 80.6 % vs. 82.4%, all P〉0.05）. Experimental items including blood routine, urine routine, aspartate transaminase, alanine aminotransferase, urea nitrogen and creatinine were all in the normal reference ranges during the treatment in the acupuncture group. Conclusions： Acupuncture therapy has a comparable effect to the medication treatment on patients with moderate to severe allergic rhinitis, and it is safe with no severe adverse effects.

补肾健脑针法联合康复训练对痉挛型脑瘫患儿精细运动功能影响的临床研究

目的 研究分析补肾健脑针法联合康复训练对痉挛型脑瘫患儿精细运动功能影响的临床效果。方法 研究选取本院2022年1—12月收治的痉挛型脑瘫患儿100例,分为对照组与实验组,每组50例。对照组采用康复训练,实验组加用补肾健脑针法干预。分析比较两组患者治疗有效性、脑瘫严重程度等指标。结果 与对照组相比,实验组患者治疗有效性增高,脑瘫严重程度好转,差异具有统计学意义(P<0.05)。结论 补肾健脑针法联合康复训练对痉挛型脑瘫患儿精细运动功能影响的临床效果较好。

基于德尔菲法的中医药临床试验监查指标体系构建研究

目的基于德尔菲法构建中医药临床试验监查指标体系。方法通过文献研究法和临床监查实践经验,形成中医药临床试验基于风险的监查指标池;通过德尔菲法进行两轮的专家咨询,对于结果进行统计分析,并运用Yaahp软件中层次分析法(AHP)为指标体系的各项指标进行权重赋值。结果①初步形成了包含9个一级指标、22个二级指标和47个三级指标的中医药临床试验风险监查指标体系。②最终共邀请到15位从事临床监查、西医/中西医结合临床、中医临床、医院/行政管理、卫生统计相关领域的专家。③两轮专家咨询问卷有效回收率分别为93.75%和100%。④两轮专家咨询的权威系数(Cr)分别为0.760和0.775。⑤两轮专家咨询的协调系数分别为0.192(P<0.05)和0.194(P<0.05),两轮专家咨询的一级、二级、三级指标的变异系数(CV)均<0.25。⑥最终构建了包含4个一级指标、11个二级指标和45个三级指标的中医药临床试验风险监查指标体系。结论参与该研究的专家权威程度和积极性高,协调程度好;最终构建的指标体系中一级指标“研究设计管理”以及其二级指标和三级指标的权重相对较高,提示中医药临床试验的设计是决定临床试验结果的关键因素。

Needling method of regulating wei qi and strengthening brain for insomnia:a multicenter randomized controlled trial

Objective To observe the clinical efficacy of the needling method for regulating wei qi and strengthening brain on insomnia.Method Two hundred patients with insomnia were randomly divided into a group of regulating wei qi and strengthening brain（group A） and a group of normal acupuncture（group B）through random number table method,with 100 cases in each group.In group A,Baihui（百会 GV20）,Dazhui（大椎 GV 14）,Shenmai（申脉 BL62）,Zhaohai（照海 KI 6） and auricular points Yuanzhong（缘中 AT 2,3,4i）,and Shenmen（神门TF 4） were selected;and in group B,Sishencong（四神聪 EX-HN 1）,Shenmen（神门 HT 7）,and Sanyinjiao（三阴交 SP 6） were selected.Acupuncture was given on these points once daily for 15 days.Pittsburgh sleep quality index（PSQI） was used for scoring and curative effect was evaluated before and after treatment.Results The total effective rate was 89.0%（89/100） in group A and 65.0%（65/100） in group B with a very significant difference between the two groups（P〈0.01）;the difference of PSQI scores before and after treatment was（-9.15±5.68）in group A and（-5.64±5.73）in group B,with a very significant difference before and after treatment in the two groups（P〈0.01）.Conclusion The therapeutic effect of the needling method for regulating wei qi and strengthening brain on insomnia is superior to that of normal needling method.

以循证思维为导向的微课程联合CBL教学法在ICU规培护士临床思维能力培养中的应用

目的 探讨以循证思维为导向的微课程联合案例为基础的教学法(case-based learning,CBL)在重症监护病房(intensive care unit,ICU)规培护士临床思维能力培养中的应用效果,为临床提供一种新的教学方法。方法 选取2021年11月至2023年10月在本院ICU轮转的72名规培护士为研究对象,将2021年11月至2022年10月在本院ICU轮转的36名规培护士设为对照组,将2022年11月至2023年10月在本院ICU轮转的36名规培护士设为试验组。对照组采用CBL教学法,试验组采用以循证思维为导向的微课程与CBL教学法。教学前后比较两组护士临床思维能力评分,理论考核和临床技能考核评分,两组规培护士对教学的满意度。结果 培训后试验组规培护士临床思维能力的总分及其批判性思维能力、系统性思维能力、循证思维能力3个维度评分均高于对照组,理论考核与临床技能考核成绩均高于对照组,教学形式、教学方式、学习氛围满意度均优于对照组,两组比较,差异有统计学意义(均P<0.05)。结论 采用以循证思维为导向的微课程联合CBL教学法能有效提高ICU规培护士的临床思维能力、理论与技能水平。

疏风宣肺法治疗感染后咳嗽的Meta分析

目的系统评价疏风宣肺法治疗感染后咳嗽的疗效和安全性。方法对外文数据库:PubMed、Cochrane Library、Web of Science;中文数据库:知网、维普、万方和中国生物医学文献服务系统进行全面检索,搜索疏风宣肺法治疗感染后咳嗽的随机对照试验,检索时间从建库到2024年6月。对纳入文献进行方法学质量评价,ReviewManage5.4软件对纳入文献的结局指标进行Meta分析。结果共纳入14项文献,1585例患者。Meta分析结果显示,与甲氧那明组(对照组)相比,疏风宣肺法(试验组)总有效率更高[OR=5.47,95%CI(3.82,7.84),P<0.00001],差异有统计学意义;试验组咳嗽症状积分低于对照组[MD=-0.49,95%CI(-0.66,-0.32),P<0.00001],差异有统计学意义;试验组患者炎性因子IL-8低于对照组[MD=-7.34,95%CI(-10.68,-4.00),P<0.0001],差异有统计学意义;两组均未出现严重不良反应,差异无统计学意义[OR=0.80,95%CI(0.49,1.28),P=0.35]。结论中医疏风宣肺法治疗感染后咳嗽具有较好疗效,有效降低患者咳嗽症状积分和IL-8水平,且无严重不良反应。

方氏头针调神三步法治疗缺血性脑卒中后抑郁随机对照试验

目的:评价方氏头针调神三步法治疗缺血性脑卒中后抑郁的临床疗效。方法:60例缺血性脑卒中后抑郁患者随机分为方氏头针组(30例,脱落3例)和普通针刺组(30例,脱落2例)。两组患者均接受缺血性脑卒中常规药物及偏瘫侧针刺治疗。方氏头针组穴选伏象头部、伏脏上焦、倒象上部、倒脏上焦、思维、书写和信号,操作时调神三步法贯穿始终,宁神进针、聚神行针和和神起针。普通针刺组穴选内关、神门、百会、印堂、三阴交和太冲。治疗3周后观察两组患者治疗前后汉密尔顿抑郁量表(HAMD-24)评分、美国国立卫生院神经功能缺损评分(NIHSS)以及改良Barthel指数(MBI)评分,评价临床疗效。结果:与治疗前比较,两组患者HAMD-24评分均显著下降,差异具有统计学意义(P<0.05),且方氏头针组HAMD-24评分低于普通针刺组,差异具有统计学意义(P<0.01)。与治疗前比较,两组患者NIHSS评分均显著下降,差异具有统计学意义(P<0.01),且方氏头针组NIHSS评分低于普通针刺组,差异具有统计学意义(P<0.01)。与治疗前比较,两组患者MBI评分均显著提高,差异具有统计学意义(P<0.05),但两组间比较差异无统计学意义(P>0.05)。方氏头针组总有效率为83.33%(25/30),普通针刺组总有效率为70.00%(21/30),两组比较差异有统计学意义(P<0.05)。结论:方氏头针调神三步法针刺可有效改善缺血性PSD患者抑郁症状,临床疗效优于普通针刺;方氏头针调神三步法针刺与普通针刺在改善患者日常生活活动能力方面疗效相当。

表象训练在基础护理实验教学中的应用探讨

目的探讨表象训练在基础护理实验教学中的应用效果。方法选择2022年1月—2023年8月于北京中医药大学东方学院实习的120名学生作为研究对象,按照随机数字表法分为A组和B组,每组60名。A组学生采用表象训练法进行教学,B组学生采用传统训练法进行教学。比较2组的铺备用床、铺无菌盘成绩以及教学满意度。结果A组学生的铺备用床单[(26.12±1.89)分]、铺无菌盘[(18.89±1.46)分]成绩高于B组学生[(25.11±1.67)分、(17.42±1.79)分],差异有统计学意义(P<0.05)。A组学生对教学的总满意度为98.33%,高于B组的83.33%,差异有统计学意义(P<0.05)。结论在基础护理实验教学中应用表象训练法能够有效提升学生的铺备用床、铺无菌盘成绩以及教学总满意度。

方氏头针结合子午流注纳子法对失眠患者血清GABA、Glu及睡眠质量的影响

目的:探索方氏头针结合子午流注纳子法治疗失眠症的疗效,并探讨其可能的机制。方法:选择60例失眠症患者随机分为观察组(30例)和对照组(30例,脱落1例)。对照组给予常规针刺,观察组给予方氏头针结合子午流注纳子法针刺治疗。两组患者1次/d,每周5次,连续2周。分别于治疗前后评定匹兹堡睡眠质量指数量表(PSQI)评分、血清γ-氨基丁酸(GABA)及谷氨酸(Glu)的变化情况。结果:治疗2周,两组患者PSQI均较治疗前下降,差异有统计学意义(P<0.05)。治疗后血清GABA水平较治疗前比较均有所上升,Glu水平较治疗前比较均有所下降。方氏头针联合子午流注纳子法组在血清GABA水平上与常规针刺组比较,差异具有统计学意义(P<0.05)。结论:方氏头针结合子午流注纳子法治疗失眠确有疗效,能够明显地改善患者的临床症状,其机制可能与调节血清GABA、Glu水平有关。

一种降低离心泵出口调节阀压降的试算方法

介绍了一种降低离心泵出口调节阀压降的试算方法,通过试算,在尽量降低调节阀压降以节约操作能耗的同时,确保调节阀在整个操作范围内均有合适的阀门开度,综合考虑工艺需求与仪表阀门的可实现性,确保了计算结果在工程上的适用性,具有很好的工程应用价值。

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.

Effectiveness of experiential teaching method on the development of nursing students’skill competence:a systematic review and meta-analysis

Objective:Skill competence is essential for nursing students and experiential teaching method has become increasingly popular in China’s nursing education.To systematically evaluate the effects of experiential teaching method on the development of nursing students’skill competence,and to provide evidence for nursing education.Methods:The China National Knowledge Infrastructure,VIP,Wanfang Data,PubMed,and Web of Science databases were searched from their inception until November 28,2019.We screened the studies according to inclusion and exclusion criteria,extracted the data,and assessed the quality.Then,a meta-analysis was conducted.Results:Totally 15 studies were included,and 1,633 nursing students were analyzed by Review Manager5.3 and Stata15.1 software.The results show that the experiential teaching method can significantly improve nursing students’nursing skills such as training(SMD=1.05,95%CI:0.95–1.16,P=0.000),learning interest(ES=0.93,95%CI:0.79–1.06),ability to analyze and solve problems(ES=0.75,95%CI:0.55–0.94),ability to judge and innovative thinking(ES=1.01,95%CI:0.77–1.25),abilities of understanding and perception(ES=0.59,95%CI:0.34–0.83),and teaching satisfaction(ES=1.26,95%CI:1.13–1.4).Conclusions:The results suggest that the experiential teaching method is more effective for the nursing students’skill competence than traditional teaching in China.However,due to the heterogeneity and bias risk,a large sample and high-quality studies are needed in future to confirm its effectiveness.

Acupuncture method of“Huoxue Sanfeng,Shugan Jianpi ” for morning blood pressure in patients with cerebral infarction combined with essential hypertension: a randomized controlled trial

Objective To observe the clinical effects of acupuncture method of'Huoxue Sanfeng,Shugan Jianpi'(activating blood and eliminating wind,soothing liver and strengthening spleen)on morning blood pressure in patients with cerebral infarction combined with essential hypertension.Methods Sixty-eight patients were randomly divided into an observation group and a control group,34 cases in each one.The patients in the

综合评价法在中医药临床疗效评价中的应用

临床疗效是中医药传承和发展的根本,而缺乏被中西医共同认可的疗效评价方法目前仍是一个亟待解决的问题。综合评价法是对一个复杂系统多个指标进行总评价的方法,其核心思想是根据不同的评价目的,利用被评价对象的各种属性信息,采用科学的评价方法对被评价对象进行客观、公正、合理的全面比较、判断及排序的过程,它可以将实验室指标、中医证候、生存质量等多个维度指标组合成一个单维度的综合指标,能够体现中医药多靶点、多维度的治疗优势,近年来已逐渐应用于中医药临床疗效评价。本文对目前中医药领域常用的几种综合评价法的原理、在中医药疗效评价应用的具体实例、以及注意事项进行介绍,以期指导中医药研究者正确选择和使用综合评价法,为全面客观地评价中医药临床真实疗效提供方法学支持。