Objective Angina pectoris presents a significant public health burden. With the aim of clarifying the clinical value of Yixinshu preparations, this study systematically reviewed the literature to assess their effectiveness as an adjunctive therapy for the management of angina pectoris in patients with coronary artery disease (CAD), and further explore the relationship between different administration methods of Yixinshu and clinical efficacy. Methods A systematic search of PubMed, Embase, Cochrane Library, CNKI, CBM, VIP, and Wanfang Database was conducted to identify randomized controlled trials (RCTs) evaluating Yixinshu as an adjunct to conventional therapy for CAD and angina pectoris. The Cochrane risk of bias tool was used to assess methodological quality. Quantitative synthesis and subgroup analysis were performed using ReviewManager5.4 software, and sensitivity analysis was performed with Stata. Results Thirteen studies with 1502 patients were included. Compared with western medicine alone, adjunctive Yixinshu preparation significantly improved ECG outcomes [OR = 2.61,95%CI (1.81,3.74), P < 0.00001], and showed higher clinical efficacy in response rate [OR = 3.38,95%CI (2.38,4.80), P < 0.00001]. Significant reduction in the duration [MD = 1.25,95%CI (0.39,2.10) and frequency [MD = 1.04,95%CI (0.35, 1.73] of angina pectoris episodes were noted. Subgroup analysis revealed correlations between angina duration and dosage, as well as between angina frequency and both dosage and treatment regime. Regarding safety, adverse reactions were reported in five studies, with a relatively lower incidence in the experimental group. Conclusion Adjunctive Yixinshu with routine pharmacological treatment significantly improves treatment efficacy in angina pectoris. The therapeutic effects on angina duration and frequency varied across different administration forms and dosages.

Diabetic cardiomyopathy, a formidable cardiovascular complication linked to diabetes, is witnessing a relentless surge in its incidence. Despite extensive research efforts, the primary pathogenic mechanisms underlying this condition remain elusive. Consequently, a critical research imperative lies in identifying a sensitive and dependable marker for early diagnosis and treatment, thereby mitigating the onset and progression of diabetic cardiomyopathy (DCM). Exosomes (EXOs), minute vesicles enclosed within bilayer lipid membranes, have emerged as a fascinating frontier in this quest, capable of transporting a diverse cargo that mirrors the physiological and pathological states of their parent cells. These exosomes play an active role in the intercellular communication network of the cardiovascular system. Within the realm of exosomes, MicroRNA (miRNA) stands as a pivotal molecular player, revealing its profound influence on the progression of DCM. This comprehensive review aims to offer an introductory exploration of exosome structure and function, followed by a detailed examination of the intricate role played by exosome-associated miRNA in diabetic cardiomyopathy. Our ultimate objective is to bolster our comprehension of DCM diagnosis and treatment strategies, thereby facilitating timely intervention and improved outcomes.

大数据技术的蓬勃发展赋予了中医药高等教育新的内涵和使命.如何以教育大数据为驱动探索信息化教学管理的改革或优化是一项紧迫的课题,目前仍面临诸多问题,如个性化自适应学习研究有待加强、课堂信息化教学模式尚需优化、教师大数据素养水平有待提升、高校信息化教育管理模式亟待变革等.文章旨在探讨如何构建学生个性化学习的精准培养模式、有效推动混合式教学改革、提升高校教师大数据素养能力、推动信息化教学管理模式变革,以期为我国中医药院校信息化教学管理的深化改革和质量提升提供参考.

在前期开展方剂学课程思政教学的基础上,方剂学教学团队从"抗疫"主题方向深入开展课程思政教学改革.文章明确了"统一行动,学生参与,考核评定,拓展延伸"的课程思政运行机制,提出了针对"抗疫"主题修订的课程思政教学目标,并重点论述了"抗疫"主题课程思政的具体实施情况,即课程思政主渠道建设、利用"第二课堂"开展"抗疫"主题系列活动以及在对外教学中融入课程思政元素等,同时探讨了课程思政质量考核评价体系,全面介绍了方剂学"抗疫"主题课程思政教学改革情况.课程思政教学改革的实施,提高了学生的政治认同,培养了学生的家国情怀,提高了学生的文化素养和道德修养.

新型冠状病毒肺炎(简称新冠肺炎)属于中医学"疫病"范畴,中医药在防治新冠肺炎中发挥了重要作用.目前针对新冠肺炎的中医病名、病因及辨证,广大中医学者提出了诸多的观点.新冠肺炎依据其病性的寒热和兼杂之邪,分属于寒湿疫、湿温疫、湿毒疫、湿毒夹燥疫等,其病因以"湿邪"为主,常兼夹寒、热、燥之邪,分别有温湿疫邪、寒湿疫邪、疫邪夹燥等,其辨证多从脏腑辨证、六经辨证、三焦辨证、卫气营血辨证、膜原理论辨证,并结合三因制宜等.新冠肺炎证候多变,但其病因病机符合中医"疫病"的规律,其病位主在肺,多累及脾胃,以湿邪为主的病理特点贯穿疾病的始终,以"湿、毒、寒、热、燥、瘀、虚"为证素要点,可按照预防、治疗、恢复3个阶段采取辨证论治.该文从新冠肺炎的中医病名、病因及辨证等方面进行综述,为完善新冠肺炎的中医诊疗提供理论依据.

目的:以《神农本草经》和《伤寒杂病论》原文入手,从"开心"和"心"字意涵、涉"心"之人参经方和用药研究3个方面,探寻本经中人参"开心"之意涵.方法:以《神农本草经》中涉及"开心"和"心"字的条文48条,和《伤寒杂病论》中涉"心"之人参经方14首建立数据库,进行频数统计和方药分析,研究人参"开心"与病位、病证、症状、病机、功效、方药等因素的关系.结果:(1)"心"字以部位和病证、病机或症状组合在《神农本草经》中出现31次,《伤寒杂病论》中出现11次;其以病证(或症状)名在《神农本草经》中出现6次,《伤寒杂病论》中出现4次;其以功效名在《神农本草经》中出现11次,而"开心"和"开心孔"仅各出现1次.因此推知"心"字可实指心之本脏,亦可泛指与"心"相邻的胸腹部位.(2)14首涉"心"之人参经方(实际该类方并非仅治神志或情志疾患)可用治"心"之本脏或与"心"相关(邻)的胸腹病变,尤其可用治心下痞.(3)13首涉"心"之经方中的人参有补中益气、补虚之功效,仅1首经方中的人参功效为益气复脉.结论:人参"开心"说可实指人参有益心调神复脉之药效,亦可泛指其能调补心脾,甚至五脏,以助"心"之本脏,或心腹(胃)或心胸之疾的开达痊愈.

对中医院校核心课程《方剂学》的“课程思政”教学改革提出了以下方案:一是结合课程特点,挖掘思政元素;二是修订融入思政教育的教学大纲,匹配教学设计;三是强化自我教育,纳入分数考核;四是督导与评教结合,强化教学过程管理;五是将课内教育与课外自主学习相结合,拓展思政教育的实效性.通过改革,使学生在《方剂学》教学中全面接受医德教育,同时增强学生对于中医药的文化自信.

目的:对《神农本草经》中102味治疗水病的药物进行分析,阐明《神农本草经》中水病治疗用药的规律及特色.方法:以《神农本草经》中102味治疗水病的药物建立数据库,进行频数统计,研究水病用药与三品分类、自然属性、药性特点、功效应用等因素的相关性.结果:三品及毒性分布以中品药物为主,尤其是以无毒药物为多,提示治疗用药当以攻补兼施,注重补虚为主,为避戕伐正气,尤需慎用作用峻烈、毒副作用强的下品药物;性味出现最多的是味苦性寒凉者,其次为味辛性温热者,故具体用药应注意配合寒温兼顾,宣上通下.上述药物沿用至现代的66味常用药物,遍及中医八法用药,但以利水、清热、泻下、发汗、补虚药为多,因此临证选药还应明辨兼夹,审证用药.结论:《神农本草经》治疗水病药物涉及水、饮、痰、湿类诸多病证和变证的治疗,研究其用药规律及特色,可为水病的临床用药或新药研发提供参考.

肾病水肿是临床常见病证,受多种内外因素的影响,症状易反复,是中、西医治疗的一大难点.随着慢性肾脏病发病率的逐年升高,其治疗备受关注,中医药能发挥其独特优势,多角度辨证施治.文章从"血不利则为水"角度阐释"血不利"与水肿的病机关系,并从肾络理论探析"血不利"与肾病水肿的发病机制.进而提出运用祛瘀通络法、养脏和络法辨证论治肾病水肿,临床常选用虫类药、藤类药及血肉有情之品,使络通血畅、血利水布,水肿得消,为中医药防治肾病水肿提供新的诊疗思路.

目的 考察注射用益气复脉(冻干)在临床广泛使用的安全性,进一步指导临床合理用药和完善说明书,并为企业制定风险管理计划提供依据.方法 采用前瞻性、大样本、多中心集中监测的方法,纳入自2016年5月-2017年6月,共计44家医疗机构10 767例使用注射用益气复脉(冻干)的住院患者进行监测.记录患者基本情况、用药情况和不良反应发生情况,并进行数据统计和分析.结果 本研究最终确定19例不良反应,发生率为0.176％;主要不良反应见于皮肤及其附属系统;其中不良反应组的滴注速度明显快于无不良反应组,差异具有统计学意义(P＜0.05);所有不良反应最终均消失.结论 注射用益气复脉(冻干)不良反应均属偶见,且不属于严重不良反应,临床应用相对安全,建议生产厂家应进行滴速方面的相关研究,进一步完善说明书信息、规范临床使用.

目的 通过对《神农本草经》中治疗火热证的药物进行研究,初步阐明火热证用药的规律性,为火热证的临床治疗提供文献学依据.方法 以《神农本草经》中治疗火热证的所有药物建立数据库,运用SPASS20.0进行频数统计,研究火热证治疗用药与药物三品分类、毒性、四气、五味等因素的相关性.结果 用于火热证治疗的183味药物以下品和中品为主,尤其是以无毒药物为主;四气以寒、平为主;五味以为苦、辛、甘为主;药物主治以除寒热、除热为主;被《中药学》收录的105味药物以清热药、补虚药为主.结论 该研究可为火热证的临床用药或新药研发提供参考.

[Objective]To observe the effect of removing turbidity and detoxication decoction combined with metformin on Lipoprotein lipase in patients with type 2 diabetes. [Methods] The 100 Patients were screened with type 2 diabetes who belong to turbidity and detoxication intrinsic type,and divided into treatment group and control group randomly.The treatment group added removing turbidity and detoxication decoction on basis of conventional treatment. Clinical symptoms and signs were evaluate, also the change of triglycerides,total cholesterol,high density lipoprotein cholesterol, low density lipoprotein cholesterol, free fatty acids, and lipoprotein lipase after 8 weeks were detected. [Results]In the course of the study,9 cases were lost,and 91 cases were completed,of which 44 cases in the treatment group and 47 cases in the control group.The two groups showed no difference before treatment.After treatment,the clinical symptoms and signs of the treatment group were significantly improved compared with the control group,the levels of serum TG, TC, LDL, FFA were significantly decreased in the treatment group, LPL level was significantly increased, compared with the control group,the difference was statistically significant. [Conclusion]Detoxication decoction may increase the level of serum LPL to affect the lipid metabolism of patients,in order to improve the level of blood lipid in type 2 diabetic patients and relieve the clinical symptoms and signs.

Introduction After stroke, hemiplegia, dysphasia and facial paralysis can manifest during the convalescent period. Currently, no Chinese patent medicine (CPM) is previously reported to cure each of these symptoms primarily, and thus, there are no relevant instructions for the use of CPM. This study presents a new approach based on comparative effectiveness research to distinguish the curative effects of three CPMs that are often used in stroke convalescence to determine the ideal medicine for the treatment of each symptom. Methods and analysis In this multicentre and double-blind clinical trial, stratified randomisation is used to group the patients according to their primary symptoms (hemiplegia, dysphasia and facial paralysis). Three strata will be enrolled, with 80 eligible participants included in each stratum. Each stratum will be randomly and equally divided into four groups, and each group will receive one of the following treatments: Naoxuekang, Xinnaoshutong (XNST), Xuesaitong (XST) or placebo. This study will include two stages: the initial treatment period (30 days) and a follow-up period (180 days). Three replicates for each data point will be completed during this trial. The first visit will occur on day 0 after enrolment, the second visit on day 30±2 and the third visit on day 210±5. The Delphi technique is adopted to achieve index weighting, which ensures that the evaluation outcome is patient oriented. The weighted index value will be computed as the final measurement index of the outcome. Ethics and dissemination This study has been approved by the Medical Ethics Committee of Tianjin University of Traditional Chinese Medicine (registration number TJUTCM-EC20160007). The results will be offered for publication in peer-reviewed journals. Trial registration number This trial was registered with the Chinese Clinical Trial Registry (ChiCTR-IOR-17010397). The date of registration was 11 January 2017.

Objective Individualized application of TCM is not easy and may lead to undesirable results, such as poor effect or even adverse reactions. This trial aims to compare two common Chinese patent medicines with similar effects. Background of the Research Four hospitals carried out the test at the same time in Tianjin city of China. Participants 144 patients were involved in this study; all patients must meet the diagnostic criteria. Interventions Qishen Yiqi pills, compound danshen pills, and their placebos; an efficacy analysis was conducted after the first medication and after crossover medication. Primary Outcome Measures The primary index of end point includes Seattle Angina Questionnaire score-7 and score of 7-point Likert Scale; the curative effect was compared with minimal clinically important differences value. Result Two drugs have their respective advantages in treating SAP. In practical application, the two drugs shall be discriminated in use based on patients' specific symptoms. Trial Registration Chinese clinical trials register is ChiCTR-TTRCC-14004406 (registered 23 March 2014).

This study observed the efficacy and safety of JinqiJiangtang tablets (JQJT tablets, a traditional Chinese patent medicine) for pre-diabetes. Four hundred patients with pre-diabetes at five centres were treated for 12months and followed for an additional 12months to investigate the preventative effects of JQJT tablets (Registration ID: ChiCTR-PRC-09000401). The incidence rate of diabetes mellitus was the primary endpoint. The risk of converting from pre-diabetes to diabetes was 0.58-fold less in the JQJT tablets group than in the placebo group [HR (95% CI): 0.58 (0.384, 0.876), P = 0.010]. Furthermore, the probability of achieving normalized blood glucose was 1.41-fold greater in the JQJT tablets group than in the placebo group [HR (95% CI): 1.41 (1.002, 1.996), P = 0.0049]. ITT analysis revealed that the incidence of diabetes upon treatment completion was 16.5% in the JQJT tablets group compared with 28.9% in the control group. The percentage of patients with normalized blood glucose upon 12-month intervention was 41.8% in the JQJT tablets group compared with 27.8% in the control group. JQJT tablets could be an effective intervention for preventative treatment of Type 2 diabetes mellitus.

Quality control is a key link in the process of clinical trials and important content, the quality of clinical trials about the reliability of test results. Therefore, clinical researchers devoted to study how to strengthen the quality control of drug clinical trials. As the electronic data and remote mode in recent years in the application and development of clinical trial data management, establishing the new clinical trials quality control system is imminent. Based on previous research experience, this paper puts forward the concept of quality of centralized control, which is based on network technology, the realization of drug clinical trials main links and personnel online interaction, through the role assignment and responsibility, realize the dynamic quality control. Centralized drug clinical trial the fundamental lies in the standardization for the implementation of quality control, including the seamless network supervision and clinical design is the key. In this paper, regarding the centralized modern drug clinical trials quality control paper introduced standardized specifications and requirements of the construction of the peer to reference.

The implementation process management plays a important role for the quality of centralized safety monitoring study of post-marketing Chinese medical injections.One of the critical link is hospital.Currently,there is no principle or specification for hospital choosing,number of monitoring points,data collection responsible part and forms of data collection as well.These issues caused uneven quality,huge differences in results and questioned conclusion.Based on the previous research experience,this paper focused on discussing the link of hospital where research data may be influenced,and proposed some suggestions.

Objectives N-of-1 trials can be aggregated to estimate population treatment effects using hierarchical Bayesian models. It is very important to report core items in hierarchical Bayesian analysis. In this study, we assessed reporting of items in hierarchical Bayesian analysis for aggregating N-of-1 trials to estimate population treatment effects. Study Design and Setting This was a systematic literature review of aggregating N-of-1 trials by hierarchical Bayesian models to estimate population treatment effects. A comprehensive search was performed to collect eligible articles. Pilot studies, formal N-of-1 trials and reports in which the data were reanalyzed using hierarchical Bayesian methods, were included. The information of reported items related with hierarchical Bayesian analysis was extracted by two independent reviewers. The guideline "ROBUST," developed for reporting Bayesian analysis of clinical studies, was published in Journal of Clinical Epidemiology in 2005. We assessed the included reports using ROBUST criteria and 18 other important items. Results After careful screening, 11 studies were identified to be eligible for inclusion. There were three pilot studies, four formal trials, and four reports in which the data were reanalyzed using hierarchical Bayesian methods. The number of reported items in ROBUST criteria ranged from six to seven, with a median number of six. Five of eleven included articles reported all items of the ROBUST criteria. But for justification and sensitivity analysis in prior distribution items, other items were reported in all of the included articles. Software and analysis data set items were reported the most frequently in additional items excluded from the ROBUST criteria. Less than half of the studies reported the other additional items. Conclusion Reporting of core items in hierarchical Bayesian analysis for aggregating N-of-1 trials to estimate population treatment effects is suboptimal. A PRISMA-like guidance on reviews of Bayesian N-of-1 trials may be required in the future.

中医药用于肿瘤的辅助治疗,具有独特优势.由于研究质量的参差不齐,中医药辅助治疗肿瘤疗效尚待进一步确证.从西方科学的临床研究方法中寻找适合中医药研究的临床评价方法是解决上述问题的重要途径.质量调整生存分析方法起源于西方医学,是将生存质量和生存时间两个纬度测量指标整合为单纬度的综合疗效评价方法,包括QALYs、Twist、Q-Twist、TIO、质量-数量Cox回归分析等.质量调整生存分析具有较高灵敏度、节省样本量和花费等优点.与单纬度的生存时间或生存质量分析相比,质量调整生存分析可能更适用于中医药辅助治疗肿瘤的疗效评价.

Safety is a critical link restricting the development of TCM injections.Hospital centralized monitoring is of importance in the safety evaluation of TCM injections.However,the results of centralized monitoring studies usually deviated from the actual situation because of problems in design and process quality.Our research team have completed several projects over centralized monitoring in recent years.Based on the previous research experience,this paper mainly discussed the current statuation,the significance and methods for standard process of hospital centralized monitoring in regard to TCM injections,in order to improve the quality of centralized monitoring studies and provide technique support for recognizing the safety of TCM injections.