Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.

OBJECTIVE:To develop a core outcome set (COS) for clinical trials on post COVID-19 condition (PCC), that is, what, when, and how to measure PCC. METHOD:A comprehensive collection of outcomes (including their measurement methods and phases) was launched via literature review and clinician and patient surveys. Two rounds of Delphi surveys were conducted under the predefined criteria for rating, followed by a consensus meeting to finalize the COS for PCC (COS-PCC). RESULTS:Fifty-two outcomes within 7 categories and 206 measurement methods were identified. Sixty participants from five stakeholder groups completed the first round of the Delphi survey and 41 the second. Consensus was reached among 36 representatives on four domains of respiratory, physical, neuropsychological, and health conditions, including nine core outcomes and their respective measurement methods of priority: dyspnea (modified Medical Research Council scale), cough (Leicester Cough Questionnaire), exercise capacity (6-min walk test), fatigue (Fatigue Severity Scale), pain (Numerical Rating Scale), sleeping disturbance (Pittsburgh Sleep Quality Index), anxiety (Generalized Anxiety Disorder Scale-7), depression (Patient Health Questionnaire-9), and health status (36-item Short Form Health Survey); 16 optional measurement methods achieved consensus for supplement. Measuring phases of each core outcome were prioritized by importance through short and long terms of PCC. CONCLUSIONS:The COS-PCC highlights the key PCC concerns and provides an essential outcome set for PCC assessment in clinical trials and evidence synthesis. With improving the understanding of PCC and accumulating research evidence, the COS-PCC needs to be continuously updated and improved in practice.

Traditional Medicine(TM),particularly Traditional Chinese Medicine(TCM),is an indispensable compo-nent of the global healthcare system,offering unique insights to modern medical science.Clinical efficacy is the bedrock for the inheritance and development of TM.To meet the growing demand for high-quality healthcare,it is imperative to integrate TM with mod-ern technology to address the issue of insufficient evi-dence for the efficacy of TM.To evaluate the clinical efficacy of TM,clinical trials are necessary,especially good clinical trials,which conform to the general prin-ciples of scientific research and also take into account the characteristics of traditional therapies.To promote the development of high-quality clinical trials that are in line with the features of TM,the attending experts held an in-depth discussion and reached the Rome con-sensus on"Good Clinical Trials for TM(GCT-TM),"at the 18th Academic Annual Meeting of the Clinical Efficacy Evaluation Committee of the World Federation of Chinese Medicine Societies and the 8th International Forum on Evidence-Based Chinese Medicine,held in Rome on June 26,2025.

OBJECTIVE:To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents. METHODS:This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs). RESULTS:This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed. CONCLUSION:STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).

BackgroundInvestigations into the role of traditional Chinese medicine (TCM) pharmacotherapy in the early stage of the COVID-19 pandemic in real clinical circumstances are necessary as we reflect on the past. PurposeTo observe the effectiveness of TCM on real-world clinical outcomes of COVID-19 patients during surges of SARS-CoV-2 alpha and delta variants. MethodsA retrospective cohort design was used. Data was collected from 9 clinical sites across mainland China. 2021 confirmed COVID-19 patients admitted between January 1, 2020 and January 17, 2022 were screened for inclusion. Exposure was TCM pharmacotherapy (prescriptions or patent drugs). Primary outcomes include hospital discharge rate and negative conversion rate of SARS-CoV-2 infection. Secondary outcomes include the length of hospital stay, negative conversion time of the SARS-CoV-2 virus, clinical recovery rate on day 7 of hospitalization, and the rate of worsened computed tomography presentations on day 14 of hospitalization. The Cox proportional hazards regression model and propensity score matching were used for statistical analysis. ResultsThree cohorts were defined for convenience of analysis. The complete cohort included 1747 COVID-19 patients (medium [IQR] age, 40[30-50] years; 1017[58.2%] male). Analysis of the complete cohort found TCM pharmacotherapy, aged 65 or younger, living in South China, and early treatment were protective factors of hospital discharge, and living in South China was a protective factor of negative conversion of the virus. Analysis of the early treatment cohort (of 1066 patients) found TCM pharmacotherapy, aged 65 or younger, and living in South China were protective factors of hospital discharge, and living in South China was a protective factor of negative conversion. Analysis of the matched-pair cohort (of 462 mild-to moderate COVID-19 patients) found TCM group had a higher discharge rate (P<0.001), a shorter hospital stay (14d v.s. 16d, P<0.001) and a higher clinical recovery rate (83.3% v.s. 31.0%, P<0.001) compared to the combined treatment group. ConclusionsTCM pharmacotherapy increased discharge rate, clinical recovery rate, and shortened hospital length of stay in mild-to-moderate COVID-19 patients during surges of the alpha and delta variants.

对证有效的中成药与随时间变迁的疾病谱、疾病证候特征是中医界存在已久的一对矛盾.宋代为解决这一矛盾并保障社会医疗需求,官药局制度和《太平惠民和剂局方》应运而生,按照该书制作的中成药虽然在当时医疗保障方面发挥了巨大作用,但终究因为疾病谱变迁、疾病证候特征改变、中成药不合理使用、医学理论进步而走向衰亡.当前,我国中成药发展面临着与《太平惠民和剂局方》相似的挑战,积极吸收其历史教训有助于解决当前遭遇的困境.基于证素学说,中成药功能主治证素化及联合用药可使其应用更具精准性、可操作性,不仅可有效减少其不合理使用,还可应对疾病谱和疾病证候特征变迁,有望成为未来应用的新模式.

Objective To explore the core targets and important pathways of severe acute respiratory syndrome coronavirus-2（SARS-CoV-2） induced atherosclerosis（AS） progression from the perspective of immune inflammation, so as to predict the potential prevention and treatment of traditional Chinese medicine（TCM）. Methods Microarray data were obtained from the Gene Expression Omnibus（GEO） database for coronavirus disease 2019（COVID-19） patients and AS patients, and the “limmar” and “Venn” packages were used to screen out the common differentially expressed genes（DEGs） genes in both diseases. The gene ontology（GO） and Kyoto encyclopedia of genes and genomes（KEGG） analyses were performed on the common DEGs to annotate their functions and important pathways. The two gene sets were scored for immune cells and immune function to assess the level of immune cell infiltration. The protein-protein interaction（PPI） network was constructed by STRING database, and the CytoHubba plug-in of Cytoscape was used to identify the hub genes. Two external validation datasets were introduced to validate the hub genes and obtain the core genes. Immuno-infiltration analysis and gene set enrichment analysis（GSEA） were performed on the core genes respectively. Finally the potential TCM regulating the core genes were predicted by Coremine Medical database. Results A total of 7898 genes related to COVID-19, 471 genes related to AS progression; And 51 common DEGs, including 32 highly expressed genes and 19 low expressed genes were obtained. GO and KEGG analysis showed that common DEGs, which were mainly localized in cypermethrin-encapsulated vesicles, platelet alpha particles, phagocytic vesicle membranes and vesicles, were involved in many biological processes such as myeloid differentiation factor 88（MyD88）-dependent Toll-like receptor signaling pathway transduction, interleukin-8（IL-8） production and positive regulation, IL-6 production and positive regulation to play a role in regulating nicotinamide adenine dinucleotide phosphate oxidase activity, Toll-like receptor binding and lipopeptide and glycosaminoglycan binding through many biological pathways, including Toll-like receptor signaling pathways, neutrophil extracellular trap formation, complement and coagulation cascade reactions. The results of immune infiltration analysis demonstrated the state of immune microenvironment of COVID-19 and AS. A total of 5 hub genes were obtained after screening, among which Toll-like receptor 2（TLR2）, cluster of differentiation 163（CD163） and complement C1q subcomponent subunit B（C1QB） genes passed external validation as core genes. The core genes showed strong correlation with immune process and inflammatory response in both immune infiltration analysis and GSEA enrichment analysis. A total of 35 TCMs, including Chuanxiong（Chuanxiong Rhizoma）, Taoren（Persicae Semen）, Danggui（Angelicae Sinensis Radix）, Huangqin（Scutellariae Radix）, Pugongying（Taraxaci Herba）, Taizishen（Pseudostellariae Radix）, Huangjing（Polygonati Rhizoma）, could be used as potential therapeutic agents. Conclusion TLR2, CD163 and C1QB were the core molecules of SARS-CoV-2-mediated immune inflammatory response promoting AS progression, and targeting predicted herbs were potential drugs to slow down AS progression in COVID-19 patients.

Objective: This systematic review and meta-analysis evaluated the efficacy of Shenlingbaizhusan (SLBZS) for antibiotic-associated diarrhea (AAD). Methods: Scientific databases such as PubMed, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), the Chinese National Knowledge Infrastructure (CNKI), the Chongqing VIP information, the Wan -fang, and the SinoMed (CBM), were searched to identify randomized control trials (RCTs) relevant to SLBZS use in AAD. The search items included "antibiotic-associated diarrhea," "Shenlingbaizhusan," and "random." There were no limits on gender, race, or disease stage. RCTs of SLBZS combined with conventional treatment versus conventional treatment alone were eligible. Results: Eight RCTs involving 774 participants were included. Two reviewers independently extracted the data and analyzed them using Review Manager 5.3 software. The GRADEpro Guideline Development Tool generated the summary of the findings table. For AAD, adding SLBZS to conventional therapy achieved higher clinical efficacy rate (RR=1.19, 95CI %[1.12-1.25], P < 0.00001), shorter duration of frequency of diarrhea (MD =-2.38 [-2.67,-2.09], P < 0.00001), shorter duration of character of stool (MD =-2.43[-3.03,-1.84], P < 0.00001), shorter duration of bowel sound, higher peripheral blood CD3+ count, higher peripheral blood CD4+ count (MD=5.04 [4.28, 5.80], P < 0.00001), higher peripheral blood CD4+/CD8+ ratio (MD = 0.35 [0.24, 0.47], P < 0.00001), and lower peripheral blood CD8+ count (MD =-2.88 [-3.73,-2.02], P < 0.00001). No trials reported serious adverse events. Even then, the level of evidence was "low" or "very low" because of its small sample size, risk of bias, and imprecision. Conclusion: SLBZS is beneficial to patients with AAD. However, more high-quality RCTs with larger sample sizes are needed to confirm and fully elucidate the efficacy of SLBZS.

目的 考察复方脑肽节苷脂注射液对细胞色素P450(CYP)1A2、CYP2B6、CYP2C8、CYP2C9、CYP2C19、CYP2D6和CYP3A4活性的影响.方法 将大鼠随机分为对照组和实验组,实验组每日尾静脉注射复方脑肽节苷脂注射液1.8 mL·kg-1,对照组给予0.9％NaCl,共10 d.最后一次给药30 min后,2组均灌胃Cocktail探针溶液(茶碱、安非他酮、瑞格列奈、甲苯磺丁脲、奥美拉唑、美托洛尔、咪达唑仑).在不同时间点采血,用LC-MS检测各探针的血药浓度,计算7个探针药的药代动力学参数,评价相应CYP450酶亚型的体内代谢活性.结果 对照组瑞格列奈的 AUC0-t为(942.01±234.99)ng·h·mL-1,AUC0-∞为(970.62±232.35)ng·h·mL-1,清除率(CL)为(328.28±83.20)L·h·kg-1,而实验组瑞格列奈的 AUC0-t 为(1 740.40±720.71)ng·h·mL-1,AUC0-∞为(1 757.03±714.44)ng·h·mL-1,CL 为(202.53±81.49)L·h·kg-1,与对照组相比,瑞格列奈的AUC0-t、AUC0-∞分别显著增加1.85倍、1.81倍,CL显著降低了 38.31％,其他探针药物的药代动力学参数差异无统计学意义.结论 复方脑肽节苷脂注射液可抑制CYP2C8的活性,而对CYP1A2、CYP2B6、CYP2C9、CYP2C19、CYP2D6 和 CYP3A4 无显著影响.

In this review, we investigated the potential mechanism of Total Salvianolic Acid Injection (TSI) in protecting against myocardial ischemia reperfusion injury (MI/RI). To achieve this, we predicted the component targets of TSI using Pharmmapper and identified the disease targets of MI/RI through GeneCards, DisGenNET, and OMIM databases. We constructed protein-protein interaction networks by analyzing the overlapping targets and performed functional enrichment analyses using Gene Ontology and Kyoto Encyclopedia of Genes and Genomes. Our analysis yielded 90 targets, which were implicated in the potential therapeutic effects of TSI on MI/RI. Seven critical signaling pathways significantly contributed to TSI's protective effects, namely, PI3K signaling, JAK-STAT signaling, Calcium signaling, HIF-1 signaling, Nuclear receptor signaling, Cell Cycle, and Apoptosis. Subsequently, we conducted a comprehensive literature review of these seven key signaling pathways to gain further insights into their role in the TSI-mediated treatment of MI/RI. By establishing these connections, our study lays a solid foundation for future research endeavours to elucidate the molecular mechanisms through which TSI exerts its beneficial effects on MI/RI.

[Objective] To evaluate the efficacy of QiShen Yiqi Dropping Pills combined with conventional Western medicine in improving left ventricular cardiac function in the convalescence of acute myocardial infarction（AMI）.[Methods] Randomized controlled trials（RCTs） of Qishen Yiqi Dropping Pills combined with conventional Western medicine in the treatment of myocardial infarction in convalescent stage were searched in CNKI,Wan Fang,Wei Pu（VIP）,Chinese biomedical literature database（CBMdisc）,PubMed,EMbase database and the Cochrane Library. After quality evaluation and effective data extraction,Revman 5.3 software was used for statistical analysis. [Result] A total of 15 qualified RCTs were included,including 1 569 subjects,including 794 in the experimental group and 775 in the control group. The quality of the included literature was generally low. Compared with conventional western medicine treatment,QiShen Yiqi Dropping Pills could improve left ventricular ejection fraction（LVEF） in AMI patients after revascularization [short term treatment（＜6 months） P ＜0.05,MD =5.94,95% CI（3.75, 8.14）;long term treatment （≥ 6 months） P＜0.05,MD=5.35,95%CI（4.16,6.54）]. In short-term treatment,left ventricular end systolic diameter（LVESD） [P＜0.05,MD=-5.56,95%CI（-6.82,-4.30）] or volume（LVESV） [P ＜0.05,MD =-10.11,95%CI（-11.73,-8.49）] were smaller. Left ventricular end diastolic diameter（LVEDD） or volume（LVEDV） were smaller [P＜0.05,MD=-9.28,95%CI（-11.43,-7.14）]. [Conclusion] Compared with conventional western medicine in the treatment of AMI convalescence,QiShen Yiqi Dropping Pills can enhance the cardiac function of patients after revascularization and delay the process of left ventricular remodeling. However,the limitation in quantity and quality of included clinical studies,the results are only used as evidence-based reference for clinical diagnosis and treatment,and more high-quality RCTs are needed to further confirm the curative effect.

Langendorff离体心脏灌流模型技术具有可重复性强、给药方便和技术要求低等特点,常被用于研究心肌缺血再灌注损伤.该模型排除了其他器官系统、神经系统或体液等影响.本文对该技术的步骤、动物的选择、灌流模式、灌注液的选择、检测的指标、缺血方式以及缺血和灌流时间的选择等方面进行了综述和优缺点的评价.

Heart failure is caused by an imbalance in cardiovascular homeostasis,which depends on the strict regulation of gene expression and is controlled by multiple types of RNA molecules.Non-coding genomes play a key role in gene regulation during genetic programming and body development,as well as in health and cardiovascular diseases.Some of these RNAs lack protein-coding capabilities,known as non-coding RNAs.Non-coding RNAs play an increasingly important role in a variety of cardiovascular diseases,including heart failure,as they play a biological function regulating the expression of related genes at the RNA level.This paper reviews the molecular mechanism of non-coding RNA in its regulation of heart failure,and summarizes the mechanism of TCM in preventing and treating heart failure by intervening in non-coding RNA,in order to provide new ideas for TCM treatment of heart failure.

目的 探讨心电图形中心室跨壁复极离散度指标和血清心肌损伤标志物对心脏毒性化疗药物诱发室性心律失常的早期诊断价值.方法 选取我院收治的使用多柔比星、表柔比星、紫杉醇、5-氟尿嘧啶、曲妥珠单抗等单独或联合化疗的各类肿瘤病人64例,根据化疗后3周期(63 d)内病人是否出现室性心律失常分为正常组和室性心律失常组,采集两组化疗前后心电图形和血清肌钙蛋白T(cTnT)、肌酸激酶同工酶(CK-MB)、肌红蛋白(MYO)浓度,比较两组化疗前后QT、校正后QT间期(QTc)、T波峰末间期(Tp-e)、校正后Tp-e间期(Tp-ec)、Tp-e/QT、JT、QT离散度(QTd)数值和cTnT、CK-MB、MYO浓度变化,并进行相关性分析.绘制受试者工作特征(ROC)曲线分析QT、QTc、Tp-e、Tp-ec、Tp-e/QT、JT、QTd对化疗后病人发生室性心律失常的诊断价值.结果 两组化疗前后Tp-e、Tp-ec、Tp-e/QT、QTd指标变化明显,差异有统计学意义(P<0.05);而QT、QTc、JT没有明显改变(P>0.05).两组之间化疗前后心肌损伤标志物CK-MB浓度变化明显,差异有统计学意义(P<0.05),cTnT、MYO浓度没有明显改变(P>0.05),但化疗后数值均较本组化疗前有所升高.相关性分析显示,化疗后两组QTd与cTnT浓度呈正相关(r=0.249,P<0.05);Tp-e、QTd与CK-MB浓度呈正相关(r值分别为0.268,0.343,P均<0.05).ROC曲线分析显示,QT、QTc、Tp-e、Tp-ec、JT、QTd对化疗期间室性心律失常的发生具有预测价值,曲线下面积(AUC)分别为0.658,0.687,0.719,0.675,0.718,0.978;最佳截断值分别为399.33 ms,441.00 ms,101.00 ms,106.84 ms,296.50 ms,19.50 ms;诊断准确率分别为68.75％,68.75％,70.31％,65.63％,73.44％,90.63％.结论 在应用具有心脏毒性的化疗药物进行抗肿瘤治疗过程中,可通过心电图形中某些心室复极离散度指标数值的变化,预测室性心律失常的发生,有助于尽早采取预防措施,防止心血管大事件发生.

目的 基于网络药理学方法探讨"黄芪-丹参"治疗心肌梗死(MI)的分子机制.方法 采用TCMSP,筛选出"黄芪-丹参"的活性成分;利用GeneGard和OMIM检索MI相关靶点;利用Biogenet分别对药物与疾病靶点进行蛋白质相互作用网络构建,并提取交集网络中"黄芪-丹参"治疗MI的核心靶点;利用Omicshare数据库对核心靶点进行GO二级分类富集,利用Metascape对核心靶点进行KEGG通路富集分析.结果 筛选出85个药效成分、药物靶点1239个、疾病靶点3678个,最终获得关键靶点251个、KEGG通路富集分析250条.治疗MI主要有效成分为山柰酚、木樨草酸、丹参酮ⅡA等,关键靶点为APP、ESR1、TP53等.与MI关系密切的富集通路为泛素介导的蛋白水解、MAPK信号通路、甲状腺激素信号通路、缺氧诱导因子-1信号通路、转化生长因子β信号通路、P3信号通路等.结论 通过网络药理学的方法,揭示了临床常用益气活血药组合"黄芪-丹参"的多途径有效抗MI作用的分子机制;同时,对本课题组后续研究的开展起到了奠定作用.

目的 通过分析某医院胆囊炎和胆结石患者急性发病的时间规律,探讨气候因素与胆系疾病发病的关系.方法 回顾性分析2018年12月1日至2021年11月30日在天津中医药大学第二附属医院急诊科就诊的以腹痛为第一主诉患者的临床资料,包括性别、年龄、发病时间,比较不同月份、不同年龄段男性和女性患者胆囊炎和胆结石发病率的差异,分析气候与胆囊炎和胆结石发病的关系.结果 共收集符合标准的腹痛患者2721例,其中男性1287例,女性1434例.腹部超声诊断为胆囊炎334例,胆结石679例.不同年龄段人群性别构成中以30～39岁的青年患者所占比例最高为22.23％,各年龄段性别比较差异无统计学意义.一年中胆囊炎的发病率在4月最高为16.47％,8月次之为15.02％,最低值出现在5月为7.56％;胆结石发病率3月最高为31.90％,7月次之为26.62％,最低值出现在2月为5.00％.女性胆结石的发病率显著高于男性 〔27.3％(392/1434)比22.3％(287/1287),P<0.05〕.不同月份不同年龄段患者胆结石发病率差异有统计学意义,外界气候的动态变化对老年男性胆结石的发病率有重要影响.结论 在天津地区,外感湿热可能并不是造成胆系疾病最主要的病机,春季亦是胆系疾病高发的季节,肝藏血主疏泄功能在春季的变化可能通过脏腑联系,影响到胆腑功能,故除夏季外,在春季也应重视对胆囊功能的保护.

Background: Combination of Polygonum capitatum Buch.-Ham. ex D. Don extract (PCE) and ciprofloxacin (CIP) was commonly prescribed in the treatment of urinary tract infections. Their pharmacokinetic herb-drug interactions (HDIs) were focused in this study to assess potential impact on the safety and effectiveness. Methods: A randomized, three-period, crossover trial was designed to study the pharmacokinetic HDI between PCE and CIP in healthy humans. Their pharmacokinetic- and tissue distribution-based HDIs were also evaluated in rats. Gallic acid (GA) and protocatechuic acid (PCA) were chosen as PK-markers of PCE in humans and rats. Potential drug interaction mechanisms were revealed by assessing the effects of PCE on the activity and expression of multiple transporters, including OAT1/3, OCT2, MDR1, and BCRP. Results: Concurrent use of PCE substantially reduced circulating CIP (approximately 40%-50%) in humans and rats, while CIP hardly changed circulating GA and PCA. PCE significantly increased the tissue distribution of CIP in the prostate and testis of rats, but decreased in liver and lungs. Meanwhile, CIP significantly increased the tissue distribution of GA or PCA in the prostate and testis of rats, but decreased in kidney and heart. In the transporter-mediated in vitro HDI, GA and PCA presented inhibitory effects on OAT1/3 and inductive effects on MDR1 and BCRP. Conclusion: Multiple transporter-mediated HDI contributes to effects of PCE on the reduced systemic exposure and altered tissue distribution of CIP. More attention should be paid on the potential for PCE-perpetrated interactions.

目的 系统评价丹参多酚酸盐注射液联合西医常规治疗对慢性心力衰竭的有效性和安全性.方法 计算机检索中国知网、万方、维普、PubMed等数据库中相关随机对照试验(randomized controlled trials,RCTs),检索时间限定为建库至2022年3月20日.采用偏倚风险评估工具进行文献质量评价,使用RevMan5.3、Stata 15.0软件进行Meta分析,通过TSA 0.9.5.10Beta软件进行试验序贯分析,并按照GRADE标准进行证据质量评价.结果 最终共纳入23个RCTs,共计2421例患者,纳入研究的整体方法学质量较低.Meta分析结果显示,与西医常规治疗相比,联合丹参多酚酸盐注射液可显著提高临床总有效率[OR=3.95,95％CI(2.92,5.35),P＜0.00001],降低 Lee 心衰评分[MD=-0.95,95％CI(-1.37,-0.52),P＜0.0001],提高 6min 步行距离[MD=44.50,95％CI(32.02,56.97),P＜0.00001],降低血浆 B 型脑钠肽(B-type natriuretic peptide,BNP)浓度[MD=-74.78,95％CI(-89.24,-60.33),P＜0.000 01];改善心功能指标,包括提高射血分数(left ventricular ejection fraction,LVEF)[MD=5.33,95％CI(4.33,6.32),P＜0.00001],降低左室收缩末期内径(left ventricular end systolic diameter,LVESD)[MD=-5.73,95％CI(-8.04,-3.43),P＜0.00001]、左室舒张末期内径(left ventricular end-diastolic diameter,LVEDD)[MD=-5.12,95％CI(-7.16,-3.08),P＜0.000 01]及室间隔厚度(interventricular septal thickness,IVST)[MD=-1.12,95％CI(-1.60,-0.64),P＜0.00001],提高心输出量(cardiac output,CO)[MD=1.12,95％CI(1.00,1.23),P＜0.00001]、心脏指数(cardiac index,CI)[MD=1.12,95％CI(1.00,1.25),P＜0.00001]及每搏量(stroke volume,SV)[MD=9.34,95％CI(5.39,13.29),P＜0.000 01];降低炎症指标,包括白细胞介素-6(interleukin-6,IL-6)[MD=-1.84,95％CI(-2.36,-1.31),P＜0.000 01]、肿瘤坏死因子-α(tumor necrosis factor-α,TNF-α)[MD=-0.74,95％CI(-0.83,-0.66),P＜0.00001]及超敏 C 反应蛋白(high-sensitivity C-reactive protein,hs-CRP)[MD=-0.97,95％CI(-1.27,-0.67),P＜0.000 01];降低心型脂肪酸结合蛋白(heart fatty acid binding protein,H-FABP)表达[MD=-9.74,95％CI(-12.21,-7.27),P＜0.000 01].在不良反应发生率方面,两组比较差异无统计学意义[RR=0.63,95％CI(0.18,2.17),P=0.47].试验序贯分析进一步肯定了联合丹参多酚酸盐注射液对慢性心力衰竭患者的疗效.GRADE证据质量分级显示临床总有效率为中等质量证据,Lee心衰评分、LVESD等8项结局指标均为低质量证据,其余均为极低质量证据.结论 与西医常规治疗相比,联合丹参多酚酸盐注射液能显著提高临床疗效,无明显不良反应,然而证据等级不高,期待开展更多高质量、大样本、多中心的RCTs,为丹参多酚酸盐注射液治疗慢性心力衰竭提供更充分的循证证据.

目的 基于整合药理学探究当归四逆汤抗寒凝心脉型心肌梗死的作用机制.方法 采用中医药整合药理学研究平台(TCMIP)V2.0,检索并获取当归四逆汤组方活性成分及靶标、心肌梗死靶标信息,构建中药-成分-靶点-通路多维分析,得到蛋白质相互作用网络(PPI).同时,通过基因本体数据库(GO)功能分析、京都基因和基因组百科全书库(KEGG)的通路富集分析,预测当归四逆汤抗急性心肌梗死的分子机制.结果 共筛选出与心肌梗死相关的靶标545个,中药活性成分1661种,可通过调控赖氨酸和孕激素介导的卵母细胞、幽门螺杆菌感染中的上皮细胞信号传导、谷胱甘肽代谢、多种氨基酸和脂类代谢、逆转录失调等方面,对GTP酶正调控、中枢神经系统发育、神经肽信号通路、ERK1和ERK2级联负调控、磷脂酰肌醇生物合成的过程等进行通路干预.结论 当归四逆汤治疗寒凝心脉型心肌梗死时,主要涉及多条代谢途径及细胞外多种酶和因子的共同调控作用.