Efficacy and safety of a sequential treatment with clearing heat and eliminating phlegm and tonifying Qi and activating blood circulation in treating acute ischemic stroke: study protocol for a randomized controlled trial

OBJECTIVE:To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm(CHEP)formula and tonifying Qi and activating blood circulation(TQABC)formula in patients with acute ischemic stroke(AIS)within a 72 h time window.METHODS:In this randomized,multicenter,doubleblinded,placebo-controlled trial,500 participants will be randomly assigned in a ratio of 1∶1 to the CHEP+TQABC group or control group.In addition to guidelinebased standard medical care,participants in the treatment group will receive the CHEP formula for the first 5 consecutive days followed by the TQABC formula for another 10 consecutive days,while those in the control group will receive CHEP formula placebo and TQABC formula placebo consecutively.The primary outcome measure will be the comparison of the change in the National Institutes of Health Stroke Scale score from baseline to 15 days after randomization.The secondary outcome measures will include the scores on the modified Rankin Scale,Barthel Index,Patient-Reported Outcomes,TCM symptom pattern(Zheng-hou)evaluation Scale,and the incidence of in-hospital complications.Safety assessment will include the physical examination,laboratory detection,any adverse events or serious adverse events,and the proportion of any complications during hospitalization.DISCUSSION:The results of this study will provide objective and scientific data with which to assess the efficacy and safety of a sequential treatment based on“integrating disease and symptom pattern”for patients with AIS.

Tonifying Qi and activating blood circulation in terms of Traditional Chinese Medicine: their effects in patients with myocardial infarction

OBJECTIVE: To investigate the effects of tonifying Qi and activating blood circulation(SQABC), a method in Traditional Chinese Medicine(TCM), on end-point events in patients with myocardial infarction(MI) in this retrospective cohort study.METHODS: Clinical data were obtained from the medical records of patients with acute MI(AMI),both during hospitalization and follow-up, and included general demographic information(age, gender, and contact information), TCM regimens used,and end-point events.RESULTS: A total of 1596 patients with AMI were enrolled to this study, but data of only 1210 casesare accessible till follow-up. We classified the patients based on the exposure levels of SQABC.When comparing the results between all exposure and non-exposure groups, significant differences were identified, both during hospitalization and follow-ups. During hospitalization, cardiac death(4.40% vs 21.55%, P < 0.05) and cardiac shock(3.04% vs 11.62%, P < 0.05) were significantly lower in the exposure group than the non-exposure group. Similarly, during the follow-up, cardiac death(12.04% vs 20.49%, P < 0.05), acute heart failure(7.27% vs 11.81%, P < 0.05), composite endpoint of reinfarction and stroke(9.11% vs 15.28%,P < 0.05), and rehospitalization due to angina(25.49% vs 34.38%, P < 0.05) were significantly lower in the exposure group than the non-exposure group.CONCLUSION: Our findings suggest that SQABC can significantly benefits the subjects in the management of high-risk AMI in them.

Effect of Chinese Herbs for Activating Blood Circulation,Removing Stasis and Supplementing Qi on the Circulating Endothelial Cells in Patients with Unstable Angina Pectoris

Objective: To observe the effect and clinical significance of circulating endothelial cells (CEC) in the pathogenesis of coronary heart disease with unstable angina pectoris (CHD-UAP), and to explore the protective effect of Chinese herbs for activating blood circulation, removing stasis and supplementing Qi (CH) on CHD-UAP patient's CEC. Methods: Sixty patients with diagnosis of CHD-UAP confirmed and differentiated to be Qi-deficiency and blood stasis by TCM were randomly divided into two groups and treated, on the basis of Western drug-therapy, with Tongxinluo capsule (通心络胶囊, TXL) and Huoxue Tongmai capsule (活血通脉胶囊, HXTM) respectively by way of oral taking three times a day, 3 capsules every time, with 1 month as one therapeutic course. The number of CEC in patients' blood circulation was counted before and after treatment. Besides, the number of CEC in 30 healthy persons was also counted for control. Results: The number of CEC in CHD-UAP patients was significantly higher than that in the healthy persons (P<0.01). After the patients were treated with CH, either TXL or HXTM, it significantly decreased (P<0.01)with insignificant difference between the two treated groups. Conclusion: CEC in CHD-UAP patients is severely damaged and endothelial function in disorder, Chinese herbs have protective effect on patients' CEC.

Clinical effect of enriching qi, activating blood circulation, clearing away dampness and heat combined with western medicine in the treatment of idiopathic membranous nephropathy: A meta-analysis

Objective:To systemically review the efficacy and safety about the method of enriching qi,activating blood circulation,clearing away dampness and heat combined with western medicine in the therapy of patients with idiopathy membranous nephropathy(IMN).Methods:We collected the randomized controlled trials(RCTs)of enriching qi,activating blood circulation,clearing away dampness and heat for the treatment of IMN from Pub Med,The Cochrane Library,Medline,China National Knowledge Infrastructure(CNKI),China Biology Medicine disc(CBM),Wanfang Data and Wiper Databases.Bias of risk of retrieval literature was evaluated according to Cochrane Collaboration standard,and Review Manager 5.3 software was used for statistical analysis.Results:Fourteen trials(836 participants)were included in the meta-analysis.This kind of traditional Chinese method combined with western medicine in the treatment of IMN exerted statistical differences in reducing 24-hour urinary protein[WMD=-0.97,95%CI(-1.30,-0.65),Z=5.86(P<0.00001)]and elevating serum albumin[WMD=3.83,95%CI(2.10,5.57),Z=4.33,P<0.0001],lowering serum cholesterol[WMD=-0.82,95%CI(-1.08,-0.56),Z=6.18,P<0.00001],triglycerides[WMD=-0.39,95%CI(-0.67,-0.11),Z=2.77,P=0.006]and reducing the risk of adverse events[OR=0.29,95%CI[0.16,0.50],Z=4.35,P<0.0001]in the patients with IMN as compared with controls.However,there was no statistically significant difference between the method and controls when combining all trials in serum creatinine[WMD=-5.52,95%CI(-18.06,7.03),Z=0.86,P=0.39],when combining all trials in urea nitrogen[WMD=-0.90,95%CI(-2.22,0.41),Z=1.35,P=0.18].Conclusion:The method of enriching qi,activating blood circulation,clearing away dampness and heat combined with western medicine exerts certain advantages and better safety in treating patients with IMN.However,for the inferiority of the included studies,the conclusion still needs high-quality and large-sample prospective randomized controlled trials to verify.

Research Progress of Tonifying Kidney and Promoting Blood Circulation in the Treatment of Steroid-induced Necrosis of Femoral Head

Osteonecrosis of the femoral head is a common disability disease of the hip joint in China,and osteonecrosis of the femoral head caused by hormone factors is the most common,which is related to the gradual increase in the utilization rate of glucocorticoids in recent years.It is a refractory disease in orthopaedics with a poor prognosis.For this disease,the treatment of traditional Chinese medicine has certain advantages.In view of this,the author reads,analyzes and summarizes its materials by searching China Journal full-text Database and Wanfang Database.This paper reviews the mechanism and clinical research progress of tonifying kidney and activating blood circulation in the prevention and treatment of steroid-induced osteonecrosis of the femoral head,hoping to provide help for the clinical treatment of hormone-related osteonecrosis of the femoral head.

Supplementing Qi and activating blood circulation method to treat vertebrobasilar dolichoectasia with posterior circulatory watershed infarction:a case report of two patients

Vertebrobasilar dolichoectasia(VBD),a rare posterior circulation vascular variant disease,is an important risk factor for many acute cerebrovascular diseases.An insufficient understanding of VBD often leads to misdiagnose.Two cases of VBD that were initially diagnosed as posterior circulation watershed infarction are reported here.Absence of common causes of stroke including hypoperfusion,blood system diseases,carotid and aortic dissection,and eosinophil elevation,the symptoms of the 2 patients met the diagnostic criteria of VBD.Both patients displayed symptoms that were in line with the Traditional Chinese Medicine(TCM)syndrome pattern of"Qi deficiency and blood stasis".Accordingly,they were comprehensively treated with Supplementing Qi and activating blood circulation method.The clinical manifestations of the 2 patients were remarkably improved and no recurrence of watershed infarction was found in a 1-year follow-up.A detailed medical history and laboratory examination are capable of improving diagnostic accuracy of VBD.TCM treatment based on syndrome identification might be a promising candidate for VBD management.

苏筋通络方结合“行气活血”针刺法治疗急性踝关节扭伤临床观察

目的观察苏筋通络方结合“行气活血”针刺法治疗急性踝关节扭伤临床效果。方法将医院创伤骨科门急诊就诊的102例急性踝关节扭伤患者(2020年5月—2022年7月)纳入研究,以随机数字表法将患者分为两组,每组51例,对照组采取西医常规治疗,观察组采取西医常规治疗同时结合苏筋通络方及“行气活血”针刺法治疗。数据比较:临床治疗效果、中医症状(踝关节疼痛肿胀、皮下瘀斑、关节活动受限等)积分变化、踝关节跖屈活动度与背伸活动度变化、视觉模拟评分(Visual Analogue Scale,VAS)变化、美国足踝外科协会(American Orthopaedic Foot and Ankle Society,AOFAS)踝-后足评分变化、血清疼痛物质(神经生长因子、神经肽、P物质)水平变化、白细胞介素-6(Interleukin-6,IL-6)、白细胞介素-1β(Interleukin-1β,IL-1β)、超敏C反应蛋白(Hypersensitive C-reactive protein,hs-CRP)变化。结果观察组患者与对照组患者治疗总有效率相比[98.04%(50/51)vs86.27%(44/51)],P<0.05;治疗后各组患者中医症状(踝关节疼痛肿胀、皮下瘀斑、关节活动受限等)积分、踝关节跖屈活动度与背伸活动度、VAS评分、AOFAS踝-后足评分、神经生长因子、神经肽、P物质、IL-6、IL-1β、hs-CRP等指标均改善,观察组患者治疗后中医症状(踝关节疼痛肿胀、皮下瘀斑、关节活动受限等)积分、踝关节跖屈活动度与背伸活动度、VAS评分、AOFAS踝-后足评分、神经生长因子、神经肽、P物质、IL-6、IL-1β、hs-CRP等指标均明显优于对照组患者,P均<0.05。结论苏筋通络方结合“行气活血”针刺法治疗急性踝关节扭伤临床效果显著,患者经治疗后临床症状显著改善,疼痛缓解,踝关节功能改善,值得应用。

4种治疗糖尿病周围神经病变补气活血类中成药的卫生技术评估

目的为临床选择糖尿病周围神经病变(DPN)治疗用补气活血类中成药提供参考。方法参考《医疗机构中成药遴选专家共识(第一版)》,结合临床实际,制订药物卫生技术评估细则,参考药品说明书、临床指南和文献,对4种中成药的安全性、有效性、经济性、适宜性、创新性、可及性、传承性进行评分,并计算总分。结果通心络胶囊、木丹颗粒、糖脉康颗粒、芪蛭降糖胶囊的评分分别为74.5分、72分、64.5分、57分。结论临床在选择治疗DPN的补气活血类中成药时,相对于糖脉康颗粒、芪蛭降糖胶囊,建议优先使用木丹颗粒、通心络胶囊。

益气活血方药治疗原发性肝癌的免疫学机制概述

归纳总结具有益气和/或活血功效的中药单体、单味中药以及中药复方治疗原发性肝癌的免疫学机制,包括对T淋巴细胞亚群、巨噬细胞、髓源性抑制细胞(myeloid-derived suppressor cell,MDSC)、肿瘤细胞表面受体、细胞因子以及红细胞免疫在数量和功能上的调节,阐述其抗肿瘤作用,为进一步的基础研究和临床应用提供思路。

Effect of Chinese Drugs for Supplementing Qi,Nourishing Yin and Activating Blood Circulation on Myocardial Perfusion in Patients with Acute Myocardial Infarction after Revascularization

Objective:To observe the effects of Chinese drugs for supplementing qi,nourishing yin and activating blood circulation on the myocardial perfusion in acute myocardial infarction(AMI) patients after revascularization.Methods:Eighty patients with anterior or inferior ventricular wall AMI,who had received revascularization by intravenous thrombolysis or coronary bypass,were randomized into the treated group and the control group equally,both treated with conventional Western medical treatment,but combined,resp...

Protective Effect of Chinese Herbs for Supplementing Qi,Nourishing Yin and Activating Blood Circulation on Heart Function of Patients with Acute Coronary Syndrome after Percutaneous Coronary Intervention

Objective： To investigate the effects of Chinese herbs for supplementing qi, nourishing yin and activating blood circulation on heart function of patients with acute coronary syndrome （ACS） after successful percutaneous coronary intervention （PCI）. Methods： One hundred patients with ACS after successful PCI were randomly assigned to a Western medicine （WM） treatment group （WMG） and a combined treatment group （CMG） treated by Chinese herbs for supplementing qi, nourishing yin and activating blood circulation, besides Western medicine treatment, with 50 cases in each group. Both treatment courses were 6 months. The follow- up was scheduled at baseline, 6 months and 1 year after PCI, and New York Heart Association （NYHA） functional class, Chinese medicine （CM） symptom scores, blood stasis syndrome scores, and major adverse cardiovascular events （MACE） were observed, serum levels of N-terminal pro-brain natriuretic peptide （NT-proBNP） and hyper-sensitivity C-reactive protein （Hs-CRP） were measured, an echocardiogram was conducted to examine left ventricular ejection fraction （LVEF）, left ventricular end-diastolic volume （LVEDV）, left ventricular end-systolic volume （LVESV）, inter-ventricular septal thickness （IVST）, left ventricular posterior wall thickness （LVPWT）, and ventricular wall motion index （VWMI）. Results： Compared with the baseline, LVEF significantly increased （P〈0.01）, and CM symptom scores, blood stasis syndrome scores, VWMI, LVEDV, LVESV, NT-proBNP, and Hs-CRP all decreased （P〈0.01） in both groups at 6 months and at 1 year after PCI. There were no significant differences in all the above parameters at 1 year vs those at 6 months after PCI （P〉0.05）. VWMI, LVEDV, LVESV, NT-proBNP, Hs-CRP, LVEF, and CM symptom and blood stasis syndrome scores were all improved obviously in CMG than those in WMG （P〈0.05 or P〈0.01） at 6 months and at 1 year after PCI. There were no significant differences in NYHA functional class between CMG and WMG at different follow-up timepoints; it was notable that P value was 0.054 when comparing the cases of NYHA functional class between the two groups at 1-year follow-up. During the 1-year follow-up, 3 MACE and 11 MACE occurred in CMG and WMG, respectively; the MACE rate in CMG was lower than that in WMG （6% vs 22%, P〈0.05）. Conclusion： Chinese herbs for supplementing qi, nourishing yin and activating blood circulation could improve heart function, reduce the CM symptom scores and blood stasis syndrome scores, and decrease the incidence of MACE in patients with ACS after successful PCI.

骨质疏松症“亏瘀致痿”的理论构建及临床应用

骨质疏松症(OP)是一种以增龄性骨量降低,骨微结构破坏,骨脆性增加且易骨折的代谢性骨病。该病好发于绝经后女性和中老年男性,起病隐匿,多数患者在骨折后才被确诊,造成了大量的医疗资源消耗。浙江中医药大学附属第三医院姚新苗教授研究团队基于“肾主骨”“肾气虚损”等基础理论,创新性提出了OP“亏瘀致痿”的致病理论,认为OP的病机是亏虚瘀互结、夹杂致痿。在该理论指导下,认为应采用“补肾健脾活血法”对OP患者进行辨证论治。补肾健脾活血法主要包括虚瘀同治;补肾为本、健脾为要;筋骨并重3个方面。该研究团队开展了一系列临床与基础研究,从不同角度阐释“亏瘀致痿”理论指导下OP康复策略的科学内涵。

单味中药有效成分治疗溃疡性结肠炎研究进展

研究表明,中药治疗溃疡性结肠炎不良反应少且复发率低,临床常用益气健脾、清热祛湿、活血化瘀、补血养阴类中药组方治疗,其主要药物的有效成分具有减轻炎症反应、修复黏膜损伤、调节肠道微生态、调节免疫反应等作用。本文对常用单味中药有效成分治疗溃疡性结肠炎的作用机制进行综述,为其临床治疗与中药新药研发提供参考。

Effects of Chinese herbs capable of replenishing qi, nourishing yin and activating blood circulation and their compatibility on differentially expressed genes of ischemic myocardium

This study was conducted to investigate the effects of Chinese herbs capable of replenishing qi, nourishing yin and activating blood circulation and their compatibility on differentially expressed genes of ischemic myocardium which were selected from differential expression profile we had established before, and to explore the underlying mechanism. The acute myocardial infarction (AMI) model was established by ligating the left anterior descending (LAD) coronary artery, then the model rats were randomly divided into the model group, the Metoprolol group, the replenishing qi nourishing yin (RN) group, the activating blood circulation (AB) group, and the replenishing qi, nourishing yin and activating blood circulation (RA) group. In addition, the normal group and the sham group were set up. The rats of medication groups were administered by intragastric gavage with corresponding drugs on the second day after operations, and the rats of the normal group and the sham group were given normal saline as the same time.Then the ischemic hearts were harvested on the 8th day after operation. The myocardial pathomorphological changes were observed under a light microscope. The mRNA changes of target genes such as COX5a and ATP5e were detected using Realtime fluorescence quantitative PCR (QPCR), and the activities of related enzymes were detected by colorimetric assay. The main results were as follows: the histological changes were observed by HE staining, and cardiocyte swelling, inflammatory cell infiltration and cytolysis were showed in regional ischemic myocardium of the model group, while the pathomorphological changes in all medication groups did not show obvious changes. Two genes related to energy metabolism, COX5a and ATP5e, were selected as the target genes which were downregulated at the mRNA level in the medication groups. The activities of correlative functional enzymes also decreased in the RA group compared to that in the model group accordingly (P<0.05). The results indicated that the abnormal expression of genes involved in energy metabolism pathways could be one of the molecular mechanisms of AMI. The compatibility of Chinese herbs capable of replenishing qi, nourishing yin and activating blood circulation affects the expression of energyrelative gene COX5a, ATP5e, which is probably the mechanism of myocardial preservation, and is more effective than single herb of replenishing qi and nourishing yin or activating blood circulation.

益气活血类方药治疗青光眼视神经损伤有效性的Meta分析

目的 系统评价益气活血类方药联合常规西药治疗青光眼视神经损伤的有效性。方法 检索PubMed、Embase、Web of Science、The Cochrane Library、中国知网、万方和维普数据库报道的益气活血类方药联合常规西药治疗青光眼视神经损伤的相关文献,检索时间为建库至2022年12月1日。对文献进行质量评价后,采用Review Manager 5.4和Stata 14软件对裸眼视力、眼压(IOP)、视野平均敏感度(MS)、视野平均缺损(MD)、图形视觉诱发电位P100潜伏期(LP100)5个结局指标进行Meta分析。结果 共纳入9篇文献,共计746例患者,其中试验组395例,对照组351例。与单纯西药治疗比较,联合益气活血类方药治疗可更有效改善IOP[MD=-1.750,95%CI(-2.900,-0.610),Z=3.000,P=0.003]、MS[MD=3.060,95%CI(2.540,3.580),Z=11.580,P=0.000]、MD[MD=-1.560,95%CI(-1.880,-1.230),Z=9.360,P=0.000],差异均有统计学意义;但在改善裸眼视力及LP100方面,2组差异无统计学意义(P>0.05)。结论 益气活血类方药联合西药治疗青光眼视神经损伤,可更好地改善该类患者的症状和体征。

基于Citespace的益气活血类方治疗心力衰竭临床研究的可视化分析

目的总结益气活血类方治疗心力衰竭临床研究的热点演变及研究不足,并且预测发展趋势。方法检索中国知网和Web of Science数据库(CNKI)建库至2022年11月1日期间有关益气活血类方治疗心力衰竭的相关临床研究文献,借助CiteSpace 6.1R4软件来完成文献研究作者、机构、关键词等可视化研究分析。结果1988—2022年有关益气活血类方治疗心力衰竭的文章整体呈波动上升趋势。发文最多的作者为张艳,辽宁中医药大学(含附属医院)、北京中医药大学(含附属医院)等机构的发文数量较多。根据高频关键词可知研究热点主要集中于证型(气虚血瘀等)、治法(益气活血、活血利水、益气温阳等)、疗效评价标准(心功能、生活质量、脑钠肽等)、合并疾病(冠心病等)。关键词突变、时间线图综合分析显示,益气活血类方治疗心力衰竭的治疗方式、评价标准都呈现多元化趋势。文献横向分析提示,目前临床报告规范仍存在较大的提升空间,疗效评价指标描述存在偏于主观等问题。结论益气活血类方治疗心力衰竭的相关临床研究领域,不同研究机构、团队间的合作仍需进一步加强,以便开展多中心大样本的高质量研究;心力衰竭的证型、治法、疗效评价标准以及合并疾病是目前的研究热点,但在临床报告规范方面仍有待完善,建议制定客观、科学的诊疗标准及报告规范,进一步探索中医或中西医结合治疗心力衰竭的临床优势。

Clinical Study on Effect of Chinese Herbal Medicine for Supplementing Kidney and Qi and Activating Blood Circulation in Treating Intrauterine Growth Retardation of Fetus

Objective: To explore the therapeutic effect and the possible working mechanism in using Chinese herbal medicine (CHM) for supplementing Kidney and Qi, and activating blood circulation in treating intrauterine growth retardation of fetus (IUGR). Methods: Fifty-five cases of IUGR were divided into two groups, 30 cases in the CHM group treated with CHM and the 25 in the control group treated with amino acids. The effect of CHM treatment was observed and compared with that of the control group, normal pregnancy group and non-treated IUGR group. Results: Body weight of the newborns in the CHM was markedly higher than that in the control group. Not only the maternal fundal height (FH) and the abdominal circumference (AC), but also the fetal growth parameters, including biparietal diameter, head circumference (HC), and femur length (FL) in the CHM group increased much faster than those in the control group. After CHM treatment, the maternal serum levels of estriol (E3) and human placental lactogen (hPL) approached to those in the normal pregnancy group, but the control group,in comparison with the normal pregnancy group, was significantly different. The umbilical venous plasma concentration of essential amino acids in both treated groups improved, but the improvement in the CHM group was more significant than that in the control group. No apparent adverse effect of CHM was observed in either mother or fetus.Conclusion: CHM for supplementing Kidney and Qi and activating blood circulation was more effective in improving placental function and enhancing amino acid transportation than amino acid

基于“二阳结谓之消”探讨糖尿病性便秘病机及防治策略

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