Objective:To systemically evaluate clinical efficacy and safety of traditional Chinese medicine(TCM)combined with ivabradine(IVA)in the treatment of chronic heart failure(CHF).Method:We searched China National Knowled...Objective:To systemically evaluate clinical efficacy and safety of traditional Chinese medicine(TCM)combined with ivabradine(IVA)in the treatment of chronic heart failure(CHF).Method:We searched China National Knowledge Infrastructure(CNKI)datebase,Wanfang datebase,Chinese Scientifific Journal Database(VIP)datebase,PubMed,Conchrane Library and EMbase database to enroll the random control trials(RCTs)of TCM combined with IVA treating CHF.Meta-analysis was performed by Review Manager 5.3 software.Results:A total of 10 RCTs involving 960 patients were included.The results of Meta-analysis showed that compared with control group,the experimental group could improve the efficiency of cardiac function improvement[RR=1.19,95%CI(1.12,1.27),P<0.00001],increase left ventricular ejection fraction[MD=4.36,95%CI(2.88,5.83),P<0.0001]and reduce heart rate[MD=-8.21,95%CI(-12.08,-4.34),P<0.00001],the incidence of adverse reactions was similar between two groups[RR=1.00,95%CI(0.62,1.61),P=1.00].Conclusion:Traditional Chinese medicine combined with ivabradine has significant efficacy and good safety in improving cardiac function,improving left ventricular ejection fraction and reducing heart rate in the treatment of chronic heart failure.展开更多
Objectives:To evaluate the effectiveness and safety of Qishen Yiqi Dripping Pill(QSYQ)in patients with acute coronary syndrome(ACS)after percutaneous coronary intervention(PCI).Methods:This multicentre prospective coh...Objectives:To evaluate the effectiveness and safety of Qishen Yiqi Dripping Pill(QSYQ)in patients with acute coronary syndrome(ACS)after percutaneous coronary intervention(PCI).Methods:This multicentre prospective cohort study was conducted at 40 centers in China.Patients with ACS after PCI entered either the QSYQ or Western medicine(WM)groups naturally based on whether they had received QSYQ before enrollment.QSYQ group received QSYQ(0.52 g,3 times a day for 12 months)in addition to WM.The primary endpoint included cardiac death,non-fatal myocardial infarction,and urgent revascularization.The secondary endpoint included rehospitalization due to ACS,heart failure,stroke,and other thrombotic events.Quality of life was assessed by the Seattle Angina Questionnaire(SAQ).Results:A total of 936 patients completed follow-up of the primary endpoint from February 2012 to December 2018.Overall,487 patients received QSYQ and WM.During a median follow-up of 566 days(inter quartile range,IQR,517–602),the primary endpoint occurred in 46(9.45%)and 65(14.48%)patients in QSYQ and WM groups respectively[adjusted hazard ratio(HR)0.60,95%confidence interval(CI)0.41–0.90;P=0.013].The secondary endpoint occurred in 61(12.53%)and 74(16.48%)patients in QSYQ and WM groups,respectively(adjusted HR 0.76,95%CI 0.53–1.09;P=0.136).In sensitivity analysis,the results still demonstrated that WM combined with QSYQ reduced the risk of the primary endpoint(HR 0.67,95%CI 0.46–0.98;P=0.039).Moreover,QSYQ improved the disease perception domain of the SAQ(P<0.05).Conclusions:In patients with ACS after PCI,QSYQ combined with WM reduced the incidence of the primary endpoint.These findings provide a promising option for managing ACS after PCI and suggest the potential treatment for reducing the risk of primary endpoint included cardiac death,non-fatal myocardial infarction,and urgent revascularization through intermittent administration of QSYQ.(Registration No.Chi CTR-OOC-14005552).展开更多
自20世纪末提出真实世界研究(real-world study,RWS)的概念至今,这一基于临床实际的研究方法近年来愈发受到关注。美国食品和药物管理局(Food and Drug Administration,FDA)在2016—2019年颁布的一系列文件,肯定了真实世界证据(real wor...自20世纪末提出真实世界研究(real-world study,RWS)的概念至今,这一基于临床实际的研究方法近年来愈发受到关注。美国食品和药物管理局(Food and Drug Administration,FDA)在2016—2019年颁布的一系列文件,肯定了真实世界证据(real world evidence,RWE)在医药和生物制品审批和监管中的作用,推动RWS成为临床研究的热点。展开更多
Objective: To examine the prognostic value of serum levels of asymmetric dimethylarginine(ADMA)in patients with stable coronary heart disease(CHD) thus explore a potential biomarker of "toxin syndrome" in CH...Objective: To examine the prognostic value of serum levels of asymmetric dimethylarginine(ADMA)in patients with stable coronary heart disease(CHD) thus explore a potential biomarker of "toxin syndrome" in CHD.Methods: In this prospective nested case-control study, 36 of 1,503 Chinese patients with stable CHD experienced at least 1 recurrent cardiovascular event(RCE) during 1-year fol ow-up. Serum levels of ADMA at the start of fol ow-up were compared between these 36 cases and 36 controls which matched to cases in terms of gender, age, history of hypertension, and myocardial infarction. Results: Based on the crude model, subjects in the 2 highest ADMA quartiles showed signi?cantly higher risk of developing RCE than those in the lowest ADMA quartile [odds ratio(OR) 4.09, 95%confidence interval(CI) 1.01 to 16.58; OR 6.76, 95% CI 1.57 to 29.07]. This association was also observed in the case-mix model(OR 5.51, 95% CI 1.23 to 24.61; OR 7.83, 95% CI 1.68 to 36.41) and multivariable model(OR 6.64,95% CI 1.40 to 31.49; OR 13.14, 95% CI 2.28 to 75.71) after adjusting for confounders. The multivariable model which combined ADMA and high-sensitivity C-reactive protein(hs CRP) showed better predictive power with areas under the receiver operator characteristic curves(0.779) than the model of either ADMA(0.694) or hs CRP(0.636). Conclusion:Serum ADMA level may be a potential biomarker of "toxin syndrome" in CHD which shows favorable prognostic value in predicting 1-year RCE in patients with stable CHD. [The registration number is Chi CTR-PRNRC-07000012]展开更多
Objective: To evaluate the effectiveness of integrative medicine(IM) on patients with coronary artery disease(CAD) and investigate the prognostic factors of CAD in a real-world setting. Methods: A total of 1,087 hospi...Objective: To evaluate the effectiveness of integrative medicine(IM) on patients with coronary artery disease(CAD) and investigate the prognostic factors of CAD in a real-world setting. Methods: A total of 1,087 hospitalized patients with CAD from four hospitals in Beijing, China were consecutively selected between August 2011 and February 2012. The patients were assigned to two groups based on the treatment: Chinese medicine(CM) plus conventional treatment, i.e., IM therapy(IM group); or conventional treatment alone(CT group). The endpoint was major adverse cardiac events [MACE; including cardiac death, myocardial infarction(MI), and revascularization]. Results: A total of 1,040 patients finished the 2-year follow-up. Of them, 49.4%(514/1,040) received IM therapy. During the 2-year follow-up, the total incidence of MACE was 11.3%. Most of the events involved revascularization(9.3%). Cardiac death/MI occurred in 3.0% of cases. For revascularization, logistic stepwise regression analysis revealed that age 65 years [odds ratio(OR), 2.224], MI(OR, 2.561), diabetes mellitus(OR, 1.650), multi-vessel lesions(OR, 2.554), baseline high sensitivity C-reactive protein level 3 mg/L(OR, 1.678), and moderate or severe anxiety/depression(OR, 1.849) were negative predictors(P<0.05); while anti-platelet agents(OR, 0.422), β-blockers(OR, 0.626), statins(OR, 0.318), and IM therapy(OR, 0.583) were protective predictors(P<0.05). For cardiac death/MI, age 65 years(OR, 6.389) and heart failure(OR, 7.969) were negative predictors(P<0.05), while statin use(OR, 0.323) was a protective predictor(P<0.05) and IM therapy showed a beneficial tendency(OR, 0.587), although the difference was not statistically significant(P=0.218). Conclusion: In a real-world setting, for patients with CAD, IM therapy was associated with a decreased incidence of revascularization and showed a potential benefit in reducing the incidence of cardiac death or MI.展开更多
Objective： To evaluate the prognosis effect of Chinese herbal medicines（CHMs） for benefiting qi and activating blood circulation adjunctive to conventional treatment in patients with acute coronary syndrome（ACS） ...Objective： To evaluate the prognosis effect of Chinese herbal medicines（CHMs） for benefiting qi and activating blood circulation adjunctive to conventional treatment in patients with acute coronary syndrome（ACS） after percutaneous coronary intervention（PCI）. Methods： A total of 702 patients with ACS who underwent PCI were enrolled and randomly assigned to receive conventional treatment plus CHMs for benefiting qi and activating blood circulation（treatment group, 351 cases） or conventional treatment alone（control group, 351 cases） for 6 months. Six months later, all patients received conventional treatment alone. Follow-ups were scheduled at 6th, 12 th, 18 th, 24 th month after enrollment in April 2008, and the final follow-up visit was during September 2011 and November 2011. The primary endpoint was the composite of cardiac death, nonfatal myocardial infarction or revascularization（PCI or coronary artery bypass grafting）; and the secondary endpoint was the composite of re-admission for ACS, congestive heart failure, nonfatal stroke or other thrombus events. Results： A total of 621（88.59%） patients completed 35.4±3.8 months follow-up, while 80（11.41%） patients withdrew from the trial（41 in the treatment group and 39 in the control group）. The incidence of primary endpoint was 5.7%（20 patients） in the treatment group versus 10.86%（38 patients） in the control group [relative risk（RR）： 0.53; 95% confidence interval（CI）： 0.30, 0.88; P=0.013; absolute risk reduction（ARR）： –0.052, 95% CI： –0.06, 0.01]. The incidence of secondary endpoint was 5.98%（21 patients） in the treatment group versus 10.28%（36 patients） in control group（RR： 0.58, 95% CI： 0.33, 0.97, P=0.037; ARR： –0.043, 95% CI： 0.06, 0.01）. Most of the primary and secondary endpoints were occurred in 18 months（84.50% in the treatment group versus 78.10% in the control group）. Conclusion： CHMs for benefiting qi and activating blood circulation adjunctive to conventional treatment improved clinical outcomes for patients with ACS after PCI in long-term follow-up.展开更多
基金National 12th Five-Year Science and Technology Support Plan(No.2013BAI02B01)National Key Science and Technology Project of"Major New Drug Creation"(No.2019ZX09201005-002-006)+1 种基金Beijing TCM Science and Technology Development Fund Project(No.JJ-2020-79)Science and Technology Innovation Project of China Academy of Chinese Medical Sciences(No.CI2021A00920)。
文摘Objective:To systemically evaluate clinical efficacy and safety of traditional Chinese medicine(TCM)combined with ivabradine(IVA)in the treatment of chronic heart failure(CHF).Method:We searched China National Knowledge Infrastructure(CNKI)datebase,Wanfang datebase,Chinese Scientifific Journal Database(VIP)datebase,PubMed,Conchrane Library and EMbase database to enroll the random control trials(RCTs)of TCM combined with IVA treating CHF.Meta-analysis was performed by Review Manager 5.3 software.Results:A total of 10 RCTs involving 960 patients were included.The results of Meta-analysis showed that compared with control group,the experimental group could improve the efficiency of cardiac function improvement[RR=1.19,95%CI(1.12,1.27),P<0.00001],increase left ventricular ejection fraction[MD=4.36,95%CI(2.88,5.83),P<0.0001]and reduce heart rate[MD=-8.21,95%CI(-12.08,-4.34),P<0.00001],the incidence of adverse reactions was similar between two groups[RR=1.00,95%CI(0.62,1.61),P=1.00].Conclusion:Traditional Chinese medicine combined with ivabradine has significant efficacy and good safety in improving cardiac function,improving left ventricular ejection fraction and reducing heart rate in the treatment of chronic heart failure.
基金Supported by the Traditional Chinese Medicine Public Welfare Scientific Research Project,State Administration of Traditional Chinese Medicine of the People's Republic of China(No.201007001)Fundamental Research Funds for the Central Public Welfare Research Institutes(No.ZZ13-YQ-005 and No.ZZ13-YQ-005-C1)。
文摘Objectives:To evaluate the effectiveness and safety of Qishen Yiqi Dripping Pill(QSYQ)in patients with acute coronary syndrome(ACS)after percutaneous coronary intervention(PCI).Methods:This multicentre prospective cohort study was conducted at 40 centers in China.Patients with ACS after PCI entered either the QSYQ or Western medicine(WM)groups naturally based on whether they had received QSYQ before enrollment.QSYQ group received QSYQ(0.52 g,3 times a day for 12 months)in addition to WM.The primary endpoint included cardiac death,non-fatal myocardial infarction,and urgent revascularization.The secondary endpoint included rehospitalization due to ACS,heart failure,stroke,and other thrombotic events.Quality of life was assessed by the Seattle Angina Questionnaire(SAQ).Results:A total of 936 patients completed follow-up of the primary endpoint from February 2012 to December 2018.Overall,487 patients received QSYQ and WM.During a median follow-up of 566 days(inter quartile range,IQR,517–602),the primary endpoint occurred in 46(9.45%)and 65(14.48%)patients in QSYQ and WM groups respectively[adjusted hazard ratio(HR)0.60,95%confidence interval(CI)0.41–0.90;P=0.013].The secondary endpoint occurred in 61(12.53%)and 74(16.48%)patients in QSYQ and WM groups,respectively(adjusted HR 0.76,95%CI 0.53–1.09;P=0.136).In sensitivity analysis,the results still demonstrated that WM combined with QSYQ reduced the risk of the primary endpoint(HR 0.67,95%CI 0.46–0.98;P=0.039).Moreover,QSYQ improved the disease perception domain of the SAQ(P<0.05).Conclusions:In patients with ACS after PCI,QSYQ combined with WM reduced the incidence of the primary endpoint.These findings provide a promising option for managing ACS after PCI and suggest the potential treatment for reducing the risk of primary endpoint included cardiac death,non-fatal myocardial infarction,and urgent revascularization through intermittent administration of QSYQ.(Registration No.Chi CTR-OOC-14005552).
文摘自20世纪末提出真实世界研究(real-world study,RWS)的概念至今,这一基于临床实际的研究方法近年来愈发受到关注。美国食品和药物管理局(Food and Drug Administration,FDA)在2016—2019年颁布的一系列文件,肯定了真实世界证据(real world evidence,RWE)在医药和生物制品审批和监管中的作用,推动RWS成为临床研究的热点。
基金Supported by Chinese National Program of Key Basic Research(No.2006CB504803)Beijing Committee of Science and Technology(No.D08050703020801)the 12th Five-Year Plan of China(No.2013BAI02B01)
文摘Objective: To examine the prognostic value of serum levels of asymmetric dimethylarginine(ADMA)in patients with stable coronary heart disease(CHD) thus explore a potential biomarker of "toxin syndrome" in CHD.Methods: In this prospective nested case-control study, 36 of 1,503 Chinese patients with stable CHD experienced at least 1 recurrent cardiovascular event(RCE) during 1-year fol ow-up. Serum levels of ADMA at the start of fol ow-up were compared between these 36 cases and 36 controls which matched to cases in terms of gender, age, history of hypertension, and myocardial infarction. Results: Based on the crude model, subjects in the 2 highest ADMA quartiles showed signi?cantly higher risk of developing RCE than those in the lowest ADMA quartile [odds ratio(OR) 4.09, 95%confidence interval(CI) 1.01 to 16.58; OR 6.76, 95% CI 1.57 to 29.07]. This association was also observed in the case-mix model(OR 5.51, 95% CI 1.23 to 24.61; OR 7.83, 95% CI 1.68 to 36.41) and multivariable model(OR 6.64,95% CI 1.40 to 31.49; OR 13.14, 95% CI 2.28 to 75.71) after adjusting for confounders. The multivariable model which combined ADMA and high-sensitivity C-reactive protein(hs CRP) showed better predictive power with areas under the receiver operator characteristic curves(0.779) than the model of either ADMA(0.694) or hs CRP(0.636). Conclusion:Serum ADMA level may be a potential biomarker of "toxin syndrome" in CHD which shows favorable prognostic value in predicting 1-year RCE in patients with stable CHD. [The registration number is Chi CTR-PRNRC-07000012]
基金Supported by the Capital Foundation of Medical Developments Project(No.SF-2009-I-09)Beijing Traditional Chinese Medicine Science and Technology Project(No.JJ2014-22)Beijing Natural Science Foundation Project(No.7152047),China
文摘Objective: To evaluate the effectiveness of integrative medicine(IM) on patients with coronary artery disease(CAD) and investigate the prognostic factors of CAD in a real-world setting. Methods: A total of 1,087 hospitalized patients with CAD from four hospitals in Beijing, China were consecutively selected between August 2011 and February 2012. The patients were assigned to two groups based on the treatment: Chinese medicine(CM) plus conventional treatment, i.e., IM therapy(IM group); or conventional treatment alone(CT group). The endpoint was major adverse cardiac events [MACE; including cardiac death, myocardial infarction(MI), and revascularization]. Results: A total of 1,040 patients finished the 2-year follow-up. Of them, 49.4%(514/1,040) received IM therapy. During the 2-year follow-up, the total incidence of MACE was 11.3%. Most of the events involved revascularization(9.3%). Cardiac death/MI occurred in 3.0% of cases. For revascularization, logistic stepwise regression analysis revealed that age 65 years [odds ratio(OR), 2.224], MI(OR, 2.561), diabetes mellitus(OR, 1.650), multi-vessel lesions(OR, 2.554), baseline high sensitivity C-reactive protein level 3 mg/L(OR, 1.678), and moderate or severe anxiety/depression(OR, 1.849) were negative predictors(P<0.05); while anti-platelet agents(OR, 0.422), β-blockers(OR, 0.626), statins(OR, 0.318), and IM therapy(OR, 0.583) were protective predictors(P<0.05). For cardiac death/MI, age 65 years(OR, 6.389) and heart failure(OR, 7.969) were negative predictors(P<0.05), while statin use(OR, 0.323) was a protective predictor(P<0.05) and IM therapy showed a beneficial tendency(OR, 0.587), although the difference was not statistically significant(P=0.218). Conclusion: In a real-world setting, for patients with CAD, IM therapy was associated with a decreased incidence of revascularization and showed a potential benefit in reducing the incidence of cardiac death or MI.
基金Supported by the Eleventh Five-Year Plan for Science and Technology Research of China(No.2006BA104A01)National Program on Key Basic Research Project of China(No.2015CB554402)
文摘Objective： To evaluate the prognosis effect of Chinese herbal medicines（CHMs） for benefiting qi and activating blood circulation adjunctive to conventional treatment in patients with acute coronary syndrome（ACS） after percutaneous coronary intervention（PCI）. Methods： A total of 702 patients with ACS who underwent PCI were enrolled and randomly assigned to receive conventional treatment plus CHMs for benefiting qi and activating blood circulation（treatment group, 351 cases） or conventional treatment alone（control group, 351 cases） for 6 months. Six months later, all patients received conventional treatment alone. Follow-ups were scheduled at 6th, 12 th, 18 th, 24 th month after enrollment in April 2008, and the final follow-up visit was during September 2011 and November 2011. The primary endpoint was the composite of cardiac death, nonfatal myocardial infarction or revascularization（PCI or coronary artery bypass grafting）; and the secondary endpoint was the composite of re-admission for ACS, congestive heart failure, nonfatal stroke or other thrombus events. Results： A total of 621（88.59%） patients completed 35.4±3.8 months follow-up, while 80（11.41%） patients withdrew from the trial（41 in the treatment group and 39 in the control group）. The incidence of primary endpoint was 5.7%（20 patients） in the treatment group versus 10.86%（38 patients） in the control group [relative risk（RR）： 0.53; 95% confidence interval（CI）： 0.30, 0.88; P=0.013; absolute risk reduction（ARR）： –0.052, 95% CI： –0.06, 0.01]. The incidence of secondary endpoint was 5.98%（21 patients） in the treatment group versus 10.28%（36 patients） in control group（RR： 0.58, 95% CI： 0.33, 0.97, P=0.037; ARR： –0.043, 95% CI： 0.06, 0.01）. Most of the primary and secondary endpoints were occurred in 18 months（84.50% in the treatment group versus 78.10% in the control group）. Conclusion： CHMs for benefiting qi and activating blood circulation adjunctive to conventional treatment improved clinical outcomes for patients with ACS after PCI in long-term follow-up.
