Background： It has been shown that administration of statins reduced the risk of peri-procedural myocardial damage. However, it remains unclear whether Chinese medicine Danlou Tablet （~）~）, similar to statins, may...Background： It has been shown that administration of statins reduced the risk of peri-procedural myocardial damage. However, it remains unclear whether Chinese medicine Danlou Tablet （~）~）, similar to statins, may protect patients undergoing percutaneous coronary intervention （PCI） from peri-procedural myocardial damage. Objective： To demonstrate the hypothesis whether treatment with Danlou Tablet would improve clinical outcome in patients undergoing selective PCI with non-ST elevation acute coronary syndrome （NSTE-ACS） in China. Methods： Approximately 220 patients with unstable angina or non-ST-segment elevation myocardial infarction undergoing PCI will be enrolled and randomized to Danlou Tablet treatment （4.5 g/day for 2 days before intervention, with a further 4.5 g/day for 90 days thereafter） or placebo. All patients will not receive Danlou Tablet before procedure. The primary end point is to evaluate the incidence of cardiac death, myocardial infarction or unplanned re-hospitalization and revascularization after 30 days in patients undergoing selective PCI treated with Danlou Tablet compared with placebo. Secondary endpoints include the incidence of peri-procedural myocardial injury, 3-month clinical outcomes, the quality of life and Chinese medicine syndromes assessment. Conclusion： This study protocol will provide important evidence of Danlou Tablet treatment on the peri-procedural myocardial injury in patients with NSTE-ACS undergoing selective PCI, which may support a strategy of routine Danlou Tablet therapy to improve the clinical outcomes.展开更多
Objective To evaluate the effect of Danhong Injection(丹红注射液,DH)on the index of microcirculatory resistance(IMR)and myocardial injury in patients with unstable angina undergoing elective percutaneous coronary inte...Objective To evaluate the effect of Danhong Injection(丹红注射液,DH)on the index of microcirculatory resistance(IMR)and myocardial injury in patients with unstable angina undergoing elective percutaneous coronary intervention(PCI).Methods Seventy-eight patients with unstable angina were randomly divided into DH group(39 cases)and the control group(39 cases)during elective PCI.Randomization was performed using a random-number table.The DH group received DH at a dosage of 40 mL(mixed with 250 mL saline,covered by a light-proof bag,intravenous drip)during PCI and daily for 7 consecutive days,while the control group only received the same dosage of saline.Both groups received standardized treatment.The IMR and fractional flow reserve(FFR)were measured at maximal hyperemia before and after PCI.Myocardial markers,including myoglobin,creatine kinase(CK),creatine kinase MB(CK-MB),and coronary troponin T(cTnT)values were measured at baseline and 24 h after PCI.Results Among the 78 patients enrolled,the baseline and procedural characteristics were similar between the two groups.There was no significant difference in pre-PCI myocardial markers and coronary physiological indexes between the two groups.However,post-PCI CK and CK-MB levels in the DH group were significantly lower than those in the control group(111.97±80.97 vs.165.47±102.99,P=0.013;13.08±6.90 vs.19.75±15.49,P=0.016).Post-PCI myoglobin and cTNT-positive tend to be lower in the DH group than in the control group but did not reach statistical significance(88.07±52.36 vs.108.13±90.94,P=0.52;2.56%vs.7.69%,P=0.065).Compared with the control group,the post-IMR levels of the DH group tended to decrease,but there was no statistical difference(20.73±13.15 vs.26.37±12.31,P=0.05).There were no statistical differences in post-FFR in both groups.The peri-procedural myocardial injury of the DH group was significantly lower than that of the control group(2.56%vs.15.38%,P=0.025).During the 30-d follow-up period,no major adverse cardiovascular events occurred in ei展开更多
基金Supported by the National Natural Science Foundation of China(No.81202782)a grant from the Department of Science and Technology and the Academy of Traditional Chinese Medicine of Guangdong Province,China(No.2012A032500013)
文摘Background： It has been shown that administration of statins reduced the risk of peri-procedural myocardial damage. However, it remains unclear whether Chinese medicine Danlou Tablet （~）~）, similar to statins, may protect patients undergoing percutaneous coronary intervention （PCI） from peri-procedural myocardial damage. Objective： To demonstrate the hypothesis whether treatment with Danlou Tablet would improve clinical outcome in patients undergoing selective PCI with non-ST elevation acute coronary syndrome （NSTE-ACS） in China. Methods： Approximately 220 patients with unstable angina or non-ST-segment elevation myocardial infarction undergoing PCI will be enrolled and randomized to Danlou Tablet treatment （4.5 g/day for 2 days before intervention, with a further 4.5 g/day for 90 days thereafter） or placebo. All patients will not receive Danlou Tablet before procedure. The primary end point is to evaluate the incidence of cardiac death, myocardial infarction or unplanned re-hospitalization and revascularization after 30 days in patients undergoing selective PCI treated with Danlou Tablet compared with placebo. Secondary endpoints include the incidence of peri-procedural myocardial injury, 3-month clinical outcomes, the quality of life and Chinese medicine syndromes assessment. Conclusion： This study protocol will provide important evidence of Danlou Tablet treatment on the peri-procedural myocardial injury in patients with NSTE-ACS undergoing selective PCI, which may support a strategy of routine Danlou Tablet therapy to improve the clinical outcomes.
基金Supported by Key Medical Professional Development Plan of the Beijing Municipal Hospital Administration(No.ZYLX201817)Capital Health Development Research Project(No.2014-2-4032)。
文摘Objective To evaluate the effect of Danhong Injection(丹红注射液,DH)on the index of microcirculatory resistance(IMR)and myocardial injury in patients with unstable angina undergoing elective percutaneous coronary intervention(PCI).Methods Seventy-eight patients with unstable angina were randomly divided into DH group(39 cases)and the control group(39 cases)during elective PCI.Randomization was performed using a random-number table.The DH group received DH at a dosage of 40 mL(mixed with 250 mL saline,covered by a light-proof bag,intravenous drip)during PCI and daily for 7 consecutive days,while the control group only received the same dosage of saline.Both groups received standardized treatment.The IMR and fractional flow reserve(FFR)were measured at maximal hyperemia before and after PCI.Myocardial markers,including myoglobin,creatine kinase(CK),creatine kinase MB(CK-MB),and coronary troponin T(cTnT)values were measured at baseline and 24 h after PCI.Results Among the 78 patients enrolled,the baseline and procedural characteristics were similar between the two groups.There was no significant difference in pre-PCI myocardial markers and coronary physiological indexes between the two groups.However,post-PCI CK and CK-MB levels in the DH group were significantly lower than those in the control group(111.97±80.97 vs.165.47±102.99,P=0.013;13.08±6.90 vs.19.75±15.49,P=0.016).Post-PCI myoglobin and cTNT-positive tend to be lower in the DH group than in the control group but did not reach statistical significance(88.07±52.36 vs.108.13±90.94,P=0.52;2.56%vs.7.69%,P=0.065).Compared with the control group,the post-IMR levels of the DH group tended to decrease,but there was no statistical difference(20.73±13.15 vs.26.37±12.31,P=0.05).There were no statistical differences in post-FFR in both groups.The peri-procedural myocardial injury of the DH group was significantly lower than that of the control group(2.56%vs.15.38%,P=0.025).During the 30-d follow-up period,no major adverse cardiovascular events occurred in ei
