Objective： To evaluate the effectiveness and safety of lyophilized Salvia salt of lithospermic acid powder for injection （SSLA） in treating coronary heart diseases angina pectoris （CHD-AP） of Xin-blood stasis syn...Objective： To evaluate the effectiveness and safety of lyophilized Salvia salt of lithospermic acid powder for injection （SSLA） in treating coronary heart diseases angina pectoris （CHD-AP） of Xin-blood stasis syndrome type, and to conduct the non-inferiority trial with Danshen injection （丹参注射液, DSI） as positive control. Methods： An non-inferiority clinical layered, segmented, randomized, and blinded trial on three parallel and multiple centered groups was conducted in 480 patients with stable effort angina grade Ⅰ , Ⅱand Ⅲ, who had two or more times of attack every week. The 240 patients in test group A were treated with SSLA 200 mg added in 250 ml of 5% glucose solution for intravenous dripping every day; the 120 patients in test group B were treated with SSLA but the dosage doubled; and the 120 patients in the control group were treated with DSI 20 ml daily in the same method as SSLA was given. The clinical effectiveness and safety were evaluated after the patients were treated for 14 days. Results： The results showed that the markedly effective rate in test groups A, B and control group was 37.45 %, 36.75 % and 30.09 % respectively, while the total effective rate in them was 88.09%, 89.74% and 67.26% respectively. Statistical significance was shown in comparisons of the therapeutic effect between control group with test group A and test group B, with that in the two test groups superior to that in the control group, and non-inferiority trial showed eligibility （P〈0.01）. Adverse reaction appeared in 8 patients in the test groups and 2 in the control group. Conclusion： SSLA has definite therapeutic effect in treating patients with CHD-AP, with its effect not inferior to that of DSI, and no evident toxic-adverse reaction.展开更多
OBJECTIVE To determine the effects of Danshen injectable powder on myocardial remodeling in pressure overload rats and isoproterenol(ISO) injection mice.METHODS SD Rats were subject to abdominal aortic constriction(AA...OBJECTIVE To determine the effects of Danshen injectable powder on myocardial remodeling in pressure overload rats and isoproterenol(ISO) injection mice.METHODS SD Rats were subject to abdominal aortic constriction(AAC) surgery to develop pressure overload.Therapeutic effect of Danshen injectable powder was assessed six weeks after AAC surgery.The lactic dehydrogenase(LDH) and creatine kinase(CK) levels in serum,biometric,echocardiographic parameters,interstitial fibrosis,the expression of DJ-1 and SOD2 were then measured.The myocardial impairment in mice was induced by ISO injection.LDH and CK in serum,biometric,interstitial fibrosis were measured to investigate the cardioprotective effect of Danshen injectable powder.Matrix-assisted laser desorption mass spectrometry imaging(MALDI-MSI) was used to detect the changes of 60-1000 Da molecules in mice heart tissue.RESULTS In AAC rats,we observed compensatory hypertrophy and perivascular fibrosis,however cardiac function had not progressed to deterioration.The levels of LDH and CK were decreased significantly in the Danshen injectable powder groups(P<0.05,P<0.05).Danshen injectable powder could alleviate the perivascular collagen deposits but not cardiac hypertrophy in AAC rats.Furthermore,Danshen injectable powder enhanced the expression levels of SOD2 and DJ-1 in cardio.myocytes(P<0.05,P<0.01).In ISO injection mice,the levels of HWI and LDH were decreased signifi.cantly in drug treatment group compared with model group(P<0.01,P<0.01).In the MALDI-MSI of mice heart section,Danshen injectable powder can improve the reduction of energy metabolism-related substances including adenosine,creatine and ADP induced by ISO impairment.CONCLUSION Danshen injectable powder can attenuate perivascular fibrosis and improve the expression of antioxidative stress-related proteins SOD2,DJ-1 in the rats with pressure overload-induced left ventricular remodeling.Danshen injectable powder has cardioprotective effect on ISO impairment in mice which is probably related to improvement of energy metabolism.展开更多
基金Supported by the Fund of National Project of High.technicResearch and Development,(No.2003AA223269)
文摘Objective： To evaluate the effectiveness and safety of lyophilized Salvia salt of lithospermic acid powder for injection （SSLA） in treating coronary heart diseases angina pectoris （CHD-AP） of Xin-blood stasis syndrome type, and to conduct the non-inferiority trial with Danshen injection （丹参注射液, DSI） as positive control. Methods： An non-inferiority clinical layered, segmented, randomized, and blinded trial on three parallel and multiple centered groups was conducted in 480 patients with stable effort angina grade Ⅰ , Ⅱand Ⅲ, who had two or more times of attack every week. The 240 patients in test group A were treated with SSLA 200 mg added in 250 ml of 5% glucose solution for intravenous dripping every day; the 120 patients in test group B were treated with SSLA but the dosage doubled; and the 120 patients in the control group were treated with DSI 20 ml daily in the same method as SSLA was given. The clinical effectiveness and safety were evaluated after the patients were treated for 14 days. Results： The results showed that the markedly effective rate in test groups A, B and control group was 37.45 %, 36.75 % and 30.09 % respectively, while the total effective rate in them was 88.09%, 89.74% and 67.26% respectively. Statistical significance was shown in comparisons of the therapeutic effect between control group with test group A and test group B, with that in the two test groups superior to that in the control group, and non-inferiority trial showed eligibility （P〈0.01）. Adverse reaction appeared in 8 patients in the test groups and 2 in the control group. Conclusion： SSLA has definite therapeutic effect in treating patients with CHD-AP, with its effect not inferior to that of DSI, and no evident toxic-adverse reaction.
文摘OBJECTIVE To determine the effects of Danshen injectable powder on myocardial remodeling in pressure overload rats and isoproterenol(ISO) injection mice.METHODS SD Rats were subject to abdominal aortic constriction(AAC) surgery to develop pressure overload.Therapeutic effect of Danshen injectable powder was assessed six weeks after AAC surgery.The lactic dehydrogenase(LDH) and creatine kinase(CK) levels in serum,biometric,echocardiographic parameters,interstitial fibrosis,the expression of DJ-1 and SOD2 were then measured.The myocardial impairment in mice was induced by ISO injection.LDH and CK in serum,biometric,interstitial fibrosis were measured to investigate the cardioprotective effect of Danshen injectable powder.Matrix-assisted laser desorption mass spectrometry imaging(MALDI-MSI) was used to detect the changes of 60-1000 Da molecules in mice heart tissue.RESULTS In AAC rats,we observed compensatory hypertrophy and perivascular fibrosis,however cardiac function had not progressed to deterioration.The levels of LDH and CK were decreased significantly in the Danshen injectable powder groups(P<0.05,P<0.05).Danshen injectable powder could alleviate the perivascular collagen deposits but not cardiac hypertrophy in AAC rats.Furthermore,Danshen injectable powder enhanced the expression levels of SOD2 and DJ-1 in cardio.myocytes(P<0.05,P<0.01).In ISO injection mice,the levels of HWI and LDH were decreased signifi.cantly in drug treatment group compared with model group(P<0.01,P<0.01).In the MALDI-MSI of mice heart section,Danshen injectable powder can improve the reduction of energy metabolism-related substances including adenosine,creatine and ADP induced by ISO impairment.CONCLUSION Danshen injectable powder can attenuate perivascular fibrosis and improve the expression of antioxidative stress-related proteins SOD2,DJ-1 in the rats with pressure overload-induced left ventricular remodeling.Danshen injectable powder has cardioprotective effect on ISO impairment in mice which is probably related to improvement of energy metabolism.
