Objective： To evaluate the efficacy and safety of a combination therapy using Chinese medicine （CM） Shenzhu Guanxin Recipe （参术冠心方, SGR） and standard Western medicine treatment （SWMT） in patients with angin...Objective： To evaluate the efficacy and safety of a combination therapy using Chinese medicine （CM） Shenzhu Guanxin Recipe （参术冠心方, SGR） and standard Western medicine treatment （SWMT） in patients with angina pectoris after percutaneous coronary intervention （PCI）. Methods： Double-blind randomized controlled trial was used in this experimental procedure. One hundred and eighty-seven patients with coronary heart disease receiving SWMT after PCI were randomly assigned to the treatment （SGR） and control （placebo） groups. Outcome measures including angina pectoris score （APS）, CM symptom score, and Seattle Angina Questionnaire （SAQ） score were evaluated in 1, 2, 3 and 12 months, and the death rate, restenosis and other emergency treatments were observed. The mixed-effects models were employed for the data analysis. Results： In the treatment group, a larger within-treatment effect size （d=1.74） was found, with a 76.7% reduction in APS from pretreatment to 12-month follow-up assessment compared with the control group （d=0.83, 53.8% symptom reduction）; between- treatment （BT） effect size was d=0.66. CM symptom scores included an 18.3% reduction in the treatment group （d=0.46）, and a 16.1% decrease in the control group （d=0.31）; d=0.62 for BT effect size. In regard to scores of SAQ, the BT effect size of cognition level of disease was larger in the treatment group （d=0.63）, followed by the level of body limitation of activity （d=0.62）, condition of angina pectoris attacks （d=0.55）, satisfaction level of treatments （d=0.31）, and steady state of angina pectoris （d=0.30）. Two cardiovascular related deaths and one incidental death were recorded in the control and treatment groups, respectively. No significant difference in any cardiovascular event （including death toll, frequency of cardiovascular hospitalization or emergency room visits） was found between the two groups. Conclusion： The combination therapy of SGR and SWMT is effective and safe in patients with angina pectoris after PCI when compared with SWMT alone.展开更多
Background: Many patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granu...Background: Many patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules(参术冠心方颗粒, SGR), a Chinese herbal compound, exerted potential impacts on increased treadmill exercise performance and angina relieve. However, there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES(ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration, electrocardiographic(ECG) evidence of myocardial ischemia, and incidence of major adverse cardiac events(MACE) in stable anginal patients. Methods: A total of 184 eligible patients with stable angina will be randomly assigned to receive placebo or SGR(10 g/day for 12 weeks) in a 1:1 ratio. The primary outcome will be the change from baseline in total exercise tolerance duration, time to onset of angina and ECG ischemia during exercise treadmill testing performed over a 12-week study period. The secondary outcome will include ECG measures, the occurrence and composite of MACE and the Seattle Angina Questionnaire score. Moreover, the coronary microcirculation will be evaluated to explore the possible effects in response to treatment of SGR. After the procedure, all participants will be followed up by interview at 3 and 6 months, enquiring about any cardiac events, hospitalizations, cardiac functional level and medication usage. Additionally, the occurrence of adverse events will be evaluated at each follow-up. Discussion: This study may provide novel evidence on the efficacy of SGR in improving exercise tolerance and potentially reducing clinical adverse events.展开更多
OBJECTIVE: To observe the therapeutic effect of Shenzhu Tiaopi granule(参术调脾颗粒, STG) on insulin resistance(IR) in the liver of diabetic Goto-Kakizaki(GK) rat and investigate underlying mechanisms.METHODS: Ten 12-...OBJECTIVE: To observe the therapeutic effect of Shenzhu Tiaopi granule(参术调脾颗粒, STG) on insulin resistance(IR) in the liver of diabetic Goto-Kakizaki(GK) rat and investigate underlying mechanisms.METHODS: Ten 12-week-old male Wistar rats were assigned as normal control(NC) group, while 4012-week-old male specific-pathogen-free GK rats were randomly divided into four experimental groups, 10 diabetic rats each. Animals were fed with a normal diet. Fasting blood glucose(FBG), water intake, and body weight were recorded during6 weeks of daily single-dose treatment: STG low-dose group, 4.5 g/kg(STG-L);STG high-dose group,9 g/kg(STG-H);metformin group, 0.1 g/kg(MET);model control(MC) and NC groups, equal volume of 0.9% Na Cl solution. The serum fasting insulin(FINS), C-Peptide and IR index(HOMA-IR) were detected every 2 weeks during treatment and glucose tolerance was measured in the 3 rd day before the material was taken. After the 6-week STG treatment, Liver tissues were processed for hematoxylin-eosin staining to perform light microscopy analysis and for assessing expression and distribution of insulin receptor substrates(IRS-1) and glucose transporter(GLUT-4) by immunohistochemistry analysis. Expression levels of liver kinase B1(LKB1)/adenosine 5’-monophosphate-activated protein kinase(AMPK)/mammalian target of rapamycin(mTOR) pathway proteins, including LKB1, phospho-AMPK(p-AMPK)/AMPK, phospho-mTOR(p-mTOR)/mTOR, and ribosomal protein S6 kinase polypeptide 1(S6 K1),were detected by Western blotting.RESULTS: STG significantly reduced the FBG level and liver fat deposition in diabetic GK rats. After STG treatment completion, FINS, HOMA-IR, C-Peptide and area under blood glucose curve(AUC)were lower in STG groups than in the MC group, indicating that IR was reduced and liver fat lesions were resolved. In liver tissues, STG groups displayed significantly higher IRS-1 and GLUT-4 expression than the MC group, along with increased LKB1 and p-AMPK/AMPK expression and decreased p-mTOR/mTOR and phospho-S6 K1 expression, suggesting that STG stimulated LKB1 activation of AMPK and suppressed themTOR/S6 K1 downstream pathway.CONCLUSION: Growing GK rats developed hepatic IR, but STG treatment significantly improved hyperglycemia and IR and resolved hepatic fatty lesions.Interestingly, STG treatment stimulated the expression of IRS-1 and GLUT-4 in the liver of diabetic GK rats, indicating a potential involvement in the regulation of the LKB1/AMPK/mTOR signaling pathway.展开更多
基金Supported by the National Key Technology Research and Development Program of the Ministry of Science and Technology of China(No.2001BAI10B02)Science and Technology Planning Project of Guangdong Province,China(No.2012A032500017)
文摘Objective： To evaluate the efficacy and safety of a combination therapy using Chinese medicine （CM） Shenzhu Guanxin Recipe （参术冠心方, SGR） and standard Western medicine treatment （SWMT） in patients with angina pectoris after percutaneous coronary intervention （PCI）. Methods： Double-blind randomized controlled trial was used in this experimental procedure. One hundred and eighty-seven patients with coronary heart disease receiving SWMT after PCI were randomly assigned to the treatment （SGR） and control （placebo） groups. Outcome measures including angina pectoris score （APS）, CM symptom score, and Seattle Angina Questionnaire （SAQ） score were evaluated in 1, 2, 3 and 12 months, and the death rate, restenosis and other emergency treatments were observed. The mixed-effects models were employed for the data analysis. Results： In the treatment group, a larger within-treatment effect size （d=1.74） was found, with a 76.7% reduction in APS from pretreatment to 12-month follow-up assessment compared with the control group （d=0.83, 53.8% symptom reduction）; between- treatment （BT） effect size was d=0.66. CM symptom scores included an 18.3% reduction in the treatment group （d=0.46）, and a 16.1% decrease in the control group （d=0.31）; d=0.62 for BT effect size. In regard to scores of SAQ, the BT effect size of cognition level of disease was larger in the treatment group （d=0.63）, followed by the level of body limitation of activity （d=0.62）, condition of angina pectoris attacks （d=0.55）, satisfaction level of treatments （d=0.31）, and steady state of angina pectoris （d=0.30）. Two cardiovascular related deaths and one incidental death were recorded in the control and treatment groups, respectively. No significant difference in any cardiovascular event （including death toll, frequency of cardiovascular hospitalization or emergency room visits） was found between the two groups. Conclusion： The combination therapy of SGR and SWMT is effective and safe in patients with angina pectoris after PCI when compared with SWMT alone.
基金Supported by Foundation from Department of Science and Technology of Guangdong Province(No.2012A032500017)Foundation from Guangdong Provincial Academy of Traditional Chinese Medicine(No.YN2014LN07,YK2013B1N10,A2016192)+1 种基金Science Foundation of Guangdong Province(No.2015A030310437,2015A030306049)National Natural Science Foundation(No.81403341,81703877)
文摘Background: Many patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules(参术冠心方颗粒, SGR), a Chinese herbal compound, exerted potential impacts on increased treadmill exercise performance and angina relieve. However, there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES(ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration, electrocardiographic(ECG) evidence of myocardial ischemia, and incidence of major adverse cardiac events(MACE) in stable anginal patients. Methods: A total of 184 eligible patients with stable angina will be randomly assigned to receive placebo or SGR(10 g/day for 12 weeks) in a 1:1 ratio. The primary outcome will be the change from baseline in total exercise tolerance duration, time to onset of angina and ECG ischemia during exercise treadmill testing performed over a 12-week study period. The secondary outcome will include ECG measures, the occurrence and composite of MACE and the Seattle Angina Questionnaire score. Moreover, the coronary microcirculation will be evaluated to explore the possible effects in response to treatment of SGR. After the procedure, all participants will be followed up by interview at 3 and 6 months, enquiring about any cardiac events, hospitalizations, cardiac functional level and medication usage. Additionally, the occurrence of adverse events will be evaluated at each follow-up. Discussion: This study may provide novel evidence on the efficacy of SGR in improving exercise tolerance and potentially reducing clinical adverse events.
基金Supported by National Natural Science Foundation of China: Study on the Clinical Comparison of Basic and Clinical Based on Chip Technology for the Precision Treatment of Diabetic Large Vascular Disease with Danzhi Jiangtang Capsule (No. 81774286)。
文摘OBJECTIVE: To observe the therapeutic effect of Shenzhu Tiaopi granule(参术调脾颗粒, STG) on insulin resistance(IR) in the liver of diabetic Goto-Kakizaki(GK) rat and investigate underlying mechanisms.METHODS: Ten 12-week-old male Wistar rats were assigned as normal control(NC) group, while 4012-week-old male specific-pathogen-free GK rats were randomly divided into four experimental groups, 10 diabetic rats each. Animals were fed with a normal diet. Fasting blood glucose(FBG), water intake, and body weight were recorded during6 weeks of daily single-dose treatment: STG low-dose group, 4.5 g/kg(STG-L);STG high-dose group,9 g/kg(STG-H);metformin group, 0.1 g/kg(MET);model control(MC) and NC groups, equal volume of 0.9% Na Cl solution. The serum fasting insulin(FINS), C-Peptide and IR index(HOMA-IR) were detected every 2 weeks during treatment and glucose tolerance was measured in the 3 rd day before the material was taken. After the 6-week STG treatment, Liver tissues were processed for hematoxylin-eosin staining to perform light microscopy analysis and for assessing expression and distribution of insulin receptor substrates(IRS-1) and glucose transporter(GLUT-4) by immunohistochemistry analysis. Expression levels of liver kinase B1(LKB1)/adenosine 5’-monophosphate-activated protein kinase(AMPK)/mammalian target of rapamycin(mTOR) pathway proteins, including LKB1, phospho-AMPK(p-AMPK)/AMPK, phospho-mTOR(p-mTOR)/mTOR, and ribosomal protein S6 kinase polypeptide 1(S6 K1),were detected by Western blotting.RESULTS: STG significantly reduced the FBG level and liver fat deposition in diabetic GK rats. After STG treatment completion, FINS, HOMA-IR, C-Peptide and area under blood glucose curve(AUC)were lower in STG groups than in the MC group, indicating that IR was reduced and liver fat lesions were resolved. In liver tissues, STG groups displayed significantly higher IRS-1 and GLUT-4 expression than the MC group, along with increased LKB1 and p-AMPK/AMPK expression and decreased p-mTOR/mTOR and phospho-S6 K1 expression, suggesting that STG stimulated LKB1 activation of AMPK and suppressed themTOR/S6 K1 downstream pathway.CONCLUSION: Growing GK rats developed hepatic IR, but STG treatment significantly improved hyperglycemia and IR and resolved hepatic fatty lesions.Interestingly, STG treatment stimulated the expression of IRS-1 and GLUT-4 in the liver of diabetic GK rats, indicating a potential involvement in the regulation of the LKB1/AMPK/mTOR signaling pathway.
