OBJECTIVE:To investigate the efficacy and safety of Angong Jiangya pill(AGJY,安宫降压丸)in the treatment of grade 2 hypertension with liver-fire hyperactivity syndrome.METHODS:This multicenter,randomized,double-blind,...OBJECTIVE:To investigate the efficacy and safety of Angong Jiangya pill(AGJY,安宫降压丸)in the treatment of grade 2 hypertension with liver-fire hyperactivity syndrome.METHODS:This multicenter,randomized,double-blind,placebo-controlled trial was conducted in eight medical institutions.Eligible patients with grade 2 hypertension were randomly allocated to receive AGJY or a placebo for 12 weeks.The primary outcome was the change in blood pressure(BP).The secondary outcomes were BP compliance rate,Traditional Chinese Medicine(TCM)symptoms,and Duchenne Hypertension Quality of Life Scale score.RESULTS:Data were analyzed for 117 participants in the AGJY group and 118 participants in the placebo group.After 12 weeks of treatment,AGJY compared with placebo resulted in a higher and significant reduction in systolic/diastolic BP(-15.58±10.16/-9.72±7.41 vs-8.13±8.28/-4.86±5.68 mm Hg,P<0.0001,<0.0001,respectively).BP compliance rate(31.86%vs 19.13%,P=0.027)was significantly higher in the AGJY group than in the placebo group.The AGJY group showed a significant reduction in TCM symptom score compared with the placebo group(10.82±2.03 vs 7.83±1.24,P<0.0001).Single TCM syndrome clinical control rates of the primary symptoms(dizziness,headache,and irritability)were superior in the AGJY group(71.95%,94.62%,72.53%,respectively)compared with the placebo group(48.39%,68.00%,30.52%,respectively).Scores on the Duchenne Hypertension Quality of Life Scale showed a significant increase in the AGJY group compared with the placebo group(30.65±21.06 vs 9.96±10.72,P=0.000).No serious adverse events occurred.CONCLUSION:AGJY demonstrated efficacy in lowering BP,increasing the rate of BP compliance,and improving TCM symptoms and quality of life in patients with grade 2 hypertension liver-fire hyperactivity syndrome.However,further in-depth studies are required to determine the mechanism of TCM in treating hypertension.展开更多
目的:对养心氏片治疗经皮冠状动脉介入治疗术(PCI)后胸痛的有效性及安全性进行Meta分析,为其临床应用提供参考。方法:检索国家知识基础设施数据库(CNKI)、中国学术期刊数据库(CSPD)、中文科技期刊数据库(CCD)、China Biology Medicine d...目的:对养心氏片治疗经皮冠状动脉介入治疗术(PCI)后胸痛的有效性及安全性进行Meta分析,为其临床应用提供参考。方法:检索国家知识基础设施数据库(CNKI)、中国学术期刊数据库(CSPD)、中文科技期刊数据库(CCD)、China Biology Medicine disc、PubMed、Embase、Web of science及Cochrane图书馆数据库,检索年限为建库至2021年8月。根据检索策略及纳入排除标准筛选养心氏片治疗经皮冠状动脉介入治疗术后胸痛的随机对照临床试验,结合“Cochrane偏倚风险评估”工具、改良Jadad量表对纳入的文献进行质量评价,Rev Man 5.3软件进行Meta分析。结果:纳入文献8篇,697例患者,养心氏片组349例,对照组348例。文献质量评价5篇4分,3篇3分。Meta分析显示,养心氏片组治疗PCI术后胸痛有效[6项研究,n=505;RR(95%CI)=1.29(1.16~1.42),P<0.001];具有改善PCI术后中医证候的趋势,但差异无统计学意义[2项研究,n=149;RR(95%CI)=1.56(0.85~2.85),P=0.15];改善PCI术后7 d心电图ST段压低幅度[2项研究,n=163;MD(95%CI)=0.07(0.05~0.09),P<0.001];降低PCI术后主要不良心血管事件发生率[2项研究,n=163,RR(95%CI)=0.41(0.25~0.70),P<0.001];增加PCI术后6 min步行距离[2项研究,n=150;MD(95%CI)=80.30,(23.12~137.47),P<0.01];不增加不良反应发生率[2项研究,n=198,RR(95%CI)=1.35(0.77~2.37),P=0.29]。结论:在规范化西药治疗基础上联合应用养心氏片,对经皮冠状动脉介入治疗术后胸痛具有改善作用,且具有较好的安全性,期待未来更多高质量的研究开展,为养心氏片的临床应用提供更多证据。展开更多
基金the Program of Discipline Backbone of high-level Public Health Talents of Beijing Municipal Health Commission:Epidemiological Survey of Acute Myocardial Infarction Inpatients in Hospital of Traditional Chinese Medicine in Beijing Area(Discipline backbone-02-25)Beijing Municipal Hospital Administration Green Seedling Talent Project:Study on Characteristics of Clinical Syndromes,Status of Traditional Chinese Medicine Treatment and Prognosis of Patients with Chronic Heart Failure in Traditional Chinese Medicine Regional Health Service Center(QML20231006)。
文摘OBJECTIVE:To investigate the efficacy and safety of Angong Jiangya pill(AGJY,安宫降压丸)in the treatment of grade 2 hypertension with liver-fire hyperactivity syndrome.METHODS:This multicenter,randomized,double-blind,placebo-controlled trial was conducted in eight medical institutions.Eligible patients with grade 2 hypertension were randomly allocated to receive AGJY or a placebo for 12 weeks.The primary outcome was the change in blood pressure(BP).The secondary outcomes were BP compliance rate,Traditional Chinese Medicine(TCM)symptoms,and Duchenne Hypertension Quality of Life Scale score.RESULTS:Data were analyzed for 117 participants in the AGJY group and 118 participants in the placebo group.After 12 weeks of treatment,AGJY compared with placebo resulted in a higher and significant reduction in systolic/diastolic BP(-15.58±10.16/-9.72±7.41 vs-8.13±8.28/-4.86±5.68 mm Hg,P<0.0001,<0.0001,respectively).BP compliance rate(31.86%vs 19.13%,P=0.027)was significantly higher in the AGJY group than in the placebo group.The AGJY group showed a significant reduction in TCM symptom score compared with the placebo group(10.82±2.03 vs 7.83±1.24,P<0.0001).Single TCM syndrome clinical control rates of the primary symptoms(dizziness,headache,and irritability)were superior in the AGJY group(71.95%,94.62%,72.53%,respectively)compared with the placebo group(48.39%,68.00%,30.52%,respectively).Scores on the Duchenne Hypertension Quality of Life Scale showed a significant increase in the AGJY group compared with the placebo group(30.65±21.06 vs 9.96±10.72,P=0.000).No serious adverse events occurred.CONCLUSION:AGJY demonstrated efficacy in lowering BP,increasing the rate of BP compliance,and improving TCM symptoms and quality of life in patients with grade 2 hypertension liver-fire hyperactivity syndrome.However,further in-depth studies are required to determine the mechanism of TCM in treating hypertension.
文摘目的:对养心氏片治疗经皮冠状动脉介入治疗术(PCI)后胸痛的有效性及安全性进行Meta分析,为其临床应用提供参考。方法:检索国家知识基础设施数据库(CNKI)、中国学术期刊数据库(CSPD)、中文科技期刊数据库(CCD)、China Biology Medicine disc、PubMed、Embase、Web of science及Cochrane图书馆数据库,检索年限为建库至2021年8月。根据检索策略及纳入排除标准筛选养心氏片治疗经皮冠状动脉介入治疗术后胸痛的随机对照临床试验,结合“Cochrane偏倚风险评估”工具、改良Jadad量表对纳入的文献进行质量评价,Rev Man 5.3软件进行Meta分析。结果:纳入文献8篇,697例患者,养心氏片组349例,对照组348例。文献质量评价5篇4分,3篇3分。Meta分析显示,养心氏片组治疗PCI术后胸痛有效[6项研究,n=505;RR(95%CI)=1.29(1.16~1.42),P<0.001];具有改善PCI术后中医证候的趋势,但差异无统计学意义[2项研究,n=149;RR(95%CI)=1.56(0.85~2.85),P=0.15];改善PCI术后7 d心电图ST段压低幅度[2项研究,n=163;MD(95%CI)=0.07(0.05~0.09),P<0.001];降低PCI术后主要不良心血管事件发生率[2项研究,n=163,RR(95%CI)=0.41(0.25~0.70),P<0.001];增加PCI术后6 min步行距离[2项研究,n=150;MD(95%CI)=80.30,(23.12~137.47),P<0.01];不增加不良反应发生率[2项研究,n=198,RR(95%CI)=1.35(0.77~2.37),P=0.29]。结论:在规范化西药治疗基础上联合应用养心氏片,对经皮冠状动脉介入治疗术后胸痛具有改善作用,且具有较好的安全性,期待未来更多高质量的研究开展,为养心氏片的临床应用提供更多证据。
