摘要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.