To explore the effect of Xiaoji Recipe on the stability of carotid artery vulnerable plaque in elderly patients with type 2 diabetes mellitus and type H hypertension(Qi-Yin deficiency with phlegm stagnation). From January 2017 to April 2019, in Endocrinology Department for Outpatients and Inpatients of the First Affiliated Hospital of Henan University of Chinese Medicine, 125 elderly patients with type 2 diabetes mellitus and type H hypertension with carotid artery vulnerable plaque(Qi-Yin deficiency with phlegm stagnation) were selected. According to the numerical table method, the patients were randomly divided into the control group(63 cases, including 56 cases completed) and Xiaoji group(62 cases, including 58 cases completed). Both groups were given control diet, hypoglycemic, hypotensive and symptomatic therapies. The control group was given Rosuvastatin Calcium Tablets 20 mg·d~(-1) before sleep. The Xiaojie group were given Ruisuvastatin Calcium Tablets 10 mg·d~(-1) before sleep, plus Xiaoji Recipe at the same time. Both groups were treated for 6 months. The number of vulnerable plaques, carotid intima-media thickness(IMT) and plaque thickness were detected by color Doppler ultrasound before and after treatment, in order to calculate IMT integral and improved Crouse integral. Meanwhile, lipid metabolism indexes, including total cholesterol(TC), triacylglycerol(TG), low-density lipoprotein cholesterol(LDL-C), high-density lipoprotein cholesterol(HDL-C) and lipoprotein a(LPa). And plaque stability indexes, including hypersensitive c-reactive protein(hs-CRP), matrix metalloproteinase-9(MMP-9), oxidized low-density lipoprotein(ox-LDL), Ⅰ type platelet depolymerization protein binding protein base sequence of metalloproteinases(ADAMTS-Ⅰ) and homocysteine(Hcy) were detected. To evaluate the 6-month curative effect on TCM syndrome, the patients were followed up for 6 months for adverse cardiovascular and cerebrovascular events and adverse drug reactions. After 6 months of treatment, the efficacy on Xiaoji group was better than that of the control group(Z=-2.600, P=0.009). The significant efficiency of the Xiaoji group was higher than that of the control group(χ~2=6.039, P=0.014). The total effective rate of the Xiaoji group was higher than that of the control group(χ~2=4.564, P=0.033). The number of vulnerable plaques form indexes(IMT, IMT integral, plaque thickness, improved Crouse integral), blood lipid metabolism indexes(TC, TG, LDL-C, HDL-C, LPa) and plaque stability indexes(hs-CRP, MMP-9, ox-LDL, ADAMTS-Ⅰ, Hcy) were significantly improved than before treatment in both groups of patients(P<0.01). Compared with the control group, the Xiaoji group showed more obvious improvement(P<0.01). The incidence of adverse cardiovascular and cerebrovascular events in the Xiaoji group was lower than that in the control group within 6 months after treatment(χ~2=4.566, P=0.033). The incidence of adverse drug reactions in the Xiaoji group was lower than that in the control group(χ~2=4.465, P=0.035). This indicated that Xiaoji Recipe combined with small-dose Rosuvastatin Calcium(10 mg·d~(-1)) was safe and effective in the treatment of elderly patients of type 2 diabetes mellitus with type H hypertension and vulnerable carotid artery plaque(Qi-Yin deficiency with phlegm stagnation), and superior to the single high-dose Risovastatin Calcium(20 mg·d~(-1)) regimen. It can reverse carotid plaque, and reduce the activity of vulnerable plaque and the incidence of adverse cardiovascular and cerebrovascular events and adverse drug reactions.
Keywords: Qi-Yin deficiency and phlegm stagnation; Xiaoji Recipe; carotid atherosclerosis; the elderly; type 2 diabetes; type H hypertension; vulnerable plaque.