OBJECTIVETo assess the clinical efficacy of danlou tablet (DT) in treating coronary heart disease angina (CHDA) patients of phlegm and stasis mutual obstruction syndrome (PSMOS).

METHODSTotally 66 CHDA patients of PSMOS were recruited from four centers (Beijing Guang'anmen Hospital, Beijing Anzhen Hospital, First Affiliated Hospital of Henan College of Traditional Chinese Medicine, and Hubei Union Hospital). They were assigned to two groups according to the random digit table, the treatment group (treated by DT +Western medicine) and the control group (treated by Western medicine), 33 in each group. All patients took Western medicine. Patients in the treatment group were given DT, 1.5 g each time, twice daily, while those in the control group took DT placebo. The treatment course was 28 days for all. The efficacy of angina, the angina attack frequency, its duration, the score of angina, the numbers of ST segment depression and flat or inversed T wave, the lead number of inversed T wave, the angina relief time after taking nitroglycerin, the amount of nitroglycerin were observed in the two groups. The changes of Chinese medicine (CM) syndrome scores, including the duration and frequency of chest tightness and pain, shortness of breath, fatigue, palpitation, spontaneous sweating, and total syndrome score were compared before and after treatment. The changes of hypersensitive C-reactive protein (hs-CRP), homocysteic acid (HCY), soluble CD40 ligand (sCD40L), interleukin-6 (IL-6), myeloperoxidase (MPO), matrix metalloproteinase-9 (MMP-9), and vascular cell adhesion molecular-1 (VCAM-1) were also observed in both groups.

RESULTSThe total effective rate was significantly higher in the treatment group (26/32 cases, 81.2%) when compared with the control group (13/30 cases, 43.3%, P < 0.05). Compared with before treatment in the same group, the duration and frequency of chest tightness and pain, the score of angina, the numbers of ST segment depression and flat or inversed T wave, the lead number of inversed T wave, the angina relief time after taking nitroglycerin, the amount of nitroglycerin, the duration and frequency of chest tightness and pain, hs-CRP, sCD40L, HCY, IL-6, MMP-9, MPO were lowered after treatment in both groups (P < 0.01, P < 0.05). The VCAM-1 level decreased in the treatment group, while it increased in the control group, showing statistical difference (P < 0.01, P < 0.05). Compared with the control group after treatment, the duration and frequency of chest tightness and pain, the score of angina, the angina relief time after taking nitroglycerin, the amount of nitroglycerin, the duration and frequency of chest tightness and pain, fatigue, the total syndrome score, the levels of hs-CRP, sCD40L, HCY, IL-6, MMP-9, MPO, and VCAM-1 were lowered in the treatment group after treatment (P < 0.01, P < 0.05).

CONCLUSIONDT could improve CHDA patients' clinical symptoms, inhibit the inflammation reaction, showing plaque stabilizing and anti-oxidization effects.