Zhenyuan Capsules( 振源胶囊) in the Treatment of Stable Angina with Abnormal Glucolipid Metabolism Patients of Deficiency of Both Qi and Yin Type: A Multicentered,Randomized,Double-blind,Placebocontrolled Clinical Trial
ZHANG Jingchun, LIU Yue, LEI Shuyan, et al. Zhenyuan Capsules( 振源胶囊) in the Treatment of Stable Angina with Abnormal Glucolipid Metabolism Patients of Deficiency of Both Qi and Yin Type: A Multicentered,Randomized,Double-blind,Placebocontrolled Clinical Trial[J]. Journal of Traditional Chinese Medicine2020, 61(6): 502-508.
ZHANG Jingchun, LIU Yue, LEI Shuyan, et al. Zhenyuan Capsules( 振源胶囊) in the Treatment of Stable Angina with Abnormal Glucolipid Metabolism Patients of Deficiency of Both Qi and Yin Type: A Multicentered,Randomized,Double-blind,Placebocontrolled Clinical Trial[J]. Journal of Traditional Chinese Medicine2020, 61(6): 502-508.DOI: 10.13288/j.11-2166/r.2020.06.011.
Objective To observe effectiveness and safety of Zhenyuan Capsules(振源胶囊
ZYC) in the treatment of stable angina(SA) with abnormal glycolipid metabolism patients of deficiency of both qi and yin type. Methods A multicentered
randomized
double-blind
placebo-controlled design was applied. A total of 200 SA patients with abnormal glycolipid metabolism of deficiency of both qi and yin were randomized to test group(100 cases) and control group(100 cases). On the basis of conventional treatment in western medicine
the patients in the test group and control group were given ZYC or placebo 500 mg each time respectively
three times a day for 12 weeks. Levels of blood glucose metabolism and blood lipid metabolism including glycosylated hemoglobin(HbA1 c)
fasting blood glucose(FBG)
2 h postprandial glucose(2 h PPG)
and triglyceride(TG)
and the score of angina symptoms
the score of traditional Chinese medicine(TCM) symptoms
as well as the score of Seattle angina questionnaire(SAQ) of both groups before and after the treatment were observed. The efficacy for angina symptoms
TCM syndrome efficacy and safety both groups were evaluated. Results A total of 188 patients finally completed this trial
including 96 cases in the test group and 92 cases in the control group. HbA1 c
2 h PPG
FBG and TG in test groups were significantly decreased after the treatment(P<0.05). The angina symptom scores and the TCM syndrome scores were also significantly decreased(P<0.01)
and the scores of SAQ were significantly increased(P<0.01) after treatment. Compared with the control group
HbA1 c and FBG were significantly decreased in the test group after the treatment(P<0.05); angina symptom score and the TCM syndrome score were significantly decreased(P<0.01)
the efficacy for angina symptoms and the efficacy for TCM syndromes were significantly increased(P<0.01); and the score of SAQ was significantly increased(P<0.01). The levels of 2 h PPG and TG showed a declining trend in both groups
but there is no statistical significance(P>0.05). The efficacy for angina symptoms
TCM syndromes(P<0.05)
and SAQ scores(P<0.01) in patients with history of myocardial infarction(MI) in the test group was better than those in patients without history of MI. No adverse reactions occurred during the treatment. Conclusion ZYC can improve symptoms of glycolipid metabolism and angina in SA patients with abnormal glycolipid metabolism of deficiency of both qi and yin type