Uyghur Medicine Yangxin Dawayimixike Honey Paste （养心达瓦依米西克蜜膏） in Treatment of 279 Cases Stable Angina Pectoris Patients with Qi Stagnation and Blood Stasis Syndrome：A Multi-center，Double-blind，Positive-controlled Randomized Clinical Trial
10.13288/j.11-2166/r.2024.21.010
- VernacularTitle:维药养心达瓦依米西克蜜膏治疗稳定型心绞痛气滞血瘀证279例
- Author:
Binghua JIANG
1
;
Lihua FAN
2
;
Xiaofeng WANG
3
;
Yingmin SONG
4
;
Yanlai ZHANG
5
;
Songyan QIAO
6
;
Jing DONG
7
;
Lihua JIN
8
;
Yanping DING
9
;
MAINISHA·MAIMAITI
10
;
Jixian ZHAO
11
;
Dongsheng GAO
12
;
Qiuping ZHAO
13
;
Lingxia GUAN
14
;
Hongbin SUN
15
;
Meise LIN
16
;
Hengliang WANG
17
;
Jun LI
18
Author Information
1. The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine，Jinan，250001
2. Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
3. Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
4. Luohe City Hospital of Chinese Medicine，Henan Province
5. Zhoukou City Hospital of Traditional Chinese Medicine，Henan Province
6. Nanyang City Hospital of Traditional Chinese Medicine，Henan Province
7. The Second Affiliated Hospital of Shanxi University of Chinese Medicine
8. Dandong First Hospital，Liaoning Province
9. Luoyang Hospital of Traditional Chinese Medicine，Henan Province
10. Hospital of Xinjiang Traditional Uyghur Medicine
11. Shiyan Renmin Hospital，Hubei Province
12. Luoyang Second Hospital of Traditional Chinese Medicine，Henan Province
13. Fuwai Central China Cardiovascular Hospital，Henan Province
14. Zhumadian TCM Hospital，Henan Province
15. The Second People's Hospital of Pingdingshan，Henan Province
16. Wenzhou Traditional Chinese Medicine Hospital，Zhejiang Province
17. Xinxiang Central Hospital，Henan Province
18. Guang'anmen Hospital，China Academy of Chinese Medical Sciences
- Publication Type:Journal Article
- Keywords:
stable angina pectoris;
qi stagnation and blood stasis syndrome;
Yangxin Dawayimixike Honey Paste （养心达瓦依米西克蜜膏）;
Treadmill exercise test;
Seattle angina scale
- From:
Journal of Traditional Chinese Medicine
2024;65(21):2225-2233
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo observe the efficacy and safety of Uyghur medicine Yangxin Dawayimixike Honey Paste （养心达瓦依米西克蜜膏， YDMHP） in the treatment of stable angina pectoris （SAP） of qi stagnation and blood stasis syndrome. MethodsA randomized ， double-blind， positive-controlled，multi-center clinical trial was conducted， in which 370 patients with SAP of qi stagnation and blood stasis syndrome were randomly divided into treatment group（279 cases）and control group（91cases）at a ratio of 3∶1. The treatment group was orally administered with YDMHP， 3 g each time， and placebo of Xuefu Zhuyu Capsule （血府逐瘀胶囊）， 2.4 g each time， while the control group was treated with Xuefu Zhuyu Capsule， 2.4 g each time， and placebo of YDMHP， 3 g each time， both twice a day for a course of 12 weeks. The primary outcome was the effect of angina pectoris symptom. The secondary outcomes include single angina symptom scores such as number of attacks， duration of attacks， pain intensity and usae of nitroglycerin scores， the total angina symptom score before and after the treatment， the usage of nitroglycerin， the exercise duration in treadmill exercise test （TET） and the Duck treadmill score among patients，the scores of Seattle Angina Questionnaire （SAQ） on five dimensions including physical limitations， anginal stability， anginal frequency， treatment satisfaction， and disease perception， and efficacy of TCM syndrome and of each single TCM symptom after treatment. The safety were evaluated by examine blood routine， urine routine， liver and kidney function， fasting blood sugar， electrocardiogram， adverse events. ResultsThe total effective rate of angina symptom in the treatment group was 71.69% （200/279）， significantly higher than 51.64% （47/91） in the control group （P＜0.01）. The curative and markedly effective rate of TCM syndrome in the treatment group was 53.05% （148/279）， which was significantly higher than 25.27% （23/91） in the control group （P＜0.01）. After treatment， scores of the number as well as duration of angina attacks and pain severity， the total score of angina symptoms， and the usage of nitroglycerin significantly decreased in both groups， and more changes were seen in the treatment group than in the control group； the scores of physical limitations， anginal stability， anginal frequency， treatment satisfaction， and disease perception in both groups significantly increased， and more improvement were shown in the experimental group regarding the anginal stability， anginal frequency and treatment satisfaction （P＜0.05 or P＜0.01）. The effects of chest pain， chest tightness， palpitation， shortness of breath and fatigue in experimental group were significantly higher than those in control group （P＜0.05 or P＜0.01）. There was no significant difference in the exercise duration of treadmill test and Duke score among patients between the two groups either before or after treatment （P＞0.05）. Adverse events occurred in 66 cases （23.66%） of the experimental group and 16 cases （17.58%） of the control group， with no statistical significance between the two groups （P＞0.05）. ConclusionThe Uyghur medicine YDMHP can effectively improve symptoms of angina pectoris， reduce the number， duration， and intensity of attacks， decrease the dosage of nitrogly-cerin and improve the individual TCM symptoms and has good safety in the treatment of SAP patients of qi stagnation and blood stasis.
