Effect of Xuefu Zhuyu Capsule (血府逐瘀胶囊) on the symptoms and signs and health-related quality of life in the unstable angina patients with blood-stasis syndrome after percutaneous coronary intervention: A Randomized controlled trial
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Compared with Shengmai Capsule (生脉胶囊, SM), the study was conducted to evaluate the efficacy and safety of Xuefu Zhuyu Capsule (血府逐瘀胶囊, XFZY) on the symptoms and signs and health-related quality of life (HR-QOL) in the unstable angina (UA) patients with blood-stasis syndrome (BSS) after percutaneous coronary intervention (PCI).
A randomized, double-blinded, double-dummy, and placebo-controlled trial was applied. Ninety patients, diagnosed as UA and BSS after successful PCI, were enrolled and equally randomized into three groups, XFZY group, SM group, and placebo group, and administered with the corresponding medications respectively for four weeks. The clinical symptoms and signs (CSS), electrocardiography (ECG), and BSS scores were recorded and compared among groups during and after the treatment. Short-form 36 (SF-36) and Seattle Angina Questionnaire (SAQ) were applied to assess the HR-QOL in each group before and after the treatment. Safety indexes (blood routine and liver and kidney function tests) were also examined at the beginning and after the treatment.
Eighty-six patients completed the whole study. After the treatment, the total effective rates of the XFZY group in ameliorating CSS and ECG were 76.7% and 60.0%, respectively, which were obviously higher than those in SM (CSS: 53.3%; ECG: 36.7%) and the placebo (CSS: 43.3%; ECG: 30.0%) groups. After one week’s treatment, BSS scores slightly decreased in each group, but no signifificant differences were found among three groups (P>0.05). After four weeks’ treatment, BSS scores in the XFZY group decreased to a lower level compared with SM (P <0.05) and the placebo (P <0.01) groups. After the treatment, the effificacy of XFZY group in improving body pain (BP), general health (GH), vitality (VT), society functioning (SF), role emotional (RE), angina stability (AS), angina frequency (AF), and treatment satisfaction (TS) were better than those in the placebo group (P <0.05,P <0.01). Meanwhile, the dimensions of BP, GH, SF, AS, AF, and TS were better improved than those in the SM group P <0.05). No obvious adverse reaction was found during and after the treatment except one case in the XFZY group reporting of stomach discomfort.
Compared with SM Capsule treatment, a short-term treatment with XFZY Capsule exhibits better effificacy on CSS and BSS scores, and HR-QOL in UA patients with BSS after PCI. However, its long-term effificacy and safety still needs further investigation.
KeywordsXuefu Zhuyu Capsule unstable angina percutaneous coronary intervention double-blind double-dummy
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- 11.Pedersena SS, Denolleta J, Daemen J, van de Sande M, de Jaegere PT, Serruys PW, et al. Fatigue, depressive symptoms, and hopelessness as predictors of adverse clinical events following percutaneous coronary intervention with paclitaxel eluting stents. J Psychosom Res 2007;62: 455–461.CrossRefGoogle Scholar
- 12.Zheng GL, Wang SH. Clinical effect and mechanism of Xuefu Zhuyu Capsule in treating unstable angina pectoris. Chin J Integr Tradit West Med (Chin) 2009;29:65–68.Google Scholar
- 14.Specialty Committee of Activating Blood Circulation and Removing Blood Stasis of Research, Chinese Association of the Integrative Medicine. Diagnostic criteria of bloodstasis syndrome. Chin J Integr Tradit West Med (Chin) 1987;7:cover 2.Google Scholar
- 15.Zheng XY, ed. Guiding principle of clinical research on new drugs of traditional Chinese medicine. Beijing: China Medic-Pharmaceutical Sciences and Technology Publishing House; 2002:69–73.Google Scholar
- 16.Li J, Zhang MZ, Chen BJ, Wang L, Ling XZ, Zhang XW, et al. Effect of Tongguan Capsule (通冠胶囊) on postintervention patients of coronary heart disease with qideficieney and blood stasis syndrome. Chin J Integr Tradit West Med (Chin) 2008;28:32–35.Google Scholar
- 17.Ware JE. SF-36 health survey mannual and interpretation guide. Boston. MA: The Health Institute; 1993:2–7.Google Scholar
- 19.Xu J, Hu YM, Yang YB, Wang BH, Xie YN. Health measurement questionnaire SF-36. Chin J Behav Med Sci (Chin) 1999;8:150–153.Google Scholar
- 28.Li CY. Progress of the study on blood stasis syndrome and prescriptions and medicinal herbs for activating blood circulation to eliminate stasis. Chin J Integr Tradit West Med (Chin) 1988; 5:317–320.Google Scholar
- 30.Liang ZJ. Research on the scientific basisi of bloodstasis pattern. In: Chen KJ ed. Research on the bloodstasis pattern and activating blood circulation to remove blood-stasis. Shanghai: Shanghai Scientific and Technical Publishers; 1990:368–488.Google Scholar
- 31.Liu TX, Kong SP, Liao ZY, Lu SK. Assessment study on physical function and the quality of life for CHD patients with SAQ. Chin J Behav Med Sci (Chin) 1997;6:127–129.Google Scholar