| Background:Antiplatelet therapy holds a crucial function in preventing stent thrombosis formation after percutaneous coronary intervention (PCI). However, even with sufficient dual-antiplatelet therapy of aspirin and clopidogrel, there is still certain percentage of the formation of stent thrombosis and the occurrence of restenosis. Besides, even without obvious stenosis appears with objective imaging evidence, some post-PCI patients still feel some kind of chest pain, chest oppression, anxiety and other symptoms. It has also been proved that patients reacted differently to the same dose of clopidogrel, some even revealed no reaction which was the so-called clopidogrel resistance.Since that clopidogrel resistance exists and the effectiveness of antiplatelet drugs is not sufficient, it has become a hot research field to find possible antiplatelet drugs with good clinical effect and fewer side effects from Chinese herbal medicine with the effect of promoting blood circulation and removing blood stasis. Academician Keji Chen believes that the vascular intimal injury caused by PCI is equal to the traditional theory that "blood stagnation is caused by external injury". According to the traditional theory of Chinese Medicine, blood stasis and blood vessel obstructed will lead to chest pain, chest oppression and other symptoms. Thus, promoting blood circulation and removing blood stasis will be helpful for post PCI patients.However, few studies have focus on the Chinese medicine syndrome distribution among post-PCI patients with clopidogrel resistance. In the current, we aim to collect the case information of post-PCI patients and to analyze the baseline characteristic of post-PCI patients with dual-antiplatelet therapy. We will also try to reveal the Chinese medicine syndrome distribution among post-PCI patients with clopidogrel resistance. Finally we will evaluate the effectiveness and safety of Xuefuzhuyu Capsule on post-PCI clopidogrel resistance.Objective:To observe the baseline characteristic of post-PCI patients with dual-antiplatelet therapy and to study the Chinese medicine pattern characteristic of syndrome distribution among post-PCI patients with clopidogrel resistance and to find out a possible Chinese medicine method to improve clinical effects. We will comprehensively evaluate the clinical effectiveness and safety of the combination of Chinese medicine and dual-antiplatelet therapy. To provide some evidence to apply Chinese medicine in post-PCI patients to reduce the occurrence of heart accidents.Methods:A total of 308 post-PCI patients who received dual-antiplatelet therapy were recruited from Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine from Jan.1,2013 to Dec.31,2014. All patients’general information and Chinese medicine pattern symptoms were collected. Venous blood samples were obtained after 7-day dual-antiplatelet therapy treatment. Data were analyzed to study the pattern characteristic of syndrome distribution among post-PCI patients.After that, a total of 60 post-PCI patients with clopidogrel resistance were selected and divided randomly into a control group and a treatment group. Patients in both groups received similar basic treatment according to guidelines. Patients in the control received dual-antiplatelet therapy aspirin and clopidogrel. For the patients allocated into the treatment group, the received Xuefuzhuyu capsule in additional to the dual-antiplatelet therapy. The Xuefuzhuyu capsule were taken orally 6 capsules a time and twice a day for four weeks (28±4 days in a consecutive 30 days) as a treatment course. The total scores of Chinese medicine symptoms and blood stasis syndromes and blood lipid were measured as outcome measurements. The thrombelastogram (TEG) was applied before and after treatment courses to monitor the activity of platelets (MAADP). This was to study the effectiveness and safety of Chinese medicine in combination with dual-antiplatelet therapy. The relationship between scores of blood stasis syndromes and activity of platelets were also analyzed.Results:Blood stagnation is the main Chinese medicine pattern in post-PCI patients.Qi deficiency with blood stagnation is the main Chinese medicine pattern in post-PCI patients with clopidogrel resistance.The MAADP and blood glucose revealed significant difference (P<0.05) between different types of post-PCI patients with clopidogrel resistance.After the treatment course, the MAADP in the treatment group revealed significant decrease compared with that before treatment (P<0.05), but no significance was observed in the control group (P>0.05). After the treatment course, the total scores of blood stasis syndromes in the treatment group showed significant decrease when compared with that before (P<0.05), but no significance was observed in the control group (P>0.05). There was significant difference between the scores of both groups after treatment (p<0.05).After the treatment course, the total scores of angina symptoms reached significant decrease when compared with that before (P=0.001), similar but smaller decrease was observed in the control group (P=0.04). There was significant difference between the scores of both groups after treatment (p<0.05).The TC, TG and LDL in both groups were significantly decreased (p<0.05), but reached no difference between groups.After the treatment course, the total scores of Chinese medicine symptoms in the treatment group showed significant decrease when compared with that before (P<0.01), but no significance was observed in the control group (P>0.05). There was significant difference between the scores of both groups after treatment (p<0.05).No adverse event happened in both groups during the treatment course and the results of Blood coagulation test and TEG were within normal range.Conclusions:Blood stagnation is the main Chinese medicine pattern in both post-PCI patients and post-PCI patients with clopidogrel resistance.The current showed that, when combined with dual-antiplatelet therapy, Xuefuzhuyu capsule can further reduce the activity of platelet and MAADP in a safe range with no more risk of bleeding. At the same time, it also revealed effects in decreasing total scores of blood stagnation, Chinese medicine symptoms, angina symptoms, and in reducing the blood level of TC, TG, and LDL.In conclusion, for those with post-PCI clopidogrel resistance, the combination of Xuefuzhuyu capsule and dual-antiplatelet therapy can reduce the occurrence of post-PCI stent thrombosis formation and vascular re-narrow in both short and long term, and can reduce the risk of ischemic heart accidents without adding the risk of bleeding in both short and long term. |
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