| ObjectiveThrough a single-center randomized, parallel controlled clinical research, observation of safflower yellow pigment injection in treatment of coronary atherosclerotic heart disease (CHD) patients with stable angina pectoris (UAP) blood stasis of the efficacy and safety, at the same time were observed before and after medication in patients with symptoms and the physical and chemical indicators such as lipid levels, high-sensitivity c-reactive protein (hs CRP) and platelet aggregation rate (PA), fibrinogen (Fib) level change, and to clarify its mechanism.MethodsAll cases are derived from guangzhou university of Chinese medicine and inside general YiFuYuan cardiology ward, a total number of cases of57cases, all cases were divided into test group (27) and control group (30), and give the corresponding unstable angina standard drug therapy, western medicine control group (conventional treatment:aspirin, clopidogrel sulfate, ACEI/ARB, beta blockers and atorvastatin) and treatment group (conventional treatment on the basis of safflower yellow pigment used group), the two combined with diabetes, and diabetes combined with hypertension antihypertensive agents, stop using other traditional Chinese medicine (TCM) or proprietary Chinese medicine preparations. Treatment for7days, observation on patients with angina, electrocardiogram (ecg) changes, the traditional Chinese medicine symptom scores in the change of the before and after treatment, detection of blood lipid levels at the same time, the hs-CRP, PA, Fib and related index changes before and after therapy. Among them, the serum levels of total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL C) using enzymatic determination, high density lipoprotein (HDL-C), were determined by direct one-step detection hs-CRP immune turbidimetric method is used to determine, PA determination using resistance KangFa, Fib assay by immune turbidity method.Results1. Improve picture of angina pectorisDegree of the two groups before and after treatment in patients with angina pectoris were obviously improved, by chi-square test, the difference statistically significant (P<0.05); After treatment, in terms of improvement of angina pectoris, experimental group is better than that of control group, the difference statistically significant (P=0.005<0.05). Follow-up found that in the control group released the second mild angina,3cases,1case for three months; Patients discharged from hospital later appeared mild angina in2cases, three months without recurrence of angina pectoris. Newly released two months follow-up of the patients had not,5cases of control group and experimental group, with visitors, which have not been hospitalized again for angina pectoris.2. Ecg ST segment to improve the situationLevel of electrocardiogram (ecg) in patients with ST segment in the control group, experimental group is obviously improved, the efficiency of20%,33.33%respectively, efficient were26.67%,25.93%, total effective rate were46.67%and59.26%, respectively, the two groups can improve the level of ST segment, but there was no significant difference between two groups (P=0.561>0.05).3. The TCM symptoms improve the situationTwo groups of cases and the contrast groups before treatment, the treatment group of chest pain, chest tightness, palpitations, shortness of breath, weakness and total score were significantly improved (P<0.05), the control group in the chest pain, palpitations, shortness of breath, weakness and total score improved significantly (P<0.05), statistically significant difference, but there was no difference in the chest in the control group compared with before treatment (P>0.05). After treatment, the treatment group is more obviously improve the symptoms of chest tightness, palpitations, statistically significant difference (P<0.05). 4. The hs CRP and Fib, the influence of the physical and chemical indicators such as the PLA2and PAgAfter treatment, the control group in reducing PLA2(P=0.042) in lowering the hs-CRP levels, test group (P=0.028) level and two groups of rising PAg (the control group (P=0.24, P=0.003) trial level differences statistically significant (P<0.05), the control group and experimental group there was no difference in the Fib levels compared with before treatment (P>0.05), and comparing the two groups, the experimental group than control group in reducing the hs-CRP level significantly, the difference was statistically significant (P=0.039<0.05), the combination of Chinese and western curative effect is better in terms of lower hs-CRP levels.5. Effect on blood lipid levelAfter treatment, the control group in reducing TC (P=0.043), TG (P=0.035) level differences statistically significant (P<0.05), while patients in lower TG (P=0.006) and TG/HDL-C (P=0.018) level difference was statistically significant (P<0.05); Experimental group lower TG levels more significantly than the control group, the difference was statistically significant (P=0.02<0.05).ConclusionThis study shows that the safflower yellow pigment is blood stasis treatment of coronary heart disease unstable angina patients with effective prescription, reflect after treatment can obviously improve the patient’s symptoms of angina pectoris, at the same time improve the patients in the chest pain, chest tightness, palpitations, shortness of breath, fatigue and so on TCM symptoms, especially in the aspect of chest tightness, palpitations, obviously superior to control group; In addition, its curative effect is also reflected in the drug can effectively reduce the hs-CRP levels, have anti-inflammatory effect. Experimental group reduce the level of PLA2in the short term than that in control group, may be associated with drug synergy, but its long-term efficacy is benefit and the specific mechanism remains to be further discussed and research.; For regulating blood lipid levels, improve blood lipid metabolism have certain effect, but the shortcoming in the period of treatment is not fully, therefore still needs further pharmacological research and clinical observation, to clear its effect on blood lipid index of the concrete. |
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