1. 1 general information
According to the Nomenclature and Diagnostic Criteria of Ischemic Heart Disease [1 2], the Guiding Principles of Clinical Research of New Chinese Medicine, and the TCM Syndrome Differentiation and Classification Criteria of Chest Obstruction [3], 264 patients with angina pectoris of coronary heart disease diagnosed by western medicine and heart blood stasis diagnosed by traditional Chinese medicine were selected. Male 146, female 1 18. The age ranged from 47 to 74 years with an average of (56.5 3.25) years. The course of disease ranged from 3 months to 8 years, with an average of 4.5 years. Among them, stable angina pectoris 177 cases and unstable angina pectoris 87 cases. There were 239 cases of ECG ischemia, 45 cases of ventricular premature beats and 28 cases of atrial premature beats. Randomly divided into two groups. Treatment group 126 cases, including 69 males and 57 females. Control group 138 cases, including 77 males and 6 females1case. There was no significant difference in sex and age between the two groups (P & gt0.05). There was no significant difference in blood lipid indexes between the two groups before treatment (P > 0.05). 0.05), which is comparable.
Diagnostic and inclusion criteria: 264 patients in this group were diagnosed as angina pectoris of coronary heart disease. According to the national revised reference standard for the diagnosis of coronary heart disease, 90.5% of patients showed myocardial ischemia in ECG. The diagnostic criteria of dyslipidemia were formulated according to the recommendations of 1997 national dyslipidemia prevention and treatment research group: cholesterol (TC) >; 5.0 mmol/L, triglyceride (TG) >: 1.7 mmol/L, HDL-C L, LDL >；; 3. Abnormal18mmol/L, excluding liver and kidney diseases.
1.2 Treatment method The treatment group took Xinshubao tablets (produced by Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd., approval number: National Medicine Zhunzi Z3502024 1) orally, 2 tablets/time, twice a day, with boiled water after breakfast and dinner, and 2 months was 1 course of treatment. The control group was given compound Danshen tablets (produced by Chengdu Wayne Pharmaceutical Co., Ltd., approval number: National Medicine Zhunzi: Z200434 13), 3 tablets each time, 3 times a day, and 2 months was 1 course of treatment. During the medication, other antianginal and antiarrhythmic drugs were stopped, and isosorbide nitrate was temporarily taken when angina pectoris occurred.
1.3 Observation indicators Before treatment, blood, urine, stool routine, liver and kidney function, blood lipid, 24-hour dynamic electrocardiogram and electrocardiogram were checked; Blood pressure and heart rate were measured regularly during medication, and the number of angina pectoris attacks was observed and recorded. Electrocardiogram 1 time was checked every two weeks to observe the changes of blood stasis syndrome in traditional Chinese medicine, and to ask when the curative effect appeared and whether there were any side effects. After the treatment, all the above examinations were reviewed.
1.4 curative effect evaluation
1.4. 1 criteria for evaluating the curative effect of angina pectoris (according to the criteria of Shanghai Cardiovascular Conference 1979) ① Effective: angina pectoris caused by exertion, and the grade of angina pectoris symptoms decreased by 2 grades after treatment. Angina pectoris in patients with grade ⅰ and ⅱ basically disappeared (that is, angina pectoris basically did not appear in heavy physical activities other than daily activities). Non-exertion angina pectoris, the symptoms disappear or basically disappear, angina pectoris attacks no more than twice a week, and nitroglycerin is basically not used. ② Improvement: After treatment, the symptoms of angina pectoris were relieved 1 grade, and nitroglycerin was reduced 1/2 or more. The angina pectoris of grade I patients basically disappeared without nitroglycerin. After treatment, the number of angina pectoris and the dosage of nitroglycerin decreased by more than 1/2. ③ Basic ineffectiveness: symptoms and nitroglycerin dosage did not change, or decreased, but did not improve. ④ Aggravation: The number of pain attacks increases, the degree increases, the duration is prolonged, or angina pectoris escalates, and the dosage of nitroglycerin increases.
1.4.2 evaluation criteria of ECG curative effect (according to the criteria of Shanghai Cardiovascular Conference 1979) ① Significant effect: ECG returned to normal or close to normal at rest. The double step exercise test changed from positive to negative. Sub-polar graded exercise test (-), or exercise tolerance increased by 2 levels (+). ② Improvement: ST segment of resting electrocardiogram or double-step exercise test decreased, and increased by more than 0.05 mV after treatment, but it was abnormal. When the dominant linkage is inverted, the T wave becomes shallower (up to more than 50%), or the T wave turns from flat to straight, and the exercise tolerance of the second maximum graded exercise test increases 1 (+) compared with that before treatment. ③ No change: ECG or exercise test at rest is basically the same as before treatment, or it has improved but failed to reach the improvement standard. ④ Aggravation: at rest, the st segment of ECG or double-step exercise test decreased by more than 0.05 mV compared with that before treatment, and the dominant inverted T wave deepened (up to more than 50%) or the vertical T wave flattened. The flat T wave becomes inverted, and the amount of exercise in sub-polar grading experiment is reduced (+) compared with that before exercise.
1.5 the self-comparison and intra-group comparison of the measurement data of each index before and after statistical processing were conducted by t test, and the comparison of the total efficiency of the two groups was conducted by χ2 test. P & lt0.05 is a significant difference.
Two results
2. In the1angina pectoris treatment group, the effective rate was 6 1 case (48.4%), the effective rate was 52 (4 1.3%), and the ineffective rate was 7.9%, with a total effective rate of 89.7%. In the control group, 13 cases were markedly effective (9.4%), 77 cases were effective (55.8%), 37 cases were ineffective (26.8%), and1/kloc-0 cases were aggravated (8.0%), with a total effective rate of 65.2%. There was significant difference between the two groups (P
2.2 ECG curative effect comparison
In the treatment group, 28 cases were markedly effective (24.3%), 52 cases were effective (45.2%), 33 cases were ineffective (28.7%) and 2 cases were aggravated (65,438 0.7%), and the total effective rate was 69.6%. In the control group, 5 cases were markedly effective (4.0%), 43 cases were effective (34.7%), 52 cases were ineffective (6 1.9%), and 24 cases were aggravated (19.4%), with a total effective rate of 38.7%. There was significant difference between the two groups (P
2.3 Comparison of lipid-lowering efficacy between the two groups TC, TG and LPL-CH were significantly lower than before treatment (P
3 discussion
Xinshubao tablet is composed of Radix Salviae Miltiorrhizae, Radix Paeoniae Alba, Radix Curcumae, Fructus Crataegi and Radix Acanthopanacis Senticosi. Compound Danshen tablet is composed of Radix Salviae Miltiorrhizae, Radix Notoginseng and Borneolum Syntheticum. According to the characteristics of prescriptions, Xinshubao tablets are superior to qi-regulating drugs on the premise of promoting blood circulation and removing blood stasis, which embodies the meaning of "qi goes with blood". It fully embodies the pathological changes of chest obstruction and blood stasis syndrome in Chinese medicine theory. Clinical observation shows that Xinshubao tablet has a strong effect of promoting blood circulation, removing blood stasis, promoting qi circulation and relieving pain, and has a good effect on angina pectoris (chest obstruction) of coronary heart disease, which belongs to blood stasis syndrome of traditional Chinese medicine [5]. The first four drugs of Xinshubao Tablet all have the effects of promoting blood circulation and removing blood stasis, especially Danshen, which has obvious curative effect under the synergistic effect with other drugs with the same curative effect. Salvia miltiorrhiza is mainly used to treat angina pectoris of coronary heart disease. Modern pharmacology of Radix Paeoniae Alba proves that its water-soluble components have obvious anti-hypoxia and anti-myocardial ischemia effects. Radix Curcumae has the functions of promoting qi circulation, removing blood stasis, cooling blood and breaking blood stasis. Hawthorn has the function of promoting blood circulation and removing blood stasis; Supplemented with acanthopanax senticosus, Xinshubao plays its therapeutic role scientifically and reasonably. This prescription has definite curative effect on angina pectoris of coronary heart disease, which can improve electrocardiogram, significantly reduce hyperlipidemia and improve platelet stretching function. The mechanism of the drug in preventing and treating angina pectoris of coronary heart disease may have many comprehensive results from modern medical theory and experimental analysis: ① the drug can improve microcirculation function, increase coronary blood supply and enhance myocardial mitochondrial ATPase activity, thus improving myocardial blood supply and relieving angina pectoris; ② The premature beats of patients with coronary heart disease are often caused by the increased excitability of cardiac ectopic rhythm points caused by myocardial ischemia and hypoxia. The mechanism of Xinshubao tablet in treating premature beats may be related to promoting blood circulation and removing blood stasis, improving microcirculation function and myocardial blood supply, reducing or counteracting adrenalin-induced β -receptor excitation, and counteracting isoproterenol-induced myocardial excitation, thus reducing ectopic pacemaker excitation. ③ The lipid-lowering effect of Xinshubao Tablet can prevent the accumulation of lipids in intima and subcellular of arterial wall, and block the important links of coronary atherosclerosis and thrombosis, thus preventing the occurrence and development of angina pectoris of coronary heart disease.
In addition, the medicine does not contain borneol, which has little effect on gastrointestinal function. After taking it, patients have no symptoms of gastrointestinal discomfort and have no adverse effects on liver and kidney systems. It is a good Chinese patent medicine for treating angina pectoris. Clinically, patients take Xinshubao tablets, which usually take effect in one week. In addition to angina pectoris, most patients also have chest tightness, shortness of breath, palpitations and other symptoms. Patients feel that their physical strength has been enhanced to varying degrees, their sleep has been significantly improved, and they are full of energy. The clinical results show that this prescription just conforms to the treatment principle of angina pectoris of coronary heart disease, and then achieves the purpose of treating diseases and protecting the heart.