| Nowadays, coronary heart disease (CHD) is one of main noncontagious diseases that endanger human's health. Prevention and treatment of CHD have been taken predominant place in health service all over the world, and have been improved greatly with technological advance, development of new drug and the evolvement of evidence-based idea in recent years. However, there is some deficiency in present treatment. Promoting blood circulation and removing blood stasis is an important method to treat coronary heart disease by traditional Chinese medicine (TCM). Safflower is one of the Chinese traditional medicines commonly used for treating CHD with the function of promoting blood circulation and removing blood stasis. Safflor yellow is the main component of safflower. Modern pharmacological research has proved that Safflor yellow has the functions of dilating the coronary arteries and restraining platelet aggregation, etc.ObjectiveTo evaluate the efficacy of Safflor yellow for treating stable angina pectoris with blood stasis in heart syndrome of TCM through investigating clinical syndrome, ECG, treadmill ECG test, blood lipid level, haemorheology , liver and kidney function, etc.materials and methodsDiagnostic standard: Modern medicine diagnoses criteria was referred to "stable angina pectoris" of the naming and diagnosing standard of ischemic heart disease established by World Health Organization and International Heart Association. Stable angina pectoris has the characteristics: The pain is caused by manual labor, rage and other things which can increase oxygen consumption of cardiac muscle, and disappears rapidly after relaxation or taking glonoine under the tongue; The character of the attack has no change over a month, namely, the frequency of pain is about the same in everyday or every week; the degree of labor and rage inducing pain is about the same; the character and locality of pain does not change; the duration of pain is about the same(3~ 5min). When using glonoine, pain disappears within about thesame time. Chinese medicine diagnostic criteria was referred to blood stasis in heart syndrome of TCM in ?the principles of clinical trial for treating CHD with new Chinese herbal medicine)) (2002 version).The main symptom of blood stasis in heart syndrome is:(l) fix sting or angina at the chest, and sometimes pain can radiate to the shoulder or the upper arm, (2) chest stuff, (3) palpitation. Including 2 of the main symptom, and with the character of lingua and pulse, we can diagnose blood stasis in heart syndrome.Case selections criteria: Angina pectoris was diagnosed in accordance with modern medicine criteria .stable angina pectoris occurs more than twice one week and remains with class I , IK III. TCM syndrome differentiation was blood stasis in heart. ST segment depression > 0. 05mV, and/or negative T wave is deeper than 0. 2 mV at the leads that R wave is the main appearance in QRS complex. The ages of patients were between 18-70 years.Case selections: The 143 stable angina pectoris patients were enrolled from outpatients of Xiyuan hospital, China Academy of TCM, Beijing from December, 2003 to July, 2004, and were randomized into treatment group (114) and control group (29) according to randomized digital form. There is no significant difference between two groups in sex, age, property of work, stature, weight of body, body temperature, blood pressure heart rate, etc (P>0.05).Treatment method: The patients of treatment group were given SY 80mg,iv, each day; the control group was given "danshen" injection 20mL, iv, each day. The treatment duration was two weeks. The patients were specially asked not to accept any medicine for CHD but glonoine during the trial.Observation item: It been divided into curative effect item and safety item. The curative effect item include the attack frequency of angina pectoris, chest pain -degree, lasting time, the dose of glonoine being taken, symptom of TCM, blood lipid, haemorheology, treadmill exercise test and electrocardiogram (ECG), etc. The safety items include the conditions of blood, urine, excrement, the liver and renal functions, etc. To evaluate the results according to ((The clinical research principle of new Chinese herbal medicine in treating of angina pectoris ))and ((The evaluating criteria of anginapectoris and electrocardiogram )) established by angina pectoris and arrhythmia symposium of integrated Western and Traditional medicine treatment in 1979.Statistics: The statistical analysis was performed with SPSS 11.5 software. The t test was used for comparison of quantitative data and %2 test was used for enumeration data.Results:114 patients were enrolled in the treatment group and 4 of them unfinished the trial; 29 patients were enrolled in control group, and 2 of them unfinished the trial. 137 patients of two groups in all fulfilled the trial.After treatment, scores of angina pectoris attack frequency, chest pain -degree, lasting time, the dose of glonoine being taken show significant decrease compared with that before treatment in both group ( P<0.05) . Score of chest pain -degree and lasting time in the treatment group is lower than that in the control group (P<0.05). TCM syndrome score, chest pain, chest stuff and palpitation in the both groups significantly decrease compared with that before treatment (P<0.05). The treatment group excels the control group in relieving chest pain and pleura ( P<0.05) . Common ECG shows that the sum of ST depression (￡ST) at all leads in the treatment group obviously decreases ( P<0.05 ) . Treadmill exercise test shows that the maximum index of oxygen consumption of cardiac muscle in treatment group obviously increases (P<0.05). After treatment TG, erythrocyte proportion of blood significantly decrease compared with that before treatment (P<0.05) ,but no significant difference between the treatment group and the control group. After treatment, ET levels in blood of both groups obviously decrease compared with that before treatment (P<0.05) , but no significant difference between the both groups. Total curative effect rate of ECG, angina pectoris and TCM syndrome are 51. 8%, 81. 8%and70. 9% of treatment group, obviously higher than that of control group: 29. 6%, 66. 7%and62. 9% ( P<0. 05 ) .Safety items of the both group show no obvious difference before and after treatment. There are no significant adverse effects in both groups during the treatment... |
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