| Objective:To explore the clinical effectiveness and safety of Gualou Danshen Granules in the treatment of unstable angina pectoris.Methods:A randomized,double-blind,placebo-controlled trial was used to collect 64 patients with unstable angina pectoris and phlegm-stasis mutual obstruction syndrome in the inpatient and outpatient department of Guang'anmen Hospital of the Chinese Academy of Chinese Medical Sciences,and SPSS 20.0 was used to generate(01-64)random serial numbers,According to 1:1 randomly divided into treatment group and control group.Both groups were treated with conventional Western medicine for unstable angina pectoris.The treatment group was given Gualou Danshen granules and the control group was given placebo granules.The administration method was 1 bag each time,twice a day,and a course of treatment was 4 weeks.Observe the baseline data of the two groups of patients(gender,age,height,weight,BMI index,blood pressure,heart rate,body temperature,breathing,course of disease,angina pectoris grade,history of smoking and drinking,and comorbid diseases),efficacy indicators(score of angina pectoris,TCM syndrome score,TCM syndrome efficacy,TCM single symptom score and Seattle Angina Pectoris Scale score)and safety indicators(liver and kidney function,blood routine,urine routine,electrocardiogram and adverse events).Use SPSS 20.0 for statistics and analysis.Results:From October 2019 to May 2020,64 patients were collected in the inpatient and outpatient department of Guang'anmen Hospital,China Academy of Chinese Medicine Sciences,and 4 patients fell off.60 patients were treated,including 30 in the treatment group and 30 in the control group.1.Seattle angina questionnaire score:In the dimension of limited physical activity(PL),the treatment group PL score 27.00(5.25)is better than the control group PL score 24.00(3.13).In the dimension of stable angina(AS),the treatment group AS score 4.00(0.50)is better than the control group AS score 3.00(0.63).In the dimension of treatment satisfaction(TS),the treatment group TS score 13.50(1.63)is better than the control group TS score 10.50(1.50).In DS dimension,after treatment,DS score of 8.00(1.63)in the treatment group is better than the control group DS score 7.00(0.50).After treatment,the scores of the two groups(PL,AS,TS,DS)were significantly different(P=0.002,P=0.000,P=0.000,P=0.006).2.There was no significant difference between the two groups in gender,age,height,weight,blood pressure,resting heart rate,body temperature,respiration,course of disease,classification of angina pectoris,smoking history and drinking history,combined diseases(P>0.05).The two groups were comparable.3.Symptom score of angina pectoris:After treatment,the symptom score of angina pectoris in the treatment group was 6.00(0.00)better than that in the control group 6.00(1.00),and the difference between the two groups was statistically significant(P=0.002).4.Syndrome score of phlegm and blood stasis syndrome:After treatment,the syndrome score of phlegm and blood stasis syndrome in the treatment group(5.30±2.41)was significantly better than that in the control group(8.371±1.94).After treatment,the difference between the two groups was statistically significant(P=0.000).5.TCM syndrome efficacy score:The total effective rate of the treatment group was 83.33%,and the total effective rate of the control group was 16.67%.After treatment,the two groups of TCM syndrome efficacy score was statistically significant(P=0.000).6.TCM single symptom(chest pain,chest distress,palpitation,insomnia)score:After treatment,the treatment group(chest pain,chest distress,palpitation,insomnia)score is better than the control group,after treatment,the two groups(chest pain,chest distress,palpitation,insomnia)score difference is statistically significant(P=0.008,P=0.000,P=0.004,P=0.004).7.Safety index score:The liver and kidney function,blood routine,urine routine and ECG of the two groups were all within the normal range,and no adverse events occurred in the two groups.Conclusion:The combination of Gualou Danshen granules and conventional western medicine can improve the times,degree and duration of angina pectoris.Gualou Danshen granules has a certain therapeutic effect on chest pain,chest distress,palpitation,insomnia and other TCM syndromes.Gualou Danshen granules can improve the physical activity of patients,help to reduce the attack of angina pectoris,improve the treatment satisfaction of patients,increase patients' awareness of angina pectoris of coronary heart disease,and play a positive role in improving the quality of life of patients.Gualou Danshen granules is a safe and effective treatment method for patients with unstable angina pectoris,which is worth further study. |
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