| Purpose:To explore the efficacy and safety of Resolving Stasis and Eliminating Phlegm Formula on coronary heart disease angina pectoris and phlegm stasis mutual junction syndrome;Proving syndrome by formula,to prove the rationality of using the Resolving Stasis and Eliminating Phlegm Formula treating the coronary heart disease angina pectoris and phlegm stasis mutual junction syndrome.Material and method:This study selected 180 inpatients or outpatients with coronary heart disease angina pectoris phlegm stasis mutual junction syndrome from The First Affiliated Hospital of Liaoning Medical University and The Yingkou Province Hospital of Traditional Chinese Medicine,from May 2016 to January 2017.According to the ratio of experimental group and control group in the proportion of 1:1,180 patients were divided into two groups by block randomized and parallel-group trial,90 patients in experimental group and 90 in the control group.Experimental group were given the Resolving Stasis and Eliminating Phlegm Formula granulas,in the control group were given the placebo for 8 weeks,followed up for 4 weeks.Observe the angina score,serum lipid(Triglyceride,Total Cholesterol,High Density Lipoprotein,Low Density Lipoprotein)level,the TCM syndrome score,as well as the Seattle angina questionnaire and the fasting blood FBGcose level changes of two groups before and after receiving treatments,and the relevant safety index.Results:1.Baseline observation results: There was no significant difference(P>0.05)between two groups in gender,nationality,marriage,job nature,age,weight,height and CCS angina class,indicating a relatively sound balance that the two groups were comparable.2.Angina score results: The total score of angina score of experimental group was lower than those of the control group in the 8th week and with significant difference(P<0.05),the experimental group had a greater decline range than the control group and also with significant difference(P<0.05).3.Four terms of serum lipid results: The TG of two groups was in a falling trend,and the falling range of the experimental group was greater than the control group,and with no significant difference(P>0.05);The level of TC,LDL-C of the experimental group in the 8th week were lower than the control group,and the decline range of LDL-C of the experimental group after 8 weeks was greater than those in the control group,and with significant difference(P<0.05);The level of HDL-C of the experimental group in the 8th week was higher than the control group,and with significant difference(P<0.05).4.TCM syndrome score results: The total score of TCM syndrome score of experimental group was lower than those of the control group in the 8th week,and with significant difference(P<0.05).5.Seattle angina questionnaire results: The 5 SAQ dimensions scores of experimental group were better than those of the control group in the 4th and 8th week,and with no significant difference(P>0.05).The 5 SAQ dimensions scores of two groups were in rising trend,and the experimental group raised more.In addition,in the 8th week,the AF dimension and the TS dimension of experimental group were better than those of control group and with statistically significant(P<0.05).6.Fasting blood FBGcose results: The FBG level in the 4th and the 8th week were not significantly different(P>0.05)between groups,the FBG level of two group were both in a falling trend,and the decline range of the experimental group was greater than those in the control group,and with no significant difference(P>0.05).7.Safety evaluation results: Some cases with normal laboratory parameters presented abnormal changes but recovered to normal after the review,and they kept on treating.Side effects happened in 3 patients of experimental group and 1patient of control group,there was no adverse reactions in two groups.Two adverse events and adverse reactions were not significant difference between the two groups(P>0.05).8.Compliance evaluation results: The experimental group and the control group compliance were all over 95%,indicating good compliance,and the compliance of experimental group was better than those of control group,and with statistically significant(P<0.05).Conclusion:1.The Resolving Stasis and Eliminating Phlegm Formula treating patients with coronary heart disease angina pectoris and phlegm stasis mutual junction syndrome showed valid license,safety.2.The Resolving Stasis and Eliminating Phlegm Formula can reduce the Angina score and the TCM syndrome score,reduce the TC,LDL-C level,rise the HDL-C level,improve the angina attack frequency,improve the treatment satisfaction of patient and the medication compliance,proved the Resolving Stasis and Eliminating Phlegm Formula is the rational formula of treating coronary heart disease angina pectoris and phlegm stasis mutual junction syndrome. |
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