| China Cardiovascular Disease Report 2018 shows that the mortality rate of cardiovascular disease is still the first in China,accounting for more than 40%of the total deaths of residents.Among them,the death toll from coronary heart disease(CHD)accounts for 20%of the total number of deaths from cardiovascular diseases,and the incidence of CHD is increasing,which has become a major public health problem.Borderline Coronary Lesions(BCL),also known as moderate stenosis,are lesions with a diameter range of 30%to 70%.There is evidence that plaques in patients with BCL are mostly vulnerable plaques,which are prone to rupture,hemorrhage,and thrombosis,resulting in ACS.However,despite the current recommended appropriate antiplatelet,lipid-lowering and other secondary prevention and treatment of CHD,the number of deaths due to BCL is still increasing.Traditional Chinese medicine(TCM)has a long history of treating CHD.Phlegm and Blood stasis is the main pathological part of plaque formation,vulnerable lesions of BCL formation is closely related to heat toxic intrinsic.Therefore ’Phlegm,blood stasis and heat syndrome’ is the main syndrome of BCL.However,there are few clinical studies on the treatment of CHD with ’clearing up heat,resolving phlegm and promoting blood circulation’.XAF is a commonly used Chinese herbal medicine(CHM)based on the TCM theory of ’clearing up heat,resolving phlegm and promoting blood circulation’.It is the experience of the Professor Wang Jie in the treatment of angina pectoris.Its clinical efficacy is exact.However,there is no evidence for XAF in the treatment of BCL.Therefore,this study used a randomized,double-blind,placebo-controlled clinical trial to investigate the efficacy and safety of XAF in treatment of BCL with ’Phlegm,blood stasis and heat syndrome’.ObjectiveTo investigate the efficacy and safety of XAF in treatment of BCL with ’Phlegm,blood stasis and heat syndrome’.MethodsIn this study,a randomized,double-blind,placebo-controlled clinical trial was used.The central randomized system was used to divide patients into the experimental group and the control group according to a 1:1 ratio.The subjects,researchers,outcomes evaluator and statistician were blind by double-blind method.The enrollment of the study participants began in December 2017.All subjects who met the inclusion and exclusion criteria were required to voluntarily sign the informed consent form before enrolling.At present,32 subjects have completed 6 months of treatment.On the basis of routine treatment of Western medicine,16 subjects in the experimental group were given granule preparation of XAF(7.72 g/bag),16 subjects in the control group were given granule preparation of XAF placebo(7.72 g/bag).The leading period of both groups was 1 week.The medications were all taken orally,1 bag each time,2 times a day by warm water.The course of treatment was 6 months.Observation indicators include general information,efficacy indicators and safety indicators.General information:gender,age,height,weight,and combined diseases.Efficacy indicators include:①Target plaque efficacy:areal and diameter stenosis degree of the target plaque,target plaque volume,the average CT value and calcification score;②Blood lipid efficacy:total cholesterol(TC),triglycerides(TG),low density lipoprotein(LDL),high-density lipoprotein(HDL),very low-density lipoprotein(VLDL);③Inflammatory index:High-sensitivity C-reactive protein(hs-CRP);④CHD angina TCM symptom score;⑤TCM syndrome score;⑥Seattle Angina Questionnaire(SAQ).Safety indicators include vital signs,blood routine,urine routine,stool routine,liver function,renal function,electrocardiogram and adverse events;Statistical analysis was performed using Excel 2010 and SPSS Statistics 20.0.Measurement data are expressed as mean±standard deviation or median and quartile.Count data is expressed in quantity and percentage,statistical test using two-sided test,P<0.05 was considered the difference was statistically significant.ResultsGeneral information baseline comparison:There were no significant differences in gender,age,height,body mass index,history of tobacco and alcohol,angina type,past history,family history and concomitant medications between the two groups before treatment.The differences were not statistically significant(P>0.05).The two groups were comparable.Target plaque efficacy:There was no significant difference in target plaque efficacy between the experimental group and the control group before and after 6 months treatment(P>0.05).① The areal stenosis degree of the experimental group was(52.00±13.15)%before treatment and decreased to(38.42±20.68)%after 6 months of treatment.The difference was statistically significant(P=0.033<0.05).There was no significant difference of the areal stenosis degree in the control group before and after 6 months treatment(P>0.05).②The diameter stenosis degree of the target plaque:The diameter stenosis degree of the experimental group was(30.83±9.81)%before treatment and decreased to(22.50±13.36)%after 6 months treatment.The difference was not statistically significant(P>0.05),There was no significant difference in diameter stenosis degree in the control group before and after 6 months treatment(P>0.05).③ Target plaque volume:The target plaque volume of the experimental group was(73.53±36.90)mm3 before treatment and decreased to(67.65±39.77)mm3 after 6 months treatment.The difference was not statistically significant(P>0.05),There was no significant difference in the target plaque volume in the control group before and after 6 months treatment(P>0.05).④Target plaque average CT value:The target plaque average CT value of the experimental group was 262.65±154.56 before treatment and increased to 278.29±138.93 after 6 months treatment.The difference was not statistically significant(P>0.05).There was no significant difference in the target plaque average CT value in the control group before and after 6 months treatment(P>0.05).⑤ Target plaque calcification score:The target plaque calcification score of the experimental group was 55.50±66.11 before treatment and increased to 76.54±98.94 after 6 months treatment.The difference was not statistically significant(P>0.05).There was no significant difference in the target plaque calcification score in the control group before and after 6 months treatment(P>0.05).Blood lipids and hs-CRP efficacy:① There were no significant differences in TC,TG,HDL,LDL and VLDL between the experimental group and the control group before and after 6 months treatment(P>0.05).② There were no significant differences in hs-CRP between the two groups before and after 6 months treatment(P>0.05).CHD angina TCM symptom efficacy:①Total CHD symptom score:The total CHD symptom scores in the experimental group and the control group decreased after 6 months treatment.The differences were statistically significant(P<0.05).②Single symptom score:After 6 months treatment,the scores of chest pain,chest tightness,insomnia,and sighing symptoms decreased in the experimental group,and the difference was statistically significant(P<0.05).After 6 months treatment,the scores of chest tightness decreased,the difference was statistically significant(P<0.05).After 6 months treatment,the decreased scores of shortness of breath in the experimental group was higher than that in the control group,and the difference was statistically significant(P<0.05).TCM syndrome efficacy:①There was no significant difference in the TCM syndrome between the experimental group and the control group group before and after 6 months treatment(P>0.05).②After 6 months treatment,the TCM syndromes scores decreased in both groups,and the differences were statistically significant(P<0.05).Seattle Angina Questionnaire(SAQ):In the experiment group,there were significant differences in the degree of physical activity limitation(PL),anginal stability(AS),anginal frequency(AF),treatment satisfaction(TS)and disease perception(DP)before and after 6 months treatment(P<0.05).In the control group,only AS,TS,and DP were statistically significant before and after 6 months treatment(P<0.05).In terms of safety aspect:The blood,urine and stool routine,liver and kidney function and electrocardiogram of the two groups subjects were within the normal range before and after 6 months treatment.No adverse events occurred in all subjects during the entire treatment period.It indicates the safety of clinical application of XAF.ConclusionXAF has a good effect on improving CHD symptoms such as chest pain,chest tightness,insomnia,sighing,shortness of breath,improving quality of life,stabilizing plaque and improving coronary stenosis.Its mechanism still needs to be further explored. |
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