Objective:To observe the clinical effect of Shu Xintong capsule on the treatment of diabetes mellitus complicated with coronary heart disease(Qi Yin deficiency and phlegm stasis syndrome),and explore its mechanism of action,in order to provide practicable clinical protocol for the treatment of diabetes mellitus complicated with coronary heart disease.Methods:Using the method of randomized control trial,70 patients(with Qi Yin deficiency and phlegm stasis syndrome of diabetes mellitus complicated with coronary heart disease) up to the diagnostic criteria were divided into two groups,35 cases in the treatment group and 35 cases in the control group.Control group:basic treatment+western medicine,treatment group: basic treatment+western medicine+Shu Xintong capsule,3 courses with 4 weeks in a course.During the observation,if patients, angina pectoris occuring,they need to take nitroglycerin to relieve the symptom.In this clinical study,the changes of FPG,2h PG,Hb Alc,blood lipid(TC,TG,HDL-C,LDL-C),hs-CRP,total score of TCM symptoms,total score of angina pectoris, electrocardiogram,stopping and decreasing rate of nitroglycerin were observed before and after therapy.The data were analyzed by SPSS17.0 statistical software.Results:(1)Comprehensive effect were compared between the two groups:The total effective rate was 88.6% in the treatment group and 60.0% in the control group,it showed that treatment group was significantly better than control group(P<0.01);(2)TCM symptoms effect were compared between the two groups:The total effective rate was 94.3% in the treatment group and 60.0% in the control group,it showed that treatment group was significantly better than control group(P<0.01);(3)Angina pectoris effect were compared between the two groups :The total effective rate was 91.4% in the treatment group and 71.4% in the control group,it showed that treatment group was better than control group(P<0.05);(4)Alectrocardiogram effect were compared between the two groups:The total effective rate was 88.6% in the treatment group and 68.6% in the control group,it showed that treatment group was better than control group(P<0.05);(5)The stopping and decreasing rate of nitroglycerin were compared between the two groups:The rate was 87.5% in the treatment group and 63.3% in the control group,it showed that treatment group was better than control group(P<0.05);(6)After the treatment,the total score of TCM syndrome and angina pectoris of the two groups were all reduced(P<0.01),but it showed that treatment group was significantly better than control group(P<0.01);(7)After the treatment,the FPG,2h PG,HbAlc and hs-CRP were all reduced(P<0.01),but it showed that 2hPG and HbAlc in the treatment group were reduced significantly better than control group(P<0.01),and there was no statistical difference between the two groups in the reducing of FPG and hs-CRP(P>0.05);(8)After the treatment,the TC,TG,HDL-C and LDL-C in the two groups were all significantly improved(P<0.01),but it showed that TC and LDL-C in the treatment group was reduced better than control group(P<0.05 and P<0.01);there was no statistical difference between the two groups in the improving of HDL-C and TG(P>0.05);(9)During the clinical observation,the blood routine examination,urine routine examination,liver function(ALT and AST)and renal function(BUN and Cr)were all normal,without occuring adverse reactions and events.Conclusion:(1)Shu Xintong capsule can effectively improve the clinical symptoms of diabetes mellitus complicated with coronary heart disease(Qi Yin deficiency and phlegm stasis syndrome);(2)Shu Xintong capsule can significantly reduce the 2h PG, Hb Alc,TC and LDL-C of diabetes mellitus complicated with coronary heart disease(Qi Yin deficiency and phlegm stasis syndrome);(3)The clinical effect of Shu Xintong capsule on the treatment of diabetes mellitus complicated with coronary heart disease(Qi Yin deficiency and phlegm stasis syndrome)was significant and safe,it can provide practicable clinical protocol for the treatment of diabetes mellitus complicated with coronary heart disease. |