Objective: To observe the clinical efficacy and safety of Guanxin Xiaoban capsule combined with folic acid in treating patients with phlegm stasis syndrome of Hyperhomocysteinemia(HHcy),and to provide more evidence for the treatment of HHcy with Guanxin Xiaoban capsule.Methods: Sixty patients with HHcy who satisfied the inclusion criteria and were identified by Chinese medicine as phlegm stasis were randomly divided into 30 cases each in the treatment group and the control group.The control group was treated with folic acid alone,and the treatment group was treated with Guanxin xiaoban Capsules on top of folic acid drugs,both for 8weeks.The changes of liver and kidney function(ALT,AST,GFR,CREA),homocysteine,lipid(TC,TG,LDL-C,HDL-C)levels and Traditional Chinese Medicine(TCM)symptoms were observed before and after treatment,and the adverse reactions during the treatment were also recorded.Results:1.The differences in liver and kidney function(ALT,AST,GFR,CREA),homocysteine(Hcy)level,lipid(TC,TG,LDL-C,HDL-C)levels and TCM symptoms scores were not statistically significant(P>0.05)and comparable between the two groups before treatment.2.Both groups could improve Hcy level and TCM syndrome score after treatment,and the test group was better than the control group in improving Hcy level,TCM syndrome score and total effective rate,and the difference was statistically significant(P<0.05).3.The test group could reduce TC,TG,LDL-C levels and increase HDL-C levels after treatment.Conclusion: Guanxin Xiaoban capsule can improve the TCM symptoms,Hcy level and lipid level in patients with HHcy phlegm stasis syndrome,and the efficacy is better than that of the folic acid alone group.No significant adverse effects were observed during the treatment of Guanxin Xiaoban capsule,which has good clinical application prospects. |