| Objective:1.To observe the lipid-regulating effect of TIAOZHITONGMAI granule directed by method qi supplement and blood activation combined with phlegm transformation treatment method on the patients with the phlegm-blood-stasis syndrome of hyperlipidemia.2.To study the genotypes and allelic frequencies of the phlegm-blood-stasis syndrome population in hyperlipidemia,at the same time, analysis the effect of ApoE gene polymorphism on serum lipid levels.3.Furthermore to ascertain the effect of gene polymorphism on the method of qi supplement and blood activation combined with phlegm transformation treatment method and the relationship between gene and drug effect.Methods:To detect ApoE genotype in 210 hyperlipidemia patients,according to random,double blind,double imitate and control principle,the course of treatment is 4 weeks.Experimental group has 106 patients,given TIAOZHITONGMAI granule,12 grain,bid,po and XUEZHIKANG placebo 2 grain,bid,po.Controlled group has 54 patients,giving XUEZHIKANG capsule 2 grain,bid,po,TIAOZHITONGMAI granule placebo 12 grain,bid po.To observe the change of TC,LDL-C,TG,HDL-C,apoA1,apoB,LP(a),D-D and TCM syndrome between pretreatment and posttreatment.Results:1.The total effective rate in regulating serum lipid of experimental group is 75.2%,decreacing TC,TG,LDL-C,ApoB,Lp(a),increasing HDL-C(p﹤0.05),there are significant difference comparing to pretreatment. The total effective rate in regulating serum lipid of controlled group is 77.9%,decreasing TC,TG,LDL-C,ApoB,increasing HDL-C(p﹤0.05),there are no difference between experimental and controlled group in serum lipid-regulating effect.2.On the treatment responses of Traditional Chinese Medicine syndrome,the total effective rate of TTG(81.1%) has an advantage over that of XUEZHIKANG (72.1%)(p<0.05).there are significant difference between two groups.TIAOZHITONGMAI granule is superior to XUEZHIKANG in improving TCM syndrome.3.Five genotypes are found in 210 patients,ε3 is the highest accounting for 88.3%.The frequency of E2/3,E3/3,E2/4,E3/4,E2/2 are 9.05%,73.81%,0.95%,15.24% and 0.95% respectively .There are not significant difference between men and women . Compared with Beijing natural population, the genotypes and allelic frequencies of ApoE has no difference.4.The levels of low density lipoprotein cholesterol(LDL-L) among the different apolipoprotein E genotypes are E3/4>E3/3>E2/3, E3/4 is significantly enhance the level of LDL-C(p﹤0.05). There is no effect of ApoE gene polymorphism on the level of TG,TC,HDL-C,apoA1,apob and LP(a).Conclusion:1.TIAOZHITONGMAI granule has a good effect regulating serum lipid and has similar total effect as XUEZHIKANG placebo.The efficacy of TIAOZHITONGMAI granule to improve the phlegm-blood-stasis syndrome has an advantage over that of XC.It illustrates that qi supplement and blood activation combined with phlegm transformation treatment method can effectively regulate serum lipid.2.There is no significant difference between the frequencies distribution of genotype and allele in patients with hyperlipidemia and in those healthy people.3.Basic blood lipid level is variable with the different ApoE genotype.E3/4 significantly enhance the level of LDL-C(p﹤0.05)4.The ApoE gene polymorphism affects the drug regulating serum lipid in various individual,E3/4 and E2/3 genotype are sensitive to the drug of qi supplement and blood activation combined with phlegm transformation treatment method.5.The patients of different ApoE genetypes has different responses to the treatment .After treatment,LDL-C lowing rate in E3/4 is highest comparing to E2/3,E3/3 and HDL-C improving rate are highest in E2/3 is highest comparing to the other two genotypes. There are significant difference between three genotypes(p﹤0.05). |