The Control Study On Patients With Hyperlipidemia After HAART Treated With Jiangzhi Granule

Highly active antiretroviral therapy which is widely used in clinic has significantly reduced the incidence and mortality of AIDS patients,which greatly prolong the life of patients.Patients need lifelong medication,so the side effects caused by long-term antiviral therapy is increasingly affecting the quality of life of AIDS patients.The most common side effects is the abnormal fat metabolism and insulin resistance.The abnormal metabolism of the body interact to promote the occurrence of cardiovascular disease in AIDS patients,such as atherosclerosis,myocardial infarction and so on.It has been reported that patients taking PIs have a higher risk of acute coronary syndrome than those taking other antiviral drugs.In the NNRTIs,Efavirenz Tablets is associated with severe dyslipidemia,which shows the elevation of TG and TC,reduction of HDL-C and redistribution of body fat.Now the treatment of abnormal lipid metabolism after HARRT includes the adjustment of antiviral drugs and the use of lipid-lowering drugs.But the drug interactions limit the clinical use.For example,Statins interact with protease inhibitors.The combination of statins and protease inhibitors may lead to the change of drug concentration and the increased adverse reaction of drugs.Lipid-lowering drugs Fibrates is more effective on hyperlipidemia characterized by elevated TG,but the effect of Fibrates is poor for LDL-C.The long-term application of Fibrates can also lead to abnormal liver function.Therefore,the western medicine treatment of hyperlipidemia after HAART is not very ideal.But Chinese medicine plays an important role in regulating the abnormal metabolism of the body.It can improve the overall level of metabolism in patients with both single drug and compound drugs which has a comprehensive effectand no obvious side effects.It can also improve the symptoms and signs of patients through the use of dialectical medicine.From the angle of modern scientific demonstration and the experimentation the modern pharmacology of traditional Chinese medicine has proved that Chinese medicine can regulate abnormal metabolism of lipid function.Therefore,the traditional Chinese medicine may have certain advantages in the prevention and treatment of HAART after fat metabolic syndrome.But at present,there is still a lack of research and reports about the treatment of hyperlipidemia by HAART in Chinese medicine.Through exploring the TCM treatment of hyperlipidemia after HAART this study is to provide the basis for TCM treatment of abnormal lipid metabolism after HAART.Research purpose:We evaluate the efficacy and safety of Jiangzhi granule in improving lipid metabolism and reducing the risk of cardiovascular disease after HAART.We extract a clinically effective and safe Chinese traditional medicine compound preparation,and provide clinical evidence for TCM clinical treatment of hyperlipidemia after HAART.Research method:The research object with hyperlipidemia is HIV antibody positive patients with deficiency of spleen and kidney in two cases and syndrome of phlegm turbidity.Patients meet the inclusion criteria of Western Medicine and Chinese Medicine.By using the method of randomized controlled study,60 patients with hyperlipidemia after HAART were randomly divided into experimental group(HAART+ Jiangzhi granules)and control group(HAART+ placebo).Before treatment and after treatment for 12 weeks and 24 weeks,we measure TCM symptom,blood lipids,liver and kidney function and other indicators,and compare the index of two groups.After the observation,the data were analyzed statistically.Research results:1.Efficacy evaluation1.1 Efficacy evaluation of Chinese MedicineIn the treatment of 12 weeks efficiency of TCM symptoms effect in the experimental group is higher than the control group.But there is no statistical significance(X2 = 2.690,p =0.101).In 24 weeks of treatment,the total efficiency of the experimental group was 65.5% and control group total effective rate was 20.7%and there is statistical significance(X2=11.881,p=0.001).This suggests that the traditional Chinese medicine granule has a good effect in improving the symptoms of Chinese medicine,but it takes a certain amount of time to work.In the experimental group,there was no significant difference in the improvement of TCM symptoms of different gender and age(p>0.05).After 24 weeks of treatment,TCM symptoms total score of the experimental group decreased more significantly than the control group and there is statistical significance(t=-2.544,p=0.014).The results indicated that Jiangzhi granules had a good effect on the improvement of TCM symptoms total score.1.2 Changes of serum lipid levels before and after treatmentAfter 12 weeks of treatment effective rate of improvement of laboratory indexes of patients in the experimental group who have received Jiangzhi granule treatment is higher than the control group.But there is no statistical significance(p>0.05).After 24 weeks of treatment,the total efficiency of the experimental group was 58.6% and control group total effective rate was 17.2% and there is statistical significance(X2=10.545,p = 0.001).The results indicated that Jiangzhi granule was effective in improving the laboratory examination indexes.In the experimental group after 24 weeks of treatment Jiangzhi granule can significantly reduce the level of TG(t=2.068,p=0.048)and can also increase the level of HDL-C with statistical significance(t=-2.562 p=0.016;12 weeks,24 weeks t=-2.450,p=0.021).On the contrary the results of treatment on TC and LDL-C levels had no statistical significance(p> 0.05).TC,TG,HDL-C,LDL-C in the control group after treatment are not statistically significant(p> 0.05).At 12 and 24 weeks of treatment,therapeutic effect of HDL-C of the experimental group is better than the control group with statistical significance(12weeks t=2.573,p=0.013;24 weeks t=3.041,p=0.004).At 24 weeks oftreatment,therapeutic effect of TG of the experimental group is better than the control group with statistical significance(t=-2.622 p=0.011).The results indicated that Jiangzhi granule can improve the level of HDL-C,TG,but requires a certain period of time.1.3 the curative effect of ApoAI and ApoB between the two groups before and after treatmentThere is no significant difference in the curative effect of ApoAI between the two groups at the end of the treatment for 12 weeks.The difference is statistically significant between the two groups(p=0.029)at the end of the treatment for 24 weeks.It is suggested that the lipid-lowering granules can improve the efficiency of ApoAI.There is no significant difference between the two groups in the treatment of ApoB at the end of the 12 and 24 weeks(p>0.05).1.4 the change of arterial stiffness indexAfter lipid-lowering granules treatment,experimental group atherosclerosis index decreased.The decline of Atherosclerosis index of experimental group is more significant than the control group at 24 weeks(t=-2.707,p=0.01).After lipid-lowering granules treatment for 12 weeks,AI of the patients in the experimental group decreases but there is no significant difference.By contraries there is significant difference at the treatment for 24 weeks.In the control group atherosclerosis index fluctuates with no statistical significance.These results suggest that the lipid-lowering granule can reduce the atherogenic index of cardiovascular risk to some extent,but it takes some time to take effect.2.safety evaluationDuring the clinical trial,vital signs,blood routine,urine routine,liver and kidney function,HIV load,CD4 cell number and other aspects in patients with hyperlipidemia after HAART were no significant abnormalities,and no obvious toxic side effects.This shows that the lipid-lowering granules is safe and worthy of clinical promotion.ConclusionIn this study,Jiangzhi granule has a good effect on the treatment of mixed hyperlipidemia with elevatory TG and descendant HDL-C after HAART.By tonifying spleen and kidney,resolving phlegm and removing blood stasis,it can improve the abnormal state of lipid metabolism after HAART and reduce the risk of cardiovascular disease.It is a traditional Chinese medicine compound preparation with good clinical efficacy and safety.