| ObjectiveTo observe the symptoms and laboratory results of HIV/AIDS patients with hyperlipidemia after HAART,and to explore the efficacy and safety of Jiangzhiling granule.So as to provide previous basis for the clinical application and study of mechanism on lipid lowering of Jiangzhiling granule.MethodsThe randomized control study was appliced.According to the inclusion criteria and exclusion criteria,48 HIV/AIDS patients with hyperlipidemia after HAART with spleen and kidney deficiency combined with phlegm turbid and blood stasis syndrome were divided into 25 experimental group(Jiangzhiling granule+HAART)and 23 control group(fenofibrate capsule+HAART).At five periods of baseline,3 and 6 months after treatment,and 3 and 6 months after drug withdrawal,symptoms,BMI and waist circumference were observed,some related indexes were measured including blood lipid,function of liver and kidney,myocardial enzymes,CD4+T lymphocytes,CD8+T lymphocytes and HIV load,some imaging were examined including IMT,chest X-ray,abdominal color ultrasound,urinary color ultrasound and cardiac color ultrasound.The indexes were compared between the two groups and the data was statistically analyzed.Results1.Main efficacy indexes:There was no significant difference on TC between the baseline and every period in each groups(P>0.05),as well as between two groups in treatment periods and after 3 months of drug withdrawal(P>0.05).TG in the control group was higher than that in the experimental group after 6 months of drug withdrawal(P<0.05).After 3 months of treatment,TG in each groups was decreased compared with the baseline(P<0.05).There was no significant difference on TG between the baseline and other periods in each group(P>0.05).After 3 months of treatment,TG in the control group was significantly lower than that in the experimental group(P<0.05),but there was no significant difference on TG between the two groups in other periods(P>0.05).After 6 months of treatment,HDL-C in the experimental group was significantly higher than that in the baseline(P<0.05),but there was no significant difference between the baseline and the period after drug withdrawal(P>0.05),After 3 months of treatment,HDL-C in the control group was significantly higher than that in the baseline(P<0.001),and significantly higher than that in the experimental group(P<0.001).After 6 months of treatment and drug withdrawal,the level of HDL-C in the control group was still higher than that in the baseline(P<0.05),but there was no significant difference compared with experimental groups(P>0.05).The LDL-C in each treatment period and drug withdrawal period in the experimental group was slightly lower than that in the baseline,but there was no significant difference(P>0.05).In the control group,the LDL-C in each treatment period and drug withdrawal period was higher than that in the baseline,especially at 6 months of treatment(P<0.05).Between the two groups,there was no significant difference on LDL-C in every period(P>0.05).After 3 months of treatment,IMT in the experimental group was significantly lower than that in baseline(P<0.01),and IMT was still significantly lower than that in the baseline after 6 months of treatment(P<0.05).In the treatment periods,IMT in the experimental group was lower than that in the control group(P<0.01).After drug withdrawal,IMT was slightly lower than that in baseline but there was no significant difference in the experimental group(P>0.05).In the control group,there was no significant difference on IMT between the baseline and each period(P>0.05).There was no significant difference on IMT between the two groups(P>0.05).2.Secondary efficacy indexes:After 3 and 6 months of treatment,BMI in the experimental group was significantly lower than that in the baseline(P<0.05),but there was no significant difference between the baseline and the periods after drug withdrawal(P>0.05).In the control group,BMI decreased at 3 months after treatment,and there was significant difference compared with the baseline(P<0.01).There was no significant difference between the baseline and 6 months after treatment as well as 3 and 6 months after drug withdrawal(P>0.05).There was no significant difference in every period between two groups(P>0.05).After 3 months of treatment,the waist circumference of the experimental group was significantly lower than that in the baseline(P<0.01).After 6 months of treatment and drug withdrawal,there was no significant difference on waist circumference compared with the baseline in the experimental group(P>0.05).After 3 and 6 months of treatment,the waist circumference of the control group was significantly lower than that in the baseline(P<0.01).After drug withdrawal,there was no significant difference on waist circumference compared with the baseline in the control group(P>0.05).There was no significant difference on waist circumference between the two groups(P>0.05).After 3 and 6 months of treatment,there was no significant difference on symptom score in the experimental group compared with the baseline(P>0.05).After drug withdrawal,the symptom score was significantly lower than that in the baseline in the experimental group(P<0.05).There was no significant difference between every period and baseline in the control group(P>0.05).There was no significant difference on symptom score between the two groups(P>0.05).In the experimental group,there was no significant difference on the score of tongue and pulse between baseline and 3 months after treatment(P>0.05),but the score of tongue and pulse decreased significantly between baseline and other periods(P<0.05).There was no significant difference between every period and baseline in the control group(P>0.05).There was no significant difference on score of tongue and pulse between the two groups at 3 and 6 months after treatment(P>0.05).After 3 and 6 months of drug withdrawal,the score of tongue and pulse in the experimental group was lower than that in the control group(P<0.05).3.Safety indexesIn the experimental group,RBC and Hb decreased after 3 and 6 months of treatment(P<0.05),but increased after drug withdrawal,and there was no significant difference compared with baseline(P>0.05).There was no significant difference on WBC and PLT between baseline and each priod in the experimental group(P>0.05).In the control group,RBC and Hb decreased after 3 months of treatment(P<0.05),PLT was higher than that in the baseline(P<0.05).There was no significant difference on RBC,Hb and PLT between baseline and 6 months after treatment,as well as 3 and 6 months after drug withdrawal in the control group(P>0.05).There was no significant difference on WBC between baseline and each period in the control group(P>0.05).There was no significant difference on RBC,Hb,WBC and PLT between the two groups(P>0.05).There was no significant difference on ALT and AST between the baseline and after 3 months of treatment in the experimental group(P>0.05).After 6 months of treatment and 3 months of drug withdrawal,ALT and AST were higher than that in the baseline in the experimental group(P<0.05)and ALT decreased after 6 months of drug withdrawal but there was no significant difference compared with baseline(P>0.05).AST was still higher than that in the baseline in the experimental group(P<0.05).After 3 months of treatment,eGFR in the experimental group was significantly higher than that in the baseline(P<0.001)and eGFR was still significantly higher than that in the baseline after 6 months of treatment(P<0.01).After drug withdrawal,eGFR decreased so that there was no significant difference compared with the baseline(P>0.05).At 3 months after treatment,the levels of ALT and AST in the control group were significantly higher than those in the baseline(P<0.05).There was no significant difference on ALT and AST between the baseline and other periods in the control group(P>0.05).After 3 months of treatment,eGFR in the control group was significantly lower than that in the baseline(P<0.001)and after 6 months of treatment,eGFR was still significantly lower than that in the baseline(P<0.01).After drug withdrawal,eGFR increased and there was no significant difference compared with the baseline in the control group(P>0.05).After 3 months of treatment,the AST in the control group was higher than that in the experimental group(P<0.01).There was no significant difference on AST in the other periods between the two groups(P>0.05).At 3 and 6 months after treatment,the eGFR in the experimental group was higher than that in the control group(P<0.01).After drug withdrawal,there was no significant difference on eGFR between the two groups(P>0.05).There was no significant difference on TBiL and ALT between the two groups in different periods(P>0.05).There was no significant difference on CK-MB between baseline and every period in each group(P>0.05).There was no significant difference on CK-MB between the two groups(P>0.05).There was no significant difference on the number of CD4+T lymphocytes between baseline and after 3 and 6 months of treatment in each group(P>0.05).After the 3 month of drug withdrawal,the number of CD4+T lymphocytes in each groups was higher than that in the baseline(P<0.05).After 6 month of drug withdrawal,there was no significant difference on the number of CD4+T lymphocytes compared with the baseline in each groups(P>0.05).There was no significant difference on the number of CD8+T lymphocytes between the baseline and every period in each groups(P>0.05).There was no significant difference on the number of CD4+T and CD8+T lymphocytes in every period between the two groups(P>0.05).There was no significant difference on HIV load,chest X-ray,abdominal color ultrasound,urinary color ultrasound and cardiac color ultrasound between the baseline and different period in each groups(P>0.05),and there was no significant difference in every period between the two groups(P>0.05).Conclusion1.The effect of Jiangzhiling granule on reducing TG and increasing HDL-C is slightly weaker than that of fenofibrate capsule;Jiangzhiling granule and fenofibrate capsule has no significant effect on reducing TC and LDL-C.Jiangzhiling granule can reduce IMT,that effect is Superior to Fenofibrate capsule.2.Jiangzhiling granule can reduce BMI,waist circumference,symptoms score and score of tongue and pulse,and improve the state of lipid in patients with hyperlipidemia after HAART with spleen and kidney deficiency combined with phlegm turbid and blood stasis syndrome by tonifying spleen and kidney,removing blood stasis and expelling phlegm.Fenofibrate capsule can also reduce BMI and waist circumference,but has no effect on symptoms score and score of tongue and pulse.3.Jiangzhiling granule can obviously improve renal function,but fenofibrate capsule has certain damage to renal function;Jiangzhiling granule and fenofibrate capsule can reduce RBC and Hb,increase ALT and AST,has no significant effects on myocardial enzymes,CD4+T lymphocytes,CD8+T lymphocytes,HIV load,chest X-ray,abdominal color ultrasound,urinary color ultrasound and heart color ultrasound.Jiangzhiling granule does not affect the efficacy of HAART and cause organic lesions to the human body.Jiangzhiling granule can treat spleen and kidney deficiency combined with phlegm turbid and blood stasis syndrome by tonifying spleen and kidney,removing blood stasis and phlegm turbid.Jiangzhiling granule can improve hyperlipidemia characterized by elevated TG and decreased HDL-C,as well as Abnormal distribution of blood lipid.At the meantime,Jiangzhiling granule can reduce IMT and increase eGFR.Jiangzhiling granule has less side effects than Fenofibrate capsule,and can effectively reduce blood lipids without affecting the efficacy of HAART.So it has a potential preventive and therapeutic effect in reducing cardiovascular events. |
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