The Application Of Replenishing Qi And Dispelling Phlegm And Stasis In Treating HIV/AIDS Patients With Hyperlipidemia After HAART

Theoretical researchObjectiveThe objective of this research is to study the "theory,methods,prescription and drug" of hyperlipidemia after HAART using theory of TCM.It can not only normalize the clinical application of replenishing Qi and dispelling phlegm and stasis in treating hyperlipidemia after HAART,but also provide a theoretical background and support to it.TheoryThe cause of AIDS is epidemic disease infection.Its pathogenesis is mixture of asthenia and sthenia.And it has apparent change with the progress of the course of the disease.The early stage of AIDS is mainly with hot and humid.Mid-term is mainly with the decline of vital qi and the endogeny of turbid phlegm and stasis blood.Later period is short of vital qi.So it suffer a great risk of evil influence and opportunistic infections often appears.The cause of hyperlipidemia is diet and emotions.The disease location of hyperlipidemia is spleen,kidney and liver.The pathogenesis of hyperlipidemia is asthenia in origin and asthenia in superficiality.Asthenia in origin means deficiency of vital energy of spleen and kidney.Asthenia in superficiality means stagnation of liver qi,stagnation of qi activity and the endogeny of turbid phlegm and stasis blood.Qi deficiency,phlegm and blood stasis is the majority of the pathogenesis of hyperlipidemia after HAART.Phlegm and blood stasis has diverse forms of performance in clinical treatment.Phlegm should be treated by warm drugs.Blood stasis should be treated by drugs used to activate blood flow.MethodsReplenishing Qi and dispelling phlegm and stasis is the common method in treating hyperlipidemia after HAART.Prescription and drugThis part have explained the clinical application of single Chinese herb,ancient prescriptions,Chinese patent medicine and other treatments in treating hyperlipidemia after HAART.Clinical researchObjectiveIt will analysis the curative effect of 100 patient treated by replenishing Qi and dispelling phlegm and stasis.The objective of this clinic trial is to explore the therapy of hyperlipidemia after HAART in TCM and testify the curative effect of replenishing Qi and dispelling phlegm and stasis.This clinic trial will indicate the direction of the therapy of hyperlipidemia after HAART in TCM.MethodsBy virtue of the Twelfth Five-year major special projects-"The study of TCM therapeutic schedule in treating HIV/AIDS patients with hyperlipidemia after HAART",it will analyze the therapeutic outcome of 100 patient treated by Jiangzhi formula.This is a randomized,double-blind,placebo-controlled trial.Participants(100)were recruited from Beijing Ditan hospital.HIV infected patients with dyslipidemia after highly active antiretroviral therapy,who would be likely to receive integrative treatment or HAART treatment alone,were recruited through hospital advertisements.The participants were randomly allocated to two groups(1:1).The participants in Jiangzhi formula group are treated by taking Jiangzhi formula(with the function of replenishing Qi and dispelling phlegm and stasis)orally twice a day.The participants in Placebo group are treated by taking placebo orally twice a day.We tested the values of TG,TC,HDL-C and LDL-C of the participants in each group at 24 weeks.We also tested the classical symptoms in TCM.ResultsGeneral data analysis:The subjects' average age is about 40 years old.The subjects'average infected time is about 5 to 6 years.The subjects' HAART treatment time is more than 4 years on average.Male patients accounted for most in the participants.The main route of transmission is gay spread.The BMI of most participants is located above average,but no more than the normal range.Most of the patients are with the bad living habits such as smoking and drinking.The proportion of high TG to high TC is about 5 to 1.Abnormal TG patients accounted for 99%,and simple TC increase is relatively rare.Main outcome indicators:There were no significant difference(P= 0.694)in TC between the Jiangzhi formula group and the placebo group at week 24.The value of TG in the Jiangzhi formula group is significantly decreased(P=0.040)compared to the placebo group at week 24.It means Jiangzhi formula can reduce the TG value of patients.We found a significantly increased value of HDL-C(P=0.038)in the Jiangzhi formula group compared to the placebo group at week 24.It means Jiangzhi formula can rise the HDL-C value of patients.There were no significant difference(P= 0.939)in LDL-C between the Jiangzhi formula group and the placebo group at week 24.Secondary outcome measures:There were no significant difference(P=0.536)in CD4+ T lymphocyte between the Jiangzhi formula group and the placebo group at week 24.Symptom analysis:We found a significantly decreased TCM symptoms score of insomnia,thirst,chest distress,abdominal distension,soreness and weakness of waist and knees in the Jiangzhi formula group compared to the placebo group at week 24(P<0.05).It means Jiangzhi formula can cure the TCM symptoms such as insomnia,thirst,chest distress,abdominal distension,soreness and weakness of waist and knees.There were no significant difference(P= 0.741)in TCM symptoms score of inappetence between the Jiangzhi formula group and the placebo group at week 24.ConclusionReplenishing Qi and dispelling phlegm and stasis has curative effect on reducing TG and rising HDL-C in patients with hyperlipidemia after HAART,but has no curative effect on reducing TC and LDL-C.The method of replenishing Qi and dispelling phlegm and stasis can cure the TCM symptoms such as insomnia,thirst,chest distress,abdominal distension,soreness and weakness of waist and knees in patients with hyperlipidemia after HAART,but has no curative effect on inappetence.During clinical trial,we did not find any side effects,the method of replenishing Qi and dispelling phlegm and stasis is safety.