| Research background:HAART has limits such as needs of the life-time therapy,toxicity of the drugs,drug resistance,and incomplete constitution of the immunity function.Some traditional Chinese medicines(TCM) have certain effects on the immunity regulations of patients and may improve the symptoms of the patients significantly.It is worth investigating the results of the combination treatments with TCM and HAART to improve the limits of HAART.Research object:To investigate the efficacy and safety of the generic drugs and try to combine the traditional Chinese medicine(TCM) and chemical medicine to reduce the side effects and toxicity of the chemical medicine and improve the patients' immune system capacity.To present the theoretic evidence on the combination HIV/AIDS regimens of TCM and HAART.Research method:2 parts are included.One is the clinical research,the other is the laboratory research.The clinical research method is open, controlled clinical observation.49 subjects are enrolled,divided into controlled arm(n=24) and treatment arm(n=25).The study lasted 24 weeks.The subjects would be checked and followed up each 8 weeks.We would record the patients' medicine-taken status and side effects,the changes of their clinical symptoms,viral load and T cell counts.The statistical analysis has been done.The laboratory research method is as follows:four dogs and ten rats were divided into 2 arms randomly and respectively.The control dog arm is on DDI 2tablets/d4t 2#/NVP 1 #.The combination TCM and HAART regimen dog arm is on DDI 2tablets/d4t 2#/NVP 1#plus xinxuepian 8#.The drugs were administered to the subjects for 7 days.The drugs were administered once daily.The dogs were fasting before the 1st dose,but they were allowed to drink.Take the blood samples at0,10,20,30 min,50,60,70,90,120,180,240, 360,480,600min and put into the tubes with heparin.After centrifugation,200μL plasmas were kept at -20℃.On the seventh day, take theblood samples at0,10,20,30 min,50,60,70,90,120, 180,240,360,480,600min and put into the tubes with heparin.After centrifugation,200μL plasmas were kept at -20℃.The control rat arm is on DDI 36mg·kg-1/d4t 7.2 mg·kg-1/NVP 36 mg·kg-1.The combination TCM and HAART regimen rat arm is on DDI 36mg·kg-1/d4t 7.2 mg·kg-1/NVP 36 mg·kg-1plus xinxuepian 864mg·kg-1.The drugs were administered to the subjects for 7 days.The drugs were administered once daily.The rats were fasting before the 1st dose,but they were allowed to drink.Take the blood samples at0,15,30 min,1,1.5,2, 3,4,6,8,12 h and put into the tubes with heparin.After centrifugation, 200μL plasmas were kept at -20℃.On the seventh day,take the blood samples at0,15,30min,1,1.5,2,3,4,6,8,12 h and put into the tubes with heparin.After centrifugation,200μL plasmas were kept at -20℃Test the concentrations of DDI /D4T/ NVP using the HPLC. Process the data and charts with Excel for Windows(version 7.0 MS)and Microcal origin 6.0.Research resultClinical research..Compare the immunological and viral changes of the two arms before and after the treatments.CD4 cell counts show increase with different degrees in both arms.In the treatment arm,CD4 counts elevated 38cells/μl.In the controlled arm,CD4 counts elevated 70cells/μl in the treatment arm,P＞0.05.The virus response rates are 60%and 28% respectively 2 months and 6 months after treatment in treatment arm.In the controlled arm,the response rates are 70.83%2 and 6 months after treatment.In terms of the viral suppressions,there is no significant difference between 2arms 2 months after treatment.But there is significant difference between 2arms 6 months after treatment.The controlled arm has more efficacy than the treatment arm.P＜0.05.No severe side effects or toxicities have been observed.And the symptoms of the patients are improved.Laboratory results:In the dog arm,no interaction was found.but in the rat arm,the concentrations of DDI have significant decrease,the concentrations of D4T have the trend to decrease,and the concentrations of NVP have no changes in TCM/HAART armsConclusion:The domestic ARV drug is safe.The chemical ARV is better than the combination of TCM and chemical drugs in terms of the virological and immunological profiles.But the incidences of OIs of both arms decrease.Patients in both groups improve to different extents in terms of their strength,appetite,body weight,diarrhea and alopecia conditions.P＞0.05.Laboratory research results show there is drug-drug interaction in some way.The increase of the pill burden will influence the adherence to the drugs directly.The efficacy of the therapy will also be influenced. |
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