| Purpose:to investigate the immunological regulation function of Fuzheng Anti-Aids Prescription on HIV/AIDS patients in immune parameters(IL-2 and IFN-γ)Research method1 Research objectsIn this topic,16 cases for clinical observation came from cases in Chinese medical hospital and disease control center in Qichun and Nanzhang counties.9 cases are male,7 are female with average age of 43.3±11.21 and average weight of 55.1±8.12kg;way of infection:2 cases were infected by uncertain cause,10 cases were infected by transfuse,4 cases were infected by sexual contact。2 Diagnosis standards2.1 Diagnosis standards for western medicine:refers to "Diagnosis standard and treatment principle of HIV/AIDS", Chinese Code GB,2001 edition.2.2 Diagnosis standards for Chinese medicine:refers to "Clinical technical program of Chinese medicines in treatment against AIDS (Tryout)"(2004 edition) established by expert team for demonstration organized by State Administration of Traditional Chinese medicine of the People's Republic of China.3 Acceptance standard of cases3.1 Being in accordance with HIV/AIDS diagnosis standards of western and Chinese medicines.3.2 CD4 ranged from100/ mm3 through to 500/ mm33.3 Testees aged from 18 through to 65.3.4 All were voluntaries and signed the Medical Informed Consent Letter.3.5 All had not taken part in other clinical test.3.6 All conforming to diagnosis standard of this disease and excluding from items in the "Exclusion standard of cases" below can be brought into the experiment.4 Exclusion standard of cases4.1 Those who have severe disease(s) in cardiovisceral vessel, respiratory,endocrine,kidney,blood or psycho systems;4.2 Those aged under 18 or above 65,females in gestation or lactation.4.3 Hyper-susceptible persons or those are allergic to this medicine;4.4 Those have severe opportunistic infection disease.5 Disposal of cases leaving treatment5.1 For those cases leaving treatment,the researcher shall strive to contact with them to complete evaluation items to be finished and record the time of last medication as far as possible.5.2 For those cases leaving treatment due to untoward reaction, makes the final judgment for relative factors of tested medicines via follow-up,and records curative effect in leaving into untoward reaction report;for those cases leaving treatment due to poor curative effect,shall be recorded as non-effectiveness;for those cases leaving treatment due to events none of curative effect and untoward reaction,curative effect of medication for cases under 1/2 period of medication treatment shall be not recorded and the last curative effect of medication shall be recorded for cases exceeding(or including) 1/2 period of medication treatment.5.3 For any cases leaving treatment,the researcher must fill one of above leaving causes into CRF.5.4 For all patients(whether or not had left) selected and had took encoded medicines,their CRF statements shall be recorded and preserved for documentation or intention to treatment(ITT analysis).No replacement needed for cases leaving treatment.6 Elimination standards6.1 Cases found unconformity with acceptance standard after bring-into.6.2 Cases with total medication quantity under 20%or exceeding 120% of specified quantity in the program after bring-into.7 Standard of suspending experiment7.1 In case CD4＜100/mm3,the clinical experiment shall be suspended.7.2 Experiment shall be suspended in case of severe complication or rapid exacerbation7.3 Patients who are reluctant to continue the clinical experiment during the experiment process can withdraw from the experiment after applying to the doctor being in charge.8 Treatment methods8.1 Resources of medicinesExperimental medicines:Fuzheng Anti-Aids particle,components of the medicine:Radix Astragali,root of Co donopsis Pilosula, liquorice,turmeric,redroot gromwell and etc.Supplied by Hubei Hospital of Traditional Chinese Medicine.8.2 PackageAll information below are indicated on the medicine package:code, name of medicine(special medicine for clinic research),ingredient of medicine,function and main treatment,usage and dosage, specification,store,use life.8.3 MedicationDosage regimen:Fuzheng Anti-Aids Prescription particle 1pack/time, 3times/day,after meal.8.4 Period of treatmentThe period of treatment shall be 5 months.From the end of September 2006 to the end of February 2007.8.5 Combined medicationDuring research,complication and medication shall be uniformly managed.8.5.1 In experiment period,all cases shall avoid take western or Chinese medicines,which will affect curative effect of this medicine.8.5.2 During observation,those cases need additional other medicines or treatments shall be recorded in observation statement (including name of medicine,dosage and usage).Those with complicated opportunistic infection shall be treated in normal method.Those with tumors shall be stopped for treatment.8.6 Medicine management8.6.1 Management before experiment:the manufacturer prepares experimental medicines before experiment. 8.6.2 Management in the period of experiment:establish management system in the period of medicine experiment.8.6.3 Management after experiment:Medicines remained shall be collected and returned to Hubei Chinese Medicine Hospital or destroyed by medicine controller.8.7 Observation indexes and measurement method8.7.1 Immune function indexes:IL-2,IFN-γ8.7.2 measurement method:ELISA methodResearch resultexpression of MIP-1βhas increased contrasting with expression before treatment,and,has significance in statistics(P＜0.05).ConclusionFuzheng Anti-Aids Prescription can improve the density of IL-2,IFN-γin blood serum of HIV/AIDS patients,more IL-2,IFN-γare secreted,more and stronger lymphocyte are obtained,the better immunologic function will be.
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