| Purpose of ResearchAs an organism immunodeficiency caused by human immune-deficiencyvirus(human immunodeficiency virus, HIV),Aids(Acquired ImmunodeficiencySyndrome,AIDS) is characterized as ongoing reduction of CD4+ cells anddamage of functions and easily causes the secondary affection of manykinds of opportunistic infections and tumors. It has so long latent period,high spreading speed and complex states that cannot be cured atpresentand has become a topic attracting attentions of the whole world. Chinesemedical filed has been striving to seek a treatment against HIV/AIDS whilemedical fields of the whole world engage in the work to overcome HIV/AIDS.Since traditional medicines has unique advantages in diagnosis andtreatment on the basis of an overall analysis of the illness and thepatient's condition as well as supporting healthy energy to eliminateevils in treatment against difficulties, therefore during this criticalperiod of science development, which put the prevention and cure of AIDSin an important position, the research and development of economical andeffective Chinese medicine or prescriptions preventing and curingHIe/AIDS has momentous and profound significance to China and the wholeworld.Clinical observation and test have been made on the basis of earlylarge quantity of pharmaceutical research (including medicamentextraction, tablet process, pilot scale-up test and quality standardresearch) and toxicological research (acute toxicity test). Purpose ofthis research is: (1) Through observing variation of indexes such as liverand kidney functions, cardiograph to assess safeness of this prescription;(2) through observing symptom and sign scores, lab indexes before andafter treatment (CD4~+ count number. CD4~+/CD8~+,virus volume, chemotacticfactor recipient CCR5,CXCR4, chemotactic factor RANTES,SDF-1,MIP-1 α,β) to assess effectiveness of this prescription. (3) Throughobserving influence of this prescription on chemotactic factor recipientbefore and after treatment (CCR5,CXCR4) and ligand (RANTES,SDF-1,MIP-1α,β) to research action mechanism.Clinical researchResearch method1 Research objectsIn this topic, 30 cases for clinical observation came from cases in Chinesemedical hospital and disease control center in Qichun and Nanzhangcounties. 18 cases are male, 12 are female with average age of 45.1±10.63 and average weight of 57.0±7.15kg; way of infection: 2 cases wereinfected by uncertain cause, 11 cases were infected by transfuse, 5caseswere infected by sexual contact, 12 cases were infection by paid bloodsupply; all cases denied familial disease and history of western and herbmedication.2 Diagnosis standards2.1 Diagnosis standards for western medicine: refers to "Diagnosisstandard and treatment principle of HIV/AIDS", Chinese Code GB, 2001edition.2.2 Diagnosis standards for Chinese medicine: refers to "Clinicaltechnical program of Chinese medicines in treatment against AIDS(Tryout)" (2004 edition) established by expert team for demonstrationorganized by State Administration of Traditional Chinese medicine of thePeople' s Republic of China.3 Acceptance standard of cases3.1 Being in accordance with HIV/AIDS diagnosis standards of western andChinese medicines.3.2 CD4 ranged from100/mm~3 through to 500/mm~33.3 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 excludingfrom items in the "Exclusion standard of cases" below can be broughtinto 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 treatmentEstablish score standards of clinical symptoms and signs Referring torelevant standards stipulated by expert teams of State Administration ofTraditional Chinese medicine of the People' s Republic of China, andstandards in "Instruction principle of clinical research of new Chinesemedicines".6 Treatment method6.1 Resources of medicinesExperimental medicines: Fuzheng Anti-Aids particle, components of themedicine: Radix Astragali, root of Co donopsis Pilosula, liquorice,turmeric, redroot gromwell and etc. Supplied by Hubei Hospital ofTraditional Chinese Medicine.6.2 MedicationDosage regimen: Fuzheng Anti-Aids particle lpack/time, 3times/day, aftermeal.6.3 Period of treatmentThe period of treatment shall be 5 months. From the end of September 2006to the end of February 2007. 6.4 Combined medicationDuring research, complication and medication shall be uniformly managed.6.4.1 In experiment period, all cases shall avoid take western or Chinesemedicines, which will affect curative effect of this medicine.6.4.2 During observation, those cases need additional other medicines ortreatments shall be recorded in observation statement (including name ofmedicine, dosage and usage). Those with complicated opportunisticinfection shall be treated in normal method. Those with tumors shall bestopped for treatment.7 Observation indexes and measurement method7.1 Clinical symptoms and signs: compare after scoring andquantization.7.2 Immune function indexes (CD4~+ count, CD4~+/CD8~+ ratio); Flow Cytometry(FAM);7.3 Virus load: fluorescence quantitative RT-PCR;7.4 Chemotactic factor recipient (CCR5 and CXCR4) expression: FlowCytometry (FAM);Chemotactic factor recipient(RANTES,MIP-1α,β,SDF-1)expression: ELISA7.5 Three routines, functions of heart, lung, liver and kidney and untowardreaction of medicines: normal check at same point.8 Evaluation standard of curative effect: refers to relevant standardsstipulated by expert teams of State Administration of Traditional Chinesemedicine of the People' s Republic of China, and standards in "Instructionprinciple of clinical research of new Chinese medicines".9 Evaluation standard of safeness:Instruction principle of clinicalresearch of new Chinese medicines, 2002 edition.10 Statistics disposal:Use SPSS12.0 statistics software for analysis. Allstatistics are two-tailed test with significance test level of P＜0.05.Research result1 Variation of symptoms and signs 1.1 Individual score of symptoms: individual score of patients who feltfatigue, anorexia, hair-loss, headache and muscle aches were dramaticallydeclined after treatment, has significance in statistics(P＜0.05,P＜0.01 )1.2 Total score: after treatment, total scores of primary and secondarysymptoms, main signs, general symptoms (primary and secondary) and totalscores (primary, secondary symptoms and main signs) were dramaticallydeclined, has significance in statistics(P＜0.05,P＜0.01)1.3 Karnofsky performance score: increased dramatically contrasting withscores before treatment, has significance in statistics (P＜0.05, P＜0.01)1.4 Curative effect of Chinese symptom: on the basis of analysis ofcomponent ratio, 16 cases were effective, or 59.3％; 2 cases were stable,or 7.4％; 9 cases were invalid, or 33.3％; total effectiveness ratio reached66.7％.2 Immune function2.1 CO4~+ count, CD4~+/CD8~+ ratio: after treatment, CD4~+ count of patientswere not increasedobviously, has not significance in statistics (P＞0.05),CD4~+/CD8~+ ratio declined a little contrasting with those before treatment.Analyze constitute ratio of CD4~+ variation according to determine standardof immune function(CD4~+ absolute count)curative effect, 5 cases (or 18.5％)were valid, 19 cases (or 70.4％)were stable; 3 cases (or 11.1％) wereinvalid, total effectiveness ratio was 88.9％.2.2 Lymphocyte count: after treatment, patient' s number of lymphocytedramatically increased contrasting with those before treatment, hassignificance in statistics (P＜0.05).3 Virus load: declined a little after treatment, has not significance in(P＞0.05). Count constitution ratio according to virus load determinationstandard, 12 cases (or 44.4％) were valid, 9 cases (or 33.3％) were stable; 6 cases (or 22.3％) were invalid, Total effectiveness ratio was 77.7％,4 Weight: the difference of patient' s weight between before and aftertreatment has not significance in statistics (P＞0.05). The trend chartof weight variation indicated the upraising trend of weight aftertreatment.5 Chemotactic factor recipient (CCR5 and CXCR4): expressions of two kindsof recipients were dramatically declined after treatment, havesignificance in statistics (CCR5 P＜0.05, CXCR4 P＜0.01)6 Chemotactic factor (RANTES,MIP,SDF-1): After treatment, expressionlevels of RANTES, MIP-1αand SDF-1 were declined, has significance instatistics (RANTES, SDF-1 P＜0.01 and MIP-1αP＜0.05); expression ofMIP-1βincreased contrasting with expression before treatment, however,has not significance in statistics (P＞0.05).7 Safeness evaluation7.1 Electrocardiogram, Chest X-ray film: monitoring results in treatmentwas normal.7.2 Liver and kidney functions: at third month, AST increased and hassignificance in statistics (P＜0.05); At fifth month, ALT increased andhas significance in statistics (P＜0.01), however, all values were fellin normal range.7.3 Three routine examinations: at third month, WBC, Ly and Hb increasedcontrasting with those before treatment (P＜0.05), however, all fell innormal range. No abnormal found in urine and faecal examinations.Conclusion1 Clinical symptoms and signs: According to research results of mainsymptom, signs individual score, total score, Karnofsky performance score,it is proved that "Fuzheng Anti-Aids Prescription" can dramaticallyimprove symptoms and signs of patient and upgrade life quality of patientand also embodied advantages of Chinese medicines in treatment against HIV/AIDS.2 Immune function: The research result indicated that this prescriptioncan maintain CD4~+ level in a stable situation and will dramaticallyincrease number of lymphocyte, therefore, this prescription has dramaticstabilization and protection effects on immune function (CD4~+ count).3 Virus load: the research results indicated that this prescription hascertain restrainability and stabilization effects on replication ofvirus.4 Weight: the variation of weight indicated that this prescription hascertain improvement effect on conditions of whole body of patient.5 Chemotactic factor recipient and its ligand: After monitoring variationof chemotactic factor recipients (CCR5 and CXCR4) before and aftertreatment, we found that this prescription is able to restrain expressionsof CCR5 and CXCR4, and further restrain HIV infection and duplication.This medicine embodied an effect as recipient antagonist.Results of research on chemotactic factor indicates that furtherresearch is needed for influence of this prescription on expression levelof above.6 Safeness evaluation: the result of safeness index indicates that thisprescription has no obvious toxic and side effect in clinic observation.
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