The Long-term Clinical Effect Analysis Of Bota For AID(?) Capsule On Prevention And Treatment For HIV Cases

ObjectiveClinical observation and test have been made on the basis of early large quantity of pharmaceutical research and clinical preliminary study. Purpose of this research is:(1)To valuate the long-term safety of BOTA FOR AID(?) (BFA) Capsule by blood test and liver and renal function test after taking BFA Capsule; (2) through observing symptom and sign scores, body weight, quality of living(Karnovsky Score), lab indexes(CD4+ count number CD8+ count number CD4+/CD8+) before and after treatment to valuate the long-term clinical effect Of BFA Capsule on prevention and cure for HIV cases; (3) through observing the deciduous causes of HIV cases to add valuate the long-term clinical effect of BFA Capsule.Research method1 Research objects In this topic, clinical observation came from cases in infection out-patient clinic of Guangzhou No.8 People's Hospital who have BOTA FOR AID(?) (BFA) Capsule. During follow-up, patients with a fall in 12 cases because of working out,2 case were shedding because of not obedient, and 14 case were shedding because of poor curative effect. Finally 44 cases completed all clinical observation, and 19 cases are male,25 are female with average age of 35.48±9.67 and average weight of 57.23±8.82kg; The way of infection:4 cases were infected by uncertain cause,2 cases were infected by transfuse,30 cases were infected by sexual contact,2 cases were mixed infection; all cases denied familial disease and history of western and herb medication.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 standards of cases3.1 Being in accordance with HIV/AIDS diagnosis standards of western and Chinese medicines;3.2 Testers aged from 18 through to 60, there is no limit on the sex;3.3 CD4 more than 200/ml, All were voluntaries and signed the Medical Informed Consent Letter;3.4 All had not taken part in other clinical test;3.5 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 standards of cases4.1 Females in gestation or lactation;4.2 Those that have severe disease(s) in cardio visceral vessel, respiratory, endocrine, kidney, blood or psycho systems;4.3 Those that have severe opportunistic infection disease;4.4 Recent applications or during treatment used for this study may have caused the contradiction of drugs, including antiviral agents;4.5 Can not be prescribed medication, information can not be determined;4.6 Other malignant tumors except Kaposi's sarcoma.5 Disposal of cases leaving treatment Establish score standards of clinical symptoms and signs Referring to relevant standards stipulated by expert teams of State Administration of Traditional Chinese medicine of the People's Republic of China, and standards in "Instruction principle of clinical research of new Chinese medicines"6 Treatment methods6.1 Resources of medicines Experimental medicines:BOTA FOR AID(?) Capsule, Supplied by Tropical Medicine Institute in Guangzhou University of Traditional Chinese Medicine.6.2 Medication Dosage regimen:BOTA FOR AID(?) Capsule, Take 3 granules each time,3 times a day, after meal. 6.3 Period of treatment Three months for a period of treatment, at least five courses of treatment (fifteen months).6.4 Combined medication During research, complication and medication shall be uniformly managed.6.4.1 In experiment period, all cases shall avoid take western or Chinese medicines, which will affect curative effect of this medicine.6.4.2 During observation, those cases need additional other medicines or treatment shall be recorded in observation statement (including name of 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.7 Observation indexes and measurement method7.1 Clinical symptoms and signs,body weight,quality of living(Karnovsky Score):Compare after scoring and quantization;7.2 Immune function indexes (CD4+ count, CD8+ count, CD4+/CD8+ ratio); Flow Cytometry (FAM);7.3 blood test,liver and renal function test and untoward reaction of medicines: Normal check at same point;7.4 Record the deciduous causes:normal record at same point.8 Evaluation standard of curative effect:refers to relevant standards stipulated by expert teams of State Administration of Traditional Chinese Medicine of the Republic of China, and standards in "Instruction principle of clinical research of new Chinese medicines".9 Evaluation standard of safeness:Instruction principle of clinical research of new Chinese medicines,2002 edition. 10 Statistics disposal:Use SPSS15.0 statistics software for analysis. Significance test level is P<0.05.Research result1 Variation of symptoms and signs1.1 Individual score of symptoms:Individual score of patients who felt cough, fatigue, diarrhea, nausea, chest pain, joint pain, skin itching, skin rashes and swollen lymph nodes were dramatically declined after treatment, has significance in statistics (** P<0.01* P<0.05). 1.2 Total score:after treatment, total scores (primary, second symptoms and main signs) were dramatically declined, has significance in statistics(** P<0.01).1.3 Karnofsky performance score:increased dramatically contrasting with scores bdfore treatment, has significance in statistics (** P<0.01)1.4 Curative effect of Chinese symptom:on the basis of analysis of component ratio,31 cases were effective, or 71%; 9 cases were stable, or 20%; 4 cases were invalid, or 9%; total effectiveness ratio reached 91%.2 Immune function (CD4+,CD8+count and CD4+/CD8+ratio):During the treatment, the quantity of CD4+T lymphocyte had a fluctuation, the decline compared with the previous had no significance in statistics (P>0.05), but it was less than the annual descendent rate of its natural course of HIV/AIDS. Analyze constitute ratio of CD4+variation according to determine standard of immune function (CD4+absolute count) curative effect,11 cases (or 25%) were valid,24 cases (or 55%) were stable;9 cases (or 20%)were invalid, total effectiveness ratio was 80%. CD8+count and CD4+/CD8+ratio compared with the previous had declined,but it had no significance in statistics(P>0.05). According to the result, it showed 3 different level of HIV asympomatic carriers which CD4+ before treated is in 200-350个/mm3,351-500个/mm3,>500个/mm3. CD4+before treated was in 200-350个/mm3 was more higher than the others, treatment after 12 months have significance in statistics (P<0.05) CD4+before treated was in 351-500个/mm3and>500个/mm3 was dropped than before, but it had still in the normal range, and had no significance in statistics, maybe because of cases of these two levels were less.3 Weight:the difference of patient's weight between before and after treatment had significance in statistics (**P<0.01). The trend chart of weight variation indicated the upraising trend of weight after treatment.4 Safeness evaluation:five courses after medication, safety indicators such as liver and kidney function and blood routine test of patients (WBC,Ly,Hb,Plat,Cr,Bun,ALT,AST) have varying degrees changes comparing with pre-treatment and have significance in statistics partically (* P<0.05),however, all values were fell in normal range. Conclusion1 Clinical symptoms and signs:According to research results of main symptom, signs individual score, total score, Karnofsky performance score, it is proved that HIV cases in long intervene of BOTA FOR AID(?) Capsule can dramatically improve symptoms and signs of patient and upgrade life quality of patient and also embodied advantages of Chinese medicines in treatment against HIV cases.2 Immune functions:The research result indicated that long-term use of BOTA FOR AID(?) Capsule can maintain CD4+ and CD4+/CD8+ level in a stable situation; therefore, this medicine has dramatic stabilization and protection effects on immune function (CD4+count and CD4+/CD8+level).3 Weight:the variation of weight indicated that long-term use of this medicine has improvement effect on conditions of whole body of patient.4 Safeness evaluations:the result of safeness index indicates that this medicine in clinical observation in a long time has no obvious toxic and side effect in clinic observation; it is safe in the existing condition, which reflects the advantages of small side effects for traditional Chinese medicine to prevent HIV/AIDS cases.5 Termination causes evaluation:According to the termination of observation time causes indicates that this medicine for patients with stable immune function, in a certain extent delaying HIV cases into AIDS period has good effect.