Document & Preliminary Clinical Study On Anti-HIV Traditional Chinese Medicine

PurposeThis thesis focused on Chinese medicine whether has anti-HIV effect,how the effect and a series of educational circles and clinical research concerned question and so on,through literature review about against HIV virus and explore the feasibility and application prospect about Chinese medicine.The feasibility and application prospect of Traditional Chinese Medicine in anti-hiv virus were discussed from two aspects of literature review and clinical research of Qudu zengning capsule in anti-HIV treatment.To discuss Chinese medicine feasibility and application prospect about anti-HIV virus.To evaluating the efficacy and safety about Qudu zengning capsule in the antiviral treatment of AIDS patients in order to provide a new clinical basis for the feasibility of Traditional Chinese Medicine against HIV-virus.Method1 Using the literature combing method,reading and collating the relevant literature on anti-HIV virus in Chinese medicine for 20 years,and arranging the basic research and clinical research results of traditional Chinese medicine in anti-HIV virus according to the existing research status,from the single-flavor Chinese medicine and its Two aspects of anti-HIV active ingredient research and Chinese medicine compound anti-HIV virus research are discussed.2 Clinical study:26 patients with HIV/AIDS who met the inclusion criteria in the 24-week clinical trial were treated with the traditional Chinese medicine preparation,Qudu Zengning Capsule and placebo.Because AIDS is a special disease,the subject has not been unmasked.According to the research method of the case itself,the virus load and TCM symptoms(fatigue,diarrhea,etc.)were observed at 0,4,12,and 24 weeks.Objective description and analysis of the efficacy of fever,body weight,and immune indicators,as well as safety monitoring(blood routine,urine routine,abdominal ultrasound,electrocardiogram,adverse events,etc.).After the interview of the subjects,the case data was analyzed and sorted.The data was processed using the statistical software spss22.0.Consequence1 Summary of literature research results1.1 Theoretical understandingChinese medicine believes that AIDS belongs to Chinese medicine QI WIN disease,according to its strong infectious,epidemic characteristics,which is consistent with the "plague" disease;Because of the damage to the immune function of the human body after its infection,resulting in chronic deficiency of Qi deficiency disease,which is in line with the category of "deficiency and fatigue" in Traditional Chinese Medicine.For the virus most scholars think that it belongs to the special epidemic virus invasion of human body caused by the pathogenic manifestations of XIE exuberant ZHENG deficiency.1.2 Single Chinese herbThrough literature review,a total of 403 Traditional Chinese Medicine were screened for antiviral activity in vitro,and 105 herbs were found to have different degrees of anti-HIV activity,among which 32 herbs had stronger activity.Red flowers,big leaf uncaria,Perilla,yellow grass,neem,litchi,yunnan yellow fine,japonica,hexagonal lotus,dahlia,mimosa,usnea,south candle,garlic,licorice,yunnan have melon caulis dendrobii,gold hair pin caulis dendrobii,water,green tree,scandent schefflera stem and leaf,dog ridge,euphorbia kansui,kunming,yunnan borage,spreading hedyotis herb,radix arnebiae seu lithospermi,blue sheep and wing smelly magic,turmeric,gear,section 9 calamus,small common clubmoss herb,small bubble root,white tonic,huanghua four-o'clock.It was found that most of the Traditional Chinese Medicine with strong anti-HIV effects were heat and detoxification and blood-activating,such as safflower,dioscorea,comfrey,turmeric,ophiopogon,and safflower.1.3 Study on the active ingredients of Traditional Chinese Medicine extracts(1)Flavonoids,such as quercetin compounds extracted from heterogenous schisandra australis,were found to have anti-HIV activity,with CC50 of 87.8,EC50 of 5.3mg·1-1 and TI of 16.6;(2)Proteins,such as bitter melon seed egg,can inhibit the production of C8166 induced by HIV-?B and reduce the production of antigen p24 in H9 cells of chronic HIV-1,with EC50 of 0.01mg·L-1 and 0.07mg·L-1,respectively;(3)Alkaloids,such as berberine extracted from coptis chinensis and phellodendron chinensis,can inhibit the activity of HIV-1 integrative reverse transcriptase by inhibiting the mechanism of HIV,and their EC50 were 63.1 ?g.mL"1 and 44.52 ? g.mL-1 respectively.(4)Polysaccharides,such as poria cocos,have strong anti-HIV-1 reverse transcriptase activity and can achieve a certain degree of immune protection through lymphocyte proliferation after hydroxylation.(5)The active components of tannins and terpenes extracts of Traditional Chinese Medicine have different inhibitory targets on HIV virus,and the cytotoxicity is small at a certain concentration.Laboratory studies have shown that they have different degrees of activity.1.4 Progress in research on Traditional Chinese Medicine compoundsThere were 44 kinds of Traditional Chinese Medicine compounds developed for anti-HIV,among which 12 were recorded in clinical trials,which showed inhibition of HIV virus in previous clinical trials,and the effective rate of reducing HIV viral load by>0.51og/ml after treatment was 13.33%to 85.29%.It suggests that Chinese medicine is not inactive in antiviral,but plays a role in inhibiting virus to some extent.2 Clinical study results2.1 Efficacy evaluation2.1.1 Evaluation of viral load efficacy:There were no statistical differences in the changes of viral load index between the 26 subjects at 4,12,and 24 weeks.The p-values were all>0.05,suggesting that the viral load index did not change significantly at each monitoring time.It indicated that the reduction of viral load in 26 subjects at each time of detection was not obvious,but it had a certain inhibitory effect on the increase of viral load.2.1.2 Efficacy evaluation of TCM symptomsThe total scores of TCM symptoms in 26 subjects showed a downward trend at 4,12,and 24 weeks.There was no significant difference in TCM symptom scores between 4 weeks and 0 weeks before treatment(p>0.05),suggesting that TCM symptoms were 4 weeks ago.The score improvement was not obvious;the total scores of TCM symptoms were statistically different at 12,24 weeks and 0 weeks(p<0.05),suggesting that the TCM symptom scores improved significantly at 12 and 24 weeks;TCM fatigue and diarrhea symptoms at each test time The frequency showed a decreasing trend,and the scores of fatigue symptoms before and after treatment were statistically different(p<0.05),indicating that the improvement of TCM symptoms and signs in HIV/AIDS patients at each test site had better curative effect,the most significant improvement in fatigue symptoms,and some relief in diarrhea.2.1.3 Evaluation of immune functionThere were no statistically significant differences in CD4+T cell counts and CD4+/CD8+ratios between the 26 subjects treated at 4,12,and 24 weeks.The p-values were all>0.05,suggesting CD4+T cell counts and CD4+at each test.The change of/CD8+ratio was not obvious,indicating that the CD4+T cell count and CD4+/CD8+ratio were not significantly increased at each detection time.2.2 Safety evaluationIn this study,blood routine,liver function,renal function,electrocardiogram,X-ray,and abdominal b-ultrasound did not change clinically at the visiting sites at 4 weeks,12 weeks,and 24 weeks compared with before treatment.No adverse events occurred during the test.It is suggested that Qudu zengning capsule has little toxicity and is safe to use in the anti-virus treatment of AIDS.ConclusionThrough the review of the anti-HIV virus literature of traditional Chinese medicine and the anti-HIV virus clinical trial of Qudu Zengning Capsule.1 In the literature research,it is concluded that the single-flavor Chinese medicine and its active ingredients and the traditional Chinese medicine compound preparation have different degrees of anti-HIV activity in vitro and clinical trials,and the safety is better,but the overall inhibition rate of the virus is lower.There is still a gap between Chinese medicine and HAART therapy in reducing the intensity and efficiency of HIV.2 Through the preliminary observation of this clinical trial--the clinical problem of antiviral treatment of AIDS in Qudu Zengning Capsule,26 subjects were treated for 24 weeks.Since the data has not been uncovered,the final evaluation of Qudu Zengning Capsule can not be obtained.From an objective point of view,the emergence of HAART therapy makes AIDS a chronic controllable disease,but HAART therapy can not completely eliminate the virus,and the side effects are large,and long-term use is prone to drug resistance.Chinese medicine can give full play to itself.Traditional Chinese medicine can give full play to its own advantages,and conduct syndrome differentiation and treatment on patients under the holistic view,so as to achieve the purpose of strengthening the righteousness,detoxification and detoxification.Modern medicine intervenes against viruses and target cells.TCM can adjust the patient's body environment to make up for the deficiency of modern medical HAART treatment.The synergy between Chinese medicine and modern medicine is a trend,and researchers should continue to explore and have Antiviral drugs with Chinese characteristics and effective methods.