Research On Clinical Therapeutic Evaluation Criterion Of Traditional Chinese Medicine In Treating Acquired Immune Deficiency Syndrome (AIDS)

Objective:Since entering the World Trade Organization (WTO), the progression of internationalization and standardization has been greatly speeded up. Recently, the study on the standardization of traditional Chinese medicine (TCM) has been becoming not only the difficult point but also the popular point. There has been more than 20 years for using TCM therapy to treat acquired immune deficiency syndrome (AIDS). However, the current evaluation methods, which assess the efficiency of the herbal medicine treatment on AIDS, are too simple and have not reflected the advantage and property of the TCM treatment on AIDS. At the same time, because of lacking an evaluation standard to assess the TCM's efficiency objectively and scientifically, the TCM therapy on AIDS has not been recognized internationally due to the deficiency of conmmunication foundation. The research is trying to explore how to reflect the very efficacy from the conclusion of TCM treating AIDS clinical therapeutic effects, to establish the correspounding therapeutic evaluation system of TCM in treating AIDS, so as to provide a good foundation for the therapeutic evaluation criterion of TCM in treating AIDS.Methods:There are three parts in the research:The first part was to delay the onset in the asymptomatic stage.60 diagnosed cases of Qi-deficiency and blood-stasis syndrome with positive human immunodeficiency virus (HIV) in their asymptomatic stage were included in the research, they were divided into two groups randomly. The experiment group was given Ailing particle (preparation for AIDS producted by guang' an men hospital), and the control group was given placebo. All study subjects were taken CD4 and viral load measurement every 3 months, and they were monitored every month for changes in symptoms. The Flow Cytometry (FCM) and quantitative PCR were used for the measurement of immunologic function and viral load. Blood routine test and urine routine test, X-ray examination, electrocardiogram(ECG) test as well as liver and kidney function test were observed for each patient before and after treatment. The purpose of this part was to explore the early intervention curative effect of TCM in treating HIV infected patients and seek for core indicators which could reflect the effect of TCM in AIDS patients.The second part was about the treatment by combining traditional TCM with western medicine in AIDS period.90 diagnosed cases with positive HIV in their AIDS period were included in the research, they were divided into two groups randomly. The experiment group was given Ailing particle and highly active anti-retroviral therapy (HAART). The control group was given placebo and HAART. Both groups were taken CD4 and viral load measurement every 3 months, and they were monitored every month for changes in symptoms. The flow cytometry (FCM) and quantitative PCR were involved for the measurement of immunologic function and viral load. Blood routine test and urine routine test, X-ray examination, electrocardiogram (ECG) test as well as liver and kidney function test were observed for all individuals in this study before and after the treatment. The purpose of this part was to explore the curative effect of combining traditional TCM with western medicine in treating HIV infected patients and selected for relative indicators and core symptoms which could reflect the effect of TCM in AIDS patients.The third part was about the quality of life scale. A retrospective study of relative AIDS literature and cases, screen for the common symptoms and clinical manifestation of AIDS patients by statistical analysis, and analyze their psychological states and the social discrimination phenomenon about AIDS, then collect the opinion of experts after several conference to form an elementary scale. The reliability and validity analysis was applied to the scale. We tried out the scale in clinical trial, exploring the effectiveness of this scale in clinical practice and looking into the life quality and influencing factors of AIDS patients. Using the internationally assessment of therapeutic effects of AIDS and the guidance documents of national treatment as reference, we concluded the above followed research results and raising the assessment system of therapeutic effects of AIDS with TCM.Results:(1) Results of the asymptomatic stage The score of clinical symptoms:①fatigue, spontaneous perspiration, night sweat, pruritus and the total scores of the clinical symptoms in the experiment group had statistically significant differences (p<0.01) after treatment, and dyspepsia, waist pain and rash also had statistically differences (p<0.05) after treatment;②the changes of fatigue, spontaneous perspiration, vomit and short of breath in the control group had statistically differences (p<0.05) after treatment.Karnovsky Score:①the Karnovsky Score of the experiment group had been raised, but there was no statistically significant (p>0.05),and the weight of this group steadily;②the Karnovsky Score of the control group also had been raised with no statistically significant (p>0.05), and the weight of this group steadily.CD4+T cells:②the quantity of CD4+T cells in the experiment group increased obviously after the treatment of 6 months (p<0.05);②the quantity of CD4+T cells in the control group decreased obviously after 12 months(p<0.01), and the quantity of CD4+T cells also decreased after 9 months with statistically differences (p< 0.05)③there were no statistically significant differences showed after 3 months in curative effect between the two groups (p<0.05), and the curative effect of the experiment group was surpass the control group after 6,9 and 12 months, there was statistically differences between the two groups (p<0.01)The viral load:①the research indicated that both groups could decrease the viral load after 6 months, however there were no statistically differences (p> 0.05);②the viral load of the experiment group had increased slightly, and no statistically differences was showed, while the control group had increased significantly (p<0.01);③there were no statistically differences showed after 6 months between the two groups in curative effects, but the curative effects of the experiment group after 12 months was surpass the control group significantly (p< 0.01)The safety index:there were no statistically differences in routine analysis of urine, X-ray examination and electrocardiogram (ECG) between the two groups before and after treatment. (2) Results of the AIDS periodThe score of clinical symptoms:①the experiment group which was given Ailing particle and HAART (AZT+3TC+NVP) improved obviously,and the total scores decreased significantly after treatment (p<0.01),and the common symptoms such as fatigue,dyspepsia and short of breath also improved with statistically differences (p<0.05);②the control group which was given placebo and HAART (AZT+3TC+NVP) could improve fatigue with statistically significant differences (P<0.01)Karnovsky Score:①the Karnovsky Score of the experiment group had been raised with statistically significant (p<0.01),and the weight of this group steadily;②the Karnovsky Score of the control group also had been raised with statistically significant (p<0.01),and the weight of this group steadily.CD4+T cells:①Ailing particle with HAART (AZT+3TC+NVP) could speeding the recovery of CD4+T cells, there were statistically differences after 6 months and 12 months(p< 0.05),and statistically significant differences after 9months,15months and 18 months (p<0.01);②the placebo with HAART (AZT+3TC+NVP) could increase the quantity of CD4+T cells, there was statistically significant differences after 6 months and 9 months (p<0.01);③there was statistically differences showed after 18months between the two groups (p<0.05)The viral load:①the research indicated that both groups could decrease the viral load after 6 months with statistically differences (p<0.05);②There was no statistically differences showed between the two groups in curative effects.The incidence of adverse reaction:Comparing the incidence of adverse reaction in the experiment group (26.08%) with that of the control group (72.72%), there was statistically significant differences between the two groups (p<0.01), and the frequency of changing the prescription in the experiment group (4.34%) and that in the other group (22.72%) had statistically differences by comparison (p<0.05)The safety index:There were no statistically differences in routine analysis of urine, X-ray examination and ECG between the two groups. (3) Research of the quality of life scaleThe Cronbach's a of the scale was 0.865, and all of eachawere greater than 0.60 expect social domain sub-scale. The correlation coefficient of each dimension in the scale with their relevant field were greater than 0.543,and there was statistically significant differences among them (p<0.001),and was greater than the correlation coefficient of this dimension with the other field.Through the single factor analysis of clinical investigation,①the scores of those who received the combined therapy of TCM and western medicine in the physical dimensions was higher than those only treated with TCM (p<0.05);②the female patients got lower scores in psychological dimension (p<0.05);③Compared with those who received education more than 9 years, individuals who received education less than 9 years got higher scores in the independent level sub-scale. Patients in the asymptomatic stage and treated with TCM got higher scores in independent level than those who received combined therapy of TCM and western medicine in AIDS period, and there was statistically significant differences between them (p<0.01)Through the multiple linear regression analysis of clinical investigation,①the male patients got higher scores in physical, psychological and environment dimension than female;②compared with those who received education more than 9 years, individuals who received education less than 9 years got lower scores in the physical sub-scale;③compared with those who married, individuals who single got lower scores in the society relation sub-scale.Conclusion:In the asymptomatic-stage-research,①Chinese medicine ailing particle could improve the clinical symptoms and Karnovsky score;②fatigue, spontaneous perspiration, night sweat, pruritus, dyspepsia, waist pain and rash was related with the clinical effects of the asymptomatic-stage of AIDS;③Chinese medicine could slow down the decrease of CD4+T ells quantity and preserving immune function effectively;④Chinese medicine could keep the viral load at a stable level. In the research of AIDS period,①Ailing particle with HAART (AZT+3TC +NVP) could alleviate the clinical symptoms and improve life quality;②fatigue, dyspepsia, diarrhea and short of breath was related with the clinical effects of the AIDS period;③the combined therapy of TCM and HAART (AZT+3TC+NVP) could increase the quantity of CD4+T cells than HAART (AZT+3TC+NVP);④the combined therapy of TCM western medicine was better than only treated by HAART,⑤the combined therapy of TCM and western medicine could alleviate toxicity and decrease the rate of change prescription so that prevent the risk of drug resistance.From the research of the quality of life scale,we could conclude as follow:①the draft life quality scale of AIDS patients in China had stable internal consistency, half-split reliability, content and construct validity in the application of AIDS patients and positive HIV individuals. It could be used both in clinical and scientific research and included in the therapeutic evaluation criterion of TCM in treating AIDS;②the single factor analysis of clinical investigation by this scale showed that sexuality, marriage, education, stage of disease and therapeutic measure effect the score of each dimension;③interfere by multiple factors, sexuality, marriage, education effect the quality of life in AIDS patients, this scale should be included into the system of clinical therapeutic evaluation criterion of traditional Chinese medicine in treating AIDS.The clinical therapeutic evaluation criterion of TCM in treating AIDS should include the evaluation of clinical symptoms, biological indicator of AIDS, quality of life, endpoint event, and the evaluation should be made according to the clinical characteristic of different period. However, we need a further study of this scale with multicentre and large samples so that we could make better evaluation and application.