The Characteristcs Of TCM Syndrome Differentiation Of AIDS And Its Clinical Research

Research purposesAIDS in 1981, first discovered in the U.S. homosexuals. September 24,1982, the U.S. Centers for Disease Control (CDC) formally proposed the acquired immunodeficiency syndrome concept that AIDS is unexplained cellular immune deficiency caused by Kaposi, sarcoma, Pneumocystis carinii pneumonia and other serious opportunistic infections. In 1986, the International Society for Microbiology and viruses credits will LAV/HTLV-Ⅲ/ARV Naming the human immunodeficiency virus (human immunodeficiency virus, called HIV), also known as HIV. The virus invades the human body immune function, so that occurrence of a variety of human infections and tumors incurable infection which eventually lead to death. The incubation period is long, speed of dissemination, disease complex, is still not fully healed, so far no specific drugs. At present, although drugs can inhibit virus replication in the body, but after stopping the virus is still breeding, therefore, difficult to cure the current drug treatment. Become one of the world difficult cases. The high esteem the West antiretroviral antiviral therapy (HAART) is significantly reduced AIDS morbidity and mortality, but the drug combination by many constraints, there are up to 60% of patients with sustained, toxicity, drug resistance and other factors. Led to the failure of antiviral therapy. Main issues include:①the body can not eradicate HIV;②need long-term and even lifelong medication;③Currently, only five made anti-HIV drugs, expensive drugs and drug side effects, makes long-term poor drug compliance;④HIV-1 high mutation rate and gradually increased resistance to antiviral therapy is facing a growing number of questions [4]. In the world are working to overcome AIDS, while also continue to explore the Chinese medical treatment for AIDS. Because traditional medicine in the treatment of difficult cases has the overall syndrome differentiation and uphold the unique advantages of research and development of Chinese medicine against AIDS, both for China and the world of great and far-reaching significance.Chinese medicine is more and more used in AIDS treatment, and increasing attention by the international medical community., How to understand from the perspective of AIDS medicine to form a theoretical and clinical guidance, has become the important subject of Chinese medicine practitioners, Chinese medicine treatment of this subject from theory and other aspects of clinical and experimental, conducting related research, presented by Qi Toxin treatment of AIDS as a basic treatment method. In order to be able to sumup the universal applicability of Chinese Medicine principles and methods of treatment.The project as a major issue in Hubei Province, is the Health Department of Hubei Provincial Government and the strong support of the selected group of parties as "anti-Ai Fang Fu Zheng", and the party made of particles as hospital preparations, a large number of pharmaceutical research in the early (including drug extraction, molding process, the pilot plant and the quality standard) and Toxicology (acute toxicity test) the basis for the clinical observation trial. The aim is to observe the passage of the clinical trial to study the anti-Ai Fuzheng Treatment of AIDS long-term clinical efficacy and to investigate its effects on immune function. The study also tested the use of psychological intervention therapy observed HAART treatment of AIDS patients being immune function.Clinical Research1 Fuzheng Anti-AIDS Preseription effects symptoms of AIDS medicine evaluation and immune functionObjective:To observe Fuzheng Anti-AIDS Preseription on AIDS clinical symptoms and immune functionResesrch Method1 Research objects36 cases of this topic from qichun case, Nanzhang Chinese medicine hospitals and CDC control cases.22 males and 14 females; mean age of 45.1±10.63 years; average weight of 57.0±7.15 kg; transmission route was:unknown causes in 3cases,13 cases of infected blood transfusion, sexual contact with 6 cases, paid blood in 14 cases; all cases both deny any family history of disease; no history of Western medicine and herbal medicine.2 diagnostic criteria2.1 Western diagnostic criteria:the light in 2001, "The People's Republic of China national standard of HIV/AIDS diagnostic criteria and principles. "2.2 TCM diagnostic criteria:Refer to the State Administration of TCM in 2004 organized an expert group set argument "of Chinese Medicine Clinical Skills Program (Trial)."3 Case inclusion criteria3.1 comply with Western HIV/AIDS diagnostic criteria, TCM standards;3.2 CD4+ range of 200-500/mm3;3.3 The subjects were 18-65 years of age;3.4 The voluntary subjects, and signed the informed consent given;3.5 were not involved in other clinical trials;3.6 Diagnosis of the disease and who meet the Diagnostic Criteria, and the exclusion of the following "rule out cases of standards" in the person, can be incorporated into test cases.4 cases of exclusion criteria4.1 with severe cardiovascular, respiratory, endocrine, kidney, blood or psychiatric disorders;4.2 the age of 18 years of age or over 65 years of age, pregnant or lactating women;4.3 allergies, or allergic to this drug;4.4 of serious opportunistic infections.5 cases of Shedding5.1 When the patient off, the researchers contact with patients as far as possible to complete the assessment of the project can be completed, as Records of the last medication time.5.2 off due to adverse events were, after follow-up tests after the judge and drug-related were recorded off the effect and the time recorded in the adverse reaction reporting form; due to poor efficacy off who, according to an invalid address; non-effects and adverse events off:the drug is less than 1/2 course of treatment were not recorded efficacy; more than (or including) 1/2 course of treatment were recorded when the last time the efficacy of medication.5.3 cases for any loss, researchers must fill in the CRF tables for more than one off the reasons.5.4 Those who have been selected and the number of drugs patients use, whether or off, shall be recorded and retained CRF tables, both for leaving files intention is to conduct analysis (ITT analysis) required. No other up off the patient.6 Excluding the standard6.1 included found no cases met the inclusion criteria;After the total dosage of 6.2 included in the program provided less than 20% of the drug or drug content under the program exceeded 120% of cases.7 standard suspension test7.1 Clinical Trials in CD4+<200/mm3 should stop testing.7.2 serious complications or rapid deterioration should stop testing.7.3 patients during clinical trials, clinical trials do not want to continue to the competent doctors argue that clinical trials out of the requirements of clinical trials may withdraw from the case.8 quantitative criteria classification of symptoms and signsState Administration of Traditional reference standards developed by expert groups and the "guiding principles of Chinese medicine clinical research new drugs, " the relevant standards, the development of clinical symptoms and signs score standards.9 treatment 9.1 Drug SourceTest drugs:Fuzheng Anti-AIDS Prescription, drugs:Astragalus, Codonopsis, licorice, turmeric, shikonin, etc.. Chinese medicine hospital in Hubei Province to provide.9.2 Pharmaceutical PackagingPharmaceutical Packaging with:number, drug name (Clinical research-specific drug), drug composition, functions, usage quantity, specifications, storage, use period.9.3 Methods of TakingAdministration of the program:Fuzheng Ai particles 1 bag/ times,3 times a day, after meals.9.4 TreatmentTreatment for 12 months. Since the end of January 2009-the end of January 2010.9.5 combination therapyIn the study, on the complications and medication should be unified control.9.5.1 All patients in the trial period can not be combined impact of the drug efficacy of traditional Chinese medicines.9.5.2 Other services added during the observation period for internal medicine or other treatment, must be recorded in the observation table (including drug name, dosage). Combined conventional treatment for opportunistic infections. Combined treatment of tumors that have terminated.9.6 Drug Administration9.6.1 Before the test management:the developer of preparation before the test by the test drugs.9.6.2 Test of management:the establishment of pilot drug trials of management system. Each of the pilot units to appoint a special administrator to use drugs. Counter medicines locked room temperature. The establishment of a dedicated "Fuzheng Ai drug use clinical trials particle log" to record the date of trial drug release, drug number, the subjects name, quantity and delivery quantity recovered drugs, drug administrator signature.9.6.3 After the test administration:the administrator responsible for the pharmaceutical drugs focus on the return of the remaining hospital of Chinese medicine or procedures to be destroyed in Hubei Province.9.7 Observation indicators and detection methods9.7.1 Clinical signs and symptoms:score quantified by comparison;9.7.2 immune function (CD4 count, CD4/CD8 ratio):flow cytometry;9.7.3IL-2, IFN-γlevels detected:double-antibody sandwich ELISA, serum IL-2, IFN-γlevels.9.7.4 viral load:quantitative RT-PCR;9.8 Clinical Quality Control9.8.1 Researchers should be required case report form, truthful, detailed, carefully record the table of the elements, to ensure that the case report form is true, reliable, case report forms may not be altered, if indeed there is clerical error, only in the trading department horizontal line on the uniform project, fill out the right in its content, and next to signature, date.9.8.2 Clinical trial results and found that all the observations should be verified to ensure data reliability, to ensure that the conclusions of clinical trials are derived from raw data. In clinical trials, and data processing phases of the appropriate management measures.10 evaluation standard:State Administration of Traditional reference standards developed by expert groups and the "guiding principles of Chinese medicine clinical research new drugs," the relevant standards.11 Statistical analysis:The chi-square test and T test.Results1 TCM symptoms and signs of change1.1 points separate symptoms:patients with post-treatment fatigue, poor appetite, hair loss, headache, muscle pain and other symptoms of the individual scores increased significantly after treatment decreased significantly (* P<0.05).1.2 Total Points:After treatment in patients with major, minor and major signs symptoms total score, and total symptoms (main, secondary symptoms) and total points score (major, minor and major signs of symptoms) before treatment were significantly less than that statistically significant (* P<0.05).1.3 Kalovsky points:before treatment significantly increased compared with statistical significance (* P<0.05).1.4 TCM syndromes:According to the syndromes the diagnostic standard, from the number of cases of TCM syndromes:Effective 24 cases,66.7%; stable in 5 cases,13.8%; ineffective in 7 cases, 19.5%. The total effective rate 80.5%.2 immune function:2.1CD4 count, CD4/CD8 ratio:patients with CD4 counts after treatment no significant increase, not significant (P> 0.05) CD4 counts constitute effective than the 7 cases,19.4%; stable in 25 cases,69.4%; invalid 4 cases, accounting for 11.1%. The total effective rate 88.9%.2.2 interleukin-2,γ-interferon of:after treatment the expression of two cytokines were significantly higher than that before treatment, were statistically significant (P<0.05).3, viral load:After treatment, viral load decreased slightly compared with before treatment, but no statistical significance (P> 0.05). Viral load determined according to standard statistical changes in the composition of its ratio, effective in 20 cases, 55.6%; stable in 9 cases,25%; ineffective in 7 cases,19.4%. The total effective rate 80.6%.Conclusions1 Clinical symptoms and signsThe results fully show that after treatment of fatigue, poor appetite, hair loss, headache, muscle pain and other symptoms of the individual scores increased, decreased, suggesting that this side can alleviate symptoms in patients with the above. After treatment, major, minor and major signs symptoms total score, and total symptoms (main, secondary symptoms) and total points score (major, minor and major signs, symptoms) were significantly lower than before treatment; Kalovsky points significantly increased compared with before treatment. And determine the criteria according to syndromes, from the form of Chinese medicine syndromes than the total effective rate was 80.5%. Suggests "Fuzheng Ai side" can significantly improve the clinical symptoms, improve quality of life, which also reflects the advantages of Chinese medicine to treat AIDS.2 immune function Patients with CD4+ counts after treatment than before treatment and no significant increase, and CD4+ /CD8+ratio decreased slightly compared with before treatment. However, according to immune function (CD4+ counts) effect changes in determining the standard of the composition of CD4+ ratio, the total effective rate 88.8%.3Interleukin-2, Interferon-γ:After treatment, the expression of two cytokines were significantly higher than before treatment, were statistically significant (P<0.05).4viral loadAfter treatment, the viral load decreased slightly compared with before treatment, but no statistical significance (P>0.05). However, according to viral load changes in determining the composition of standard statistical ratio of its total effective rate 80.6%. Tip of the parties on virus replication also has a certain role of inhibition and stability.2 Of psychological intervention on the treatment of AIDS patients HARRT effectObjective:To explore the psychological intervention for AIDS patients with highly active antiretroviral therapy (HARRT) during the CD4 + cell counts and immune indicators (IL-2 and IFN-γ) effects.Methods:The control group,16 cases by merely HARRT therapy: nevirapine (NVP)+stavudine (D4T)+didanosine creatinine powder (DDI). Psychological intervention group,16 patients treated in the HARRT on the basis of psychological intervention, were used to detect CD4+ cell counts and immune indicators (IL-2 and IFN-γ).Results:1, pre-treatment CD4+ cell count differences between the two groups was not statistically significant (P>0.05), the two groups after treatment CD4+ cell counts were statistically significant (P<0.05), but the psychological intervention group was significantly higher CD4+ cell count, compared with the control group was statistically significant; 2, psychological immune parameters before and after treatment intervention group cytokines IL-2, IFN-γsignificantly (P<0.05), control group, immune parameters before and after treatment of cytokines IL-2, IFN-γwas no significant change (P> 0.05).Conclusion:HAART treatment of psychological intervention on the basis of cooperation can be effective in improving chronic AIDS patients CD4+ cell counts and immune indicators (IL-2 and IFN-γ).