| 1. Objective:F-GC is the pure natural extraction of seaweeds, which is produced by the Modern biological technology. Through the experiments of outside body, it has been proved that F-GC has the function of anti-HIV and it can improve the immune function and also can protect the T-Lymphocyte. Through using F-GC to proceed the intervention therapy of domestic wild region AIDS-patients, thereby we can increase the immune function of patients and inhibit the viral load, improve clinical symptoms of patients and the quality of life, then we can further test the clinical safety and effectiveness. And we will proceed a preliminary exploration of Chinese medicine about domestic AIDS groups to provide the experiences in the future Chinese medicine clinical therapy.2. MethodThis research was divided into two phases. Through the first phase, the Clinic cases were divided into F-GC 3g treatment group (11 cases), F-GC and western medicine group (7 cases, HARRT: AZT+3TC+EFV). Through the second phase, for identifying the therapeutic efficacy of F-GC, and to explore its clinic optimal dose and therapeutic tool, we used single-blind method, clinic treatment group was divided into F-GC 6g group (30 cases) and western medicine control group (30 cases, HARRT: AZT+3TC+EFV), at the same time, giving the patients in the western medicine group placebo, which is one tenth of does of F-GC group. The symptoms and physical signs were observed on pre-treatment and post-treatment, we detected safe index, blood test, urine test, X ray, ECG, liver function, renal function, and use FCS, RT-PCR to detect the immune function and virus on the 0,3,6 month, verified the safety and utility of F-GC. At the same time, we also summarized and analyzed the symptom complex of TCM of the Central Plains region of China.3. ResultThe first phase: the patients have some major clinical manifestations such asweakness, cough, and anorexia. Tongue pictures: pale and red tongue, tooth marked tongue, white greasy coating, yellow greasy coating, exfoliated coating. Manifestation of the pulse, mainly are deep pulse, or wiry pulse or thready pulse. Clinical major syndrome differentiation: Qi deficiency leading to blood stagnation and deficiency of Qi and Yin.3g FGC treatment group: clinical manifestations and signs : accumulative scores of the patients decrease, clinical symptoms were improved. And there was no difference in statistics. Index of immune function: the account of CD4 T cell and viral load is stable. There is no significant difference in statistics between pre-treatment and post-treatment.3g FGC +HAART treatment group: clinical manifestations and signs : accumulative scores of the patients significantly decrease, clinical symptoms were significantly improved. And there was significant difference in statistics. Index of immune function: the account of CD4 T cell is up, and viral load is stable. But there is no significant difference in statistics between pre-treatment and post-treatment.Safety: there are not any side effect and toxicity in 3g FGC treatment group, and the blood routine and biochemistry index are normal.The second phase: the patents have some major clinical manifestations such as weakness, cough, anorexia;Minor clinical manifestations such as short breath, headache, joint pain, lumbago. Mainly sign is itch. Tongue pictures: slightly red and red tongue, tooth marked tongue, white coating, yellow greasy coating, cracked tongue, exfoliated coating. Manifestation of the pulse, mainly are deep pulse, or wiry pulse or thready pulse. Clinical major syndrome differentiation: Qi deficiency leading to blood stagnation and deficiency of Qi and Yin.6g FGC treatment group: clinical manifestations and signs : accumulative scores of the patients significantly decrease, clinical symptoms were significantly improved. And there was significant difference in statistics. Index of immune function: the accounts of CD4 T cell drop significantly, and there is difference in statistics between pre-treatment and post-treatment. Viral load is stable, there is no significant in statistics between pre-treatment and post-treatment.HAART treatment group: clinical manifestations and signs : accumulative scores of the patients significantly decrease, clinical symptoms were significantly improved. And there was significant in statistics. Index of immune function: the accounts of CD4 T cell retain stable, and viral load drop. But there is no significant difference in statistics between pre-treatment and post-treatment.Safety: there are not any side effect and toxicity in 6g FGC observation group, and the blood routine and biochemistry index are normal.4. ConclusionClinical symptom and sign: F-GC may improve the clinical symptoms of AIDS patients and improve its quality of their lives. Index of immune function: F-GC can gradually stabilize and enhance the CD4 accounts of patients, but there is no difference in statistics. VL: F-GC can stabilize the VL of patients, the changes between pre-treatment and post-treatment have not difference in statistics. The best dosage: 6g treatment group is better than 3g treatments group, and there is significant difference in statistics between 3g and 6g treatment group.The Chinese medicine symptom of AIDS crowds in the south area of Yellow River: The syndrome differentiation of Chinese medicine think that it is Qi Deficiency leading to Blood Stagnation and Qi Deficiency and Yin Deficiency primarily, the main clinical symptoms are weakness, cough, anorexia, and the skin rash symptom and lymph swollen almost can be seen. Tongue pictures are complex, during the performance of Qi Deficiency Leading to Blood Stagnation and Qi Deficiency and Yin Deficiency, which appears pale and red, dark red, tooth marked tongue, crack tongue, tongue stasis, concurrently sees the yellow greasy fur which Endogenous Dampness stays in the body. Manifestation of the pulse, mainly are deep pulse, or wiry pulse or thready pulse. |
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