| Objective:With asymptomatic HIV infectious period as the starting point, and through a more standardized clinical study, this research examines the clinical efficacy of Fuzheng Paidu Tablet. Based on this clinical study, we measured the concentration of associated immune factors, discussed the effect of Fuzheng Paidu Tablet in regulating the immune functions of asymptomatic HIV infection Patients, observed whether there are differences and correlation of the immune factor between the two, and established the theoretical foundation for the diagnosis and treatment. Finally we provided asymptomatic HIV carriers with Chinese materia medica preparations that can enhance immunity and delay the occurrence and progress of the disease.Methods:This research is divided into two parts. The first part is theoretical study. We discussed this from the following six aspects:the origin and ambiguity of asymptomatic HIV infectious period; symptoms in asymptomatic HIV infectious period; TCM symptoms types that can be differentiated in asymptomatic HIV infectious period; the reason of choosing HIV infectious patients in TCM treatment; advances in Chinese medicine treatment during asymptomatic HIV infectious period; treatment of asymptomatic HIV carriers based on etiology, pathogenesis and syndrome differentiation. In the second part cluster random sampling and Single-blind, parallel-group method were used. Outcome measures such as clinical symptoms and signs, immunological indexes (CD4+ cell count, CD8+ cell count and the ratio of CD4+/CD8+), viral load, quality of life, routine analysis of blood, urine and stool, liver Function and kidney function, etc. were observed. Altogether 56 cases in the treatment group met the inclusion criteria, and in the control group 52 cases did. CD4+ cell count, viral load, interleukin-6, interleukin-8, soluble interleukin-2 receptor, tumor necrosis factor-a, neopterin, interferon-a etc of the 32 patients with good clinical effect were measured. Observation was made on whether there are differences and correlation of the cell factor, and discussions were carried out on the moderating effect of Fuzheng Paidu Tablet to the asymptomatic HIV infection Patients' Immunological indexes.Results:1 Symptoms existed and TCM symptoms type could be differentiated in asymptomatic HIV infectious period. Treatment of asymptomatic HIV infectious period based on etiology, pathogenesis and syndrome differentiation provided a theoretical foundation for the early intervention of Fuzheng Paidu Tablet to the patients during asymptomatic HIV infectious period.2 Research on the efficacy of Fuzheng Paidu Tablet to the patients in asymptomatic HIV infectious period indicated that there was statistical significance in the total score after treatment of the two groups at the significance level a=0.05. Effective rate and efficiently individual quantity were higher than that of the control group. There was no statistical significance in the change of CD4+ cell count of the two groups after the treatment. But to calculate the effectiveness by CD4+ cell count increase or decrease by 50/mm3, there is statistical significance between the data before treatment and 6 and 12 months after treatment. However, there was no statistical significance between the data before treatment and 3 and 9 months after treatment, but the efficacy of the treatment group was significantly higher than control group.34 patients in asymptomatic HIV infectious period were randomly selected (1/3 cases of the total number, including 20 patients of the treatment group and 14 patients of the control group) to measure viral load. Compared with the data before treatment, there was no statistical significance in viral load in 6 and 12 months after treatment of the two groups at the significance level a=0.05 (P>0.05), but the efficacy of the treatment was higher than the control group; there was no statistical significance on the change of viral load at the significance level a=0.05 (P>0.05),but the average of the viral load of the treatment group was markedly decreased. Analysis of the quality of life showed that there was statistical significance in the score of energy-latitude, emotional-latitude, pain-latitude, sleep-latitude (P<0.05), there was no statistical significance in the score of physical activity latitude and social life latitude (P> 0.05), but the score of the treatment group was obvious decreased than the score obtained before treatment and lower than the control group. Analysis of the safety indicator of Fuzheng Paidu Tablet found no damage to liver and kidney function, and no adverse effects to routine analysis of blood, urine and stool, and no adverse effects to electrocardiogram and chest X-ray fluoroscopy.3 The mechanism based on the immune activation related factors of the intervention to the immune regulation of Fuzheng Paidu Tablet showed that after 6 months of treatment, there was statistical significance on the change of IL-6, IL-8, TNF-a, NPI, and IFN-a at the significance level a=0.05(P<0.05), but no statistical significance in sIL-2R (P>0.05). Before treatment there was statistical significance in IL-8, sIL-2R, TNF-a, NPI, and IFN-a compared with the healthy control group (P<0.05), and before treatment, there was no statistical significance in IL-6 compared the healthy control group (P>0.05). Positive correlation exists between each indicator except TNF-αand IFN-α. There was negative correlation between NPI (before treatment) and TNF-α(after treatment), and also negative correlation between fellowing indicators:NPI (after treatment) and TNF-α(after treatment), IFN-α(before treatment) and IL-8 (before treatment), IFN-α(before treatment) and IL-8(after treatment), CD4+ (before treatment) and sIL-2R (before treatment). There was positive correlation between viral load (before treatment) and sIL-2R (before treatment), and also positive correlation between fellowing indicators:viral load (before treatment) and NPI (after treatment), viral load (after treatment) and NPI(before treatment), viral load (after treatment) and NPI (after treatment).Conclusion:1 Chinese medicine treatment for HIV/AIDS should take asymptomatic HIV infectious period as the starting point.2 Fuzheng Paidu Tablet can significantly improve the symptoms and signs of the patients during the asymptomatic HIV infection period, since this has a tendency to increase or stabilize the quantity of CD4 cell, and in some patients it can decrease the viral load, improve the quality of life from different levels and different aspects, and is safe in clinical use.3 This research suggests that there were close correlation between IL-8, sIL-2R, TNF-a, NPI, IFN-a and the symptom of the asymptomatic HIV infectious period. And cellular immunity correlated to those factors plays an important role in the whole process of the disease, and those factors can be important indicators of the cellular immunity condition and therapeutic effect and prognosis.4 There were correlations between each indicator, but the mechanism is unknown, and further research is needed on the mechanism of Fuzheng Paidu Tablet in the treatment of the patients during the asymptomatic HIV infection period.5 This resarch suggest that IL-6, IL-8, TNF-a, NPI, IFN-a have certain significance in determining the efficacy of Fuzheng Paidu Tablet in the treatment of the patients during the asymptomatic HIV infection period. And those factors can serve as important reference indexes.
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