康愛保生丸對氣陰兩虛型HIV感染者干預(yù)作用研究
發(fā)布時間:2018-06-04 20:16
本文選題:人類免疫缺陷病毒 + 中醫(yī)藥; 參考:《云南中醫(yī)學(xué)院》2017年碩士論文
【摘要】:目的:本研究旨在通過觀察康愛保生丸治療的人類免疫缺陷病毒(Human Immunodeficiency Virus,HIV)感染患者的臨床癥狀體征、CD4+T淋巴細(xì)胞計數(shù)、病毒載量(Viral Load,VL)水平以及病程進(jìn)展變化情況,評價其治療HIV感染的臨床療效和安全性,探索中醫(yī)藥治療HIV感染的可行性和方法,從而為進(jìn)一步開展中醫(yī)藥規(guī)范化治療提供理論依據(jù)。方法:選取132例符合納入標(biāo)準(zhǔn)(CD4≥350/mm3)的HIV感染患者,按照2:1的比率隨機(jī)分為兩組,試驗組88例給予康愛保生丸治療,對照組44例不給予中藥或西藥干預(yù)(受試者均為無癥狀期HIV/AIDS患者并簽署知情同意書,符合倫理學(xué)要求),進(jìn)行為期12個月治療觀察。對癥狀體征變化情況、卡洛夫斯基積分、CD4+T淋巴細(xì)胞計數(shù)、病毒載量、生存質(zhì)量、HIV感染進(jìn)展、生化、常規(guī)檢測等情況進(jìn)行監(jiān)測,制定專門的臨床觀察表記錄相應(yīng)的資料和指標(biāo)。使用SPSS軟件對以上數(shù)據(jù)進(jìn)行統(tǒng)計學(xué)分析。結(jié)果:1、CD4+T淋巴細(xì)胞計數(shù)治療后試驗組CD4細(xì)胞數(shù)高于對照組,差異有統(tǒng)計學(xué)意義(P0.05);試驗組治療前后CD4細(xì)胞數(shù)變化無統(tǒng)計學(xué)差異(P0.05);對照組治療后CD4細(xì)胞數(shù)下降,差異有統(tǒng)計學(xué)意義(P0.05)。2、HIV病毒載量治療后試驗組病載低于對照組,差異有統(tǒng)計學(xué)意義(P0.05);試驗組治療后病載下降,差異有統(tǒng)計學(xué)意義(P0.05);對照組治療后病載上升,差異有統(tǒng)計學(xué)意義(P0.05)。3、癥狀體征積分治療后試驗組積分低于對照組,差異有統(tǒng)計學(xué)意義(P0.05);試驗組治療后積分下降,差異有統(tǒng)計學(xué)意義(P0.05);對照組治療后積分上升,差異有統(tǒng)計學(xué)意義(P0.05)。4、卡洛夫斯基評分治療后試驗組評分高于對照組,差異有統(tǒng)計學(xué)意義(P0.05);試驗組治療后評分上升,差異有統(tǒng)計學(xué)意義(P0.05);對照組治療前后評分變化無統(tǒng)計學(xué)差異(P0.05)。5、基于HIV/AIDS病人報告的臨床結(jié)局評價量表(PRO)治療前試驗組總分高于對照組,治療后試驗組總分低于對照組,差異有統(tǒng)計學(xué)意義(P0.05)。6、疾病進(jìn)展(ⅡA期→ⅡB期)試驗組進(jìn)入ⅡB期時間低于對照組3.163月,差異有統(tǒng)計學(xué)意義(P0.05)。7、安全性指標(biāo)試驗組與對照組治療前、治療后的WBC、HB、PLT、ALT、AST、BUN組間比較均無統(tǒng)計學(xué)差異(P0.05);試驗組治療后SCR下降,差異有統(tǒng)計學(xué)意義(P0.05)。結(jié)論:1、康愛保生丸能夠穩(wěn)定HIV/AIDS患者的CD4+T淋巴細(xì)胞計數(shù);2、康愛保生丸能夠穩(wěn)定或降低HIV病毒載量;3、康愛保生丸能夠改善HIV/AIDS患者的臨床癥狀體征,提高患者生存質(zhì)量;4、康愛保生丸能夠延緩HIV/AIDS患者的病程進(jìn)展;5、康愛保生丸可能對HIV/AIDS患者腎功能具有保護(hù)作用,安全性較好。
[Abstract]:Objective: the aim of this study was to observe the clinical symptoms and signs of patients infected with human immunodeficiency virus (Immunodeficiency) infected by Kangaibaosheng pills, including the count of CD4 T lymphocytes, viral load and viral load, as well as the progress of the disease. To evaluate the clinical efficacy and safety of HIV infection, to explore the feasibility and method of TCM treatment of HIV infection, so as to provide theoretical basis for further standardized treatment of TCM. Methods: 132 patients with HIV infection were randomly divided into two groups according to the 2:1 rate. 88 patients in the trial group were treated with Kangaibaosheng pills. In the control group, 44 cases were not treated with traditional Chinese medicine or western medicine (the subjects were all asymptomatic HIV/AIDS patients and signed informed consent, in accordance with ethical requirements, for 12 months treatment observation. The changes of symptoms and signs, including CD4 T lymphocyte count, viral load, quality of life (QOL), HIV infection progression, biochemistry, routine detection and so on, were monitored, and a special clinical observation table was established to record the corresponding data and indicators. Use SPSS software to carry on statistical analysis to the above data. Results the number of CD4 cells in the experimental group was higher than that in the control group after treatment, and there was no significant difference in the number of CD4 cells before and after treatment in the experimental group, and the number of CD4 cells in the control group was decreased after treatment. After treatment, the disease load in the experimental group was lower than that in the control group, the difference was statistically significant (P 0.05), the disease load in the test group was decreased after treatment, the difference was statistically significant (P 0.05), and the disease load in the control group was increased after treatment. After treatment, the score of the test group was lower than that of the control group, the difference was statistically significant (P 0.05), the score of the test group decreased after treatment, the difference was statistically significant (P 0.05), and the integral of the control group increased after treatment. The difference was statistically significant (P 0.05). After treatment, the scores of the experimental group were higher than those of the control group, and the difference was statistically significant (P 0.05), and the score of the test group was higher after treatment, and the score of the experimental group was higher than that of the control group. There was no significant difference in the scores of the control group before and after treatment. The total score of the trial group before and after treatment was higher than that of the control group, and the total score of the trial group was lower than that of the control group. The time of disease progression (stage 鈪,
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