康爱保生丸对气阴两虚型HIV感染者干预作用研究

发布时间：2018-06-04 20:16

  本文选题：人类免疫缺陷病毒 + 中医药　； 参考：《云南中医学院》2017年硕士论文

【摘要】：目的:本研究旨在通过观察康爱保生丸治疗的人类免疫缺陷病毒(Human Immunodeficiency Virus,HIV)感染患者的临床症状体征、CD4+T淋巴细胞计数、病毒载量(Viral Load,VL)水平以及病程进展变化情况,评价其治疗HIV感染的临床疗效和安全性,探索中医药治疗HIV感染的可行性和方法,从而为进一步开展中医药规范化治疗提供理论依据。方法:选取132例符合纳入标准(CD4≥350/mm3)的HIV感染患者,按照2:1的比率随机分为两组,试验组88例给予康爱保生丸治疗,对照组44例不给予中药或西药干预(受试者均为无症状期HIV/AIDS患者并签署知情同意书,符合伦理学要求),进行为期12个月治疗观察。对症状体征变化情况、卡洛夫斯基积分、CD4+T淋巴细胞计数、病毒载量、生存质量、HIV感染进展、生化、常规检测等情况进行监测,制定专门的临床观察表记录相应的资料和指标。使用SPSS软件对以上数据进行统计学分析。结果:1、CD4+T淋巴细胞计数治疗后试验组CD4细胞数高于对照组,差异有统计学意义(P0.05);试验组治疗前后CD4细胞数变化无统计学差异(P0.05);对照组治疗后CD4细胞数下降,差异有统计学意义(P0.05)。2、HIV病毒载量治疗后试验组病载低于对照组,差异有统计学意义(P0.05);试验组治疗后病载下降,差异有统计学意义(P0.05);对照组治疗后病载上升,差异有统计学意义(P0.05)。3、症状体征积分治疗后试验组积分低于对照组,差异有统计学意义(P0.05);试验组治疗后积分下降,差异有统计学意义(P0.05);对照组治疗后积分上升,差异有统计学意义(P0.05)。4、卡洛夫斯基评分治疗后试验组评分高于对照组,差异有统计学意义(P0.05);试验组治疗后评分上升,差异有统计学意义(P0.05);对照组治疗前后评分变化无统计学差异(P0.05)。5、基于HIV/AIDS病人报告的临床结局评价量表(PRO)治疗前试验组总分高于对照组,治疗后试验组总分低于对照组,差异有统计学意义(P0.05)。6、疾病进展(ⅡA期→ⅡB期)试验组进入ⅡB期时间低于对照组3.163月,差异有统计学意义(P0.05)。7、安全性指标试验组与对照组治疗前、治疗后的WBC、HB、PLT、ALT、AST、BUN组间比较均无统计学差异(P0.05);试验组治疗后SCR下降,差异有统计学意义(P0.05)。结论:1、康爱保生丸能够稳定HIV/AIDS患者的CD4+T淋巴细胞计数;2、康爱保生丸能够稳定或降低HIV病毒载量;3、康爱保生丸能够改善HIV/AIDS患者的临床症状体征,提高患者生存质量;4、康爱保生丸能够延缓HIV/AIDS患者的病程进展;5、康爱保生丸可能对HIV/AIDS患者肾功能具有保护作用,安全性较好。
[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，

本文编号：1978694