地五养肝胶囊联合HAART对免疫重建不良HIV/AIDS患者疗效分析  

Effect of Diwu Liver-Nourishing Capsule combine with HAART on HIV/AIDS patients with poor immune reconstitution

作　　者：雷恩泽 阮连国 陈瑶 倪维[3,4,5] 余晓丽 洪可 王映林 肖明中[3,4,5] 刘建忠 LEI Enze;RUAN Lianguo;CHEN Yao;NI Wei;YU Xiaoli;HONG Ke;WANG Yinglin;XIAO Mingzhong;LIU Jianzhong(College of of Traditional Chinese Medicine,Hubei University of Chinese Medicine,Wuhan 430061,China;Wuhan Jinyintan Hospital,Wuhan 430014;Hubei Provincial Hospital of Traditional Chinese Medicine,Wuhan 430061;Affiliated Hospital of Hubei University of Traditional Chinese Medicine,Wuhan 430061;Hubei Instituteof Traditional Chinese Medicine,Wuhan 430074)

机构地区：[1]湖北中医药大学中医临床学院,武汉430061 [2]武汉市金银潭医院,武汉430014 [3]湖北省中医院,武汉430061 [4]湖北中医药大学附属医院,武汉430061 [5]湖北省中医药研究院,武汉430074

出　　处：《中国艾滋病性病》2022年第10期1127-1131,共5页Chinese Journal of Aids & STD

基　　金：国家自然科学基金面上项目(81774280)。

摘　　要：目的 研究地五养肝胶囊联合HAART对免疫重建不良HIV/AIDS患者(肝肾精虚型)的临床疗效,并通过分析对CD45RA+细胞的影响探讨免疫重建机制。方法 本研究采用随机、对照、双盲、单模拟的研究方法。对57例免疫重建不良患者(肝肾精虚型),按随机数字表法分为两组,对照组予地五养肝胶囊模拟剂联合HAART,试验组予地五养肝胶囊联合HAART,疗程均为24周,观察治疗前后中医证候积分、生存质量评分、CD4细胞、CD45RA^(+)、CD45RA^(+)CD31^(+)等。结果 共纳入57例患者,其中对照组28例,试验组29例。在治疗24周后,对照组与试验组中医证候总积分和生存质量积分较基线的差值为分别为(-0.46±1.79vs.-1.10±2.74,-8.61±5.68vs.-7.17±4.07,P均<0.01);两组均较基线CD4细胞计数呈正增长,且试验组较基线的增值大于对照组(P<0.01)。按照临床疗效评价标准,试验组的疗效评价优于对照组(P<0.05)。两组CD45RA+细胞占比呈上升趋势,且试验组较对照组上升更显著(平均值2.99%vs.1.63%,P<0.01);两组CD45RA+CD31+细胞占比呈下降趋势,且对照组较试验组下降更显著(平均值-9.93%vs.-3.76%,P<0.01)。两组均未发生不良事件。结论 地五养肝胶囊联合HAART能提高CD45RA+细胞占比、稳定CD45RA+CD31+细胞,提升CD4细胞计数水平,以促进重建免疫功能,并改善中医证候,减缓生存质量下降。Objective To study the clinical effect of Diwu Yanggan capsule combined with HAART on HIV/AIDS patients with poor immune reconstitution(liver-kidney essence deficiency type), and to explore the mechanism of immune reconstitution by analyzing the effect on CD45RAcells. Methods A randomized, controlled, double-blind, singledummy study was conducted. 57 patients with poor immune reconstitution(liver-kidney essence deficiency type) were divided into two groups according to the random number table. The control group was given Diwu Yanggan Capsule simulant combined with HAART and the study group was given Diwu Yanggan Capsule combined with HAART for 24weeks. TCM syndrome score, quality of life score, CD4 cells, CD45RA^(+), CD45RA^(+)CD31^(+), etc. were observed before and after treatment. Results 28 patients in the control group and 29 patients in the study group. After 24 weeks of treatment,the differences of total TCM syndrome score and quality of life score from baseline between the control group and the study group were(-0.46±1.79 vs.-1.10±2.74,-8.61±5.68 vs.-7.17±4.07, P<0.01). Both groups showed a positive increase in CD4 cell count from baseline, and the increase from baseline in the test group was greater than that in the control group(P<0.01). According to the clinical efficacy evaluation criteria, the efficacy evaluation of the study group was better than that of the control group(P<0.05). The proportion of CD45RAcells in the two groups increased, and the increase was more significant in the study group than in the control group(mean 2.99% vs. 1.63%, P<0.01). The proportion of CD45RACD31cells in the two groups showed a decreasing trend, and the decrease was more significant in the control group than in the study group(mean-9.93% vs.-3.76%, P<0.01). No adverse events occurred in either group. Conclusions Diwu Yanggan capsule combined with HAART can increase the proportion of CD45RAcells, stabilize CD45RACD31cells,increase the level of CD4 cell count, promote the reconstruction of immune function, improve T

关 键 词：艾滋病 免疫重建不良 高效抗反转录病毒治疗 地五养肝胶囊 CD45RA~+/CD45RA~+CD31~+ 

分 类 号：R512.91[医药卫生—内科学] R373.9[医药卫生—临床医学]