目的:探讨中医药联合高效抗逆转录病毒联合疗法(High active antiretroviral therapy，HAART)辨体治疗无症状期虚性体质HIV感染者的临床疗效及相关性分析。方法:采用随机、双盲、模拟剂对照的研究方法，选取2019年3月至2020年10月期间西昌市疾病预防控制中心和攀枝花市第四人民医院的HIV感染者60例。按1:1比例随机分为治疗组和对照组各30例，根据入组辨体情况，治疗组分别给予益艾康胶囊(脾弱质)、健艾康浓缩丸(阳虚质)联合HAART，对照组相应体质分别给予对应的模拟剂联合HAART，疗程均为12个月。观察治疗前后的中医证候积分、免疫指标、病毒载量及肠道菌群等情况。结果:治疗组中医证候总积分及主要证候积分在治疗后均明显下降(P＜0。05)，且低于对照组(P＜0。05)，主要表现在脾弱质倦怠乏力、神疲懒言以及阳虚质畏寒肢冷整体上证候表现消失;阳虚质治疗组有效率明显高于对照组(P＜0。05)，脾弱质血清CD4+T、CD4+/CD8+、CD4+CD45RO+T、CD4+CD45RA+T、CD4CCR5细胞计数以及阳虚质血清CD4+/CD8+、CD4+CD45RO+T、CD4CCR5细胞计数在治疗后明显升高(P＜0。05)，阳虚质CD8+细胞计数明显降低(P＜0。05);患者病毒载量整体上在治疗前后均在检测限以下，治疗组与对照组比较均无差异(P＞0。05)，治疗前后两组均未发生明显不良反应;相关性分析得出脾弱质血清IL-4与倦怠乏力，血清IL-17、TNF-α与神疲懒言呈负相关，IFN-γ与自汗呈正相关，阳虚质血清CD4+CD45RO+T、CD4+CD45RA+T、CD4CCR5、CD4CXCR4与CD4+T细胞计数呈正相关;肠道菌群结果显示脾弱质治疗组拟杆菌属、扭链胃球菌属相对丰度以及阳虚质普雷沃氏菌属、巨单胞菌属、瘤胃球菌属UCG-002相对丰度在治疗后均明显高于对照组(P＜0。05)。结论:益艾康胶囊和健艾康浓缩丸联合HAART能改善虚性体质HIV感染者相应的中医临床证候，并促进虚性体质向平和质转变，增加肠道有益菌群丰度;虽然对提高患者的T细胞亚群相关免疫水平并不优于单纯HAART治疗，但能维持免疫状态的稳定，促进免疫重建，尤其对于阳虚质免疫疗效的提高有一定的作用，同时安全性良好。
Efficacy of Traditional Chinese Medicine and Correlation among HIV-Infected Patients with Deficiency Constitution in Asymptomatic Stage
Objective:To observe the clinical efficacy and correlation of traditional Chinese medicine(TCM)combined with highly active antiretro-viral therapy(HAART)in the treatment of human immunodeficiency virus(HIV)-infected patients with deficiency constitution in the asymp-tomatic stage based on constitution differentiation.Methods:A randomized,double-blind,and simulant-controlled study was conducted,and 60 cases of HIV-infected patients admitted to Xichang City Disease Prevention and Control Centre and Panzhihua City No.4 People's Hospi-tal from March 2019 to October 2020 were selected.They were randomly divided into a treatment group and a control group in a ratio of 1∶1.According to the results of constitution differentiation,the treatment group was given Yiaikang(益艾康)Capsules(spleen-weak type)and Jianaikang(健艾康)Condensed Pills(yang-deficiency type),combined with HAART,and corresponding simulants combined with HAART were given to the corresponding constitution in the control group.The treatment lasted for 12 months.The TCM symptom scores,im-munological indexes,viral loads,and intestinal flora before and after treatment were observed.Results:The total TCM symptom scores and the main symptom scores of the treatment group decreased significantly after treatment(P＜0.05)and were lower than those of the control group(P＜0.05).The symptoms such as lassitude,mental exhaustion,and fewer words of spleen-weak type,as well as fear of cold and cold limbs of yang-deficiency type disappeared.The effective rate of yang-deficiency type in the treatment group was higher than that in the control group(P＜0.05).The CD4+T,CD4+/CD8+,CD4+CD45RO+T,CD4+CD45RA+T,and CD4CCR5 cell counts of spleen-weak type,as well as the CD4+/CD8+,CD4+CD45RO+T,and CD4CCR5 cell counts of yang-deficiency type were significantly improved after treatment(P＜0.05),and the CD8+cell counts of yang-deficiency type were significantly reduced after the treatment(P＜0.05).There was no significant difference between the treatment group and the control group(P＞0.05)as the overall viral load of patients was below the detection limit be-fore and after treatment,and no significant adverse reactions occurred in the two groups before and after treatment.The correlation analysis yielded a negative correlation between IL-4 and the lassitude and between IL-17 and TNF-d a nemental exhaustion and fewer words of spleen-weak type,and IFN-plwas positively correlated with spontaneous sweating.CD4+CD45RO+T,CD4+CD45RA+T,CD4CCR5,and CD4CXCR4 were positively correlated with CD4+T cell counts of yang-deficiency type.The results of intestinal flora showed that the relative abundance of Bacteroides and Ruminococcus torques of spleen-weak type,as well as that of Prevotella,Megamonas,and Ruminococcaceae UCG-002 of yang-deficiency type in the treatment group was significantly higher than that in the control group after treatment(P＜0.05).Conclusion:The combination of HAART with Yiaikang Capsules and Jianaikang Condensed Pills can improve the clinical TCM symptoms of HIV-infected patients with deficiency constitution,promote the transformation of deficiency constitution to neutral type,and increase the a-bundance of intestinal beneficial bacteria.Although it is not superior to HAART alone in improving the immune level of T lymphocyte subsets of the patients,it can maintain the stability of immune status and promote immune reconstruction,especially for the improvement of immune efficacy of patients with yang-deficiency type,with high safety.
AIDSAsymptomatic stageHighly active antiretroviral therapySpleen-weak typeYang-deficiency type
万方数据
维普
