|
扶正益补颗粒联合HAART治疗气血亏虚型HIV感染者的临床研究
|
Abstract:
目的:探讨扶正益补颗粒联合HAART治疗气血亏虚型HIV感染者的临床疗效及对免疫系统(T淋巴细胞亚群)的影响。方法:选取100例于2022年7月~11月到昆明市第三人民医院就诊的气血亏虚型HIV感染者。采用随机数字表法将HIV患者随机分为中西药组与西药组,每组各50例。西药组给予HAART治疗方案;中西药组在HAART的基础上加用扶正益补颗粒;疗程均为24周。观察两组临床疗效,比较治疗前后两组患者中医证候积分、HIV病毒载量、T淋巴细胞亚群、IFN-γ、IL-4水平及不良反应发生率。结果:治疗后,中西药组在缓解乏力、气短、神疲、懒言、面色淡白或萎黄及纳呆症状的疗效优于西药组(P < 0.01),且中西药组中医证候总积分显著低于西药组总积分(P < 0.01)。两组CD4+、CD4+/CD8+均较治疗前显著升高显著(P < 0.01),且中西药组显著高于西药组(P < 0.01);中西药组CD3+显著高于西药组(P < 0.01);两组CD8+均较治疗前降低(P < 0.01)。两组IFN-γ水平均显著升高(P < 0.01)、IL-4水平均显著降低(P < 0.01)。结论:扶正益补颗粒联合HAART治疗可以显著改善气血亏虚型HIV感染者的临床症状、调节Th1/Th2细胞平衡、改善患者的免疫功能,且无明显毒副作用。
Objective: To explore the clinical efficacy and impact on the immune system (T lymphocyte subpopulations) of Fuzheng Yibu Granules combined with HAART in the treatment of HIV-infected people with deficiency of qi and blood. Methods: A total of 100 HIV-infected individuals who fulfilled the diagnostic criteria for HIV infection accompanied by qi and blood deficiency were enrolled in this study and received treatment at the Third People’s Hospital of Kunming from July 2022 to November 2022. The participants were randomly allocated into two groups: the Chinese and Western medicine group and the Western medicine group, with 50 individuals in each group. The Western medicine group was given the HAART treatment; the Chinese and Western medicine group was given Fuzheng Yibu Granules on the basis of HAART. The treatment course was 24 weeks. The therapeutic effects of the two groups were observed, and the TCM syndrome scores, HIV viral load, T lymphocyte subsets, IFN-γ, IL-4 levels, and the incidence of adverse reactions before and after treatment were compared between the two groups. Results: After treatment, the Chinese and Western medicine group was superior to the Western medicine group in alleviating symptoms such as fatigue, shortness of breath, mental fatigue, reluctance to speak, pale or sallow complexion, and anorexia (P < 0.01), and the total TCM syndrome score of the Chinese and Western medicine group was significantly lower than that of the Western medicine group (P < 0.01). The levels of CD4+ and CD4+/CD8+ in both groups were significantly increased compared with those before treatment (P < 0.01), and the levels in the Chinese and Western medicine group were
[1] | 雷玉林, 刘强, 彭昌伟, 等. 150例HIV/AIDS人群3年免疫状态监测结果[J]. 预防医学情报杂志, 2020, 36(7): 912-927. |
[2] | 徐洪吕, 保武生, 史小颜, 等. 1995-2013年曲靖市HIV感染者发展为AIDS影响因素分析[J]. 中国皮肤性病学杂志, 2015, 29(3): 271-282. |
[3] | 韩孟杰. 我国艾滋病流行形势分析和防治展望[J]. 中国艾滋病性病, 2023, 29(3): 247-250. |
[4] | 刘纯, 王敏, 李晓萍. 长沙市第一医院23例艾滋病母婴阻断效果分析[J]. 中国感染控制杂志, 2017, 16(4): 355-358. |
[5] | 宋春鑫, 危剑安, 黄霞珍, 等. 中药艾灵颗粒对HIV/AIDS病人免疫细胞功能影响的初步探讨[J]. 中国艾滋病性病, 2010, 16(1): 4-17. |
[6] | 陶庄, 董继鹏, 郭会军, 等. 青蒿琥酯片对HIV/AIDS患者ART后免疫功能重建不全影响的研究[J]. 中国艾滋病性病, 2021, 27(9): 921-925. |
[7] | 中华医学会感染病学分会艾滋病丙型肝炎学组, 中国疾病预防控制中心. 中国艾滋病诊疗指南(2021年版) [J]. 协和医学杂志, 2022, 13(2): 203-226. |
[8] | 国家中医药管理局, 国家卫生健康委. 艾滋病(成人)中医诊疗方案(2016版)[S]. 2016. |
[9] | 谢世平, 郭会军, 王健. 艾滋病中医诊疗指南(2013版) [J]. 中医学报, 2014, 29(5): 617-620. |
[10] | 郑筱萸. 中药新药临床研究指导原则(试行) [M]. 北京: 中国医药科技出版社, 2002: 378-383. |
[11] | 徐祉君. 益艾康胶囊治疗HIV/AIDS肺脾气虚证的临床疗效及对NF-κB信号通路的观察[D]: [硕士学位论文]. 郑州: 河南中医药大学, 2018. |
[12] | 岑科. 益气培元法对HAART后HIV/AIDS免疫重建不良患者T淋巴细胞亚群的影响[D]: [硕士学位论文]. 广州: 广州中医药大学, 2017. |
[13] | 疾病预防控制局. 2021年全国法定传染病疫情概况[EB/OL]. http://www.nhc.gov.cn/jkj/s3578/202204/4fd88a291d914abf8f7a91f6333567e1.shtml, 2022-04-22. |
[14] | Zondi, S.L. and Naidoo, P. (2022) Reporting and Recording of Adverse Drug Reactions of Highly Active Antiretroviral Therapy by HIV Infected Patients and Healthcare Professionals Respectively in the Ethekwini Metropolitan, of Kwa-Zulu Natal, South Africa: A Cross Sectional and Retrospective Comparative Study. Pan African Medical Journal, 42, Article 218. https://doi.org/10.11604/pamj.2022.42.218.32239 |
[15] | 周天玉, 刘晶晶, 杨欣怡, 等. 四川省591例HIV/AIDS患者中医证候及证型的分布规律研究[J]. 中国艾滋病性病, 2021, 27(4): 399-401. |
[16] | 王健, 刘颖, 何丽云, 等. 2237例HIV/AIDS患者中医证候分布及演变规律[J]. 中医杂志, 2012, 53(11): 948-951. |
[17] | 朱勇, 李丽, 郭燕, 等. 艾滋病患者CD4+T细胞基线值与长期高效抗逆转录病毒治疗免疫重建效果的相关性研究[J]. 现代生物医学进展, 2017, 17(15): 2880-2883. |
[18] | 王爱莉. CD3+、CD4+、CD8+T淋巴细胞亚群在HIV感染者外周血中检测的临床意义[J]. 中国医药指南, 2019, 17(10): 115-116. |
[19] | 孙续禄, 马骁, 敬小莉, 等. 芪灵汤联合高效抗逆转录病毒疗法对HIV/AIDS炎性因子和免疫功能的影响研究[J]. 中华中医药学刊, 2018, 36(7): 1756-1759. |
[20] | 陈学武, 姜靖雯, 张永杰, 等. 加味八珍汤联合放化疗对气血亏虚型鼻咽癌晚期患者的临床疗效[J]. 中成药, 2021, 43(8): 2053-2057. |
[21] | 刘惠, 周晋华. 八珍汤在提高恶性肿瘤患者免疫功能方面疗效Meta分析[J]. 中医药临床杂志, 2019, 31(1): 88-93. |
[22] | 李宏雅, 纪鹏, 魏彦明, 等. 加味玉屏风及其多糖对小鼠免疫功能的影响[J]. 动物医学进展, 2022, 43(12): 73-79. |
[23] | 曹发昊, 王艳萍. 党参总皂苷纳米乳对小鼠免疫功能的影响[J]. 西北农林科技大学学报(自然科学版), 2019, 47(5): 125-131. |
[24] | 常彦祥, 孙利平. 柴胡皂苷D对肝癌大鼠肿瘤生长和免疫功能的影响[J]. 中国临床药理学杂志, 2020, 36(14): 2059-2062. |
[25] | Amagase, H. and Farnsworth, N.R. (2011) A Review of Botanical Characteristics, Phytochemistry, Clinical Relevance in Efficacy and Safety of Lycium barbarum Fruit (Goji). Food Research International, 44, 1702-1717. https://doi.org/10.1016/j.foodres.2011.03.027 |
[26] | 李静茹, 马建萍, 马秀兰, 等. 基于CD4+T淋巴细胞亚群平衡状态探讨中药复方治疗HIV感染者疗效研究进展[J]. 中国医药导刊, 2017, 19(9): 880-882. |
[27] | Romagnani, S. (2000) T-Cell Subsets (Th1 versus Th2). Annals of Allergy, Asthma & Immunology, 85, 9-21. https://doi.org/10.1016/s1081-1206(10)62426-x |
[28] | Klein, S.A., Dobmeyer, J.M., Dobmeyer, T.S., Pape, M., Ottmann, O.G., Helm, E.B., et al. (1997) Demonstration of the Th1 to Th2 Cytokine Shift during the Course of HIV-1 Infection Using Cytoplasmic Cytokine Detection on Single Cell Level by Flow Cytometry. AIDS, 11, 1111-1118. https://doi.org/10.1097/00002030-199709000-00005 |
[29] | Becker, Y. (2004) The Changes in the T Helper 1 (Th1) and T Helper 2 (Th2) Cytokine Balance during HIV-1 Infection Are Indicative of an Allergic Response to Viral Proteins That May Be Reversed by Th2 Cytokine Inhibitors and Immune Response Modifiers—A Review and Hypothesis. Virus Genes, 28, 5-18. https://doi.org/10.1023/b:viru.0000012260.32578.72 |