首页|以"祛邪"为治则探索愈疡胶囊联合HAART干预HIV感染者的前瞻性研究

以"祛邪"为治则探索愈疡胶囊联合HAART干预HIV感染者的前瞻性研究

扫码查看
目的:探索愈疡胶囊联合HAART药物在促进HIV感染者免疫重建、延缓发病方面的有效性与安全性。方法:采用多中心、随机、双盲、对照的前瞻性临床研究,纳入120例符合条件的受试者,试验组和对照组各60例,均采用HAART疗法。试验组予愈疡胶囊口服,对照组给予安慰剂,服法相同。观察24个月,统计分析药物的有效性(对患者CD4+T细胞等淋巴细胞亚群、临床症状体征的影响)与安全性(血常规、肝肾功、心电图及胸部X线片等安全性指标的变化、不良事件的发生情况)。结果:两组治疗前后CD4+/CD8+、CD8+HLA-DR+、CD8+HLA-DR+/CD3+CD8+,均有明显差异(P<0。05)。两组治疗后均在乏力、腹泻、自汗、盗汗、肌肉痛、关节痛、皮肤瘙痒方面有明显改善(P<0。05);试验组受试者腹痛、淋巴结肿大明显改善(P<0。05),对照组受试者纳呆、胸痛、皮疹、黏膜溃疡明显改善(P<0。05)。与对照组比较,治疗组纳呆、关节痛两项评分的治疗效果明显改善(P<0。05)。两组均有部分患者由于CD4+T<200个/μL触发终点事件,发生人数比较无统计学意义(P>0。05)。安全性指标及不良事件两组各个访视点比较均无统计学差异(P>0。05)。结论:愈疡胶囊与HAART方案联用不会引起拮抗效果、不增加用药安全风险,有改善腹痛、淋巴结肿大的作用。
Prospective Study of Yuyang(愈疡)Capsules Combined with HAART in the Treatment of HIV-Infected Patients by Eliminating Evil Factors
Objective:To explore the effectiveness and safety of Yuyang(愈疡)Capsules combined with highly active antiretroviral therapy(HAART)in promoting immune reconstruction and delaying the onset of human immunodeficiency virus(HIV)infection in patients.Meth-ods:A multicenter,randomized,double-blind,and controlled prospective clinical study was conducted,and 120 eligible subjects were in-cluded,with 60 cases in the experimental group and 60 cases in the control group,all of whom were treated with HAART.The experimental group took Yuyang Capsules orally,while the control group took placebos orally.After observation of 24 months,the effectiveness(the influ-ence on CD4+T,other lymphocyte subsets,and clinical symptoms and signs)and safety(the changes in safety indexes such as blood rou-tine,liver and kidney function,electrocardiogram,chest X-ray film,as well as the occurrence of adverse events)of the drug were statistical-ly analyzed.Results;CD4+/CD8+,CD8+HLA-DR+,and CD8+HLA-DR+/CD3+CD8+were significant in the two groups before and after treatment(P<0.05).The patients in the two groups were improved in terms of fatigue,diarrhea,spontaneous sweating,night sweats,mus-cle pain,joint pain,and skin itching after treatment(P<0.05),in addition,the abdominal pain and lymphadenopathy in the experimental group were significantly improved(P<0.05),while the anorexia,chest pain,rash,and mucosal ulcer in the control group were significantly improved(P<0.05).Compared with those of the control group,the therapeutic effects of anorexia and joint pain of the experimental group were significant(P<0.05).In both groups,there were some patients whose CD4+T<200/μL triggered endpoint events,and there was no statistical significance(P>0.05).Moreover,there was no statistical difference in safety index and adverse events between the two groups(P>0.05).Conclusion;Yuyang Capsules combined with HAART will not cause antagonism.They can significantly improve abdominal pain and lymphadenopathy and will not increase the safety risk of medication.

Yuyang(愈疡)CapsulesHIV-infected patientsHAARTStrengthening body resistance and eliminating evil FactorsAb-dominal painLymphadenopathy

彭鑫、杨欣怡、周天玉、苏琛、罗伦才、阎玉萍、刘晶晶、张毅

展开 >

四川省中医药科学院,成都 610041

凉山彝族自治州第二人民医院,西昌 615000

凉山彝族自治州中西医结合医院,西昌 615000

愈疡胶囊 HIV感染者 HAART 扶正祛邪 腹痛 淋巴结肿大

2024

中药药理与临床
中国药理学会 四川省中医药科学院

中药药理与临床

北大核心
影响因子:0.996
ISSN:1001-859X
年,卷(期):2024.40(4)