摘要
目的:本研究观察参灵扶正胶囊和清毒胶囊干预无症状艾滋病病毒(HIV)感染者的临床疗效与安全性。方法:将210例无症状HIV感染者按2∶1的比例随机分配到试验组和对照组,前者予中医药辨证治疗,后者予模拟剂,观察发病百分比,CD4+T细胞、CD8+T细胞计数,细胞因子水平,生活质量和不良反应。结果:试验组发病百分比为22.73%,对照组为36.92%,差异有统计学意义(P<0.05);试验组治疗后CD4+T计数及白介素-12(IL-12)水平高于对照组(P<0.05),白介素-6(IL-6)低于对照组(P<0.05);试验组治疗后WHOQOL-HIV-BREF评分项目生理领域、心理领域、独立性领域、总体健康状况和总体生活质量评分增加,高于对照组治疗后的相应评分(P<0.05)。在观察期间,试验组发生不良反应事件6例,对照组2例,差异无统计学意义。结论:中医药干预可延缓HIV感染者进入艾滋病期,降低艾滋病期的发病百分比,提高患者生活质量,安全性良好。
Objective:To observe the curative effect and safety of intervening asymptomatic HIV infection with Shenling Fuzheng Capsule and Qingdu Capsule.Methods:Two hundred and ten asymptomatic HIV-infected patients were randomly divided in to two groups as treatment group and control group according to the proportion of 2:1.Patients in treatment group were treated with traditional Chinese medicine treatment based on syndrome differentiation,and patients in control group were treated with simulative prescription.The morbidity,number of CD_4~+T and CD_8~+ cells,cytokines levels,quality of life and adverse reactions were observed.Results:The morbidity of treatment group was 22.73%,while the morbidity of control group was36.92%,and the difference between the two groups was significant(P〈0.05).The number of CD_4~+T cells and the level of IL-12 of patients in treatment group were higher than that of patients in control group after treatment(P〈0.05),and the level of IL-6of patients in treatment group was lower than that of control group(P〈0.05).The items of WHOQOL-HIV-BREF as score of physiological field,psychological field,independence field,general health and quality of life of patients in treatment group were higher than that of patients in control group after treatment(P〈0.05).There were 6 cases of adverse reaction in treatment group and 2 cases of adverse reaction in control group,and the differencebetween the two groups was not significant.Conclusion:TCM intervention could postpone the time of HIV infection turning into AIDS,reduce the morbidity of AIDS,and improve the quality of life of patients,which has satisfactory safety in clinical application.
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2015年第10期3520-3523,共4页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
国家"十二五"科技重大专项资助课题(No.2012ZX10005010)
国家科技部国际合作课题(No.2014DFA30580)
广西八桂学者专项资助
广西科学研究与技术开发项目资助课题(No.桂科攻1398047-7
No.桂科攻1355006-7
No.桂科攻14124004-2-2
No.桂科攻1140003B-62)
广西自然科学基金项目(No.2013GXNSFAA019172
No.2011GXNSFB018101)
广西中医药行业专项资助课题(No.GZZY13-22)~~
关键词
无症状艾滋病
HIV
中医药
参灵扶正胶囊
清毒胶囊
No symptoms of AIDS
HIV
Traditional Chinese medicine
Shenling Fuzheng Capsule
Qingdu Capsule