摘要
目的探讨前1个月常用一线高效抗反转录病毒治疗(HAART)相关不良反应,并观察清毒胶囊的有效性及安全性。方法观察分析380例HIV感染者常用一线HAART方案,即拉米夫定(3TC)+替诺福韦(TDF)+依非韦伦(EFV)前1个月内所致的相关不良反应,并将患者随机分为对照组和观察组,每组各190例,对照组给予HAART+西医对症治疗,观察组在对照组治疗基础上+清毒胶囊治疗,疗程均为15天。观察两组患者治疗前后WHO-HIV生存质量量表、卡氏评分,并对临床疗效及安全性进行评估。结果高效抗反转录病毒方案(3TC+TDF+EFV)相关不良反应主要以消化道症状(24.5%)、药疹(20.5%)、中枢神经毒性(3.1%)、肝功能损害(25.3%)、肾功能损害(19.5%)为主。经治疗后,观察组临床总有效率为91.8%,换药率为7.9%;对照组总有效率为82.6%,换药率为17.4%,差异均有统计学意义(P<0.05)。其中胃肠道症状、药疹、肾功能损害等毒性不良反应,观察组改善率显著优于对照组(P<0.05);肝功能损害、中枢神经毒性改善率差异无统计学意义(P>0.05)。生存质量评分,观察组优于对照组,差异有统计学意义(P<0.05);治疗过程中两组患者均无严重不良事件的发生。结论清毒胶囊能够有效减少HAART方案(3TC+TDF+EFV)所致的胃肠道症状、药疹及肾功能损害等相关不良反应,提高患者生活质量,并具有良好的安全性,值得临床上推广应用。
Objective To investigate drug- related adverse of common firstline highly active antiretroviral therapy （HAART） in one month before, and observe the efficacy and safety of Qingdu capsule. Methods Observed and analyzed adverse reactions of the 380 cases HIV infection who used commonly first - line HAART scheme（3TC ＋ TDF ＋ EFV）. The patients were randomly divided into control group and observation group, 190 cases in each group. The control group was given HAART ＋ western medicine symptomatic treatment, the observation group adding Qingdu capsule on the basis of control group, treatment for 15 days. WHO - HIV quality of life scale and Karnofsky score were observed before and after treatment in the two groups, and evaluated the clinical efficacy and safety. Results The adverse reactions to HAART （3TC ＋ TDF ＋ EFV） mainly for gastrointestinal symptoms （24.5%） , drug eruption （20.5%） , neurotoxicity（3.1% ）, liver function damage （25.3%） and renal dysfunction （ 19.5% ）. After treatment, the total efficiency of the observation group was 91.8% , Dressing rate was 7.9% ; the control group total effective rate was 82.6% , Dressing rate was 17.4% , the differences were statistically significant （P 〈0. 05）. The improvement rate of gastrointestinal symptoms, drug eruption, renal dysfunction and other side effects, The observation group was significantly better than the control group （ P 〈 0.05 ）. Liver function damage and improvement rate of neurotoxicity was not significantly different （ P 〉 0. 05 ）. Comparing the scores of life quality , the observation group better than the con- trol group, the difference was statistically significant （P 〈 0.05）. The treatment process of two groups of patients had no serious adverse events. Conclusion Qingdu capsule can effectively reduce the adverse reactions which contain gastrointestinal symptoms, drug eruption and impaired renal function caused by HAART （3TC ＋ TDF ＋ EFV） ,improve the life quality of patients and h
出处
《医学研究杂志》
2016年第1期62-65,共4页
Journal of Medical Research
基金
国家科技部国际合作项目(2014DFA30580)
国家中医药管理局课题基金资助项目(JDZX2012022)
教育部新世纪优秀人才支持计划基金资助项目(NCET-13-0745)
广西壮族自治区八桂学者专项基金资助项目
广西壮族自治区中医药管理局科技专项基金资助项目(GZZY13-24
GZPT1223)
广西壮族自治区科技攻关课题(14124004-2-2
1355006-7)
关键词
高效抗反转录病毒治疗
清毒胶囊
不良反应
临床疗效
生活质量
安全性
Highly active antiretroviral therapy
Qingdu capsule
Adverse reaction
Clinical efficacy
Quality of life
Safety
