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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 the HAART-related adverse reactions in the first month before the first-line anti-retroviral therapy (HAART) and to observe the effectiveness and safety of Qingdu capsules. Methods Observe and analyze the adverse reactions caused by the first-line HAART regimen, which is commonly used in 380 HIV-infected patients, that is, within 1 month before lamivudine (3TC) + TDF + EFV and The patients were randomly divided into control group and observation group, 190 cases in each group. The control group was given HAART + Western symptomatic treatment. The observation group was treated with Qingdu capsule on the basis of the control group. The course of treatment was 15 days. The WHO-HIV Quality of Life Scale and Karnofsky’s scores before and after treatment were observed in both groups, and the clinical efficacy and safety were evaluated. Results The adverse reactions related to 3TC + TDF + EFV were mainly gastrointestinal symptoms (24.5%), drug eruptions (20.5%), central neurotoxicity (3.1%) and liver dysfunction (25.3% Renal dysfunction (19.5%) dominated. After treatment, the observation group, the total effective rate was 91.8%, the dressing rate was 7.9%; control group, the total effective rate was 82.6%, the dressing rate was 17.4%, the difference was statistically significant (P <0.05). Gastrointestinal symptoms, drug eruption, renal dysfunction and other toxic adverse reactions, the observation group improved significantly better than the control group (P <0.05); liver function damage, central neurotoxicity improvement rate was no significant difference (P> 0.05) . Quality of life score, the observation group was superior to the control group, the difference was statistically significant (P <0.05); no severe adverse events occurred in both groups during the treatment. Conclusion Qingdu capsule can effectively reduce the adverse reactions such as gastrointestinal symptoms, drug eruption and renal dysfunction caused by HAART regimen (3TC + TDF + EFV), improve the quality of life of patients, and has good safety and is worthy of clinical promotion application.