Trizivir^TM治疗80例HIV／AIDS患者临床研究

Clinical study of Trizivir in the treatment of HIV/AIDS patients

目的1.评估TrizivirTM(AZT+3TC+ABC,TZV)治疗中国HIV/AIDS患者的疗效和安全性;2.HIV/AIDS患者的依从性;3.考察中国社区内HIV/AIDS患者服用固定剂量三联片治疗的可行性。方法80例HIV/AIDS患者进入治疗组。是一项单中心、开放式、无对照的临床试验。患者接受36个月的治疗,在治疗1,2,3,4,5,6,9,12,18,24,30和36个月按时到门诊随访。结果57例(71.3%)患者完成36个月治疗随访,23例(28.7%)在治疗过程中因药物不良反应、机会性感染复发、依从性不好或治疗失败而退出。57例治疗36个月后,CD4+T淋巴细胞计数平均增加252/μL,93.0%的患者显示病毒载量<400拷贝/mL。在36个月的治疗期间,有4例患者出现耐药。结论TZV抗病毒效果显著,对于病毒载量>500000拷贝/mL的患者也有很好的效果,CD4+T淋巴细胞计数均显示明显增加。TZV不良反应较少,与其他药物的相互作用较少,服用方便,患者服药依从性好,对某些患者尤其有毒瘾者不失为一种可以选用的治疗方案。

Objective To assess the efficacy and safety of Trizivir in Chinese people living with HIV infection; treatment compliance; and the feasibility of anti-HIV therapy with a simple, fixed-dose combination product involving three antiretroviral agents in HIV infected patients in urban communities in China. Methods The Trizivir treatment project began on Oct 30, 2002 and ended on Aug 20, 2003. Eighty HIV/AIDS patients received Trizivir in a single centre, open label and non-comparative study. Patients received Trizivir bid for 36 months and were followed-up at the end of Month 1, 2, 3, 4, 5, 6, 9, 12, 18, 24, 30 and 36 during the treatment period. Trizivir was provided by GlaxoSmithKline China Investment Co. , Ltd. Results Fifty- seven patients （71.3%） completed their 36-month treatment and follow-up, 23 （28.7%） discontinued early because of various reasons such as adverse drug effects, relapse of opportunistic infection, treatment failure or use of other treatments, and poor adherence. After treatment for 36 months, the average count of CD4 ＋ T lymphocyte increased by 252 cells/μL in the 57 patients. During the 36-month treatment, 7 patients bad viral rebound. Drug-resistance was observed in 4 patients. Conclusions Trizivir shows significant anti-virus effects after 36-month treatment. It is effective for patients with the viral load 〉500 000 copies/ mL. The CD4 ＋ count increased significantly after 36-month treatment. Trizivir has advantages in terms of fewer adverse reactions, good compliance, less drug interactions and convenient use. It may be a good choice for some patients like drug addicts.