我国目前一线抗HIV治疗方案的疗效与不良反应

Comparative Study on Safety and Efficacy of Zidovudine Versus Stavudine Containing Combination Antiretroviral Therapy

目的比较我国现有一线抗HIV治疗方案(齐多夫定+拉米夫定+依非韦伦与司他夫定+拉米夫定+依非韦伦)的临床疗效以及不良反应。方法对2005年9月～2010年4月上海市公共卫生临床中心门诊接受一线抗病毒治疗的艾滋病患者的资料进行回顾性分析,分析抗病毒治疗疗效及不良反应的差异。结果共收治362例患者,其中接受齐多夫定(AZT)+拉米夫定(3T C)+依非韦伦(EFV)治疗的患者231例(AZT组),接受司他夫定(D4T)+3TC+EFV的患者131例(D4T组)。两组基线情况无差异。治疗6个月时AZT组与D4T组的有效率分别为70.8%和75.2%(P>0.05);治疗1年时AZT组与D4T组的有效率分别为50.8%和59.8%(P>0.05)。治疗多少年后两组患者中血糖和三酰甘油升高者的比例无统计学差异(P>0.05),但与治疗前比较,抗病毒治疗后两组患者中血糖和三酰甘油升高者的比例均显著增加(P<0.05,P<0.05)。基于AZT治疗组患者中有39例在2年内更换药物治疗,而基于D4T治疗组有19例更换药物治疗,换药患者的比例两组无显著差异(P>0.05);2年后更换药物治疗的例数两组则分别为4例和25例,换药患者的比例两组存在(P<0.05),其中D4T治疗组中22例是因为药物不良反应换药,3例为耐药换药,而AZT治疗组则均为药物耐药而换药。结论我国目前常用的一线抗病毒治疗方案的疗效相似,发生血糖和甘油三酯升高的情况相似,但含D4T治疗方案用药2年以上因药物不良反应而换药的比例较高,在临床上应注意监测。

Objective Earlier reports did not compare treatment regimens according to the nucleoside backbone. We studied a co- hort of individuals who did not switch between stavudine and zidovudine. Evaluation of the efficacy and tolerability of various nucleoside - sparing combination antiretroviral therapy （cART） regimens. Methods Enrolled 362 ARV - na ve adults between September 2005 and April 2011, treated with zidovndine versus stavudine containing combination antiretroviral therapy. The laboratory results and signs were observed and analyzed with SPSS 11.5 statistical software package. Results Totally 231 patients were treated by zidovudine cARl＇ regi- mens, and 131patients were treated by stavudine cART regimens. No statistically significant difference was found between group zidovudi- ne cART regimens and group stavudine cART regimens in terms of gender, age and the baseline of CD4 cell count. The average CD4 ＋ T cell count increase at half year was 76.9 ＋ 76.5 cells/ram3 and 114.5 ＋ 99.2 cells/ram3 at one years with no significantly gain in the ZDV/d4T arm. Although after treatment there were a significant raising in sugur and serum triglyeerides, there were no statistically signifi- cant difference in the ZDV/d4T arm. Thirty nine patients switch the regimens in group zidovudine cART regimens and 19 patients switch the regimens in group stavudine cART regimens in two years and the switch rate were no statictically significant difference. After two years treatmen, the switch rate due to the adverse event were raising in group stavudine cART regimens. Conclusion No statistically significant difference was found between group zidovudine cART regimens and group stavudine cART regimens in the efficacy and incidence of in- crease in sugar and serum triglycerides. The switch rate due to the adverse event were raising in group stavudine cART regimens after two years treatment. We should monitor ofen.