Ibáñez A, Peraire J, Arnó A, Gutiérrez C, Cervantes M, Colomer J, Villalonga C, Camafort M, Ruiz L, Balaguer M, Vidal F, Richart C, Clotet B
Internal Medicine Department, Germans Trias i Pujol University Hospital, Badalona, Barcelona, Spain.
Antivir Ther. 1997 Apr;2(2):105-11.
We evaluated the effect of combination therapy with zidovudine (AZT) plus zalcitabine (ddC) in human immunodeficiency virus type 1 (HIV-1)-infected patients who had not previously received antiretroviral treatment ('naive' patients). The immunological and virological parameters evaluated were CD4 cell count, syncytium-inducing (SI) viral phenotype and plasma HIV-1 RNA copies/ml (HIV viral load). A total of 75 patients entered the study, with CD4 cell counts between 200 and 500 cells/mm3. All received zidovudine (200 mg) plus zalcitabine (0.75 mg) three times daily for 24 weeks. Treatment was well tolerated. However, four patients presented with anaemia (haemoglobin < 10.0 g/dl) and one patient had both anaemia and neutropenia (0.8 x 10(9) neutrophils/l). Combination therapy with zidovudine plus zalcitabine resulted in a pronounced improvement of virological and immunological markers. Approximately 25% of patients achieved undetectable plasma HIV RNA levels (< 200 copies/ml) at week 24. At the end of the study (24 weeks) a significant reduction (> 0.5 log) of plasma HIV RNA was observed in approximately 70% of patients and in 50% an even greater decrease (> 1 log) was achieved. The most significant decrease in mean plasma HIV RNA levels was observed at week 4, whereas the highest increase in CD4 cell count was found at week 24. Approximately 80% of patients who showed baseline plasma HIV RNA levels below 20000 copies/ml had less than 5000 copies/ml at week 24. The plasma HIV RNA reduction observed at week 4 was significantly maintained at week 24. Therefore, we can rapidly select those who will not respond to therapy and adjust the treatment after a short interval. Our study supports the idea of early therapy because all patients who reached undetectable levels of plasma HIV RNA at week 24 had at baseline a median plasma HIV RNA load of 2560 copies/ml. In conclusion, zidovudine in combination with zalcitabine was well tolerated in the majority of patients and led to a significant reduction in plasma HIV RNA copies in most of the patients with initial viraemia lower than 20000 copies/ml.
我们评估了齐多夫定（AZT）联合扎西他滨（ddC）的联合疗法对之前未接受过抗逆转录病毒治疗的1型人类免疫缺陷病毒（HIV-1）感染患者（“初治”患者）的疗效。所评估的免疫学和病毒学参数包括CD4细胞计数、合胞体诱导（SI）病毒表型以及血浆HIV-1 RNA拷贝数/毫升（HIV病毒载量）。共有75例患者进入研究，其CD4细胞计数在200至500个细胞/立方毫米之间。所有患者均接受齐多夫定（200毫克）联合扎西他滨（0.75毫克），每日3次，共24周。治疗耐受性良好。然而，有4例患者出现贫血（血红蛋白<10.0克/分升），1例患者同时患有贫血和中性粒细胞减少症（0.8×10⁹中性粒细胞/升）。齐多夫定联合扎西他滨的联合疗法使病毒学和免疫学指标有显著改善。约25%的患者在第24周时血浆HIV RNA水平降至检测不到（<200拷贝/毫升）。在研究结束时（24周），约70%的患者血浆HIV RNA有显著降低（>0.5对数），50%的患者降低幅度更大（>1对数）。血浆HIV RNA平均水平在第4周时下降最为显著，而CD4细胞计数在第24周时升高幅度最大。基线血浆HIV RNA水平低于20000拷贝/毫升的患者中，约80%在第24周时低于5000拷贝/毫升。在第4周时观察到的血浆HIV RNA降低情况在第24周时仍显著维持。因此，我们可以迅速筛选出对治疗无反应的患者，并在短时间间隔后调整治疗方案。我们的研究支持早期治疗的观点，因为在第24周时血浆HIV RNA水平降至检测不到的所有患者，其基线血浆HIV RNA载量中位数为2560拷贝/毫升。总之，在大多数患者中，齐多夫定联合扎西他滨耐受性良好，并且使大多数初始病毒血症低于20000拷贝/毫升的患者血浆HIV RNA拷贝数显著降低。
