Lancet. 1994 Apr 9;343(8902):871-81.
Concorde is a double-blind randomised comparison of two policies of zidovudine treatment in symptom-free individuals infected with human immunodeficiency virus (HIV): (a) immediate zidovudine from the time of randomisation (Imm); and (b) deferred zidovudine (Def) until the onset of AIDS-related complex (ARC) or AIDS (CDC group IV disease) or the development of persistently low CD4 cell counts if the clinician judged that treatment was indicated. Between October, 1988, and October, 1991, 1749 HIV-infected individuals from centres in the UK, Ireland, and France were randomly allocated to zidovudine 250 mg four times daily (877 Imm) or matching placebo (872 Def). Follow-up was to death or Dec 31, 1992 (total 5419 person-years; median 3.3 years) and only 7% of the 1749 had not had a full clinical assessment after July 1, 1992. Of those allocated to the Def group, 418 started zidovudine at some time during the trial, 174 (42%) of them at or after they were judged by the clinician to have developed ARC or AIDS (nearly all confirmed subsequently) and most of the remainder on the basis of low CD4 cell counts. Those in the Imm group spent 81% of the time before ARC or AIDS on zidovudine compared with only 16% for those in the Def group. Despite the large difference in the amount of zidovudine between the two groups and the fact that the number of clinical endpoints (AIDS and death) in Concorde (347) outnumbers the total of those in all other published trials in symptom-free and early symptomatic infection, there was no statistically significant difference in clinical outcome between the two therapeutic policies. The 3-year estimated survival probabilities were 92% (95% CI 90-94%) in Imm and 94% (92-95%) in Def (log-rank p = 0.13), with no significant differences overall or in subgroup analyses by CD4 cell count at baseline. Similarly, there was no significant difference in progression of HIV disease: 3-year progression rates to AIDS or death were 18% in both groups, and to ARC, AIDS, or death were 29% (Imm) and 32% (Def) (p = 0.18), although there was an indication of an early but transient clinical benefit in favour of Imm in progression to ARC, AIDS, or death. However, there was a clear difference in changes in CD4 cell count over time in the two groups.(ABSTRACT TRUNCATED AT 400 WORDS)
协和研究是一项双盲随机对照试验，比较齐多夫定在无症状人类免疫缺陷病毒（HIV）感染者中的两种治疗策略：（a）从随机分组时起立即使用齐多夫定（Imm）；（b）延迟使用齐多夫定（Def），直到出现艾滋病相关综合征（ARC）或艾滋病（美国疾病控制与预防中心IV类疾病），或者如果临床医生判断需要治疗，则在CD4细胞计数持续偏低时使用。1988年10月至1991年10月期间，来自英国、爱尔兰和法国各中心的1749名HIV感染者被随机分配至每日4次服用250mg齐多夫定组（877例Imm）或匹配的安慰剂组（872例Def）。随访至死亡或1992年12月31日（总计5419人年；中位数3.3年），1749例中只有7%在1992年7月1日后未进行全面临床评估。在Def组中，418例在试验期间的某个时间开始使用齐多夫定，其中174例（42%）在临床医生判断其出现ARC或艾滋病时或之后开始使用（几乎所有随后均得到证实），其余大多数是基于CD4细胞计数偏低开始使用。Imm组在出现ARC或艾滋病之前81%的时间服用齐多夫定，而Def组仅为16%。尽管两组齐多夫定用量差异巨大，且协和研究中的临床终点（艾滋病和死亡）数量（347例）超过了所有其他已发表的无症状和早期有症状感染试验的总和，但两种治疗策略的临床结局无统计学显著差异。Imm组3年估计生存概率为92%（95%CI 90 - 94%），Def组为94%（92 - 95%）（对数秩检验p = 0.13），总体及按基线CD4细胞计数进行的亚组分析均无显著差异。同样，HIV疾病进展也无显著差异：两组至艾滋病或死亡的3年进展率均为18%，至ARC、艾滋病或死亡的进展率分别为29%（Imm）和32%（Def）（p = 0.18），尽管在进展至ARC、艾滋病或死亡方面有迹象表明Imm组有早期但短暂的临床益处。然而，两组CD4细胞计数随时间的变化存在明显差异。（摘要截断于400字）
