Lenderking W R, Gelber R D, Cotton D J, Cole B F, Goldhirsch A, Volberding P A, Testa M A
Statistical and Data Analysis Center, Harvard School of Public Health, Boston, MA 02115.
N Engl J Med. 1994 Mar 17;330(11):738-43. doi: 10.1056/NEJM199403173301102.
Zidovudine therapy is recommended for asymptomatic patients infected with the human immunodeficiency virus (HIV) who have fewer than 500 CD4+ cells per cubic millimeter. An analysis of the quality of life associated with therapy that integrated both the effects of adverse events and the benefits of delayed disease progression might influence this recommendation.
We applied a survival analysis adjusted for the quality of life to data from a randomized trial conducted by the AIDS Clinical Trials Group. The trial compared treatment with 500 mg of zidovudine per day, 1500 mg of zidovudine per day, and placebo (Protocol 019) in 1338 asymptomatic HIV-infected patients.
The average time with neither a progression of disease nor an adverse event (symptom or laboratory finding) was 15.7, 15.6, and 14.8 months for patients receiving placebo, 500 mg of zidovudine, and 1500 mg of zidovudine, respectively. The incidence of severe symptoms was 13.8 percent in the placebo group, 15.2 percent in the 500-mg group, and 19.9 percent in the 1500-mg group (P = 0.038). After 18 months, the 500-mg group gained an average of 0.5 months without disease progression, as compared with the placebo group, but had severe adverse events an average of 0.6 months sooner. The 500-mg group had more quality-of-life--adjusted time than the placebo group only if the time lived after the progression of disease was considered by a patient to have less value than the time after the occurrence of a severe symptom.
For asymptomatic patients treated with 500 mg of zidovudine, a reduction in the quality of life due to severe side effects of therapy approximately equals the increase in the quality of life associated with a delay in the progression of HIV disease.
对于每立方毫米CD4+细胞少于500个的无症状人类免疫缺陷病毒（HIV）感染者，推荐使用齐多夫定治疗。一项综合不良事件影响和疾病进展延迟益处的治疗相关生活质量分析可能会影响这一推荐。
我们将生活质量调整后的生存分析应用于艾滋病临床试验组进行的一项随机试验数据。该试验在1338例无症状HIV感染者中比较了每天500毫克齐多夫定、每天1500毫克齐多夫定和安慰剂（方案019）的治疗效果。
接受安慰剂、500毫克齐多夫定和1500毫克齐多夫定治疗的患者，无疾病进展且无不良事件（症状或实验室检查结果）的平均时间分别为15.7个月、15.6个月和14.8个月。严重症状的发生率在安慰剂组为13.8%，500毫克组为15.2%，1500毫克组为19.9%（P = 0.038）。18个月后，与安慰剂组相比，500毫克组无疾病进展的平均时间增加了0.5个月，但严重不良事件的发生平均提前了0.6个月。仅当患者认为疾病进展后存活的时间比严重症状出现后存活的时间价值更低时，500毫克组的生活质量调整时间才比安慰剂组更多。
对于接受500毫克齐多夫定治疗的无症状患者，治疗严重副作用导致的生活质量下降大致等同于HIV疾病进展延迟带来的生活质量提高。
