硫酸茚地那韦这一HIV蛋白酶抑制剂使用者队列中泌尿系统症状的风险因素：ATHENA队列研究

Risk factors for urological symptoms in a cohort of users of the HIV protease inhibitor indinavir sulfate: the ATHENA cohort.

作者信息

Dieleman Jeanne P, Sturkenboom Miriam C J M, Jambroes Marielle, Gyssens Inge C, Weverling Gerrit-Jan, ten Veen Jacob H, Schrey Gerrit, Reiss Peter, Stricker Bruno H Ch

机构信息

Pharmaco-Epidemiology Unit, Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.

出版信息

Arch Intern Med. 2002 Jul 8;162(13):1493-501. doi: 10.1001/archinte.162.13.1493.

DOI:10.1001/archinte.162.13.1493

PMID:12090886

Abstract

BACKGROUND

Nephrolithiasis is a well-known complication of indinavir treatment and may result in urological symptoms ranging from renal colic to renal insufficiency.

OBJECTIVE

To obtain further knowledge regarding the incidence and risk factors of urological symptoms associated with indinavir sulfate use.

METHODS

This study was performed in the ATHENA (AIDS Therapy Evaluation National AIDS Therapy Evaluation Centre) cohort of patients infected with human immunodeficiency virus (HIV) receiving antiretroviral therapy in the Netherlands. The incidence rate of urological symptoms was assessed in a subcohort of 1219 patients starting HIV protease inhibitor treatment after 1996. Urological symptoms were defined as an initial report of nephrolithiasis, renal colic, flank pain, hematuria, renal insufficiency, or nephropathy. Using multivariate Cox regression analysis, risk factors for urological symptoms during indinavir treatment were subsequently studied among the subset of 644 patients who started indinavir treatment after 1996.

RESULTS

The incidence of urological symptoms was 8.3 per 100 treatment-years for indinavir vs 0.8 per 100 treatment-years for other HIV protease inhibitors. Risk factors for urological symptoms during indinavir treatment were low weight (relative risk [RR], 2.1; 95% confidence interval [CI], 1.1-3.9), low lean body mass (RR, 1.7; 95% CI, 1.0-2.9), undetectable HIV-1 RNA when starting indinavir treatment (RR, 3.2; 95% CI, 1.5-6.0), prior treatment change because of intolerance (RR, 2.4; 95% CI, 1.2-5.1), indinavir regimens of 1000 mg or more twice daily (RR, 3.1; 95% CI, 1.3-8.2), and warm environmental temperatures (RR, 3.9; 95% CI, 1.7-8.8). Risk estimates were highest among patients with a low lean body mass.

CONCLUSION

Increased alertness for urological symptoms is warranted for patients starting indinavir treatment, particularly among those with a low lean body mass, during indinavir regimens of 1000 mg or more twice daily, and in warm weather environments.

摘要

背景

肾结石是茚地那韦治疗的一种常见并发症，可能导致从肾绞痛到肾功能不全等一系列泌尿系统症状。

目的

进一步了解与硫酸茚地那韦使用相关的泌尿系统症状的发生率及危险因素。

方法

本研究在荷兰接受抗逆转录病毒治疗的人类免疫缺陷病毒（HIV）感染患者的ATHENA（艾滋病治疗评估国家艾滋病治疗评估中心）队列中进行。在1996年后开始接受HIV蛋白酶抑制剂治疗的1219例患者亚组中评估泌尿系统症状的发生率。泌尿系统症状定义为首次报告肾结石、肾绞痛、胁腹痛、血尿、肾功能不全或肾病。随后，在1996年后开始使用茚地那韦治疗的644例患者子集中，采用多因素Cox回归分析研究茚地那韦治疗期间泌尿系统症状的危险因素。

结果

茚地那韦治疗期间泌尿系统症状的发生率为每100治疗年8.3例，而其他HIV蛋白酶抑制剂为每100治疗年0.8例。茚地那韦治疗期间泌尿系统症状的危险因素包括体重低（相对危险度[RR]，2.1；95%置信区间[CI]，1.1 - 3.9）、瘦体重低（RR，1.7；95%CI，1.0 - 2.9）、开始使用茚地那韦治疗时HIV-1 RNA检测不到（RR，3.2；95%CI，1.5 - 6.0）、因不耐受而先前改变治疗方案（RR，2.4；95%CI，1.2 - 5.1）、每日两次1000mg或更高剂量的茚地那韦治疗方案（RR，3. --- 1；95%CI，1.3 - 8.2）以及环境温度较高（RR，3.9；95%CI，1.7 - 8.8）。瘦体重低的患者风险估计最高。