Institute of Occupational Medicine and Industrial Hygiene, College of Public Health, National Taiwan University, Taipei, Taiwan.
Am J Kidney Dis. 2010 Mar;55(3):507-18. doi: 10.1053/j.ajkd.2009.10.055. Epub 2010 Feb 8.
Taiwan has a remarkably high incidence of end-stage renal disease (ESRD). The objective of this study is to determine the association between prescribed herbal products containing aristolochic acid and ESRD.
Population-based case-control study.
SETTING & PARTICIPANTS: All new ESRD cases in Taiwan and a simple random sample (200,000 people) drawn from the national health insurance reimbursement database in 1997-2002.
Age; sex; hypertension; diabetes; cumulative doses of nonsteroidal anti-inflammatory drugs, acetaminophen, and adulterated herbal supplements potentially containing aristolochic acid before the development of chronic kidney disease; and indications for prescribing such herbs, including chronic hepatitis, chronic urinary tract infection, chronic neuralgia, or chronic musculoskeletal diseases.
OUTCOMES & MEASUREMENTS: Occurrence of ESRD through construction of multiple logistic regression models.
There were 36,620 new ESRD cases from 1998 through 2002. After exclusion of cases with chronic kidney disease diagnosed before July 1, 1997, there were 25,843 new cases of ESRD and 184,851 controls in the final analysis. Women, older age, hypertension, and diabetes were significantly associated with increased risks of the development of ESRD. After adjustment for known risk factors, cumulative doses >60 g of Mu Tong (OR, 1.47 [95% CI, 1.01-2.14] for 61-100 g; OR, 5.82 [95% CI, 3.89-8.71] for >200 g) or Fangchi (OR, 1.60 [95% CI, 1.20-2.14] for 61-100 g; OR, 1.94 [95% CI, 1.29-2.92] for >200 g) were associated with increased risk of the development of ESRD with a dose-response relationship. This relationship persisted when analyses were limited to participants who consumed <500 pills of nonsteroidal anti-inflammatory drugs and those without diabetes.
No measurement of renal function, no contact with patients, over-the-counter sales were not recorded, and potential underestimation of exposure dose for cases and ORs.
Consumption of >60 g of Mu Tong or Fangchi from herbal supplements was associated with an increased risk of developing kidney failure.
台湾末期肾脏疾病（ESRD）的发病率极高。本研究旨在确定含马兜铃酸的处方草药产品与 ESRD 之间的关联。
基于人群的病例对照研究。
所有台湾新的 ESRD 病例和 1997-2002 年从国家健康保险报销数据库中抽取的简单随机样本（20 万人）。
年龄；性别；高血压；糖尿病；在慢性肾脏病发生之前，非甾体抗炎药、对乙酰氨基酚和潜在含有马兜铃酸的掺假草药补充剂的累积剂量；以及开此类草药的适应症，包括慢性肝炎、慢性尿路感染、慢性神经痛或慢性肌肉骨骼疾病。
通过构建多个逻辑回归模型来确定 ESRD 的发生情况。
1998 年至 2002 年期间，共出现 36620 例新的 ESRD 病例。排除 1997 年 7 月 1 日之前诊断出的慢性肾脏病病例后，最终分析包括 25843 例新的 ESRD 病例和 184851 例对照。女性、年龄较大、高血压和糖尿病与 ESRD 发生风险增加显著相关。在调整已知危险因素后，累积剂量 >60 克木通（OR，1.47[95%CI，1.01-2.14]，61-100g；OR，5.82[95%CI，3.89-8.71]，>200g）或防己（OR，1.60[95%CI，1.20-2.14]，61-100g；OR，1.94[95%CI，1.29-2.92]，>200g）与 ESRD 发生风险增加相关，且呈剂量反应关系。当分析仅限于服用<500 片非甾体抗炎药和无糖尿病的参与者时，这种关系仍然存在。
未测量肾功能，未与患者联系，非处方药销售未记录，病例和 OR 暴露剂量可能被低估。
食用>60 克木通或防己草药补充剂与肾衰竭风险增加有关。
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