Center for Human Experimental Therapeutics, University of Rochester Medical Center, Rochester, New York, USA.
Mov Disord. 2014 Feb;29(2):263-5. doi: 10.1002/mds.25734. Epub 2013 Dec 3.
The risk for malignant melanoma is higher than expected in Parkinson's disease (PD). The National Institutes of Health (NIH) Exploratory Trials in PD (NET-PD) Long-term Study 1 (LS-1) trial is a contemporary phase 3 study of subjects with early, treated PD. The objective of this work was to assess the incidence of malignant melanoma in a PD cohort.
Incident melanoma cases were identified from the adverse events log. The expected number of cases was calculated, using the expected incidence rates and the number of person-years.
A total of 618 females and 1119 males were followed for 6452 person-years; 19 new melanoma cases were observed. The expected number was 5.29. The standardized event ratio compared to the general population was 3.6 (95% confidence interval, 2.2-5.6).
The risk for developing melanoma was higher than expected in the NET-PD LS-1 cohort and was similar to the risk reported in earlier comparable clinical trial cohorts. Dermatologic screening may be useful in Parkinson's disease to identify melanoma at an early stage.
帕金森病(PD)患者发生恶性黑色素瘤的风险高于预期。美国国立卫生研究院(NIH)探索性帕金森病试验(NET-PD)长期研究 1(LS-1)试验是一项针对早期治疗 PD 患者的当代 3 期研究。本研究旨在评估 PD 队列中恶性黑色素瘤的发病率。
从不良事件日志中确定黑色素瘤病例。使用预期发病率和人年数计算预期病例数。
618 名女性和 1119 名男性共随访 6452 人年;观察到 19 例新发黑色素瘤病例。预期病例数为 5.29 例。与一般人群相比,标准化事件比为 3.6(95%置信区间,2.2-5.6)。
NET-PD LS-1 队列中黑色素瘤的发病风险高于预期,与早期可比临床试验队列报告的风险相似。在帕金森病中进行皮肤筛查可能有助于早期发现黑色素瘤。