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早期治疗帕金森病中的恶性黑色素瘤:NET-PD 试验。

Malignant melanoma in early-treated Parkinson's disease: the NET-PD trial.

机构信息

Center for Human Experimental Therapeutics, University of Rochester Medical Center, Rochester, New York, USA.

出版信息

Mov Disord. 2014 Feb;29(2):263-5. doi: 10.1002/mds.25734. Epub 2013 Dec 3.

DOI:10.1002/mds.25734
PMID:24323565
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4375545/
Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.

摘要

背景

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。

方法

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。

结果

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)。

结论

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。

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