Freeman Scott R, Drake Amanda L, Heilig Lauren F, Graber Marla, McNealy Kristie, Schilling Lisa M, Dellavalle Robert P
Department of Dermatology, University of Colorado at Denver and Health Sciences Center, Aurora, CO, USA.
J Natl Cancer Inst. 2006 Nov 1;98(21):1538-46. doi: 10.1093/jnci/djj412.
Large randomized, controlled clinical trials of lovastatin and gemfibrozil for heart disease prevention have reported statistically significantly lower melanoma incidences in persons receiving these medications. Results of in vitro animal model and human case-control studies also suggest that statins and fibrates may reduce the risk of melanoma.
We performed a systematic review of trials that randomly assigned participants to receive statins or fibrates versus an alternative therapy for a minimum of 6 months. Trials were identified by searching five electronic databases and the reference lists of eligible publications. Unpublished data were solicited from trial investigators and pharmaceutical companies. A meta-analysis was performed using a fixed-effects model, and odds ratios (ORs) with 95% confidence intervals (CIs) were calculated to estimate pooled treatment effects. All statistical tests were two-sided.
We obtained data on incident melanomas from 20 of 36 qualifying randomized controlled trials (12 statin trials and eight fibrate trials), with a total of 70,820 participants. A total of 127 melanomas occurred among the 39,426 participants in the statin trials (59 among the 19,872 statin group participants and 68 among the 19,554 control group participants). A total of 27 melanomas occurred among the 31,394 participants enrolled in the fibrate trials (seven among the 12,324 fibrate group participants and 20 among the 19,070 control group participants). Overall, incidence of melanoma was not statistically significantly associated with the use of either statins (OR = 0.87, 95% CI = 0.61 to 1.23) or fibrates (OR = 0.45, 95% CI = 0.20 to 1.01). In a subgroup analysis by drug, only lovastatin use (in one trial) was statistically significantly associated with lower incidence of melanoma (OR = 0.52, 95% CI = 0.27 to 0.99).
These findings do not validate the possibility that statins or fibrates prevent melanoma.
关于洛伐他汀和吉非贝齐预防心脏病的大型随机对照临床试验报告称，服用这些药物的人群中黑色素瘤发病率在统计学上显著降低。体外动物模型和人类病例对照研究的结果也表明，他汀类药物和贝特类药物可能会降低黑色素瘤的风险。
我们对将参与者随机分配接受他汀类药物或贝特类药物与替代疗法至少6个月的试验进行了系统评价。通过搜索五个电子数据库和符合条件出版物的参考文献列表来识别试验。向试验研究者和制药公司索要未发表的数据。使用固定效应模型进行荟萃分析，并计算具有95%置信区间（CI）的比值比（OR）以估计合并治疗效果。所有统计检验均为双侧检验。
我们从36项符合条件的随机对照试验中的20项（12项他汀类药物试验和8项贝特类药物试验）获得了黑色素瘤发病数据，共有70,820名参与者。在他汀类药物试验的39,426名参与者中，共发生了127例黑色素瘤（他汀类药物组的19,872名参与者中有59例，对照组的19,554名参与者中有68例）。在贝特类药物试验的31,394名参与者中，共发生了27例黑色素瘤（贝特类药物组的12,324名参与者中有7例，对照组的19,070名参与者中有20例）。总体而言，黑色素瘤的发病率与使用他汀类药物（OR = 0.87，95% CI = 0.61至1.23）或贝特类药物（OR = 0.45，95% CI = 0.20至1.01）均无统计学显著关联。在按药物进行的亚组分析中，仅使用洛伐他汀（在一项试验中）与黑色素瘤发病率较低有统计学显著关联（OR = 0.52，95% CI = 0.27至0.99）。
这些发现并未证实他汀类药物或贝特类药物可预防黑色素瘤的可能性。
