醫(yī)藥新知【44】

1、醫(yī)藥新知【44】 公告日期: 摘錄藥師: 黃子蕓¡ 主題:Raloxifene May Not Signficantly Affect Heart Disease RiskRaloxifene不會(huì)顯著影響心臟疾病的危險(xiǎn)性¡ 內(nèi)容摘要：July 12, 2006 Raloxifene has no effect on heart disease but reduces the risk for breast cancer and vertebral fracture, although it increases the risk for thromboembolism and

2、 stroke, according to the results of a randomized study reported in the July 13 issue of The New England Journal of Medicine."The effect of raloxifene, a selective estrogen-receptor modulator, on coronary heart disease (CHD) and breast cancer is not established," write Elizabeth Barrett-Co

3、nnor, MD, from the University of California, San Diego, and colleagues from the Raloxifene Use for The Heart (RUTH) Trial Investigators. "Raloxifene therapy has been associated with improvement in the levels of serum lipoprotein cholesterol, fibrinogen, and homocysteine. The favorable effect of

4、 raloxifene on markers of cardiovascular risk, coupled with evidence from observational studies that treatment with estrogen was associated with a reduced risk of coronary heart disease (CHD) in postmenopausal women, led to the design of the RUTH trial to determine the effect of raloxifene on clinic

5、al coronary events."The investigators randomized 10,101 postmenopausal women (mean age, 67.5 years) with CHD or multiple risk factors for CHD to receive 60 mg of raloxifene daily or placebo. Median follow-up was 5.6 years. The 2 main endpoints were coronary events, defined as death from coronar

6、y causes, myocardial infarction, or hospitalization for an acute coronary syndrome; and invasive breast cancer.Compared with placebo, raloxifene had no significant effect on the risk for primary coronary events (533 vs 553 events; hazard ratio HR, 0.95; 95% confidence interval CI, 0.84 - 1.07). Howe

7、ver, it was associated with lower risk for invasive breast cancer (40 vs 70 events; HR, 0.56; 95% CI, 0.38 - 0.83; absolute risk reduction, 1.2 invasive breast cancers per 1000 women treated for 1 year). This benefit was primarily accounted for by a reduced risk for estrogen-receptorpositive invasiv

8、e breast cancers.The rates of death from any cause or total stroke were not significantly different between groups. However, raloxifene was associated with an increased risk for fatal stroke (59 vs 39 events; HR, 1.49; 95% CI, 1.00 - 2.24; absolute risk increase, 0.7 per 1000 woman-years) and venous

9、 thromboembolism (103 vs 71 events; HR, 1.44; 95% CI, 1.06 - 1.95; absolute risk increase, 1.2 per 1000 woman-years). Raloxifene was associated with reduced risk for clinical vertebral fractures (64 vs 97 events; HR, 0.65; 95% CI, 0.47 - 0.89; absolute risk reduction, 1.3 per 1000)."In postmeno

10、pausal women with CHD or at increased risk for CHD, treatment with raloxifene for a median of 5.6 years reduced the risk of invasive breast cancer and did not change the incidence of coronary events," the authors write. "In these women, the difference in the absolute rates of events that w

11、ere decreased (i.e., breast cancer and clinical vertebral fractures) was similar to the difference in the absolute rates of events that were increased (i.e., venous thromboembolic events and fatal strokes). When considering the use of raloxifene in a postmenopausal woman, the clinician should take i

12、nto account the individual woman's risk of disease and her personal preferences and weigh potential benefits against risks and against the availability of alternative interventions."¡中文摘要：2006年7月12日，根據(jù)發(fā)表於7月13日 The New England Journal of Medicine期刊上的研究報(bào)告顯示，Raloxifene雖然增加血栓和中風(fēng)的危險(xiǎn)性，但沒(méi)有明顯影

13、響心臟疾病，且降低罹患乳癌和脊椎壓迫性骨折的風(fēng)險(xiǎn)。 美國(guó)加州大學(xué)聖地牙哥醫(yī)學(xué)院的Elizazbeth Barrett-Connor醫(yī)師與使用Raloxifene 對(duì)心臟作用之臨床試驗(yàn)( RUTH )的研究團(tuán)隊(duì)，依據(jù)所發(fā)表的研究報(bào)告指出Raloxifene是一種選擇性雌性激素受體調(diào)節(jié)劑，對(duì)於冠狀動(dòng)脈心臟疾病及乳癌的影響尚未被建立。已有研究結(jié)果發(fā)現(xiàn)使用raloxifene治療可以改善lipoprotein cholesterol, fibrinogen和homocysteine的血中濃度，而減少心血管疾病危險(xiǎn)因子的產(chǎn)生，另外也有證據(jù)顯示雌性激素用於停經(jīng)後婦女可以降低罹患冠狀動(dòng)脈心臟疾病的危險(xiǎn)，於是

14、設(shè)計(jì)RUTH臨床試驗(yàn)來(lái)評(píng)估raloxifene對(duì)於冠狀動(dòng)脈疾病的影響。 作者隨機(jī)納入了10101位有心血管疾病或是有多重心血管疾病危險(xiǎn)因子的停經(jīng)後婦女 ( 平均年齡為67.5歲 )，每天給予60 mg raloxifene或安慰劑治療並進(jìn)行評(píng)估5.6年。二個(gè)主要評(píng)估的指標(biāo)是冠狀動(dòng)脈疾病的發(fā)生事件，其定義為因冠狀動(dòng)脈疾病、心肌梗塞造成死亡或是因急性冠狀動(dòng)脈徵後群導(dǎo)致住院，與產(chǎn)生侵犯性乳癌。 和安慰劑比較，raloxifene對(duì)於產(chǎn)生冠狀動(dòng)脈事件的危險(xiǎn)沒(méi)有顯著影響 ( 533 vs. 553事件; 風(fēng)險(xiǎn)比, 0.95; 95% CI, 0.84-1.07 )，但會(huì)降低罹患侵犯性乳癌的危險(xiǎn) ( 40

15、 vs. 70事件; 風(fēng)險(xiǎn)比，0.56; 95% CI, .83; 每1000位婦女治療一年可以降低1.2個(gè)案例產(chǎn)生侵犯性乳癌 )，主要是減少雌性激素受體陽(yáng)性侵犯性乳癌的危險(xiǎn)。總死亡率或是中風(fēng)的死亡率，raloxifene和安慰劑並沒(méi)有顯著差異，而raloxifene卻會(huì)增加致命性中風(fēng) ( 59 vs. 39事件; 風(fēng)險(xiǎn)比, 1.49; 95% CI, 1.00-2.24; 每1000位婦女治療一年會(huì)增加0.7個(gè)案例產(chǎn)生致命性中風(fēng) )與靜脈血栓的危險(xiǎn) (103 vs. 71事件; 風(fēng)險(xiǎn)比, 1.44; 95%CI, 1.06-1.95; 每1000位婦女治療一年會(huì)增加1.2個(gè)案例產(chǎn)生靜脈血栓 )。另外raloxifene可以減少脊椎壓迫性骨折的危險(xiǎn) ( 64 vs. 97事件; 風(fēng)險(xiǎn)比, 0.65; 95% CI, 0.47-0.89; 每1000位婦女將減少1.3個(gè)案例產(chǎn)生脊椎壓迫性骨折 )。 Raloxife