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實證醫學專題報告 服用綜合維他命,未來發生心血管疾病的機率有多少?

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Presentation on theme: "實證醫學專題報告 服用綜合維他命,未來發生心血管疾病的機率有多少?"— Presentation transcript:

1 實證醫學專題報告 服用綜合維他命,未來發生心血管疾病的機率有多少?
實證醫學專題報告 服用綜合維他命,未來發生心血管疾病的機率有多少? 報告者:Intern 張邦彥 潘泊諺 指導者:王啟忠 主任 門諾醫院 家醫科 March 12th, 2013

2 情境 王先生今年 62 歲,高血壓已服藥 (CCB) 將近 10 年,血壓控制良好。體重過重 (BMI:26),是個老菸槍,常常咳嗽有濃痰。

3 問題形成 病人:服用綜合維他命,未來發生心血管疾病 的機率 介入或暴露 : 服用綜合維他命 比較:沒有服用綜合維他命
臨床結果:心血管疾病的發病率及死亡率 這是關於 「治療」的問題

4 文獻搜尋 關鍵字 : multivitamin, cardiovascular disease, men
資料庫 : PubMed, ACP journal club 優先順序 : Systematic review/Meta-analysis >RCT>… The Oxford 2011 Levels of Evidence


6 Systematic review



9 Meta-analysis

10 RCT

11 ACP journal club



14 文獻評讀 1. 病人的治療分派是隨機的嗎? YES!
A total of men were randomized and stratified by age, prior diagnosis of cancer, prior diagnosis of CVD, etc.

15 2. 對照組與實驗組在進 入試驗時是否相似? YES!



18 3. 病人、醫生、研究者是否對治療不知情? YES! The PHS II was a randomized, double-blind, placebo-controlled trial evaluating the balance of risks and benefits of a multivitamin (Centrum Silver or placebo daily).

19 4. 病人的追蹤是否夠久、夠充足完整? YES! The trial began in 1997 with continued treatment and follow-up through June 1, 2011(a mean of 11.2 years of treatment and follow-up in men) Morbidity and mortality follow-up in PHS II were high—98.2% and 99.9%, respectively. In addition, morbidity and mortality follow-up as a percentage of person-time each exceeded 99.9%.

20 5. 是否所有的病人都被放到原先分派的組別中做分析?
YES! All primary analyses were based on the intention-to-treat principle.

21 6. 所有組別是否被平等對待? Yes! Every 6 months for the first year, then annually thereafter, PHS II participants were sent monthly calendar packs containing a multivitamin or placebo. Annual mailed questionnaires asked about adherence, adverse events, end points, and risk factors.

22 Multivitamins in the Prevention of Cardiovascular Disease in Men
文獻評讀之效度/信度 Multivitamins in the Prevention of Cardiovascular Disease in Men JAMA, November 7, 2012 病人的治療分派是隨機 對照組與實驗組在進入試驗時相似 病人、醫生、研究者對治療不知情 病人的追蹤夠久、夠充足完整 所有的病人都被放到原先分派的組別中做分析 所有組別被平等對待

23 研究結果 During a median follow-up of 11.2 (interquartile range, ) years, there were 1732 confirmed major cardiovascular events. There was no significant effect of a daily multivitamin on major cardiovascular events. A daily multivitamin had no effect on total MI, total stroke, or CVD mortality. A daily multivitamin was also not significantly associated with total mortality.

24 Hazard Ratio(風險比值) : 是被用來比較兩組的“發生事件所需時間 (time to event)” ,即是介入組死亡的風險除以對照組死亡的風險。

25 There were no significant difference in major cardiovascular events, total MI, total stroke between cumulative incidence curves. Cumulative incidence rate:某世代族群或某固定族群的人,經過某段觀察時間後,發生某事件﹙疾病﹚的人口佔該世代族群人口總數的百分比。

26 No significant interaction by baseline CVD history status (P=
No significant interaction by baseline CVD history status (P=.62 for interaction) for primary (HR, 1.02; 95% CI, ) vs secondary (HR, 0.96; 95% CI, ) prevention. The cumulative incidence curves did not differ for primary (crude log-rank P=.71) or secondary (crude log-rank P=.94) prevention during up to 14 years of treatment and follow-up. 對CVD的初級預防和次級預防都無顯著效果


28 Potential Adverse Effects
No significant effects on gastrointestinal tract symptoms (peptic ulcer, constipation, diarrhea, gastritis, and nausea), fatigue, drowsiness, skin discoloration, and migraine (P=.05 for all). Participants taking the multivitamin vs placebo were more likely to have skin rashes (2125 in the multivitamin group and 2002 in the placebo group; HR, 1.07; 95% CI, ; P=.03).

29 研究結論 在超過十年的治療和追蹤下,服用綜合維他命並無法讓這群美國男性醫師降低心血管疾病、心肌梗塞、中風的發生率,以及心血管疾病的死亡率。

30 回到我們的病患身上 病人性質與治療方式是否與我們的病患條件一致? 其研究結論是否可應用在我們的病患身上? 經濟效益評估 種族 職業 年齡
本身潛在的疾病 其研究結論是否可應用在我們的病患身上? 經濟效益評估

31 自我評估 是否提出一個可以回答的問題? 是否能從廣大資料來源中找到有用的證據? 是否知道現有的最佳證據來源? 是否能審慎評讀證據的正確性?

32 謝謝大家 !

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