高血壓藥物臨床試驗中樣本代表性的探討_《中國循證醫學雜志》

作者：

胡晶 ,  康德英

四川大學華西醫院循證醫學與臨床流行病學教研室（成都610041）;

關鍵詞：

高血壓臨床試驗樣本代表性

DOI：

10.7507/1672-2531.20080043

視頻：

導出 下載 收藏 掃碼 引用

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目的　分析與評價高血壓藥物臨床試驗中樣本代表性及其存在的問題。
方法　電子檢索MEDLINE、CBMdisc、CNKI、VIP等數據庫，收集1996年1月至2006年12月期間發表的國內藥物治療高血壓的隨機對照試驗。經嚴格評價后，納入方法學質量評分≥3分的RCT，進一步探討其樣本代表性。
結果　共納入164個RCT，其中122個RCT（74.4%）在省市級以上醫院或研究院所進行；81個RCT（49.4%）報告的受試者來源，醫院門診或住院患者占納入受試者總數的86.3%，社區患者占13.7%；8個研究（4.9%）報告不符合納入標準的患者比例為24.6%；3個研究描述了符合納入標準但拒絕參加試驗的患者比例為8.4%；12個研究（7.3%）在隨機入組前的安慰劑篩選期排除患者占16.7%；輕中度高血壓患者占89.4%；女性和≥65歲老年患者分別占41.1%和16.9%，與高血壓患者流行病學分布相比均偏低（P lt;0.001）。
結論　藥物治療高血壓臨床試驗中樣本代表性較差且樣本納入過程報道不充分，影響了試驗結果在高血壓一般患者群中的推廣應用。

引用本文： 胡晶,康德英. 高血壓藥物臨床試驗中樣本代表性的探討. 中國循證醫學雜志, 2008, 08(3): 199-202. doi: 10.7507/1672-2531.20080043 復制

1.	Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet, 2005, 365(9453): 82-93.
2.	Gross CP, Mallory R, Heiat A, et al. Reporting the recruitment process in clinical trials: who are these patients and how did they get there? Ann Intern Med, 2002, 137(1): 10-16.
3.	Persaud N, Mamdani MM. External validity: the neglected dimension in evidence ranking. J Eval Clin Pract, 2006, 12(4): 450-453.
4.	Steg PG, López-Sendón J, Lopez de Sa E, et al. External validity of clinical trials in acute myocardial infarction. Arch Intern Med, 2007, 167(1): 68-73.
5.	衛生部心血管病防治研究中心. 中國心血管病報告2005. 北京: 中國大百科全書出版社, 2006. 84-94.
6.	Britton A, McKee M, Black N, et al. Threats to applicability of randomised trials: exclusions and selective participation. J Health Serv Res Policy, 1999, 4(2):112-121.
7.	Roberts C. The implications of variation in outcome between health professionals for the design and analysis of randomized controlled trials. Stat Med, 1999, 18(19): 2605-2615.
8.	Petersen MK, Andersen KV, Andersen NT, et al. "To whom do the results of this trial apply?" External validity of a randomized controlled trial involving 130 patients scheduled for primary total hip replacement. Acta Orthop, 2007, 78(1): 12-18.
9.	Packer M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med, 1996, 334(21): 1349-1355.
10.	Uijen AA, Bakx JC, Mokkink HG, et al. Hypertension patients participating in trials differ in many aspects from patients treated in general practices. J Clin Epidemiol, 2007, 60(4): 330-335.
11.	Coca SG, Krumholz HM, Garg AX, et al. Under-representation of renal disease in randomized controlled trials of cardiovascular disease. JAMA, 2006, 296(11): 1377-1384.

1. Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet, 2005, 365(9453): 82-93.
2. Gross CP, Mallory R, Heiat A, et al. Reporting the recruitment process in clinical trials: who are these patients and how did they get there? Ann Intern Med, 2002, 137(1): 10-16.
3. Persaud N, Mamdani MM. External validity: the neglected dimension in evidence ranking. J Eval Clin Pract, 2006, 12(4): 450-453.
4. Steg PG, López-Sendón J, Lopez de Sa E, et al. External validity of clinical trials in acute myocardial infarction. Arch Intern Med, 2007, 167(1): 68-73.
5. 衛生部心血管病防治研究中心. 中國心血管病報告2005. 北京: 中國大百科全書出版社, 2006. 84-94.
6. Britton A, McKee M, Black N, et al. Threats to applicability of randomised trials: exclusions and selective participation. J Health Serv Res Policy, 1999, 4(2):112-121.
7. Roberts C. The implications of variation in outcome between health professionals for the design and analysis of randomized controlled trials. Stat Med, 1999, 18(19): 2605-2615.
8. Petersen MK, Andersen KV, Andersen NT, et al. "To whom do the results of this trial apply?" External validity of a randomized controlled trial involving 130 patients scheduled for primary total hip replacement. Acta Orthop, 2007, 78(1): 12-18.
9. Packer M, Bristow MR, Cohn JN, et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med, 1996, 334(21): 1349-1355.
10. Uijen AA, Bakx JC, Mokkink HG, et al. Hypertension patients participating in trials differ in many aspects from patients treated in general practices. J Clin Epidemiol, 2007, 60(4): 330-335.
11. Coca SG, Krumholz HM, Garg AX, et al. Under-representation of renal disease in randomized controlled trials of cardiovascular disease. JAMA, 2006, 296(11): 1377-1384.

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高血壓藥物臨床試驗中樣本代表性的探討

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《中國循證醫學雜志》

高血壓藥物臨床試驗中樣本代表性的探討

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