理论上,临床实践与临床对照试验的方法相互不断影响.恰当的试验设计应该能反映医生和病人的想法,反之,熟悉临床试验可以改进日常临床实践的方法.换句话说,每一种方法学的原则都源于临床实践.例如:随机化(带有建设性地怀疑是否形成真正的对照),独立性(对药品公司善意的不信任),知情同意(与患者共同分担不确定性),Ⅰ型错误(对单个试验不要错误地乐观),Ⅱ型错误(对单个试验不要错误地悲观),选择正确的判效指标(相关性比精确性重要),意向性治疗原则(重实效的分析)以及亚组分析的危险["我的前一个患者综合征"(the my-last-patient syndrome)].
Citation： J. Van Gijn. Evidence-based Stroke Medicine. Chinese Journal of Evidence-Based Medicine, 2004, 04(3): 146-149. doi: Copy
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| 1. | ［1］Medical Research Counci. Streptomycin treatment of pulmonary tuberculosis [J]. Br Med J, 1948; ii: 769-782. |
| 2. | ［2］Doll R. Controlled trials: the 1948 watershed [J]. BMJ,1998; 317(7 167): 1 217-1 220. |
| 3. | ［3］Yoshioka A. Use of randomisation in the Medical Research Council’s clinical trial of streptomycin in pulmonary tuberculosis in the 1940s [J]. BMJ, 1998; 317(7 167): 1220-1 223. |
| 4. | ［4］Matthews JR. Quantification and the quest for medical certainty. Princeton: Princeton University Press, 1995. |
| 5. | ［5］Lilienfeld AM. The Fielding H. Garrison Lecture: Ceteris paribus: the evolution of the clinical trial [J]. Bull Hist Med,1982; 56(1): 1-18. |
| 6. | ［6］Kuhn TS. The structure of scientific revolutions. Chicago:Chicago University Press, 1962. |
| 7. | ［7］Descartes R. De homine. 2 edn. Leiden: F Schuyl, 1664. |
| 8. | ［8］Fisher CM. Occlusion of the internal carotid artery [J]. Arch Neurol Psych, 1951; 65: 346-377. |
| 9. | ［9］Fisher CM. Transient monocular bhndness associated with hemiplegia [J]. Arch Ophthalmol, 1952; 47:167-203. |
| 10. | ［10］Chiari H. ? ber das Verhalten des Teilungswinkels des Carotis Communis bei der Endarteritis chronica deformans [J]. Verh Ddtsch Path Ges, 1905; 9: 326-330. |
| 11. | ［11］Eastcott HHG, Pickering GW, Robb CG. Reconstruction of internal carotid artery in a patient with intermittent attacks of hemiplegia [J]. Lancet, 1954; ii: 994-996. |
| 12. | ［12］Barnett HJ, Phim F, Walton JN. Carotid endarterectomyan expression of concern [J]. Stroke, 1984 ; 15(6): 941-943. |
| 13. | ［13］Warlow C. Carotid endarterectomy: does it work [J ] .? Stroke,1984; 15(6): 1 068-1 076. |
| 14. | ［14］European Carotid Surgery Trial Collaborative Group. Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST) [J]. Lancet, 1998; 351(9 113): 1379-87. |
| 15. | ［15］Barnett HJ, Taylor DW, Eliasziw M, Fox AJ, Ferguson GG,Haynes RB, Rankin RN, Clagett GP, Hachinski VC,Sackett DL, Thorpe KE, Meldrum HE, Spence JD and for the North American Sympotomatic Endarterectomy Collaborators. Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis [J]. N Engl J Med, 1998; 339(20): 1415-25. |
| 16. | ［16］GCP committee. Good Chnical Practice [M]. 3 edn. Utrecht:Nefarma, 1998. |
| 17. | ［17］Shaw GB. The doctors dilemma [M]. London: Penguin Books ( herdruk in 1946 ) , 1908. |
| 18. | ［18］Silvernan WA. Informing and consenting. In: Anonymous Wheres the evidence? Debates in modem medicine [ M]. Oxford:Oxford University Press, 1998, pp. 78-84. |
| 19. | ［19］Gelmers HJ, Gorter K, de Weerdt CJ, Wiezer HJ. A controlled thai of nimodipine in acute ischemic stroke [J ]. N Engl J Med, 1988; 318(4): 203-207. |
| 20. | ［20］Wallenburg HC, Dekker GA, Makovitz JW, R otmans P.Low-dose aspirin prevents pregnancy-induced hypertension and pre-eclampsia in angiotensin-sensitive primigravidae [ J ].Lancet, 1986; 1(8471): 1-3. |
| 21. | ［21］Di Mascio R, Marchioli R, Tognoni G. From pharmacological promises to controlled clinical trials to meta-analysis and back: the case of nimodipine in cerebrovascular disorders [J].Clin Trials Metaanal, 1994; 29( 1 ): 57-79. |
| 22. | ［22］Darling M. Low-dose aspirin not for pre-eclampsia [J]. Lancet,1998; 352(9125): 342. |
| 23. | ［23］The Canadian Cooperative Study Group. A randomized trial of aspirin and sulfinpyrazone in threatened stroke [J]. N Engl J Med, 1978; 299(2): 53-59. |
| 24. | ［24］Dyken ML, Barnett HJ, Easton JD, Fields WS, Fuster V,Hachinski V, Norris JW, Sherman DG. Low-dose aspirin and stroke. "It ain’t necessarily so" [J]. Stroke, 1992; 23(10):1395-1399. |
| 25. | ［25］Anfiplatelet Trialists’ Collaboration. Collaborative overview of randomised trials of antiplatelet therapy-I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients [J]. BM J,1994; 308(6921): 81-106. |
| 26. | ［26］van Gijn J. Measurement of outcome in stroke prevention trials [J]. Cerebrovasc Dis, 1992; 2 (suppl 1): 23-34. |
| 27. | ［27］van Gijn J. Warlow CP. Down with stroke scales [J ] . Cerebrovasc Dis, 1992; 2:244-246. |
| 28. | ［28］De Haan R, Horn J, Limburg M, Van Der Meulen J, Bossuyt P. A comparison of five stroke scales with measures of disability, handicap, and quality of life [J]. Stroke, 1993;24(8): 1178-1181. |
| 29. | ［29］Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials [J]. J Chronic Dis, 1967; 20(8): 637-648. |
| 30. | ［30］ISI5-2 (Second International Study of Infarct Survival) Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2 [J]. Lancet, 1988; 2(8607): 349-360. |
| 31. | ［31］van Gijn J, Algra A. Ticlopidine, triais, and torture[J].Stroke, 1994; 25(6): 1 097-1 098. |
- 1. ［1］Medical Research Counci. Streptomycin treatment of pulmonary tuberculosis [J]. Br Med J, 1948; ii: 769-782.
- 2. ［2］Doll R. Controlled trials: the 1948 watershed [J]. BMJ,1998; 317(7 167): 1 217-1 220.
- 3. ［3］Yoshioka A. Use of randomisation in the Medical Research Council’s clinical trial of streptomycin in pulmonary tuberculosis in the 1940s [J]. BMJ, 1998; 317(7 167): 1220-1 223.
- 4. ［4］Matthews JR. Quantification and the quest for medical certainty. Princeton: Princeton University Press, 1995.
- 5. ［5］Lilienfeld AM. The Fielding H. Garrison Lecture: Ceteris paribus: the evolution of the clinical trial [J]. Bull Hist Med,1982; 56(1): 1-18.
- 6. ［6］Kuhn TS. The structure of scientific revolutions. Chicago:Chicago University Press, 1962.
- 7. ［7］Descartes R. De homine. 2 edn. Leiden: F Schuyl, 1664.
- 8. ［8］Fisher CM. Occlusion of the internal carotid artery [J]. Arch Neurol Psych, 1951; 65: 346-377.
- 9. ［9］Fisher CM. Transient monocular bhndness associated with hemiplegia [J]. Arch Ophthalmol, 1952; 47:167-203.
- 10. ［10］Chiari H. ? ber das Verhalten des Teilungswinkels des Carotis Communis bei der Endarteritis chronica deformans [J]. Verh Ddtsch Path Ges, 1905; 9: 326-330.
- 11. ［11］Eastcott HHG, Pickering GW, Robb CG. Reconstruction of internal carotid artery in a patient with intermittent attacks of hemiplegia [J]. Lancet, 1954; ii: 994-996.
- 12. ［12］Barnett HJ, Phim F, Walton JN. Carotid endarterectomyan expression of concern [J]. Stroke, 1984 ; 15(6): 941-943.
- 13. ［13］Warlow C. Carotid endarterectomy: does it work [J ] .? Stroke,1984; 15(6): 1 068-1 076.
- 14. ［14］European Carotid Surgery Trial Collaborative Group. Randomised trial of endarterectomy for recently symptomatic carotid stenosis: final results of the MRC European Carotid Surgery Trial (ECST) [J]. Lancet, 1998; 351(9 113): 1379-87.
- 15. ［15］Barnett HJ, Taylor DW, Eliasziw M, Fox AJ, Ferguson GG,Haynes RB, Rankin RN, Clagett GP, Hachinski VC,Sackett DL, Thorpe KE, Meldrum HE, Spence JD and for the North American Sympotomatic Endarterectomy Collaborators. Benefit of carotid endarterectomy in patients with symptomatic moderate or severe stenosis [J]. N Engl J Med, 1998; 339(20): 1415-25.
- 16. ［16］GCP committee. Good Chnical Practice [M]. 3 edn. Utrecht:Nefarma, 1998.
- 17. ［17］Shaw GB. The doctors dilemma [M]. London: Penguin Books ( herdruk in 1946 ) , 1908.
- 18. ［18］Silvernan WA. Informing and consenting. In: Anonymous Wheres the evidence? Debates in modem medicine [ M]. Oxford:Oxford University Press, 1998, pp. 78-84.
- 19. ［19］Gelmers HJ, Gorter K, de Weerdt CJ, Wiezer HJ. A controlled thai of nimodipine in acute ischemic stroke [J ]. N Engl J Med, 1988; 318(4): 203-207.
- 20. ［20］Wallenburg HC, Dekker GA, Makovitz JW, R otmans P.Low-dose aspirin prevents pregnancy-induced hypertension and pre-eclampsia in angiotensin-sensitive primigravidae [ J ].Lancet, 1986; 1(8471): 1-3.
- 21. ［21］Di Mascio R, Marchioli R, Tognoni G. From pharmacological promises to controlled clinical trials to meta-analysis and back: the case of nimodipine in cerebrovascular disorders [J].Clin Trials Metaanal, 1994; 29( 1 ): 57-79.
- 22. ［22］Darling M. Low-dose aspirin not for pre-eclampsia [J]. Lancet,1998; 352(9125): 342.
- 23. ［23］The Canadian Cooperative Study Group. A randomized trial of aspirin and sulfinpyrazone in threatened stroke [J]. N Engl J Med, 1978; 299(2): 53-59.
- 24. ［24］Dyken ML, Barnett HJ, Easton JD, Fields WS, Fuster V,Hachinski V, Norris JW, Sherman DG. Low-dose aspirin and stroke. "It ain’t necessarily so" [J]. Stroke, 1992; 23(10):1395-1399.
- 25. ［25］Anfiplatelet Trialists’ Collaboration. Collaborative overview of randomised trials of antiplatelet therapy-I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients [J]. BM J,1994; 308(6921): 81-106.
- 26. ［26］van Gijn J. Measurement of outcome in stroke prevention trials [J]. Cerebrovasc Dis, 1992; 2 (suppl 1): 23-34.
- 27. ［27］van Gijn J. Warlow CP. Down with stroke scales [J ] . Cerebrovasc Dis, 1992; 2:244-246.
- 28. ［28］De Haan R, Horn J, Limburg M, Van Der Meulen J, Bossuyt P. A comparison of five stroke scales with measures of disability, handicap, and quality of life [J]. Stroke, 1993;24(8): 1178-1181.
- 29. ［29］Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials [J]. J Chronic Dis, 1967; 20(8): 637-648.
- 30. ［30］ISI5-2 (Second International Study of Infarct Survival) Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2 [J]. Lancet, 1988; 2(8607): 349-360.
- 31. ［31］van Gijn J, Algra A. Ticlopidine, triais, and torture[J].Stroke, 1994; 25(6): 1 097-1 098.