目的 系統(tǒng)評(píng)價(jià)干細(xì)胞移植治療腦卒中患者的有效性和安全性。
方法 檢索CENTRAL (2007年4月)、MEDLINE (1966年至2007年4月)、EMBase (1980年至2007年4月)等資源庫(kù),納入干細(xì)脆移植治療腦卒中的臨床研究,并按照J(rèn)uni等的標(biāo)準(zhǔn)對(duì)納入研究的質(zhì)量進(jìn)行評(píng)價(jià),對(duì)干細(xì)胞治療在病死率、功能性結(jié)局、認(rèn)知功能改善、影像學(xué)改變、生命質(zhì)量和副作用等方面的效果進(jìn)行評(píng)估。二分類(lèi)變量以相對(duì)危險(xiǎn)度及其95%表示;連續(xù)性變量以加權(quán)均數(shù)差及其試驗(yàn)95%CI表示。統(tǒng)計(jì)分析采用RevMan軟件。
結(jié)果 納入3個(gè)隨機(jī)對(duì)照,1個(gè)歷史回顧性研究,共69例。其中1個(gè)試驗(yàn)報(bào)告了不同治療對(duì)于病死率的影響,顯示干細(xì)胞移植與僅使用常規(guī)療法相比,并不能降低患者病死率[RR 0.11, 95%CI(0.01,2.31), P = 0.16]。有3個(gè)研究的結(jié)果顯示干細(xì)胞移植能改善某些功能性結(jié)局,與對(duì)照組相比結(jié)果有統(tǒng)計(jì)學(xué)意義。另有一篇文章報(bào)告干細(xì)胞移植可改善認(rèn)知功能。一個(gè)試驗(yàn)顯示與對(duì)照組比較,干細(xì)胞移植顯著提高了患者生活質(zhì)量。
結(jié)論 現(xiàn)有證據(jù)還不足以證明干細(xì)胞移植治療腦卒中患者安全、有效。評(píng)價(jià)干細(xì)胞移植對(duì)于腦卒中的作用還有賴(lài)于更多高質(zhì)量且大規(guī)模的隨機(jī)對(duì)照試驗(yàn)。
引用本文: 袁勇,曾筱茜,吳泰相. 干細(xì)胞移植治療腦卒中的系統(tǒng)評(píng)價(jià). 中國(guó)循證醫(yī)學(xué)雜志, 2007, 07(10): 743-749. doi: 復(fù)制
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- 1. William A. Pulsinelli. Cerebrovascular Diseases-principles. In: Lee Goldman, J. Claude Bennett, eds. Cecil Textbook of Medicine. Philadelphia: Saunders, 2000: 2092.
- 2. American Heart Association. Heart disease and stroke statistics – 2006 update. www. Stroke Association. Org.
- 3. American Heart Association. Heart disease and stroke statistics – 2006 update. Circulation, 2006, 133: 85.
- 4. Will iam A, Pulsinelli. Cerebrovascular disease-principles. In: Goldman L, Bennett JC. Editor-in-Chief. Cecil Textbook of Medicine. Philadelphia: Saunders. 2000: 2523.
- 5. Bang OY, Lee JS, Lee PH, et al. Autologous mesenchymal stem cell transplantation in stroke patients. Ann Neurol, 2005, 57: 874.
- 6. Zivin JA, Choi DW. Stroke therapy. Science of American, 1991, 265: 56.
- 7. Kondziolka D, Wechsler L, Goldstein S, et al. Transplantation of cultured human neuronal cells for patients with stroke. Neurology, 2000, 55: 565.
- 8. Meltzer CC, Kondziolka D, Villemagne VL, et al. Serial[18F] fluorodeoxyglucose positron emission tomography after human neuronal implantation for stroke. Neurosurgery, 2001, 49: 586.
- 9. Nelson PT, Kondziolka D, Wechsler L, et al. Clonal human (hNT) neuron grafts for stroke therapy: neuropathology in a patient 27 months after implantation. Am J Sci, 2002, 160: 1201.
- 10. Savitz SI, Dinsmore J, Wu J, et al. Neurotransplantation of fetal porcine cells in patients with basal ganglia infarcts: a preliminary safety and feasibility study. Cerebrovasc Dis, 2005, 20: 101.
- 11. Wechsler L. Stem cell transplantation for stroke. Hong Kong Med J, 2001, 7: 9.
- 12. Bl iss T, Guzman R, Daadi M, et al. Cell transplantation therapy for stroke. Stroke, 2007, 38: 817.
- 13. Kornblurm HI. Introduction to neural stem cells. Stroke, 2007, 38: 810.
- 14. Wechsler L. Stem cell transplantation for stroke. Cleve Clin J Med, 2004, 71: 40.
- 15. Juni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of randomized controlled trials. BMJ, 2001, 323: 42.
- 16. Kondziolka D, Steinberg GK, Wechsler L, et al. Neurotransplantation for patients with subcortical motor stroke: a phase 2 randomized trial. J Neurosurg, 2005, 103: 38.
- 17. Stilley C, Ryan CM, Kondziolka D, et al. Changes in cognitive function after neuronal cell transplantation for basal gangl ia stroke. Neurology, 2004, 63: 1320.
- 18. Rabinovich SS, Seledtsov VI, Banul NV, et al. Cell therapy of brain stroke. Bull Exp Biol Med, 2005, 139: 126.