• 四川大學(xué)華西醫(yī)院循證醫(yī)學(xué)與臨床流行病學(xué)教研室(成都 610041);

目的  探討采用CONSORT和STRICTA標(biāo)準(zhǔn)評(píng)價(jià)針刺治療急性缺血性腦卒中隨機(jī)對(duì)照試驗(yàn)的報(bào)告質(zhì)量。
方法  系統(tǒng)檢索Cochrane圖書(shū)館臨床對(duì)照試驗(yàn)數(shù)據(jù)庫(kù)(2005年第4期)、PubMed(1980~2005.12)、EMbase(1984~2005.12)、CNKI(1994~2005.12)、CBMdisc(1980~2005.12)和VIP(1989~2005.12)6個(gè)數(shù)據(jù)庫(kù)。文種限制為中文和英文。手工檢索已納入文獻(xiàn)的參考文獻(xiàn)。納入針刺治療急性缺血性腦卒中的隨機(jī)對(duì)照試驗(yàn),并采用國(guó)際公認(rèn)的CONSORT聲明和報(bào)告針刺臨床試驗(yàn)中干預(yù)措施的國(guó)際標(biāo)準(zhǔn)(STRICTA)進(jìn)行報(bào)告質(zhì)量評(píng)價(jià)。
結(jié)果  共納入74篇文獻(xiàn)。根據(jù)CONSORT條目,在針刺治療急性缺血性腦卒中的報(bào)告中,54篇(72.97%)描述了各組的基線情況和臨床特征;26篇(35.14%)提及產(chǎn)生隨機(jī)分配序列的方法,其中4篇(5.41%)提及用計(jì)算機(jī)產(chǎn)生隨機(jī)分配序列;僅有6篇(8.11%)分配方案隱藏充分,其中5篇采用密封不透光的信封,1篇采用中心隨機(jī)分組;8篇(10.81%)采用盲法的文獻(xiàn)中5篇采用雙盲;4篇(5.41%)提及樣本含量的計(jì)算,多數(shù)文獻(xiàn)樣本含量較小;僅5篇(6.76%)文獻(xiàn)采用意向治療(ITT)分析法。根據(jù)STRICTA,4篇(5.41%)文獻(xiàn)提及用針數(shù)目;有35篇(47.30%)提及針具型號(hào),只有26篇(35.14%)提及針刺深度;6篇文獻(xiàn)(8.11%)報(bào)告了治療師的資歷,其中僅有1篇(1.35%)提及醫(yī)師的臨床實(shí)踐時(shí)間,沒(méi)有1篇提及治療師的訓(xùn)練時(shí)間。
結(jié)論  目前針刺治療急性缺血性腦卒中的研究報(bào)告質(zhì)量普遍較低。今后應(yīng)采用國(guó)際公認(rèn)的CONSORT聲明和STRICTA標(biāo)準(zhǔn)對(duì)針刺療法進(jìn)行規(guī)范報(bào)告。

引用本文: 張小利,李 靜,張鳴明,袁文明. 采用CONSORT和STRICTA評(píng)價(jià)針刺治療急性缺血性腦卒中隨機(jī)對(duì)照試驗(yàn)報(bào)告質(zhì)量. 中國(guó)循證醫(yī)學(xué)雜志, 2006, 06(8): 586-590. doi: 復(fù)制

1. 陳松清, 王一萍, 李怡新. 頸部針刺治療急性期腦梗塞95例. 中國(guó)康復(fù)理論與實(shí)踐, 1997; 3(4): 161-162.
2. 司全明, 吳根誠(chéng), 曹小定. 電針治療急性腦梗塞患者臨床療效觀察. 中國(guó)針灸, 1999;(3):137-139.
3. 段國(guó)俊, 唐強(qiáng), 張春英, 等. 不同部位腦梗塞針刺效應(yīng)比較. 中國(guó)針灸, 1997; (10): 591-593.
4. 姜松鶴, 孟慶剛, 唐強(qiáng), 等. 頭穴透刺配合尿激酶治療急性腦梗塞的臨床研究. 中醫(yī)藥學(xué)報(bào), 1998; (3): 51-52.
5. 張小澍,袁玉民. 急性腦梗塞患者VIP,SS,PP改變及電針對(duì)其的影響. 針刺研究, 1996; (4): 10-16.
6. Park J, Hophood V, White AR, et al. Effectiveness of acupuncture for stroke: A systematic review. Journal of Neurology, 2001; 248(7):558-63.
7. Johansson K, Lindgren I, Widner H, et al. Can sensory stimulation improve the functional outcome in stroke patients? Neurology, 1993; 43: 2189-2192.
8. Chen SQ, Wang YP, Li YX. Effects of acupuncture on neck in the treatment of 95 cases of acute cerebral infarction. Chinese Journal of Rehabilitation Therapy and Practic, 1997; 3(4):161-162.
9. Si QM, Wu GC, Cao XL. Effects of electroacupuncture on acute cerebral infarction. Chinese Acupuncture and Moxibustion, 1999;(3):137-139.
10. Duan GJ, Tang Q, Zhang CY, et al. Comparison of effects of acupuncture on cerebral infarction in different parts. Chinese Acupuncture and Moxibustion, 1997;(10):591-593.
11. Jiang SH, Meng QG, Tang Q, et al. Effect of scalp acupuncture combinated with urokinase on acute cerebral infarction. Acta Chinese Medicine and Pharmacology, 1998; (3): 51-52.
12. Gunilla GH, Lisbet C, Ulrika K, et al. Effects of Acupuncture Treatment on Daily Life Activities and Quality of Life. Stroke, 1998; 29: 2100-2108.
13. Johansson BB, Haker E, Arbin MV, et al. Acupuncture and transcutaneous nerve stimulation in stroke rehabilitation-A randomized, controlled trial. Stroke, 2001; 32: 707-713.
14. Zhang XS, Yuan YM. The changes of vasoactive intestinal peptide somatostatin and pancreatic polypeptide in blood and CSF of acute cerebral infarction patients and the effect of acupuncture. Acupuncture Research, 1996; (4):10-16.
15. Altman DG, Schulz K, Moher D, et al. The Revised CONSORT Statement for Reporting Randomized Trials Explanation and Elaboration. Ann Intern Med, 2001; 134(8): 663-694.
16. MacPherson H, White A, Cummings M, et al. STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture). Acupuncture in Medicine, 2002; 20(1): 22-25.
17. Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias - dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA, 1995; 272: 408-412.
  1. 1. 陳松清, 王一萍, 李怡新. 頸部針刺治療急性期腦梗塞95例. 中國(guó)康復(fù)理論與實(shí)踐, 1997; 3(4): 161-162.
  2. 2. 司全明, 吳根誠(chéng), 曹小定. 電針治療急性腦梗塞患者臨床療效觀察. 中國(guó)針灸, 1999;(3):137-139.
  3. 3. 段國(guó)俊, 唐強(qiáng), 張春英, 等. 不同部位腦梗塞針刺效應(yīng)比較. 中國(guó)針灸, 1997; (10): 591-593.
  4. 4. 姜松鶴, 孟慶剛, 唐強(qiáng), 等. 頭穴透刺配合尿激酶治療急性腦梗塞的臨床研究. 中醫(yī)藥學(xué)報(bào), 1998; (3): 51-52.
  5. 5. 張小澍,袁玉民. 急性腦梗塞患者VIP,SS,PP改變及電針對(duì)其的影響. 針刺研究, 1996; (4): 10-16.
  6. 6. Park J, Hophood V, White AR, et al. Effectiveness of acupuncture for stroke: A systematic review. Journal of Neurology, 2001; 248(7):558-63.
  7. 7. Johansson K, Lindgren I, Widner H, et al. Can sensory stimulation improve the functional outcome in stroke patients? Neurology, 1993; 43: 2189-2192.
  8. 8. Chen SQ, Wang YP, Li YX. Effects of acupuncture on neck in the treatment of 95 cases of acute cerebral infarction. Chinese Journal of Rehabilitation Therapy and Practic, 1997; 3(4):161-162.
  9. 9. Si QM, Wu GC, Cao XL. Effects of electroacupuncture on acute cerebral infarction. Chinese Acupuncture and Moxibustion, 1999;(3):137-139.
  10. 10. Duan GJ, Tang Q, Zhang CY, et al. Comparison of effects of acupuncture on cerebral infarction in different parts. Chinese Acupuncture and Moxibustion, 1997;(10):591-593.
  11. 11. Jiang SH, Meng QG, Tang Q, et al. Effect of scalp acupuncture combinated with urokinase on acute cerebral infarction. Acta Chinese Medicine and Pharmacology, 1998; (3): 51-52.
  12. 12. Gunilla GH, Lisbet C, Ulrika K, et al. Effects of Acupuncture Treatment on Daily Life Activities and Quality of Life. Stroke, 1998; 29: 2100-2108.
  13. 13. Johansson BB, Haker E, Arbin MV, et al. Acupuncture and transcutaneous nerve stimulation in stroke rehabilitation-A randomized, controlled trial. Stroke, 2001; 32: 707-713.
  14. 14. Zhang XS, Yuan YM. The changes of vasoactive intestinal peptide somatostatin and pancreatic polypeptide in blood and CSF of acute cerebral infarction patients and the effect of acupuncture. Acupuncture Research, 1996; (4):10-16.
  15. 15. Altman DG, Schulz K, Moher D, et al. The Revised CONSORT Statement for Reporting Randomized Trials Explanation and Elaboration. Ann Intern Med, 2001; 134(8): 663-694.
  16. 16. MacPherson H, White A, Cummings M, et al. STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture). Acupuncture in Medicine, 2002; 20(1): 22-25.
  17. 17. Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias - dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA, 1995; 272: 408-412.