• 四川大學華西醫(yī)院中西醫(yī)結(jié)合科（成都 610041）;

目的 　調(diào)查《中國中西醫(yī)結(jié)合雜志》發(fā)表的隨機對照試驗（RCT）報告的方法學質(zhì)量。
方法 　手工檢索《中國中西醫(yī)結(jié)合雜志》1999～2004年刊載的RCT，采用CONSORT標準修訂版和自擬其它評價指標對所有RCT進行質(zhì)量評價。
結(jié)果 　共檢索了6卷72期2 765篇已發(fā)表的文獻，其中RCT 1 288篇，占臨床試驗類文獻（1 874篇）的68.73％。該1 288篇RCTs中，描述了隨機方法的有630篇(48．92％)，與1999年以前相比，其差異有統(tǒng)計學意義 (P  lt;0.001)，但采用安慰劑對照僅有21篇(1.63％)，描述了終點指標者有114篇(8.85％)，進行了樣本量估算者有7篇(0.55％)，無一篇描述隨機分配，采用盲法的有54篇(4.20％)、對具體P值進行了描述的有9篇(0.70％)、無一篇報道隨機試驗流程圖，描述了依從性的有2篇(0.16％)，報告陰性結(jié)果的有1篇(0.08％)，進行了輔助分析的有33篇(2.57％)，采用多中心試驗的有10篇(0.78％)，進行了倫理學審批者為零，報道了患者知情同意者有3篇(0.24％)，進行了致謝的有3篇(0.24％)，描述了中醫(yī)證型的有163篇(12.66％)，采用了干預措施質(zhì)量控制標準的有2篇(0.15％)，采用模擬方法的有8篇(0.63％)，描述了中醫(yī)證候療效指標的有258篇(20.04％)，以上調(diào)查項目的質(zhì)量評分均偏低。
結(jié)論 　隨著循證醫(yī)學理念的深入和中國生物醫(yī)學雜志編輯的重視，中醫(yī)藥臨床試驗報告質(zhì)量已有提高，但與目前國際公認的CONSORT標準比較尚有差距。

引用本文： 毛 兵,王 剛,陳小東,樊 濤,劉 佳,王 蕾,常 靜,張 穎,郭 佳,李廷謙. 《中國中西醫(yī)結(jié)合雜志》發(fā)表隨機對照試驗報告的質(zhì)量評價. 中國循證醫(yī)學雜志, 2006, 06(4): 297-304. doi: 復制

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13. LI TQ,MAO Bing,CHANG Jing,et al. Evaluation of clinical trails published in the Chinese Journal of Integrated Traditional and Western Medicine. Chinese Journal of Integrated Traditional and Western Medicine, 1999; 19(7): 435-436.
14. LI TQ,MAO Bing,CHANG Jing,et al. An Evaluation of Clinical Research Literatures in Core Journals of Traditional Chinese Medicine Integrated with Western Medicine or Traditional Chinese Medicine. West China Medical Journal, 2000;15(3):266-269.
15. The Cochrane Collaboration Handbook. In: the Cochrane Library. ChiChester, UK: John Wiley&Sons, Ltd. 2004.
  1. 1. 李廷謙，王剛，王蕾等.我國中醫(yī)藥臨床研究的現(xiàn)狀和評價.中國循證醫(yī)學雜志, 2005;5(6)：431～437.
  2. 2. 衛(wèi)茂玲，辜蕊，張鳴明等.11種地方性中醫(yī)藥期刊1995～2000年臨床研究文獻質(zhì)量的初步分析.中國循證醫(yī)學雜志, 2004;4(6):410～413.
  3. 3. 李廷謙，毛兵，常靜等.《中國中西醫(yī)結(jié)合雜志》發(fā)表的論文中有關臨床試驗的評價.中國中西醫(yī)結(jié)合雜志,1999;19(7): 435～436.
  4. 4. 李廷謙，毛兵，常靜等.中西醫(yī)、中醫(yī)核心雜志臨床研究文獻評價. 華西醫(yī)學, 2000; 15(3):266～269.
  5. 5. Moher D, Schulz KF, Altman DG.The CONSORT statement revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet, 2001:357(9263):1191-1194.
  6. 6. Instructions for authors.Chin Med J, 2005; 118(1):1140-1144.
  7. 7. Liu YX, Yao C, Chen Feng, et al. Introductionn to CONSORT statement reporting randomized controlled clinical trials. National Journal of Andrology, 2001; 32(26): 288-291.
  8. 8. Liu XM, Liu JP. Improving quality of medical journals by CONSORT using. Acta Editologica, 2002; 14(3):228-229.
  9. 9. Liu YX, Yao C, Sheng M.The CONSORT statement：Universe requirements for reporting randomized controlled trials. Chin J Clin Pharmacol, 2004; 20:76-80.
  10. 10. Tang JL, Zhan SY, Ernst E. Review of randomized controlled trials of traditional Chinese medicine. BMJ,1 999;319(7 203):160-161.
  11. 11. LI TQ,WANG Gang, WANG Lei,et al. Clinical trials of traditional Chinese medicine in China: status and evaluation. Chin J EBM, 2005; 5(6)：431-437.
  12. 12. WEI ML,GU Rui,ZHANG MM.A brief study on the quality of clinical trials in 11 medical journals of traditional Chinese medicine from 1995 to 2000. Chin J EBM, 2004;4(6):410-413.
  13. 13. LI TQ,MAO Bing,CHANG Jing,et al. Evaluation of clinical trails published in the Chinese Journal of Integrated Traditional and Western Medicine. Chinese Journal of Integrated Traditional and Western Medicine, 1999; 19(7): 435-436.
  14. 14. LI TQ,MAO Bing,CHANG Jing,et al. An Evaluation of Clinical Research Literatures in Core Journals of Traditional Chinese Medicine Integrated with Western Medicine or Traditional Chinese Medicine. West China Medical Journal, 2000;15(3):266-269.
  15. 15. The Cochrane Collaboration Handbook. In: the Cochrane Library. ChiChester, UK: John Wiley&Sons, Ltd. 2004.