實施臨床試驗報告規范，提高臨床試驗透明度_《中國循證醫學雜志》

作者：

吳泰相 ¹ ,  李幼平 ¹ , 卞兆祥 ² , 陳可冀 ³ , 張伯禮 ⁴ , 商洪才 ¹⁴ , David Moher ⁵

1. 衛生部中國循證醫學中心，中國Cochrane中心， INCLEN華西資源與培訓中心，中國臨床試驗注冊中心（成都 610041）2. 香港浸會大學中醫學院3. 中國中醫科學院4. 天津中醫藥大學5. Chalmers Research Group (CRG), University of Ottawa Evidence-Based Practice Center (UO-EPC), Department of Pediatrics, Epidemiology & Community Medicine, University of Ottawa, Canada;

關鍵詞：

臨床試驗報告規范臨床試驗

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引用本文： 吳泰相,李幼平,卞兆祥,陳可冀,張伯禮,商洪才,David Moher. 實施臨床試驗報告規范，提高臨床試驗透明度. 中國循證醫學雜志, 2007, 07(8): 551-554. doi: 復制

1.	Wu TX, Li YP, Li J, et al. A milestone for clinical trials: the globalcl inical trial registration system lauched up. Chin J Evid-Based Med,2007, 7(7): 479-480.
2.	Chang J, Li TQ, Wan MH, et al. Quality assessment for randomized controlled trials published in four acta of traditional Chinese medicine. Chin J Evid-Based Med, 2006, 6(3): 171-178.
3.	中國循證醫學雜志, 2006; 6(4): 297-304.
4.	Mao B, Wang G, Chen XD, et al. Quality Assessment of the Reporting of Randomized Controlled Trials Published in the Chinese Journal of Integrated Traditional and Western Medicine with the Revised CONSORT Statement. Chin J Evid-Based Med, 2006, 6(4): 297-304.
5.	The Journal of Evidence-based Medicine, 2005, 5(1): 26-28, 32.
6.	Duan X, Zhou LK, Wu TX, et al. Quality Analysis of Literatures on Clinical Randomized Controlled Trial of Coronary Heart Diseases Treated with TCM. Chinese Journal of Integrated Traditional and Western Medicine, 2003, 23(3): 164-167.
7.	Ni J, Chen XY, Zheng J. Comment on Literatures of Clinical Randomized Controlled Trials of Traditional Chinese Medicine for Acute Myocardial Infarction. Journal of Guangzhou University of Traditional Chinese Medicine, 2003, 20(1): 82-85.
8.	Chen HY, Chen J, Wu TX, et al. Quality evaluation on methodology of clinical research of yinzhihuang injection in the treatment of icteric virus hepatitis. China Pharmacy, 2005, 16(13): 1031-1033.
9.	Wang Q, Wu TX, Liu GJ. Quality evaluation for randomized controlled trials of traditional Chinese medicinal for unstable angina pectoris. Journal of Chengdu Unversity of Tarditional Chinese Medicine, 2003, 26(2): 52-55.
10.	Wei JF, Qiao JQ, Ni J, et al. Quality Assessment for Randomized Controlled Trials of Traditional Chinese Medicinal Herbs in the Treatment of Acute Appear Respiratory Infection. West China Medical Journal, 2003, 18(3): 297-299.
11.	http://www.chictr.org/Site/Question.aspx.
12.	Human subjects research definitions. http://grants.nih.gov/grants/funding/phs398/instructions2/p2_human_subjects_definitions.htm.
13.	世界醫學大會赫爾辛基宣言, 人體醫學研究的倫理準則, 2000年10月修改版.http://www.wma.net/policy/b3.htm.
14.	Ottawa Statement. http://ottawagroup.ohri.ca/statement.html.
15.	China and India join WHO clinical trial registry platform. http://www.who.int/mediacentre/news/releases/2007/pr41/en/index.html.
16.	吳泰相, 李幼平, 李靜, 等. 臨床試驗的里程碑事件: 全球臨床試驗注冊制度建成運行. 中國循證醫學雜志, 2007, 7(7): 479-80.
17.	Angel is CD, Drazen JM, Frizelle FA, et al. Is This Cl inical Trial Fully Registered?: A Statement from the International Committee of Medical Journal Editors. http://www.icmje.org/clin_trialup.htm.
18.	Moher D, Schulz KF, Altman D, et al. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA, 2001, 285(15): 1987-1991.
19.	Campbell MK, Elbourne DR, Altman DG, et al. CONSORT statement: extension to cluster randomised trials. BMJ, 2004, 328(7441): 702-708.
20.	Gagnier JJ, Boon H, Rochon P, et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Annals of Internal Medicine, 2006;144(5): 364-367.
21.	Moher D, Jones A, Lepage L, et al. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before and after evaluaton? JAMA, 2001; 285(15):1992-1995.
22.	吳泰相, 李幼平, 劉關鍵, 等. 臨床試驗注冊制度與循證醫學. 中國循證醫學雜志, 2007, 7(4): 239-243. Wu TX, Li YP, Liu GJ, et al. Clinical trial registration system and evidence-based medicine. Chin J Evid-Based Med, 2007, 7(4): 239-243.
23.	李幼平, 吳泰相, 劉關鍵, 等. 中國循證醫學中心促進中醫藥現代化的策略. 中國循證醫學雜志, 2007, 7(3): 159-161. Li YP, Wu TX, Liu GJ, et al. The strategy of chinese evidence-based medicine center for promoting the modernization of traditional Chinese medicine. Chin J Evid-Based Med, 2007, 7(3): 159-161.
24.	Wu TX, Li YP, Bian ZX, et al. Randomized trials in China: How many are authentic? Cochrane Colloquium 14th, Dublin.
25.	李廷謙, 王剛, 王蕾, 等. 我國中醫藥臨床研究的現狀和評價. 中國循證醫學雜志, 2005, 5(6): 431-437. Li TQ, Wang G, Wang L, et al. Clinical trials of traditional chinese medicine in China: status and evaluation. Chin J Evid-Based Med, 2005, 5(6): 431-437.
26.	李廷謙, 毛兵, 常靜, 等. 中西醫、中醫核心雜志臨床研究文獻評價. 華西醫學. 2000, 15(3): 266-269. Li TQ, Mao B, Chang J, 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.
27.	常靜, 李廷謙, 萬美華, 等. 中國4種中醫藥大學學報隨機對照臨床試驗文獻的質量評價. 中國循證醫學雜志, 2006, 6(3): 171-178.
28.	毛兵, 王剛, 陳小東, 等. 《中國中西醫結合雜志》發表隨機對照試驗報告的質量評價.
29.	溫澤淮, 賴世隆, 梁偉雄, 等. 進一步改善中醫藥臨床試驗報告的質量. 中國中西醫結合雜志, 2004, 24(11): 1022-1025. Wen ZH, Lai SL, Liang WX, et al. Further improve the reporting quality ofTCM clinical trials. Chinese Journal of Integrated Traditional and Western Medicine, 2004, 24(11): 1022-1025.
30.	劉曉雁, 賴世隆, 劉鵬熙. 中醫藥及中西醫結合治療乳腺癌研究文獻的質量評價. 循證醫學, 2005, 5(1): 26-28, 32. Liu XY, Lai SL, Liu PX. Quality analysis ofliterature of traditional Chinese medicine or integrated traditional and western medicines on breast cancer.
31.	韓麗琳, 黃旭春. 中醫藥治療抑郁癥研究文獻的質量評價. 云南中醫學院學報, 2005, 28(2): 8-10, 18. Han LL, Huang XC. Quality evaluation on treatment of depression with TCM by clinical document. Journal of Yunnan College of Chinese Medicine, 2005, 28(2): 8-10, 18.
32.	段鑫, 周禮鯤, 吳泰相, 等. 中醫藥治療冠心病的臨床隨機對照試驗文獻的質量分析. 中國中西醫結合雜志, 2003, 23(3): 164-167.
33.	倪娟, 陳小燕, 鄭潔. 我國中醫藥治療治療急性心肌梗死臨床試驗文獻的質量評價. 廣州中醫藥大學學報, 2003, 20(1): 82-85.
34.	陳輝揚, 陳軍, 吳泰相, 等. 茵梔黃注射液治療黃疸型病毒性肝炎臨床研究的方法學質量評價. 中國藥房. 2005, 16(13): 1031-1033.
35.	許衛華, 謝紅. 雷公藤制劑治療類風濕關節炎隨機對照試驗文獻方法學質量評價. 中華風濕病學雜志, 2004, 8(12): 740-742. Xu WH, Xie H. Methodological quality evaluation of randomized controlled trials in rheumatoid arthritist related with preparations of Tripterygium wilfordii. Chinese Journal of Rheumatology, 2004, 8(12): 740-742.
36.	王覃, 吳泰相, 劉關鍵. 關于不穩定型心絞痛的中醫藥臨床隨機對照試驗質量的評價. 成都中醫藥大學學報, 2003, 26(2): 52-55.
37.	魏家富, 喬杰奇, 倪娟, 等. 關于上呼吸道感染的中醫藥臨床隨機對照試驗的質量評價. 華西醫學, 2003, 18(3): 297-299.
38.	段寧, 王文梅. 從循證醫學角度評價中醫藥治療RAU相關文獻. 江蘇中醫藥, 2004, 25(7): 50-52.Duan N, Wang WM. Evidence-based evaluation of relevantliterature involving TCM treatment for RAU. Jiangsu Journal of Traditional Chinese Medicine, 2004, 25(7): 50-52.
39.	衛茂玲, 辜蕊, 張鳴明, 等. 11種地方性中醫藥期刊1995～2000年臨床研究文獻質量的初步分析. 中國循證醫學雜志, 2004, 4(6): 410-413. Wei ML, Gu R, Zhang MM, et al. A brief study on the quality of clinical trials in 11 medical journals of traditional Chinese medicine from 1995 to 2000. Chin J of Evid-Based Med, 2004, 4(6): 410-413.
40.	許良智, 陳進, 王家良, 等. 部分中華醫學會系列雜志防治性研究論文中隨機問題的商榷. 中華醫學雜志, 1999; 79(2): 97-98. Xu LZ, Chen J, Wang JL, et al. On the randomization methods used in the preventive and therapeutic studies published in some Chinese Medical Journal Series. National Medical Journal of China, 1999; 79(2): 97-98.
41.	Tang JL, Zhan SY, Ernst E: Review of randomized controlled trials of traditional Chinese medicine. BMJ, 1999, 319: 160-161.
42.	Bian ZX, Li YP, Moher D, et al . Improving the quality of randomized controlled trials in Chinese herbal medicine, part I: clinical trial design and methodology. Zhong Xi Yi Jie He Xue Bao, 2006, 4(2):120-129.
43.	Bian ZX, Moher D, Dagenais S, et al. Improving the quality of randomized controlled trials in Chinese herbal medicine, part II: control group design. Zhong Xi Yi Jie He Xue Bao, 2006, 4(2): 130-136.
44.	Leung KS, Bian ZX, Moher D, et al. Improving the quality of randomized controlled trials in Chinese herbal medicine, part III: quality control of Chinese herbal medicine used in randomized controlled trials. Zhong Xi Yi Jie He Xue Bao. 2006, 4(3): 225-232.
45.	Bian ZX, Moher D, Dagenais S, et al. Improving the quality of randomized controlled trials in Chinese herbal medicine, part IV: applying a revised CONSORT checklist to measure reporting quality. Zhong Xi Yi Jie He Xue Bao, 2006, 4(3): 233-242.

1. Wu TX, Li YP, Li J, et al. A milestone for clinical trials: the globalcl inical trial registration system lauched up. Chin J Evid-Based Med,2007, 7(7): 479-480.
2. Chang J, Li TQ, Wan MH, et al. Quality assessment for randomized controlled trials published in four acta of traditional Chinese medicine. Chin J Evid-Based Med, 2006, 6(3): 171-178.
3. 中國循證醫學雜志, 2006; 6(4): 297-304.
4. Mao B, Wang G, Chen XD, et al. Quality Assessment of the Reporting of Randomized Controlled Trials Published in the Chinese Journal of Integrated Traditional and Western Medicine with the Revised CONSORT Statement. Chin J Evid-Based Med, 2006, 6(4): 297-304.
5. The Journal of Evidence-based Medicine, 2005, 5(1): 26-28, 32.
6. Duan X, Zhou LK, Wu TX, et al. Quality Analysis of Literatures on Clinical Randomized Controlled Trial of Coronary Heart Diseases Treated with TCM. Chinese Journal of Integrated Traditional and Western Medicine, 2003, 23(3): 164-167.
7. Ni J, Chen XY, Zheng J. Comment on Literatures of Clinical Randomized Controlled Trials of Traditional Chinese Medicine for Acute Myocardial Infarction. Journal of Guangzhou University of Traditional Chinese Medicine, 2003, 20(1): 82-85.
8. Chen HY, Chen J, Wu TX, et al. Quality evaluation on methodology of clinical research of yinzhihuang injection in the treatment of icteric virus hepatitis. China Pharmacy, 2005, 16(13): 1031-1033.
9. Wang Q, Wu TX, Liu GJ. Quality evaluation for randomized controlled trials of traditional Chinese medicinal for unstable angina pectoris. Journal of Chengdu Unversity of Tarditional Chinese Medicine, 2003, 26(2): 52-55.
10. Wei JF, Qiao JQ, Ni J, et al. Quality Assessment for Randomized Controlled Trials of Traditional Chinese Medicinal Herbs in the Treatment of Acute Appear Respiratory Infection. West China Medical Journal, 2003, 18(3): 297-299.
11. http://www.chictr.org/Site/Question.aspx.
12. Human subjects research definitions. http://grants.nih.gov/grants/funding/phs398/instructions2/p2_human_subjects_definitions.htm.
13. 世界醫學大會赫爾辛基宣言, 人體醫學研究的倫理準則, 2000年10月修改版.http://www.wma.net/policy/b3.htm.
14. Ottawa Statement. http://ottawagroup.ohri.ca/statement.html.
15. China and India join WHO clinical trial registry platform. http://www.who.int/mediacentre/news/releases/2007/pr41/en/index.html.
16. 吳泰相, 李幼平, 李靜, 等. 臨床試驗的里程碑事件: 全球臨床試驗注冊制度建成運行. 中國循證醫學雜志, 2007, 7(7): 479-80.
17. Angel is CD, Drazen JM, Frizelle FA, et al. Is This Cl inical Trial Fully Registered?: A Statement from the International Committee of Medical Journal Editors. http://www.icmje.org/clin_trialup.htm.
18. Moher D, Schulz KF, Altman D, et al. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA, 2001, 285(15): 1987-1991.
19. Campbell MK, Elbourne DR, Altman DG, et al. CONSORT statement: extension to cluster randomised trials. BMJ, 2004, 328(7441): 702-708.
20. Gagnier JJ, Boon H, Rochon P, et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Annals of Internal Medicine, 2006;144(5): 364-367.
21. Moher D, Jones A, Lepage L, et al. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before and after evaluaton? JAMA, 2001; 285(15):1992-1995.
22. 吳泰相, 李幼平, 劉關鍵, 等. 臨床試驗注冊制度與循證醫學. 中國循證醫學雜志, 2007, 7(4): 239-243. Wu TX, Li YP, Liu GJ, et al. Clinical trial registration system and evidence-based medicine. Chin J Evid-Based Med, 2007, 7(4): 239-243.
23. 李幼平, 吳泰相, 劉關鍵, 等. 中國循證醫學中心促進中醫藥現代化的策略. 中國循證醫學雜志, 2007, 7(3): 159-161. Li YP, Wu TX, Liu GJ, et al. The strategy of chinese evidence-based medicine center for promoting the modernization of traditional Chinese medicine. Chin J Evid-Based Med, 2007, 7(3): 159-161.
24. Wu TX, Li YP, Bian ZX, et al. Randomized trials in China: How many are authentic? Cochrane Colloquium 14th, Dublin.
25. 李廷謙, 王剛, 王蕾, 等. 我國中醫藥臨床研究的現狀和評價. 中國循證醫學雜志, 2005, 5(6): 431-437. Li TQ, Wang G, Wang L, et al. Clinical trials of traditional chinese medicine in China: status and evaluation. Chin J Evid-Based Med, 2005, 5(6): 431-437.
26. 李廷謙, 毛兵, 常靜, 等. 中西醫、中醫核心雜志臨床研究文獻評價. 華西醫學. 2000, 15(3): 266-269. Li TQ, Mao B, Chang J, 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.
27. 常靜, 李廷謙, 萬美華, 等. 中國4種中醫藥大學學報隨機對照臨床試驗文獻的質量評價. 中國循證醫學雜志, 2006, 6(3): 171-178.
28. 毛兵, 王剛, 陳小東, 等. 《中國中西醫結合雜志》發表隨機對照試驗報告的質量評價.
29. 溫澤淮, 賴世隆, 梁偉雄, 等. 進一步改善中醫藥臨床試驗報告的質量. 中國中西醫結合雜志, 2004, 24(11): 1022-1025. Wen ZH, Lai SL, Liang WX, et al. Further improve the reporting quality ofTCM clinical trials. Chinese Journal of Integrated Traditional and Western Medicine, 2004, 24(11): 1022-1025.
30. 劉曉雁, 賴世隆, 劉鵬熙. 中醫藥及中西醫結合治療乳腺癌研究文獻的質量評價. 循證醫學, 2005, 5(1): 26-28, 32. Liu XY, Lai SL, Liu PX. Quality analysis ofliterature of traditional Chinese medicine or integrated traditional and western medicines on breast cancer.
31. 韓麗琳, 黃旭春. 中醫藥治療抑郁癥研究文獻的質量評價. 云南中醫學院學報, 2005, 28(2): 8-10, 18. Han LL, Huang XC. Quality evaluation on treatment of depression with TCM by clinical document. Journal of Yunnan College of Chinese Medicine, 2005, 28(2): 8-10, 18.
32. 段鑫, 周禮鯤, 吳泰相, 等. 中醫藥治療冠心病的臨床隨機對照試驗文獻的質量分析. 中國中西醫結合雜志, 2003, 23(3): 164-167.
33. 倪娟, 陳小燕, 鄭潔. 我國中醫藥治療治療急性心肌梗死臨床試驗文獻的質量評價. 廣州中醫藥大學學報, 2003, 20(1): 82-85.
34. 陳輝揚, 陳軍, 吳泰相, 等. 茵梔黃注射液治療黃疸型病毒性肝炎臨床研究的方法學質量評價. 中國藥房. 2005, 16(13): 1031-1033.
35. 許衛華, 謝紅. 雷公藤制劑治療類風濕關節炎隨機對照試驗文獻方法學質量評價. 中華風濕病學雜志, 2004, 8(12): 740-742. Xu WH, Xie H. Methodological quality evaluation of randomized controlled trials in rheumatoid arthritist related with preparations of Tripterygium wilfordii. Chinese Journal of Rheumatology, 2004, 8(12): 740-742.
36. 王覃, 吳泰相, 劉關鍵. 關于不穩定型心絞痛的中醫藥臨床隨機對照試驗質量的評價. 成都中醫藥大學學報, 2003, 26(2): 52-55.
37. 魏家富, 喬杰奇, 倪娟, 等. 關于上呼吸道感染的中醫藥臨床隨機對照試驗的質量評價. 華西醫學, 2003, 18(3): 297-299.
38. 段寧, 王文梅. 從循證醫學角度評價中醫藥治療RAU相關文獻. 江蘇中醫藥, 2004, 25(7): 50-52.Duan N, Wang WM. Evidence-based evaluation of relevantliterature involving TCM treatment for RAU. Jiangsu Journal of Traditional Chinese Medicine, 2004, 25(7): 50-52.
39. 衛茂玲, 辜蕊, 張鳴明, 等. 11種地方性中醫藥期刊1995～2000年臨床研究文獻質量的初步分析. 中國循證醫學雜志, 2004, 4(6): 410-413. Wei ML, Gu R, Zhang MM, et al. A brief study on the quality of clinical trials in 11 medical journals of traditional Chinese medicine from 1995 to 2000. Chin J of Evid-Based Med, 2004, 4(6): 410-413.
40. 許良智, 陳進, 王家良, 等. 部分中華醫學會系列雜志防治性研究論文中隨機問題的商榷. 中華醫學雜志, 1999; 79(2): 97-98. Xu LZ, Chen J, Wang JL, et al. On the randomization methods used in the preventive and therapeutic studies published in some Chinese Medical Journal Series. National Medical Journal of China, 1999; 79(2): 97-98.
41. Tang JL, Zhan SY, Ernst E: Review of randomized controlled trials of traditional Chinese medicine. BMJ, 1999, 319: 160-161.
42. Bian ZX, Li YP, Moher D, et al . Improving the quality of randomized controlled trials in Chinese herbal medicine, part I: clinical trial design and methodology. Zhong Xi Yi Jie He Xue Bao, 2006, 4(2):120-129.
43. Bian ZX, Moher D, Dagenais S, et al. Improving the quality of randomized controlled trials in Chinese herbal medicine, part II: control group design. Zhong Xi Yi Jie He Xue Bao, 2006, 4(2): 130-136.
44. Leung KS, Bian ZX, Moher D, et al. Improving the quality of randomized controlled trials in Chinese herbal medicine, part III: quality control of Chinese herbal medicine used in randomized controlled trials. Zhong Xi Yi Jie He Xue Bao. 2006, 4(3): 225-232.
45. Bian ZX, Moher D, Dagenais S, et al. Improving the quality of randomized controlled trials in Chinese herbal medicine, part IV: applying a revised CONSORT checklist to measure reporting quality. Zhong Xi Yi Jie He Xue Bao, 2006, 4(3): 233-242.

《中國循證醫學雜志》

實施臨床試驗報告規范，提高臨床試驗透明度

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

Format

Content

《中國循證醫學雜志》

實施臨床試驗報告規范，提高臨床試驗透明度

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

Format

Content

摘要全文圖表視頻參考文獻施引文獻補充材料