臨床試驗質量評價工具及其應用_《中國循證醫學雜志》

作者：

郭新峰 ¹ , 溫澤淮 ¹ , 老膺榮 ² , 賴世隆 ¹

1. 廣州中醫藥大學DME中心，廣州，5104052. 廣州中醫藥大學第二附屬醫院(廣東省中醫院)臨床流行病學應用研究室;

關鍵詞：

臨床試驗方法學評價工具

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摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

闡述國內外臨床試驗質量評價工具的產生背景與應用現狀，介紹國內外常用的評價表，并對該領域存在的問題進行了討論.

引用本文： 郭新峰,溫澤淮,老膺榮,賴世隆. 臨床試驗質量評價工具及其應用. 中國循證醫學雜志, 2004, 04(7): 484-487. doi: 復制

1.	［1］Moher D，Pham B，Jones A，Cook DJ，Jaded AR，Moher M，Tugwell P.Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses[J].Lancet，1998; 352(9 128):609-613.
2.	［2］Moher D，Jadad AR，Nichol G，Penman M，Tugwell P，Walsh S.Assessing the quality of randomized controlled trials:an annotated bibliography of scales and checklists[J].Control Clin Trials，1995; 21(16):62-73.
3.	［3］Jadad AR，Moore RA，Carroll D，Jenkinson C，ReynoldsDJ，Gavaghan DJ，McQuay HJ.Assessing the quality of reports of randomized clinical trials:Is blinding necessary[J].Control Clin Trials，1996，12(17):1-12.
4.	［4］Chalmers TC，Smith H，Blackburn B，Silverman B，Schroeder B，Reitman D，Ambroz A.A method for assessing the quality of a randomized control trial[J].Controlled Clin Trials，1981;2(3):31-49.
5.	［5］Ma B.Quality analysis and recommendations of randomized controlled trials on treating Alzheimer’s Disease by Traditional Chinese Medicine[J].Traditional Chinese Medicine Journal of Liaonin Province，2004.31(3):203-204.
6.	馬斌.中醫藥治療老年癡呆-隨機對照資料的質量分析和建議[J].遼寧中醫雜志，2004.31(3):203～204.
7.	［6］Liu JP，Ling TJ，Assessment of the clinical literatures on treating the viral hepatitis in recent eight years[J].Journal of Disease Control，1998;2(3):188-190.
8.	劉建平，冷泰俊.病毒性肝炎臨床治療試驗八年文獻評價[J].疾病控制雜志，1998;2(3):188～190.
9.	［7］Wang X，Liu Q，Yue XQ，Hou FG，Deng WZ，Gu W，Shen XB.Quality assessment of clinical studies on treating the primary carcinoma of liver with Traditional Chinese Medicine[J].Traditional Chinese Medicine Journal of Hunan College，2003;23(4):50-52.
10.	王喜，劉慶，岳小強，侯鳳剛，鄧偉哲，顧偉，沈旭波.對中醫藥治療原發性肝癌臨床研究的方法學評價[J].湖南中醫學院學報，2003;23(4):50～52.
11.	［8］Teng DH，Lu YP，Wang L，Li X，Wei Q，Xin YP，Liu XD，Yang YR.Quality assessment of clinical studies on treating the chronic prostatitis with Traditional Chinese Medicine[J].West China Medicine，2004;19(1):2～3.
12.	滕東海，盧一平，王莉，李響，魏強，辛宇鵬，劉孝東，楊宇如.中醫藥治療慢性前列腺炎臨床隨機對照試驗的方法學質量評價[J].華西醫學，2004;19(1):2～3.
13.	［9］Wang T，Wu TX，Liu GJ.Quality assessment of randomized controlled trials on treating the unstable angina pectoris with Traditional Chinese Medicine[J].J Chengdu Univ of TCM，2003;26(2):52-55.
14.	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[J].成都中醫藥大學學報，2003;26(2):52～55.
15.	［10］Sun DZ，Xu L，Jiang LD，Wei PK.Quality assessment of clinical studies on treating the carcinoma of stomach with Traditional Chinese Medicine[J].Chinese Clinical Medicine.2003;10(6):833-835.
16.	孫大志，許玲，姜林娣，魏品康.中醫藥治療胃癌臨床研究文獻質量的調查評價[J].中國臨床醫學，2003;10(6):833～835.
17.	［11］Wang XK，Cui XJ，Qiu YQ.Studies of quality of clinical studies on treating the chronic prostatitis with Traditional Chinese Medicine[J].Chinese Journal of TCM information，2001;8(1):82-83.
18.	王璽坤，崔學教，邱云橋.中醫藥治療慢性前列腺炎臨床研究文獻質量的調查研究[J].中國中醫藥信息雜志，2001;8(1):82～83.
19.	［12］Mao ZF，Yu MJ，Bi YY.Comment s on the Methodological Quality of Drug Therapeutic Concurrent Controlled Trials[J].Hunan Medicine，2000;17(6):401-403.
20.	毛宗福，余鳴嬌，畢勇毅.藥物防治性同期對照試驗論著的方法學質量評價[J].湖南醫學，2000;17(6):401～403.
21.	［13］Yu MJ，Bi YY，Mao ZF，He L.Investigation on the quality of the treaties about clinical medical treatment trials[J].Medicine and Society，2001;14(3):59-61.
22.	余鳴嬌，畢勇毅，毛宗福，何立.臨床藥物治療性研究論著質量的調查[J].醫學與社會，2001;14(3):59～61.
23.	［14］Ran XW，Li N，Liu Y.Methodological Evaluation of Randomized Controlled Trials of Diabetic Peripheral Neuropathy Treatment by Chinese Medicine Herb.West China Medicine，2003;18(3):299-301.
24.	冉興無，李寧，劉雅.中醫藥治療糖尿病患者周圍神經病變臨床隨機對照試驗的方法學質量評估[J].華西醫學，2003;18(3):299～301.
25.	［15］Guo XF，Lai SL，Yang XB，Li XT，Wen ZH，Liang WX.Quality Evaluation and Analysis of the Therapeutic Literature of Traditional Chinese Medicine on stroke[J].J Guangzhou Univ TCM，2000;17(1):15-19.
26.	郭新峰，賴世隆，楊小波，李先濤，溫澤淮，梁偉雄.中醫藥治療中風研究文獻的質量評價[J].廣州中醫藥大學學報.2000;17(1):15～19.
27.	［16］Zhang Y，Mao B，Li TQ.Assessment of the Thesis on Clinical Research in Shanghai Journal of Traditional Chinese Medicine[J].Shanghai J TCM，2000;34(11):46-48.
28.	張穎，毛兵，李廷謙.<上海中醫藥雜志>臨床治療研究論文評價[J].上海中醫藥雜志.2000;34(11):46～48.
29.	［17］Huang ZW，Yu YC，Wang L，Mao B.Evaluation of the Randomized Controlled Trials Papers Published in Jiangsu Journal of Traditional Chinese Medicine from 1980 to 1998[J].West China Medicine，2001;16(3):257-258.
30.	黃宗文，于迎春，王蕾，毛兵.<江蘇中醫>隨機對照臨床治療試驗文獻評價1980-1998手檢分析[J].華西醫學.2001;16(3):257～258.
31.	［18］Nicolucci A; Grilli R; Alexanian AA，Apolone G，Torri V，Liberati.A.Quality，.
32.	evolution，and clinical implications of randomized，controlled trials on the treatment of lung cancer.A lost opportunity for meta-analysis[J].JAMA，1989 ; 262(15):2 101-2 107.
33.	［19］Powe NR，Kinnison ML，Steinberg EP.Quality assessment of randomized controlled trials of contrast media[J].Radiology.1989 ; 170(2):377-380.
34.	［20］S.Marsoni，W.Torri，A.Taiana，A.Gambino，R.Grilli，P.Liati，M.G.Franzosi，V.Pistotti，F.Parazzini，F.Focarile.Critical review of the quality and development of randomized clinical trials (RCTs) and their influence on the treatment of advanced epithelial ovarian cancer[J].Ann Oncol.1990 ; 1(5):343-350.
35.	［21］Koes BW，Bouter LM，vander Heijden GJ.Methodological quality of randomized clinical trials on treatment efficacy in low back pain[J].Spine.1995; 20(2):228-235.
36.	［22］Egglin TK，Horwitz RI.The case for better research standards in peripheral thrombolysis:poor quality of randomized trials during the past decade[J].Acad-Radiol.1996 ; 3(1):1-9.
37.	［23］Lent V，Langenbach A.A retrospective quality analysis of 102 randomized trials in four leading urological journals from 1984-1989[J].Urol-Res.1996; 24(2):119-122.
38.	［24］Begg C，Cho M，Eastwood S，Horton R，Moher D，Olkin I，Pitkin R，Rennie D，Schulz KF，Simel D，Stroup DF.Improving the quality of reporting of randomized controlled trials.The CONSORT statement[J].JAMA.1996; 276(8):637-639.
39.	［25］Moher D，Jadad AR，Tugwell P.Assessing the quality of randomized controlled trials.Current issues and future directions[J].Int J Technol Assess Health Care.1996; 12(2):195-208.

1. ［1］Moher D，Pham B，Jones A，Cook DJ，Jaded AR，Moher M，Tugwell P.Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses[J].Lancet，1998; 352(9 128):609-613.
2. ［2］Moher D，Jadad AR，Nichol G，Penman M，Tugwell P，Walsh S.Assessing the quality of randomized controlled trials:an annotated bibliography of scales and checklists[J].Control Clin Trials，1995; 21(16):62-73.
3. ［3］Jadad AR，Moore RA，Carroll D，Jenkinson C，ReynoldsDJ，Gavaghan DJ，McQuay HJ.Assessing the quality of reports of randomized clinical trials:Is blinding necessary[J].Control Clin Trials，1996，12(17):1-12.
4. ［4］Chalmers TC，Smith H，Blackburn B，Silverman B，Schroeder B，Reitman D，Ambroz A.A method for assessing the quality of a randomized control trial[J].Controlled Clin Trials，1981;2(3):31-49.
5. ［5］Ma B.Quality analysis and recommendations of randomized controlled trials on treating Alzheimer’s Disease by Traditional Chinese Medicine[J].Traditional Chinese Medicine Journal of Liaonin Province，2004.31(3):203-204.
6. 馬斌.中醫藥治療老年癡呆-隨機對照資料的質量分析和建議[J].遼寧中醫雜志，2004.31(3):203～204.
7. ［6］Liu JP，Ling TJ，Assessment of the clinical literatures on treating the viral hepatitis in recent eight years[J].Journal of Disease Control，1998;2(3):188-190.
8. 劉建平，冷泰俊.病毒性肝炎臨床治療試驗八年文獻評價[J].疾病控制雜志，1998;2(3):188～190.
9. ［7］Wang X，Liu Q，Yue XQ，Hou FG，Deng WZ，Gu W，Shen XB.Quality assessment of clinical studies on treating the primary carcinoma of liver with Traditional Chinese Medicine[J].Traditional Chinese Medicine Journal of Hunan College，2003;23(4):50-52.
10. 王喜，劉慶，岳小強，侯鳳剛，鄧偉哲，顧偉，沈旭波.對中醫藥治療原發性肝癌臨床研究的方法學評價[J].湖南中醫學院學報，2003;23(4):50～52.
11. ［8］Teng DH，Lu YP，Wang L，Li X，Wei Q，Xin YP，Liu XD，Yang YR.Quality assessment of clinical studies on treating the chronic prostatitis with Traditional Chinese Medicine[J].West China Medicine，2004;19(1):2～3.
12. 滕東海，盧一平，王莉，李響，魏強，辛宇鵬，劉孝東，楊宇如.中醫藥治療慢性前列腺炎臨床隨機對照試驗的方法學質量評價[J].華西醫學，2004;19(1):2～3.
13. ［9］Wang T，Wu TX，Liu GJ.Quality assessment of randomized controlled trials on treating the unstable angina pectoris with Traditional Chinese Medicine[J].J Chengdu Univ of TCM，2003;26(2):52-55.
14. 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[J].成都中醫藥大學學報，2003;26(2):52～55.
15. ［10］Sun DZ，Xu L，Jiang LD，Wei PK.Quality assessment of clinical studies on treating the carcinoma of stomach with Traditional Chinese Medicine[J].Chinese Clinical Medicine.2003;10(6):833-835.
16. 孫大志，許玲，姜林娣，魏品康.中醫藥治療胃癌臨床研究文獻質量的調查評價[J].中國臨床醫學，2003;10(6):833～835.
17. ［11］Wang XK，Cui XJ，Qiu YQ.Studies of quality of clinical studies on treating the chronic prostatitis with Traditional Chinese Medicine[J].Chinese Journal of TCM information，2001;8(1):82-83.
18. 王璽坤，崔學教，邱云橋.中醫藥治療慢性前列腺炎臨床研究文獻質量的調查研究[J].中國中醫藥信息雜志，2001;8(1):82～83.
19. ［12］Mao ZF，Yu MJ，Bi YY.Comment s on the Methodological Quality of Drug Therapeutic Concurrent Controlled Trials[J].Hunan Medicine，2000;17(6):401-403.
20. 毛宗福，余鳴嬌，畢勇毅.藥物防治性同期對照試驗論著的方法學質量評價[J].湖南醫學，2000;17(6):401～403.
21. ［13］Yu MJ，Bi YY，Mao ZF，He L.Investigation on the quality of the treaties about clinical medical treatment trials[J].Medicine and Society，2001;14(3):59-61.
22. 余鳴嬌，畢勇毅，毛宗福，何立.臨床藥物治療性研究論著質量的調查[J].醫學與社會，2001;14(3):59～61.
23. ［14］Ran XW，Li N，Liu Y.Methodological Evaluation of Randomized Controlled Trials of Diabetic Peripheral Neuropathy Treatment by Chinese Medicine Herb.West China Medicine，2003;18(3):299-301.
24. 冉興無，李寧，劉雅.中醫藥治療糖尿病患者周圍神經病變臨床隨機對照試驗的方法學質量評估[J].華西醫學，2003;18(3):299～301.
25. ［15］Guo XF，Lai SL，Yang XB，Li XT，Wen ZH，Liang WX.Quality Evaluation and Analysis of the Therapeutic Literature of Traditional Chinese Medicine on stroke[J].J Guangzhou Univ TCM，2000;17(1):15-19.
26. 郭新峰，賴世隆，楊小波，李先濤，溫澤淮，梁偉雄.中醫藥治療中風研究文獻的質量評價[J].廣州中醫藥大學學報.2000;17(1):15～19.
27. ［16］Zhang Y，Mao B，Li TQ.Assessment of the Thesis on Clinical Research in Shanghai Journal of Traditional Chinese Medicine[J].Shanghai J TCM，2000;34(11):46-48.
28. 張穎，毛兵，李廷謙.<上海中醫藥雜志>臨床治療研究論文評價[J].上海中醫藥雜志.2000;34(11):46～48.
29. ［17］Huang ZW，Yu YC，Wang L，Mao B.Evaluation of the Randomized Controlled Trials Papers Published in Jiangsu Journal of Traditional Chinese Medicine from 1980 to 1998[J].West China Medicine，2001;16(3):257-258.
30. 黃宗文，于迎春，王蕾，毛兵.<江蘇中醫>隨機對照臨床治療試驗文獻評價1980-1998手檢分析[J].華西醫學.2001;16(3):257～258.
31. ［18］Nicolucci A; Grilli R; Alexanian AA，Apolone G，Torri V，Liberati.A.Quality，.
32. evolution，and clinical implications of randomized，controlled trials on the treatment of lung cancer.A lost opportunity for meta-analysis[J].JAMA，1989 ; 262(15):2 101-2 107.
33. ［19］Powe NR，Kinnison ML，Steinberg EP.Quality assessment of randomized controlled trials of contrast media[J].Radiology.1989 ; 170(2):377-380.
34. ［20］S.Marsoni，W.Torri，A.Taiana，A.Gambino，R.Grilli，P.Liati，M.G.Franzosi，V.Pistotti，F.Parazzini，F.Focarile.Critical review of the quality and development of randomized clinical trials (RCTs) and their influence on the treatment of advanced epithelial ovarian cancer[J].Ann Oncol.1990 ; 1(5):343-350.
35. ［21］Koes BW，Bouter LM，vander Heijden GJ.Methodological quality of randomized clinical trials on treatment efficacy in low back pain[J].Spine.1995; 20(2):228-235.
36. ［22］Egglin TK，Horwitz RI.The case for better research standards in peripheral thrombolysis:poor quality of randomized trials during the past decade[J].Acad-Radiol.1996 ; 3(1):1-9.
37. ［23］Lent V，Langenbach A.A retrospective quality analysis of 102 randomized trials in four leading urological journals from 1984-1989[J].Urol-Res.1996; 24(2):119-122.
38. ［24］Begg C，Cho M，Eastwood S，Horton R，Moher D，Olkin I，Pitkin R，Rennie D，Schulz KF，Simel D，Stroup DF.Improving the quality of reporting of randomized controlled trials.The CONSORT statement[J].JAMA.1996; 276(8):637-639.
39. ［25］Moher D，Jadad AR，Tugwell P.Assessing the quality of randomized controlled trials.Current issues and future directions[J].Int J Technol Assess Health Care.1996; 12(2):195-208.

《中國循證醫學雜志》

臨床試驗質量評價工具及其應用

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》

臨床試驗質量評價工具及其應用

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