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華西醫(yī)學(xué)期刊出版社

《中國循證醫(yī)學(xué)雜志》

《中國循證醫(yī)學(xué)雜志》

主管：中華人民共和國教育部主辦：四川大學(xué)
主編：李幼平
刊期：月刊 ISSN：1672-2531 CN：51–1656/R

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您的位置：中國循證醫(yī)學(xué)雜志  2004, 7  文章全文

臨床試驗質(zhì)量評價工具及其應(yīng)用

來源期刊：中國循證醫(yī)學(xué)雜志 | 2004, 04(7): 484-487
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作者：

郭新峰 ¹ , 溫澤淮 ¹ , 老膺榮 ² , 賴世隆 ¹

1. 廣州中醫(yī)藥大學(xué)DME中心，廣州，5104052. 廣州中醫(yī)藥大學(xué)第二附屬醫(yī)院(廣東省中醫(yī)院)臨床流行病學(xué)應(yīng)用研究室;

關(guān)鍵詞：

臨床試驗方法學(xué) 評價工具

視頻：

導(dǎo)出 下載 收藏 掃碼 引用

摘要 全文 圖表 視頻 參考文獻 施引文獻 補充材料

闡述國內(nèi)外臨床試驗質(zhì)量評價工具的產(chǎn)生背景與應(yīng)用現(xiàn)狀，介紹國內(nèi)外常用的評價表，并對該領(lǐng)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(zhì)量評價工具及其應(yīng)用. 中國循證醫(yī)學(xué)雜志, 2004, 04(7): 484-487. doi: 復(fù)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(yī)藥治療老年癡呆-隨機對照資料的質(zhì)量分析和建議[J].遼寧中醫(yī)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(yī)藥治療原發(fā)性肝癌臨床研究的方法學(xué)評價[J].湖南中醫(yī)學(xué)院學(xué)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(yī)藥治療慢性前列腺炎臨床隨機對照試驗的方法學(xué)質(zhì)量評價[J].華西醫(yī)學(xué)，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(guān)鍵.關(guān)于不穩(wěn)定型心絞痛的中醫(yī)藥臨床隨機對照試驗質(zhì)量的評價[J].成都中醫(yī)藥大學(xué)學(xué)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(yī)藥治療胃癌臨床研究文獻質(zhì)量的調(diào)查評價[J].中國臨床醫(yī)學(xué)，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(xué)教，邱云橋.中醫(yī)藥治療慢性前列腺炎臨床研究文獻質(zhì)量的調(diào)查研究[J].中國中醫(yī)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(xué)質(zhì)量評價[J].湖南醫(yī)學(xué)，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(zhì)量的調(diào)查[J].醫(yī)學(xué)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(yī)藥治療糖尿病患者周圍神經(jīng)病變臨床隨機對照試驗的方法學(xué)質(zhì)量評估[J].華西醫(yī)學(xué)，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(yī)藥治療中風(fēng)研究文獻的質(zhì)量評價[J].廣州中醫(yī)藥大學(xué)學(xué)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(yī)藥雜志>臨床治療研究論文評價[J].上海中醫(yī)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(yī)>隨機對照臨床治療試驗文獻評價1980-1998手檢分析[J].華西醫(yī)學(xué).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(xiàn).Parazzini，F(xiàn).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(yī)藥治療老年癡呆-隨機對照資料的質(zhì)量分析和建議[J].遼寧中醫(yī)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(yī)藥治療原發(fā)性肝癌臨床研究的方法學(xué)評價[J].湖南中醫(yī)學(xué)院學(xué)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(yī)藥治療慢性前列腺炎臨床隨機對照試驗的方法學(xué)質(zhì)量評價[J].華西醫(yī)學(xué)，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(guān)鍵.關(guān)于不穩(wěn)定型心絞痛的中醫(yī)藥臨床隨機對照試驗質(zhì)量的評價[J].成都中醫(yī)藥大學(xué)學(xué)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(yī)藥治療胃癌臨床研究文獻質(zhì)量的調(diào)查評價[J].中國臨床醫(yī)學(xué)，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(xué)教，邱云橋.中醫(yī)藥治療慢性前列腺炎臨床研究文獻質(zhì)量的調(diào)查研究[J].中國中醫(yī)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(xué)質(zhì)量評價[J].湖南醫(yī)學(xué)，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(zhì)量的調(diào)查[J].醫(yī)學(xué)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(yī)藥治療糖尿病患者周圍神經(jīng)病變臨床隨機對照試驗的方法學(xué)質(zhì)量評估[J].華西醫(yī)學(xué)，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(yī)藥治療中風(fēng)研究文獻的質(zhì)量評價[J].廣州中醫(yī)藥大學(xué)學(xué)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(yī)藥雜志>臨床治療研究論文評價[J].上海中醫(yī)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(yī)>隨機對照臨床治療試驗文獻評價1980-1998手檢分析[J].華西醫(yī)學(xué).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(xiàn).Parazzini，F(xiàn).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.

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