中药上市后安全性医院集中监测技术规范(征求意见稿)
[7] 中国药典. 一部[S]. 2010.
[8] Hurwitz N, Wade O L. Intensive hospital monitoring of adverse reactions to drugs [J]. Bri Med J, 1969, 1(5643): 531.
[9] 王家良. 临床流行病学[M]. 北京:人民卫生出版社, 2008:126.
[10] 《药品不良反应报告和监测管理办法》(中华人民共和国卫生部令81号)[EB/OL].[2011-05-04]. http://www.moh.gov.cn/mohzcfgs/pgz/201105/51770.shtml.
[11] Tubert-Bitter P, Begaud B, Moride Y, et al. Sample size calculations for single groups postmarketing cohort studies[J]. J Clin Epidemiol,1994,47:435.
, 百拇医药
[12] Wu Y Te, Makuch R W. Detecting rare adverse events in post-marketing studies: sample size considerations[J]. Drug Inform J,2006(40):87.
[13] 任德全, 张伯礼, 翁维良. 中药注射剂临床应用指南[M]. 北京:人民卫生出版社, 2011.
[14] Sampson H A, Muoz-Furlong A, Campbell R L, et al. Second symposium on the definition and management of anaphylaxis: summary report——second national institute of allergy and infectious disease/food allergy and anaphylaxis network symposium[J]. J Allergy Clin Immunol, 2006,117(2):391.
, 百拇医药
[15] 戴自英, 陈灏珠, 林果为. 实用内科学[M]. 北京:人民卫生出版社, 2009.
[16] World Medical Association. World medical association declaration of helsinki: ethical principles for medical research involving human subjects[J]. 中国结合医学杂志:英文版, 2001(3):10.
[17] 卜擎燕,熊宁宁,吴静.人体生物医学研究国际道德指南[J].中国临床药理学与治疗学,2003,8(1):107.
Technical specifications for intensive hospital safety monitoring of
post-marketing Chinese medicine(draft version for comments)
, http://www.100md.com
XIE Yan-ming1, LIAO Xing1*, ZHAO Yu-bin1,2, LI Ming-quan1,3, ZHANG Yun-ling4, MA Rong5, XIAN Shao-xiang6,LIU Jian7, LI Su-yun8, WEN Ze-huai9, YANG Zhong-qi6, ZOU Jian-dong10, SUN Hong-sheng11,HE Yan12, LI Xue-lin8, JIANG Jun-jie1, WANG Zhi-fei1, LI Yuan-yuan1, WANG Lian-xin1, CHANG Yan-peng1,YANG Wei1, ZHANG Wen1
(1. Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
2. Traditional Chinese Medicine Hospital of Shijiazhuang Affiliated to Hebei Medical University, Shijiazhuang 050051, China;
, 百拇医药
3.The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun 130021, China;
4. Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China;
5. The First Affiliated Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;
6. The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China;
7. The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230031, China;, 百拇医药(谢雁鸣 廖星 赵玉斌 黎明全 张允岭 马融 冼绍祥 刘健 李素云 温泽淮 杨忠奇)
[8] Hurwitz N, Wade O L. Intensive hospital monitoring of adverse reactions to drugs [J]. Bri Med J, 1969, 1(5643): 531.
[9] 王家良. 临床流行病学[M]. 北京:人民卫生出版社, 2008:126.
[10] 《药品不良反应报告和监测管理办法》(中华人民共和国卫生部令81号)[EB/OL].[2011-05-04]. http://www.moh.gov.cn/mohzcfgs/pgz/201105/51770.shtml.
[11] Tubert-Bitter P, Begaud B, Moride Y, et al. Sample size calculations for single groups postmarketing cohort studies[J]. J Clin Epidemiol,1994,47:435.
, 百拇医药
[12] Wu Y Te, Makuch R W. Detecting rare adverse events in post-marketing studies: sample size considerations[J]. Drug Inform J,2006(40):87.
[13] 任德全, 张伯礼, 翁维良. 中药注射剂临床应用指南[M]. 北京:人民卫生出版社, 2011.
[14] Sampson H A, Muoz-Furlong A, Campbell R L, et al. Second symposium on the definition and management of anaphylaxis: summary report——second national institute of allergy and infectious disease/food allergy and anaphylaxis network symposium[J]. J Allergy Clin Immunol, 2006,117(2):391.
, 百拇医药
[15] 戴自英, 陈灏珠, 林果为. 实用内科学[M]. 北京:人民卫生出版社, 2009.
[16] World Medical Association. World medical association declaration of helsinki: ethical principles for medical research involving human subjects[J]. 中国结合医学杂志:英文版, 2001(3):10.
[17] 卜擎燕,熊宁宁,吴静.人体生物医学研究国际道德指南[J].中国临床药理学与治疗学,2003,8(1):107.
Technical specifications for intensive hospital safety monitoring of
post-marketing Chinese medicine(draft version for comments)
, http://www.100md.com
XIE Yan-ming1, LIAO Xing1*, ZHAO Yu-bin1,2, LI Ming-quan1,3, ZHANG Yun-ling4, MA Rong5, XIAN Shao-xiang6,LIU Jian7, LI Su-yun8, WEN Ze-huai9, YANG Zhong-qi6, ZOU Jian-dong10, SUN Hong-sheng11,HE Yan12, LI Xue-lin8, JIANG Jun-jie1, WANG Zhi-fei1, LI Yuan-yuan1, WANG Lian-xin1, CHANG Yan-peng1,YANG Wei1, ZHANG Wen1
(1. Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;
2. Traditional Chinese Medicine Hospital of Shijiazhuang Affiliated to Hebei Medical University, Shijiazhuang 050051, China;
, 百拇医药
3.The Affiliated Hospital to Changchun University of Chinese Medicine, Changchun 130021, China;
4. Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China;
5. The First Affiliated Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;
6. The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China;
7. The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230031, China;, 百拇医药(谢雁鸣 廖星 赵玉斌 黎明全 张允岭 马融 冼绍祥 刘健 李素云 温泽淮 杨忠奇)