39例仙灵骨葆胶囊不良反应/事件分析
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摘要
目的:分析仙灵骨葆胶囊所致不良反应/事件(ADR/ADE),为仙灵骨葆胶囊临床安全使用提供依据。方法:采用回顾性研究方法,收集北京市药品不良反应监测中心2004年1月～2017年9月收到的仙灵骨葆胶囊ADR/ADE报告39例,从患者因素、药品因素、发生时间、反应类型与临床表现等方面进行综合分析。结果:39例ADR/ADE中,男7例(17. 9%),女32例(82. 1%);患者平均年龄(60. 2±12. 2)岁; 27例ADR/ADE患者为正确用法用量,9例(23. 08%)超剂量使用,3例用药剂量不足;单用仙灵骨葆胶囊25例(64. 1%),联合其他药物14例(35. 9%)。39例ADR/ADE中肝损伤17例(43. 59%),其他消化系统损害12例(30. 77%);严重ADR/ADE 10例(25. 64%)。39例平均服用仙灵骨葆胶囊时间为(43. 62±57. 18) d;严重ADR/ADE患者平均用药时间为(85. 30±60. 92) d;肝损伤患者平均用药时间为(80. 18±57. 77) d。结论:仙灵骨葆胶囊广泛应用于临床,但也存在用药不当或不良反应情况,临床应用时应注意合理规范使用,辨证用药,加强监测,减少不良反应和事件的发生。
Objective: To analyze the adverse reactions/events( ADR/ADE) caused by Xianling Gubao capsules,and to provide the basis for clinical safe use of Xianling Gubao capsules. Methods: Totally 39 cases of ADR/ADE reports of Xianling Gubao capsules received by Beijing ADR Monitoring Center from January 2004 to September 2017 were collected. The factors of patients,drugs,occurrence time,reaction types and clinical manifestations were comprehensively analyzed with the retrospective study. Results: Of the 39 cases of ADR/ADE,7 were males( 17. 9%) and 32 were females( 82. 1%). The age of the patients ranged from 28 to 82 years,with an average age of( 60. 2 ± 12. 2) years and a median age of 60 years. Among the 39 cases of ADR/ADE,27 cases used 3 tablets/bid correctly,9 cases( 23. 08%) were with overdose and 3 cases were with insufficient dose; 25 cases( 64. 1%) used Xianling Gubao capsules alone and 14 cases( 35. 9%) were combined with other drugs. Among the 39 cases of ADR/ADE,17 cases( 43. 59%) had liver injury,12 cases( 30. 77%) had other digestive system damage,and 10 cases( 25. 64%) had severe ADR/ADE. The average administration time of Xianling Gubao capsules was( 43. 62 ± 57. 18) days in the 39 patients,( 85. 30 ± 60. 92) days in severe ADR/ADE patients and( 80. 18 ± 57. 77) days in liver injury patients. Conclusion: Xianling Gubao capsules are widely used in clinic,while there are still inappropriate use and adverse reactions. More attention should be payed to rational and standardized use of drugs in clinic,and monitoring should be strenghtened to reduce the occurrence of adverse reactions and events.
Objective: To analyze the adverse reactions/events( ADR/ADE) caused by Xianling Gubao capsules,and to provide the basis for clinical safe use of Xianling Gubao capsules. Methods: Totally 39 cases of ADR/ADE reports of Xianling Gubao capsules received by Beijing ADR Monitoring Center from January 2004 to September 2017 were collected. The factors of patients,drugs,occurrence time,reaction types and clinical manifestations were comprehensively analyzed with the retrospective study. Results: Of the 39 cases of ADR/ADE,7 were males( 17. 9%) and 32 were females( 82. 1%). The age of the patients ranged from 28 to 82 years,with an average age of( 60. 2 ± 12. 2) years and a median age of 60 years. Among the 39 cases of ADR/ADE,27 cases used 3 tablets/bid correctly,9 cases( 23. 08%) were with overdose and 3 cases were with insufficient dose; 25 cases( 64. 1%) used Xianling Gubao capsules alone and 14 cases( 35. 9%) were combined with other drugs. Among the 39 cases of ADR/ADE,17 cases( 43. 59%) had liver injury,12 cases( 30. 77%) had other digestive system damage,and 10 cases( 25. 64%) had severe ADR/ADE. The average administration time of Xianling Gubao capsules was( 43. 62 ± 57. 18) days in the 39 patients,( 85. 30 ± 60. 92) days in severe ADR/ADE patients and( 80. 18 ± 57. 77) days in liver injury patients. Conclusion: Xianling Gubao capsules are widely used in clinic,while there are still inappropriate use and adverse reactions. More attention should be payed to rational and standardized use of drugs in clinic,and monitoring should be strenghtened to reduce the occurrence of adverse reactions and events.
引文
1郑勇,高建美,龚其海.仙灵骨葆的药理作用和临床应用研究进展[J].中国新药与临床杂志,2018,37(1):1-5
2 Zhu HM,Qin L,Garnero P,et al.The first multicenterand randomized clinical trial of herbal Fufang for treatment ofpostmenopausal osteoporosis[J].Osteoporosis Int,2012,23(4):1317-1327
3垚淼鑫.2017年医药产业经济运行分析[DB/OL].(2018-05-01)[2018-06-23]http://www.sohu.com/a/230072027_564023
4原国家食品药品监督管理总局.国家食品药品监督总局提醒关注仙灵骨葆口服制剂的用药风险[EB/OL].(2016-12-08)[2017-02-12]http://www.sfda.gov.cn/WS01/CL1033/167183.html
5 The Uppsala Monitoring Centre.The use of the WHO-UMC system for standardised case causality assessment[EB/OL].(2018-03-18)[2018-09-25]https://www.who-umc.org/media/2768/standardised-case-causality-assessment.pdf
6原卫生部.药品不良反应报告和监测管理办法[S].2011
7张真.绝经后女性骨质疏松症相关问题研究[J].中国初级卫生保健,2007,21(6):44
8田忠林.我院2012~2013年度146例药物不良反应的分析研究[J].中国现代药物应用,2014,8(12):141-142
9张林.均匀设计结合多元回归分析用于淫羊藿对大鼠肝毒性的影响[J].中国实验方剂学杂志,2018,24(6):189-197
10徐建东,沈敏,李莹,等.某院160例药物不良反应报告分析[J].重庆医学,2012,41(14):1407-1408
11林红.151例临床药物不良反应报告[J].中国医院药学杂志,2007,27(7):156-157
12赵敏.骨康胶囊致药物性肝炎1例[J].中国药物警戒,2016,13(1):55-56
13 Nam SW,Baek JT,Lee DS,et al.A Case of Acute Cholestatic Hepatitis Associated with the Seeds of Psoralea corylifolia[J].Clin Toxicol(Phila),2005,43(6):589-591
14 Zhang Y,Li J,Chen Y,et al.The role of hepatic antioxidant capacity and hepatobiliary transporter in liver injury induced by isopsoralen in zebrafish larvae[J].Hum Exp Toxicol,2018,1(9):1-9
15 Cheung WI,Tse ML,Ngan T,et al.Liver injury associated with the use of Fructus Psoraleae(Bol-gol-zhee or Bu-gu-zhi)and its related proprietary medicine[J].Clin Toxicol,2009,47(7):683-685
16 Nam SW,Baek JT,Lee DS,et al.A case of acute cholestatic hepatitis associated with the seeds of Psoralea corylifolia(Boh-Gol-Zhee)[J].Clin Toxicol,2008,43(6):589-591
17马昆.中药引起的药物性肝损伤研究进展[J].光明中医,2015,30(4):907-911
18毕亚男.补骨脂水提物对小鼠的肝毒性及胆汁酸转运的影响[J].药物评价研究,2015,38(3):267-269
19尤力都孜·买买提,艾西木江·热甫卡提,阿布都吉力力·阿布都艾尼,等.补骨脂水提取物小鼠灌胃急性毒性及亚急性毒性试验研究[J].中国药理学通报,2007,33(1):147-148
20 Matsuda H,Kiyohara S,Sugimoto S,et al.Bioactive constituents from Chinese naturalmedicines.XXXIII.Inhibitors from the seeds of Psoralea corylifolia on production of nitric oxide in lipopolysaccharide-activated macrophages[J].Biol Pharm Bull,2009,32(1):147-149
21杜倩,王哲,运乃茹,等.仙灵骨葆胶囊致不良反应185例文献分析[J].中国药房,2017,28(27):3785-3787
22 Cheung WI,Tse ML,Ngan T,et al.Liver injury associated with the use of fructus psoraleae(Bol-gol-zhee or Buguzhi)and its related proprietarymedicine[J].Clin Toxicol,2009,47(7):683-685
23赵子婧,巩政,史少泽,等.补骨脂及其与甘草配伍单次给药大鼠的毒代动力学及肝肾毒性初探[J].中国中药杂志,2015,40(11):2221-2226
24张秀娟,曹慧琪,邢志华,等.补骨脂对小鼠肝细胞形态、肝功能及线粒体膜电位的影响[J].中成药,2014,36(1):160-162
25杨良芹,彭官良.仙灵骨葆胶囊致重度肝损害1例[J].中国药物警戒,2013,10(1):62-62
26程经华,蔡皓东.壮骨关节丸不良反应原因分析[J].药物不良反应杂志,2000,1(1):15-19
27宋捷,钟荣玲.中药肝毒性研究方法技术的新进展及其应用[J].中国中药杂志,2017,42(1):41-48
28章轶立.仙灵骨葆胶囊上市后用药安全性系统评价[J].中国中药杂志,2017,42(15):2845-2856
29杜倩,王哲,运乃茹,等.仙灵骨葆胶囊安全性系统评价[J].中国药业,2017,26(19):37-43
30王丹,贾德贤,李真真,等.淫羊藿的安全性评价与风险控制措施探讨[J].中国中药杂志,2019,44(8):1715-1723
31郑明节,周耘,吕小琴.仙灵骨葆胶囊与双氯芬酸钠缓释胶囊合用致肝衰竭1例[J].中国药物警戒,2014,11(8):507-508
2 Zhu HM,Qin L,Garnero P,et al.The first multicenterand randomized clinical trial of herbal Fufang for treatment ofpostmenopausal osteoporosis[J].Osteoporosis Int,2012,23(4):1317-1327
3垚淼鑫.2017年医药产业经济运行分析[DB/OL].(2018-05-01)[2018-06-23]http://www.sohu.com/a/230072027_564023
4原国家食品药品监督管理总局.国家食品药品监督总局提醒关注仙灵骨葆口服制剂的用药风险[EB/OL].(2016-12-08)[2017-02-12]http://www.sfda.gov.cn/WS01/CL1033/167183.html
5 The Uppsala Monitoring Centre.The use of the WHO-UMC system for standardised case causality assessment[EB/OL].(2018-03-18)[2018-09-25]https://www.who-umc.org/media/2768/standardised-case-causality-assessment.pdf
6原卫生部.药品不良反应报告和监测管理办法[S].2011
7张真.绝经后女性骨质疏松症相关问题研究[J].中国初级卫生保健,2007,21(6):44
8田忠林.我院2012~2013年度146例药物不良反应的分析研究[J].中国现代药物应用,2014,8(12):141-142
9张林.均匀设计结合多元回归分析用于淫羊藿对大鼠肝毒性的影响[J].中国实验方剂学杂志,2018,24(6):189-197
10徐建东,沈敏,李莹,等.某院160例药物不良反应报告分析[J].重庆医学,2012,41(14):1407-1408
11林红.151例临床药物不良反应报告[J].中国医院药学杂志,2007,27(7):156-157
12赵敏.骨康胶囊致药物性肝炎1例[J].中国药物警戒,2016,13(1):55-56
13 Nam SW,Baek JT,Lee DS,et al.A Case of Acute Cholestatic Hepatitis Associated with the Seeds of Psoralea corylifolia[J].Clin Toxicol(Phila),2005,43(6):589-591
14 Zhang Y,Li J,Chen Y,et al.The role of hepatic antioxidant capacity and hepatobiliary transporter in liver injury induced by isopsoralen in zebrafish larvae[J].Hum Exp Toxicol,2018,1(9):1-9
15 Cheung WI,Tse ML,Ngan T,et al.Liver injury associated with the use of Fructus Psoraleae(Bol-gol-zhee or Bu-gu-zhi)and its related proprietary medicine[J].Clin Toxicol,2009,47(7):683-685
16 Nam SW,Baek JT,Lee DS,et al.A case of acute cholestatic hepatitis associated with the seeds of Psoralea corylifolia(Boh-Gol-Zhee)[J].Clin Toxicol,2008,43(6):589-591
17马昆.中药引起的药物性肝损伤研究进展[J].光明中医,2015,30(4):907-911
18毕亚男.补骨脂水提物对小鼠的肝毒性及胆汁酸转运的影响[J].药物评价研究,2015,38(3):267-269
19尤力都孜·买买提,艾西木江·热甫卡提,阿布都吉力力·阿布都艾尼,等.补骨脂水提取物小鼠灌胃急性毒性及亚急性毒性试验研究[J].中国药理学通报,2007,33(1):147-148
20 Matsuda H,Kiyohara S,Sugimoto S,et al.Bioactive constituents from Chinese naturalmedicines.XXXIII.Inhibitors from the seeds of Psoralea corylifolia on production of nitric oxide in lipopolysaccharide-activated macrophages[J].Biol Pharm Bull,2009,32(1):147-149
21杜倩,王哲,运乃茹,等.仙灵骨葆胶囊致不良反应185例文献分析[J].中国药房,2017,28(27):3785-3787
22 Cheung WI,Tse ML,Ngan T,et al.Liver injury associated with the use of fructus psoraleae(Bol-gol-zhee or Buguzhi)and its related proprietarymedicine[J].Clin Toxicol,2009,47(7):683-685
23赵子婧,巩政,史少泽,等.补骨脂及其与甘草配伍单次给药大鼠的毒代动力学及肝肾毒性初探[J].中国中药杂志,2015,40(11):2221-2226
24张秀娟,曹慧琪,邢志华,等.补骨脂对小鼠肝细胞形态、肝功能及线粒体膜电位的影响[J].中成药,2014,36(1):160-162
25杨良芹,彭官良.仙灵骨葆胶囊致重度肝损害1例[J].中国药物警戒,2013,10(1):62-62
26程经华,蔡皓东.壮骨关节丸不良反应原因分析[J].药物不良反应杂志,2000,1(1):15-19
27宋捷,钟荣玲.中药肝毒性研究方法技术的新进展及其应用[J].中国中药杂志,2017,42(1):41-48
28章轶立.仙灵骨葆胶囊上市后用药安全性系统评价[J].中国中药杂志,2017,42(15):2845-2856
29杜倩,王哲,运乃茹,等.仙灵骨葆胶囊安全性系统评价[J].中国药业,2017,26(19):37-43
30王丹,贾德贤,李真真,等.淫羊藿的安全性评价与风险控制措施探讨[J].中国中药杂志,2019,44(8):1715-1723
31郑明节,周耘,吕小琴.仙灵骨葆胶囊与双氯芬酸钠缓释胶囊合用致肝衰竭1例[J].中国药物警戒,2014,11(8):507-508