注射用唑来膦酸药品不良反应文献及临床病例分析
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摘要
目的总结分析注射用唑来磷酸致药品不良反应发生(ADR)的规律和特点,为临床安全用药提供参考。方法收集我院2012年10月～2018年11月使用注射用唑来膦酸致ADR并上报至国家药品不良反应监测中心的病例报告;同时检索中国期刊网全文数据库、万方数据库以及维普中文期刊全文数据库中符合纳入标准的病例报道。将二者提取出的病例信息分别进行归纳分析。结果无论临床病例还是文献病例患者年龄主要分布在40岁以上,分别为91.14%和96.30%;所患疾病均为恶性肿瘤伴骨相关疾病,肿瘤原发病灶以肺癌和乳腺癌居多。临床病例中ADR累及系统-器官以全身性反应的最多(78.57%),文献报道则以骨骼肌肉系统居多(51.85%)。严重病例共收集到28例,除1例来自临床病例外,其余27例均来自文献,其中用药后发生颌骨坏死的严重病例有13例,用药后死亡病例1例。结论该药急性期ADR多数转归良好,应警惕其可能发生的延迟性严重不良反应,特别是罕见的颌骨坏死反应,建议用药后加强ADR监测,促进临床用药安全。
Objective To summarize and analyze the regularity and characteristics of adverse drug reactions(ADR) in clinical use of zoledronic acid injection, so as to provide reference for clinical safe medication. Methods Cases of ADR induced by the use of zoledronic acid injection and reported to the national adverse drug reaction monitoring center from October 2012 to November 2018 were included. At the same time articles in the CNKI database, Wanfang database and VIP Chinese full-text database were searched, and the patients in the references which met the inclusion criteria were extracted. Then the ADR information of the patients both from the hospital and the literatures were analyzed together. Results The age of patients in both clinical cases and literature cases was mainly over 40 years old, accounting for 91.14% and 96.30% of all patients with medication respectively. All the patients suffered from malignant tumor with bone related diseases, and the primary tumor lesions were mainly lung cancer and breast cancer.In clinical cases, systemic response was the most involved organ/system of ADR(78.57%), while musculoskeletal system was the most reported(51.85%) in literature. A total of 28 severe cases were collected, except one from clinical cases,and the remaining 27 cases were all from literature. Among them, there were 13 severe cases of jaw necrosis and 1 death. Conclusion Most of ADR in the acute phase of this drug have achieved good results, and we should be alert to the possible delayed severe adverse reactions, especially the rare osteonecrosis of the jaw. It is suggested that ADR monitoring should be strengthened during the period of medication to promote the safety of clinical drug use.
Objective To summarize and analyze the regularity and characteristics of adverse drug reactions(ADR) in clinical use of zoledronic acid injection, so as to provide reference for clinical safe medication. Methods Cases of ADR induced by the use of zoledronic acid injection and reported to the national adverse drug reaction monitoring center from October 2012 to November 2018 were included. At the same time articles in the CNKI database, Wanfang database and VIP Chinese full-text database were searched, and the patients in the references which met the inclusion criteria were extracted. Then the ADR information of the patients both from the hospital and the literatures were analyzed together. Results The age of patients in both clinical cases and literature cases was mainly over 40 years old, accounting for 91.14% and 96.30% of all patients with medication respectively. All the patients suffered from malignant tumor with bone related diseases, and the primary tumor lesions were mainly lung cancer and breast cancer.In clinical cases, systemic response was the most involved organ/system of ADR(78.57%), while musculoskeletal system was the most reported(51.85%) in literature. A total of 28 severe cases were collected, except one from clinical cases,and the remaining 27 cases were all from literature. Among them, there were 13 severe cases of jaw necrosis and 1 death. Conclusion Most of ADR in the acute phase of this drug have achieved good results, and we should be alert to the possible delayed severe adverse reactions, especially the rare osteonecrosis of the jaw. It is suggested that ADR monitoring should be strengthened during the period of medication to promote the safety of clinical drug use.
引文
[1]唐文军,朱益平,吴跃文,等.唑来膦酸联合化疗治疗31例肿瘤骨转移性疼痛[J].皖南医学院学报,2010,(6):417-419.
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[3]Reid I R,Gamble G D,Mesenbrink P,et al.Characterization of and risk factors for the acute-phase response after zoledronic acid[J].J Clin Endocrinol Metab,2010,95(9):4380-4387.
[4]车建华,杨保庆,杨玲玲,等.希罗达联合唑来膦酸治疗乳腺癌多发骨转移疗效观察[J].实用医学杂志,2012,28(6):979-981.
[5]叶文成,李莹,张波.双膦酸盐相关性颌骨坏死1例报告及文献复习[J].上海口腔医学,2012,21(3):354-358.
[6]章斌,田泾,金剑.唑来膦酸致多发性骨髓瘤患者下颌骨坏死1例报告与分析[J].上海医药,2017,38(19):3-5.
[7]陈菊仙,郭雪华,阮宏,等.唑来膦酸并发的上颌骨坏死2例报告[J].口腔颌面外科杂志,2012,22(5):378-380.
[8]盛璐,文建民,童昕.双磷酸盐相关性颌骨坏死1例报道及文献复习[J].广东牙病防治,2013,21(12):660-662.
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[10]刁晓洁,张立平,英杰,等.双磷酸盐相关上颌骨坏死:一例报道并文献复习[J].新疆医学,2014,44(9):116-118.
[11]王琴,秦燕,孙燕,等.唑来膦酸治疗膀胱癌骨转移致上颌骨坏死一例.中华医学杂志,2016,96(16):1303-1303.
[12]李冉,李宁.唑来膦酸相关下颌骨骨坏死病例报告1例及文献复习[J].西南军医,2012,14(6):921-922
[13]刘燕.唑来膦酸致骨髓炎4例[J].临床合理用药杂志,2018,11(7):39,42.
[14]戴月华,张海军.唑来膦酸加速肾功能损害引起死亡1例[J].中国药师,2006,9(9):814
[15]贾晓峰,刘莹莹.唑来膦酸致下颌骨疼痛一例[J].山西医药杂志,2014,43(7):845-845.
[16]张改英,李晓彦,刘永兰,等.唑来膦酸注射液治疗骨继发性恶性肿瘤致高热1例[J].中国保健营养,2018,28(11):290.
[17]肖玉芹,李莉.唑来膦酸致高热1例[J].当代临床医刊,2015,28(5):1682-1683.
[18]吴东媛,关尚为,刘铎,等.唑来膦酸致严重骨痛1例[C]//2014年中国临床药学学术年会暨第十届中国临床药师论坛论文集.2014:130-133.
[19]曹斌,曹国文,潘杰.临床药师参与唑来膦酸致全血细胞减少的会诊病例分析[J].药物资讯,2018,7(3):52-56.
[20]曹永红.唑来膦酸钠注射剂致低钙血症2例[J].中国药师,2007,10(4):372.
[21]王颖轶,管梅,白春梅,等.唑来膦酸钠静脉注射导致低钙血症一例[J].中国肿瘤临床与康复,2013,20(12):1429-1430.
[22]曾俊权,刘彬,方木水.唑来膦酸治疗肺癌骨转移出现全身皮疹的个案报告[J].赣南医学院学报,2016,36(3):431,433.
[23]张梁.唑来膦酸致患者过度兴奋1例[J].中南药学,2018,16(10):1500-1501.
[24]吴学勇,朱悦茗,谢芳.唑来膦酸治疗骨质疏松致严重皮疹一例[J].中国肿瘤临床与康复,2015,22(12):1527.
[25]杨麟.静脉给双膦酸盐类药物出现严重低钙血症[J].中国处方药,2004,29(8):78-80
[26]Ristow O,GerngroβC,Schwaiger M,et al.Is bone turnover of jawbone and its possible over suppression by bisphosphonates of etiologic importance in pathogenesis of bisphosphonate-related osteonecrosis?[J].Journal of Oral&Maxillofacial Surgery,2014,72(5):903-910.
[27]Patel V,Mcleod N M,Rogers S N,et al.Bisphosphonate osteonecrosis of the jaw-a literature of UK policies versus interational policies on bisphosphonates,risk factors and precention[J].Br J Oral Maxillofac Sufg,2011,49(4):251-257.
[28]Hoff A O,Toth B B,Altundag K,et al.Frequency and risk factors associated with osteonecrosis of the jaw in cancer patients treated with intravenous bisphosphonates[J].J Bone Miner Res,2008,23(6):826-836.
[29]Hoefert S,Schmitz I,Tannapfel A,et al.Importance of microcracks in etiology of bisphosphonate-related osteonecrosis of the jaw:a possible pathogenetic model of symptomatic and non-symptomatic osteonecrosis of the jaw based on scanning electron microscopy findings[J].Clin Oral Invertig,2010,14(3):271-284.
[30]Allen M R,Burr D B.The pathogenesis of bisphosphonate-related osteonecrosis of the jaw:so many hypotheses,so few data[J].JOral Maxillofac Surg,2009,67(5 Suppl):61-70.
[31]Orwoll E,Blank J B,Barret T-Connor E,et al.Design and baseline characteristics of the osteoporotic fractures in men(MrOS)study-a large observational study of the determinants of fracture in oldermen[J].Contemp Clin Trials,2005,26(5):569-585.
[32]Berenson J,Hirschberg R.Safety and convenience of a 15-minute infusion of zoledronic acid[J].Oncologist,2009,9(3):319-329.
[33]Dicuonzo G,Vincenzi B,Santini D,et al.Fever after zoledronic acid administration is due to increase in TNF-alpha and IL-6[J].JInterferon Cytokine Res,2003,23(11):649-654.
[34]李妹英,柴华,甘海洁,等.89SrCl2联合唑来膦酸治疗骨转移瘤的临床护理[J].大家健康(上旬版),2017,(12):238-239.
[35]陆琳松,旭合热提·吾提库尔,哈巴西·卡肯,等.唑来膦酸对维吾尔族绝经后妇女骨质疏松性骨折骨代谢指标的影响[J].中国骨科临床与基础研究杂志,2013,5(3):138-142.
[36]黄红霞.唑来膦酸治疗恶性肿瘤骨转移不良反应护理体会[J].中国现代医药杂志,2013(5):104-105.
[37]王芳芳,陈维红.我院417例ADR报告分析[J].中国药房,2015,26(8):1093-1095.
[2]Alegre A,Gironella M,Bailen A,et al.Zoledronic acid in the management of bone disease as a consequence of multiple myeloma:a review[J].Eur J Haemato,2014,92(3):181-188.
[3]Reid I R,Gamble G D,Mesenbrink P,et al.Characterization of and risk factors for the acute-phase response after zoledronic acid[J].J Clin Endocrinol Metab,2010,95(9):4380-4387.
[4]车建华,杨保庆,杨玲玲,等.希罗达联合唑来膦酸治疗乳腺癌多发骨转移疗效观察[J].实用医学杂志,2012,28(6):979-981.
[5]叶文成,李莹,张波.双膦酸盐相关性颌骨坏死1例报告及文献复习[J].上海口腔医学,2012,21(3):354-358.
[6]章斌,田泾,金剑.唑来膦酸致多发性骨髓瘤患者下颌骨坏死1例报告与分析[J].上海医药,2017,38(19):3-5.
[7]陈菊仙,郭雪华,阮宏,等.唑来膦酸并发的上颌骨坏死2例报告[J].口腔颌面外科杂志,2012,22(5):378-380.
[8]盛璐,文建民,童昕.双磷酸盐相关性颌骨坏死1例报道及文献复习[J].广东牙病防治,2013,21(12):660-662.
[9]秦铁军,杨舟,徐泽锋,等.唑来膦酸钠致多发性骨髓瘤患者下颌骨坏死一例[J].中华血液学杂志,2008,29(10):714.
[10]刁晓洁,张立平,英杰,等.双磷酸盐相关上颌骨坏死:一例报道并文献复习[J].新疆医学,2014,44(9):116-118.
[11]王琴,秦燕,孙燕,等.唑来膦酸治疗膀胱癌骨转移致上颌骨坏死一例.中华医学杂志,2016,96(16):1303-1303.
[12]李冉,李宁.唑来膦酸相关下颌骨骨坏死病例报告1例及文献复习[J].西南军医,2012,14(6):921-922
[13]刘燕.唑来膦酸致骨髓炎4例[J].临床合理用药杂志,2018,11(7):39,42.
[14]戴月华,张海军.唑来膦酸加速肾功能损害引起死亡1例[J].中国药师,2006,9(9):814
[15]贾晓峰,刘莹莹.唑来膦酸致下颌骨疼痛一例[J].山西医药杂志,2014,43(7):845-845.
[16]张改英,李晓彦,刘永兰,等.唑来膦酸注射液治疗骨继发性恶性肿瘤致高热1例[J].中国保健营养,2018,28(11):290.
[17]肖玉芹,李莉.唑来膦酸致高热1例[J].当代临床医刊,2015,28(5):1682-1683.
[18]吴东媛,关尚为,刘铎,等.唑来膦酸致严重骨痛1例[C]//2014年中国临床药学学术年会暨第十届中国临床药师论坛论文集.2014:130-133.
[19]曹斌,曹国文,潘杰.临床药师参与唑来膦酸致全血细胞减少的会诊病例分析[J].药物资讯,2018,7(3):52-56.
[20]曹永红.唑来膦酸钠注射剂致低钙血症2例[J].中国药师,2007,10(4):372.
[21]王颖轶,管梅,白春梅,等.唑来膦酸钠静脉注射导致低钙血症一例[J].中国肿瘤临床与康复,2013,20(12):1429-1430.
[22]曾俊权,刘彬,方木水.唑来膦酸治疗肺癌骨转移出现全身皮疹的个案报告[J].赣南医学院学报,2016,36(3):431,433.
[23]张梁.唑来膦酸致患者过度兴奋1例[J].中南药学,2018,16(10):1500-1501.
[24]吴学勇,朱悦茗,谢芳.唑来膦酸治疗骨质疏松致严重皮疹一例[J].中国肿瘤临床与康复,2015,22(12):1527.
[25]杨麟.静脉给双膦酸盐类药物出现严重低钙血症[J].中国处方药,2004,29(8):78-80
[26]Ristow O,GerngroβC,Schwaiger M,et al.Is bone turnover of jawbone and its possible over suppression by bisphosphonates of etiologic importance in pathogenesis of bisphosphonate-related osteonecrosis?[J].Journal of Oral&Maxillofacial Surgery,2014,72(5):903-910.
[27]Patel V,Mcleod N M,Rogers S N,et al.Bisphosphonate osteonecrosis of the jaw-a literature of UK policies versus interational policies on bisphosphonates,risk factors and precention[J].Br J Oral Maxillofac Sufg,2011,49(4):251-257.
[28]Hoff A O,Toth B B,Altundag K,et al.Frequency and risk factors associated with osteonecrosis of the jaw in cancer patients treated with intravenous bisphosphonates[J].J Bone Miner Res,2008,23(6):826-836.
[29]Hoefert S,Schmitz I,Tannapfel A,et al.Importance of microcracks in etiology of bisphosphonate-related osteonecrosis of the jaw:a possible pathogenetic model of symptomatic and non-symptomatic osteonecrosis of the jaw based on scanning electron microscopy findings[J].Clin Oral Invertig,2010,14(3):271-284.
[30]Allen M R,Burr D B.The pathogenesis of bisphosphonate-related osteonecrosis of the jaw:so many hypotheses,so few data[J].JOral Maxillofac Surg,2009,67(5 Suppl):61-70.
[31]Orwoll E,Blank J B,Barret T-Connor E,et al.Design and baseline characteristics of the osteoporotic fractures in men(MrOS)study-a large observational study of the determinants of fracture in oldermen[J].Contemp Clin Trials,2005,26(5):569-585.
[32]Berenson J,Hirschberg R.Safety and convenience of a 15-minute infusion of zoledronic acid[J].Oncologist,2009,9(3):319-329.
[33]Dicuonzo G,Vincenzi B,Santini D,et al.Fever after zoledronic acid administration is due to increase in TNF-alpha and IL-6[J].JInterferon Cytokine Res,2003,23(11):649-654.
[34]李妹英,柴华,甘海洁,等.89SrCl2联合唑来膦酸治疗骨转移瘤的临床护理[J].大家健康(上旬版),2017,(12):238-239.
[35]陆琳松,旭合热提·吾提库尔,哈巴西·卡肯,等.唑来膦酸对维吾尔族绝经后妇女骨质疏松性骨折骨代谢指标的影响[J].中国骨科临床与基础研究杂志,2013,5(3):138-142.
[36]黄红霞.唑来膦酸治疗恶性肿瘤骨转移不良反应护理体会[J].中国现代医药杂志,2013(5):104-105.
[37]王芳芳,陈维红.我院417例ADR报告分析[J].中国药房,2015,26(8):1093-1095.