喹诺酮类药物:修订间差异
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=== 肌肉骨骼系统 === |
=== 肌肉骨骼系统 === |
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* 肌腱:喹诺酮药物最严重的不良反应之一就是[[肌腱炎]]和肌腱断裂。在超过60岁的老人中,2%-6%的肌腱损伤与氟喹诺酮类药有关,同时使用激素会增加风险<ref>{{Cite journal |last=van der Linden |first=Paul D. |last2=Sturkenboom |first2=Miriam C. J. M. |last3=Herings |first3=Ron M. C. |last4=Leufkens |first4=Hubert M. G. |last5=Rowlands |first5=Sam |last6=Stricker |first6=Bruno H. Ch. |date=2003-08-11 |title=Increased Risk of Achilles Tendon Rupture With Quinolone Antibacterial Use, Especially in Elderly Patients Taking Oral Corticosteroids |url=http://archinte.jamanetwork.com/article.aspx?doi=10.1001/archinte.163.15.1801 |journal=Archives of Internal Medicine |language=en |volume=163 |issue=15 |doi=10.1001/archinte.163.15.1801 |issn=0003-9926}}</ref>。在高龄、合用激素、肾功能不全、既往肌腱病、缺镁、甲状旁腺功能亢进、利尿剂使用、周围血管疾病、类风湿性关节炎、糖尿病和剧烈运动等情形下,肌腱损害风险增加<ref>{{Cite journal |last=Gold |first=L. |last2=Igra |first2=H. |date=2003-09-01 |title=Levofloxacin-Induced Tendon Rupture: A Case Report and Review of the Literature |url=http://www.jabfm.org/cgi/doi/10.3122/jabfm.16.5.458 |journal=The Journal of the American Board of Family Medicine |language=en |volume=16 |issue=5 |doi=10.3122/jabfm.16.5.458 |issn=1557-2625}}</ref>。机制尚不完全清楚,可能与氧化应激、影响细胞外基质合成、缺血和影响成纤维细胞代谢<ref>{{Cite journal |last=Williams |first=Riley J. |last2=Attia |first2=Erik |last3=Wickiewicz |first3=Thomas L. |last4=Hannafin |first4=Jo A. |date=2000-05 |title=The Effect of Ciprofloxacin on Tendon, Paratenon, and Capsular Fibroblast Metabolism |url=http://journals.sagepub.com/doi/10.1177/03635465000280031401 |journal=The American Journal of Sports Medicine |language=en |volume=28 |issue=3 |doi=10.1177/03635465000280031401 |issn=0363-5465}}</ref><ref>{{Cite journal |last=Simonin |first=Marie-Agnes |last2=Gegout-Pottie |first2=Pascale |last3=Minn |first3=Alain |last4=Gillet |first4=Pierre |last5=Netter |first5=Patrick |last6=Terlain |first6=Bernard |date=2000-04 |title=Pefloxacin-Induced Achilles Tendon Toxicity in Rodents: Biochemical Changes in Proteoglycan Synthesis and Oxidative Damage to Collagen |url=https://journals.asm.org/doi/10.1128/AAC.44.4.867-872.2000 |journal=Antimicrobial Agents and Chemotherapy |language=en |volume=44 |issue=4 |doi=10.1128/AAC.44.4.867-872.2000 |issn=0066-4804 |pmc=89784 |pmid=10722483}}</ref>相关。 |
* 肌腱:喹诺酮药物最严重的不良反应之一就是[[肌腱炎]]和肌腱断裂。在超过60岁的老人中,2%-6%的肌腱损伤与氟喹诺酮类药有关,同时使用激素会增加风险<ref>{{Cite journal |last=van der Linden |first=Paul D. |last2=Sturkenboom |first2=Miriam C. J. M. |last3=Herings |first3=Ron M. C. |last4=Leufkens |first4=Hubert M. G. |last5=Rowlands |first5=Sam |last6=Stricker |first6=Bruno H. Ch. |date=2003-08-11 |title=Increased Risk of Achilles Tendon Rupture With Quinolone Antibacterial Use, Especially in Elderly Patients Taking Oral Corticosteroids |url=http://archinte.jamanetwork.com/article.aspx?doi=10.1001/archinte.163.15.1801 |journal=Archives of Internal Medicine |language=en |volume=163 |issue=15 |doi=10.1001/archinte.163.15.1801 |issn=0003-9926}}</ref>。在高龄、合用激素、肾功能不全、既往肌腱病、缺镁、甲状旁腺功能亢进、利尿剂使用、周围血管疾病、类风湿性关节炎、糖尿病和剧烈运动等情形下,肌腱损害风险增加<ref>{{Cite journal |last=Gold |first=L. |last2=Igra |first2=H. |date=2003-09-01 |title=Levofloxacin-Induced Tendon Rupture: A Case Report and Review of the Literature |url=http://www.jabfm.org/cgi/doi/10.3122/jabfm.16.5.458 |journal=The Journal of the American Board of Family Medicine |language=en |volume=16 |issue=5 |doi=10.3122/jabfm.16.5.458 |issn=1557-2625}}</ref>。机制尚不完全清楚,可能与氧化应激、影响细胞外基质合成、缺血和影响成纤维细胞代谢<ref>{{Cite journal |last=Williams |first=Riley J. |last2=Attia |first2=Erik |last3=Wickiewicz |first3=Thomas L. |last4=Hannafin |first4=Jo A. |date=2000-05 |title=The Effect of Ciprofloxacin on Tendon, Paratenon, and Capsular Fibroblast Metabolism |url=http://journals.sagepub.com/doi/10.1177/03635465000280031401 |journal=The American Journal of Sports Medicine |language=en |volume=28 |issue=3 |doi=10.1177/03635465000280031401 |issn=0363-5465}}</ref><ref>{{Cite journal |last=Simonin |first=Marie-Agnes |last2=Gegout-Pottie |first2=Pascale |last3=Minn |first3=Alain |last4=Gillet |first4=Pierre |last5=Netter |first5=Patrick |last6=Terlain |first6=Bernard |date=2000-04 |title=Pefloxacin-Induced Achilles Tendon Toxicity in Rodents: Biochemical Changes in Proteoglycan Synthesis and Oxidative Damage to Collagen |url=https://journals.asm.org/doi/10.1128/AAC.44.4.867-872.2000 |journal=Antimicrobial Agents and Chemotherapy |language=en |volume=44 |issue=4 |doi=10.1128/AAC.44.4.867-872.2000 |issn=0066-4804 |pmc=89784 |pmid=10722483}}</ref>相关。 |
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* 关节:由于在幼年动物的实验中出现[[關節骨|关节软骨]]受损<ref>{{Cite journal |last=Ingham |first=B. |last2=Brentnall |first2=D. W. |last3=Dale |first3=Eugenie A. |last4=McFadzean |first4=J. A. |date=1977-07-01 |title=Arthropathy induced by antibacterial fused N-alkyl-4-pyridone-3-carboxylic acids |url=https://www.sciencedirect.com/science/article/pii/0378427477900169 |journal=Toxicology Letters |volume=1 |issue=1 |doi=10.1016/0378-4274(77)90016-9 |issn=0378-4274}}</ref>,氟喹诺酮类未被批准用于 16 岁以下儿童(某些适应症,如[[囊性纤维化]]中[[假单胞菌属|假单胞菌]]感染除外,且临床实践中可能作为二线药物超说明书使用)<ref>{{cite web |url=https://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4399s1-06%20%28Levofloxacin%29.pdf |title=Adverse Event Review: Levaquin® (levofloxacin): Pediatric Advisory Committee Meeting |date=18 November 2008 |publisher=Food and Drug Administration |access-date=2023-10-21 |archive-date=2016-03-07 |archive-url=https://web.archive.org/web/20160307233555/https://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4399s1-06%20(Levofloxacin).pdf |dead-url=no }}</ref>。儿童的关节不良反应估计在 2%~3%,而成人发生率约为0.1%<ref>{{Cite journal |last=Gendrel |first=Dominique |last2=Chalumeau |first2=Martin |last3=Moulin |first3=Florence |last4=Raymond |first4=Josette |date=2003-09 |title=Fluoroquinolones in paediatrics: a risk for the patient or for the community? |url=https://linkinghub.elsevier.com/retrieve/pii/S1473309903007369 |journal=The Lancet Infectious Diseases |language=en |volume=3 |issue=9 |doi=10.1016/S1473-3099(03)00736-9}}</ref>。发病机制可能与氟喹诺酮[[络合]]镁离子、氧化应激等损伤软骨<ref>{{Cite journal |last=Pfister |first=Kerstin |last2=Mazur |first2=Dago |last3=Vormann |first3=Jürgen |last4=Stahlmann |first4=Ralf |date=2007-03 |title=Diminished Ciprofloxacin-Induced Chondrotoxicity by Supplementation with Magnesium and Vitamin E in Immature Rats |url=https://journals.asm.org/doi/10.1128/AAC.01175-06 |journal=Antimicrobial Agents and Chemotherapy |language=en |volume=51 |issue=3 |doi=10.1128/AAC.01175-06 |issn=0066-4804 |pmc=1803142 |pmid=17210779}}</ref><ref>{{Cite journal |last=Sendzik |first=Judith |last2=Lode |first2=Hartmut |last3=Stahlmann |first3=Ralf |date=2009-03-01 |title=Quinolone-induced arthropathy: an update focusing on new mechanistic and clinical data |url=https://www.sciencedirect.com/science/article/pii/S0924857908003531 |journal=International Journal of Antimicrobial Agents |volume=33 |issue=3 |doi=10.1016/j.ijantimicag.2008.08.004 |issn=0924-8579}}</ref>有关 。 |
* 关节:由于在幼年动物的实验中出现[[關節骨|关节软骨]]受损<ref>{{Cite journal |last=Ingham |first=B. |last2=Brentnall |first2=D. W. |last3=Dale |first3=Eugenie A. |last4=McFadzean |first4=J. A. |date=1977-07-01 |title=Arthropathy induced by antibacterial fused N-alkyl-4-pyridone-3-carboxylic acids |url=https://www.sciencedirect.com/science/article/pii/0378427477900169 |journal=Toxicology Letters |volume=1 |issue=1 |doi=10.1016/0378-4274(77)90016-9 |issn=0378-4274}}</ref>,氟喹诺酮类未被批准用于 16 岁以下儿童(某些适应症,如[[囊性纤维化]]中[[假单胞菌属|假单胞菌]]感染除外,且临床实践中可能作为二线药物超说明书使用)<ref>{{cite web |url=https://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4399s1-06%20%28Levofloxacin%29.pdf |title=Adverse Event Review: Levaquin® (levofloxacin): Pediatric Advisory Committee Meeting |date=18 November 2008 |publisher=Food and Drug Administration |access-date=2023-10-21 |archive-date=2016-03-07 |archive-url=https://web.archive.org/web/20160307233555/https://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4399s1-06%20(Levofloxacin).pdf |dead-url=no }}</ref>。儿童的关节不良反应估计在 2%~3%,而成人发生率约为0.1%<ref>{{Cite journal |last=Gendrel |first=Dominique |last2=Chalumeau |first2=Martin |last3=Moulin |first3=Florence |last4=Raymond |first4=Josette |date=2003-09 |title=Fluoroquinolones in paediatrics: a risk for the patient or for the community? |url=https://linkinghub.elsevier.com/retrieve/pii/S1473309903007369 |journal=The Lancet Infectious Diseases |language=en |volume=3 |issue=9 |doi=10.1016/S1473-3099(03)00736-9}}</ref>。发病机制可能与氟喹诺酮[[络合]]镁离子、氧化应激等损伤软骨<ref>{{Cite journal |last=Pfister |first=Kerstin |last2=Mazur |first2=Dago |last3=Vormann |first3=Jürgen |last4=Stahlmann |first4=Ralf |date=2007-03 |title=Diminished Ciprofloxacin-Induced Chondrotoxicity by Supplementation with Magnesium and Vitamin E in Immature Rats |url=https://journals.asm.org/doi/10.1128/AAC.01175-06 |journal=Antimicrobial Agents and Chemotherapy |language=en |volume=51 |issue=3 |doi=10.1128/AAC.01175-06 |issn=0066-4804 |pmc=1803142 |pmid=17210779}}</ref><ref>{{Cite journal |last=Sendzik |first=Judith |last2=Lode |first2=Hartmut |last3=Stahlmann |first3=Ralf |date=2009-03-01 |title=Quinolone-induced arthropathy: an update focusing on new mechanistic and clinical data |url=https://www.sciencedirect.com/science/article/pii/S0924857908003531 |journal=International Journal of Antimicrobial Agents |volume=33 |issue=3 |doi=10.1016/j.ijantimicag.2008.08.004 |issn=0924-8579}}</ref>有关 。 |
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=== 神经系统 === |
=== 神经系统 === |
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周围神经病变:迅速起病,可能永久损伤 |
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* [[周围神经病变]]:包括疼痛、感觉迟钝等。与给药时间有关,存在长期持续损害的风险<ref name=":2">{{Cite journal |last=Rusu |first=Aura |last2=Munteanu |first2=Alexandra-Cristina |last3=Arbănași |first3=Eliza-Mihaela |last4=Uivarosi |first4=Valentina |date=2023-03-01 |title=Overview of Side-Effects of Antibacterial Fluoroquinolones: New Drugs versus Old Drugs, a Step Forward in the Safety Profile? |url=https://www.mdpi.com/1999-4923/15/3/804 |journal=Pharmaceutics |language=en |volume=15 |issue=3 |doi=10.3390/pharmaceutics15030804 |issn=1999-4923 |pmc=PMC10056716 |pmid=36986665}}</ref>。原因在于阻断[[Γ-氨基丁酸|GABA]]受体<ref>{{Cite journal |last=Stahlmann |first=Ralf |last2=Lode |first2=Hartmut |date=1999 |title=Toxicity of Quinolones: |url=http://link.springer.com/10.2165/00003495-199958002-00007 |journal=Drugs |language=en |volume=58 |issue=Supplement 2 |doi=10.2165/00003495-199958002-00007 |issn=0012-6667}}</ref>。 |
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中枢神经系统毒性:资料很少。从轻度(头晕)、中度(意识模糊) 至重度(癫痫发作)都有。NSAID类药可能使其加重。 |
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* 中枢神经系统毒性与精神毒性:精神毒性包括躁狂、失眠、急性精神病、谵妄、以及自杀行为,神经系统不良反应包括大发作、意识模糊、惊厥和肌阵挛。机制同样可能与阻断GABA受体、激活[[NMDA受體|NMDA受体]]有关,此外,血清素水平降低、微小RNA表达改变和氧化应激也被认为是机制。<ref name=":2" /> |
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* [[重症肌無力|重症肌无力]]:氟喹诺酮类药物可能加重重症肌无力患者的肌无力症状<ref>{{Cite journal |last=Jones |first=S. Christopher |last2=Sorbello |first2=Alfred |last3=Boucher |first3=Robert M. |date=2011-10-01 |title=Fluoroquinolone-Associated Myasthenia Gravis Exacerbation |url=https://doi.org/10.2165/11593110-000000000-00000 |journal=Drug Safety |language=en |volume=34 |issue=10 |doi=10.2165/11593110-000000000-00000 |issn=1179-1942}}</ref>。 |
* [[重症肌無力|重症肌无力]]:氟喹诺酮类药物可能加重重症肌无力患者的肌无力症状<ref>{{Cite journal |last=Jones |first=S. Christopher |last2=Sorbello |first2=Alfred |last3=Boucher |first3=Robert M. |date=2011-10-01 |title=Fluoroquinolone-Associated Myasthenia Gravis Exacerbation |url=https://doi.org/10.2165/11593110-000000000-00000 |journal=Drug Safety |language=en |volume=34 |issue=10 |doi=10.2165/11593110-000000000-00000 |issn=1179-1942}}</ref>。 |
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腕管综合征:药物流行病学研究显示应用氟诺酮类药物可增加发生腕管综合征的风险 (CID 65:684,2017) |
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* 糖代谢紊乱(低血糖/高血糖):高血糖与低血糖均有报道,糖尿病药物、类固醇激素都会增加风险<ref>{{Cite journal |last=Althaqafi |first=Abdulrhman |last2=Ali |first2=Majid |last3=Alzahrani |first3=Yusuf |last4=Ming |first4=Long Chiau |last5=Hussain |first5=Zahid |date=2021 |title=How Safe are Fluoroquinolones for Diabetic Patients? A Systematic Review of Dysglycemic and Neuropathic Effects of Fluoroquinolones |url=https://pubmed.ncbi.nlm.nih.gov/34675522 |journal=Therapeutics and Clinical Risk Management |volume=17 |doi=10.2147/TCRM.S284171 |issn=1176-6336 |pmc=8520959 |pmid=34675522}}</ref>。发生原因是促进胰岛素分泌,类似于[[磺酰脲类|磺酰脲类药物]]<ref>{{Cite journal |last=Lewis |first=Gareth |last2=Juhasz |first2=Albert |last3=Smith |first3=Euan |date=2012-08-01 |title=Environmental metabolites of fluoroquinolones: synthesis, fractionation and toxicological assessment of some biologically active metabolites of ciprofloxacin |url=https://doi.org/10.1007/s11356-012-0766-7 |journal=Environmental Science and Pollution Research |language=en |volume=19 |issue=7 |doi=10.1007/s11356-012-0766-7 |issn=1614-7499}}</ref><ref>{{Cite journal |last=Ghaly |first=Hany |last2=Kriete |first2=Christine |last3=Sahin |first3=Seher |last4=Pflöger |first4=Anja |last5=Holzgrabe |first5=Ulrike |last6=Zünkler |first6=Bernd Joachim |last7=Rustenbeck |first7=Ingo |date=2009-03-15 |title=The insulinotropic effect of fluoroquinolones |url=https://www.sciencedirect.com/science/article/pii/S000629520800854X |journal=Biochemical Pharmacology |volume=77 |issue=6 |doi=10.1016/j.bcp.2008.11.019 |issn=0006-2952}}</ref>。 |
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假性脑瘤:据报道可明显增加发生风险 (4~6倍)(Neurology 2017;89:892) |
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* 肝毒性:现存药物肝毒性不突出,但有药物(如{{le|曲伐沙星|trovafloxacin}}<ref>{{Cite journal |last=Pannu |first=H. K. |last2=Gottlieb |first2=L. |last3=Fishman |first3=E. K. |date=2001-04-27 |title=Acute liver failure due to trovafloxacin: CT findings |url=http://link.springer.com/10.1007/PL00011876 |journal=Emergency Radiology |language=en |volume=8 |issue=2 |doi=10.1007/PL00011876 |issn=1070-3004}}</ref>)因此被撤市。 |
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糖代谢紊乱(低血糖/高血糖):风险增加,尤其糖尿病患者的低血糖,任何已上市的氟喹诺酮均可致(CID 57:971,2013) |
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* 血小板减少:多种喹诺酮药物均可能引起<ref>{{Cite journal |last=Landi |first=A. Justine |last2=Burkes |first2=Robert |date=2016 |title=Probable Levofloxacin-Induced Thrombocytopenia in a Patient Previously on Ciprofloxacin: A Case Report and Literature Review |url=http://www.hindawi.com/journals/crim/2016/2860645/ |journal=Case Reports in Medicine |language=en |volume=2016 |doi=10.1155/2016/2860645 |issn=1687-9627 |pmc=4738914 |pmid=26884767}}</ref>。属于免疫性血小板减少,可能和诱导药物依赖性血小板反应性抗体有关<ref>{{Cite journal |last=Cheah |first=C. Y. |last2=De Keulenaer |first2=B. |last3=Leahy |first3=M. F. |date=2009-09 |title=Fluoroquinolone‐induced immune thrombocytopenia: a report and review |url=https://onlinelibrary.wiley.com/doi/10.1111/j.1445-5994.2009.01996.x |journal=Internal Medicine Journal |language=en |volume=39 |issue=9 |doi=10.1111/j.1445-5994.2009.01996.x |issn=1444-0903}}</ref>。 |
* 血小板减少:多种喹诺酮药物均可能引起<ref>{{Cite journal |last=Landi |first=A. Justine |last2=Burkes |first2=Robert |date=2016 |title=Probable Levofloxacin-Induced Thrombocytopenia in a Patient Previously on Ciprofloxacin: A Case Report and Literature Review |url=http://www.hindawi.com/journals/crim/2016/2860645/ |journal=Case Reports in Medicine |language=en |volume=2016 |doi=10.1155/2016/2860645 |issn=1687-9627 |pmc=4738914 |pmid=26884767}}</ref>。属于免疫性血小板减少,可能和诱导药物依赖性血小板反应性抗体有关<ref>{{Cite journal |last=Cheah |first=C. Y. |last2=De Keulenaer |first2=B. |last3=Leahy |first3=M. F. |date=2009-09 |title=Fluoroquinolone‐induced immune thrombocytopenia: a report and review |url=https://onlinelibrary.wiley.com/doi/10.1111/j.1445-5994.2009.01996.x |journal=Internal Medicine Journal |language=en |volume=39 |issue=9 |doi=10.1111/j.1445-5994.2009.01996.x |issn=1444-0903}}</ref>。 |
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* [[艰难梭菌]]感染:艰难梭菌属于[[机会致病菌]],当使用广谱抗生素时,艰难梭菌会过多增殖,导致腹泻等症状。同其他抗菌药物类似,氟喹诺酮也可能导致艰难梭菌感染,但存在争议<ref>{{Cite journal |last=Weiss |first=Karl |date=2009-03-01 |title=Clostridium difficile and fluoroquinolones: is there a link? |url=https://www.sciencedirect.com/science/article/pii/S0924857909700135 |journal=International Journal of Antimicrobial Agents |series=New views on Clostridium difficile infections |volume=33 |doi=10.1016/S0924-8579(09)70013-5 |issn=0924-8579}}</ref>。 |
* [[艰难梭菌]]感染:艰难梭菌属于[[机会致病菌]],当使用广谱抗生素时,由于菌群的破坏,艰难梭菌会过多增殖,导致腹泻等症状。同其他抗菌药物类似,氟喹诺酮也可能导致艰难梭菌感染,但存在争议<ref>{{Cite journal |last=Weiss |first=Karl |date=2009-03-01 |title=Clostridium difficile and fluoroquinolones: is there a link? |url=https://www.sciencedirect.com/science/article/pii/S0924857909700135 |journal=International Journal of Antimicrobial Agents |series=New views on Clostridium difficile infections |volume=33 |doi=10.1016/S0924-8579(09)70013-5 |issn=0924-8579}}</ref>。 |
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* [[视网膜脱落]]:有报道,但支持证据薄弱<ref name=":1">{{Cite journal |last=Gatti |first=Milo |last2=Bianchin |first2=Matteo |last3=Raschi |first3=Emanuel |last4=De Ponti |first4=Fabrizio |date=2020-05 |title=Assessing the association between fluoroquinolones and emerging adverse drug reactions raised by regulatory agencies: An umbrella review |url=https://linkinghub.elsevier.com/retrieve/pii/S0953620520300091 |journal=European Journal of Internal Medicine |language=en |volume=75 |doi=10.1016/j.ejim.2020.01.009}}</ref>。可能也与干扰[[细胞外基质]]的胶原蛋白与弹性蛋白,进而影响其强度有关。 |
* [[视网膜脱落]]:有报道,但支持证据薄弱<ref name=":1">{{Cite journal |last=Gatti |first=Milo |last2=Bianchin |first2=Matteo |last3=Raschi |first3=Emanuel |last4=De Ponti |first4=Fabrizio |date=2020-05 |title=Assessing the association between fluoroquinolones and emerging adverse drug reactions raised by regulatory agencies: An umbrella review |url=https://linkinghub.elsevier.com/retrieve/pii/S0953620520300091 |journal=European Journal of Internal Medicine |language=en |volume=75 |doi=10.1016/j.ejim.2020.01.009}}</ref>。可能也与干扰[[细胞外基质]]的胶原蛋白与弹性蛋白,进而影响其强度有关。 |
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* 过敏反应:一般为皮肤反应,也少量存在危及生命的反应。存在[[即發性過敏反應|I型(即发型)]]和[[延遲性過敏反應|IV型(迟发型)超敏反应]]<ref>{{Cite journal |last=Scherer |first=Kathrin |last2=Bircher |first2=Andreas J. |date=2005-01 |title=Hypersensitivity reactions to fluoroquinolones |url=https://link.springer.com/10.1007/s11882-005-0049-1 |journal=Current Allergy and Asthma Reports |language=en |volume=5 |issue=1 |doi=10.1007/s11882-005-0049-1 |issn=1529-7322}}</ref>。 |
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过敏反应: |
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光敏反应: |
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* [[光毒性]]:存在光毒性<ref>{{Cite journal |last=Viola |first=Giampietro |last2=Facciolo |first2=Laura |last3=Canton |first3=Marcella |last4=Vedaldi |first4=Daniela |last5=Dall'Acqua |first5=Francesco |last6=Aloisi |first6=Gian Gaetano |last7=Amelia |first7=Matteo |last8=Barbafina |first8=Arianna |last9=Elisei |first9=Fausto |last10=Latterini |first10=Loredana |date=2004-05 |title=Photophysical and Phototoxic Properties of the Antibacterial Fluoroquinolones Levofloxacin and Moxifloxacin |url=https://onlinelibrary.wiley.com/doi/10.1002/cbdv.200490061 |journal=Chemistry & Biodiversity |language=en |volume=1 |issue=5 |doi=10.1002/cbdv.200490061 |issn=1612-1872}}</ref>、光致癌<ref>{{Cite journal |last=Lhiaubet‐Vallet |first=Virginie |last2=Bosca |first2=Francisco |last3=Miranda |first3=Miguel Angel |date=2009-07 |title=Photosensitized DNA Damage: The Case of Fluoroquinolones † |url=https://onlinelibrary.wiley.com/doi/10.1111/j.1751-1097.2009.00548.x |journal=Photochemistry and Photobiology |language=en |volume=85 |issue=4 |doi=10.1111/j.1751-1097.2009.00548.x |issn=0031-8655}}</ref>作用。与药物在光下形成氧自由基有关。 |
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肝毒性: |
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=== 黑框警告及其他安全公告 === |
=== 黑框警告及其他安全公告 === |
2023年11月9日 (四) 08:51的版本
喹诺酮类药物 | |
---|---|
药物种类 | |
用途 | 細菌感染 |
ATC代码 | J01M |
外部链接 | |
MeSH | D015363 |
AHFS/Drugs.com | 药物分类 |
喹诺酮类药物是一类常用的广谱人工合成抗菌药物[a],因其中含有与4-喹诺酮相同或相似的含氮双并杂环结构而得名,这些药物一般名称都是“某某沙星”(-oxacin)[1]。
自1984年开发的诺氟沙星以来,大部分新的喹诺酮类药物都属于分子结构中含有氟原子的氟喹诺酮类药物(如环丙沙星)[2][3]。
目前,喹诺酮类药物除用于治疗人畜的细菌感染外,也会掺入畜牧业的饲料中,以预防禽畜(尤其是家禽)的感染[4]。
历史
一般认为1962年初次作为抗治疗尿路感染药物问世的萘啶酸是人类历史上第一种喹诺酮类药物。萘啶酸由美国Sterling Winthrop公司的乔治·莱舍(George Y. Lesher)与同事在一次合成氯喹的实验过程中偶然发现的。虽然从严格的化学意义上而言萘啶酸并不算是一种喹诺酮类化合物,但後來所有的喹诺酮类药物都是萘啶酸的衍生物,因此一般认定萘啶酸是人类历史上第一次发现的喹诺酮类药物[5][6][7]。自从萘啶酸问世以来,已经合成了 10,000 多种类似物,但只有少数进入了临床应用。
分类
根据研发时间和抗菌活性,喹诺酮类药物可以被分为四代[8]。第一代喹诺酮主要针对革兰氏阴性菌感染,第二代喹诺酮的抗菌谱增加到了部分革兰氏阳性球菌、军团菌,以及分歧杆菌、支原体、衣原体等非典型微生物[9][10],第三代喹诺酮扩大了革兰氏阳性球菌的范围,第四代喹诺酮还增加了部分抗厌氧菌的活性[11]。[b]
第一代
以下是一些常见的第一代喹诺酮类药物:
此外,还有一些药物从化学意义上讲不存在4-喹诺酮母核,但习惯上也称为第一代喹诺酮类药物[12],例如:
由于抗菌谱窄、副作用大、药物体内分布不佳等原因,多数第一代喹诺酮类药物已不再用于治疗人类细菌感染,在发达国家尤其如此[13]。
第二代
第二代及以后的喹诺酮类药物大都是氟喹诺酮,一般6号或8号位碳上有氟原子[14]。常见的第二代喹诺酮类药物包括:
依诺沙星虽然严格化学意义上不属于喹諾酮化合物,但一般常被划入第二代喹诺酮类药物之列[12]。
第三代
常见的第三代喹诺酮类药物包括:
妥舒沙星然严格化学意义上不属于喹諾酮化合物,但一般常被划入第三代喹诺酮类药物之列[17]。
第四代
常见的四代喹诺酮类药物包括:
吉米沙星和曲伐沙星虽然严格化学意义上不属于喹諾酮化合物,但一般常被划入第四代喹诺酮类药物之列[12][15]。
作用机理
一般认为,喹诺酮类药物的作用机理主要是干扰细菌中两种II型拓扑异构酶:DNA旋转酶和拓扑异构酶IV的工作,从而导致细菌DNA断裂,达到杀菌作用[19][20]。
在细菌DNA复制中,双螺旋二级结构被DNA解旋酶打开的过程会影响到更高的三级结构,形成正超螺旋,阻碍DNA进一步打开[c]。DNA旋转酶在这个过程中通过不断切开、移动和封闭DNA链条来松弛DNA,从而使得复制得以继续。细菌中的DNA旋转酶由2个gyrA亚基和2个gyrB亚基组成。在松弛过程中,先由A亚基负责切开DNA;B亚基结合ATP获得能量,使得DNA前链后移;之后A亚基再次将切口封闭形成负超螺旋。[21]
细菌中的拓扑异构酶IV由2个ParC亚基和2个ParE亚基组成,它们分别于gyrA和gyrB同源,这种酶负责在DNA复制后解开DNA之间的环联。[22]
喹诺酮类药物不会直接阻止这些酶发挥作用,而是在这些酶切断DNA时,与之形成酶-DNA-药物的三元复合物,阻止酶将切口重新封闭,从而使得其他酶有机会与其结合,导致细菌的DNA双链断裂,进而达到杀灭细菌的作用[1]。
在革兰氏阴性菌中,抗菌作用主要依靠干扰DNA旋转酶实现;而在革兰氏阳性菌中,抗菌作用则主要依靠干扰拓扑异构酶IV实现[21]。由于真核细胞中不含有这两种酶,而真核细胞中同功能的拓扑异构酶II在治疗剂量下不会被影响,因此真核细胞的DNA复制不受影响。然而,一些喹诺酮类化合物已被证明可以抑制线粒体 DNA 的合成[23][24]。(也存在针对真核生物拓扑异构酶IIα的喹诺酮类化合物[25],但目前不属于“药物”范畴,此处不讨论)
此外,一些研究者则主张喹诺酮类药物能将细菌细胞内的鸟嘌呤残基氧化为8-氧代鸟嘌呤,进而使细菌中的DNA出现断裂,从而起到杀灭细菌作用[26]。
【【在这里补充10.1016/j.ejmech.2013.01.057和10.1016/j.ejmech.2013.01.057的内容】】
临床应用
目前大部分临床上使用的喹诺酮都是氟喹诺酮。氟喹诺酮通常用于治疗引起泌尿生殖系统感染或肺炎的院内感染,同时也是治疗肾盂肾炎或细菌性前列腺炎的一线药物[27]。而在治疗社区获得性感染时,只有在可能发生出现多抗药菌风险时或其他抗生素治疗已失败的情况下,方才会考虑使用氟喹诺酮[28][29]。
不良反应
常用喹诺酮药物的总体安全性良好不良反应一般是轻度或中度的,但存在产生严重甚至永久副作用的可能,因此这类药物通常不被作为一线选择[30][31]。此外,还有一些喹诺酮类药物(如格帕沙星、克林沙星等)由于严重不良反应而被停止使用。
肌肉骨骼系统
- 肌腱:喹诺酮药物最严重的不良反应之一就是肌腱炎和肌腱断裂。在超过60岁的老人中,2%-6%的肌腱损伤与氟喹诺酮类药有关,同时使用激素会增加风险[32]。在高龄、合用激素、肾功能不全、既往肌腱病、缺镁、甲状旁腺功能亢进、利尿剂使用、周围血管疾病、类风湿性关节炎、糖尿病和剧烈运动等情形下,肌腱损害风险增加[33]。机制尚不完全清楚,可能与氧化应激、影响细胞外基质合成、缺血和影响成纤维细胞代谢[34][35]相关。
- 关节:由于在幼年动物的实验中出现关节软骨受损[36],氟喹诺酮类未被批准用于 16 岁以下儿童(某些适应症,如囊性纤维化中假单胞菌感染除外,且临床实践中可能作为二线药物超说明书使用)[37]。儿童的关节不良反应估计在 2%~3%,而成人发生率约为0.1%[38]。发病机制可能与氟喹诺酮络合镁离子、氧化应激等损伤软骨[39][40]有关 。
心血管系统
- 主动脉瘤/夹层:非常少见,但致命。研究证明氟喹诺酮类药物使得主动脉夹层风险增加到两倍以上,长期使用会导致风险增加[41][42]。机制不完全清楚,同样可能与干扰细胞外基质的胶原蛋白与弹性蛋白,进而影响其强度有关[43]。
- 二尖瓣/主动脉瓣反流:有此方面的报告[44],但存在矛盾证据[45]。
- QT间期延长:所有氟喹诺酮都可能引起 QT和QTc (校正QT)间期延长,但不同药物在这方面风险不同。QT间期延长可导致尖端扭转型室速和室颤,可能致命。增加风险的情况包括女性、低钾或低镁血症、心动过缓以及合用其他延长QT间期药物。机制为阻断hERG基因编码的钾离子通道,从而影响心室复极化。[46]
神经系统
- 中枢神经系统毒性与精神毒性:精神毒性包括躁狂、失眠、急性精神病、谵妄、以及自杀行为,神经系统不良反应包括大发作、意识模糊、惊厥和肌阵挛。机制同样可能与阻断GABA受体、激活NMDA受体有关,此外,血清素水平降低、微小RNA表达改变和氧化应激也被认为是机制。[47]
其他
- 过敏反应:一般为皮肤反应,也少量存在危及生命的反应。存在I型(即发型)和IV型(迟发型)超敏反应[57]。
黑框警告及其他安全公告
由于上述的安全性风险,美国FDA、欧洲EMA和中国大陆NMPA等药物主管机构多次对喹诺酮类药物发出不同等级的安全警告和使用限制,甚至包括最严重的“黑框警告”。
- 2008年,由于肌腱损伤的风险,FDA对所有氟喹诺酮类药物的全身使用添加了黑框警告 [60] 。
- 2011年,由于可能导致重症肌无力患者症状恶化,FDA对所有氟喹诺酮类药物的全身使用又增加了一项黑框警告。
- 2013年,由于周围神经病变副作用,FDA要求在药物标签标明风险[61]。
- 2016年,FDA 认定全身使用(口服或注射)氟喹诺酮类药物与肌腱、肌肉、关节、神经和中枢神经系统等部位的“致残和潜在永久性严重副作用”相关,并给出了“有其他治疗选择时,不应在急性鼻窦炎、急性支气管炎和单纯性尿路感染患者中使用”的结论 [30] 。
- 2016年,FDA又一次修订了黑框警告[62]。
- 2017年,由于肌腱损伤、周围神经病变、中枢神经影响和重症肌无力患者症状恶化的风险,NMPA(当时称为CFDA)对所有氟喹诺酮类药物的全身使用添加了黑框警告,并要求在说明书中标明QT间期延长、超敏反应、艰难梭菌腹泻、对血糖的干扰、光毒性等风险[63]。
- 2018年,由于低血糖昏迷和精神损害(如注意力障碍、定向力障碍、焦虑甚至谵妄)的风险,FDA又一次要求在标签中标明风险[64]。
- 2018年,由于主动脉夹层和主动脉瘤的风险,FDA发出了安全公告[65]。
- 2019年,由于涉及中枢神经系统、骨骼、肌肉、关节和肌腱的副作用,EMA宣布限制使用喹诺酮类药物的全身和吸入使用[31]。
- 2020年,由于心脏瓣膜反流的风险,EMA发出了警告[66]。
- 2021年,由于主动脉夹层和主动脉瘤的风险,NMPA要求在药物说明书中标明风险[67]。
耐药性
随着喹诺酮类抗菌药物的广泛应用,目前在许多细菌中均已发现针对喹诺酮类药物的抗药基因,其中以大肠杆菌、肺炎链球菌、葡萄球菌等最为常见。在治疗过程中细菌也会获得喹诺酮类药物的抗药性[68],这也是限制其使用的一个重要因素[69]畜牧业中大量使用喹诺酮类药物是促成喹诺酮抗药菌广泛存在的一个重要原因[70]。
耐药菌种类
此章节尚無任何内容,需要扩充。 |
机制
细菌对喹诺酮类药物存在多种耐药机制,包括以下几种:
- 细菌产生外排泵蛋白,降低细胞内的喹诺酮类药物浓度;
- 细菌产生qnr家族蛋白,改变DNA旋转酶药物结合区的构象,从而阻止药物-酶-DNA复合体形成;
- 细菌的DNA旋转酶或DNA拓扑异构酶相关位点(称为喹诺酮耐药决定区,QRDR)发生突变,使其不再受喹诺酮类药物的影响[68][70];
- 细菌通过外膜蛋白和脂多糖变异降低膜通透性,从而阻碍喹诺酮类药物的摄取[71]。
参见
参考文献
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