28例GLP-1受体激动药不良反应/事件分析
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摘要
目的:探讨GLP-1受体激动药不良反应/事件(ADR/ADE)的发生特点。方法:计算机检索CNKI、万方数据、PubMed等数据库,对艾塞那肽、利拉鲁肽、贝那鲁肽、利司那肽、阿必鲁肽、度拉糖肽、索马鲁肽等7种GLP-1受体激动药所致ADR/ADE个例报道文献进行整理分析,分别统计ADR/ADE的患者因素、药物因素和ADR/ADE相关特征等信息。结果:收集文献31篇,获取病例32例,剔除3例用药差错事件,1例阴性报道,纳入分析报道28例。GLP-1受体激动药ADR/ADE女性多于男性,ADR/ADE发生多发生在用药后2个月内,主要涉及消化系统、泌尿生殖系统、皮肤及其附件系统等,其中以胰腺炎与急性肾损伤较为严重。肾功能不全、合并使用血管紧张素受体抑制药±利尿药者可能是急性肾损伤的危险因素,可能机制为严重呕吐、脱水导致低血压、肾血流量不足所致。结论:GLP-1受体激动药较为安全,对于有胰腺炎及急性肾损伤高危因素者用药前2个月内,药师应加强监护与随访,注意患者有无腹痛、严重呕吐、脱水、无尿等症状,以防严重ADR/ADE发生。
Objective: To explore the characteristics of adverse drug reactions/events induced by GLP-1 agonist preparation.Methods:Using computer retrieval the database such as CNKI, Wanfang, PubMed, etc, the adverse reactions/events of GLP-1 agonist preparation were collected and analyzed, including exenatide,liraglutide, albiglutide, dulaglutide, benalutide, semaglutide. The patient factors, medicine factors and ADR/ADE relevant characteristics were examined respectively. Results: 31 articles and 32 cases were collected. 3 medication error events were removed and 1 case report was negative, 28 cases were included in the review analysis. It showed that the ADR/ADE of GLP-1 agonist preparation in women more than men, the majority adverse reactions occurred in the first two months after medication, ADR/ADE involving was major in digestive system,urogenital system and skin accessories. The most notable ADRs were pancreatitis and acute kidney injury. Renal insufficiency, or combined with ARBs±diuretics might be a risk factor for acute renal injury, possibly due to severe vomiting and dehydration leading to hypotension and insufficient renal blood flow. Conclusion:GLP-1 agonist preparation was safe, for those with high-risk factors of pancreatitis and acute kidney injury, the pharmacist should strengthen the monitoring and follow-up, and pay attention to the symptoms of abdominal pain, severe vomiting, dehydration and no urine, to avoid serious adverse events.
Objective: To explore the characteristics of adverse drug reactions/events induced by GLP-1 agonist preparation.Methods:Using computer retrieval the database such as CNKI, Wanfang, PubMed, etc, the adverse reactions/events of GLP-1 agonist preparation were collected and analyzed, including exenatide,liraglutide, albiglutide, dulaglutide, benalutide, semaglutide. The patient factors, medicine factors and ADR/ADE relevant characteristics were examined respectively. Results: 31 articles and 32 cases were collected. 3 medication error events were removed and 1 case report was negative, 28 cases were included in the review analysis. It showed that the ADR/ADE of GLP-1 agonist preparation in women more than men, the majority adverse reactions occurred in the first two months after medication, ADR/ADE involving was major in digestive system,urogenital system and skin accessories. The most notable ADRs were pancreatitis and acute kidney injury. Renal insufficiency, or combined with ARBs±diuretics might be a risk factor for acute renal injury, possibly due to severe vomiting and dehydration leading to hypotension and insufficient renal blood flow. Conclusion:GLP-1 agonist preparation was safe, for those with high-risk factors of pancreatitis and acute kidney injury, the pharmacist should strengthen the monitoring and follow-up, and pay attention to the symptoms of abdominal pain, severe vomiting, dehydration and no urine, to avoid serious adverse events.
引文
1 中国2型糖尿病防治指南(2017年版)[J].中国实用内科杂志,2018,38(4):292-344
2 Suggested definitions and relationships among medication misad ventures,medication errors,adverse drug events,and adverse drug reactions)[J]Am J Health-Syst Pharm,1998,55(2):165-166
3 Denker PS.Exenatide (exendin-4)-induced pancreatitis:a case report[J].Diabetes Care,2006,29(2):471
4 Ayoub WA,Kumar AA,Naguib HS.Exenatide-induced acute pancreatitis[J].Endocr Pract,2010,16(1):80-83
5 Shridhar N.Iyer,Almond J.Drake,R.Lee West.et al.Case report of acute necrotizing pancreatitis associated with combination treatment of sitagliptin and exenatied[J].Endocr Pract,2012,1(18):e10-e13
6 Lee PH,Stockton MD.Acute pancreatitis associated with liraglutide[J].Annals of Pharmacotherapy,2011,45(4):e22
7 Famularo G,Gasbarrone L.Pancreatitis during treatment with liraglutide[J].Journal ofPancreas,2012,13(5):540-541
8 Bourezane H,Kastler B.Late and severe acute necrotizing pancreatitis in a patient with liraglutide[J].Therapie,2012,67(6):539-543
9 Kaakeh Y,Kanjee S,Boone K.Liraglutide-induced acute kidney injury[J].Pharmacotherapy,2012,32(1):e7-11
10 Kern E,VanWagner LB,Yang GY.Liraglutide-induced autoimmune hepatitis[J].JAMA Internal Medicine,2014,174(6):984-987
11 顾晔,徐书杭,倪学建,等.胰岛素和艾塞那肽过敏两例报道并文献复习[J].标记免疫分析与临床,2015,22(1):78-80
12 Korkmaz H,Araz M,Alkan S.Liraglutide-related cholelithiasis[J].Aging Clinical and Experimental Research,2015,27(5):751-753
13 Nakata H,Sugitani S,Yamaji S,et al.Pancreatitis with pancreatic tail swelling associated with incretin-based therapies detected radiologically in two cases of diabetic patients with end-stage renal disease[J].Internal Medicine (Tokyo,Japan),2012,51(21):3045-3049
14 张凡,王丽霞.利拉鲁肽注射液致转氨酶升高1例[J].中国药物警戒,2018,15(6):372-373
15 López-Ruiz A,del Peso-Gilsanz C,Meoro-Avilés A,et al.Acute renal failure when exenatide is co-administered with diuretics and angiotensin Ⅱ blockers[J].Pharmacy world &Science,2010,32(5):559-561
16 Nandakoban H,Furlong TJ.Acute tubulointerstitial nephritis following treatment with exenatide[J].Diabetic Medicine,2013,30(1):123-125
17 Kaakeh Y,Kanjee S,Boone K.Liraglutide-induced acute kidney injury[J].Pharmacotherapy,2012,32(1):e7-11
18 Dubois-Laforgue D,Boutboul D,Lévy DJ,et al.Severe acute renal failure in patients treated with glucagon-like peptide-1 receptor agonists[J].Diabetes Research and Clinical Practice,2014,103(3):e53-55
19 Gariani K,de Seigneux S.Acute interstitial nephritis after treatment with liraglutide[J].American Journal of Kidney Diseases,2014,63(2):347
20 Aijazi I,Abdulla FM,Zuberi BJ.Exenatide induced acute kidney injury[J].Journal of Ayub Medical College,2014,26(4):636-639
21 Fontoura P,Cardoso MC,Erthal-Martins MC,et al.The effects of liraglutide on male fertility:a case report[J].Reproductive Biomedicine Online,2014,29(5):644-646
22 Pérez E,Martínez-Tadeo J,Callero A,et al.A case report of allergy to exenatide[J].Jjournal of Allergy and Clinical Immunology,2014,2(6):822-823
23 Hamann CR,Chung C,Kaffenberger BH.Pyoderma gangrenosum associated with dulaglutide therapy[J].Int J Dermatol,2018,49(10):1-3.
24 赵文成,张建中,李洋,等.百泌达致低血糖1例报告[J].吉林大学学报(医学版),2013,39(3):543
25 王琦,翟爱华,刘书东,等.艾塞那肽注射液引起过敏性休克1例[J].中国医院药学杂志,2017,37(22):2312-2313
26 Kohen I.Exenatide-induced depression in a geriatric patient[J].InternationalJournal of Geriatric Psychiatry,2008,23(4):443-444
27 Ambrosio ML,Monami M,Sati L,et al.GLP-1 receptor agonist-induced polyarthritis:a case report[J].Acta Diabetologica,2014,51(4):673-674
28 Ruby RJ,Armato JP,Pyke C.GLP-1 provoked severe hypoglycemia in an individual with type 2 diabetes and a benign insulinoma[J].Diabetes Care,2014,37(8):e177-178
2 Suggested definitions and relationships among medication misad ventures,medication errors,adverse drug events,and adverse drug reactions)[J]Am J Health-Syst Pharm,1998,55(2):165-166
3 Denker PS.Exenatide (exendin-4)-induced pancreatitis:a case report[J].Diabetes Care,2006,29(2):471
4 Ayoub WA,Kumar AA,Naguib HS.Exenatide-induced acute pancreatitis[J].Endocr Pract,2010,16(1):80-83
5 Shridhar N.Iyer,Almond J.Drake,R.Lee West.et al.Case report of acute necrotizing pancreatitis associated with combination treatment of sitagliptin and exenatied[J].Endocr Pract,2012,1(18):e10-e13
6 Lee PH,Stockton MD.Acute pancreatitis associated with liraglutide[J].Annals of Pharmacotherapy,2011,45(4):e22
7 Famularo G,Gasbarrone L.Pancreatitis during treatment with liraglutide[J].Journal ofPancreas,2012,13(5):540-541
8 Bourezane H,Kastler B.Late and severe acute necrotizing pancreatitis in a patient with liraglutide[J].Therapie,2012,67(6):539-543
9 Kaakeh Y,Kanjee S,Boone K.Liraglutide-induced acute kidney injury[J].Pharmacotherapy,2012,32(1):e7-11
10 Kern E,VanWagner LB,Yang GY.Liraglutide-induced autoimmune hepatitis[J].JAMA Internal Medicine,2014,174(6):984-987
11 顾晔,徐书杭,倪学建,等.胰岛素和艾塞那肽过敏两例报道并文献复习[J].标记免疫分析与临床,2015,22(1):78-80
12 Korkmaz H,Araz M,Alkan S.Liraglutide-related cholelithiasis[J].Aging Clinical and Experimental Research,2015,27(5):751-753
13 Nakata H,Sugitani S,Yamaji S,et al.Pancreatitis with pancreatic tail swelling associated with incretin-based therapies detected radiologically in two cases of diabetic patients with end-stage renal disease[J].Internal Medicine (Tokyo,Japan),2012,51(21):3045-3049
14 张凡,王丽霞.利拉鲁肽注射液致转氨酶升高1例[J].中国药物警戒,2018,15(6):372-373
15 López-Ruiz A,del Peso-Gilsanz C,Meoro-Avilés A,et al.Acute renal failure when exenatide is co-administered with diuretics and angiotensin Ⅱ blockers[J].Pharmacy world &Science,2010,32(5):559-561
16 Nandakoban H,Furlong TJ.Acute tubulointerstitial nephritis following treatment with exenatide[J].Diabetic Medicine,2013,30(1):123-125
17 Kaakeh Y,Kanjee S,Boone K.Liraglutide-induced acute kidney injury[J].Pharmacotherapy,2012,32(1):e7-11
18 Dubois-Laforgue D,Boutboul D,Lévy DJ,et al.Severe acute renal failure in patients treated with glucagon-like peptide-1 receptor agonists[J].Diabetes Research and Clinical Practice,2014,103(3):e53-55
19 Gariani K,de Seigneux S.Acute interstitial nephritis after treatment with liraglutide[J].American Journal of Kidney Diseases,2014,63(2):347
20 Aijazi I,Abdulla FM,Zuberi BJ.Exenatide induced acute kidney injury[J].Journal of Ayub Medical College,2014,26(4):636-639
21 Fontoura P,Cardoso MC,Erthal-Martins MC,et al.The effects of liraglutide on male fertility:a case report[J].Reproductive Biomedicine Online,2014,29(5):644-646
22 Pérez E,Martínez-Tadeo J,Callero A,et al.A case report of allergy to exenatide[J].Jjournal of Allergy and Clinical Immunology,2014,2(6):822-823
23 Hamann CR,Chung C,Kaffenberger BH.Pyoderma gangrenosum associated with dulaglutide therapy[J].Int J Dermatol,2018,49(10):1-3.
24 赵文成,张建中,李洋,等.百泌达致低血糖1例报告[J].吉林大学学报(医学版),2013,39(3):543
25 王琦,翟爱华,刘书东,等.艾塞那肽注射液引起过敏性休克1例[J].中国医院药学杂志,2017,37(22):2312-2313
26 Kohen I.Exenatide-induced depression in a geriatric patient[J].InternationalJournal of Geriatric Psychiatry,2008,23(4):443-444
27 Ambrosio ML,Monami M,Sati L,et al.GLP-1 receptor agonist-induced polyarthritis:a case report[J].Acta Diabetologica,2014,51(4):673-674
28 Ruby RJ,Armato JP,Pyke C.GLP-1 provoked severe hypoglycemia in an individual with type 2 diabetes and a benign insulinoma[J].Diabetes Care,2014,37(8):e177-178