注射用生长抑素安全性风险分析

doi:10.19803/j.1672-8629.2021.11.18

摘要/Abstract

摘要： 目的分析注射用生长抑素的安全性风险,为其安全用药提供参考。方法分析世界卫生组织药品不良反应监测数据库和我国国家药品不良反应监测数据库中关于注射用生长抑素不良反应报告,汇总国内外注射用生长抑素不良反应文献报道,统计注射用生长抑素说明书记载情况及风险控制措施。结果注射用生长抑素不良反应累及多个系统-器官,可致胃肠系统损害、皮肤及其附件损害、心血管系统损害、代谢和营养障碍等,主要严重不良反应为过敏反应,严重过敏反应可导致过敏性休克。结论应关注注射用生长抑素所致的严重过敏反应,进一步完善药品说明书,促进临床安全合理用药。

关键词: 注射用生长抑素, 药品不良反应, 过敏性休克, 安全, 风险

Abstract: Objectiv eTo analyze the risks of somatostatin for injection so as to provide reference for clinical rational drug use. Methods The related adverse drug reaction reports in WHO VigiAccess and China adverse drug reaction database were analyzed. The cases of adverse drug reactions caused by somatostatin for injection reported in China were summarized. Instructions for somatostatin for injection and risk control measures and were statistically analyzed. Results Adverse drug reactions of somatostatin for injection involved multiple systems or organs, including gastrointestinal system damage, skin and accessory damage, cardiovascular system damage, metabolic and nutritional disorders. The main serious adverse drug reactions were allergic reactions, which could lead to allergic shock. Conclusion The serious allergic reactions induced by somatostatin for injection deserve more attention. Drug instructions should be made more specific while clinical safe and rational drug use should be ensured.

Key words: somatostatin for injection, adverse drug reactions, allergic shock, safety, risk

中图分类号:

R73R979.1

王春婷, 马敏康, 郑明节. 注射用生长抑素安全性风险分析[J]. 中国药物警戒, 2021, 18(11): 1080-1082.

WANG Chunting, MA Minkang, ZHENG Mingjie. Safety Risks of Somatostatin for Injection[J]. Chinese Journal of Pharmacovigilance, 2021, 18(11): 1080-1082.

参考文献

[1] Zhang LX, Wang YY, Liu FQ, et al.Fatty liver and metabolic syndrome: prevention and medication guidelines(脂肪肝与代谢综合征:防治及用药指南)[M]. Beijing: The People's Military Medical Publishing House, 2010:10-20.
[2] WHO. VigiAccess[EB/OL].[2021-08-01]. https://www.who-umc.org/whodrug/whodrug-pOrtfolio.
[3] Center for Drug Reevaluation, NMPA. Adverse reactions/event reporting [EB/OL].[2021-08-01]. https://www.cdr-adr.org.cn/.
[4] Scarpignato C, Pelosini I.Somatostatin for upper gastrointestinal hemor-rhage and pancreatic surgery[J]. Digestion, 1999, 60(suppl 3): 1-16.
[5] Roehr CC, Jung A, Hans P, et al.Somatostatin or octreotide as treatment options for chylothorax in young children:a systematic review[J]. Intensive Care Med, 2006, 32: 650-657.
[6] Tsibouris P, Zintzaras E, Lappas C, et al.High-dose pantoprazole continuous infusion is superior to somatostatin after endoscopic hemostasis in patients with peptic ulcer bleeding[J]. American Journal of Gastroenterology, 2007, 102: 1192-1199.
[7] Chen GS, Xue QP, Zhu GQ, et al.Polyuria caused by flushing dose of somatostatin in treatment of gastrointestinal hemorrhage:a case report[J]. Chin J Gastroenterol(胃肠病学), 2011, 16(8): 511-512.
[8] Chen Y, Luo YP, Cao M.Somatostatin induced arrhythmia:a case report[J]. Chin Pharm J(中国药学杂志), 2011, 46(1): 70.
[9] Gu TB, Song XY, Zhou XF.Somatostatin was stopped in one case with severe diarrhea[J]. Central South Pharmacy(中南药学), 2010, 8(10): 796-797.
[10] Liu HY, Li BJ, Zhang LN.Nursing care of a case of hypoglycemia induced by senile dieulafoy disease treated with somatostatin[J]. Chinese Nursing Research(护理研究), 2014, 28(31): 3967-3968.
[11] Nie CX, Lin YJ, Zhao QZ, et al.An analysis of somatostatin-induced bradycardia was reported[J]. Evaluation and Analysis of Drug-use in Hospitals of China(中国医院用药评价与分析), 2015, 15(4): 558.
[12] Wang L, Ren CM, Wen LM.Autostatin to bradycardia in one case[J]. China Pharmacist(中国药师), 2020, 23(1): 129.
[13] Wu ZL.Nursing report of hypoglycemia using somatostatin[C]. National Hypertension Prevention and Control Knowledge Promotion Training Course and Healthy Blood Pressure Travel to Haikou Conference, Hainan(全国高血压防治知识推广培训班暨健康血压中国行海南海口会), 2014: 1.
[14] Yan JL, Yu R.Three cases of somatostatin-induced gallbladder enlargement were reported[J]. Journal of Clinical Hepatology(临床肝胆病杂志), 2002, 18(3): 133.
[15] Yang Y, Din JW, Lei ZB.Somatostatin caused lip numbness by injection[J]. Chinese Journal of Phomarcovigilance(中国药物警戒), 2010, 7(6): 378.
[16] Shao JB.Nursing reports of hypoglycemia after withdrawal of somatostatin[J]. Chinese Geriatric Health Care Medicine(中国老年保健医学), 2013, 11(6): 97.
[17] Wang YW, Lyu MN, Kang FB.Patients with upper gastrointestinal bleeding and continued pumping of somatostatin caused a hypoglycemic coma[J]. Clinical Misdiagnosis & Mistherapy(临床误诊误治), 2011, 24(5): 97.
[18] Zhang XB, Zhao MY, Zhao QC, et al.A case of low blood sugar reaction induced by somatostatin[J]. Practical Pharmacy and Clinical Remedies(实用药物与临床), 2014, 17(3): 390.
[19] Wang JS, Wang QX, Chen FX, et al.Somatostatin-induced hyperglycemia in case of diabetes and pharmacology analysis[J]. Clin J Clin Pharmacol Ther(中国临床药理学与治疗学), 2011, 16(11): 1260-1263.
[20] Han LP, Peng J.Analysis of hypoglycemia of somatostatin and nursing countermeasures[J]. General Practice Care(全科护理), 2015, 13(35): 3583-3584.
[21] Jin HF, Zhang CY, Tian J.Nursing experience of the occurrence of hypoglycemia reaction after continuous infusion of somatostatin in the treatment of acute pancreatitis[J]. Chinese Modern Doctor(中国现代医生), 2017, 55(10): 152-154.
[22] Li HM, Zhang YB.Methods to prevent hypoglycemia during sustained pumping of somatostatin[J]. Journal of Practical Clinical Medicine(实用临床医药杂志), 2012, 16(16): 122-123.
[23] Lu YF, Zhou XJ.Analysis and nursing of patients treated with continuous pumping of somatostatin[J]. Contemporary Nurses (the first ten-day period of a month)(当代护士(上旬刊)), 2019, 26(1): 43-45.
[24] Xiao ZY.Analysis of 24 cases caused by micropump with somatostatin[J]. Chinese Journal of Primary Medicine and Pharmacy(中国基层医药), 2013, 20(12): 1897-1898.
[25] Yao ML, Bian ZY, Li LH, et al.Nursing care of continuous pumping of somatostatin in patients with acute pancreatitis[J]. Mod Med J China(中国现代医药杂志), 2015, 17(4): 95-96.
[26] Ye YB.Analysis of the causes of hypoglycemia and diarrhea after the withdrawal of somatostatin[J]. Chinese Rural Medicine(中国乡村医药), 2015, 22(11): 16.
[27] NMPA. Announcement of the state food and drug administration on revision of somatostatin for injection (No.85, 2021) [EB/OL]. (2021-06-24)[2021-07-01]. https://www.nmpa.gov.cn/so/s?tab=all&qt.
[28] Meng G. Revision asfor orasand et class 2 drugs[N]. China Consumer Daily(中国消费者报), 2021-06-28(6).
[29] Wei MJ, Chen L.Injection Joint Application Manual(注射药联合应用手册)[M]. Beijing: The People's Military Medical Publishing House, 2010: 50-62.