知识与财富的链接
目的 分析替加环素相关不良反应的临床特点,为安全合理使用该药提供依据。 方法 收集2019年1月1日至2024年6月30日北京市药品不良反应监测中心收到的以怀疑药品为替加环素的不良反应报告,采用《世界卫生组织不良反应术语集》中文更新版（2015版）中首选术语（PT）和系统器官分类（SOC）对不良反应进行标准化处理。对患者的一般情况、替加环素用药情况、不良反应发生情况（潜伏期、严重程度、治疗、转归及关联性评价等）进行描述性统计分析。 结果 共收到替加环素相关不良反应报告408例,女性153例（37.5%）,男性255例（62.5%）;年龄（68±21）岁,年龄范围2~99岁。使用替加环素的原因主要为肺部、血流、皮肤及皮肤软组织感染等,病原体主要为肺炎克雷伯菌、鲍曼不动杆菌、大肠埃希菌等。多数患者替加环素的用法用量符合说明书规定。408例报告涉及11个SOC和580个PT。排名居前3位的SOC依次为胃肠疾病（195例次,33.62%）,血管、出血及凝血疾病（183例次,31.55%）和肝胆疾病（142例次,24.48%）,主要临床表现为恶心、呕吐、腹泻等,主要实验室检测异常为血浆纤维蛋白原减少、血小板计数降低、丙氨酸转氨酶升高、天冬氨酸转氨酶升高、胆红素升高等。说明书未记载的不良反应27例次,主要为白细胞减少症、腹胀、发热、菌群失调等。408例不良反应的潜伏期最短5 min,最长65 d,中位时间5 d。不良反应分级为一般者379例（92.89%）,严重者29例（7.11%）。53例次严重不良反应涉及的SOC排名居前3位者依次是肝胆疾病（30例次,56.60%）、血管、出血及凝血疾病（8例次,15.09%）和尿路疾病（4例次,7.55%）,主要表现为肝酶升高、凝血障碍、胰腺炎等。发生不良反应后,所有患者均停药,分别接受保肝、静脉滴注人纤维蛋白原、静脉输注血小板、止泻等对症治疗;结局为痊愈者66例（16.18%）,好转297例（72.79%）,未好转20例（4.90%）,不详25例（6.13%）;痊愈或好转的最短时间为0.5 h,最长44 d,中位时间5 d。不良反应与替加环素关联性为很可能者132例（32.35%）,可能276例（67.65%）。 结论 替加环素相关不良反应涉及多个器官系统,主要为胃肠疾病,血管、出血及凝血疾病和肝胆疾病,可导致急性胰腺炎、凝血障碍等严重不良反应。停药和对症治疗后大部分患者转归良好。
Objective To analyze the clinical characteristics of tigecycline-related adverse reactions and provide the basis for the safe and rational use of the drug. Methods Adverse reaction reports with suspected drug as tigecycline from Beijing Adverse Drug Reaction Monitoring Center from January 1st, 2019 to June 30th, 2024 were collected. The adverse reaction reports were standardized using the preferred term (PT) and system organ class (SOC) in the Chinese updated edition (2015 version) of the World Health Organization Adverse Reaction Terminology. The patients' general condition, tigecycline use, and adverse reaction occurrence (including latency, severity, treatment, outcome, and correlation evaluation) were descriptively and statistically analyzed. Results A total of 408 tigecycline-related adverse reaction reports were entered, including 153 females (37.5%) and 255 males (62.5%). The age was (68±21) years, ranging from 2 to 99. The main reasons for tigecycline use were infections of lung, blood flow, skin and skin soft tissue, etc. The pathogens were mainly Klebsiella pneumoniae, Acinetobacter baumanii, Escherichia coli, etc. The usage and dosage of tigecycline in most patients were in line with the instructions. Four hundred and eight adverse event reports involved 11 SOCs and 580 PTs. The top 3 SOCs were gastrointestinal diseases (195 case times, 33.62%), vascular, bleeding and coagulation diseases (183 case times, 31.55%), and hepatobiliary diseases (142 case times, 24.48%). The main clinical manifestations were nausea, vomiting, diarrhea, etc. The main laboratory abnormalities were decreased plasma fibrinogen, decreased platelet count, increased alanine aminotransferase, increased aspartate aminotransferase, and increased bilirubin. There were 27 case times of adverse reactions that were not recorded in the instructions, mainly including leukopenia, abdominal distension, fever, dysbacteriosis, etc. The latency of adverse reactions ranged from 5 min to 65 days, with a median time of 5 days. The grade of adverse reactions was general in 379 patients (92.89%) and severe in 29 patients (7.11%). The top 3 SOCs involved in 53 case times of severe adverse reactions were hepatobiliary diseases (30 case times, 56.60%), vascular, bleeding and coagulation diseases (8 case times, 15.09%), and urinary tract diseases (4 case times, 7.55%), the main clinical manifestations were elevated liver enzymes, coagulation disorders, pancreatitis, etc. After the occurrence of adverse reactions, all patients stopped tigecycline, and received symptomatic treatments such as liver protection, intravenous infusion of human fibrinogen, intravenous infusion of platelets, and antidiarrheal therapy. Among 408 patients, 66 (16.18%) were cured, 297 (72.79%) were improved, 20 (4.90%) were not improved, and 25 cases' outcome (6.13%) were unknown. The shortest time for recovery or improvement was 0.5 hour, the longest was 44 days, with a median time of 5 days. The correlation between tigecycline and adverse reactions was probable in 132 patients (32.35%), and possible in 276 patients (67.65%). Conclusions Tigecycline-related adverse reactions involve multiple organ systems, mainly including gastrointestinal diseases, vascular, bleeding and coagulation diseases, and hepatobiliary diseases, etc. which can lead to severe adverse reactions such as acute pancreatitis and coagulation disorders. After drug withdrawal and symptomatic treatments, most patients had a good prognosis.
