摘要
目的分析单唾液酸四己糖神经节苷脂钠注射液致新的/严重的药品不良反应(ADR)特点,为临床提供参考。方法按照《药品不良反应报告和监测管理办法》的新的/严重的ADR纳入标准,检索CNKI、CBM、VIP和万方数据库中单唾液酸四己糖神经节苷脂钠注射液致ADR的个案报道,2名研究者独立选择、提取数据,并交叉核对,并应用文献计量分析方法进行整理分析。结果共纳入31例病例。研究结果显示:(1)男性较女性易发生ADR;(2)年龄大于50岁的中老年患者易发生ADR。(3)有既往病史的患者易发生ADR。(4)溶媒为0.9%氯化钠注射液较5%葡萄糖注射液易发生ADR。(5)合并用药更易发生ADR,合并用药品种数越多,越易发生ADR。(6)吉兰-巴雷综合征、心血管系统反应和过敏性休克是主要的ADR,心血管反应和过敏性休克多发生在用药30 min内,吉兰-巴雷综合征多发生在用药10d左右。结论药品说明书中ADR一项已不能满足临床需要,建议相关部门及时更新药品说明书。
Objective To analyze the characteristics of new/ severe adverse drug reactions （ADRs） caused by single sialic acid four hexose ganglioside sodium injections （SSAFHGSI） and provide reference for clinical applications.Methods According to the inclusion criteria of new/ severe ADRs in Adverse Drug Reaction Reporting and Monitoring Measures , case reports about SSAFHGSI were searched for in CNKI, CBM, VIP and Wangfang Database. Two researchers selected and extracted data independently, cross-checked them,sorted out and analyzed them with biliometric analytical methods.Results A total of 31 cases were included. Results of research suggested that ： （1） Males were more susceptible to ADRs than females. （2）Middle-aged and elderly patients above 50 were more susceptible to ADRs. （3）Patients with a previous history were more susceptible to ADRs. （4）0.9% chloride injections were more contributive to ADRs than 5% glucose injection.（5）A combined use of drugs was more contributive to ADRs. The more varieties of drugs used in combination, the higher chance of ADRs. （6）Guillain-Barre syndromes, cardiovas- cular system reactions and anaphylactic shocks were major ADRs. Cardiovascular reactions and anaphylac- tic shocks mostly occurred 30 rain after drug use. Guillain-Barre syndromes mostly occurred 10 days after drug use.Conclusion Instructions on ADRs cannot satisfy clinical needs. It is suggested that China＇s Food and Drug Administration update these instructions promptly.
出处
《解放军药学学报》
CAS
CSCD
2017年第3期282-284,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
关键词
单唾液酸四己糖神经节苷脂钠
药品不良反应
single sialic acid four hexose ganglioside sodium injections
adverse drug reactions
