复方脑肽节苷脂治疗3884例颅脑损伤患者安全性再评价  

Reevaluation of the safety of compound porcine cerebroside and ganglioside in the treatment of 3,884 patients with craniocerebral injury

作　　者：谭安军 文君 文娟[3] 胡浪 毕晓梅[5] TAN Anjun;WEN Jun;WEN Juan;HU Lang;BI Xiaomei(Department of Pharmacy,Chongqing Yongchuan Hospital of Traditional Chinese Medicine,Chongqing,China,402160;Department of Pharmacy,The First People's Hospital of Chongqing Liangjiang New Area,Chongqing,China,401121;Department of Pharmacy,Jiangjin Hospital of Traditional Chinese Medicine,Chongqing,China,402260;Department of Pharmacy,Siyang Hospital of Traditional Chinese Medicine,Suqian,Jiangsu,China,223798;Department of Pharmacy,Siyang People's Hospital of Suqian,Suqian,Jiangsu,China,223702)

机构地区：[1]重庆市永川区中医院药学部,重庆402160 [2]重庆两江新区第一人民医院药剂科,重庆401121 [3]重庆市江津区中医院药学部,重庆402260 [4]宿迁市泗阳县中医院药学部,江苏宿迁223798 [5]宿迁市泗阳县人民医院药剂科,江苏宿迁223702

出　　处：《分子诊断与治疗杂志》2023年第10期1680-1684,共5页Journal of Molecular Diagnostics and Therapy

基　　金：重庆市永川区科委科技计划项目(自然科学基金项目)(Ycstc,2014nc 5016);重庆市永川区制度创新项目(2021yc-zdcx20004)。

摘　　要：目的评价并探究复方脑肽节苷脂注射治疗3 884例颅脑损伤患者临床安全性。方法 应用多中心、前瞻性、大样本医院集中监测方式评估颅脑损伤患者复方脑肽节苷脂治疗安全性,主要评价指标为患者治疗相关情况、转归、不良事件/反应发生率及严重程度,用药前后生命体征及血常规变化。结果 患者用药剂量为6(4,16)mL,注射时间为90(60,125)min,用药时间为7(4,11)d;3 884例患者治疗总有效率为87.92%;患者不良事件及不良反应发生率分别为7.13%与0.28%,轻度、中度、重度不良事件发生率分别为4.12%、2.78%、0.41%,轻度、中度不良反应发生率分别为0.18%、0.10%,不良事件及反应涉及机体多个系统;患者用药前后体温、脉搏、呼吸频率、收缩压以及舒张压等比较差异无统计学意义(t=1.662,1.299,1.208,1.852,0.767;P>0.05);患者治疗前后红细胞计数(RBC)、血小板计数(PLT)、白细胞计数(WBC)异常发生率比较差异无统计学意义(χ^(2)=3.242,3.170,3.471;P>0.05)。结论颅脑损伤患者采用复方脑肽节苷脂治疗疗效显著,安全性高,值得临床推广应用。Objective To evaluate the clinical safety of compound porcine cerebroside and ganglioside in the treatment of 3,884 patients with craniocerebral injury.Methods A multi-center,prospective,and large-sample method was adopted to evaluate the safety of compound porcine cerebroside and ganglioside in the treatment of patients with craniocerebral injury.The main evaluation indicators included treatment related conditions,outcome,the incidence rates and severity of adverse events/reactions,changes in vital signs and blood routine before and after medication.Results The dosage,injection time and medication time were 6(4,16)mL,90(60,125)min,and 7(4,11)d.The total effective rate in this study was 87.92%.The incidence rates of adverse events and adverse reactions were 7.13%and 0.28%.The incidence rates of mild,moderate,and severe adverse events were 4.12%,2.78%and 0.41%.The incidence rates of mild and moderate adverse reactions were 0.18%and 0.10%.The adverse events and reactions involved multiple systems.The patients'temperature,pulse,respiratory rate,systolic blood pressure and diastolic blood pressure showed no statistically significant difference before and after medication(t=1.662,1.299,1.208,1.852,0.767,P>0.05).There was no statistically significant difference in the incidence rates of abnormal red blood cell count(RBC),platelet count(PLT)and white blood cell count(WBC)before and after treatment(X^(2)=3.242,3.170,3.471,P>0.05).Conclusion The use of compound brain peptide gangliosides in the treatment of patients with traumatic brain injury has significant therapeutic effects and high safety,which is worthy of clinical promotion and application.

关 键 词：复方脑肽节苷脂 颅脑损伤 安全性 

分 类 号：R269[医药卫生—中西医结合]