6269例正清风痛宁注射液临床病例回顾性用药特点与安全性分析  

Retrospective Analysis of Medication Characteristics and Safety of 6269 Clinical Cases of Zhengqing Fengtongning(正清风痛宁)Injection

作　　者：张冬[1] 钟露苗 杜娟 薛运华[3] 彭晓珊 李璐璐 仇萍 谷丽红 ZHANG Dong;ZHONG Lumiao;DU Juan;XUE Yunhua;PENG Xiaoshan;LI Lulu;QIU Ping;GU Lihong(Research Institute of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;Center for Drug Review and ADR Monitoring,Changsha Hunan 411000,China;School of Mathematical Sciences,Nankai University,Tianjin 30071,China;Hunan Zhengqing Pharmaceutical Group Co.,Ltd,Huaihua Hunan 418000,China)

机构地区：[1]天津中医药大学中医药研究院,天津300193 [2]湖南省药品审评与不良反应监测中心,湖南长沙411000 [3]南开大学数学科学学院,天津300071 [4]湖南正清制药集团股份有限公司,湖南怀化418000

出　　处：《中医药导报》2022年第10期172-176,共5页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：2020年湖南省科药联合基金项目(2020JJ9039);天津市中医药重点领域科技项目(2021002)。

摘　　要：目的:考察正清风痛宁注射液在临床实际应用中的用药特点与安全性,以期进一步指导临床合理用药和完善药品说明书,并为企业制定风险管理计划提供依据。方法:采用回顾性研究方法,调取湖南省中医药研究院附属医院、长沙市中医康复医院两家医疗单位连续3年使用正清风痛宁注射液治疗的病历7613份,采集正清风痛宁注射液使用的真实世界数据,包括患者的一般信息、用药情况、不良事件/反应信息等。结果:经过筛查、排除分析后,得到有效病例6269例,女性患者占74.94%(4698/6269),年龄在40岁以上的占92.57%(5803/6269)。适应病症集中在腰椎间盘突出症、颈椎病、骨关节炎。用药特点主要为透皮治疗,每日使用1次,每次用量为2 mL,平均疗程为8.22 d;发生不良反应136例,总体不良反应的发生率为2.17%(136/6269),不良反应的主要表现为皮肤瘙痒、咳嗽等,主要累及皮肤黏膜及其附件、呼吸系统、胃肠道等。发现新的不良反应7例,表现为眼睛瘙痒干涩、视物模糊不清、流泪不适5例,呃逆1例,便秘1例。腱鞘炎患者的不良反应率较高,为9.26%(5/54)。不良反应症状转归缓解的有41例,占不良反应总人数的30.15%(41/136);消失的有59例,占不良反应总人数的43.38%(59/136);症状持续的有7例,占不良反应总人数的5.15%(7/136);另外29例未注明不良反应结局,占21.32%(29/136)。结论:正清风痛宁注射液使用范围较广,且以中老年为主。医务人员在用正清风痛宁注射液治疗腱鞘炎时,需要重点关注其不良反应。正清风痛宁注射液不良反应以皮肤及附件和呼吸系统为主,所发生的不良反应程度轻微,预后良好,医务人员需熟悉正清风痛宁注射液常见的不良反应,及时发现并处理,确保用药安全。Objective:To investigate the medication characteristics and safety of Zhengqing Fengtongning injection in clinical use,including the types,incidence and related risk factors of adverse events/adverse reactions,then to further guide the clinical rational use of drugs and improve the drug instructions,and provide a basis for enterprises to formulate risk management plans.Methods:Using retrospective research methods,7613 cases treated with Zhengqing Fengtongning injection in two medical units of Hunan Academy of Traditional Chinese Medicine and Changsha Traditional Chinese Medicine Rehabilitation Hospital for three consecutive years were collected,and the real-world data of Zhengqing Fengtongning injection,including general patient information,medication status,adverse event/reaction information were extracted.Results:After screening and exclusion analysis,6269 effective cases were obtained,of which 74.94%(4698/6269)were female patients and 92.57%(5803/6269)were over 40 years old.The indications focus on lumbar disc herniation,cervical spondylosis,and osteoarthritis.The characteristics of medication are mainly trans-dermal treatment,once a day,the dosage is 2 mL each time,and the average course of treatment is 8.22 days.136 cases of adverse reactions were found and the overall incidence of adverse reactions was 2.17%(136/6269).The main types of adverse reactions were skin pruritus,cough,etc.,which mainly involved skin and mucous membranes and their accessories,respiratory system,gastrointestinal tract,etc.New adverse reactions were found in 7 cases,including pruritus and dryness of eyes,blurred vision,and discomfort in tears in 5 cases,hiccup in 1 case,and constipation in 1 case.The adverse reaction rate of patients with tenosynovitis was 9.26%(5/54).41 cases of adverse reactions were relieved,accounting for 30.15%(41/136)of the total number of adverse reactions;59 cases were cured,accounting for 43.38%(59/136)of the total number of adverse reactions;7 cases had persistent symptoms,accounting for 5.15%(7/136)of the

关 键 词：正清风痛宁注射液 临床安全性 不良事件 不良反应 

分 类 号：R288[医药卫生—中药学]