2608例正清风痛宁注射液医院集中监测分析  

Intensive Hospital Monitoring of 2608 Cases Treated with Zhengqing Fengtongning Injection

作　　者：张冬[1] 钟露苗[2] 杜娟[2] 彭晓珊 李璐璐 仇萍 谷丽红 ZHANG Dong;ZHONG Lumiao;DU Juan;PENG Xiaoshan;LI Lulu;QIU Ping;GU Lihong(Research Institute of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin,China 300193;Hunan Drug Evaluation,Certification and Adverse Reaction Monitoring Center,Changsha,Hunan,China 411000;Hunan Zhengqing Pharmaceutical Group Co.,Ltd.,Huaihua,Hunan,China 418000)

机构地区：[1]天津中医药大学中医药研究院,天津300193 [2]湖南省药品审评认证与不良反应监测中心,湖南长沙411000 [3]湖南正清制药集团股份有限公司,湖南怀化418000

出　　处：《中国药业》2023年第5期111-115,共5页China Pharmaceuticals

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研项目[2021002]。

摘　　要：目的评价正清风痛宁注射液治疗骨关节炎的有效性和安全性。方法选取湖南省中医药研究院附属医院2015年1月至2017年12月收治的正清风痛宁注射液治疗骨关节炎病例122例及湖南省长沙市中医康复医院2013年1月至2015年12月收治的相关病例2486例,收集病例报告表信息,包括一般资料、用药信息、有效性指标、安全性指标,并分析药品不良反应(ADR)相关影响因素。结果共纳入2608例病例。正清风痛宁注射液治疗骨关节炎的专科项目评分由治疗前的(9.96±2.86)分降至治疗后的(3.19±1.91)分;临床疗效评价为显效和有效的分别有1087例(41.68%)和1453例(55.71%),总有效率为97.39%。治疗过程中,共发生ADR 48例(1.84%),主要累及呼吸系统、皮肤黏膜及其附件,以咳嗽咳痰、咽干咽痛、皮肤瘙痒为主要表现。ADR发生后,89.58%患者的正清风痛宁注射液使用剂量未改变;对97.92%患者的原患疾病影响不明显;ADR结局以消失和缓解为主,分别占47.92%和35.42%。ADR与年龄、性别、疗程、给药途径、每天使用次数、单次用量、合并用药等因素均无相关性(P>0.05)。结论正清风痛宁注射液治疗骨关节炎的临床疗效较好,安全性较高。Objective To evaluate the effectiveness and safety of Zhengqing Fengtongning Injection in the treatment of osteoarthritis.MethodsA total of 122 patients with osteoarthritis treated with Zhengqing Fengtongning Injection admitted to the Affiliated Hospital of Hunan Academy of Chinese Medicine from January 2015 to December 2017 and 2486 related patients admitted to the Changsha Rehabilitation Hospital of Traditional Chinese Medicine from January 2013 to December 2015 were selected,the information in the case report form including general information,medication information,effectiveness indicators and safety indicators were recorded,and the related influencing factors of adverse drug reactions(ADR)were analyzed.ResultsA total of 2608patients were included.The scores of special items of Zhengqing Fengtongning Injection in the treatment of osteoarthritis decreased from(9.96±2.86)points before treatment to(3.19±1.91)points after treatment.There were 1087 cases(41.68%)with the clinical efficacy of significant effectiveness and 1453 cases(55.71%)with the clinical efficacy of effectiveness,with the total effective rate of 97.39%.During the treatment,48 cases(1.84%)had ADR,mainly involving the respiratory system,skin,mucosa and their appendages,and with cough,expectoration,dry throat,sore throat and skin pruritus as the main manifestations.After the occurrence of ADR,the dosage of Zhengqing Fengtongning Injection in 89.58%of patients did not change.ADR had no obvious effect on the primary disease in 97.92%of patients.The main outcomes of ADR were disappearance and remission,accounting for47.92%and 35.42%respectively.There was no correlation between ADR and age,sex,course of treatment,route of administration,times of use per day,single dose,combined medication and other factors(P>0.05).ConclusionZhengqing Fengtongning Injection is effective and safe in the treatment of osteoarthritis.

关 键 词：正清风痛宁注射液 骨关节炎 医院集中监测 安全性 有效性 合理用药 

分 类 号：R932[医药卫生—生药学] R288[医药卫生—药学]