基于真实世界的喜炎平注射液治疗肺炎患者特征和用药规律研究

Characteristics and medication rules of Xiyanping Injection in treatment of patients with pneumonia based on real world study

目的考察喜炎平注射液治疗肺炎患者的特征和用药规律,为其更好地发挥疗效和合理用药提供依据。方法从医院信息系统数据库中提取喜炎平注射液治疗肺炎患者的电子病历,使用SAS 9.2和R软件进行统计描述和关联规则分析。从知网、万方、维普、中国生物医学、PubMed、Cochrane Library、Embase、Web of Science检索2019年11月—2022年11月收录的喜炎平注射液治疗肺炎的临床研究,并与真实世界研究结果进行比较。结果通过检索共得到63篇喜炎平注射液治疗肺炎的临床研究文献。从电子病历共得到39038例患者,男女比例为1.78∶1,平均年龄(5.17±12.89)岁,且痰热证最为常见(35.82%)。关联分析发现喜炎平注射液常用的合并用药组合为中西药组合:皮质甾体激素类、清热剂→黏液溶解药;化学药组合:皮质甾体激素类、选择性β2肾上腺素受体促效药→黏液溶解药;抗感染药组合:皮质甾体激素类、第3代头孢菌素→黏液溶解药。患者出院转归的治愈率随年龄、喜炎平注射液疗程和日用药剂量呈现一定的规律:治愈率随日剂量/疗程增加呈现先增高后降低的趋势,即日剂量(5,25)mg治愈率72.55%,[25,50)mg治愈率75.26%,[50,100]mg治愈率80.19%,(100,250)mg治愈率63.09%,[250,500]mg治愈率44.6%;疗程1~3 d治愈率65.04%,4~7 d治愈率78.23%,8~14 d治愈率69.76%,15~28 d治愈率57.14%,28 d以上治愈率60%。治愈率随年龄增长先增高到4~6岁为顶点(81.79%),7~12岁陡降到51.18%,13~17岁略有升高(63.64%),然后逐渐降低。真实世界研究显示第2代头孢菌素是最常与喜炎平注射液联用治疗肺炎的抗生素,而近3年却鲜有文献报道二者联用治疗肺炎。仅有文献报道喜炎平注射液与布地奈德联用、与特布他林和布地奈德联用、与布地奈德和异丙托溴铵联用,均为治疗儿童支气管肺炎。结论喜炎平注射液的疗效与其用药剂量、疗程和患者年龄存在一定规律,临床试验文献报道和真实世界研究结果之间存在一定的差异,这为今后深入开展临床研究以更好地运用喜炎平注射液提供了线索。

Objective To investigate the characteristics and medication rules of Xiyanping Injection(喜炎平注射液) in the treatment of patients with pneumonia,so as to provide the basis for better efficacy and rational drug use.Methods The electronic medical records of patients with pneumonia treated by Xiyanping Injection were extracted from the hospital information system database.SAS 9.2 and R software were used for statistical description and association rule analysis.The clinical studies on Xiyanping Injection in the treatment of pneumonia collected from CNKI,Wanfang,VIP,China Biomedicine,PubMed,Cochrane Library,Embase and Web of Science from November 2019 to November 2022 were retrieved,and the results were compared with those in the real world.Results A total of 63 clinical studies on Xiyanping injection in the treatment of pneumonia were obtained.A total of 39 038 patients were obtained from electronic medical records,the ratio of male to female was 1.78︰1,the average age was(5.17 ± 12.89) years old,and phlegm-heat syndrome was the most common(35.82%).Association analysis showed that the commonly used combination of Xiyanping Injection was Chinese and Western medicine combination:corticosteroid hormones,heat-clearing agents → mucolytic agents;Western medicine combination:corticosteroid hormones,selectivity β2 adrenergic receptor agonists → mucolytic agents;Antiinfective drug combination:corticosteroid hormones,the third generation of cephalosporins → mucolytic agents.The cure rate of discharged patients showed certain rules with age,course of Xiyanping Injection and daily dosage:The cure rate firstly increased and then decreased with the increase of daily dose/course.The cure rate of daily dose(5,25) mg was 72.55%,[25,50) mg was 75.26%,[50,100] mg was 80.19%,(100,250) mg was 63.09%,[250,500] mg was 44.6%.The cure rate was 65.04% after 1—3 d,78.23% after 4—7 d,69.76% after 8—14 d,57.14% after 15—28 d,and 60% after 28 d.The cure rate increased with age first to the peak of 4—6years old(81.79%),dropped sharply to 51.18% at 7—12 years old,slightly increased at 13—17 years old(63.64%),and then gradually decreased.Real-world studies have shown that the second-generation cephalosporin was the most commonly used antibiotic in combination with Xiyanping Injection in the treatment of pneumonia,but in recent three years,there have been few reports on the combination of the two in the treatment of pneumonia.It was only reported that Xiyanping Injection combined with budesonide,or terbutaline and budesonide,or budesonide and ipratropium bromide were used in the treatment of bronchopneumonia in children.Conclusion The efficacy of Xiyanping Injection has certain rules with its dosage,course of treatment and age of patients,and there are some differences between the results reported in clinical trials and real world studies,which provides clues for further clinical studies to better use Xiyanping Injection in the future.