止喘灵口服液治疗支气管哮喘有效性和安全性研究:一项随机开放平行对照的多中心临床试验  

Study on the efficacy and safety of Zhichuanling oral solution in the treatment of bronchial asthma:a randomized open,parallel controlled multicenter clinical trial

作　　者：王文雅 林江涛 孙增涛[2] 魏葆琳[2] 孙智娜[3] 孟自力[4] 孙辉[5] 周燕斌[6] 樊茂蓉[7] 张伟[8] 缪志龙 姜淑娟[10] 王静[11] 白明 WANG Wen-ya;LIN Jiang-tao;SUIN Zeng-ao;WEI bao-lin;SUN Zhi-na;MENG Zi-li;SUN Hui;ZHOU Yan-bin;FAN Mao-rong;ZHANG Wei;MIU Zhi-long;JIANG Shu-juan;WANG Jing;BAI Ming(National Center for Respiratory Medicine,State Key Laboratory of Respiratory Health and Multimorbidity,National Clinical Research Center for Respiratory Diseases,Institute of Respiratory Medicine,Chinese Academy of Medical Sciences,Department of Pulmonary and Critical Care Medicine,Center of Respiratory Medicine,China-Japan Friendship Hospital,Beijing 100029,China;不详)

机构地区：[1]国家呼吸医学中心呼吸和共病全国重点实验室国家呼吸疾病临床研究中心、中国医学科学院呼吸病学研究院、中日友好医院呼吸中心呼吸与危重症医学科,北京100029 [2]天津中医药大学第二附属医院,天津300150 [3]青海红十字医院,青海西宁810099 [4]淮安市第一人民医院,江苏淮安223399 [5]上海市肺科医院,上海200433 [6]中山大学附属第一医院,广东广州510062 [7]中国中医科学院西苑医院,北京100091 [8]山东中医药大学附属医院,山东济南250011 [9]镇江市中医院,江苏镇江212008 [10]山东省立医院,山东济南250021 [11]陕西省第二人民医院,陕西西安710068 [12]华中科技大学协和深圳医院,广东深圳518052

出　　处：《中国实用内科杂志》2023年第11期922-927,共6页Chinese Journal of Practical Internal Medicine

摘　　要：目的评价止喘灵口服液治疗支气管哮喘的有效性和安全性。方法以纳入的中国12家研究中心共计385例受试者作为研究对象,随机入组353例分为试验组(止喘灵组)、联合治疗组(止喘灵联合沙美特罗丙酸氟替卡松50/100μg吸入)和对照组(沙美特罗丙酸氟替卡松50/100μg吸入),观察各组治疗前后哮喘控制率、哮喘控制测试(ACT)评分、哮喘生命质量表(AQLQ)评分变化值及不良反应发生情况。结果止喘灵组102例,联合治疗组108例,沙美特罗丙酸氟替卡松对照组103例。治疗4周后,3组哮喘控制率分别为91.49%、90.10%和94.79%,止喘灵组不劣于对照组。3组ACT评分较基线变化值分别为(6.49±2.96)分、(7.07±2.75)分和(6.20±2.83)分,组间比较差异无统计学意义(P=0.0545)。3组AQLQ评分变化值分别为(39.30±24.03)分、(42.20±22.70)分和(37.18±26.75)分,组间比较差异无统计学意义(P>0.05),止喘灵组和沙美特罗丙酸氟替卡松对照组均有提高患者生活质量的作用且差异无统计学意义。结论止喘灵口服液可有效治疗支气管哮喘,疗效不差于沙美特罗丙酸氟替卡松粉吸入剂。相比单独用药,联合用药可能在控制哮喘发作、提高患者生活质量、改善临床症状、减少缓解药物用量方面发挥其优势。Objectivee To evaluate the efficacy and safety of Zhichuanling oral solution in the treatment of bronchial asthma.Methods A total of 385 subjects from 12 research centers in China were included as the study subjects.Totally 353 subjects were randomly divided into three groups:the test group(Zhichuanling group),the combined treatment group(Zhichuanling combinedwith salmeteroplropionatefluticasone50/100μg for inhalation)and thecontrol group(salmeterol propionate fluticasone 50/100μg for inhalation).The asthma control rate,the score of asthma control test(ACT),the changes in asthma quality of life table(AQLQ)score and the adverse reactionswere observed before and after treatment.ResultsTThere were 102 cases in the Zhichuanling group,108 cases in the combined treatment group,and 103 cases in the salmeterol and fluticasone control group.After 4 weeks of treatment,the asthma control rates of the three groups were 91.49%,90.10%and 94.79%,respectively,and the asthma control rate of the Zhichuanling group was not inferior to that of the salmeterol fluticasone group.The changes in ACT scores of the three groups were(6.49±2.96)points,(7.07±2.75)points and(6.20±2.83)points from the baseline,and there was no statistically significant difference among groups(P=0.0545).The change values of AQLQ scores in the three groups were(39.30±24.03)points,(42.20±22.70)points and(37.18±26.75)points,respectively,and there was no statistically significant difference among groups(P>0.05).It indicated that the Zhichuanling group and salmeterol fluticasone group had the effect of improving the patients'quality of life and there was no difference.The combined treatment group might have some advantages.Conclusion Zhichuanling oral solution can effectively treat bronchial asthma.Its efficacy is not inferior to that of salmeterol fluticasone.Compared with single medication,combined medication may have advantages in controlling asthma attacks,improving patients'quality of life,improving clinical symptoms,and reducing the dosage of relief dru

关 键 词：支气管哮喘 疗效 止喘灵 哮喘控制 

分 类 号：R562.25[医药卫生—呼吸系统]