孟鲁司特钠片联合沙美特罗替卡松吸入气雾剂治疗老年中重度支气管哮喘有效性和安全性的系统评价

郑子恢; 潘慧杰; 张亚同; 马琳; 李文英; 原涵; 金鹏飞

doi:10.14009/j.issn.1672-2124.2021.10.019

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孟鲁司特钠片联合沙美特罗替卡松吸入气雾剂治疗老年中重度支气管哮喘有效性和安全性的系统评价

用药评价 | 更新时间：2022-10-08

- 孟鲁司特钠片联合沙美特罗替卡松吸入气雾剂治疗老年中重度支气管哮喘有效性和安全性的系统评价
- Systematic Review of Efficacy and Safety of Montelukast Sodium Tablets Combined with Salmeterol Xinafoate and Fluticasone Propionate Inhalation Aerosol in the Treatment of Moderate and Severe Bronchial Asthma in the Elderly
- 中国医院用药评价与分析 2021年21卷第10期页码：1227-1234
- 作者机构：
  
  1. 北京医院药学部国家老年医学中心中国医学科学院老年医学研究院北京市药物临床风险与个体化应用评价重点实验室(北京医院)
  2. 北京医院检验科国家老年医学中心中国医学科学院老年医学研究院
- 作者简介：
- 基金信息：
  
  国家重点研发计划项目(No.2020YFC2009001)
- DOI：10.14009/j.issn.1672-2124.2021.10.019
  中图分类号： R562.25
- 纸质出版日期：2021，
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郑子恢, 潘慧杰, 张亚同, 等. 孟鲁司特钠片联合沙美特罗替卡松吸入气雾剂治疗老年中重度支气管哮喘有效性和安全性的系统评价[J]. 中国医院用药评价与分析, 2021,21(10):1227-1234.

Systematic Review of Efficacy and Safety of Montelukast Sodium Tablets Combined with Salmeterol Xinafoate and Fluticasone Propionate Inhalation Aerosol in the Treatment of Moderate and Severe Bronchial Asthma in the Elderly[J]. 2021,21(10):1227-1234.
郑子恢, 潘慧杰, 张亚同, 等. 孟鲁司特钠片联合沙美特罗替卡松吸入气雾剂治疗老年中重度支气管哮喘有效性和安全性的系统评价[J]. 中国医院用药评价与分析, 2021,21(10):1227-1234. DOI： 10.14009/j.issn.1672-2124.2021.10.019.

Systematic Review of Efficacy and Safety of Montelukast Sodium Tablets Combined with Salmeterol Xinafoate and Fluticasone Propionate Inhalation Aerosol in the Treatment of Moderate and Severe Bronchial Asthma in the Elderly[J]. 2021,21(10):1227-1234. DOI： 10.14009/j.issn.1672-2124.2021.10.019.

摘要

目的:系统评价孟鲁司特钠片联合沙美特罗替卡松吸入气雾剂治疗老年中重度支气管哮喘的有效性和安全性。方法:计算机检索Embase、PubMed、the Cochrane Library、中国知网、万方数据库和中国生物医学文献数据库

纳入孟鲁司特钠片联合沙美特罗替卡松吸入气雾剂治疗老年中重度支气管哮喘的随机对照试验(研究组治疗方案为孟鲁司特钠片与沙美特罗替卡松吸入气雾剂联合治疗

对照组为单独使用沙美特罗替卡松吸入气雾剂治疗)

检索时间为建库至2021年6月。筛选文献、提取资料并评价纳入文献的偏倚风险后

采用Rev Man 5.4软件进行荟萃分析(Meta分析)。结果:共纳入21项研究

包括1 903患者(研究组患者958例

对照组患者945例)。Meta分析结果显示

有效性方面

研究组患者的总有效率(OR=3.95

95%CI=2.95～5.27

0.000 01)、显效率(OR=1.52

95%CI=1.23～1.89

0.000 1)、控制率(OR=2.05

95%CI=1.51～2.78

0.000 01)、第1秒用力呼气容积(FEV

)(SMD=1.47

95%CI=0.94～2.01

0.000 01)、哮喘控制测试量表评分(MD=4.36

95%CI=3.72～5.00

0.000 01)、呼气峰值流速(SMD=1.02

95%CI=0.63～1.40

0.000 01)、用力肺活量(FVC)(SMD=1.32

95%CI=0.66～1.99

0.000 1)和FEV

/FVC(SMD=2.59

95%CI=1.16～4.02

P=0.000 4)均显著优于对照组

差异均有统计学意义;安全性方面

研究组患者的不良反应发生率显著低于对照组

差异有统计学意义(OR=0.24

95%CI=0.09～0.59

P=0.002)。结论:现有证据表明

孟鲁司特钠片联合沙美特罗替卡松吸入气雾剂治疗老年中重度支气管哮喘

在疗效和安全性方面较单独使用沙美特罗替卡松吸入气雾剂有显著优势。因受纳入文献数量和质量的限制

上述结论有待今后更多高质量随机对照研究予以验证。

Abstract

OBJECTIVE: To systematically evaluate the efficacy and safety of Montelukast sodium tablets combined with salmeterol xinafoate and fluticasone propionate inhalation aerosol in the treatment of moderate and severe bronchial asthma in the elderly. METHODS: Embase

PubMed

the Cochrane Library

CNKI

Wanfang Data and CBM database were retrieved to collect the randomized controlled trial of Montelukast sodium tablets combined with salmeterol xinafoate and fluticasone propionate inhalation aerosol in the treatment of moderate and severe bronchial asthma in the elderly（the study group was given Montelukast sodium tablets combined with salmeterol xinafoate and fluticasone propionate inhalation aerosol

while the control group received salmeterol xinafoate and fluticasone propionate inhalation aerosol alone）

the retrieval time was from the establishment of the database to Jun. 2021. After literature screening

data extraction and evaluation of bias risk of included literature

RevMan 5. 4 software was used for metaanalysis. RESULTS: Totally 21 literature were collected

including 1 903 patients（958 patients in the study group and 945 patients in the control group）. Meta-analysis results show that the total effective rate（OR= 3. 95

95%CI= 2. 95-5. 27

0. 000 01）

significant effective rate（OR= 1. 52

95%CI= 1. 23-1. 89

0. 000 1）

control rate（OR= 2. 05

95%CI= 1. 51-2. 78

0. 000 01）

forced expiratory volume in one second（FEV

）（SMD= 1. 47

95%CI= 0. 94-2. 01

0. 000 01）

asthma control test score（MD= 4. 36

95%CI= 3. 72-5. 00

0. 000 01）

peak expiratory flow rate（SMD= 1. 02

95%CI= 0. 63-1. 40

0. 000 01）

forced vital capacity（FVC）（SMD= 1. 32

95%CI= 0. 66-1. 99

0. 000 1） and FEV

/FVC（SMD= 2. 59

95%CI= 1. 16-4. 02

P= 0. 000 4） in the study group were significantly better than those in the control group

the differences were statistically significant. The incidence of adverse drug reactions in the study group was significantly lower than that in the control group

and the difference was statistically significant（OR= 0. 24

95%CI= 0. 09-0. 59

P= 0. 002）. CONCLUSIONS: Available evidence indicates that Montelukast sodium tablets combined with salmeterol xinafoate and fluticasone propionate inhalation aerosol has significant efficacy and safety advantages over salmeterol xinafoate and fluticasone propionate inhalation aerosol alone in the treatment of elderly patients with moderate and severe bronchial asthma. Due to the limitation of the quantity and quality of the included literature

the above findings need to be validated by more high-quality randomized controlled studies in the future.

关键词

孟鲁司特钠片沙美特罗替卡松吸入气雾剂支气管哮喘Meta分析随机对照试验

Keywords

Montelukast sodium tabletsSalmeterol xinafoate and fluticasone propionate inhalation aerosoBronchial asthmaMeta-analysisRandomized controlled trial

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