Article(id=1291405044121850545, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404807152067353, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.08.002, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1731168000000, receivedDateStr=2024-11-10, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824555664, onlineDateStr=2026-08-04, pubDate=1745769600000, pubDateStr=2025-04-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824555664, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824555663, creator=13701087609, updateTime=1785824555663, updator=13701087609, issue=Issue{id=1291404807152067353, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='8', pageStart='1051', pageEnd='1200', issueExtLink='null', onlineDate='null', pubDate='1745769600000', pubDateStr='2025-04-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824499166, creator='13701087609', updateTime=1785824499166, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1056, endPage=1061, ext={EN=ArticleExt(id=1291405044629361330, articleId=1291405044121850545, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of omalizumab combined with salmetero ticasone in the treatment of patients with chest tightness variant asthma, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective

To observe the clinical efficacy and safety of omalizumab injection combined with salmeterol ticasone inhalation powder in the treatment of patients with chest tightness variant asthma (CTVA).

Methods

Patients with CTVA were randomly divided into treatment group and control group. Patients in the control group were given salmeterol ticasone inhalation powder one puff each time, twice a day. Treatment group was given subcutaneous injection of omalizumab injection on the basis of control group, 150-600 mg per time according to symptoms, once every 4 weeks, continuous treatment for 12 weeks. Clinical efficacy, improvement of symptoms, airway resistance and lung function and safety were compared between the two groups.

Results

A total of 10 cases dropped out during the trial, and 49 cases and 48 cases were included in the final control group and treatment group, respectively. After treatment, the total effective rates of the control group and treatment group were 79.59% (39 cases/49 cases) and 93.75% (45 cases/48 cases), respectively, with statistical significance (P<0.05). After treatment, the daytime cough scores of the control group and the treatment group were (0.51±0.17) and (0.42±0.13) score, the nighttime cough scores were (0.72±0.20) and (0.54±0.18) score, and the chest tightness scores were (0.44±0.12) and (0.37±0.09) score, forced expiratory volume in one second was (2.44±0.33) and (2.60±0.37) L, peak expiratory flow rates were (4.72±0.45) and (4.95±0.39) L·s-1, total airway resistance measured value/predicted values were 126.34±10.77 and 121.94±9.28, central airway resistance measured value/predicted values were 86.47±6.20 and 82.16±7.33, and the differences were statistically significant (all P<0.05). The adverse drug reactions in the treatment group mainly included mild oropharyngeal edema, headache, swelling at the injection site, and epigastric pain, while those in the control group mainly included mild oropharyngeal edema, subjective palpitation, and headache. The total incidences of adverse drug reactions in the treatment group and the control group were 10.42% (5 cases/48 cases) and 8.16% (4 cases/49 cases), respectively. There was no statistically significant difference (P>0.05).

Conclusion

Omalizumab injection combined with salmeterol ticasone inhalation powder is more effective than monotherapy in the treatment of patients with CTVA, without increasing the incidences of adverse drug reactions.

, authors=Ye-ting SHI1, 2, Fang CHEN2, authorsList=Ye-ting SHI, Fang CHEN, authorCompany=null, correspAuthors=Fang CHEN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291405046562935475, articleId=1291405044121850545, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=奥马珠单抗联合沙美特罗替卡松治疗胸闷变异性哮喘患者的临床研究, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的

观察注射用奥马珠单抗联合沙美特罗替卡松吸入粉雾剂治疗胸闷变异性哮喘(CTVA)患者的临床疗效及安全性。

方法

将CTVA患者随机分为试验组和对照组。对照组予以沙美特罗替卡松吸入粉雾剂每次1吸,每天2次;试验组在对照组治疗的基础上,予以注射用奥马珠单抗皮下注射,根据症状予以每天150~600 mg,每4周给药1次,持续治疗12周。比较2组患者的临床疗效、相关症状改善情况、气道阻力和肺功能指标变化,以及安全性。

结果

试验过程中共脱落10例,最终对照组和试验组分别纳入49例和48例。治疗后,对照组和试验组的总有效率分别为79.59%(39例/49例)和93.75%(45例/48例),在统计学上差异有统计学意义(P<0.05)。治疗后,对照组和试验组的日间咳嗽评分分别为(0.51±0.17)和(0.42±0.13)分,夜间咳嗽评分分别为(0.72±0.20)和(0.54±0.18)分,胸闷评分分别为(0.44±0.12)和(0.37±0.09)分,第1秒用力呼气容积分别为(2.44±0.33)和(2.60±0.37)L、呼气高峰流量分别为(4.72±0.45)和(4.95±0.39)L·s-1,总气道阻力实测值/预计值分别为126.34±10.77和121.94±9.28,中心气道阻力实测值/预计值分别为86.47±6.20和82.16±7.33,在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有轻度口咽水肿、头痛、注射部位肿胀和上腹痛,对照组的药物不良反应主要有轻度口咽水肿、主观性心悸和头痛。试验组和对照组的总药物不良反应发生率分别为10.42%(5例/48例)和8.16%(4例/49例),在统计学上差异无统计学意义(P>0.05)。

结论

注射用奥马珠单抗联合沙美特罗替卡松吸入粉雾剂较单一用药治疗CTVA患者的临床疗效更佳,且不增加药物不良反应发生率。

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施烨汀(1998-),男,硕士研究生,主要从事呼吸病学方面的相关研究

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陈芳,主任中医师,硕士生导师 MP: 13867130008 E-mail:
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奥马珠单抗联合沙美特罗替卡松治疗胸闷变异性哮喘患者的临床研究
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施烨汀 1, 2 , 陈芳 2
中国临床药理学杂志 | 临床与基础桥接研究 2025,41(8): 1056-1061
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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (8) : 1056 -1061
奥马珠单抗联合沙美特罗替卡松治疗胸闷变异性哮喘患者的临床研究
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施烨汀(1998-),男,硕士研究生,主要从事呼吸病学方面的相关研究

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施烨汀1, 2, 陈芳2
作者信息
  • 1.浙江中医药大学 第一临床医学院,浙江 杭州 310000
  • 2.浙江中医药大学 附属第一医院 肺功能室,浙江 杭州 310006
通讯作者:
陈芳,主任中医师,硕士生导师 MP: 13867130008 E-mail:
作者简介:

施烨汀(1998-),男,硕士研究生,主要从事呼吸病学方面的相关研究

Clinical trial of omalizumab combined with salmetero ticasone in the treatment of patients with chest tightness variant asthma
Ye-ting SHI1, 2, Fang CHEN2
Affiliations
  • 1.The First Clinical College, Zhejiang Chinese Medicine University, Hangzhou 310000, Zhejiang Province, China
  • 2.Department of Pulmonary Function, The First Affiliated Hospital of Zhejiang Chinese Medicine University, Hangzhou 310006, Zhejiang Province, China
出版时间: 2025-04-28 doi: 10.13699/j.cnki.1001-6821.2025.08.002
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目的

观察注射用奥马珠单抗联合沙美特罗替卡松吸入粉雾剂治疗胸闷变异性哮喘(CTVA)患者的临床疗效及安全性。

方法

将CTVA患者随机分为试验组和对照组。对照组予以沙美特罗替卡松吸入粉雾剂每次1吸,每天2次;试验组在对照组治疗的基础上,予以注射用奥马珠单抗皮下注射,根据症状予以每天150~600 mg,每4周给药1次,持续治疗12周。比较2组患者的临床疗效、相关症状改善情况、气道阻力和肺功能指标变化,以及安全性。

结果

试验过程中共脱落10例,最终对照组和试验组分别纳入49例和48例。治疗后,对照组和试验组的总有效率分别为79.59%(39例/49例)和93.75%(45例/48例),在统计学上差异有统计学意义(P<0.05)。治疗后,对照组和试验组的日间咳嗽评分分别为(0.51±0.17)和(0.42±0.13)分,夜间咳嗽评分分别为(0.72±0.20)和(0.54±0.18)分,胸闷评分分别为(0.44±0.12)和(0.37±0.09)分,第1秒用力呼气容积分别为(2.44±0.33)和(2.60±0.37)L、呼气高峰流量分别为(4.72±0.45)和(4.95±0.39)L·s-1,总气道阻力实测值/预计值分别为126.34±10.77和121.94±9.28,中心气道阻力实测值/预计值分别为86.47±6.20和82.16±7.33,在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有轻度口咽水肿、头痛、注射部位肿胀和上腹痛,对照组的药物不良反应主要有轻度口咽水肿、主观性心悸和头痛。试验组和对照组的总药物不良反应发生率分别为10.42%(5例/48例)和8.16%(4例/49例),在统计学上差异无统计学意义(P>0.05)。

结论

注射用奥马珠单抗联合沙美特罗替卡松吸入粉雾剂较单一用药治疗CTVA患者的临床疗效更佳,且不增加药物不良反应发生率。

注射用奥马珠单抗  /  胸闷变异性哮喘  /  炎症  /  气道阻力  /  气道重塑
Objective

To observe the clinical efficacy and safety of omalizumab injection combined with salmeterol ticasone inhalation powder in the treatment of patients with chest tightness variant asthma (CTVA).

Methods

Patients with CTVA were randomly divided into treatment group and control group. Patients in the control group were given salmeterol ticasone inhalation powder one puff each time, twice a day. Treatment group was given subcutaneous injection of omalizumab injection on the basis of control group, 150-600 mg per time according to symptoms, once every 4 weeks, continuous treatment for 12 weeks. Clinical efficacy, improvement of symptoms, airway resistance and lung function and safety were compared between the two groups.

Results

A total of 10 cases dropped out during the trial, and 49 cases and 48 cases were included in the final control group and treatment group, respectively. After treatment, the total effective rates of the control group and treatment group were 79.59% (39 cases/49 cases) and 93.75% (45 cases/48 cases), respectively, with statistical significance (P<0.05). After treatment, the daytime cough scores of the control group and the treatment group were (0.51±0.17) and (0.42±0.13) score, the nighttime cough scores were (0.72±0.20) and (0.54±0.18) score, and the chest tightness scores were (0.44±0.12) and (0.37±0.09) score, forced expiratory volume in one second was (2.44±0.33) and (2.60±0.37) L, peak expiratory flow rates were (4.72±0.45) and (4.95±0.39) L·s-1, total airway resistance measured value/predicted values were 126.34±10.77 and 121.94±9.28, central airway resistance measured value/predicted values were 86.47±6.20 and 82.16±7.33, and the differences were statistically significant (all P<0.05). The adverse drug reactions in the treatment group mainly included mild oropharyngeal edema, headache, swelling at the injection site, and epigastric pain, while those in the control group mainly included mild oropharyngeal edema, subjective palpitation, and headache. The total incidences of adverse drug reactions in the treatment group and the control group were 10.42% (5 cases/48 cases) and 8.16% (4 cases/49 cases), respectively. There was no statistically significant difference (P>0.05).

Conclusion

Omalizumab injection combined with salmeterol ticasone inhalation powder is more effective than monotherapy in the treatment of patients with CTVA, without increasing the incidences of adverse drug reactions.

omalizumab injection  /  chest tightness variant asthma  /  inflammation  /  airway resistance  /  airway remodeling
施烨汀, 陈芳. 奥马珠单抗联合沙美特罗替卡松治疗胸闷变异性哮喘患者的临床研究. 中国临床药理学杂志, 2025 , 41 (8) : 1056 -1061 . DOI: 10.13699/j.cnki.1001-6821.2025.08.002
Ye-ting SHI, Fang CHEN. Clinical trial of omalizumab combined with salmetero ticasone in the treatment of patients with chest tightness variant asthma[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (8) : 1056 -1061 . DOI: 10.13699/j.cnki.1001-6821.2025.08.002

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doi: 10.13699/j.cnki.1001-6821.2025.08.002
  • 接收时间:2024-11-10
  • 首发时间:2026-08-04
  • 出版时间:2025-04-28
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  • 收稿日期:2024-11-10
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作者信息
    1.浙江中医药大学 第一临床医学院,浙江 杭州 310000
    2.浙江中医药大学 附属第一医院 肺功能室,浙江 杭州 310006

通讯作者:

陈芳,主任中医师,硕士生导师 MP: 13867130008 E-mail:
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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2025.08.002
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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