Article(id=1292126363805311802, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.04.002, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1768147200000, receivedDateStr=2026-01-12, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996531677, onlineDateStr=2026-08-06, pubDate=1772208000000, pubDateStr=2026-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996531677, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996531677, creator=13701087609, updateTime=1785996531677, updator=13701087609, issue=Issue{id=1292126355785802497, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='4', pageStart='451', pageEnd='600', issueExtLink='null', onlineDate='null', pubDate='1772208000000', pubDateStr='2026-02-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996529766, creator='13701087609', updateTime=1786014519902, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201811952292026, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201811952292027, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126355785802497, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=457, endPage=463, ext={EN=ArticleExt(id=1292126363994055483, articleId=1292126363805311802, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of salmeterol/fluticasone combined with cetirizine for allergic rhinitis complicated by small airway dysfunction in children, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective

To observe the efficacy and safety of salmeterol/fluticasone propionate inhalation powder combined with cetirizine oral solution in the treatment of allergic rhinitis (AR) complicated with small airway dysfunction (SAD) in children.

Methods

Children with AR and SAD were divided into control group and treatment group using a random number table method. Both groups were given montelukast sodium chewable tablets as basic treatment, taken before bedtime, 4 mg each time, once a day; children in the control group were additionally treated with cetirizine oral solution on the basis of the basic medication, 2.5~10 mL per dose according to age once a day, for 12 consecutive weeks. The treatment group was given salmeterol/fluticasone propionate inhalation powder inhalation powder by oral inhalation on the basis of the control group’s treatment, 1 inhalation each time, twice a day, for 12 consecutive weeks. The clinical efficacy, lung function, eosinophil (Eos) count, inflammatory response indicators, recurrence rate were compared between the two groups, and safety evaluation was conducted.

Results

A total of 83 cases were enrolled, with 39 cases in the control group and 44 cases in the treatment group. After treatment, the total effective rates of the control group and the treatment group were 74.36% (29 cases/39 cases) and 90.91% (40 cases/44 cases), respectively, with statistically significant difference (P<0.05). After treatment, the forced expiratory volume in 1 second (FEV1) of the control group and the treatment group were 88.75±3.20 and 90.49±3.26, respectively; FEV1/maximal vital capacity (VCmax) were 89.47±10.83 and 94.57±10.21, respectively; maximal mid-expiratory flow (MMEF) pred were (61.06±6.72)% and (64.39±6.34)%, respectively; Eos counts were (4.81±0.72)% and (4.45±0.68)%, respectively; fraction of exhaled nitric oxide (FeNO) were (24.92±3.30) and (22.86±3.18) ppb, respectively; T-cell immunoglobulin domain and mucin domain protein-1 (Tim-1) were (125.08±20.19) and (113.27±18.06) ng·L-1, respectively; high mobility group box 1 protein (HMGB1) were (5.12±0.94) and (4.65±0.79) ng·L-1, respectively, with statistically significant differences (P<0.05, P<0.01). The main adverse drug reactions in the control group were headache, drowsiness, nausea and vomiting, and the main adverse drug reactions in the treatment group were nausea and vomiting, headache and oropharyngeal candidiasis. The total incidence of adverse reactions in the control group and the treatment group were 7.69% (3 cases/39 cases) and 11.36% (5 cases/44 cases), respectively, and the difference was not statistically significant (P>0.05). The recurrence rates of the control group and the treatment group were 33.33% (13 cases/39 cases) and 13.64% (6 cases/44 cases), respectively, with statistically significant difference (P<0.05).

Conclusion

Salmeterol/fluticasone propionate inhalation powder combined with cetirizine oral solution in the treatment of children with AR complicated with SAD can significantly improve efficacy, relieve clinical symptoms, improve lung function, reduce inflammation levels, and has good safety and a low recurrence rate.

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目的

观察沙美特罗替卡松吸入粉雾剂联合西替利嗪口服溶液治疗儿童过敏性鼻炎(AR)合并小气道功能障碍(SAD)的临床疗效和安全性。

方法

将AR合并SAD的患儿按照随机数表法分为对照组与试验组。2组患儿均给予孟鲁司特钠咀嚼片基础治疗,睡前服用,每次4 mg,每天1次,对照组患儿在此基础上给予西替利嗪口服溶液治疗,根据年龄每次给予2.5~10 mL,每天1次;试验组在对照组基础上经口吸入沙美特罗替卡松吸入粉雾剂,每次1吸,每天2次。2组均连续治疗12 w。比较2组的临床疗效、肺功能、嗜酸性粒细胞(Eos)计数及炎症反应指标水平和复发率并进行安全性评价。

结果

本研究共纳入83例患儿,对照组39例,试验组44例。治疗后,对照组和试验组的治疗总有效率分别为74.36%(29例/39例)和90.91%(40例/44例),在统计学上差异有统计学意义(P<0.05)。治疗后,对照组和试验组的第1 s用力呼气容积(FEV1)分别为88.75±3.20和90.49±3.26,FEV1/最大肺活量(VCmax)分别为89.47±10.83和94.57±10.21,最大呼气中期流量(MMEF)pred分别为(61.06±6.72)%和(64.39±6.34)%,Eos计数分别为(4.81±0.72)%和(4.45±0.68)%,呼出气一氧化氮分数(FeNO)分别为(24.92±3.30)和(22.86±3.18)ppb,T细胞免疫球蛋白域黏蛋白域蛋白-1(Tim-1)分别为(125.08±20.19)和(113.27±18.06)ng·L-1,高迁移率族蛋白B1(HMGB1)分别为(5.12±0.94)和(4.65±0.79)ng·L-1,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(P<0.05,P<0.01)。对照组的药物不良反应主要有头痛、嗜睡、恶心呕吐,试验组的药物不良反应主要有恶心呕吐、头痛、口咽部念珠菌病,对照组和试验组的药物不良反应总发生率分别为7.69%(3例/39例)和11.36%(5例/44例),在统计学上差异无统计学意义(P>0.05)。对照组和试验组的复发率分别为33.33%(13例/39例)和13.64%(6例/44例),在统计学上差异有统计学意义(P<0.05)。

结论

沙美特罗替卡松吸入粉雾剂联合西替利嗪口服溶液治疗儿童AR合并SAD可显著提高疗效,缓解临床症状,改善肺功能,降低炎症水平,且安全性良好,复发率较低。

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康利娜(1982-),女,副主任医师,主要从事儿童过敏性鼻炎合并小气道功能障碍与哮喘的工作和研究

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康利娜 MP: 13731063506 E-mail:
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沙美特罗替卡松联合西替利嗪治疗儿童过敏性鼻炎合并小气道功能障碍的临床研究
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康利娜 1 , 张菲菲 2 , 安红 1 , 冯树青 1 , 国春柘 1
中国临床药理学杂志 | 临床与基础桥接研究 2026,42(4): 457-463
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中国临床药理学杂志 |临床与基础桥接研究 2026 , 42 (4) : 457 -463
沙美特罗替卡松联合西替利嗪治疗儿童过敏性鼻炎合并小气道功能障碍的临床研究
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康利娜(1982-),女,副主任医师,主要从事儿童过敏性鼻炎合并小气道功能障碍与哮喘的工作和研究

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康利娜(1982-),女,副主任医师,主要从事儿童过敏性鼻炎合并小气道功能障碍与哮喘的工作和研究

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康利娜1 , 张菲菲2, 安红1, 冯树青1, 国春柘1
作者信息
  • 1.邢台市人民医院 儿二科,河北 邢台 054000
  • 2.邢台医学院 临床医学系,河北 邢台 054000
通讯作者:
康利娜 MP: 13731063506 E-mail:
作者简介:

康利娜(1982-),女,副主任医师,主要从事儿童过敏性鼻炎合并小气道功能障碍与哮喘的工作和研究

Clinical trial of salmeterol/fluticasone combined with cetirizine for allergic rhinitis complicated by small airway dysfunction in children
Li-na KANG1 , Fei-fei ZHANG2, Hong AN1, Shu-qing FENG1, Chun-zhe GUO1
Affiliations
  • 1.Department of Pediatrics Ⅱ, Xingtai People’s Hospital, Xingtai 054000, Hebei Province, China
  • 2.Department of Clinical Medicine, Xingtai Medical College, Xingtai 054000, Hebei Province, China
出版时间: 2026-02-28 doi: 10.13699/j.cnki.1001-6821.2026.04.002
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目的

观察沙美特罗替卡松吸入粉雾剂联合西替利嗪口服溶液治疗儿童过敏性鼻炎(AR)合并小气道功能障碍(SAD)的临床疗效和安全性。

方法

将AR合并SAD的患儿按照随机数表法分为对照组与试验组。2组患儿均给予孟鲁司特钠咀嚼片基础治疗,睡前服用,每次4 mg,每天1次,对照组患儿在此基础上给予西替利嗪口服溶液治疗,根据年龄每次给予2.5~10 mL,每天1次;试验组在对照组基础上经口吸入沙美特罗替卡松吸入粉雾剂,每次1吸,每天2次。2组均连续治疗12 w。比较2组的临床疗效、肺功能、嗜酸性粒细胞(Eos)计数及炎症反应指标水平和复发率并进行安全性评价。

结果

本研究共纳入83例患儿,对照组39例,试验组44例。治疗后,对照组和试验组的治疗总有效率分别为74.36%(29例/39例)和90.91%(40例/44例),在统计学上差异有统计学意义(P<0.05)。治疗后,对照组和试验组的第1 s用力呼气容积(FEV1)分别为88.75±3.20和90.49±3.26,FEV1/最大肺活量(VCmax)分别为89.47±10.83和94.57±10.21,最大呼气中期流量(MMEF)pred分别为(61.06±6.72)%和(64.39±6.34)%,Eos计数分别为(4.81±0.72)%和(4.45±0.68)%,呼出气一氧化氮分数(FeNO)分别为(24.92±3.30)和(22.86±3.18)ppb,T细胞免疫球蛋白域黏蛋白域蛋白-1(Tim-1)分别为(125.08±20.19)和(113.27±18.06)ng·L-1,高迁移率族蛋白B1(HMGB1)分别为(5.12±0.94)和(4.65±0.79)ng·L-1,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(P<0.05,P<0.01)。对照组的药物不良反应主要有头痛、嗜睡、恶心呕吐,试验组的药物不良反应主要有恶心呕吐、头痛、口咽部念珠菌病,对照组和试验组的药物不良反应总发生率分别为7.69%(3例/39例)和11.36%(5例/44例),在统计学上差异无统计学意义(P>0.05)。对照组和试验组的复发率分别为33.33%(13例/39例)和13.64%(6例/44例),在统计学上差异有统计学意义(P<0.05)。

结论

沙美特罗替卡松吸入粉雾剂联合西替利嗪口服溶液治疗儿童AR合并SAD可显著提高疗效,缓解临床症状,改善肺功能,降低炎症水平,且安全性良好,复发率较低。

沙美特罗替卡松吸入粉雾剂  /  西替利嗪口服溶液  /  过敏性鼻炎  /  小气道功能障碍  /  儿童
Objective

To observe the efficacy and safety of salmeterol/fluticasone propionate inhalation powder combined with cetirizine oral solution in the treatment of allergic rhinitis (AR) complicated with small airway dysfunction (SAD) in children.

Methods

Children with AR and SAD were divided into control group and treatment group using a random number table method. Both groups were given montelukast sodium chewable tablets as basic treatment, taken before bedtime, 4 mg each time, once a day; children in the control group were additionally treated with cetirizine oral solution on the basis of the basic medication, 2.5~10 mL per dose according to age once a day, for 12 consecutive weeks. The treatment group was given salmeterol/fluticasone propionate inhalation powder inhalation powder by oral inhalation on the basis of the control group’s treatment, 1 inhalation each time, twice a day, for 12 consecutive weeks. The clinical efficacy, lung function, eosinophil (Eos) count, inflammatory response indicators, recurrence rate were compared between the two groups, and safety evaluation was conducted.

Results

A total of 83 cases were enrolled, with 39 cases in the control group and 44 cases in the treatment group. After treatment, the total effective rates of the control group and the treatment group were 74.36% (29 cases/39 cases) and 90.91% (40 cases/44 cases), respectively, with statistically significant difference (P<0.05). After treatment, the forced expiratory volume in 1 second (FEV1) of the control group and the treatment group were 88.75±3.20 and 90.49±3.26, respectively; FEV1/maximal vital capacity (VCmax) were 89.47±10.83 and 94.57±10.21, respectively; maximal mid-expiratory flow (MMEF) pred were (61.06±6.72)% and (64.39±6.34)%, respectively; Eos counts were (4.81±0.72)% and (4.45±0.68)%, respectively; fraction of exhaled nitric oxide (FeNO) were (24.92±3.30) and (22.86±3.18) ppb, respectively; T-cell immunoglobulin domain and mucin domain protein-1 (Tim-1) were (125.08±20.19) and (113.27±18.06) ng·L-1, respectively; high mobility group box 1 protein (HMGB1) were (5.12±0.94) and (4.65±0.79) ng·L-1, respectively, with statistically significant differences (P<0.05, P<0.01). The main adverse drug reactions in the control group were headache, drowsiness, nausea and vomiting, and the main adverse drug reactions in the treatment group were nausea and vomiting, headache and oropharyngeal candidiasis. The total incidence of adverse reactions in the control group and the treatment group were 7.69% (3 cases/39 cases) and 11.36% (5 cases/44 cases), respectively, and the difference was not statistically significant (P>0.05). The recurrence rates of the control group and the treatment group were 33.33% (13 cases/39 cases) and 13.64% (6 cases/44 cases), respectively, with statistically significant difference (P<0.05).

Conclusion

Salmeterol/fluticasone propionate inhalation powder combined with cetirizine oral solution in the treatment of children with AR complicated with SAD can significantly improve efficacy, relieve clinical symptoms, improve lung function, reduce inflammation levels, and has good safety and a low recurrence rate.

salmeterol/fluticasone propionate inhalation powder  /  cetirizine oral solution  /  allergic rhinitis  /  small airway dysfunction  /  children
康利娜, 张菲菲, 安红, 冯树青, 国春柘. 沙美特罗替卡松联合西替利嗪治疗儿童过敏性鼻炎合并小气道功能障碍的临床研究. 中国临床药理学杂志, 2026 , 42 (4) : 457 -463 . DOI: 10.13699/j.cnki.1001-6821.2026.04.002
Li-na KANG, Fei-fei ZHANG, Hong AN, Shu-qing FENG, Chun-zhe GUO. Clinical trial of salmeterol/fluticasone combined with cetirizine for allergic rhinitis complicated by small airway dysfunction in children[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (4) : 457 -463 . DOI: 10.13699/j.cnki.1001-6821.2026.04.002
  • 邢台市重点研发计划自筹项目(2022ZC067)
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doi: 10.13699/j.cnki.1001-6821.2026.04.002
  • 接收时间:2026-01-12
  • 首发时间:2026-08-06
  • 出版时间:2026-02-28
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  • 收稿日期:2026-01-12
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邢台市重点研发计划自筹项目(2022ZC067)
作者信息
    1.邢台市人民医院 儿二科,河北 邢台 054000
    2.邢台医学院 临床医学系,河北 邢台 054000

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康利娜 MP: 13731063506 E-mail:
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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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