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赛培新增产品文献：人MIP-1α，MCP -1，IL-1β，IL-8 ELISA试剂盒
发布时间：2022-04-08 11:03:29
奥马珠单抗联合布地奈德福莫特罗粉吸入剂 治疗中、重度过敏性哮喘患儿的临床研究
Clinical trial of omazumab combined with budesonide and formoterol powder inhalation in the treatment of children with moderate and severe allergic asthma
摘要: 目的 观察奥马珠单抗联合布地奈德福莫特罗粉吸入剂治疗中、重度过敏 性哮喘患儿的临床疗效及安全性。方法 将 133 例中、重度过敏性哮喘患儿随 机分为对照组 67 例和试验组 66 例。对照组给予布地奈德福莫特罗粉吸入剂吸 入治疗，每次 164. 5 μg，bid，12 周后改为每次 164. 5 μg，qd，维持至 16 周; 试验组 在对照组治疗的基础上，给予奥马珠单抗每次 150 ～ 600 mg，2 次给药时间间隔 2 周或 4 周，皮下注射，治疗 16 周。比较 2 组患儿的临床疗效、儿童哮喘控制测试 ( C － ACT) 评分、肺功能，以及药物不良反应的发生情况。结果 试验过程中脱 落 3 例。治疗后，试验组和对照组的总有效率分别为 92. 31% ( 60 例/65 例) 和 78. 46% ( 51 例/65 例) ，差异有统计学意义( P ＜ 0. 05) 。治疗后，试验组和对照 组的 C － ACT 评分分别为( 23. 41 ± 1. 06) 和( 20. 02 ± 1. 23) 分，第 1 秒用力呼气 量占预计值百分比分别为( 98. 77 ± 29. 19) % 和( 86. 94 ± 27. 32) % ，用力肺活量 占预计值百分比别为( 88. 95 ± 9. 49) % 和( 83. 08 ± 7. 68) % ，最大呼气流量占预 计值百分比分别为( 93. 42 ± 30. 14) % 和( 81. 33 ± 26. 68) % ，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头痛、咽部刺激症状、发热和上 腹痛，对照组的药物不良反应主要有头痛和咽部刺激症状。试验组和对照组的 总药 物 不 良 反 应 发 生率分别为 9. 23% 和 6. 15% ，差异无统计学意义 ( P ＞ 0. 05) 。结论 奥马珠单抗治疗中、重度过敏性哮喘患儿的临床疗效较好， 可有效控制哮喘，改善肺功能，且安全性好。 关键词: 奥马珠单抗; 布地奈德福莫特罗粉吸入剂; 过敏性哮喘; 儿童; 安全性 评价 DOI: 10. 13699 /j. cnki. 1001 － 6821. 2021. 19. 008 中图分类号: Ｒ974. 3 文献标志码: A 文章编号: 1001 － 6821( 2021) 19 － 2577 － 04 Abstract: Objective To observe the clinical efficacy and safety of omalizumab combined with budesonide formoterol powder inhalation in the treatment of children with moderate and severe allergic asthma. Methods A total of 133 children with moderate and severe allergic asthma were randomly divided into control group ( n = 67 cases) and treatment group ( n = 66 cases) . The control group was given budesonide formoterol powder inhalation 164. 5 μg per time，twice a day，after treatment 12 weeks，the dose was changed to 164. 5 μg per time，once a day，and maintained until 16 weeks. The treatment group was given omalizumab 150 － 600 mg per time，the interval between the two administrations was 2 or 4 weeks，subcutaneous injection for 16 weeks， on the basis of control group. The clinical efficacy，the childhood asthma2578 中国临床药理学杂志 第 37 卷 第 19 期 2021 年 10 月( 总第 345 期) control test ( C － ACT) scores，lung function and adverse drug reactions were compard between two groups. Ｒesults There were 3 cases of shedding during the trial. After treatment，the total effective rates of treatment and control groups were 92. 31% ( 60 cases / 65 cases) and 78. 46% ( 51 cases / 65 cases) with significant difference ( P ＜ 0. 05) . After treatment，the C － ACT scores of treatment and control groups were ( 23. 41 ± 1. 06) and ( 20. 02 ± 1. 23) points， forced expiratory volume in one second / percentage of predicted values were ( 98. 77 ± 29. 19 ) % and ( 86. 94 ± 27. 32 ) % ， forced vital capacity / percentage of predicted values were ( 88. 95 ± 9. 49 ) % and ( 83. 08 ± 7. 68 ) % ， peak expiratory flow / percentage of predicted values were ( 93. 42 ± 30. 14 ) % and ( 81. 33 ± 26. 68) % ，the differences were statistically significant ( all P ＜ 0. 05 ) . The adverse drug reactions of treatment group were headache，pharyngeal irritation，fever and upper abdominal pain，while those in control group were headache and pharyngeal irritation. The total incidences of adverse drug reactions in treatment and control group were 9. 23% and 6. 15% without significant difference ( P ＞ 0. 05) . Conclusion Omalizumab has a good clinical efficacy in the treatment of children with moderate to severe allergic asthma，can effectively control asthma，improve lung function，and the safety was good. Key words: omalizumab; budesonide formoterol powder inhalation; allergic asthma; children; safety evaluation
奥马珠单抗联合布地奈德福莫特罗粉吸入剂治疗中、重度过敏性哮喘患儿的临床研究.pdf
