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小儿咳嗽变异性哮喘是儿童常见的气道慢性疾病,病因尚不明确,临床多表现为发作性反复咳嗽[1],而喘息、气促症状并不明显。小儿咳嗽变异性哮喘的发病率约为6%,且呈现出逐年上升趋势,其早期症状多不典型,易误诊,若未能及时合理治疗,严重影响患儿的身心健康,降低患儿的生活质量,给家庭、社会增加不必要的负担[2]。临床上需要更为有效的药物治疗小儿咳嗽变异性哮喘。研究[3-4]显示,在布地奈德气雾剂吸入治疗的基础上联合白三烯受体拮抗剂(孟鲁司特钠)或左西替利嗪等药物治疗,可能是更有效的治疗手段,但三联用药目前仍较少,为探究如何才能使小儿咳嗽变异性哮喘得到最佳的治疗效果,获得最好的收益,本研究将我院2018年1月至2021年1月收治的6岁以上确诊为咳嗽变异性哮喘的患儿共80例作为研究对象,进行临床疗效分析,现作报道。
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80例咳嗽变异性哮喘患儿采用随机数表法分为观察组和对照组,各40例。观察组男22例,女18例,年龄6~11岁,病程15~90 d;对照组男21例,女19例;年龄6.8~11.3岁,病程20~90 d。2组患儿年龄、性别、年龄、病程等一般临床资料比较差异均无统计学意义(P>0.05)(见表 1),具有可比性。
分组 n 年龄/岁 男 女 病程/d 观察组 40 8.45±2.37 22 18 43.35±16.26 对照组 40 8.82±2.63 21 19 45.75±17.63 t — 0.66 0.05* 0.56 P — >0.05 >0.05 >0.05 *示χ2值 表 1 2组患儿一般临床资料的比较(x±s)
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病例纳入标准:(1)严格按照儿童咳嗽变异性哮喘的诊断标准[5];(2)无药物过敏史及家族史;(3)依从性好,临床资料完整。排除标准:(1)由其他原因导致的咳嗽、哮喘;(2)合并其他系统的疾病;(3)本次研究15 d内,患儿接受过其他皮质激素药物治疗;(4)依从性差,中途退出本次研究。本研究经我院医学伦理委员会批准通过,患儿的法定监护人均知情并签署同意书。
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2组患儿入院后行常规检查及相应的对症支持治疗,对照组给予山东鲁南制药的布地奈德吸入气雾剂(商品名:吉舒,规格:0.1 mg×200揿),每天1次,每次2揿。观察组患儿加用孟鲁司特钠咀嚼片(生产厂家:Merck Sharp & Dohme Ltd.,批准证号:H20181208,规格:4毫克/片),每次6 mg;口服盐酸西替利嗪糖浆(生产厂家:山东鲁南贝特制药有限责任公司,批准文号:国药准字H20050889,规格:120 mL∶0.12 g),患儿起始剂量为5 mL,每天1次,服药治疗1周后,增加至10 mL,每天1次。2组均治疗3个月后进行相关指标的观察。
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细胞因子测定:早晨空腹状态下抽取患儿静脉血5 mL,2 500~3 500 r/min离心10 min后留存血清,采用ELISA法测定血清IgE、白细胞介素(IL)-4、IL-13水平,试剂盒为中杉金桥生物有限公司(北京)生产。肺功能指标:采取肺功能检测仪检测患儿的呼气流量峰值(PEF)、第1秒用力呼气量(FEV1)、用力肺活量(FVC)。不良反应:皮肤过敏、腹痛、呕吐等发生情况。
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根据临床表现将疗效分为:(1)显著有效,咳嗽、咳嗽变异性哮喘等临床症状完全消失;(2)有效,患儿咳嗽、咳嗽变异性哮喘等症状有所改善;(3)无效,患儿临床症状及体征无改变,甚至恶化。总有效率=显著有效率+有效率。
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采用χ2检验和t检验。
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观察组患儿治疗显著有效27例、有效13例、无效0例, 总有效率为100.00%(40/40);对照组显著有效18例、有效11例、无效11例,总有效率为72.50%(29/40)。观察组总有效率显著高于对照组(χ2=12.75,P < 0.01)。
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治疗前,2组患儿的IgE、IL-4、IL-13水平比较差异均无统计学意义(P>0.05);治疗后,观察组与对照组IgE、IL-4、IL-13水平均明显低于治疗前(P < 0.01),且观察组降低幅度大于对照组(P < 0.01)(见表 2)。
分组 n IgE/(mg/L) IL-4/(pg/mL) IL-13/(pg/mL) 治疗前 观察组 40 1 268.95±92.58 127.59±7.59 51.50±1.38 对照组 40 1 273.25±75.39 129.69±6.47 50.95±1.12 t — 0.23 1.33 1.96 P — >0.05 >0.05 >0.05 治疗后 观察组 40 266.30±20.47** 22.65±1.75** 20.12±0.97** 对照组 40 521.96±25.92** 42.98±1.91** 32.46±1.05** t — 48.96 49.67 45.84 P — < 0.01 < 0.01 < 0.01 组内配对t检验:**P < 0.01 表 2 2组治疗前后血清细胞因子水平比较(x±s)
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治疗前,2组患儿的肺功能指标PEF、FEV1、FVC比较差异均无统计学意义(P>0.05);治疗后,观察组和对照组肺功能指标均明显高于治疗前(P < 0.01), 且观察组升高幅度大于对照组(P < 0.01)(见表 3)。
分组 n PEF/(L/s) FEV1/L FVC/L 治疗前 观察组 40 2.19±0.05 1.61±0.03 2.69±0.05 对照组 40 2.20±0.05 1.61±0.03 2.68±0.05 t — 0.81 0.84 0.27 P — >0.05 >0.05 >0.05 治疗后 观察组 40 3.98±0.06** 3.64±0.05** 4.13±0.06** 对照组 40 2.93±0.06** 2.79±0.04** 3.23±0.05** t — 82.37 79.81 70.71 P — < 0.01 < 0.01 < 0.01 组内配对t检验:**P < 0.01 表 3 治疗前后肺功能指标比较(x±s)
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在治疗期间,观察组出现皮肤过敏1例、腹痛2例、呕吐0例,不良反应发生率为7.50%;对照组出现皮肤过敏3例、腹痛3例、呕吐3例,不良反应发生率为22.50%。2组不良反应发生率差异有统计学意义(χ2=3.53,P < 0.05)。
吸入用布地奈德联合孟鲁司特钠、左西替利嗪治疗6~12岁小儿咳嗽变异性哮喘的临床疗效观察
Clinical curative effect of budesonide inhalation combined with montelukast sodium and levocetirizine on the treatment of 6-12 years old children with cough variant asthma
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摘要:
目的探讨吸入用布地奈德联合孟鲁司特钠、左西替利嗪治疗小儿咳嗽变异性哮喘的临床疗效。 方法选取80例6~12岁确诊为咳嗽变异性哮喘的患儿作为研究对象, 随机分为观察组和对照组, 各40例。对照组采取吸入用布地奈德吸入气雾剂吸入治疗及相应的对症支持治疗, 观察组在对照组的基础上加用口服孟鲁司特钠及左西替利嗪治疗。通过测定治疗前后炎症因子水平及肺功能指标, 并记录总有效率和不良反应发生情况, 评价临床疗效。 结果观察组总有效率为100.00%高于对照组的72.50%(P < 0.01)。治疗前, 2组患儿的炎症因子水平及肺功能指标差异均无统计学意义(P>0.05);治疗后, 观察组与对照组IgE、IL-4、IL-13水平均明显低于治疗前(P < 0.01), 且观察组降低幅度大于对照组(P < 0.01), 治疗后, 观察组和对照组肺功能指标均明显高于治疗前(P < 0.01), 且观察组升高幅度大于对照组(P < 0.01)。观察组的不良反应发生率7.50%与对照组的22.50%差异有统计学意义(P < 0.05)。 结论吸入用布地奈德联合孟鲁司特钠、左西替利嗪治疗小儿咳嗽变异性哮喘能够显著提升有效率, 降低炎症因子水平, 改善肺功能, 效果显著, 值得临床上推广使用。 Abstract:ObjectiveTo explore the curative effect of budesonide inhalation combined with montelukast sodium and levocetirizine on the treatment of children with cough variant asthma. MethodsA total of 80 children aged 6-12 diagnosed with cough variant asthma were selected as the research objects, and randomly divided into the observation group and the control group, with 40 cases in each group.The control group received budesonide inhalation aerosol inhalation therapy and corresponding supportive treatment, while the observation group received oral montelukast sodium and levocetirizine on the basis of the control group.The clinical efficacy was evaluated by measuring the levels of inflammatory factors and other pulmonary function indicators before and after treatment, and recording the total effective rate and the occurrence of adverse reactions. ResultsThe total effective rate of the observation group was 100.00%, which was higher than 72.50% of the control group (P < 0.01).Before treatment, there was no significant difference in the levels of inflammatory factors and lung function indexes between the two groups (P>0.05).After treatment, the levels of IgE, IL-4 and IL-13 in the observation group and the control group were significantly lower than those before treatment (P < 0.01), and the reduction range in the observation group was greater than that in the control group (P < 0.01).After treatment, the indexes of lung function in the observation group and the control group were significantly higher than those before treatment (P < 0.01), and the increase in the observation group was greater than that in the control group (P < 0.01).The rate of adverse reactions in the observation group occurred was also lower than that of the control group, and the difference was statistically significant (P < 0.05). ConclusionsBudesonide inhalation combined with montelukast sodium and levocetirizine in the treatment of children with cough variant asthma can significantly improve the effective rate and lung function, reduce the levels of inflammatory factors and the incidence of adverse reactions, which is worth promoting in clinical appilcation. -
Key words:
- cough variant asthma /
- montelukast sodium /
- levocetirizine /
- cytokines /
- pulmonary function
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表 1 2组患儿一般临床资料的比较(x±s)
分组 n 年龄/岁 男 女 病程/d 观察组 40 8.45±2.37 22 18 43.35±16.26 对照组 40 8.82±2.63 21 19 45.75±17.63 t — 0.66 0.05* 0.56 P — >0.05 >0.05 >0.05 *示χ2值 表 2 2组治疗前后血清细胞因子水平比较(x±s)
分组 n IgE/(mg/L) IL-4/(pg/mL) IL-13/(pg/mL) 治疗前 观察组 40 1 268.95±92.58 127.59±7.59 51.50±1.38 对照组 40 1 273.25±75.39 129.69±6.47 50.95±1.12 t — 0.23 1.33 1.96 P — >0.05 >0.05 >0.05 治疗后 观察组 40 266.30±20.47** 22.65±1.75** 20.12±0.97** 对照组 40 521.96±25.92** 42.98±1.91** 32.46±1.05** t — 48.96 49.67 45.84 P — < 0.01 < 0.01 < 0.01 组内配对t检验:**P < 0.01 表 3 治疗前后肺功能指标比较(x±s)
分组 n PEF/(L/s) FEV1/L FVC/L 治疗前 观察组 40 2.19±0.05 1.61±0.03 2.69±0.05 对照组 40 2.20±0.05 1.61±0.03 2.68±0.05 t — 0.81 0.84 0.27 P — >0.05 >0.05 >0.05 治疗后 观察组 40 3.98±0.06** 3.64±0.05** 4.13±0.06** 对照组 40 2.93±0.06** 2.79±0.04** 3.23±0.05** t — 82.37 79.81 70.71 P — < 0.01 < 0.01 < 0.01 组内配对t检验:**P < 0.01 -
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