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CHEN Chunjuan, ZHENG Zhixin, LI Li. Clinical curative effect of Pingchuan prescription combined with montelukast sodium on patients with bronchial asthma[J]. Journal of Pharmaceutical Practice and Service. doi: 10.12206/j.issn.2097-2024.202405035
Citation: CHEN Chunjuan, ZHENG Zhixin, LI Li. Clinical curative effect of Pingchuan prescription combined with montelukast sodium on patients with bronchial asthma[J]. Journal of Pharmaceutical Practice and Service. doi: 10.12206/j.issn.2097-2024.202405035

Clinical curative effect of Pingchuan prescription combined with montelukast sodium on patients with bronchial asthma

doi: 10.12206/j.issn.2097-2024.202405035
  • Received Date: 2024-05-14
  • Rev Recd Date: 2024-09-18
  •   Objective  To explore the clinical curative effect of Pingchuan prescription combined with montelukast sodium on patients with bronchial asthma.   Methods  A total of 102 patients with bronchial asthma admitted to the hospital were enrolled between May 2022 and December 2023. According to simple randomization method, they were divided into control 1 group (n=34, montelukast sodium), control 2 group (n=34, Pingchuan prescription) and observation group (n=51, Pingchuan prescription combined with montelukast sodium). All patients were treated for 21d. The clinical curative effect in the three groups was evaluated. The scores of TCM syndromes, inflammatory factors [interleukin(IL)-4, IL-17, interferon(IFN)-γ, transforming growth factor-β1(TGF-β1), immunoglobulin(Ig)E] and scores of the test for respiratory and asthma control in kids (TRACK) in the three groups were compared before and after treatment. The adverse reactions were recorded.   Results  Compared with control 1 group and control 2 group, total response rate was higher in observation group (P<0.05). After treatment, scores of TCM syndromes (wheezing due to phlegm in throat, tachypnea, choking)in observation group were lower than those in control 1 group and control 2 group (P<0.05). After treatment, levels of IL-4, IL-17, TGF-β1 and IgE in observation group were lower than those in control 1 group and control 2 group, while IFN-γ level and TRACK score were higher than those in control 1 group and control 2 group (P<0.05). There was no difference in adverse reactions among the three groups (P>0.05).   Conclusion  Pingchuan prescription combined with montelukast sodium could improve clinical curative effect in patients with bronchial asthma, which was beneficial to alleviate inflammatory response and disease severity, with certain safety.
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    [4] 杨勤军, 童佳兵, 杨程, 等. 麻芍平喘汤治疗支气管哮喘冷哮证临床疗效观察及对血清炎症因子的影响[J]. 中药新药与临床药理, 2021, 32(4):573-578.
    [5] 东雪洁, 贾广媛, 张葆青, 等. 清咳平喘颗粒联合布地奈德和硫酸特布他林治疗小儿支气管哮喘急性发作期(热哮证)的疗效观察[J]. 现代药物与临床, 2023, 38(5):1142-1146.
    [6] 祖雅琪, 张洪春. 祛痰化浊方联合辨证贴敷对支气管哮喘急性发作期患者气道重塑指标的影响[J]. 环球中医药, 2020, 13(4):730-733. doi:  10.3969/j.issn.1674-1749.2020.04.043
    [7] 中华医学会儿科学分会呼吸学组, 《中华儿科杂志》编辑委员会. 儿童支气管哮喘诊断与防治指南(2016年版)[J]. 中华儿科杂志, 2016, 54(3):167-181. doi:  10.3760/cma.j.issn.0578-1310.2016.03.003
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    [12] 李红华. “清肺平喘、祛风解痉” 法联合西药治疗支气管哮喘急性发作(热哮证)临床疗效及对血清趋化因子影响[J]. 辽宁中医药大学学报, 2021, 23(8):130-134.
    [13] 许丽菲, 高鸿博, 张艳文, 等. 小儿支气管哮喘发病的中医理论探讨[J]. 四川中医, 2023, 41(4):26-29.
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Clinical curative effect of Pingchuan prescription combined with montelukast sodium on patients with bronchial asthma

doi: 10.12206/j.issn.2097-2024.202405035

Abstract:   Objective  To explore the clinical curative effect of Pingchuan prescription combined with montelukast sodium on patients with bronchial asthma.   Methods  A total of 102 patients with bronchial asthma admitted to the hospital were enrolled between May 2022 and December 2023. According to simple randomization method, they were divided into control 1 group (n=34, montelukast sodium), control 2 group (n=34, Pingchuan prescription) and observation group (n=51, Pingchuan prescription combined with montelukast sodium). All patients were treated for 21d. The clinical curative effect in the three groups was evaluated. The scores of TCM syndromes, inflammatory factors [interleukin(IL)-4, IL-17, interferon(IFN)-γ, transforming growth factor-β1(TGF-β1), immunoglobulin(Ig)E] and scores of the test for respiratory and asthma control in kids (TRACK) in the three groups were compared before and after treatment. The adverse reactions were recorded.   Results  Compared with control 1 group and control 2 group, total response rate was higher in observation group (P<0.05). After treatment, scores of TCM syndromes (wheezing due to phlegm in throat, tachypnea, choking)in observation group were lower than those in control 1 group and control 2 group (P<0.05). After treatment, levels of IL-4, IL-17, TGF-β1 and IgE in observation group were lower than those in control 1 group and control 2 group, while IFN-γ level and TRACK score were higher than those in control 1 group and control 2 group (P<0.05). There was no difference in adverse reactions among the three groups (P>0.05).   Conclusion  Pingchuan prescription combined with montelukast sodium could improve clinical curative effect in patients with bronchial asthma, which was beneficial to alleviate inflammatory response and disease severity, with certain safety.

CHEN Chunjuan, ZHENG Zhixin, LI Li. Clinical curative effect of Pingchuan prescription combined with montelukast sodium on patients with bronchial asthma[J]. Journal of Pharmaceutical Practice and Service. doi: 10.12206/j.issn.2097-2024.202405035
Citation: CHEN Chunjuan, ZHENG Zhixin, LI Li. Clinical curative effect of Pingchuan prescription combined with montelukast sodium on patients with bronchial asthma[J]. Journal of Pharmaceutical Practice and Service. doi: 10.12206/j.issn.2097-2024.202405035
  • 据相关流行病学调查[1]显示,全球约有3亿人患有支气管哮喘,其中,中国占1/10,且病情控制现状并不理想。孟鲁司特钠作为指南推荐的可单独应用的长期控制性药物,虽可抑制支气管痉挛现象,但长期使用药物毒副作用增加,加之患者依从性较低,影响了整体疗效[2-3]。与现代医学相比,中医强调从整体着眼,根据患者个体情况辨证论治,以极大的发挥中医中药独特优势,现在支气管哮喘的治疗中取得良好成效[4-5]。支气管哮喘在中医中归属“哮病”、“喘证”范畴,多由饮食不当,邪气外侵,引动伏痰,痰壅气道,郁而化热,肺气上逆,肺失宣降所致。因而治疗应以化痰平喘,宣肺降气,疏风清热为主。同时,中医整体观念认为肺主气,鼻为肺之窍,喉为肺之门,故而肺部病变多伴有鼻、咽喉证候。因此在治疗时应重视整体肺系,强调辨主病,抓主症,标本兼治,寒热兼顾。平喘方将张仲景麻杏石甘汤作为主方,辅以王琦教授脱敏调体方,起到了体、病、证并调的作用,具有宣肺平喘,清热化痰的功效。祖雅琪等[6]研究显示,中西医联合治疗可明显提高支气管哮喘患者临床疗效。鉴于此,本研究拟将平喘方联合孟鲁司特钠应用于支气管哮喘患者的治疗中,从疗效、中医证候积分、炎症因子及不良反应等方面探讨临床影响,现整理报道如下。

    • 选取2022年5月−2023年12月本院收治的102例支气管哮喘患者。纳入标准:①西医:满足支气管哮喘诊断标准[7];②中医[8]:热哮证,主症:喉中痰鸣,气粗息涌,咳呛阵作;次症:胸髙胁胀,口渴喜饮,面赤,汗出,烦闷不安,口苦;舌脉象:舌质红、苔黄腻,脉滑数或弦滑。同时有以上2项主症和1项次症、舌脉即可确诊。排除标准:对此次研究药物过敏者;存在重度和危重哮喘者;存在因其他原因引起的胸闷、咳嗽者;存在恶性肿瘤者;存在肝、肾、心、脑等脏器功能障碍者;入组前接受过相关治疗者。

      将试验患者按照简单随机法分为对照1组(n=34)、对照2组(n=34)与观察组(n=34)。对照1组:男/女=14/20例,年龄(平均年龄)2~5(3.09±0.71)岁,病程(平均病程)3~11(7.35±1.21)个月,轻度18例,中度16例;对照2组:男/女=16/18例,年龄(平均年龄)2~5(3.17±0.82)岁,病程(平均病程)3~11(7.26±1.09)个月,轻度19例,中度15例;观察组:男/女=11/23例,年龄(平均年龄)2~5(3.28±0.75)岁,病程(平均病程)3~11(7.42±1.13)个月,轻度20例,中度14例。3组基线资料经对比,无明显差异(P>0.05)。此次研究经医院伦理委员会审批通过,且患者监护人对此次研究知情同意。

    • 对照1组予以孟鲁司特钠(杭州民生滨江制药有限公司,国药准字H20183239)治疗,4 mg/次,1次/d,睡前服用,持续治疗21 d。

      对照2组予以平喘方治疗。平喘方药方组成:生石膏30 g、乌梅20 g、炙麻黄10 g、杏仁10 g、蝉蜕10 g、防风10 g、赤芝10 g,生甘草6 g。由我院药剂科以水煎制,200 mg/d,分早晚2次服用。7 d为一个疗程,持续治疗21 d。

      观察组予以孟鲁司特钠联合平喘方治疗。孟鲁司特钠用法用量同对照1组;平喘方用法用量同对照2组。

    • 于疗程治疗结束后评估临床疗效,分为临床控制、显效、有效和无效。临床控制:患者气急、胸闷和咳嗽等症状及体征基本消失,偶有哮喘发作但无需用药即可恢复,中医证候积分减少>95%;显效:患者气急、胸闷和咳嗽等症状和体征明显改善,中医证候积分减少70%~95%;有效:患者气急、胸闷和咳嗽等症状和体征均有好转,中医证候积分减少30%~69%;无效:证候积分减少29%以下,气急、胸闷和咳嗽等症状和体征均无改善。总有效率=临床控制率+显效率+有效率。

    • 于治疗前后根据《中医病证诊断疗效标准》评估患者主症(喉中痰鸣,气粗息涌,咳呛阵作)中医证候积分,根据症状程度分别记为0(无)、2(轻度)、4(中度)、6分(重度),分数降低,提示症状好转。

    • 采集患者治疗前后空腹静脉血3 ml,经离心处理后取上层清液,放置于−40 ℃环境中保存待检。采用酶联法(试剂购自浙江羽翔生物科技有限公司)检测白细胞介素(IL)-12、IL-17、干扰素(IFN)-γ、免疫球蛋白(Ig)E、转化生长因子(TGF)-β1水平。

    • 于治疗前后评估患者呼吸和哮喘控制测试(TRACK)评分[11],该测试包括5项内容,采用0、5、10、15、20分,总分0~100分,分数越高哮喘控制越好。

    • 记录不良反应(如腹泻、头痛、皮疹、恶心呕吐)发生情况。

    • 将SPSS 22.0作为数据处理软件,计量资料经检验均满足正态分布,以($ \bar{x} $±s)表示,计数资料用[例(n),百分比(%)]表示,分别行t检验、单因素方差分析和χ2检验,以P<0.05为有统计学意义。

    • 与对照1组和对照2组相比,观察组总有效率更高(P<0.05),但对照1组与对照2组总有效率比较,差异无统计学意义(P>0.05),见表1

      组别 例数 临床控制 显效 有效 无效 总有效率
      观察组 34 5(14.71) 19(55.88) 8(23.53) 2(5.88) 94.12
      对照1组 34 1(2.94) 11(32.35) 13(38.24) 9(26.47) 73.53a
      对照2组 34 3(8.82) 12(35.29) 11(32.35) 8(23.53) 76.47
      x2/P(观察组vs 对照1组) 5.314/0.021
      x2/P(观察组vs 对照2组) 4.221/0.040
      x2/P(对照1组vs 对照2组) 0.078/0.779
    • 与对照1组和对照2组相比,治疗后观察组(喉中痰鸣、气粗息涌、咳呛阵作)中医证候积分均更低(P<0.05),但对照1组与对照2组中医证候积分比较,差异均无统计学意义(P>0.05),见表2

      组别喉中痰鸣气粗息涌咳呛阵作
      治疗前治疗后治疗前治疗后治疗前治疗后
      观察组4.43±0.381.37±0.31*#▲4.38±0.441.12±0.22*#▲4.35±0.501.09±0.31*#▲
      对照1组4.49±0.361.96±0.42*4.41±0.471.37±0.29*4.33±0.481.48±0.26*
      对照2组4.46±0.371.82±0.35*4.36±0.451.31±0.30*4.39±0.461.41±0.29*
      F0.22324.5400.1057.8090.13817.796
      P0.800<0.0010.9010.0010.872<0.001
      *P<0.05,与同组治疗前比较;#P<0.05,与对照1组比较;P<0.05,与对照2组比较。
    • 治疗后观察组IL-4、IL-17、TGF-β1及IgE水平均低于对照1组与对照2组,IFN-γ水平高于对照1组与对照2组(P<0.05),但对照1组与对照2组上述指标比较,差异均无统计学意义(P>0.05),见表3

      指标时间观察组对照1组对照2组FP
      IFN-γ(pg/ml)治疗前79.37±5.4279.85±5.2779.52±5.340.0720.931
      治疗后136.43±9.19*#▲120.72±8.74*122.48±8.63*32.112<0.001
      IL-4(ng/L)治疗前48.96±4.5149.13±4.3649.05±4.270.0130.987
      治疗后24.60±2.42*#▲30.55±2.50*29.63±2.71*53.094<0.001
      IL-17(pg/ml)治疗前13.58±2.6013.78±2.3913.91±2.450.1530.859
      治疗后5.96±1.23*#▲10.39±1.46*10.47±1.32*126.142<0.001
      TGF-β1(ng/ml)治疗前25.73±3.1825.85±3.2125.90±3.420.0240.976
      治疗后11.81±1.32*#▲16.33±2.14*15.45±1.98*57.186<0.001
      IgE(IU/ml)治疗前218.39±18.72218.82±19.03218.62±18.750.0040.996
      治疗后132.56±9.14*#▲167.70±12.52*163.84±11.13*104.015<0.001
      *P<0.05,与同组治疗前比较;#P<0.05,与对照1组比较;P<0.05,与对照2组比较。
    • 治疗前,观察组、对照1组、对照2组TRACK评分分别为(52.48±2.37)、(52.57±2.41)、(52.69±2.32)分,差异无统计学意义(F=0.067、P=0.935);治疗后,观察组TRACK评分为(74.39±3.54)分,高于对照1组的(67.25±2.16)分和对照2组的(66.73±2.40)分(F=81.401、P<0.001)。

    • 3组均无严重不良反应发生,仅观察组出现3例恶心呕吐、2例头晕和3例皮疹,对照1组发生3例腹泻和2例恶心呕吐,对照2组发生3例恶心呕吐和1例皮疹,经对比差异无统计学意义(x2=1.835,P=0.399)。

    • 中医认为支气管哮喘的主要病位为肺,并涉及到脾、肾,当其受损后,肺失宣降,脾不健运,肾不制水,导致津液聚集成痰,伏藏于肺,成为发病的“夙根”,再加之外感风邪、内伤饮食,或先天禀赋不足,导致积痰蒸热,热痰蕴肺,壅阻气道,肺失宣降,肺管狭窄,通畅不利,痰和气交结于此,相互搏结,出现痰鸣、喘促等病症,发为哮喘[12-13]。元·朱丹溪也曾在《丹溪心法》中提出:“哮喘专主于痰”,故痰阻气闭为发作时的主要病理环节,并以邪实为主,伏痰或因素体阳盛导致痰从热化,热痰伏肺,肺气上逆,遇感而生,属痰热则发为热哮证。因小儿肺脏娇嫩,肺常不足,气宣发功能尚不健全,腠理开合、固表抗邪的功能较弱,御邪能力较弱,藩篱不固,抗病能力不强,故更易受风邪侵袭而发病。因而临床对于本病的治疗应以清肺平喘、化痰宣肺为主。

      平喘方主要由生石膏、炙麻黄、乌梅、杏仁、蝉蜕、防风、赤芝及生甘草组成,其中乌梅一能入肺则收,针对肺气失于宣降可收敛浮热,纳气归元,助纳气定喘,二则生津润肺,可防辛散之药损耗津气。防风乃风药中之润剂,更是祛风之要药,微温而不燥,药性缓和,用于热哮证哮喘可发挥祛风止痉的功效。乌梅与防风配伍使用,散收兼顾,相辅相成,在祛除外邪的同时而不耗伤气津,起到敛肺祛邪,化痰而不耗其气的功效。蝉蜕散风除热,利咽;赤芝止咳平喘,二者配伍相用,扶正祛邪,标本兼治,以调禀质。炙麻黄质轻味薄之品,入肺经,具宣肺平喘之功,可疏通营卫,开宣肺气,透达表邪。生石膏清泄肺胃之热以生津,与麻黄相配,既能宣肺,又能泻热。杏仁祛痰止咳,平喘,润肠,可宣肺降气行滞而消痰饮,通胸阳以开肺闭,既助石膏沉降下行,又助麻黄泻肺热,甘草防石膏之大寒伤胃,调和麻黄与石膏的寒热。纵观全方,配伍严谨,清宣降、调体质,紧扣病因病机,共奏清肺平喘、宣泄郁热、祛风化痰的功效。本研究中根据样本量公式N=[2pq(Za+Zβ)2]/(p1-p2)2,计算出总例数为102例,按简单随机法分组,各组均为34例。与对照1组和对照2组相比,观察组总有效率更高,中医证候(喉中痰鸣、气粗息涌、咳呛阵作)积分均更低,表明平喘方联合孟鲁司特钠治疗利于提高支气管哮喘患者临床疗效,改善临床症状。可能为平喘方从哮喘发病的根本出发,宣降肺气定其喘,祛热化痰撼其根,以调其脏腑功能达到治本目的,继而起到提高整体疗效的作用。

      支气管哮喘发病机制复杂,随着现代医学的不断深入研究认为免疫炎症与支气管哮喘发病密切相关,其中Th1/Th2、Th17/Treg细胞失衡为重要发病机制[14-15]。Th17细胞属于促炎性Th细胞,在促炎和自身免疫性疾病中发挥重要作用,主要分泌IL-17等炎性因子,Treg细胞是抑制性T细胞的一种功能亚群,能分泌TGF-β1等因子,有效抑制免疫强度,降低炎症损伤;INF-γ为Th1细胞的标志性因子,其含量可间接反映Th1功能活性,介导细胞免疫应答;IL-4由Th2细胞分泌,可对体液免疫产生介导作用,诱导IgE大量产生,从而加重气道炎症[16-17]。本研究中治疗后观察组IL-4、IL-17、TGF-β1及IgE水平均低于对照1组和对照2组,IFN-γ水平高于对照1组和对照2组,但对照1组与对照2组上述指标比较,差异均无统计学意义,提示平喘方联合孟鲁司特钠治疗更利于改善支气管哮喘患者Th1/Th2、Th17/Treg细胞失衡现象,缓解炎症反应造成的免疫损伤。考虑为现代药理学研究表明麻黄具有抗炎、抗过敏、平喘的作用;生石膏具有增强免疫功能的作用;杏仁止咳平喘、抗炎、调节免疫;甘草中多种成分如甘草酸、多糖等均能起到抗炎、增强免疫力的功效。诸药合用,进一步调节免疫应答,减轻炎症反应。本研究中治疗后观察组TRACK评分较对照1组和对照2组均更高,但对照1组与对照2组比较无差异,这一结果再次证实了平喘方联合孟鲁司特钠治疗的有效性,对于缓解病情,控制哮喘发生有积极意义。本研究中3组不良反应比较差异无统计学意义,提示平喘方联合孟鲁司特钠治疗具较高的安全性,并不会增加患者不良反应的发生率。

      综上所述,平喘方联合孟鲁司特钠治疗利于提高支气管哮喘患者临床疗效,并可缓解病情,调节炎症因子水平。本研究不足之处在于纳入样本量偏少,结果可能存在偏倚性,今后应扩大样本量对更多的可能机制进一步探讨研究。

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