鼻鼽合剂治疗风寒型变应性鼻炎的临床与实验研究
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摘要
变应性鼻炎(allergic rhinitis, AR)是特异性个体接触变应原后导致的以IgE介导为主的炎症介质释放和多种免疫活性细胞、细胞因子参与的鼻粘膜慢性炎症反应性疾病,为耳鼻咽喉科的高发疾病。ARIA(变应性鼻炎及其对哮喘的影响)工作会议报告指出：该病世界范围内的患病率大约在15%-20%,我国的患病人数应超过5千万,高发地区已达37.74%。随着工业化的发展和大气污染加重,以及全球气候变暖,植物花粉期提前、延长,本病发病率有明显上升趋势。
由于该病严重影响病人的生活质量和工作效率,且能诱发或加重支气管哮喘等疾病的发生,因此,防治该病成为世界公共卫生问题。2001年WHO制订了防治变应性鼻炎的临床指南,并加以推广,对于深入开展变应性鼻炎的防治及发病机制研究有着重要意义。
鼻鼽合剂由王鹏教授创方,并结合我科鼻炎Ⅰ号协定方综合优化而成,为治疗变应性鼻炎的有效经验方剂,其组方为：麻黄10g、防风15g、白芷12g、细辛5g、辛夷15g、苍耳12g、鹅不食草12g、黄芩12g、黄芪25g、甘草10g。该方具有宣肺散寒,祛风通窍之功,临床运用,疗效确切,但该方治疗变应性鼻炎的作用机制尚不明确,为探讨其疗效以及寻求其治疗变应性鼻炎的依据,遂展开本临床与实验研究。
[目的]本试验观察鼻鼽合剂治疗风寒型变应性鼻炎的临床症状、体征改善等疗效,检测其对变应性鼻炎患者的血清分子免疫水平、局部鼻分泌物中嗜酸性粒细胞含量的改变,并设辛芩颗粒对照组相比较,了解其对患者体内免疫环境的影响,探讨中药制剂治疗变应性鼻炎的作用机制,从而为临床寻找治疗变应性鼻炎的优效方法,同时为临床提供疗效确切、更好的治疗方剂。并进行动物实验,进一步观测中药鼻鼽合剂对变应性鼻炎大鼠模型血清免疫球蛋白IgE、IL-4、INF-γ含量等免疫指标的影响。
[方法]动物实验将SD大鼠46只,随机分正常组、模型组、对照组和治疗组,采用卵清蛋白致敏和激发方法复制变应性鼻炎大鼠模型。于第二次致敏的第一天(即第8天)给予中药鼻鼽合剂进行干预治疗,并设辛芩颗粒作对照组,治疗14天后,测定各组大鼠模型血清IgE、IL-4、IFN-Y含量,检测鼻分泌物中EOS含量,并记分,然后进行组间比较。
临床试验则经中医辨证,吸入物变应原检测,将符合条件的120例风寒型变应性鼻炎患者随机分为治疗组(60例)和对照组(60例),两组病例临床资料分布均衡,无显著性差异。治疗组口服鼻鼽合剂15ml,1日三次,温水稀释至60-8 0ml后服用,疗程21天；对照组口服无糖型辛芩颗粒1袋(5g),温水溶解为60-80ml后服用,1日三次,疗程21天。
试验中分别观察治疗前后患者临床症状、体征积分改变；检测鼻分泌物中嗜酸性粒细胞(EOS)的含量；检测血清中IgA、IgG、IgM、总IgE、细胞因子IL-4的含量水平；并分析与病情程度、病程之间的关系,记录两组病例的不良反应,以比较其临床疗效。
[结果]动物实验结果显示：鼻鼽合剂治疗组血清总IgE、IL-4水平明显低于模型组及辛芩颗粒对照组(P<0.05),IFN-γ含量水平明显高于模型组(P＜0.05)。
临床试验中鼻鼽合剂组与辛芩颗粒组治疗风寒型变应性鼻炎均有较好疗效,治疗显效率分别为91.67%、68.33%,但在改善临床症状及体征上鼻鼽合剂组较辛芩颗粒组疗效更为明显(P<0.05)；两组均能降低鼻分泌物中嗜酸性粒细胞的含量,组间具有统计学差异(P＜0.05),其含量高低与病情相关,与病程无直接相关；均能下调血清中总IgE、IL-4的含量水平,但鼻鼽合剂组较辛芩颗粒组在下调IL-4的血清含量水平上表现更为显著(P<0.05),其中IL-4的水平与病情有相关性,但与病程未见明显相关；然而两组对改变变应性鼻炎患者血清中免疫球蛋白IgG、IgM、IgA的含量并不显著(P>0.05),且组间无统计学差异(P>0.05)。
两组病例服药期间均末见明显副反应发生。
[结论]通过临床及动物实验研究证实：鼻鼽合剂可显著缓解风寒型变应性鼻炎患者的症状和体征,改善其生活质量,其可通过抑制或减少Th2细胞细胞因子IL-4的产生,从而使Th细胞分化向Thl细胞偏移,调节Thl／Th2之间的动态平衡；同时能显著减少嗜酸性粒细胞的浸润,降低血清总IgE含量,达到减轻变应性鼻炎的炎症反应,从而达到治疗变应性鼻炎的目的。
鼻鼽合剂疗效确切,副作用小,通过临床观察和实验研究,认为可作为基础方使用,辨证加减,即可实行个体化治疗方案,值得在临床上推广使用,
中医药治疗变应性鼻炎以改善患者免疫病理体质为目标,从关键病理机制入手,对变应性鼻炎的多个病理环节,发挥阻断或双向调节的药理作用,应在临床受到重视,并推荐为变应性鼻炎的首选病因治疗方法。
Objective:To explore the clinical effect on Biqiu mixture of treating allergic rhinitis of Fenghan pattern. Include symptoms and syndromes. And to investigate the effects of Biqiu mixture on IgE, IL-4, and IgG, IgM, IgA in the serum, eosinophill in nasal secretions. Observe the improvement of the matas in order to find out an efffective traditional chinese medicine prescription and method of treating allergic rhinitis.discuss the mechanism of Biqiu mixture on rats with allergic rhinitis of Fenghan pattern. And conduct animal experiments, further observations Chinese Medicine Biqiu mixture treat Allergic rhinitis rat model on serum immunoglobulin IgE, IL-4, INF-γcontent of immune indices.
Method:Animal experiments will be 46 SD rats were randomly divided into nomal group and model group, control group and treatment group, sensitized with ovalbumin and stimulation methods of reproduction Rats with Allergic Rhinitis. On the first day of the second sensitization (ie 8 days) to give medicine to intervene in the treatment of Biqiu mixture, and set Xinqin particles parallel control group,14 days after treatment, rats in each group measured serum IgE, IL-4, IFN-γlevels detected in nasal secretions of EOS content and scoring, and then a comparison between groups.
After distinguishment of traditional chinese medicine, Examination of allergen test.120 cases of the allergic rhinitis of Fenghan pattern were randomized into two groups. One was treatment group(60 cases), the other was constrol group(60 cases). Both of the groups had almost the same clinical precondition. without apparent differences. The treatment group of 60 cases took Biqiu mixture 15ml, T. i. d. p. o. with harm water diluted to 60-80ml, the constrol group of 60 cases took a piece of Xinqin granule, T. i. d. p.o. with harm water infuse to 60-80ml.The course of the treatment was 21 days. And then, observe and compare the improvement of patients'symptoms and syndromes in the two groups. Check the quantity of IgG, IgM, IgA, IgE and IL-4 in the serum, Eosinophill in the nasal secretions. And analysis of severity, the relationship between duration, make notes of the negative effect. so as to evaluate the clinical effect of them.
Results:Animal experiments showd that:Biqiu mixture treatment total serum IgE, IL-4 levels were significantly lower than modal group and control group Xinqin particles (P<0.05), INF-γlevels were significantly higher than the model group (P<0.05).
The two treatments were both effective on treating allergic rhinitis of Fenghan pattern. But Biqiu mixture was more excellent (P <0.05) than another.the effective rate of treatment group was 91.67%; the effective rate of the constrol group was 68.33%.Two groups were also to reduce the quantity of eosinophill in the nasal secretions.but there was a significant difference between the two groups (P<0.05). The levels of its disease-related, not directly related with the course; They were both to down the quantity of IgE, IL-4 in the serum.but the Biqiu mixture was significant diff icent (P < 0.05) than Xinqin granule group in reducing the quantity of IL-4 in the serum. In which the level of IL-4 is correlated with the disease, but no significant correlation with the course; But both of the groups were not effective on changing the quantity of IgG, IgM, IgA(P>0.05). and there wasn't a significant difference(P >0.05).
Conclusions:Through clinical and experimental research confirmed that:Biqiu mixture can effective treat the symptoms and syndromes of allergic rhinitis of Fenghan pattern and change the quanlity of patient's lives. This method was effective on treating allergic rhnitis of Fenghan pattern by decreasing IL-4 production of the Th2 cells, and urging Th cells to Thl cells deviation from Th2 cells, adjusting the moving blance of the Thl/Th2 cytokine network. In the same time, significant reducing the quantity of eosinophill in the nasal secretions and lowering the content of IgE in the serum.
Biqiu mixture has no negative effect. It is a safe and effective measure. As a basis of prescription, with addition and subtraction according to symptoms and syndromes, it is widely used to treating various kinds of allergic rhinitis.
The treatment of allergic rhinitis in Chinese Medicine to improve physical fitness in patients with the objective of immunopathological, links from the key pathological to play multi-targets of the pharmacological action of two-way adjustment. Should be taken seriously in the clinical and recommended for remission in patients with Allergic Rhinitis preferred method of treatment.
由于该病严重影响病人的生活质量和工作效率,且能诱发或加重支气管哮喘等疾病的发生,因此,防治该病成为世界公共卫生问题。2001年WHO制订了防治变应性鼻炎的临床指南,并加以推广,对于深入开展变应性鼻炎的防治及发病机制研究有着重要意义。
鼻鼽合剂由王鹏教授创方,并结合我科鼻炎Ⅰ号协定方综合优化而成,为治疗变应性鼻炎的有效经验方剂,其组方为：麻黄10g、防风15g、白芷12g、细辛5g、辛夷15g、苍耳12g、鹅不食草12g、黄芩12g、黄芪25g、甘草10g。该方具有宣肺散寒,祛风通窍之功,临床运用,疗效确切,但该方治疗变应性鼻炎的作用机制尚不明确,为探讨其疗效以及寻求其治疗变应性鼻炎的依据,遂展开本临床与实验研究。
[目的]本试验观察鼻鼽合剂治疗风寒型变应性鼻炎的临床症状、体征改善等疗效,检测其对变应性鼻炎患者的血清分子免疫水平、局部鼻分泌物中嗜酸性粒细胞含量的改变,并设辛芩颗粒对照组相比较,了解其对患者体内免疫环境的影响,探讨中药制剂治疗变应性鼻炎的作用机制,从而为临床寻找治疗变应性鼻炎的优效方法,同时为临床提供疗效确切、更好的治疗方剂。并进行动物实验,进一步观测中药鼻鼽合剂对变应性鼻炎大鼠模型血清免疫球蛋白IgE、IL-4、INF-γ含量等免疫指标的影响。
[方法]动物实验将SD大鼠46只,随机分正常组、模型组、对照组和治疗组,采用卵清蛋白致敏和激发方法复制变应性鼻炎大鼠模型。于第二次致敏的第一天(即第8天)给予中药鼻鼽合剂进行干预治疗,并设辛芩颗粒作对照组,治疗14天后,测定各组大鼠模型血清IgE、IL-4、IFN-Y含量,检测鼻分泌物中EOS含量,并记分,然后进行组间比较。
临床试验则经中医辨证,吸入物变应原检测,将符合条件的120例风寒型变应性鼻炎患者随机分为治疗组(60例)和对照组(60例),两组病例临床资料分布均衡,无显著性差异。治疗组口服鼻鼽合剂15ml,1日三次,温水稀释至60-8 0ml后服用,疗程21天；对照组口服无糖型辛芩颗粒1袋(5g),温水溶解为60-80ml后服用,1日三次,疗程21天。
试验中分别观察治疗前后患者临床症状、体征积分改变；检测鼻分泌物中嗜酸性粒细胞(EOS)的含量；检测血清中IgA、IgG、IgM、总IgE、细胞因子IL-4的含量水平；并分析与病情程度、病程之间的关系,记录两组病例的不良反应,以比较其临床疗效。
[结果]动物实验结果显示：鼻鼽合剂治疗组血清总IgE、IL-4水平明显低于模型组及辛芩颗粒对照组(P<0.05),IFN-γ含量水平明显高于模型组(P＜0.05)。
临床试验中鼻鼽合剂组与辛芩颗粒组治疗风寒型变应性鼻炎均有较好疗效,治疗显效率分别为91.67%、68.33%,但在改善临床症状及体征上鼻鼽合剂组较辛芩颗粒组疗效更为明显(P<0.05)；两组均能降低鼻分泌物中嗜酸性粒细胞的含量,组间具有统计学差异(P＜0.05),其含量高低与病情相关,与病程无直接相关；均能下调血清中总IgE、IL-4的含量水平,但鼻鼽合剂组较辛芩颗粒组在下调IL-4的血清含量水平上表现更为显著(P<0.05),其中IL-4的水平与病情有相关性,但与病程未见明显相关；然而两组对改变变应性鼻炎患者血清中免疫球蛋白IgG、IgM、IgA的含量并不显著(P>0.05),且组间无统计学差异(P>0.05)。
两组病例服药期间均末见明显副反应发生。
[结论]通过临床及动物实验研究证实：鼻鼽合剂可显著缓解风寒型变应性鼻炎患者的症状和体征,改善其生活质量,其可通过抑制或减少Th2细胞细胞因子IL-4的产生,从而使Th细胞分化向Thl细胞偏移,调节Thl／Th2之间的动态平衡；同时能显著减少嗜酸性粒细胞的浸润,降低血清总IgE含量,达到减轻变应性鼻炎的炎症反应,从而达到治疗变应性鼻炎的目的。
鼻鼽合剂疗效确切,副作用小,通过临床观察和实验研究,认为可作为基础方使用,辨证加减,即可实行个体化治疗方案,值得在临床上推广使用,
中医药治疗变应性鼻炎以改善患者免疫病理体质为目标,从关键病理机制入手,对变应性鼻炎的多个病理环节,发挥阻断或双向调节的药理作用,应在临床受到重视,并推荐为变应性鼻炎的首选病因治疗方法。
Objective:To explore the clinical effect on Biqiu mixture of treating allergic rhinitis of Fenghan pattern. Include symptoms and syndromes. And to investigate the effects of Biqiu mixture on IgE, IL-4, and IgG, IgM, IgA in the serum, eosinophill in nasal secretions. Observe the improvement of the matas in order to find out an efffective traditional chinese medicine prescription and method of treating allergic rhinitis.discuss the mechanism of Biqiu mixture on rats with allergic rhinitis of Fenghan pattern. And conduct animal experiments, further observations Chinese Medicine Biqiu mixture treat Allergic rhinitis rat model on serum immunoglobulin IgE, IL-4, INF-γcontent of immune indices.
Method:Animal experiments will be 46 SD rats were randomly divided into nomal group and model group, control group and treatment group, sensitized with ovalbumin and stimulation methods of reproduction Rats with Allergic Rhinitis. On the first day of the second sensitization (ie 8 days) to give medicine to intervene in the treatment of Biqiu mixture, and set Xinqin particles parallel control group,14 days after treatment, rats in each group measured serum IgE, IL-4, IFN-γlevels detected in nasal secretions of EOS content and scoring, and then a comparison between groups.
After distinguishment of traditional chinese medicine, Examination of allergen test.120 cases of the allergic rhinitis of Fenghan pattern were randomized into two groups. One was treatment group(60 cases), the other was constrol group(60 cases). Both of the groups had almost the same clinical precondition. without apparent differences. The treatment group of 60 cases took Biqiu mixture 15ml, T. i. d. p. o. with harm water diluted to 60-80ml, the constrol group of 60 cases took a piece of Xinqin granule, T. i. d. p.o. with harm water infuse to 60-80ml.The course of the treatment was 21 days. And then, observe and compare the improvement of patients'symptoms and syndromes in the two groups. Check the quantity of IgG, IgM, IgA, IgE and IL-4 in the serum, Eosinophill in the nasal secretions. And analysis of severity, the relationship between duration, make notes of the negative effect. so as to evaluate the clinical effect of them.
Results:Animal experiments showd that:Biqiu mixture treatment total serum IgE, IL-4 levels were significantly lower than modal group and control group Xinqin particles (P<0.05), INF-γlevels were significantly higher than the model group (P<0.05).
The two treatments were both effective on treating allergic rhinitis of Fenghan pattern. But Biqiu mixture was more excellent (P <0.05) than another.the effective rate of treatment group was 91.67%; the effective rate of the constrol group was 68.33%.Two groups were also to reduce the quantity of eosinophill in the nasal secretions.but there was a significant difference between the two groups (P<0.05). The levels of its disease-related, not directly related with the course; They were both to down the quantity of IgE, IL-4 in the serum.but the Biqiu mixture was significant diff icent (P < 0.05) than Xinqin granule group in reducing the quantity of IL-4 in the serum. In which the level of IL-4 is correlated with the disease, but no significant correlation with the course; But both of the groups were not effective on changing the quantity of IgG, IgM, IgA(P>0.05). and there wasn't a significant difference(P >0.05).
Conclusions:Through clinical and experimental research confirmed that:Biqiu mixture can effective treat the symptoms and syndromes of allergic rhinitis of Fenghan pattern and change the quanlity of patient's lives. This method was effective on treating allergic rhnitis of Fenghan pattern by decreasing IL-4 production of the Th2 cells, and urging Th cells to Thl cells deviation from Th2 cells, adjusting the moving blance of the Thl/Th2 cytokine network. In the same time, significant reducing the quantity of eosinophill in the nasal secretions and lowering the content of IgE in the serum.
Biqiu mixture has no negative effect. It is a safe and effective measure. As a basis of prescription, with addition and subtraction according to symptoms and syndromes, it is widely used to treating various kinds of allergic rhinitis.
The treatment of allergic rhinitis in Chinese Medicine to improve physical fitness in patients with the objective of immunopathological, links from the key pathological to play multi-targets of the pharmacological action of two-way adjustment. Should be taken seriously in the clinical and recommended for remission in patients with Allergic Rhinitis preferred method of treatment.
引文
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