益气温阳方治疗变应性鼻炎的临床研究
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摘要
变应性鼻炎又称过敏性鼻炎,中医药具有良好的治疗效果,一般从两个方面切入：一是在方剂中选用具有抗过敏作用的中药；二是调节脏腑气血阴阳,通过改善机体内环境来降低其异感性。二者相比,前者起效较快,后者的疗效作用更为持久,副作用小,更能体现中医特色。
变应性鼻炎属于中医“鼻鼽”范畴,中医辨证属肺脾虚寒者多见,约占80%以上。本研究通过选择临床最常见证型,用前瞻性、多中心、盲法对照临床研究方法,获得临床疗效科学证据,并应用客观指标评价益气温阳方对变应性鼻炎肺脾虚寒证临床疗效,以期建立中医药对变应性鼻炎的规范化诊疗方案。
目的：以安慰剂、西药为对照,评价中医益气温阳方对变应性鼻炎肺脾虚寒证患者的临床疗效；通过对健康人群、变应性鼻炎肺脾虚寒证患者治疗前后外周血单个核细胞(peripheral blood mononuclear cell, PBMC)培养上清的白介素(Interleukin, IL)-4、干扰素(Interferon, IFN)-γ、IL-5、IL-10的水平测定,反映Th1/Th2平衡情况,应用客观指标评价中医益气温阳方对变应性鼻炎肺脾虚寒证临床疗效。探讨运用益气温阳方治疗变应性鼻炎肺脾虚寒证的原理与免疫调节的相关性。
方法：1、益气温阳方对变应性鼻炎肺脾虚寒证患者临床疗效的观察
共分为两项研究：
①研究一：分层随机,双盲,安慰剂对照研究：样本量100例(1：1)。
②研究二：中药辨证论治与西药阳性药物对照研究,共入组231例。
2、益气温阳方对变应性鼻炎肺脾虚寒证患者PBMC培养上清的IL-4、IFN-γ、IL-5、IL-10等细胞因子影响的观察
研究二中选取符合纳入标准的观察对象40例,并选取5例正常健康者作空白对照。将40例观察对象分为中药组和西药组两组,每组各20例,其中中药组以中药益气温阳方口服,西药组以西替利嗪口服。用药4周后,采用自身前后比较法及组间对照比较法。观察病例症状积分改变情况,兼症改变情况。在治疗前后分别抽取患者静脉血2ml,分离PBMC后、体外T细胞的刺激活化,测定PBMC培养上清中的IL-4、IFN-γ、IL、IL-10的水平。同法测定5例正常健康者的IL-4、IFN-γ、IL-5、IL-10水平。比较治疗前后及空白对照组、中药组、西药组组间培养上清中的IL-4、IFN-γ、IL-5、IL-10水平。
结果：1、研究一：经治疗后中药组：显效有37例,有效有9例,无效有4例。总有效率为92%,显效率为74%。兼症畏寒怕冷便溏明显好转。安慰剂组：显效有13例,有效有14例,无效有23例。总有效率为54%,显效率为26%。症状体征积分方面中药组和安慰剂组有显著差异,兼症畏寒怕冷便溏方面改善无显著差异。
研究二：经治疗后中药组：显效有78例,有效有53例,无效有8例。总有效率为94.2%,显效率为56.1%。畏寒怕冷便溏等兼症方面明显好转。西药组：显效有60例,有效有28例,无效有4例。总有效率为95.65%,显效率为65.22%。兼症几乎没有改善。说明两种药都有治疗作用,而且有效率都很高,但比较兼症的改变中药组与西药组有显著差异。
2、两组观察对象的PBMC培养上清中的IL-4、IFN-γ治疗前后相比,有明显的统计学意义(p<0.01)。说明中药益气温阳方及西药西替利嗪均为有效药物,能降低培养上清中的IL-4、IFN-γ值,改善患者免疫水平。而组间比较,中药组的培养上清中的IL-4、IFN-γ值降低情况与西药组降低情况,无显著性差异(p>0.05),说明治疗变态反应性鼻炎,改善变应性鼻炎的发病的免疫学基础Th1/Th2失衡上,中药复方益气温阳方与西替利嗪具有相同的效果。IL-5、IL-10治疗前后相比,无显著性差异(p>0.05)。
结论：益气温阳方是治疗变应性鼻炎肺脾虚寒证的有效方剂,值得向临床推广应用。
Allergic rhinitis is also known as hypersensitive rhinitis. Chinese herbal medication used for allergic rhinitis has good therapeutic effects, which can generally be interpreted in two aspects:first, choose effective antiallergic herbal medicine; second, regulate yin and yang of blood and viscera in the body, by which it can improve the body inner environment to reduce its sensitivity to external differences .For comparison, the first one has the advantage of fast effectiveness, while the latter one has long-lasting therapeutic effects with fewer side effects and reflects the characteristics of traditional Chinese medication.
Allergic rhinitis belongs to the category of "biqiu" in Chinese medication, where rhinitis is often seen on people with syndrome of deficient-cold of spleen-lung, most likely over 80% In this study, by selecting the most common clinical syndromes with a prospective, multicenter and blind-controlled clinical research method,-we obtained scientific evidence of clinical efficacy. By applying industry objective indicators, we also evaluated the clinic effect of Yiqiwenyang formula for treating allergic rhinitis with syndrome of deficient-cold of spleen-lung, and expected to establish a standard herbal therapy for diagnosis and treatment of allergic rhinitis.
Objective:By comparison with placebo and Cetirizine, to evaluate the clinical efficacy of Yiqiwenyang formula to allergic rhinitis with syndrome of deficient-cold of spleen-lung. By measuring the IL-4, IFN-y, IL-5 and IL-10 levels from supernatants of PBMC culture before and after the treatment from healthy and diseased people, to reflect the Thl/Th2 balance, and further evaluate the clinic efficacy of Yiqiwenyang formula for allergic rhinitis with syndrome of deficient-cold of spleen-lung by using objective indicators and explore the correlations between Yiqiwenyang formula and immune regulation in allergic rhinitis with syndrome of deficient-cold of spleen-lung.Methodology:1. Study of the clinic effect on Yiqiwenyang formula for treating allergic rhinitis with spleen-lung deficient-cold syndrome, subdivided into two studies:
①StudyⅠ:Stratified randomized, double-blind, placebo-controlled study, sample size 100 (1:1).
②StudyⅡ:Differential Treatment of herbal medicine and Cetirizine, total sample size 231.
2. Study of the influence of Yiqiwenyang formula on IL-4, IFN-γand other cytokines from supernatants of patient's PBMC culture.
40 patients who meet the criteria and 5 healthy people are selected for comparison. The 40 patients were divided into two groups,20 each, giving yiqiwenyang method and Cetirizine respectively. After 4 weeks, we use the before and after comparison and inter-group comparison to observe the changes of major and side symptoms by accumulated points. We also take blood samples of 2ml each person before and after the treatment. After separating mononuclear cells (PBMC) and stimulating T-cell in vitro, the IL-4, IFN-y, IL-5and IL-10 levels are measured in PBMC culture supernatant, and compared between herbal medicine group, modern medicine group and control group for before and after treatment.
Results:1.Study I:After the treatment in the herbal medicine group, there are 37 cases excellent,9 cases effective and 4 no effective. The total effective rate is 92% and excellent effective rate is 74%. General syndromes of fear of cold and loose stool are greatly improved. In control group:there are 13 cases excellent,14 cases effective and 23 no effective. The total effective rate is 54% and excellent effective rate is 26%. There also has pronounced difference on the accumulated points of symptoms and signs between herbal treatment group and control group. In control group, the general syndromes of fear of cold and loose stool remain unchanged.
Study 2:After the treatment in herbal medicine group, there are 78 cases excellent,53 cases effective and 8 no effective. The total effective rate is 94.2%and excellent effective rate is 56.1%. General syndromes of fear of cold and loose stool are greatly improved. In modern medicine group: there are 60 cases excellent,28 cases effective and 4 no effective. The total effective rate is 95.65% and excellent effective rate is 65.22% and almost no general symptom is improved. The comparison shows that both groups present the therapeutic result and high effective rate, but the improvement of general symptoms are obviously higher in the herbal medicine group.
2. After the treatment, the concentrations of IL-4 and IFN-y are greatly lowered in the treatment groups (p<0.01), which indicates both yiqiwenyang formula and Cetirizine are effective in decreasing IL-4 and IFN-y in the supernatants of PBMC culture and improving patients'immune system. But the comparison between the groups shows no big difference in decreasing IL-4 and IFN-y in the supernatants of PBMC culture (p>0.05), which proved that the Yiqiwenyang formula has the same therapeutic effects as Cetirizine in treating allergic rhinitis, improving the imbalance between Thl and Th2, which serves as the immunological basis for occurrence of allergic rhinitis.
Conclusion:Yiqiwenyang formula is a sort of effective Chinese herbs to treatment allergic rhinitis allergic rhinitis with syndrome of deficient-cold of spleen-lung, so it is worth to clinical application widely.
变应性鼻炎属于中医“鼻鼽”范畴,中医辨证属肺脾虚寒者多见,约占80%以上。本研究通过选择临床最常见证型,用前瞻性、多中心、盲法对照临床研究方法,获得临床疗效科学证据,并应用客观指标评价益气温阳方对变应性鼻炎肺脾虚寒证临床疗效,以期建立中医药对变应性鼻炎的规范化诊疗方案。
目的：以安慰剂、西药为对照,评价中医益气温阳方对变应性鼻炎肺脾虚寒证患者的临床疗效；通过对健康人群、变应性鼻炎肺脾虚寒证患者治疗前后外周血单个核细胞(peripheral blood mononuclear cell, PBMC)培养上清的白介素(Interleukin, IL)-4、干扰素(Interferon, IFN)-γ、IL-5、IL-10的水平测定,反映Th1/Th2平衡情况,应用客观指标评价中医益气温阳方对变应性鼻炎肺脾虚寒证临床疗效。探讨运用益气温阳方治疗变应性鼻炎肺脾虚寒证的原理与免疫调节的相关性。
方法：1、益气温阳方对变应性鼻炎肺脾虚寒证患者临床疗效的观察
共分为两项研究：
①研究一：分层随机,双盲,安慰剂对照研究：样本量100例(1：1)。
②研究二：中药辨证论治与西药阳性药物对照研究,共入组231例。
2、益气温阳方对变应性鼻炎肺脾虚寒证患者PBMC培养上清的IL-4、IFN-γ、IL-5、IL-10等细胞因子影响的观察
研究二中选取符合纳入标准的观察对象40例,并选取5例正常健康者作空白对照。将40例观察对象分为中药组和西药组两组,每组各20例,其中中药组以中药益气温阳方口服,西药组以西替利嗪口服。用药4周后,采用自身前后比较法及组间对照比较法。观察病例症状积分改变情况,兼症改变情况。在治疗前后分别抽取患者静脉血2ml,分离PBMC后、体外T细胞的刺激活化,测定PBMC培养上清中的IL-4、IFN-γ、IL、IL-10的水平。同法测定5例正常健康者的IL-4、IFN-γ、IL-5、IL-10水平。比较治疗前后及空白对照组、中药组、西药组组间培养上清中的IL-4、IFN-γ、IL-5、IL-10水平。
结果：1、研究一：经治疗后中药组：显效有37例,有效有9例,无效有4例。总有效率为92%,显效率为74%。兼症畏寒怕冷便溏明显好转。安慰剂组：显效有13例,有效有14例,无效有23例。总有效率为54%,显效率为26%。症状体征积分方面中药组和安慰剂组有显著差异,兼症畏寒怕冷便溏方面改善无显著差异。
研究二：经治疗后中药组：显效有78例,有效有53例,无效有8例。总有效率为94.2%,显效率为56.1%。畏寒怕冷便溏等兼症方面明显好转。西药组：显效有60例,有效有28例,无效有4例。总有效率为95.65%,显效率为65.22%。兼症几乎没有改善。说明两种药都有治疗作用,而且有效率都很高,但比较兼症的改变中药组与西药组有显著差异。
2、两组观察对象的PBMC培养上清中的IL-4、IFN-γ治疗前后相比,有明显的统计学意义(p<0.01)。说明中药益气温阳方及西药西替利嗪均为有效药物,能降低培养上清中的IL-4、IFN-γ值,改善患者免疫水平。而组间比较,中药组的培养上清中的IL-4、IFN-γ值降低情况与西药组降低情况,无显著性差异(p>0.05),说明治疗变态反应性鼻炎,改善变应性鼻炎的发病的免疫学基础Th1/Th2失衡上,中药复方益气温阳方与西替利嗪具有相同的效果。IL-5、IL-10治疗前后相比,无显著性差异(p>0.05)。
结论：益气温阳方是治疗变应性鼻炎肺脾虚寒证的有效方剂,值得向临床推广应用。
Allergic rhinitis is also known as hypersensitive rhinitis. Chinese herbal medication used for allergic rhinitis has good therapeutic effects, which can generally be interpreted in two aspects:first, choose effective antiallergic herbal medicine; second, regulate yin and yang of blood and viscera in the body, by which it can improve the body inner environment to reduce its sensitivity to external differences .For comparison, the first one has the advantage of fast effectiveness, while the latter one has long-lasting therapeutic effects with fewer side effects and reflects the characteristics of traditional Chinese medication.
Allergic rhinitis belongs to the category of "biqiu" in Chinese medication, where rhinitis is often seen on people with syndrome of deficient-cold of spleen-lung, most likely over 80% In this study, by selecting the most common clinical syndromes with a prospective, multicenter and blind-controlled clinical research method,-we obtained scientific evidence of clinical efficacy. By applying industry objective indicators, we also evaluated the clinic effect of Yiqiwenyang formula for treating allergic rhinitis with syndrome of deficient-cold of spleen-lung, and expected to establish a standard herbal therapy for diagnosis and treatment of allergic rhinitis.
Objective:By comparison with placebo and Cetirizine, to evaluate the clinical efficacy of Yiqiwenyang formula to allergic rhinitis with syndrome of deficient-cold of spleen-lung. By measuring the IL-4, IFN-y, IL-5 and IL-10 levels from supernatants of PBMC culture before and after the treatment from healthy and diseased people, to reflect the Thl/Th2 balance, and further evaluate the clinic efficacy of Yiqiwenyang formula for allergic rhinitis with syndrome of deficient-cold of spleen-lung by using objective indicators and explore the correlations between Yiqiwenyang formula and immune regulation in allergic rhinitis with syndrome of deficient-cold of spleen-lung.Methodology:1. Study of the clinic effect on Yiqiwenyang formula for treating allergic rhinitis with spleen-lung deficient-cold syndrome, subdivided into two studies:
①StudyⅠ:Stratified randomized, double-blind, placebo-controlled study, sample size 100 (1:1).
②StudyⅡ:Differential Treatment of herbal medicine and Cetirizine, total sample size 231.
2. Study of the influence of Yiqiwenyang formula on IL-4, IFN-γand other cytokines from supernatants of patient's PBMC culture.
40 patients who meet the criteria and 5 healthy people are selected for comparison. The 40 patients were divided into two groups,20 each, giving yiqiwenyang method and Cetirizine respectively. After 4 weeks, we use the before and after comparison and inter-group comparison to observe the changes of major and side symptoms by accumulated points. We also take blood samples of 2ml each person before and after the treatment. After separating mononuclear cells (PBMC) and stimulating T-cell in vitro, the IL-4, IFN-y, IL-5and IL-10 levels are measured in PBMC culture supernatant, and compared between herbal medicine group, modern medicine group and control group for before and after treatment.
Results:1.Study I:After the treatment in the herbal medicine group, there are 37 cases excellent,9 cases effective and 4 no effective. The total effective rate is 92% and excellent effective rate is 74%. General syndromes of fear of cold and loose stool are greatly improved. In control group:there are 13 cases excellent,14 cases effective and 23 no effective. The total effective rate is 54% and excellent effective rate is 26%. There also has pronounced difference on the accumulated points of symptoms and signs between herbal treatment group and control group. In control group, the general syndromes of fear of cold and loose stool remain unchanged.
Study 2:After the treatment in herbal medicine group, there are 78 cases excellent,53 cases effective and 8 no effective. The total effective rate is 94.2%and excellent effective rate is 56.1%. General syndromes of fear of cold and loose stool are greatly improved. In modern medicine group: there are 60 cases excellent,28 cases effective and 4 no effective. The total effective rate is 95.65% and excellent effective rate is 65.22% and almost no general symptom is improved. The comparison shows that both groups present the therapeutic result and high effective rate, but the improvement of general symptoms are obviously higher in the herbal medicine group.
2. After the treatment, the concentrations of IL-4 and IFN-y are greatly lowered in the treatment groups (p<0.01), which indicates both yiqiwenyang formula and Cetirizine are effective in decreasing IL-4 and IFN-y in the supernatants of PBMC culture and improving patients'immune system. But the comparison between the groups shows no big difference in decreasing IL-4 and IFN-y in the supernatants of PBMC culture (p>0.05), which proved that the Yiqiwenyang formula has the same therapeutic effects as Cetirizine in treating allergic rhinitis, improving the imbalance between Thl and Th2, which serves as the immunological basis for occurrence of allergic rhinitis.
Conclusion:Yiqiwenyang formula is a sort of effective Chinese herbs to treatment allergic rhinitis allergic rhinitis with syndrome of deficient-cold of spleen-lung, so it is worth to clinical application widely.
引文
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