摘要
1目的评价中医治疗鼻鼽(变应性鼻炎)的疗效,并分析北京城区变应性鼻炎患者的变应原特点。
2方法
2.1检索鼻鼽的古代相关文献和近十年来变应性鼻炎的文献,整理分析中医、西医对变应性鼻炎的研究现状。
2.2采用多中心、随机、对照的试验设计方法,将来自北京市海淀区、西城区、东城区、朝阳区、宣武区、崇文区、丰台区等城区符合纳入病例标准的670例变应性鼻炎患者分为四组,即单纯中药组407例、单纯西药组133例、中医综合组98例、西医综合组32例,分别给予中药汤剂、西药盐酸西替利嗪、中药汤剂加辛细滴鼻液、西替利嗪加丙酸倍氯米松鼻喷雾剂,用药20天。在单纯中药组中将患者分为肺气虚型、脾虚湿困型、肺经郁热型、肺肾阴虚型和肾阳虚型五种类型,分别应用玉蝉卫肺丸、健脾通窍汤、清热通窍汤、滋阴润肺汤和温肾止涕汤进行治疗；在中医综合组中也分为以上五种证型,分别采用上述五种方剂同时配合辛细滴鼻液、辛麻滴鼻液进行局部治疗,观察用药20天和停药后30天时的治疗效果,分析评价药物的证候等级疗效、症状积分疗效、证候总积分疗效以及对鼻黏膜嗜酸性粒细胞的作用。
2.3检测北京城区这670名变应性鼻炎患者的变应原,总结其分布规律。
3结果
3.1单纯中药组、单纯西药组、中医综合组及西医综合组四大组间治疗结果比较
3.1.1中医证候等级疗效：治疗后各组均具有很好的疗效,单纯中药组的总有效率是87.00%,单纯西药组是78.40%,中医综合组是94.68%,西医综合组是90.62%。经Ridit分析,单纯中药组与单纯西药组相比,单纯中药组中医证候等级疗效明显优于单纯西药组(P<0.01)；中医综合组与西医综合组相比,中医综合组中医证候等级疗效优于西医综合组(P<0.05)；单纯中药组与中医综合组相比,中医综合组中医证候等级疗效优于单纯中药组(P<0.05)。
3.1.2症状积分比较：治疗后20天单纯中药组、单纯西药组、中医综合组及西医综合组四组的症状积分都较治疗前有显著的下降,经统计学比较,差异有非常显著意义(P<0.01)；组间比较,单纯中药组与单纯西药组比较无统计学意义(P>0.05),中医综合组与西医综合组比较无统计学意义(P>0.05),单纯中药组与中医综合组比较有统计学意义(P<0.05)。
治疗后50天症状积分比较,单纯中药组与单纯西药组症状积分与治疗前比较有非常显著意义(P<0.01),与治疗后20天比较无统计学意义(P>0.05),但均较治疗后20天略有升高；中医综合组较治疗后20天症状积分有所下降,但是两者比较并无统计学差异(P>0.05),与治疗前比较有非常显著意义(P<0.01)；西医综合组与治疗前比较有统计学意义(P<0.01),但是症状积分较治疗后20天略有升高,经统计学处理发现无统计学意义(P>0.05)。
3.1.3证候总积分比较：治疗后20天四组的证候总积分都较治疗前有显著的下降,经统计学比较,差异有非常显著意义(P<0.01)；组间比较,单纯中药组与单纯西药组比较无统计学意义(P>0.05),中医综合组与西医综合组比较无统计学意义(P>0.05),单纯中药组与中医综合组比较有统计学意义(P<0.05)。
3.1.4治疗后20天鼻腔分泌物涂片中嗜酸性粒细胞变化比较：治疗后20天鼻腔分泌物涂片中嗜酸性粒细胞下降率,单纯中药组为48.75%,单纯西药组为50.4%,中医综合组为70.21%,西医综合组为75%。组间比较,经CMH统计方法分析,单纯中药组与单纯西药组疗效无统计学意义(P>0.05),中医综合组与西医综合组比较无统计学意义(P>0.05),单纯中药组与中医综合组比较有非常显著意义(P<0.01)。
3.2单纯中药组中各治疗亚组与相应对照组间治疗结果比较
3.2.1中医证候等级疗效：
单纯中药组中各治疗亚组治疗后均显示出很好的疗效,玉蝉卫肺丸治疗组的总有效率是89.00%,玉蝉卫肺丸对照组的总有效率是79.59%；健脾通窍汤治疗组的总有效率是87.29%,健脾通窍汤对照组的总有效率是78.85%；清热通窍汤治疗组的总有效率是88.24%,清热通窍汤对照组的总有效率是75.00%；滋阴润肺汤治疗组的总有效率是80.77%,滋阴润肺汤对照组的总有效率是83.33%；温肾止涕汤治疗组的总有效率是80.00%,温肾止涕汤对照组的总有效率是66.67%。
单纯中药组中各治疗亚组证候等级疗效比较,玉蝉卫肺丸组与相应对照组相比、健脾通窍汤治疗组与相应对照组相比、清热通窍汤治疗组与相应对照组相比、温肾止涕汤治疗组与相应对照组相比,差异均具有非常显著意义(P<0.01),治疗组疗效明显优于对照组。滋阴润肺汤治疗组疗效与相应对照组相比,两组比较无统计学意义(P>0.05)。
3.2.2症状积分：治疗后单纯中药组中各治疗亚组与相应对照组症状积分均较治疗前均明显下降(P<0.01),但是组间比较无显著性差异(P>0.05)。停药后一个月(治疗后第50天),各治疗组与相应对照组症状积分与治疗前比较仍有显著性差异(P<0.01),与治疗第20天时比较无显著性差异(P>0.05),组间比较亦无显著性差异(P>0.05)。
3.2.3证候总积分比较：治疗后单纯中药组中各治疗亚组与相应对照组证候总积分均较治疗前明显下降(P<0.01),但是组间比较无显著性差异(P>0.05)。单纯中药组中各治疗亚组组间比较无显著性差异(P>0.05)。
3.2.4嗜酸性粒细胞变化比较：经CMH统计方法分析,单纯中药组各治疗亚组与相应对照治疗后20天鼻腔分泌物涂片中嗜酸性粒细胞下降率组间比较,无统计学意义(P>0.05),单纯中药组各治疗亚组之间比较无统计学意义(P>0.05)。
3.3变应原测试结果：在670例变应性鼻炎患者中,至少对一种变应原呈阳性反应共487例,阳性率72.69%。北京城区变应性鼻炎患者中变应原种类分布由强到弱依次排列为屋尘螨、粉尘螨、杂草、树Ⅰ、树Ⅱ、藜、大豚草、动物毛、室内霉菌、室外霉菌、羽毛等。豚草花粉在本研究中占有较高的皮试阳性率,且其再生能力极强、花粉量很大,应引起重视。
3.4安全性监测结果：在本研究中,各组均具有良好的安全性,治疗前后血常规、尿常规变化均无显著性差异(P>0.05)。各组患者ALT、CREA、BUN在服药前后均在正常范围内,治疗前后没有波动超过正常值50%的病例。
4结论
4.1中医药分证型辨证治疗变应性鼻炎具有很好的疗效,能够很好地改善患者的症状和体征,明显降低患者的症状和证候积分。
4.2中药汤剂能够显著降低鼻腔分泌物涂片中嗜酸性粒细胞的数目。
4.3中药汤剂内服合用局部滴鼻剂能够明显提高治疗变应性鼻炎的疗效。
4.4北京城区变应性鼻炎阳性率为72.69%,变应原种类分布由强到弱依次排列为屋尘螨、粉尘螨、杂草、树Ⅰ、树Ⅱ等。
4.5豚草花粉在本研究中占有较高的皮试阳性率,且其再生能力极强、花粉量很大,应引起重视。
4.6中医药治疗本病具有较好的安全性,无明显毒副作用。
1 Objective:To evaluate the effect of traditional Chinese medicine treatment on allergic rhinitis, and analyze the characteristics of rhinitis allergens in Beijing area.
2 Methods
2.1 Searched the ancient and modern literature of allergic rhinitis published in the last ten years, and analysed the current research situation of Chinese medicine and western medicine on allergic rhinitis.
2.2 670 cases of Patients in this multi-centers, randomized and controlled trial were randomly assigned to four groups:407 cases in traditional Chinese medicine group,133 cases in western medicine group,98 cases in Comprehensive traditional Chinese medicine group, and 32 cases in comprehensive western medicine group. Which were respectively given Chinese decoction, cetirizine hydrochloride, Chinese decoction combined XinXi naristillae, and cetirizine combined Beconase AQ Nasal Spray. Besides, The Chinese traditional medicine group was divided into 5 types according to their syndrome:Lung qi deficiency type, Spleen deficiency and fluid-retention type, lung heat stagnation type, yin deficiency of lung and kidney type, kidney-yang deficiency type. Each of them was treated by the following prescription:Yuchanweifei pill, Jianpitongqiao decoction, Qingretongqiao decoction, Ziyinrunfei decoction and Wenshenzhiti decoction. The Comprehensive traditional Chinese medicine group was also divided into 5 types as the traditional Chinese medicine group, and XinXi or XinMa naristillae was added to each type on the basis of the treatment of traditional Chinese medicine group.The total treatment period was 20 days. Then observed the treatment effect just at the 20 days and after 30 days of withdrawal of drugs, to analyze and evaluate the therapeutic efficacy of drugs on syndrome degree, total symptom scores and effect on nasal membrane eosinophils.
2.3 Detected the rhinitis allergens of 670 patients with allergic rhinitis in Beijing area to summarize their distribution characteristics.
3 Results
3.1 The comparison of results of traditional Chinese medicine group, western medicine group, Comprehensive traditional chinese medicine group and comprehensive western medicine group
3.1.1 Rating effect of traditional Chinese medicine syndrome:All the groups had proved to be effective. The total effective percentage of traditional Chinese medicine group was 87.00%, western medicine group 78.40%, Comprehensive traditional Chinese medicine group 94.68% and comprehensive western medicine group 90.62%. By the ridit analysis, the total effect of traditional Chinese medicine group was better than western medicine group (P<0.05); and the total effect of comprehensive traditional Chinese medicine group was better than comprehensive western medicine group (P<0.05); besides the total effect of comprehensive traditional Chinese medicine group was better than traditional Chinese medicine group (P<0.05).
3.1.2 Comparison of symptom scores:After 20 days' treatment, the symptom scores of all groups decreased than before treatment, which had significant difference (P<0.01). And there was statistical significance on symptom scores between comprehensive traditional Chinese medicine group and traditional Chinese medicine group (P<0.05). However, there was no statistical difference on symptom scores between traditional Chinese medicine group and western medicine group, neither was between comprehensive traditional Chinese medicine group and comprehensive western medicine group (P>0.05).
30 days after withdrawal of drugs, compared to before treatment, there was remarkable significance of symptom scores in traditional Chinese medicine group, western medicine group and comprehensive western medicine group (P<0.01), while compared to 20 days after treatment, there was little increase but had no statistical significance(P>0.05);In comprehensive traditional Chinese medicine group, the symptom score decreased compared to 20 days after treatment, but had no statistical significance (P>0.05), while had remarkable significance compared to before treatment(P<0.01),
3.1.3 Comparison of syndrome scores:After the treatment, the syndrome scores of every group had obviously decreased than before treatment (P <0.01). There was no statistical difference on syndrome scores between traditional Chinese medicine group and western medicine group, between comprehensive traditional Chinese medicine group and comprehensive western medicine group (P>0.05). But there was statistical difference between traditional Chinese medicine group and comprehensive traditional Chinese medicine group (P<0.05).
3.1.4 Comparison of the changes of eosinophil numbers:20 days later, the eosinophils of rhinal secretion smear of every group had decreased obviously. With the rate in traditional Chinese medicine group was 48.75%. Western medicine group 50.40%. Comprehensive traditional Chinese medicine group 70.21% and comprehensive Western medicine group 75.00%. There was no statistical difference between traditional Chinese medicine group and western medicine group, neither was between comprehensive traditional Chinese medicine group and comprehensive western medicine group (P>0.05). But there was statistical difference between comprehensive traditional Chinese medicine group and traditional Chinese medicine group (P<0.01).
3.2 The comparison of results of subgroups in traditional Chinese medicine group with relevant control groups
3.2.1 Rating effect of syndromes in traditional Chinese medicine:Every subgroup of traditional Chinese medicine group had achieved good efficacy. The total effective rate of Yuchanweifei pill treatment group was 89.00%. Yuchanweifei pill control group was 79.59%. The total effective rate of Jianpitongqiao decoction treatment group was 87.29%. Jianpitongqiao decoction control group was 78.85%. Total effective rate of Qingretongqiao decoction treatment group was 88.24%, and Qingretongqiao decoction control group was75.0%. Total effective rate of Ziyinrunfei decoction treatment group was 80.77%, and Ziyinrunfei decoction control group was 83.33%. Total effective of Wenshenzhiti decoction treatment group was 80.00%, and Wenshenzhiti decoction control group was 66.67%.
Among the subgroups, except for the Ziyinrunfei decoction group, the rest groups all had statistical significance compared to their corresponding control groups. The effect of treatment groups were better than those of control groups (P<0.01).
3.2.2 Comparison of symptom scores:After treatment, the symptom scores of every subgroup had obviously decreased than before (P<0.01). There was no statistical difference between every subgroup and corresponding control group (P>0.05). After one month of withdrawal, compared to before treatment, the symptom scores had statistical significance, while had no difference compared to 20 days' treatment and among the subgroups (P >0.05).
3.2.3 Comparison of syndrome scores:After treatment, the syndrome scores of every subgroup had obviously decreased than before (P<0.01). There was no statistical difference between every subgroup and corresponding control group (P>0.05).
3.2.4 Comparison of changes of eosinophil numbers:After statistical analysis, there was no difference of eosinophil numbers changes before and after treatment (P>0.05), and there was no statistical difference between every subgroup and their corresponding control group (P> 0.05).
3.3 Allergens test results:Among the 670 allergic rhinitis patients of Beijing city, there were 487 patients which showed positive reaction to at least one allergen, with positive rate 72.69%. The distribution of allergens species from strong to weak were as follows:House dust mites, Dust mites, Weeds, TreesⅠ, TreesⅡ, Chenopodiaceae, Ragweed, Animals' wool, Indoor mold, Outdoor mold, Feathers, and so on. In this study, ragweed pollen occupied a high positive rate of skin test. We should pay more attention to it, as it had strong regeneration ability and large dose of pollen.
3.4 Safety monitoring results:In this study, each group had good safety. Changes of blood and urine routine examinations had no significance before and after treatment(P> 0.05). ALT, CREA and BUN were all in normal range, the fluctuation was no more than 50% of the normal value.
4 Conclusions
4.1 The treatment of allergic rhinitis according to syndrome differentiation of traditional Chinese medicine had good effect, and could greatly decrease the scores of their symptom and syndrome, so as to improve their life quality.
4.2 Traditional Chinese decoction could significantly reduce the number of eosinophil in rhinal secretion smear.
4.3 Traditional Chinese decoction combined with nose drops could significantly improve the treatment effect of allergic rhinitis.
4.4 The positive rate of allergic rhinitis in Beijing city was 72.69 %, the distribution of allergens species from strong to weak were as follows:House dust mites, Dust mites, Weeds, TreesⅠ, TreesⅡ, et al.
4.5 Attention should be paid to Ragweed pollen, as it occupied a high positive rate of skin test, meanwhile had strong regeneration ability and large dose of pollen.
4.6 Traditional Chinese medicine treatment on allergic rhinitis was safe and had no significant side-effects.
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