| 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 Methods2.1 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 Results3.1 The comparison of results of traditional Chinese medicine group, western medicine group, Comprehensive traditional chinese medicine group and comprehensive western medicine group3.1.1 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 groups3.2.1 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, Trees?, Trees?, 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 Conclusions4.1 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, Trees?, Trees?, 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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