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玉蝉卫肺丸治疗变应性鼻炎肺脾气虚证的临床研究
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摘要
变应性鼻炎是耳鼻喉科的常见病,属中医“鼻鼽”范畴。近年来,尽管对鼻变态反应的研究和防治有了较大进展,但该病仍未得到有效控制。中医对本病的认识有着独特的理论体系,治疗上强调整体观念和辨证论治,取得了满意的临床疗效。本课题针对肺脾气虚证变应性鼻炎的患者以玉蝉卫肺丸作为治疗用药,进行客观系统的分析研究。
     研究目的
     客观评价玉蝉卫肺丸治疗变应性鼻炎肺脾气虚证的临床疗效及安全性。研究方法
     将150例符合变应性鼻炎肺脾气虚证的患者按2:1随机分为治疗组和对照组。治疗组患者口服玉蝉卫肺丸,对照组患者口服盐酸西替利嗪片。观察患者用药前后及随访期主观症状、客观指标的变化情况。
     研究结果
     1、症候综合疗效的评价,在FAS中,治疗组和对照组的等级疗效差别有统计学意义,治疗组优于对照组(P<0.05);在PPS中,两组的等级疗效差别无统计学意义(P>0.05)。这是由于Fas的样本含量多于PPS, PPS中脱落病例的原因为使用对照药无效,患者要求改为中药治疗。
     2、治疗期单项症状变化分析,两组的鼻塞、喷嚏、嗅觉减退症状、鼻粘膜肿胀的变化在统计学上无差异(P>0.05),流涕变化治疗组明显优于对照组(P<0.01),鼻痒及鼻腔分泌物变化治疗组优于对照组(P<0.05)。
     3、治疗组和对照组在随访期鼻塞、流涕、喷嚏的变化,治疗组优于对照组,说明中药疗效的持续性要优于对照组。
     4、研究过程中,治疗组患者用药期间及用药后1月,均未发现不良事件。
     结论
     1、玉蝉卫肺丸具有补益肺脾,益气固表,祛风止痒,止嚏敛涕,通利鼻窍,,抗过敏的功效。
     2、玉蝉卫肺丸治疗肺脾气虚证变应性鼻炎具有很好的临床疗效及安全性。
Allergic rhinitis(AR) is a common otorhinolaryngologic disease, belongs to "Bi Qiu" category in Chinese medicine. Although the studies and treatments on nasal allergic have made great progress, but the AR has not been effectively controlled. Chinese medicine has a unique theoretical system for the AR, it emphasized the holism and differentiation treatment, and achieved satisfactory clinical curative effect. The paper is to objectively and systematically research Allergic rhinitis with lung spleen deficiency syndrome, by analyzing the patients who take Yu Chan Wei Fei pill as a treatment medicine.
     Objective
     To evaluate objectively the curative effect and safety of Yu Chan Wei Fei pill in treating allergic rhinitis with lung spleen deficiency syndrome.
     Methods
     150 patients of allergic rhinitis with lung spleen deficiency syndrome were randomly divided into treatment and control groups, by ratio 2:1. Treatment group patients were treated with Yu Chan Wei Fei pill, control group patients were treated with cetirizine hydrochloride tablet. The patients were observed their subjective symptoms and physical sign of change before and after treatment.
     Results
     1. Symptom comprehensive evaluation of curative effect. In FAS, the difference in level of curative effect of treatment group and control group is statistically significant. The curative effect of treatment group is better than control group (P<0.05). In PPS, the difference in level of curative effect of two groups was not statistically significant (P> 0.05). This is because that the samples of FAS were more than PPS. The reason for PPS samples'leave was the drugs ineffective of controlled groups, hence the patient asked to treat by traditional Chinese medicine.
     2. Changes analysis of individual symptoms during the treatment. The changes in nasal obstruction, sneezing, hyposmia symptoms, and nasal swelling of two groups were not statistical difference (P> 0.05). The treatment group of rhinorrhea was better than control group obviously(P<0.01). The treatment group of nasal itching and nasal discharge was better than the control group (P<0.05).
     3. Changes analysis of nasal obstruction, runny nose, sneezing during follow up phase. The treatment group was better than the control group, which indicated that the continued curative effect of Chinese medicine is better than the control group.
     4. Adverse events were not found in treatment group, during treatment and after one month of treatment
     Conclusion
     1. Yu Chan Wei Fei pill can tonify the lung and the spleen, replenish Qi and secure the exterior, dispel wind and itching, stop sneezing and rhinorrhea. It has the effect of relieving the stuffy nose, and anti-allergic effect.
     2. Yu Chan Wei Fei Pill has a good clinical efficacy and safety, when treating allergic rhinitis with lung spleen deficiency syndrome.
引文
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