【作者】 吴幸周；

【导师】 林培政；

【作者基本信息】 广州中医药大学 ， 中医临床基础学， 2010， 博士

【摘要】 目的观察藿香正气散治疗感冒挟湿的临床疗效和安全性,以期为临床应用提供安全性和药效学依据。方法研究对象为符合感冒挟湿的辨证标准,同时符合西医普通感冒诊断标准的患者。随机分为两组,治疗组服用藿香正气散,对照组采用利巴韦林注射联合复方氨酚烷胺胶囊口服,以临床综合疗效、中医症状评分为观察指标,评价藿香正气散的有效性和安全性。统计方法：分类资料用χ2检验,等级资料用两样本比较Wilcoxon秩和检验(校正),两样本均数比较用t检验或Wilcoxon秩和检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。结果本次研究共有合格受试者90例,治疗组45例,男23例,女22例,年龄18-50岁,平均年龄37.5±9.7岁；对照组45例,男20例,女25例,年龄19-50岁,平均年龄39.8±7.9岁。均为门诊病人。治疗前可比性检测表明,两组治疗前年龄、病程、病情程度等各项指标比较,差异均无显著性意义。提示影响两组预后的主要因素具有均衡性。治疗组治疗后痊愈率为55.6%,显效率为17.8%,有效率为15.6%；而对照组治疗后痊愈率为13.3%,显效率为13.3%,有效率为44.4%。经比较,两组总疗效差异有统计学意义(P<0.05)。治疗3天后,两组在改善感冒症状(恶寒、发热、鼻塞、流涕、自汗、头痛、咳嗽吐痰、脘闷恶心、纳差、体倦乏力、肢体酸痛、便溏、恶风)程度上,差异有统计学意义(P<0.05)。两组治疗3天后,恶寒、发热、鼻塞、恶风、流涕、自汗、头痛、咳嗽吐痰、肠鸣腹泻、脘闷恶心、纳差、体倦乏力、肢体酸痛、便溏症状消失率两组比较差异有统计学差异(P<0.05)。两组治疗前后血常规、血糖、肝功能、肾功能经检测差异无统计学意义(P>0.05),可认为两组药均安全可靠。结论总疗效比较,治疗组的总有效率为88.9%,对照组的总有效率为71.1%,经比较,差异有统计学意义(P<0.05),可认为治疗组疗效优于对照组。治疗组在恶寒、发热、鼻塞、流涕、自汗、头痛、咳嗽吐痰、脘闷恶心、纳差、体倦乏力、肢体酸痛、便溏、恶风症状的改善作用与对照组比较,差异有显著性意义(P<0.05)。提示治疗组在改善上述症状作用上较对照组有优势。藿香正气散具有解表化湿,理气和中的作用。对感冒挟湿有较好的疗效,并且临床检测本方安全可靠。更多还原

【Abstract】 ObjectiveTo observe the clinical curative effect and safety about the curatio of Agastachis Powder for Restoring Healthy Energy on diseases caused by exogenous pathogenic factor with moist type cold in order to offer its safety and pharmacodynamics basis on clinical application.MethodsThe research objects were the ones which fit the standard of diseases caused by exogenous pathogenic factor with moist type cold, match the standard of medical common code as well. Randomly divided them into two groups, the treatment group was used by Agastachis Powder for Restoring Healthy Energy, the control group was deployed ribovirin injection associate complex prescription AM alcohol phenyl-ane amine caps for oral use. To estimate the availability and safety of Agastachis Powder for Restoring Healthy Energy by standard on clinical synthetic curative effect and TCMsymptom score. Statistical method:classify data tested byχ2 test, ranked data was used the comparison between two samples which were Wilcoxon rank sum test(corrected). The comparison between two samples’mean tested by using Wilcoxon rank sum test.The self AP:PA comparison used matched-pairs test t or Wilcoxon rank sum test.ResultsThere were 90 cases of qualified subjects,45cases were treatment group, (23cases of man,22cases of woman) the age from 18 to 50, the average age is 37.5±9.7,45cases were control group(20cases of men,25cases of women) the age from 19 to 50years old, the average age was 39.8±7.9years. All subjects were medical outpatient.Prior treatment comparability test indicated that there weren’t significant senses on the comparison about age, course of disease, pathogenetic conditionDEG and every index which cued that the major factor on effecting prognostic result possessed equilibration. The treatment group after treatment was 55.6%, the excellence rate was 13.3%, the effective power was 15.6%. The healing rate of control group is 13.3%, the excellence rate was 13.3%, the effective power was 44.4%. After comparison, there was statistical significance on the differences between two groups on curative effects(P<0.05).After 3-day treatment, there was statistical significance on improving cold symptom (nephrasthenia asthma, calor febrilis, nasal obstruction, nasal discharge, spontaneous perspiration, angina capitis, begma and spit, gastric cavity tightly closed and sicchasia, nauseated, tired and debilitation, limbs aching pain, loose stool, aversion to wind)differences between two groups(P<0.05).After 3-day treatment, there was statistical significance on different disappearance rate between two groups on nephrasthenia asthma, calor febrilis, nasal obstruction, nasal discharge, spontaneous perspiration, angina capitis, begma and spit, gastric cavity tightly closed and sicchasia, nauseated, tired and debilitation, limbs aching pain, loose stool, aversion to wind(P<0.05).There was not statistically significant on blood convention、blood glucose、liver function and renal function after treatment(P>0.05). It was considered that two groups of medicine were safe. ConclusionAccording to total curative effect comparison, the total effective rate of treatment group was 88.9%, the total effective rate of control group was 71.1%. There was statistical significance so that we can conclude that the curative effect of healing group was better than the control group (P<0.05).There was significant difference between two groups of improving effect on curing nephrasthenia asthma, calor febrilis, nasal obstruction, nasal discharge, spontaneous perspiration, angina capitis, begma and spit, gastric cavity tightly closed and sicchasia, bad nano, tired and debilitation, limbs aching pain, loose stool, aversion to wind(P<0.05). The result cued that the curative effect on above-mentioned symptom of the healing group was better than control group.Agastachis Powder for Restoring Healthy Energy not only could diaphoresis relieving superficies and dissipating dampness but also principle the breath. It done well in diseases caused by exogenous pathogenic factor with moist type cold treatment and the clinical detection was safe and reliability.更多还原