【作者】 王日荣；

【导师】 许能贵；

【作者基本信息】 广州中医药大学 ， 针灸推拿学， 2010， 博士

【摘要】 目的本课题采用临床流行病学、临床科研方法学及数理统计分析方法,进行临床随机对照研究,以针灸疗法和中药组为对照,观察针刺与中药结合的方法治疗常年变应性鼻炎的临床疗效,并初步探讨两种方法治疗常年变应性鼻炎的免疫学机制。方法选取2009年4月至2010年3月期间在台湾王日荣耳鼻喉科诊所治疗的,符合病例筛选标准的90例常年变应性鼻炎患者。按1：1：1的比例随机分配至针药结合组、针刺组和中药组三组,每组各有30例。1周为一疗程,共治疗4个疗程。分别测量患者治疗前和治疗后的中医临床症状和体征及外周血血浆白细胞介素-4(IL-4)及干扰素-γ(IFN-γ)水平,并进行安全性检测。用EPIDATA3.1软件建立数据库,用SPSS 15.0软件进行统计分析。计量资料用均数±标准差(x±S)表示,计数资料用构成比(%)表示；计量资料组问比较采用F检验(方差不齐采用Kruskal-Wallis H秩和检验),组间多重比较用q检验(Newman-Keuls法),自身前后比较用配对t检验或Wilcoxon配对秩和检验。分类资料组间比较采用χ2验,等级资料组间比较采用Kruskal-Wallis H秩和检验。统计图形的制作采用软件Graph Pad Prism 4.03完成。结果共收到合格病例报告表90例,其中男43例,女47例；年龄19岁～42岁；病程1年～15年。其中针药结合组30例(男18例,女12例)、针灸组30例(男14例,女16例)、中药组30例(男11例,女19例)。三组平均年龄分别为27.84岁、25.52岁、28.13岁；平均病程分别为6.51年、7.48年、5.52年。主要研究指标的疗效,治疗一月后,针药结合组、针灸组和中药组均能降低患者临床症状体征积分及其总积分,三组之间比较,鼻痒、鼻塞、流涕、鼻粘膜体征有统计学意义(P<0.05),而喷嚏无统计学意义(P>0.05)。经两两比较可知,针药结合组在改善鼻痒、鼻塞、流涕、鼻粘膜体征方面疗效优于针灸组和中药组。但是在改善喷嚏方面三组疗效相当。通过对三组症状体征总积分比较也可得出,针药结合组能明显减低症状体征总积分方面,优于其它两组；针灸组优于中药组。三组均可使常年变应性鼻炎患者血清IL-4含量、IgE水平显著降低；三种治疗方法对IFN-γ水平均无明显影响。经过1月治疗后,针药结合组30例患者,显效17例,占56.7%；有效10例,占33.3%；无效3例,占10.0%,总有效率90.0%。针灸组30例患者,显效8例,占26.7%；有效15例,占50.0%；无效7例,占23.3%,总有效率76.6%。中药组30例患者,显效6例,占20.0%,有效16例,占53.3%；无效8例,占26.7%,总有效率73.3%。三组临床疗效的比较,差异有统计意义,根据平均秩和大小,针药组最小,疗效最好。但三组总有效率比较,差异无统计意义。治疗期间,三组未见一例不良反应,表明针药结合临床应用安全可靠。结论综合以上临床研究结果,初步证明了采用针刺结合中药的方法治疗常年变应性鼻炎,可有效提高其临床疗效,能显著改善患者整体证候,提高患者的生存质量,安全可靠,值得推广。本疗法治疗本病的机制有可能是通过抑制Th细胞向Th2方向分化,调节体内失衡的Th1／Th2细胞,从而减少IgE的合成来抑制变态反应的发生。更多还原

【Abstract】 ObjectiveTo observe clinical curative effect and to explore the immunology mechanism on perennial allergic rhinitis (PAR) applied with combination acupuncture and traditional Chinese medicine which used Clinical epidemiology、clinical scientific research technology and mathematical statistics analytical methods, applied clinical random control study in which set up acupuncture group and Chinese medicine group.MethodsThe 90 PAR patients that were consistent with screen standard and were treated in Wang Rirong’s ENT department in Taiwan during April 2009 and March 2010 were selected.1:1:1 random distribution into 3 groups:combination acupuncture and traditional Chinese medicine group, acupuncture group and Chinese medicine group. Each group was 30 cases. One week as a course of treatment, all in four courses of treatment. At prior treatment and post treatment, Chinese clinical sings and symptom was observed, the level of interleukin-4 and IFN-γin peripheral blood plasma was studied and safe detection was adopted.Set up the database by the software of EPIDATA3.1 and statistical analyzed by the software of SPSS15.0. Measurement data was represented by mean±tandard deviation (x±S), numeration data was represented by constituent ratio (%). Interclass multiple comparison will be observed using q test (Newman-Keuls), t test or Wilcoxon paring rank-sum test for self AP:PA comparison, X2 test for classification group comparison, Kruskal-Wallis H rank-sum test for ranked data group comparison. The software of Graph Pad Prism 4.03 was used for statistical figure. Results90 candidates have been collected, and man was 43cases,47cases in female, who the age was from 19 to 42 years old and with lyear to 5year course of PAR. 90candidates randomly divided into 3 groups:combination acupuncture and traditional Chinese medicine group (18 cases in man,12 cases in female), acupuncture group (14ceases in man,16 cases in female) and Chinese medicine group(11 cases in man, and 19 cases in female). Each group has 30 candidates. The age of these three groups was 27.84years、25.52years and 28.13years respectively, and the course of the PAR disease was 6.51years、7.48years and 5.52years respectively.Combination acupuncture and traditional Chinese medicine group、acupuncture group and Chinese medicine group could decrease the accumulated points of clinical symptom and overall score after lmonth treatment. Compared among three groups, it has statistical significance in rhinocnesmus、nasal obstruction、nasal discharge、physical sign of nasal mucosa (P<0.05), but sneezing has not (P> 0.05). From the comparison with two groups, the combination acupuncture and traditional Chinese medicine group has better effect than other two groups on rhinocnesmus、nasal obstruction、nasal discharge、physical sign of nasal mucosa. It has the same effect on the improving sneezing symptom.According to the comparison of overall score among three groups, the combination acupuncture and traditional Chinese medicine group could significantly decrease the overall score which has better effect than the other two groups. Acupuncture group was better than the Chinese medicine group. These three groups all could decrease the level of IL-4 and IgE of the PAR patients. It has not significantly effect on the IFN-γwith these three kinds of treatment.After lmonth treatment, there were 17cases had significantly effect in 30 candidates used combination acupuncture and traditional Chinese medicine (account to 56.7%), 10cases has general effect (account to 33.3%). There were 3cases had nothing effect in 30 candidates (account to 10.0%). The total effective rate was 90.0%. There were 8cases had significantly effect in 30 candidates used acupuncture group (account to 26.7%),15cases has general effect (account to 50.0%). There were 7cases had nothing effect in 30 candidates (account to 23.3%). The total effective rate was 76.6%. There were 6cases had significantly effect in 30 candidates used Chinese medicine only (account to20.0%),16cases has general effect (account to 53.3%). There were 8cases had nothing effect in 30 candidates (account to 26.7%). The total effective rate was 73.3%. It has significantly difference among three treatment groups. The combination acupuncture and traditional Chinese medicine group has the smallest average sum of ranks and has the best effect of treatment. It has not significantly difference in total effective rate among three groups. There was not adverse effect case among three groups during the time of treatment. The result presented that it has safety clinical application with combination acupuncture and traditional Chinese medicine to the PAR patients.ConclusionCombined with clinical research results, it was demonstrated that the clinical curative effect of perennial allergic rhinitis (PAR) applied with combination acupuncture and traditional Chinese medicine was enhanced and the patients’symptoms survival quality were improved. The treatment was effective and safe which was worth to extend. The treatment mechanism maybe was by that restraining Th differentiated to Th2, adjusting the disequilibrium of Th1/Th2 cell, so as to decrease the synthesis of IgE for repressing the occurrence of allergies.更多还原