天灸治疗变应性鼻炎临床疗效研究及免疫机制探讨
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摘要
目的：
了解天灸治疗变应性鼻炎(allergic rhinitis, AR)的临床疗效及其规律。检测天灸治疗AR前后外周血血清中IL-4、IFN-γ的浓度,探讨天灸治疗AR的免疫学机制。
方法：
根据符合纳入标准120名AR患者,根据患者的意愿分为三组：1组(三伏三九灸组)：受试者按要求于三伏(7-8月)、三九(12月至次年1月)进行天灸治疗,每个时段各5次治疗,共10次；2组(日常灸组)：受试者按要求于非三伏(4—5月)、非三九(9—10月)时段进行天灸治疗,每个时段各5次治疗,共10次；3组(四季灸组)：受试者接受上述两组所述时段的所有治疗,共20次。各组按1：1：1比例分配。后期因病例脱落较多补充纳入25例(1组16例,2组9例),共纳入145例患者,本研究实际观察123例患者。另招募39例健康对照者进行血清细胞因子测定。
三组天灸用药、取穴方案相同,选用白芥子、细辛、甘遂、延胡索按一定比例(具体依照广东省中医院的天灸散药物配方)配伍研细末,姜汁调和；选用的穴位有三组：①肺俞(双侧)、胃俞(双侧)、志室(双侧)；②脾俞(双侧)、风门(双侧)、气海、关元；③肾俞(双侧)、定喘、中脘、下脘。第1次治疗取第1组穴位,第2次治疗取第2组穴位,3组穴位依次交替使用。由治疗师将膏方贴在特定穴位,患者自觉贴敷处灼热难忍为度则取下药物,三九期间9天1次,其余10天贴1次。三伏三九天灸组、日常灸组在每5次天灸治疗前、治疗后1周进行临床疗效评价和抽血检测IL-4、IFN-γ浓度；四季灸组在每10次天灸治疗前、治疗后1周进行临床疗效评价,在总治疗前和总治疗后1周抽血检测IL-4、IFN—γ浓度；三个组研究对象在完成所有治疗后半年、1年进行随访和临床疗效评价。健康对照组在三伏天灸治疗规定时间进行抽血检验,只检验1次,结果作为标准基线。疗效评价以AR4分症状评估、鼻部体征评分、视觉模拟评分量表(Visual Analogue Scale, VAS)、鼻结膜炎生活质量量表(Rhinoconjunctivitis Quality of Life Questionnaire, RQLQ)作为指标。采用酶联免疫吸附测定法(Enzyme-Linked Immunosorbent Assay, ELISA)方法检测细胞因子IL-4、IFN-γ浓度。
收集数据采用Epidata3.1软件通过数据双人双录入法建立数据库,组内治疗前后比较用的是非参数配对符号秩和检验,组间不同时点的比较采用PASW statistics18.O软件包的一般线性模型过程中的重复测量、单变量进行统计分析,基线不等采用协方差分析。临床疗效评价指标(症状、体征、VAS和RQLQ)与实验指标(IL一4,IFN—γ)的相关性分析采用两两相关分析。
结果：
1.天灸疗效分析
(1)三伏三九灸组的症状总分在第一阶段治疗前后、总治疗前后比较差异有显著的统计学意义(P (2)日常灸组的症状总分在第二阶段治疗前后比较差异有统计学意义(P0.05)。
(3)四季灸组的症状总分在第二阶段治疗前后比较差异有统计学意义(P 2.疗效持续性分析
(1)三伏三九灸组第二阶段治疗前(暂停治疗4个月)与第一阶段治疗前症状总分、体征比较,差异均有统计学意义(P0.05)。疗后半年、1年与总治疗前症状总分、VAS评分比较差异有显著的统计学意义(P (2)日常灸组第二阶段治疗前(暂停治疗4个月)与第一阶段治疗前比较,体征评分差异均有统计学意义(P0.05)。症状总分在第一阶段治疗后和第二阶段治疗前(暂停治疗4月)比较差异有统计学意义(PO.05)；VAS评分在疗后半年与治疗前比较差异有统计学意义(P (3)四季灸组第二阶段治疗前(暂停治疗4个月)与第一阶段治疗前比较,症状总分差异有统计学意义(PO.05)。在第一阶段治疗后和第二阶段治疗前的症状总分比较差异有统计学意义(P 3.天灸时效性分析
三伏三九灸组与日常灸组除在第二阶段治疗后症状总分、治疗后1年的体征评分比较差异有统计学意义(PO.05)。
4.天灸量效性分析
(1)三伏三九灸组与四季灸组在第二阶段治疗前后症状总分比差异均有统计学意义(P (2)日常灸组与四季灸组在第二阶段治疗前的症状总分、VAS评分和RQLQ总分比较差异均有统计学意义(P 5.免疫学指标分析
(1)IL-4
三组AR患者治疗前的IL-4浓度与健康对照组比较有差异(P<0.05)。
三伏三九灸组总治疗前后、日常灸组第一阶段治疗前后、总治疗前后IL-4浓度比较差异有显著统计学意义(P 三伏三九灸组和日常灸组第一阶段治疗后IL-4浓度比较差异有显著的统计学意义(P (2)INF—γ
三伏三九灸组、日常灸组治疗前的INF-γ浓度与健康对照组比较差异有统计学意义(PO.05)。
三伏三九灸组总治疗前后IFN-γ浓度比较差异有显著的统计学意义(P 三伏三九灸组和日常灸组、日常灸组和四季灸组第二阶段治疗后比较差异有统计学意义(P 6.相关性分析
第一阶段治疗前后和第二阶段治疗前后症状总分与VAS评分呈负相关关系(P 第一阶段治疗前IL-4浓度与IFN-γ浓度呈正相关关系(P 结论：
1.天灸治疗AR有效。主要体现在两个方面：①天灸控制AR患者的症状、改善鼻部体征。②天灸提高AR患者的生活质量。
2.天灸治疗AR的疗效有一定持续性,治疗次数多,疗效持续时间长。
3.天灸治疗AR的近期疗效不一存在时效性,天灸治疗不局限于三伏三九时间,可以常年推广；天灸治疗AR的远期疗效可能存在一定的时效关系。
4.天灸治疗AR的量效性有待进一步研究。
5.天灸治疗AR的免疫学机制可能是提高机体的INF-γ浓度,另可能还存在其他免疫学机制。
6.AR的症状严重程度与患者生活质量成负相关,症状、体征和RQLQ,总分与INF—Y成负相关,体征与IL-4成正相关。
Objectives
To observe the clinical effect of medicinal vesiculation therapy and its regularity. The concentration of IL-4, the IFN-gamma in peripheral blood were tested before and after treatment,to explore the immunological mechanism of medicinal vesiculation act on allergic rhinitis.
Methods
120patients with allergic rhinitis were adopted in the otorhinolaryngology department,then according to their will divided into three groups. Each group have40patients. The first group named the group of sanfujiu and sanjiujiu, patients in this group were treated during sanfudays (from July and August)and sanjiudays(from December and January in the following year), five times in each period, a total of ten times. The second group named the group of ordinary medicinal vesiculation, patients in this group were treated during nonsanfudays (from April to May), and nonsanjiudays (from September to October), five times in each period, a total of ten times. The third group named the group of medicinal vesiculation in four seasons, patients in this group receive medicinal vesiculation therapy as much as the total of the frist group and the second group, twenty times in total. Because the case fall off become more in the late period,25patients were added (16cases in the first group,9cases in the second group),144patients were included in total,123cases were observed in this study. Another39healthy controls were recruited to test serum cytokine.
Three groups choose the same herbal paste and acupoints. The herbal paste was composed of Bai Jie Zi (Semen Sinapis Albae),Xi Xin (Herba Asari), Gan Sui (Radix Kansui), Yan Hu Suo (Rhizoma Cordalis), the proportion according to recipe of Tianjiu Powder of Guangdong Hospital of Chinese Medicine; the four kinds of herbs were ground into powder, and fresh ginger(Zingiber officinale) was blended into juice, then the powder and juice were mixed and made into paste. There are there groups Acupoints:①Feishu, Weishu, Zhishi, three acupoints are on back;②Pishu(on back), Fengmen(on back), Qihai, Guanyuan;③Shenshu(on back), Dingchuan, Zhongwan, Xiawan, points on back are choosed both sides, there are six acupoints in each group. The treatment at first time choose the acupoints of first group, the second time choose the acupoints of the second group, three groups acupoints used interchangeably in each treatment period. Each time the herbal paste will be sticked on the special aucpoints by the therapist, and it will be took off when patients feel unbearable. There is one treatment in every nine days during the sanjiudays, and every ten days during other treatment period. The evaluation of clinic effect and test of concentration of IL-4and IFN-gamma for the group of sanfujiu and sanjiujiu and the group of ordinary medicinal vesiculation before treatment and one week after finish every5times treatment. The clinic effect of the group of medicinal vesiculation in four seasons was evaluated before and after every10times treatment, and the concentration of IL-4and IFN-gamma were tested before and after finish all treatment. There were follow-up for three groups after all treatment, clinic effect will be evaluated at6months and1year after all treatment. Healthy controls were taken blood test one time and the results as a standard baseline. Clinic effect evaluation choose the symptom assessment scale, physical sign, visual analogue scale (VAS) and the rhinoconjunctivitis quality of life questionnaire (RQLQ)as indicators.Adopting the method of ELISA test the concentration of cytokines IL-4and IFN-gamma.
Data is collected by Epidata3.1software, and the database established by double person entry data each. Compared before and after treatment in the group with Nonparametric paired signed rank test. The comparison of different time between groups using repeated measurement and univariate statistical analysis in general linear model in the PASW statistics18.0package. The analysis of covariance was used if the baseline is unequal. The correlation analysis of Clinical effect evaluation indicators (symptoms, physical signs, VAS and RQLQ) and the experimental index (IL-4, IFN-gamma) use multivariate correlation analysis.
Result
1. the effect of medicinal vesiculation therapy
(1) The comparison of total score of symptoms and VAS of the group of sanfujiu and sanjiujiu before and after treatment in the first period, before and after total treatment are statistically significantly (P<0.01), and the comparison of VAS before and after treatment in the second period is statistically significant (P<0.05). The comparison of the score of physical signs of the group of sanfujiu and sanjiujiu before and after treatment in the first and second period, before and after total treatment are statistically significantly (P<0.01). The comparison of total score of RQLQ of the group of sanfujiu and sanjiujiu before and after treatment in the first and second period, before and after total treatment are statistically significant (P<0.05).
(2) The comparison of total score of symptoms of the group of ordinary medicinal vesiculation before and after treatment in the second period is statistically significant(P<0.05). The comparison of the score of physical signs of the group of ordinary medicinal vesiculation before and after treatment in the first period, before and after total treatment, there are significant statistical significance (P<0.01). There are no statistical significance for comparison of VAS and total score of RQLQ before and after treatment in the first and second period, before and after total treatment (P>0.05).
(3) The comparison of total score of symptoms of the group of medicinal vesiculation in four seasons before and after treatment in the second period is statistical significant (P<0.05). The comparison of the score of physical signs and VAS of the group of medicinal vesiculation in four seasons before and after treatment in the first period is statistical significant (P<0.05), and there are significant statistical significance in the second period (P<0.01). The comparison of total score of RQLQ of the group of medicinal vesiculation in four seasons before and after treatment in the first and second period are statistically significantly (P<0.01).
2. Analysis of the persistent effect of medicinal vesiculation
(1) In the group of sanfujiu and sanjiujiu, compared before treatment in the second period (stop treatment for four months) with before total treatment, there are statistical significance on total score of symptoms and physical signs (P<0.05), and there are no statistical significance on VAS and total score of RQLQ (P>0.05). Compared six months and one year after total treatment with before total treatment, there are significant statistical significance on total score of symptoms and VAS(P<0.01); there are statistical significance on physical score and total score of RQLQ at six months after treatment (P<0.05), and significant statistical significance at
1year after treatment (P<0.01).
(2) In the group of ordinary medicinal vesiculation, compared before treatment in the second period (stop treatment for four months) with before total treatment, there is statistical significance on physical signs (P<0.05), and there are no statistical significance on VAS and total score of RQLQ (P<0.05). Compared treatment before the second period (stop treatment for four months) with after treatment in the first period, there is significant statistical significance on symptom scores (P<0.01). Compared six months and one year after total treatment with before total treatment, there is statistical significance on total score of symptoms (P<0.05), significant statistical significance on physical sign (P<0.01), and there is on statistical significance on RQLQ total score(P<0.05). Compared six months after total treatment with before total treatment, there is statistical significance on VAS(P<0.05)
(3) In the group of medicinal vesiculation in four seasons, compared before treatment in the second period (stop treatment for four months) with before total treatment, there are statistical significance on total score of symptoms, physical signs and VAS (P<0.05) and there is no statistical significance on RQLQ total score (P>0.05). Compared before treatment in the second period (stop treatment for four months) with after the first period treatment, there is significant statistical significance on total score of symptoms (P<0.01), and there are statistical significance on physical signs and total score of RQLQ (P<0.05). Compared one year after total treatment with before total treatment, there is statistical significance on total score of symptoms (P<0.05), Compared six months and one year after total treatment with before total treatment, there is significant statistical significance on physical sign (P<0.01). Compared six months after total treatment with before total treatment, there are statistical significance on VAS and total score of RQLQ (P<0.05), and there are significant statistical significance compared one year after total treatment with before total treatment (P<0.01).
3. the time-effect analysis of medicinal vesiculation therapy
Between the group of sanfujiu and sanjiujiu and the group of ordinary medicinal vesiculation, except the comparison of total score of symptoms after treatment in the second period and physical sign at one year after total treamtment are statistical significance(P<0.05), the comparison of the total score of symptoms, physical sign, VAS and RQLQ total score of each time is not significant(P<0.05).
4. the quantity-effect analysis of medicinal vesiculation therapy
(1) Between the group of sanfujiu and sanjiujiu and the group of medicinal vesiculation in four seasons, there are statistical significance on the comparison of total score of symptoms before and after treatment in the second period(P<0.05),there are statistical significance on the comparison of physical sign after treatment in the first period, before and after treatment in the second period and one year after total treatment(P<0.05), and there are significant statistical significance on the comparison of physical sign at six month after total treatment (P<0.01). the comparison of VAS before the second period treatment is statistically significant(P<0.05).
(2) Between the group of ordinary medicinal vesiculation and the group of medicinal vesiculation in four seasons, there are statistical significance on the comparison of total score of symptoms, VAS and RQLQ total score before treatment in the second period(P<0.05), there are statistical significance on the comparison of physical sign after treatment in the first period, before treatment in the second period a (P<0.05), and there are significant statistical significance on the comparison of physical sign at six month after total treatment (P<0.01).
5. the cytokines of AR
(1) interlukin-4
There are statistical significance on the comparison of IL-4between three groups of allergic rhinitis patients before treatment and healthy control group (P<0.05).
There are significant statistical significance on the comparison of IL-4of the group of sanfujiu and sanjiujiu before and after total treatment, and IL-4of the group of ordinary medicinal vesiculation before and after treatment in the first period and total treatment (P<0.01).
Between the group of sanfujiu and sanjiujiu and the group of ordinary medicinal vesiculation, there is significant statistical significance on the comparison of IL-4before and after treatment in the first period, and there is statistical significance before and after treatment in the second period(P <0.05). Between the group of sanfujiu and sanjiujiu and the group of medicinal vesiculation in four seasons, and between the group of ordinary medicinal vesiculation and the group of medicinal vesiculation in four seasons, there are significant statistical significance on the comparison of IL-4after treatment in the second period (P<0.01).
(2) INF-γ
There are significant statistical significance on the comparison of INF-gamma between patients in the group of sanfujiu and sanjiujiu and the group of ordinary medicinal vesiculation before treatment and healthy control group (P<0.01), but there isn't statistical significance on the comparison of INF-gamma between patients in the group of medicinal vesiculation in four seasons before treatment and healthy control group(P>0.05).
There are significant statistical significance on the comparison of INF-gamma of the group of sanfujiu and sanjiujiu before and after total treatment, but there isn't statistical significance on the other comparison of INF-gamma between different group and different time.
Between the group of sanfujiu and sanjiujiu and the group of ordinary medicinal vesiculation, and between the group of ordinary medicinal vesiculation and the group of medicinal vesiculation in four seasons, there is statistical significance on the comparison of INF-gamma before and after treatment in the second period.
6. The correlation analysis
Before and after treatment in the first and second period total score of symptoms is negatively related with VAS score (P<0.001), and positively related with the total score of RQLQ (P<0.001). Before treatment in the first period IL-4was positively related with INF-gamma (P<0.001)
After treatment in the first period total score of symptoms is negatively related with INF-gamma (P<0.01).physical sign and the total score of RQLQ are negatively related with INF-gamma (P<0.05).Before treatment in the second period total score of symptoms is negatively related with INF-gamma (P<0.05).After treatment in the second period physical sign positively related with IL-4(P<0.05).
Conclusion
1. The medicinal vesiculation therapy is effective for AR. It mainly reflected in two aspects:①The medicinal vesiculation therapy can control the nasal symptoms of AR and improve physical signs.②The medicinal vesiculation therapy can improve the quality of life of AR patients.
2. The effect of medicinal vesiculation therapy for AR is sustainable, the more times treated, the longer duration it sustain.
3. There isn't time-effect relationship for the short-term effect of medicinal vesiculation therapy, medicinal vesiculation therapy can be treated-throughout the year;but there maybe time-effect relationship for the long-term effect of medicinal vesiculation therapy.
4. The quality-effect relationship for medicinal vesiculation therapy needs further research.
5. The immunological mechanism of medicinal vesiculation therapy maybe improve INF-gamma in the human body, and there may be other complicated immunological mechanisms.
6. The severity of symptoms of AR is negatively related to the quality of life in patients; symptoms, physical signs and the total score of RQLQ are negatively related with INF-gamma; physical signs is positively related with IL-4.
了解天灸治疗变应性鼻炎(allergic rhinitis, AR)的临床疗效及其规律。检测天灸治疗AR前后外周血血清中IL-4、IFN-γ的浓度,探讨天灸治疗AR的免疫学机制。
方法：
根据符合纳入标准120名AR患者,根据患者的意愿分为三组：1组(三伏三九灸组)：受试者按要求于三伏(7-8月)、三九(12月至次年1月)进行天灸治疗,每个时段各5次治疗,共10次；2组(日常灸组)：受试者按要求于非三伏(4—5月)、非三九(9—10月)时段进行天灸治疗,每个时段各5次治疗,共10次；3组(四季灸组)：受试者接受上述两组所述时段的所有治疗,共20次。各组按1：1：1比例分配。后期因病例脱落较多补充纳入25例(1组16例,2组9例),共纳入145例患者,本研究实际观察123例患者。另招募39例健康对照者进行血清细胞因子测定。
三组天灸用药、取穴方案相同,选用白芥子、细辛、甘遂、延胡索按一定比例(具体依照广东省中医院的天灸散药物配方)配伍研细末,姜汁调和；选用的穴位有三组：①肺俞(双侧)、胃俞(双侧)、志室(双侧)；②脾俞(双侧)、风门(双侧)、气海、关元；③肾俞(双侧)、定喘、中脘、下脘。第1次治疗取第1组穴位,第2次治疗取第2组穴位,3组穴位依次交替使用。由治疗师将膏方贴在特定穴位,患者自觉贴敷处灼热难忍为度则取下药物,三九期间9天1次,其余10天贴1次。三伏三九天灸组、日常灸组在每5次天灸治疗前、治疗后1周进行临床疗效评价和抽血检测IL-4、IFN-γ浓度；四季灸组在每10次天灸治疗前、治疗后1周进行临床疗效评价,在总治疗前和总治疗后1周抽血检测IL-4、IFN—γ浓度；三个组研究对象在完成所有治疗后半年、1年进行随访和临床疗效评价。健康对照组在三伏天灸治疗规定时间进行抽血检验,只检验1次,结果作为标准基线。疗效评价以AR4分症状评估、鼻部体征评分、视觉模拟评分量表(Visual Analogue Scale, VAS)、鼻结膜炎生活质量量表(Rhinoconjunctivitis Quality of Life Questionnaire, RQLQ)作为指标。采用酶联免疫吸附测定法(Enzyme-Linked Immunosorbent Assay, ELISA)方法检测细胞因子IL-4、IFN-γ浓度。
收集数据采用Epidata3.1软件通过数据双人双录入法建立数据库,组内治疗前后比较用的是非参数配对符号秩和检验,组间不同时点的比较采用PASW statistics18.O软件包的一般线性模型过程中的重复测量、单变量进行统计分析,基线不等采用协方差分析。临床疗效评价指标(症状、体征、VAS和RQLQ)与实验指标(IL一4,IFN—γ)的相关性分析采用两两相关分析。
结果：
1.天灸疗效分析
(1)三伏三九灸组的症状总分在第一阶段治疗前后、总治疗前后比较差异有显著的统计学意义(P
(3)四季灸组的症状总分在第二阶段治疗前后比较差异有统计学意义(P
(1)三伏三九灸组第二阶段治疗前(暂停治疗4个月)与第一阶段治疗前症状总分、体征比较,差异均有统计学意义(P
三伏三九灸组与日常灸组除在第二阶段治疗后症状总分、治疗后1年的体征评分比较差异有统计学意义(P
4.天灸量效性分析
(1)三伏三九灸组与四季灸组在第二阶段治疗前后症状总分比差异均有统计学意义(P
(1)IL-4
三组AR患者治疗前的IL-4浓度与健康对照组比较有差异(P<0.05)。
三伏三九灸组总治疗前后、日常灸组第一阶段治疗前后、总治疗前后IL-4浓度比较差异有显著统计学意义(P
三伏三九灸组、日常灸组治疗前的INF-γ浓度与健康对照组比较差异有统计学意义(P
三伏三九灸组总治疗前后IFN-γ浓度比较差异有显著的统计学意义(P
第一阶段治疗前后和第二阶段治疗前后症状总分与VAS评分呈负相关关系(P
1.天灸治疗AR有效。主要体现在两个方面：①天灸控制AR患者的症状、改善鼻部体征。②天灸提高AR患者的生活质量。
2.天灸治疗AR的疗效有一定持续性,治疗次数多,疗效持续时间长。
3.天灸治疗AR的近期疗效不一存在时效性,天灸治疗不局限于三伏三九时间,可以常年推广；天灸治疗AR的远期疗效可能存在一定的时效关系。
4.天灸治疗AR的量效性有待进一步研究。
5.天灸治疗AR的免疫学机制可能是提高机体的INF-γ浓度,另可能还存在其他免疫学机制。
6.AR的症状严重程度与患者生活质量成负相关,症状、体征和RQLQ,总分与INF—Y成负相关,体征与IL-4成正相关。
Objectives
To observe the clinical effect of medicinal vesiculation therapy and its regularity. The concentration of IL-4, the IFN-gamma in peripheral blood were tested before and after treatment,to explore the immunological mechanism of medicinal vesiculation act on allergic rhinitis.
Methods
120patients with allergic rhinitis were adopted in the otorhinolaryngology department,then according to their will divided into three groups. Each group have40patients. The first group named the group of sanfujiu and sanjiujiu, patients in this group were treated during sanfudays (from July and August)and sanjiudays(from December and January in the following year), five times in each period, a total of ten times. The second group named the group of ordinary medicinal vesiculation, patients in this group were treated during nonsanfudays (from April to May), and nonsanjiudays (from September to October), five times in each period, a total of ten times. The third group named the group of medicinal vesiculation in four seasons, patients in this group receive medicinal vesiculation therapy as much as the total of the frist group and the second group, twenty times in total. Because the case fall off become more in the late period,25patients were added (16cases in the first group,9cases in the second group),144patients were included in total,123cases were observed in this study. Another39healthy controls were recruited to test serum cytokine.
Three groups choose the same herbal paste and acupoints. The herbal paste was composed of Bai Jie Zi (Semen Sinapis Albae),Xi Xin (Herba Asari), Gan Sui (Radix Kansui), Yan Hu Suo (Rhizoma Cordalis), the proportion according to recipe of Tianjiu Powder of Guangdong Hospital of Chinese Medicine; the four kinds of herbs were ground into powder, and fresh ginger(Zingiber officinale) was blended into juice, then the powder and juice were mixed and made into paste. There are there groups Acupoints:①Feishu, Weishu, Zhishi, three acupoints are on back;②Pishu(on back), Fengmen(on back), Qihai, Guanyuan;③Shenshu(on back), Dingchuan, Zhongwan, Xiawan, points on back are choosed both sides, there are six acupoints in each group. The treatment at first time choose the acupoints of first group, the second time choose the acupoints of the second group, three groups acupoints used interchangeably in each treatment period. Each time the herbal paste will be sticked on the special aucpoints by the therapist, and it will be took off when patients feel unbearable. There is one treatment in every nine days during the sanjiudays, and every ten days during other treatment period. The evaluation of clinic effect and test of concentration of IL-4and IFN-gamma for the group of sanfujiu and sanjiujiu and the group of ordinary medicinal vesiculation before treatment and one week after finish every5times treatment. The clinic effect of the group of medicinal vesiculation in four seasons was evaluated before and after every10times treatment, and the concentration of IL-4and IFN-gamma were tested before and after finish all treatment. There were follow-up for three groups after all treatment, clinic effect will be evaluated at6months and1year after all treatment. Healthy controls were taken blood test one time and the results as a standard baseline. Clinic effect evaluation choose the symptom assessment scale, physical sign, visual analogue scale (VAS) and the rhinoconjunctivitis quality of life questionnaire (RQLQ)as indicators.Adopting the method of ELISA test the concentration of cytokines IL-4and IFN-gamma.
Data is collected by Epidata3.1software, and the database established by double person entry data each. Compared before and after treatment in the group with Nonparametric paired signed rank test. The comparison of different time between groups using repeated measurement and univariate statistical analysis in general linear model in the PASW statistics18.0package. The analysis of covariance was used if the baseline is unequal. The correlation analysis of Clinical effect evaluation indicators (symptoms, physical signs, VAS and RQLQ) and the experimental index (IL-4, IFN-gamma) use multivariate correlation analysis.
Result
1. the effect of medicinal vesiculation therapy
(1) The comparison of total score of symptoms and VAS of the group of sanfujiu and sanjiujiu before and after treatment in the first period, before and after total treatment are statistically significantly (P<0.01), and the comparison of VAS before and after treatment in the second period is statistically significant (P<0.05). The comparison of the score of physical signs of the group of sanfujiu and sanjiujiu before and after treatment in the first and second period, before and after total treatment are statistically significantly (P<0.01). The comparison of total score of RQLQ of the group of sanfujiu and sanjiujiu before and after treatment in the first and second period, before and after total treatment are statistically significant (P<0.05).
(2) The comparison of total score of symptoms of the group of ordinary medicinal vesiculation before and after treatment in the second period is statistically significant(P<0.05). The comparison of the score of physical signs of the group of ordinary medicinal vesiculation before and after treatment in the first period, before and after total treatment, there are significant statistical significance (P<0.01). There are no statistical significance for comparison of VAS and total score of RQLQ before and after treatment in the first and second period, before and after total treatment (P>0.05).
(3) The comparison of total score of symptoms of the group of medicinal vesiculation in four seasons before and after treatment in the second period is statistical significant (P<0.05). The comparison of the score of physical signs and VAS of the group of medicinal vesiculation in four seasons before and after treatment in the first period is statistical significant (P<0.05), and there are significant statistical significance in the second period (P<0.01). The comparison of total score of RQLQ of the group of medicinal vesiculation in four seasons before and after treatment in the first and second period are statistically significantly (P<0.01).
2. Analysis of the persistent effect of medicinal vesiculation
(1) In the group of sanfujiu and sanjiujiu, compared before treatment in the second period (stop treatment for four months) with before total treatment, there are statistical significance on total score of symptoms and physical signs (P<0.05), and there are no statistical significance on VAS and total score of RQLQ (P>0.05). Compared six months and one year after total treatment with before total treatment, there are significant statistical significance on total score of symptoms and VAS(P<0.01); there are statistical significance on physical score and total score of RQLQ at six months after treatment (P<0.05), and significant statistical significance at
1year after treatment (P<0.01).
(2) In the group of ordinary medicinal vesiculation, compared before treatment in the second period (stop treatment for four months) with before total treatment, there is statistical significance on physical signs (P<0.05), and there are no statistical significance on VAS and total score of RQLQ (P<0.05). Compared treatment before the second period (stop treatment for four months) with after treatment in the first period, there is significant statistical significance on symptom scores (P<0.01). Compared six months and one year after total treatment with before total treatment, there is statistical significance on total score of symptoms (P<0.05), significant statistical significance on physical sign (P<0.01), and there is on statistical significance on RQLQ total score(P<0.05). Compared six months after total treatment with before total treatment, there is statistical significance on VAS(P<0.05)
(3) In the group of medicinal vesiculation in four seasons, compared before treatment in the second period (stop treatment for four months) with before total treatment, there are statistical significance on total score of symptoms, physical signs and VAS (P<0.05) and there is no statistical significance on RQLQ total score (P>0.05). Compared before treatment in the second period (stop treatment for four months) with after the first period treatment, there is significant statistical significance on total score of symptoms (P<0.01), and there are statistical significance on physical signs and total score of RQLQ (P<0.05). Compared one year after total treatment with before total treatment, there is statistical significance on total score of symptoms (P<0.05), Compared six months and one year after total treatment with before total treatment, there is significant statistical significance on physical sign (P<0.01). Compared six months after total treatment with before total treatment, there are statistical significance on VAS and total score of RQLQ (P<0.05), and there are significant statistical significance compared one year after total treatment with before total treatment (P<0.01).
3. the time-effect analysis of medicinal vesiculation therapy
Between the group of sanfujiu and sanjiujiu and the group of ordinary medicinal vesiculation, except the comparison of total score of symptoms after treatment in the second period and physical sign at one year after total treamtment are statistical significance(P<0.05), the comparison of the total score of symptoms, physical sign, VAS and RQLQ total score of each time is not significant(P<0.05).
4. the quantity-effect analysis of medicinal vesiculation therapy
(1) Between the group of sanfujiu and sanjiujiu and the group of medicinal vesiculation in four seasons, there are statistical significance on the comparison of total score of symptoms before and after treatment in the second period(P<0.05),there are statistical significance on the comparison of physical sign after treatment in the first period, before and after treatment in the second period and one year after total treatment(P<0.05), and there are significant statistical significance on the comparison of physical sign at six month after total treatment (P<0.01). the comparison of VAS before the second period treatment is statistically significant(P<0.05).
(2) Between the group of ordinary medicinal vesiculation and the group of medicinal vesiculation in four seasons, there are statistical significance on the comparison of total score of symptoms, VAS and RQLQ total score before treatment in the second period(P<0.05), there are statistical significance on the comparison of physical sign after treatment in the first period, before treatment in the second period a (P<0.05), and there are significant statistical significance on the comparison of physical sign at six month after total treatment (P<0.01).
5. the cytokines of AR
(1) interlukin-4
There are statistical significance on the comparison of IL-4between three groups of allergic rhinitis patients before treatment and healthy control group (P<0.05).
There are significant statistical significance on the comparison of IL-4of the group of sanfujiu and sanjiujiu before and after total treatment, and IL-4of the group of ordinary medicinal vesiculation before and after treatment in the first period and total treatment (P<0.01).
Between the group of sanfujiu and sanjiujiu and the group of ordinary medicinal vesiculation, there is significant statistical significance on the comparison of IL-4before and after treatment in the first period, and there is statistical significance before and after treatment in the second period(P <0.05). Between the group of sanfujiu and sanjiujiu and the group of medicinal vesiculation in four seasons, and between the group of ordinary medicinal vesiculation and the group of medicinal vesiculation in four seasons, there are significant statistical significance on the comparison of IL-4after treatment in the second period (P<0.01).
(2) INF-γ
There are significant statistical significance on the comparison of INF-gamma between patients in the group of sanfujiu and sanjiujiu and the group of ordinary medicinal vesiculation before treatment and healthy control group (P<0.01), but there isn't statistical significance on the comparison of INF-gamma between patients in the group of medicinal vesiculation in four seasons before treatment and healthy control group(P>0.05).
There are significant statistical significance on the comparison of INF-gamma of the group of sanfujiu and sanjiujiu before and after total treatment, but there isn't statistical significance on the other comparison of INF-gamma between different group and different time.
Between the group of sanfujiu and sanjiujiu and the group of ordinary medicinal vesiculation, and between the group of ordinary medicinal vesiculation and the group of medicinal vesiculation in four seasons, there is statistical significance on the comparison of INF-gamma before and after treatment in the second period.
6. The correlation analysis
Before and after treatment in the first and second period total score of symptoms is negatively related with VAS score (P<0.001), and positively related with the total score of RQLQ (P<0.001). Before treatment in the first period IL-4was positively related with INF-gamma (P<0.001)
After treatment in the first period total score of symptoms is negatively related with INF-gamma (P<0.01).physical sign and the total score of RQLQ are negatively related with INF-gamma (P<0.05).Before treatment in the second period total score of symptoms is negatively related with INF-gamma (P<0.05).After treatment in the second period physical sign positively related with IL-4(P<0.05).
Conclusion
1. The medicinal vesiculation therapy is effective for AR. It mainly reflected in two aspects:①The medicinal vesiculation therapy can control the nasal symptoms of AR and improve physical signs.②The medicinal vesiculation therapy can improve the quality of life of AR patients.
2. The effect of medicinal vesiculation therapy for AR is sustainable, the more times treated, the longer duration it sustain.
3. There isn't time-effect relationship for the short-term effect of medicinal vesiculation therapy, medicinal vesiculation therapy can be treated-throughout the year;but there maybe time-effect relationship for the long-term effect of medicinal vesiculation therapy.
4. The quality-effect relationship for medicinal vesiculation therapy needs further research.
5. The immunological mechanism of medicinal vesiculation therapy maybe improve INF-gamma in the human body, and there may be other complicated immunological mechanisms.
6. The severity of symptoms of AR is negatively related to the quality of life in patients; symptoms, physical signs and the total score of RQLQ are negatively related with INF-gamma; physical signs is positively related with IL-4.
引文
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