桂枝芍药知母汤对阳虚型干燥综合征治疗作用的临床研究
发布时间：2019-05-15 13:45
【摘要】：干燥综合征(Sj?gren’s syndrome;SS)是一种主要累及外分泌腺的慢性炎症性自身免疫病,为第二常见的自身免疫性风湿病,可累及多系统、多脏器,严重影响患者的生活质量。本研究在临床经验的基础上,以前瞻性对照研究的方法观察桂枝芍药知母汤治疗阳虚型SS的效果,为临床提供有效的方法及理论依据。目的:通过与羟氯喹的对比研究,客观评价桂枝芍药知母汤治疗阳虚型SS的疗效,验证阳不化气理论的正确性,探讨温阳化气法为主治疗阳虚型SS可能的机理。方法:采用随机对照的方法,将符合标准的70例患者分为治疗组和对照组,每组各35例,均给予硫酸羟氯喹片口服,治疗组加桂枝芍药知母汤辨证加减治疗,按疗程服用,观察两组患者中医证候积分表症状评分,阳虚证量化积分、疾病活动度积分、实验室检测指标改善情况及安全性指标。结果:(1)病例脱落3例,最终入组病例67例,治疗组35例,对照组32例。(2)在总有效率方面,治疗组临床痊愈0例、显效14例、有效17例、无效4例,总有效率88.57%,对照组临床痊愈0例、显效6例、有效13例、无效13例,总有效率59.37%,比较存在显著统计学意义(P0.05)。(3)在中医症状改善方面,两组治疗后均可降低中医症状总积分及除腮部肿大外其余各个单项的中医症状积分,且治疗组优于对照组(P0.05),其中在降低口干、眼干积分方面治疗组明显优于对照组,具有显著统计学意义(P0.01);在改善阳虚证方面治疗组能降低总评分(P0.01),对照组则无此作用(P0.05),两组间治疗后比较差异具有显著统计学意义(P0.01)。(4)在改善ESSDAI方面,两组治疗前后比较差异存在显著统计学意义(P0.01);治疗后组间比较存在显著统计学意义(P0.01)。(5)在物理及实验室检查方面,两组治疗后均能降低ESR、CRP、IgG、IgM、IgA,并增加泪液、唾液分泌量,且治疗组优于对照组,以上均具有显著统计学意义(P0.05)。(6)在各项安全指标方面,与治疗前相比,两组治疗后均无统计学意义(P0.05)。结论:桂枝芍药知母汤可提高单纯西药治疗SS的疗效,增强羟氯喹调节机体免疫和抑制炎症反应的功能,改善阳虚型SS的临床症状和中医证候;验证阳气不足,气化失职是SS发生的重要机理,温阳化气可做为本病治疗的基本法则。
[Abstract]:Sjogren's syndrome (Sj?gren's syndrome;SS) is a chronic inflammatory autoimmune disease which mainly involves exocrine gland. Sjogren's syndrome (Sjogren's syndrome) is the second common autoimmune rheumatism, which can involve multiple systems and organs, and seriously affect the quality of life of patients. On the basis of clinical experience, this study observed the effect of Guizhi Shaoyao Zhimu decoction on Yang deficiency type SS by prospective controlled study, and provided effective method and theoretical basis for clinic. Objective: to objectively evaluate the efficacy of Guizhi Shaoyao Zhimu decoction in the treatment of yang deficiency type SS by comparing with hydroxychloroquine, to verify the correctness of Yang deficiency qi theory, and to explore the possible mechanism of warming yang and removing gas method in the treatment of yang deficiency type SS. Methods: 70 patients who met the standard were randomly divided into treatment group (n = 35) and control group (n = 35). All patients in each group were given hydroxychloroquine sulfate tablets by oral administration. The treatment group was treated with Guizhi Shaoyao Zhimu decoction according to the course of treatment. The symptom score of TCM syndrome table, the quantitative score of Yang deficiency syndrome, the score of disease activity, the improvement of laboratory test index and the safety index of the two groups were observed. Results: (1) there were 3 cases falling off, 67 cases in the final group, 35 cases in the treatment group and 32 cases in the control group. (2) in the total effective rate, 0 cases were cured, 14 cases were markedly effective, 17 cases were effective and 4 cases were ineffective. The total effective rate was 88.57%. In the control group, 0 cases were cured, 6 cases were markedly effective, 13 cases were effective and 13 cases were ineffective, the total effective rate was 59.37%. There was significant statistical significance (P 0.05). (3) in the improvement of TCM symptoms. After treatment, the total score of TCM symptoms and the score of other individual TCM symptoms in the treatment group were lower than those in the control group (P 0.05), and the treatment group was superior to the control group in reducing the score of dry mouth and eye stem, and the treatment group was obviously superior to the control group in reducing the score of dry mouth and eye. There was significant statistical significance (P01). In the improvement of yang deficiency syndrome, the treatment group could reduce the total score (P 0.01), while the control group had no such effect (P 0.05). There was significant difference between the two groups after treatment (P 0.01). (4) in improving ESSDAI. There was significant difference between the two groups before and after treatment (P 0.01). After treatment, there was significant difference between the two groups (P01). (5) in physical and laboratory examination. After treatment, both groups could decrease ESR,CRP,IgG,IgM,IgA, and increase the secretion of tears and saliva. The treatment group was superior to the control group, the above were statistically significant (P 0.05). (6) in terms of safety indicators, compared with before treatment, there was no significant difference between the two groups after treatment (P 0.05). Conclusion: Guizhi Shaoyao Zhimu decoction can improve the curative effect of western medicine alone in the treatment of SS, enhance the function of hydroxychloroquine in regulating immunity and inhibiting inflammatory reaction, and improve the clinical symptoms and TCM syndromes of yang deficiency type SS. It is proved that insufficient yang qi and gasification dereliction of duty are the important mechanism of SS. Wenyang Huaiqi can be used as the basic law of the treatment of this disease.
【学位授予单位】：河北大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R259
，
本文编号：2477547
[Abstract]:Sjogren's syndrome (Sj?gren's syndrome;SS) is a chronic inflammatory autoimmune disease which mainly involves exocrine gland. Sjogren's syndrome (Sjogren's syndrome) is the second common autoimmune rheumatism, which can involve multiple systems and organs, and seriously affect the quality of life of patients. On the basis of clinical experience, this study observed the effect of Guizhi Shaoyao Zhimu decoction on Yang deficiency type SS by prospective controlled study, and provided effective method and theoretical basis for clinic. Objective: to objectively evaluate the efficacy of Guizhi Shaoyao Zhimu decoction in the treatment of yang deficiency type SS by comparing with hydroxychloroquine, to verify the correctness of Yang deficiency qi theory, and to explore the possible mechanism of warming yang and removing gas method in the treatment of yang deficiency type SS. Methods: 70 patients who met the standard were randomly divided into treatment group (n = 35) and control group (n = 35). All patients in each group were given hydroxychloroquine sulfate tablets by oral administration. The treatment group was treated with Guizhi Shaoyao Zhimu decoction according to the course of treatment. The symptom score of TCM syndrome table, the quantitative score of Yang deficiency syndrome, the score of disease activity, the improvement of laboratory test index and the safety index of the two groups were observed. Results: (1) there were 3 cases falling off, 67 cases in the final group, 35 cases in the treatment group and 32 cases in the control group. (2) in the total effective rate, 0 cases were cured, 14 cases were markedly effective, 17 cases were effective and 4 cases were ineffective. The total effective rate was 88.57%. In the control group, 0 cases were cured, 6 cases were markedly effective, 13 cases were effective and 13 cases were ineffective, the total effective rate was 59.37%. There was significant statistical significance (P 0.05). (3) in the improvement of TCM symptoms. After treatment, the total score of TCM symptoms and the score of other individual TCM symptoms in the treatment group were lower than those in the control group (P 0.05), and the treatment group was superior to the control group in reducing the score of dry mouth and eye stem, and the treatment group was obviously superior to the control group in reducing the score of dry mouth and eye. There was significant statistical significance (P01). In the improvement of yang deficiency syndrome, the treatment group could reduce the total score (P 0.01), while the control group had no such effect (P 0.05). There was significant difference between the two groups after treatment (P 0.01). (4) in improving ESSDAI. There was significant difference between the two groups before and after treatment (P 0.01). After treatment, there was significant difference between the two groups (P01). (5) in physical and laboratory examination. After treatment, both groups could decrease ESR,CRP,IgG,IgM,IgA, and increase the secretion of tears and saliva. The treatment group was superior to the control group, the above were statistically significant (P 0.05). (6) in terms of safety indicators, compared with before treatment, there was no significant difference between the two groups after treatment (P 0.05). Conclusion: Guizhi Shaoyao Zhimu decoction can improve the curative effect of western medicine alone in the treatment of SS, enhance the function of hydroxychloroquine in regulating immunity and inhibiting inflammatory reaction, and improve the clinical symptoms and TCM syndromes of yang deficiency type SS. It is proved that insufficient yang qi and gasification dereliction of duty are the important mechanism of SS. Wenyang Huaiqi can be used as the basic law of the treatment of this disease.
【学位授予单位】：河北大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R259
，
本文编号：2477547
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