增液活露汤治疗原发性干燥综合征的临床研究

发布时间：2018-06-17 19:36

本文选题：干燥综合征 + 中医　；参考：《南京中医药大学》2016年博士论文

【摘要】：研究目的通过文献研究从理论上探讨原发性干燥综合征的中医病机与证型,并观察导师汪悦治疗原发性干燥综合征经验方增液活露汤的临床疗效及安全性。方法1.理论研究方法：检索古今中外关于本病的相关记载,分析现代医学对于原发性干燥综合征的病因病机研究,结合中医比类取象的古典哲学,为中医在治疗本病时提供较为简便的辨证程序。2.临床研究方法：对60例符合原发性干燥综合征临床诊断标准的患者,采用1：1平行对照原则建立治疗组与对照组,每组各含30例,疗程为12周。治疗组给予中药增液活露汤,每日1剂,早晚口服。对照组予本病两种常规口服药：硫酸羟氯喹片,每次O.1g,2次/日；白芍总苷胶囊每次0.6g,2次/日。观察治疗前后的症状、中医证候、泪液流量、唾液流量、实验室检查及安全性观测等指标,并进行比较与统计学分析。结果1.理论研究结果：认为其病机应包含阴虚津亏、内火伤津、津气失常、痰湿瘀阻、燥毒为患共5个津液流通节点,任何一个节点上的异常状况,如相关脏腑津液纳藏不足,津液耗损程度过高,津气无力推运,通道存在阻碍,津液质量变异,都可导致终端生燥的症状。2.临床研究结果：①治疗前各观测项目在治疗组和对照组间无显著性差异,提示本研究基线具可比性。②治疗组中医证候疗效总有效率为90.00%,优于对照组总有效率63.33%(P0.05)。③治疗组疾病疗效总有效率为86.67%,优于对照组疾病疗效总有效率60.00%(P0.05)。④两组的泪液和唾液流量与治疗前相比均有改善(P0.05),治疗组改善优于对照组(P0.05)。⑤在中医证候量化评分和生活质量评分的改善上,中药治疗组亦明显优于照组(P0.05)。⑥相关肝、肾功能检查均无异常,未见毒副反应及其他明显不良事件的发生。结论1.提出先辨病性,再审病位,依其所患,选药组方的燥痹辨证流程,作为本病临床辨证上的一个新的思维模式。其类比理论在国内可协助患者对医疗方案的理解,在国际上可作为拓展中医辨治本病的交流辅助方案。2.增液活露汤兼顾滋阴润燥、活血通络、清热解毒法,在治疗原发性干燥综合征上较常规西药具有显著优势,能明显减轻患者口眼干燥症状,增加泪液与唾液流量,改善中医证候和生活质量评分,且在临床观察中未降低安全性,值得深入研究与推广应用。
[Abstract]:Objective to study the TCM pathogenesis and syndrome type of primary Sjogren syndrome through literature research, and observe the clinical efficacy and safety of Wang Yue, the Tutor Wang Yue, in the treatment of primary Sjogren syndrome. Method 1. theoretical research methods: retrieve the related records of the disease in ancient and modern, and analyze the modern medicine The etiology and pathogenesis of primary Sjogren syndrome (Sjogren syndrome), combined with the classical philosophy of traditional Chinese medicine, provides a simple.2. clinical study method for TCM in the treatment of the disease: 60 cases of patients with primary Sjogren syndrome clinical diagnostic criteria, the treatment group and control group were set up by 1:1 control principle, each group was set up. The treatment group was given 30 cases, the treatment course was 12 weeks. The treatment group was given the decoction of Zeng liquid and live dew, 1 doses per day and orally. The control group was given two conventional oral medicine for the disease: Hydroxychloroquine Sulfate Tablets, O.1g, 2 times per day, and Total Glucosides of Paeony Capsules each time, 2 times / day. The symptoms and symptoms of the treatment, the volume of tear, the flow of saliva, the laboratory examination and the safety of the treatment were observed. Results of total observation and comparison and statistical analysis. Results the results of 1. theoretical studies were that the disease machine should include deficiency of yin deficiency, internal fire injury, phlegm dampness, phlegm dampness and blood stasis, and dryness toxin as the node of 5 body fluid, and the abnormal condition on any one node, such as the insufficiency of the related Zang Fu Zang fluid storage and the excessive loss of body fluid. The results of the clinical study of the symptoms of terminal dryness with the obstruction of the passage and the quality variation of the body fluid could lead to the clinical results of.2.. (1) there was no significant difference between the observation items before treatment in the treatment group and the control group, suggesting that the baseline of the study was comparable. The total effective rate of TCM syndrome treatment in the treatment group was 90%, which was better than the control group with a total effective rate of 63. .33% (P0.05). (3) the total effective rate of the treatment group was 86.67%, which was better than the control group, the total effective rate was 60% (P0.05). (4) the tear and saliva flow in the two groups were improved (P0.05) and the treatment group was better than the control group (P0.05). 5. In the improvement of TCM syndrome quantifying score and quality of life score, Chinese medicine treatment group Also obviously better than the group (P0.05). (6) related liver, renal function examination no abnormal, no toxic side effects and other obvious adverse events. Conclusion 1. proposed first identify the disease, retrial of the disease, according to the disease, the dryness arthralgia syndrome process of selection group, as a new mode of thinking in the clinical syndrome differentiation. Its analogy theory can be combined in China. To help the patients understand the medical scheme, in the world, it can be used as an auxiliary scheme to expand the treatment of the disease of traditional Chinese medicine (.2.). It has a remarkable advantage over the conventional western medicine in the treatment of primary dry syndrome. It can obviously reduce the dry symptoms of the mouth of the patients and increase the tears and saliva. The flow rate improved the score of TCM syndrome and quality of life, and did not reduce the safety in clinical observation. It is worthy of further research and application.
【学位授予单位】：南京中医药大学
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R259

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