【作者】 刘彦；

【导师】 丁淑华；

【作者基本信息】 南京中医药大学 ， 中医五官科学（专业学位）， 2013， 博士

【摘要】 背景：干眼症是由于泪液的量或质或流体动力学异常引起的泪膜不稳定和(或)眼表损害,从而导致眼不适症状及视功能障碍的一类疾病。随着人类老龄化、空气污染等问题日益严重,以及电脑的普及和隐形眼镜的广泛应用等,干眼症已成为影响人们生活质量的一类重要的眼表疾病。其影响因素多,针对性的治疗困难,祛除病因和治疗原发病是提高干眼症治疗效果的关键,目前的治疗方法中人工泪液是一线用药,泪点塞在轻中度干眼症中效果确切,伴有中重度炎症者应用糖皮质激素、免疫抑制剂,全身应用促泪液分泌、性激素等有副作用风险。干眼症属于祖国医学“白涩症、干涩昏花症和神水将枯”范畴,中药润目灵和针刺单独应用治疗干眼症均取得较好疗效,在此基础上寻找安全可靠、疗效确切的传统治疗方法,需要进一步规范化整合中医综合疗法。目的：通过规范性研究,归纳整合优化中医综合疗法治疗水样液缺乏性干眼症方案,完善针灸使用的技术标准操作规程,评价中医综合疗法对水样液缺乏性干眼症的疗效,形成便于在西医院和基层医院推广的应用指南和临床诊疗规范。方法：采用随机、平行设计、阳性药对照、多中心方法,分为润目灵治疗组(A组)、中医综合疗法治疗组(B组)及泪然对照(C组),总例数645例,润目灵组215例,泪然组215例,中医综合疗法组215例。观察疗前疗后的症状、泪液分泌量、泪膜破裂时间和角膜荧光染色,进行优效性检验。结果：中医综合疗法和中药润目灵疗效优于对照药泪然滴眼液：中医证候疗效有效率：A组为79.88%,B组为84.85%,C组为67.74%,差异有统计学意义,A组、B组优于C组；对于中、重度病人,B组疗效优于C组,差异有统计学意义；“单项症状”疗效中,A组干涩感、畏光症状消失率为12.35%和69.41%高于C组的10.86%和57.01%,组间差异有统计学意义,B组干涩感、异物感、烧灼感和视物疲劳症状消失率分别为21.89%、60.36%、81.66%和53.25%高于C组的10.86%、43.44%、74.21%和23.53%,两组间差异有统计学意义；治疗前后症状总积分改善情况,第6、8周A组和B组优于C组,差异有统计学意义；治疗前后泪膜破裂时间延长及泪流量增加,A、B组优于C组,差异有统计学意义；中医综合疗法疗效优于中药润目灵：两组有效率相比,差异有统计学意义,B组优于A组；B组眼干涩、视物疲劳症状的消失率均高于A组,组间差异有统计学意义；症状总积分改善情况,第8周B组优于A组；“单项症状”疗效中,眼干涩、视物疲劳症状改善B组优于A组。结论：中药润目灵治疗干眼症疗效确切,而中药润目灵联合针灸的综合疗法又优于单纯中药润目灵。更多还原

【Abstract】 Background:Xeroma is a disease of ocular surface characterized by Symptoms of ocular discomforts and visual dysfunction, which is the result of abnormal tear quantity or quality or fluid dynamics of the tear film. With the problem of human aging, air pollution and the popularization of computer and contact lenses is increasingly serious.Xeroma has a Serious impact on people’s quality of life. For the time being the cause and mechanism of xeroma are not fully known to us. The methods of effective treatments are still not present.Removing the causes and remedy of the primary disease is the key to the treatment of xeroma. Artificial tear substituent is the first-line drug, eternal or temporary blockage of tear duct in mild to moderate dry eye is effective,and Corticosteroids and immunosuppressants is effective for those with moderate to severe inflammatory reaction. There is risk of significant complications with systemic application of sex hormone and tear secretion. We have demonstrated that Runmuling, an oral granule preparation composed of Bidens Bipinnata L, medlar and chrysanthemum and acupuncture separately showed better curative effect in treatment of xeroma,on the basis of looking for safe, reliable and effective traditional treatment methods, we need to further standardize integration of integrated traditional Chinese medicine therapy.Objective:Through standardized research,to summarize the integration and optimization of integrated traditional Chinese medicine therapy in the treatment of xeroma, improve the technical standards of operation procedures of acupuncture, investigate the exact curative effect and security of integrated Traditional Chinese Medicine therapy on xeroma, forming the guide of the clinical diagnosis and therapy standard and which is facilitated application and popularization in West hospitals and primary hospitals.Methods:645patients with xeroma are investigated with A randomized, parallel design, positive drug control, multi-center method, divided into Runmuling treatment group (group A)215cases, integrated Traditional Chinese Medicine therapy group (group B)215cases and tears natural control group (group C)215cases separately, Since the beginning of the treatment, the patients are observed and evaluated every two weeks in terms of symptom score, SIT, BUT, corneal staining and the results were statistically analyzed by superiority test. Results:The efficacy of Integrated traditional Chinese medicine therapy group and Runmuling treatment group is superior to tears natural control group:The efficiency of TCM syndrome curative effect of group A,B,and C is79.88%,84.85%and67.74%separately, Group A and B are superior to group C, the difference is statistically significant,especially efficiency in moderate to severe patients in group B is superior to group C statistically; About "symptom disappearance rate " efficacy, dryness, fear of light symptom disappearance rate in group A and group C is12.35%,69.41%and10.86%,57.01%, there was statistically significant difference between the groups; Symptom disappearance rate of dryness, foreign body sensation, burning sensation and visual fatigue symptoms in group B was21.89%,60.36%,81.66%and53.25%and those in group C was10.86%,43.44%,74.21%and23.53%, there are significant differences between the two groups before and after treatment, group B is superior to group C;there is statistically significant difference among the three groups in the total symptom score after6and8weeks of treatment, group A and B are superior to group C; there was also significant difference in BUT and SIT in group A, B than in group C, the difference was statistically significant;The efficacy of Integrated Traditional Chinese Medicine therapy group is better than that of Runmuling group:The difference of curative effect between two groups was statistically significant, group B is better than group A;there was statistically significant difference in symptom disappearance rate of dryness and visual fatigue between group B and A; the total symptom score after8weeks of treatment in group B is superior to group A, the difference is statistically significant, the total symptom score improvement of dryness and visual fatigue in group B is better than that of group C, the difference was statistically significant;Conclusion:Effect of Runmuling in treatment of xerophthalmia is exact,integrated traditional Chinese medicine therapy that combined of Runmuling and acupuncture is better than that of pure Chinese herbal medicine runmuling.更多还原