复方西瓜霜滴眼液治疗肺胃郁热型视疲劳有效性和安全性的临床分析-中医眼科学专业论文.docx

成都中医药大学硕 成都中医药大学硕士学位论文 PAGE PAGE 1 中文摘要 目的：初步评价复方西瓜霜滴眼液治疗肺胃郁热型视疲劳的有效性和安全性。 为复方西瓜霜滴眼液研制开发提供科学依据。 方法：确诊为肺胃郁热型视疲劳的患者 240 人例，采用对照、随机、双盲、 平行、多中心临床试验的研究方法分成试验组（120 例）和对照组（120 例），试验 组采用复方西瓜霜滴眼液治疗，对照组采用生理盐水滴眼液治疗，连续用药 2 周， 用药结束时观察用药前后两组患者的临床症状、安全性指标等情况。 结果： 1. 综合疗效：用药后试验组愈显率 46.61%，总有效率 87.29%，对照组愈显率 13.68%，总有效率 57.26%，两组综合疗效相比差异有统计学意义( P＜0. 05) 。 2. 各症疗效：用药后两组各症状积分均下降，组间用药前症状积分比较差异无 统计学意义( P＞0. 05) ，组内用药前后、组间用药后症状积分差异均有统计学意义( P ＜0. 05) 。 3. 安全性：两组患者治疗结束时血、尿、大便常规、肝肾功能、心电图检测均 无明显异常变化。表明本实验条件下复方西瓜霜滴眼液安全有效，无毒副作用。 结论：复方西瓜霜滴眼液能有效治疗肺胃郁热型视疲劳，明显改善相关临床 症状，临床应用安全有效，无毒副作用, 值得进一步研究和临床推广使用。 关键词：视疲劳；肺胃郁热；复方西瓜霜滴眼液；临床观察。 Abstract Objective: To observe the effect and safety of Fu-Fang-Xi-Gua-Shuang gutta in treating asthenopia syndrome (lungs and stomach heat retention pattern),to provide scientific support for the exploitation of Fu-Fang-Xi-Gua-Shuang gutta. Methods：240 patients suffered by asthenopia syndrome (lungs and stomach heat retention pattern) are chosen and respectively divided into test group (120 patients) and control group (120 patients) with the positive control，random，double-blind，double- simulation, polycentric method. 120 patients of test group were treated continually with Fu-Fang-Xi-Gua-Shuang gutta for two weeks; 120 patients of control group with Sheng-Li-Yan-Shui gutta.The clinical symptoms, changes in system and the safety of the two medicines were observed after two weeks treatment. Results: General effect：Total effective rate of test group is 87.29%,57.26% for control group,which has significance according to statistics between two groups(p＜0.05). Symptoms：The accumulated scores of clinical symptoms each group declined evidently，and no significant difference exists comparing with that of the symptoms patients have before treatment in Between Groups (p＞0.05)，but the opposite result was gotten between two groups and in Within Groups.(p＜0.05). Safety analysis:The results of blood routine test，urinary routine test，stool routine test，liver functio