文章摘要
张陶陶,王露露,肖艳萍,廖良.固阳化水方治疗脾肾阳虚型糖尿病黄斑水肿的临床研究[J].南京中医药大学学报,2019,35(6):646-650.
固阳化水方治疗脾肾阳虚型糖尿病黄斑水肿的临床研究
Clinical Study on Guyang Huashui Formula in Treating Diabetic Macular Edema with Spleen and Kidney Yang Deficiency Type
  
DOI:
中文关键词: 关键词:固阳化水方  糖尿病黄斑水肿  脾肾阳虚  光学相干断层成像  黄斑中心厚度
英文关键词: Guyang Huashui formula  diabetic macular edema  spleen and kidney yang deficiency  optical coherence tomography  macular center thickness
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作者单位
张陶陶1,王露露2,肖艳萍2,廖良2 1.北京中医药大学第二临床医学院北京 1000782.北京中医药大学东方医院北京 100078 
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中文摘要:
      目的 评价固阳化水方治疗脾肾阳虚型糖尿病黄斑水肿(DME)的临床疗效。方法 采用前瞻性随机对照试验的研究方法,观察2016年1月至2018年12月在北京中医药大学东方医院眼科门诊就诊的糖尿病黄斑水肿患者66例(66只眼),纳入患者需同时符合糖尿病黄斑水肿国际临床分型中度及以上和中医证型脾肾阳虚型的诊断标准,随机分为试验组和对照组各33例,分别给予固阳化水方中药配方颗粒剂或羟苯磺酸钙胶囊及迈之灵片口服治疗3月,根据患者的最佳矫正视力、黄斑区视网膜厚度和体积、中医证候积分等进行疗效评价。结果 2组各有30例患者完成全部治疗和观察。治疗后2组患者最佳矫正视力较治疗前均有明显改善(P<\i><0.05~0.01),组间差异无显著性意义(P<\i>>0.05);试验组黄斑中心视网膜厚度显著降低(P<\i><0.01),2组黄斑区视网膜体积、黄斑区平均视网膜厚度均明显降低(P<\i><0.01),试验组明显优于对照组(P<\i><0.01);试验组中医证候积分明显改善(P<\i><0.05~0.01),2组比较,P<\i><0.05~0.01。结论 固阳化水方可明显改善糖尿病黄斑水肿患者视力并降低黄斑区视网膜厚度,显著缓解患者中医症状。
英文摘要:
      OBJECTIVE To evaluate the clinical efficacy of Guyang Huashui formula in treating diabetic macular edema (DME) with spleen and kidney yang deficiency type. METHODS A prospective randomized controlled trial was conducted to observe 66 patients (66 eyes) with DME outpatients in the department of ophthalmology in Dongfang Hospital from January in 2016 to December in 2018. Patients admitted to the study should meet the diagnostic criteria for moderate and worse international clinical classification of DME and traditional Chinese medicine (TCM) syndrome type of spleen and kidney yang deficiency. Randomly divided into the experimental group and the control group, 33 cases each, who were given Guyang Huashui formula granules or calcium hydroxybenzenesulfonate capsules and Maizhiling tablets for oral treatment for 3 months. The efficacy was evaluated according to the patient's best corrected visual acuity, macular retinal thickness and volume, and TCM syndrome scores. RESULTS 30 patients in each group completed all treatment and observation. After treatment, the best corrected visual acuity in both groups was significantly improved compared with that before treatment (P<\i><0.05, P<\i><0.01 ) and difference between groups has no significant meaning (P<\i>>0.05). The thickness of the retinal film in the macular center of the test group was significantly reduced (P<\i><0.01 ). The thickness of the retinal membrane and the average thickness of the retinal membrane in the macular area of the two groups were significantly reduced (P<\i><0.01), and the test group was significantly better than the control group (P<\i><0.01). In the trial group, the medical syndrome was clearly improved (P<\i><0.05, P<\i><0.01). The two groups were compared and the difference was significant (P<\i><0.05, P<\i><0.01). CONCLUSION Guyang Huashui formula can significantly improve DME patient's vision and reduced retinal thickness in the macular area so as to relieve their TCM syndrome.
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