Effect of Tangshiming Capsules on visual acuity and quality of life in patients with diabetic retinopathy in TCM syndrome type of qi-yin deficiency and blood stasis
RONG Wenqing1 TENG Tao2 HUANG Yanqin3 XU Yunsheng4
1.The First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Shandong Province, Ji′nan 250014, China;
2.Department of Endocrinology, The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong Province, Ji′nan 250001, China; 3.Department of Endocrinology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong Province, Ji′nan 250011, China;
4.Office of the Director, the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong Province, Ji′nan 250001, China
Abstract:Objective To observe the effect of Tangshiming Capsules on the visual acuity and quality of life in patients with diabetic retinopathy (DR) in TCM syndrome type of qi-yin deficiency and blood stasis. Methods Ninety two (184 eyes) DR cases admitted to the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine from February to August 2017 were selected from Ward and Outpatient of Departments of Endocrinology and Ophthalmology. They were divided into experimental group and control group by random number table method with 45 cases (90 eyes) in the experimental group and 47 cases in the control group (94 eyes). Eventually, eighty DR cases finished follow-up, with 40 cases (80 eyes) in each group. The control group was given the treatment of control blood pressure, blood glucose, blood lipids and lifestyle intervention. The experimental group was given Tangshiming Capsules orally on the basis of the treatment of the control group. Quality of life, visual acuity, TCM syndrome scores, fasting blood glucose, 2 h postprandial blood glucose, glycosylated hemoglobin changes and safety evaluation indicators (blood routine, urine routine, liver and kidney function, electrocardiogram) were observed before and after treatment. Results Before treatment, there was no significant difference in the scores of quality of life between the two groups (P > 0.05), which were all significantly improved after treatment (P < 0.05), and the improvement in the experimental group was superior than the control group (P < 0.05). Before treatment, there was no significant difference in visual acuity between the two groups (P > 0.05), which both improved in the two groups after treatment (P < 0.05), and the improvement in the experimental group was superior to the control group (P < 0.05). Before treatment, there was no significant difference in the syndrome scores between the two groups (P > 0.05), which both reduced after treatment in the two groups (P < 0.05), and the scores was lower in the experimental group than the control group (P < 0.05). There was no significant difference in glycosylated hemoglobin, fasting blood glucose, and postprandial blood glucose 2 h before treatment between the two groups (P > 0.05), which all reduced significantly after treatment (P < 0.05), and those in the experimental group was lower than the control group (P < 0.05). The total effective rate was 82.50% in the experimental group, which was higher than 55.00% in the control group (P < 0.05). Blood and urine routine, liver and kidney function were normal in both groups before and after treatment, and no adverse reactions occurred. Conclusion Tangshiming Capsules can significantly improve the visual acuity and quality of life of DR patients, and the security was good.
荣汶青1 滕涛2 黄延芹3 徐云生4. 糖视明胶囊对气阴两虚血瘀型糖尿病视网膜病变患者视力及生活质量的影响[J]. 中国医药导报, 2018, 15(34): 118-121,134.
RONG Wenqing1 TENG Tao2 HUANG Yanqin3 XU Yunsheng4. Effect of Tangshiming Capsules on visual acuity and quality of life in patients with diabetic retinopathy in TCM syndrome type of qi-yin deficiency and blood stasis. 中国医药导报, 2018, 15(34): 118-121,134.
[1] Bucolo C,Ward KE. Protective effects of a coumarin derivative in diabetic rats [J]. Invest Ophthalmol Vis Sci,2009, 50(8):3846-3852.
[2] Malone JI,Morrison AD,Pavan PR,et al. Prevalence and significance of retinopathy in subjects with type 1 diabetes of less than 5 years′ duration screened for the diabetes control and complications trial [J]. Diabetes Care,2001,24(3):522.
[3] Crawford TN,Kerrison JB,Jablon EP. Diabetic retinopathy and angiogenesis [J]. Current Diabetes Reviews,2009,5(1):8-13.
[4] Weltgesundheitsorganisation. The World Health Report [M]. Geneva:WHO,1998:1-8.
[5] Drake L. Prevention of Blindness from Diabetes Mellitus-Report of a WHO Consultation Prevention of Blindness from Diabetes Mellitus-Report of a WHO Consultation [J]. Nursing Standard,2006,21(32):30-30.
[6] 王少杰.糖尿病患者糖尿病性视网膜病变调查[J].临床内科杂志,2008,25(3):204-206.
[7] Villarroel M,Ciudin A,Hernández C,et al. Neurodegeneration:An early event of diabetic retinopathy [J]. World J Diabetes,2010,1(2):57-64.
[8] Kollias AN,Ulbig MW. Diabetic retinopathy:Early diagnosis and effective treatment [J]. Dtsch Arztebl Int,2010, 107(5):75.
[9] World Health Organization. Definition,diagnosis and classification of diabetes mellitus and its complicationg. Report of a WHO consultation. [R]. Geneva:WHO,1999.
[10] 宋振英.眼科诊断学[M].北京:人民卫生出版社,1985:577-579.
[11] 第三届全国眼科学术会议.糖尿病性视网膜病变临床分期标准[J].中华眼科杂志,1985,21(2):113.
[12] 郑筱萸.中药新药临床研究指导原则(试行)[S].北京:中国医药科技出版社,2002:234-237.
[13] 倪琳琳.消渴目病患者报告临床结局(PRO)评估量表的研制和考评[D].济南:山东中医药大学,2016.
[14] Yang W,Lu J,Weng J,et al. Prevalence of diabetes among men and women in China [J]. N Engl J Med,2010, 362(25):2425-2426.
[15] Orley J. World Health Organization: Programme on Mental Health [J]. Journal of Mental Health,1996,5(3):319-322.
[16] 刘建平.循证中医药临床研究方法学[M].北京:人民卫生出版社,2006.
[17] Chistiakov DA. Diabetic retinopathy:Pathogenic mechanisms and current treatments [J]. Diabetes Metab Syndr,2011,5(3):165-172.
[18] 祝俊香.血府逐瘀汤加减对气阴两虚血瘀型糖尿病视网膜病变出血期的临床疗效观察[D].济南:山东中医药大学,2015.
[19] 王静,柯根杰,顾永昊,等.糖尿病视网膜病变对生活质量的影响[J].安徽医药,2010,14(9):1031-1034.
[20] Wolffsohn JS,Cochrane AL. Design of the low vision quality of life questionnaire(LVQOL)and measuring the outcome of low vision rehabilitation [J]. Am Jophthalmol,2000,130(6):793-802.