| ObjectiveTo observe the clinical effect of supplementing Qi and nourishing Yin combined with sodium hyaluronate eye drops for dry eye in type 2 diabetic patients with Qi-Yin deficiency.Methods170 dry eye patients in type 2 diabetes(340 eyes)were randomly divided into two groups,the treatment group and the control group,they all include 85 cases(170 eyes).Patients in both tthe treatment group and the control group received basic treatment based on the Guidelines for Prevention and Control of Type 2 Diabetes in China(2013 edition)[1].The control group was given sodium hyaluronate eye drops(Qilu pharmacy Co,Ltd.)for treatment,three times a day,one drop every time,continuous treatment for 4 weeks(one course).The treatment group was not only given the same therapy of the control group,but also given supplementing Qi and nourishing Yin for treatment at the same time.And the prescription was Qiju Dihuang and Sijunzi decoction which was provided by Xiamen hospital of tradition Chinese medicine,oral administraton,twice a day)one package(150 ml)every time,continuous treatment for 4 weeks(one course).Before and after one course of treatment,the symptoms and signs of traditional Chinese medicine(TCM)of the two groups were graded respectively according to the "Guiding Principles for Clinical Research on New Chinese Medicine"[2].And evaluate tear film breakup time and tear meniscus height by applying German OULUS Keratograph(?)5m ocular surface analyzer.Statistical software SPSS20.0 was used for statistical analysis of the data.Results:1.The study included 170 cases(340 eyes),5 cases were shed,and the shedding rate was 2.9%;2.Before treatment,according to statistic analysis,there was no statistical difference in the collecting 165 cases(330eyes)in the proportion of men and women,ages,testing data(BUT and TMH),TCM symptoms and signs scores(P>0.05).They were comparable;3.After treatment in terms of the score of the symptoms and signs of TCM compared with before treatment,we found that:in the treatment group,20 cases excellence,47 cases utility and 15 cases nullity,the marked effective rate,effective rate and total effective rate respectively is 24.4%,57.3%,81.7%.In the control group,3 cases excellence,39 cases utility and 41 cases nullity,the marked effective rate,effective rate and total effective rate respectively is 3.6%,47.0%,50.6%.According to statistic analysis,there is a significant difference between two groups in the total effective rate(P<0.05),the treatment group curative effect is better than the control group;4.BUT,TMH treatment curative effect comparison of data with median(quartile)on the lower quartile-M(P25-P75)Interquartile range said:After one course of treatment,the treatment group of tear film breakup time is 7.01(5.35-8.58)s and the control group is 5.54(4.05-6.66)s.The difference-between two groups have statistical significance(P<0.05).And the curative effect of the treatment group is superior to the control group.After one course of treatment,the treatment group of tear meniscus height is 0.18(0.14-0.21)mm and the control group is 0.15(0.12-0.19)mm.The differences between two groups have statistical significance(P<0.05).And the curative effect of the treatment group is better than the control group.5.During the treatment,no adverse drug reactions were found in two groups.Conclusion:1.It’s effective of Supplementing Qi and Nourishing Yin combined with sodium hyaluronate eye drops for the treatment of diabetic dry eye patients with Qi-Yin deficiency.2.It’s effective of Supplementing Qi and Nourishing Yin combined with sodium hyaluronate eye drops for the treatment of diabetic dry eye patients with Qi-Yin deficiency is superior to the use of sodium hyaluronate eye drops alone. |
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