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眼底激光联合蒙药明目十一味丸治疗重度非增生性糖尿病视网膜病变的临床研究

Clinical Study on the Treatment of Severe Non Proliferative Diabetic Retinopathy with Fundus Laser Combined with Mongolian Medicine Mingmu Eleven Pills

【作者】 王额尔敦

【导师】 鲁占军;

【作者基本信息】 内蒙古民族大学 , 中西医结合临床(专业学位), 2020, 硕士

【摘要】 目的:客观评价眼底激光联合蒙药明目十一味丸治疗重度非增生性糖尿病性视网膜病变的临床疗效。方法:本次研究的所有患者都来自内蒙古民族大学附属医院眼科,在2018年11月至2019年12月份收治的年龄在18~75岁之间的重度NPDR患者120例(120眼),随机分成治疗组(激光联合蒙药组),对照组(单纯激光治疗组),每组各60只眼,两组受试者均在有效控制血糖的基础上全部行局部视网膜激光光凝术,治疗组激光治疗后服用蒙药明目十一味丸,15粒,2次/日口服,3周为一个疗程,共2个疗程。对照组不给药物治疗,分别在试验治疗前后及6周各检查一次视力、眼压、验光、最佳矫正视力及mfERG和OCT、超广角眼底彩照及眼底荧光血管造影,检查操作前的所有安全性指标。检查前将收集患者的一般资料(姓名,年龄,性别,住址及检查日期),使用辅助检查结果来诊断,观察治疗前和治疗6周后的各项血液指标是否正常或在治疗范围内,两组患者在fmERG检查中P1波的振幅及潜伏期、N1波的振幅及潜伏期的变化和两者的振幅密度值和潜伏期来对比疗效,应用超广角眼底彩照和FFA检查视网膜的出血、渗出、静脉串珠样改变、出血面积及激光光凝术后的激光斑等,应用相干光断层扫描仪测量平均视网膜厚度的变化,结合最终矫正视力来观察临床疗效。结果:把两组患者入组时眼数、眼压、年龄、体重指数、腰臀围比、血压、糖尿病病程、空腹血糖、糖化血红蛋白、血脂四等进行比较后的结果P>0.05无统计学意义。两组患者治疗6周后与组内治疗前的低密度脂蛋白、高密度脂蛋白、总胆固醇、甘油三酯比较没有明显的差异(P>0.05),所以这些指标在本次治疗中不会带来任何影响。每组的空腹血糖、糖化血红蛋白和治疗6周后的结果比治疗前稍有下降,说明实验期间两组的患者把血糖控制都良好,而且肝肾功能的指标都在正常值范围。比较多焦视网膜电图检查结果得出:组间比较在激光光凝治疗前和治疗后0周的P1波和N1波在5个环内的振幅密度值都没有明显的差异,将两组患者组内比较发现,激光治疗前后及6周后的P1波和N1波的振幅密度值进行对比有明显差别(P<0.001)。将两组患者治疗6周后的P1波和N1波振幅组间比较在5个环内的差异有统计学意义(P<0.05)。将俩组治疗前后的P1波和N1波的潜伏期组内和组间比较,在R1-R5环中的差异无统计学意义(P>0.05)。结合眼底照相得出结果:各组治疗前后及治疗6周后的出血面积、渗出面积比较,差异有统计学意义(P<0.05)。治疗组和对照组总有效率分别达到96.7%和85.1%。两组治疗前后的OCT检查得出结果显示平均视网膜厚度差异有统计学意义(P<0.05)。两组患者的治疗前后OCT平均视网膜厚度差值比较差异有统计学意义(P<0.05)。两组患者组内比较激光治疗前和治疗0周的差异均无统计学意义(P>0,05)。治疗组的0周和6周比较有统计学意义(P<0.001),治疗6周后两组差异有统计学意义(P<0.001),单纯激光治疗对BCVA没有明显影响,治疗6周后,激光联合蒙药组的BCVA明显提高,差异有统计学意义(P<0.001)。两组BCVA差值比较,治疗6周后治疗组的BCVA高于对照组,差异有统计学意义(P<0.001)。结论:1.眼底激光联合蒙药明目十一味丸和单纯眼底激光均能有效治疗重度NPDR。2.两组相比眼底激光联合蒙药治疗组效果显著优于单纯眼底激光对照组。

【Abstract】 Objective:The purpose of the research is to evaluate the clinical effect of Fundus laser combined with Mongolian medicine Mingmu Eleven pills in the treatment of severe non-proliferative diabetic retinopathy objectively.Methods:The study of all patients were from Inner Mongolia national university affiliated hospital of ophthalmology,in November 2018 to December 2019 were between ages 18 to 75 years in 120 cases(120 eyes)of severe NPDR patients,randomly divided into treatment group(laser joint Mongolian group)and control group(simple laser treatment group),each group of 60 eye,both the two groups in effective control of blood sugar on the basis of all local retinal laser photocoagulation,the treatment group take Mongolian bright eye Eleven pills bolus after laser treatment,15granule,2 times/day of oral,3 weeks for a period of treatment,a total of two period of treatment.In the control group,no drug treatment was given.Visual acuity,intraocular pressure,optometry,best corrected visual acuity,mfERG and OCT,ultra-wide-angle fundus color photography and fundus fluorescence angiography were examined before and after the treatment and 6 weeks after treatment,respectively.All safety indicators were examined before operation.Check before will collect the patient’s general information(name,age,gender,address and date of inspection),used to diagnose the auxiliary examination results,observed before and after 6 weeks of treatment the blood indexes are normal or within the scope of the treatment,two groups of patients in fmERG check P1 wave amplitude and latency,N1 wave amplitude and the change of the incubation period and the comparison between the incubation period and amplitude of the density value of curative effect,application of color pictures super-wide fundus and FFA examination of bleeding,seepage,retinal vein beaded change,bleeding area and laser photocoagulation surgery such as the laser spot,The changes in average retinal thickness were measured using a coherent optical tomography(ct)scanner,and the clinical effect was observed in combination with the final correction of visual acuity.Results:The results of comparison of the number of eyes,intraocular pressure,age,body mass index,waist-to-hip ratio,blood pressure,course of diabetes,fasting blood glucose,glycosylated hemoglobin,and blood lipid in the two groups were not statistically significant at the time of admission.There was no significant difference in LDL,HDL,total cholesterol and triglycerides between the two groups after 6 weeks of treatment and before treatment(P>,0.05),so these indicators did not have any effect in this treatment.Fasting blood glucose,hbalc,and the results after 6 weeks of treatment in each group were slightly lower than those before treatment,indicating that patients in both groups had good blood glucose control during the experiment,and the indicators of liver and kidney function were in the normal range.More focal retinal electricity concluded that results in laser photocoagulation is compared between groups before and after treatment of 0 weeks of P1 and N1 wave amplitude in the five ring density value,have no obvious difference,compare two groups of patients within the group found that laser before and after treatment and 6 weeks after the P1 and N1 wave amplitude of the density value comparison have obvious difference(P<0.001).The difference in the amplitude of P1 wave and N1 wave between the two groups after 6 weeks of treatment was statistically significant(P<0.05).The incubation period of P1 wave and N1 wave between the two groups before and after treatment was compared within and between the two groups,and the difference in R1-R5 ring was not statistically significant(P>,0.05).Combined with fundus photography,the results showed that the bleeding area and exudation area of each group before and after treatment and 6 weeks after treatment were statistically significant(P<0.05).The total effective rate of treatment group and control group was 96.7%and 85.1%respectively.The results of OCT examination before and after treatment showed a statistically significant difference in average retinal thickness between the two groups(P<0.05).The difference in the average OCT retinal thickness between the two groups before and after treatment was statistically significant(P<0.05).There was no statistically significant difference between the two groups of patients before and at week 0 of laser treatment(P>,05).The comparison between the treatment group at week 0 and week 6 was statistically significant(P<0.001),and the difference between the two groups at week 6 was statistically significant(P<0.001).The simple laser treatment had no significant effect on BCVA.The difference in BCVA between the two groups showed that the BCVA of the treatment group was higher than that of the control group after 6 weeks of treatment,and the difference was statistically significant(P<0.001).Conclusion:1.Fundus laser combined with Mongolian medicine mingmu shijiao pill and fundus laser alone can effectively treat severe NPDR.2.The therapeutic effect of fundus laser combined with Mongolian medicine in the two groups was significantly better than that of the single fundus laser control group.

  • 【分类号】R779.63;R587.2
  • 【被引频次】1
  • 【下载频次】62
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