| Background:Although we have entered a well-off society,people have a lot of rich life,but the prevalence of diabetes is rising,diabetes has become one of the most common chronic diseases in the world,its ocular complications diabetic retinopathy has been included in the global four roughly blind diseases.Treatment of diabetic retinopathy,delay the progress of the disease,save the patient’s vision,has become a common concern around the world.However,drugs that can cure diabetic retinopathy have not been found at present,so it is particularly important to seek new therapeutic medications for early intervention and treatment of diabetic complications.Objective:To confirm the safety and effectiveness of Shuangdan Mingmu capsule,and find the occasional,unexpected,special,serious,long-term adverse reactions;evaluate the benefit and risk relationship between the use of Shuangdan Mingmu capsule in patients with type 2 diabetic retinopathy;and conduct risk/benefit assessment through analysis of safety and effectiveness data.Methods:Select 19 patients(38 eyes)aged 18-80 who were treated at the ophthalmology clinic of Huaihe Hospital,Henan University,Kaifeng City,from April 2018 to June 2019.sign informed consent form,collect general data of patients: age,sex,nation,height,weight,and carry out general physical examination of the patients: general situation,skin mucous membrane,eyes,head,neck,chest,abdominal,musculoskeletal,limbs,nervous system,mental system,Record basic vital signs: breathing,temperature,heart rate,sysion,diastou pressure,diabetes course,medications,vision,fundus: microangioma,hemorrhage,exudation,TCM syndromes: blurred vision,dry eyes,dizziness tinnitus,dry throat,five heart trouble,soft lumbar knee acid,electrocardiogram,liver function: alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(ALP),gamma-glutamyltransferase(GGT),serum total bilirubin(Tbil),renal function: serum creatinine(Scr/CREA),blood urea nitrogen(BUN),fasting blood glucose(FBG),glycosylated hemoglobin(Hb A1c)and blood and urine routine,Give Shuangdan Mingmucapsule orally,4 capsules at a time(0.5 g each),3 times a day,after meals warm boiled water delivery.After8 weeks,the first visit was carried out,the patients were examined by physical examination of the whole body,the patients were asked whether they were taking the medicine regularly,and the basic vital signs,electrocardiogram,fasting vision,blood sugar and TCM syndromes were recorded.After 16 weeks,the above-mentioned operation was carried out again,and the liver and kidney function,glycosylated hemoglobin,fundus and so on were examined,and the results of the examination were recorded,and the results of the experiment were statistically analyzed and concluded.Results:1.A total of 19 patients(38 eyes)with type 2 diabetic retinopathy were observed,including 7 males(14 eyes)and 12 females(24 eyes).There was no significant difference in vision after 8 weeks of treatment(P>0.05);after 16 weeks of treatment,the difference was statistically significant(P<0.05).2.There was significant difference in retinal microangioma before and after treatment(P<0.05);there was no significant difference in retinal hemorrhage before and after treatment(P>0.05);there was no statistically significant difference in retinal exudation before and after treatment(P>0.05);the total effective rate of fundus was 55.0% after 16 weeks of treatment.3.Before and after treatment,the difference was statistically significant(P < 0.05)in the symptoms of blurred vision,dry throat(P < 0.05);there was no significant difference in the symptoms of dry eyes,dizziness tinnitus,five heart trouble,and soft lumbar knee acid(P > 0.05);the total effective rate of TCM syndromes was 73.7% after 16 weeks of treatment.4.A total of 24 patients with type 2 diabetic retinopathy(48 eyes)were observed,including 10 males(20 eyes)and 14 females(28 eyes).The age range was 44-74 years old,with an average age of 58 years.the average course of disease was more than 10 years.During the 16 weeks of treatment,patients with abnormal ECG,liver and kidney function remained abnormal at the end of the study,but did not appear more severe than before,some patients after taking medicine appeared different degrees of decline,or even disappear,so it can not prove its causal relationship with the medicine.5.The course of this study,there were 4 patients with adverse events,the incidence rate was 16.7%.One patient had a history of "stomach disease ",followed by stomach pain,acid regurgitation,heartburn after taking the medicine,symptoms relieved after stopping the medicine;one patient had a history of " type2 diabetes mellitus with peripheral neuropathy ",after taking the medicine,the edema of both lower limbs appeared,disappeared after stopping the medicine,and repeated twice,outpatient follow-up did not see lower extremity edema,check urine routine,liver and kidney function,the results were not abnormal,no symptoms of edema after continuing taking the medicine;1 patient sudden diarrhea during taking the medicine,self-medication after the improvement;1 patient had a cold during taking the medicine;above 4Cases of adverse events,after timely treatment did not cause adverse consequences.Conclusions:1.Shuangdan Mingmu capsule can obviously improve the vision of type 2 diabetic retinopathy patients;2.Shuangdan Mingmu capsule can effectively improve the fundus of patients with type 2 diabetic retinopathy and reduce the occurrence of retinal microangioma,but there is no significant difference in the clinical efficacy of the treatment of fundus hemorrhage and exudation;3.Shuang Dan Ming Ming Ming capsule has a good effect in improving the symptoms of blurred vision and dry throat in patients with type 2 diabetic retinopathy,but there is no obvious difference in the clinical effect of treating the symptoms of dry eyes,dizziness tinnitus,five heart trouble,soft lumbar knee acid.4.Shuangdan Mingmu capsule is used in patients with type 2 diabetic retinopathy with greater benefits than risk,and has better safety,which can safely and effectively treat diabetic retinopathy and benefit patients. |
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