Comprehensive clinical evaluation of Shuangdan Mingmu Capsule in diabetic retinopathy treatment
10.3969/j.issn.1006-2157.2025.08.007
- VernacularTitle:双丹明目胶囊治疗糖尿病视网膜病变的临床综合评价
- Author:
Yutong MA
1
;
Xiaoyan WANG
1
;
Yuanyuan LI
1
;
Yanming XIE
1
Author Information
1. 中国中医科学院中医临床基础医学研究所 北京 100700
- Publication Type:Journal Article
- Keywords:
Shuangdan Mingmu Capsule;
diabetic retinopathy;
comprehensive clinical evaluation;
multi-criteria decision analysis
- From:
Journal of Beijing University of Traditional Chinese Medicine
2025;48(8):1095-1106
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the clinical evidence and overall value of Shuangdan Mingmu Capsule in treating diabetic retinopathy(DR),highlight its advantages and characteristics,clarify the exact clinical positioning for DR,and propose a reference that can aid the National Medical Management Department in its decision-making.Methods This study combined qualitative and quantitative evaluation methods.Multiple method ologies were used to analyze the"6+1"dimensions.Each dimension was measured using the Multi-criteria Decision Analysis Model and calculated using CSC software V2.0.Results SRS monitored since the launch of Shuangdan Mingmu Capsule were general adverse reactions and those reported in the literature;phase Ⅱ,Ⅲ,and Ⅳ clinical studies primarily focused on the gastrointestinal system,no serious adverse reactions were reported,and the safety was rated as A.When Shuangdan Mingmu Capsule was combined with calcium hydroxybenzenesulfonate or laser photocoagulation in the treatment of DR in a meta-analysis,it further enhanced ophthalmologic parameters such as macular thickness,hemorrhagic spot area,leakage area,best-corrected visual acuity,and the degree of visual field defect.It also increased serum vascular endothelial growth factor and platelet-derived growth factor levels,the scores from the low vision quality of life scale and ultrasound indexes,and the validity was rated as grade A.A pharmacoeconomic evaluation study of Shuangdan Mingmu Capsule combined with calcium hydroxybenzenesulfonate compared to calcium hydroxybenzenesulfonate alone for DR treatment indicated that assuming the per capita disposable income in 2023 was applied as the willingness-to-pay threshold for patients,with an ICER of 3,730.98—which is approximately 2.85％of the per capita disposable income in 2023—the treatment regimen of Shuangdan Mingmu Capsule combined with calcium hydroxybenzenesulfonate was more economical than the calcium hydroxybenzenesulfonate treatment plan alone.The economy was rated as grade B.Therefore,Shuangdan Mingmu Capsule can meet clinical needs,and the formula includes medicines to tonify the liver and kidney,activate blood,and clear the channels,which is a combination of both symptomatic and fundamental treatments.Shuangdan Mingmu Capsule can also tonify the kidney,nourish the liver,stimulate blood circulation,and improve eyesight,and it is rated as grade A for innovativeness.Therefore,the drug is widely used,has no special technical and administrative requirements,is convenient to carry,and does not need to be administered at special times.The comprehensive questionnaire survey indicated that the appropriateness of the drug is good(grade B),that the production capacity is sufficient,and that the accessibility has been rated as grade B.This drug originates from ancient prescriptions of Er Zhi Pill and Liuwei Dihuang Pill,which have a long-standing reputation in traditional medicine.The combination of disease and evidence embodies the Chinese medicine characteristics of holistic concept and identification of evidence-based treatment,and the special features of Chinese medicine are rated as grade A.Conclusion The clinical value of Shuangdan Mingmu Capsule was evaluated as Class A by synthesizing the"6+1"dimensions and calculated using CSC V2.0 software.The clinical value of Shuangdan Mingmu Capsule is Class A.However,clinical needs must be focused upon and transformed into relevant clinical medication policies,providing a strong reference for the efficacy research of clinical trials.
