Treatment of Diabetic Retinopathy with Blood Stasis， Collateral Obstruction， and Qi and Yin Deficiency Syndrome with Tongluo Mingmu Capsules： A Randomized， Double-blind， and Multi-center Phase Ⅲ Clinical Trial
10.13422/j.cnki.syfjx.20240895
- VernacularTitle:通络明目胶囊治疗糖尿病视网膜病变血瘀络阻、气阴两虚证随机、双盲、多中心Ⅲ期临床试验
- Author:
Junxia REN
1
;
Yongzheng WANG
1
;
Xiaofei LIU
1
;
Li SUN
1
;
Libo YANG
1
;
Lie WU
2
;
Fengmei LIAN
2
;
Qiping WEI
3
;
Lijuan WEI
4
;
Jingsheng YU
5
;
Jianke HAN
1
Author Information
1. National Key Laboratory of Collaterals Theory Innovation and Transformation， Shijiazhuang Yiling Pharmaceutical Co.Ltd.，Shijiazhuang 050035，China
2. Guang'anmen Hospital， China Academy of Chinese Medical Sciences，Beijing 100053，China
3. Dongfang Hospital of Beijing University of Chinese Medicine，Beijing 100078；China
4. Affiliated Hospital of Changchun University of TCM Changchun 130021，China
5. The First Affiliated Hospital of Hunan University of TCM，Changsha 410007，China
- Publication Type:Journal Article
- Keywords:
Tongluo Mingmu capsules;
diabetic retinopathy;
randomized and double-blind;
multi-center;
clinical trials
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2024;30(7):170-178
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the clinical efficacy and safety of Tongluo Mingmu capsules in the treatment of diabetic retinopathy with blood stasis， collateral obstruction， and Qi and Yin deficiency syndrome. MethodA randomized， double-blind， positive-control， and multi-center clinical trial design method was used. 416 patients with diabetic retinopathy with blood stasis， collateral obstruction， and Qi and Yin deficiency syndrome in four test centers were included （the ratio of the treatment group to the control group was 3∶1）. On the basis of standardized hypoglycemic treatment， the treatment group was given both four Tongluo Mingmu capsules and two Calcium Dobesilate capsule agents three times a day， while the control group were given both two Calcium Dobesilate capsules and four Tongluo Mingmu capsule agents three times a day. The course of treatment was 12 weeks. The curative effect of Tongluo Mingmu capsules was evaluated by comparing the comprehensive curative effect of diabetic retinopathy， traditional Chinese medicine（TCM） syndrome score， corrected visual acuity， fundus changes， fundus fluorescence angiography， and other curative effect indexes before and after treatment in the two groups. At the same time， general examination， laboratory examination， and adverse events were performed to evaluate the safety of the drug. ResultThe baseline demographic data and disease characteristics of the treatment group and the control group were balanced and comparable， with the difference not statistically significant. After 12 weeks of treatment， the total effective rate of the comprehensive curative effect of diabetic retinopathy in the treatment group （61.0%， 189/310） was better than that in the control group （44.1%， 45/102）， and the difference was statistically significant （χ2=8.880， P<0.01）. The total effective rate of TCM syndromes in the treatment group （88.4%， 259/293） was better than that in the control group （69.9%， 65/93）， and the difference was statistically significant （χ2=17.927， P<0.01）. The disappearance rate of dry eyes （χ2=8.305）， dull complexion （χ2=4.053）， lassitude （χ2=10.267）， shortness of breath （χ2=8.494）， and dry stool （χ2=8.657） in the treatment group was higher than that in the control group， and the difference between the groups was statistically significant （P<0.05， P<0.01）. In terms of improving corrected visual acuity （χ2=8.382）， fundus changes （χ2=6.026） ， the treatment group was significantly better than the control group （P<0.05）. During the trial， the incidence of adverse events in the treatment group and the control group was 1.3% and 2.9%， respectively. There was no significant difference between the two groups. In addition， there were no serious adverse events and adverse events leading to withdrawal in both groups. ConclusionTongluo Mingmu capsules can improve the comprehensive curative effect of diabetic retinopathy and enhance the efficacy of TCM syndromes， visual acuity， fundus changes， and fundus fluorescein angiography， with great safety. Therefore， it can provide a new alternative therapeutic drug for patients with diabetic retinopathy.
