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  

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

作　　者：任君霞[1,2] 王永争 刘晓飞 孙利[1] 杨立波[1] 吴烈[3] 连凤梅[3] 韦企平[4] 魏丽娟[5] 喻京生[6] 韩建科 REN Junxia;WANG Yongzheng;LIU Xiaofei;SUN Li;YANG Libo;WU Lie;LIAN Fengmei;WEI Qiping;WEI Lijuan;YU Jingsheng;HAN Jianke(National Key Laboratory of Collaterals Theory Innovation and Transformation,Shijiazhuang Yiling Pharmaceutical Co.Ltd.,Shijiazhuang 050035,China;High-Level Key Discipline of Traditional Chinese Medicine(TCM)of State Administration of TCM Chinese Collaterals,Hebei Yiling Hospital,Shijiazhuang 050091,China;Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;Dongfang Hospital of Beijing University of Chinese Medicine,Beijing 100078,China;Affiliated Hospital of Changchun University of TCM Changchun 130021,China;The First Affiliated Hospital of Hunan University of TCM,Changsha 410007,China)

机构地区：[1]石家庄以岭药业股份有限公司,络病理论创新转化全国重点实验室,石家庄050035 [2]河北以岭医院,国家中医药管理局中医络病学高水平中医药重点学科,石家庄050091 [3]中国中医科学院广安门医院,北京100053 [4]北京中医药大学东方医院,北京100078 [5]长春中医药大学附属医院,长春130021 [6]湖南中医药大学第一附属医院,长沙410007

出　　处：《中国实验方剂学杂志》2024年第7期170-178,共9页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：河北省省级科技计划资助项目(21282501Z);石家庄市科技计划项目(236200247);石家庄市科技计划项目(236200247A);石家庄市技术创新中心绩效后补助项目(237790639A);河北省中医药管理局科研计划项目(2023391)。

摘　　要：目的:评价通络明目胶囊治疗糖尿病视网膜病变血瘀络阻、气阴两虚证的临床有效性和安全性。方法:采用区组随机、双盲、阳性对照、多中心临床试验设计方法。共纳入4家试验中心416例糖尿病视网膜病变血瘀络阻、气阴两虚证患者(观察组-对照组数量比为3∶1)。在规范降糖治疗基础上,观察组服用通络明目胶囊(4粒/次,3次/d)+羟苯磺酸钙胶囊模拟剂(2粒/次,3次/d),对照组服用羟苯磺酸钙胶囊(2粒/次,3次/d)+通络明目胶囊模拟剂(4粒/次,3次/d)。疗程为12周。通过比较两组患者治疗前后糖尿病视网膜病变综合疗效、中医证候积分、矫正视力、眼底改变、眼底荧光血管造影等疗效指标评价通络明目胶囊疗效。同时进行一般检查、实验室检查和不良事件评价药物的安全性。结果:观察组和对照组患者基线人口学资料和疾病特征差异无统计学意义,均衡可比。治疗12周后,观察组糖尿病视网膜病变综合疗效总有效率(61.0%,189/310)优于对照组(44.1%,45/102),差异具有统计学意义(χ^(2)=8.880,P<0.01)。观察组中医证候总有效率(88.4%,259/293)优于对照组(69.9%,65/93),差异具有统计学意义(χ^(2)=17.927,P<0.01)。与对照组治疗后比较,观察组患者中医证候单项症状“目睛干涩(χ^(2)=8.305)、面色晦暗(χ^(2)=4.053)、倦怠乏力(χ^(2)=10.267)、气短懒言(χ^(2)=8.494)、大便干结(χ^(2)=8.657)”消失率均明显增高,组间比较差异均有统计学意义(P<0.05,P<0.01)。在改善矫正视力(χ^(2)=8.382)、眼底改变(χ^(2)=6.026)方面,观察组显效+有效率均优于对照组(P<0.05)。试验期间观察组与对照组的不良事件发生率分别为1.3%和2.9%,两组间比较差异无统计学意义,两组均无严重不良事件及导致退出的不良事件发生。结论:通络明目胶囊可以提高糖尿病视网膜病变综合疗效,改善中医证候疗效、视力、眼底改变和眼底荧光血管造影,且安�Objective:To 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.Method:A 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.Result:The 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(χ^(2)=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(χ^(2)=17.927,P<0.01).The disappearance rate of dry eyes(χ^(2)=8.305),d

关 键 词：通络明目胶囊 糖尿病视网膜病变 随机双盲 多中心 临床试验 

分 类 号：R2-0[医药卫生—中医学] R22R242R2-031R259R587.2R774.1