止血祛瘀明目片治疗视网膜静脉阻塞眼底出血瘀血伤络、阴虚内热证的多中心随机双盲对照临床研究  

A Multicenter Randomized Double-blind Controlled Clinical Trial in the Treatment of Fundus Hemorrhage after Retinal Vein Occlusion Patients with Blood Stasis and Yin Deficiency Syndrome by Zhixue Quyu Mingmu Tablets

作　　者：武丹蕾[1] 樊冬生[2] 陈红娟[3] 解孝峰[4] 范忠义[5] 李磊[6] 吴烈[1] WU Dan-lei;FAN Dong-sheng;CHEN Hong-juan;XIE Xiao-feng;FAN Zhong-yi;LI Lei;WU Lie(Ophthalmology Department of Guang’anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053;Ophthalmology Department,Luoyang Center Hospital,Henan 471009;Ophthalmology Department,Affiliated Hospital of Hebei University,Hebei 071000;Ophthalmology Department,Eye Hospital of Shandong University of Traditional Chinese Medicine,Ji'nan 250001;Ophthalmology Department,No.463 Hospital of the People’s Liberation Army,Shenyang 110042;Ophthalmology Department,Center for Drug Research and Evaluation,Chinese Association of Traditional Chinese Medicine,Beijing 100101)

机构地区：[1]中国中医科学院广安门医院眼科,北京100053 [2]洛阳市中心医院眼科,河南471009 [3]河北大学附属医院眼科,河北071000 [4]山东中医药大学附属眼科医院眼科,济南250001 [5]中国人民解放军第四六三医院眼科,沈阳110042 [6]中国中药协会药物研究评价技术中心,北京100101

出　　处：《中国中西医结合杂志》2021年第1期35-40,共6页Chinese Journal of Integrated Traditional and Western Medicine

摘　　要：目的评价止血祛瘀明目片治疗视网膜静脉阻塞(RVO)眼底出血瘀血伤络、阴虚内热证的有效性和安全性。方法采用随机、双盲双模拟、阳性药平行对照、多中心临床研究的方法,将311例2014年6月—2016年2月全国12家医院收治的RVO眼底出血瘀血伤络、阴虚内热证患者采用随机数字表法分为试验组233例,对照组78例。试验组采用止血祛瘀明目片治疗,对照组采用复方血栓通胶囊治疗,服药疗程12周。分别对2组患者治疗后疗效及安全性进行对比,主要疗效指标:眼底出血面积和视力改善情况。次要疗效指标:视网膜循环时间、中医证候总积分、黄斑中心凹厚度及总容积、改善血管新生情况以及单项症状评价视物不清、目睛干涩、视物变形、头晕耳鸣、口咽干燥;安全性指标以不良反应发生率为主。结果与本组基线比较,两组患者治疗12、18、24周眼底出血面积减少,视力(矫正视力)改善,试验组优于对照组(P<0.05)。两组患者视网膜循环时间、黄斑中心凹厚度较基线减少(P<0.05),黄斑总容积较基线增加(P<0.05),但两组间比较差异无统计学意义(P>0.05)。与对照组比较,试验组治疗18周视物不清及治疗18、24周目睛干涩症状疗效总有效率更高(P<0.05)。同时两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论止血祛瘀明目片可促进RVO眼底出血瘀血伤络、阴虚内热证患者眼底出血吸收,减少新生血管生成,改善视物不清、目睛干涩等临床症状,促进视力恢复,提高治疗有效率,与对照药疗效相当。Objective To evaluate the clinical efficacy and safety of Zhixue Quyu Mingmu Tablets(ZXQYMMT)in the treatment of eye fundus hemorrhage after retinal vein occlusion(RVO)patients with blood stasis,and yin deficiency syndrome.Methods A randomized,double-blind double simulation,positive drug parallel control,multi-center clinical trial was conducted.Totally 311 patients with fundus hemorrhage after RVO of blood-stasis and yin deficiency syndrome who admitted to 12 hospitals from December 2014 to February 2016 were assigned to experimental group(233 cases)and control group(78 cases).The experimental group was treated with ZXQYMMT,and the control group was treated with Compound Xueshuantong Capsule.The treatment course was 12 weeks.The efficacy and safety of treatment in the two groups were compared.The main efficacy indicators included the area of fundus hemorrhage and visual acuity improvement.The secondary efficacy index included retinal circulation time,total integral of TCM syndromes,macular fovea thickness and total volume,improvement of angiogenesis,and evaluation of individual symptoms(unclear vision,dry eyes,distorted vision,dizziness and tinnitus,and dry oropharynx).The incidence of adverse reactions was the main safety index.Results Compared with the baseline of the same group,the area of fundus hemorrhage decreased and the visual acuity(corrected visual acuity)reduced at12,18,and 24 weeks of treatment.The above indicators of experimental group was superior than the control group(P<0.05).The retinal circulation time and the thickness of the macular fovea were decreased compared with the baseline(P<0.05),and the macular total volume increased(P<0.05).while the difference between the two groups was not statistically significant(P>0.05).The improvement of unclear vision at the 18 th week and the symptom of dry eyes at 18 th and 24 th weeks were better than those of the control group(P<0.05).Meanwhile,there was no statistically significant difference in the incidence of adverse reactions between the two groups(P

关 键 词：视网膜静脉阻塞 眼底出血 止血祛瘀明目片 瘀血伤络、阴虚内热证 

分 类 号：R276.7[医药卫生—中医五官科学]