注射用血塞通(冻干)治疗视网膜中央静脉阻塞瘀血阻滞证的多中心随机双盲对照临床研究  

Clinical effect of Xuesaitong lyophilized injection for central retinal vein occlusion(CRVO) patients with blood stasis——a multicenter, randomized, controlled, double-blind clinical trial

作　　者：郝美玲[1] 路明[1] 唐豪 张丽霞[3] 郑秋平[4] 刘芳[5] 高丰 历慧茹 孙艳红[1] 宫晓红[1] 俞兴源[1] 苏艳[1] 曹京源[1] 李丽[1] 周剑[1] HAO Meiling;LU Ming;TANG Hao(Dongfang Hospital of Beijing University of Chinese Medicine,Beijing 100078,China)

机构地区：[1]北京中医药大学东方医院,北京100078 [2]重庆市第九人民医院,重庆400700 [3]中国中医科学院眼科医院,北京100040 [4]黑龙江省牡丹江医学院红旗医院,牡丹江157000 [5]河南省焦作市第二人民医院,焦作454150 [6]湖北省襄阳市第一人民医院,襄阳441100 [7]河北省廊坊市中医医院,廊坊065000

出　　处：《中国中医眼科杂志》2019年第5期351-355,共5页China Journal of Chinese Ophthalmology

摘　　要：目的观察注射用血塞通(冻干)治疗视网膜中央静脉阻塞瘀血阻滞证的有效性和安全性。方法采取多中心、随机、双盲、阳性药与安慰剂平行对照的临床对照试验方法,按照随机数字表法将患者分为试验组、阳性对照组和安慰剂组。试验组采用注射用血塞通(冻干)静脉滴注,阳性对照组采用复方血栓通胶囊口服,安慰剂组采用复方血栓通胶囊模拟剂口服。15 d为1个疗程,共计2个疗程。主要疗效评价指标:眼底血管荧光造影视网膜循环时间;次要疗效评价指标:最佳矫正视力(BCVA)、眼底出血面积、无灌注区面积、有无新生血管生成、中医证候等。结果(1)视网膜循环时间3组比较,差异无统计学意义(P=0.5658);(2)3组间BCVA比较差异有统计学意义(P=0.002),试验组、阳性对照组分别与安慰剂比较,2组差异均有统计学意义(试验组P=0.001,阳性对照组P=0.003),试验组与阳性对照组疗效比较,差异无统计学意义(P=0.826);(3)中医证候疗效结果,3组间比较差异有统计学意义(P<0.001);试验组、阳性对照组分别与安慰剂比较,2组差异均有统计学意义(试验组P<0.001,阳性对照组P=0.006),试验组与阳性对照组疗效比较,差异无统计学意义(P>0.05);(4)眼底出血面积、无灌注区面积、有无新生血管生成方面,3组间比较差异无统计学意义。结论注射用血塞通(冻干)可以改善视网膜中央静脉阻塞瘀血阻滞证患者视力及中医证候,临床使用安全,注射用血塞通(冻干)治疗视网膜中央静脉阻塞(瘀血阻滞证)具有较好的临床应用前景。OBJECTIVE To observe the clinical effect and safety of Xuesaitong lyophilized injection on central retinal vein occlusion(CRVO)patients with blood stasis syndrome.METHODS A randomized,double-blind,positive drug and placebo parallel controlled,multi-center clinical trial was conducted.The patients were randomly divided into trial group(Xuesaitong lyophilized injection),positive control group(compound Xuesaitong capsule)and placebo control group.They were intervened for 15 days as a course,2 courses for all patients.The primary evaluation index was retinal circulation time of fundus fluorescein angiography(FFA).The secondary outcome measurements included corrected distant vision,fundus hemorrhage area,non-perfusion area,neovascularization,the scores of TCM syndrome manifestations.RESULTS There was no significant difference among the three groups in retinal circulation time(P=0.5658).There were significant differences among the three groups in best corrected distant vision(P=0.002).Both trial group and positive control group acquired better vision than placebo control group(trial group P=0.001,positive control group P=0.003).But there was no significant difference between the trial group and the positive control group,the difference was not statistically significant(P=0.826).There were also significant differences among the three groups in scores of TCM syndrome manifestation(P<0.001).Both trial group and positive control group acquired higher scores than placebo control group(trial group P<0.001,positive group P=0.006).But there was no significant difference between the trial group and the positive drug group,the difference was not statistically significant(P=0.514).There was no significant difference among the three groups in fundus hemorrhage area(P=0.498),non-perfusion area(P=0.3079)and neovascularization(P=0.8330).CONCLUSIONS Xuesaitong lyophilized injection had definite effect on CRVO patients with blood stasis syndrome in that it improved vision and the manifestation of TCM syndrome in addition to that it was

关 键 词：注射用血塞通 视网膜中央静脉阻塞 瘀血阻滞证 

分 类 号：R276.7[医药卫生—中医五官科学]