消肿颗粒联合康柏西普治疗DME的疗效观察  

Observation on the therapeutic effect of Xiaozhong Granule combined with Conber⁃cept on the treatment of diabetic macular edema

作　　者：王建伟[1] 接传红[1] 陶永健[1] 严京[1] 胡元春[1] 吴正正[1] 任燕如[1] 陈子燕[1] WANG Jianwei;JIE Chuanhong;TAO Yongjian;YAN Jing;HU Yuanchun;WU Zhengzheng;REN Yanru;CHEN Ziyan(Eye Hospital,China Academy of Chinese Medical Sciences,Beijing 100040,China)

机构地区：[1]中国中医科学院眼科医院,北京100040

出　　处：《中国中医眼科杂志》2023年第5期412-417,共6页China Journal of Chinese Ophthalmology

基　　金：首都卫生发展科研专项(2020-3-4184);北京市中医药科技发展资金项目(JCZX-2020-14);中国中医科学院自主选题(ZZ0808008)。

摘　　要：目的观察消肿颗粒联合康柏西普治疗糖尿病黄斑水肿(DME)患者的临床疗效。方法纳入2016年1月—2018年6月符合纳入标准的DME患者216例(216只眼),证属脾肾阳虚兼瘀阻目络证,随机分为治疗组和对照组,每组108例(108只眼)。对照组予安慰剂联合康柏西普治疗。治疗组予消肿颗粒联合康柏西普治疗。分别在治疗前、治疗后7 d、1个月、2个月、3个月检测受试者的最佳矫正视力(BCVA)、视网膜中央厚度(CRT),评定受试者治疗前及治疗后3个月中医证候积分,并做统计分析。结果2组治疗前BCVA、CRT、中医证候积分比较,差异均无统计学意义(P>0.05)。(1)BCVA:治疗前后比较,治疗组治疗后各时间点BCVA较治疗前均明显提高,差异均有统计学意义(t_(7 d)=2.678,P=0.008;t_(1个月)=3.087,P=0.002;t_(2个月)=3.132,P=0.002;t_(3个月)=2.100,P=0.037);对照组治疗后7 d、1个月BCVA较治疗前均明显提高,差异均有统计学意义(t_(7 d)=2.652,P=0.009;t1个月=2.966,P=0.003),治疗后2个月、3个月BCVA较治疗前均无明显变化,差异均无统计学意义(P>0.05)。治疗后2组间比较,治疗组的BCVA提高幅度均大于对照组,差异均有统计学意义(t7 d=2.130,P=0.035;t_(1个月)=5.383,t_(2个月)=10.715,t_(3个月)=29.024,均P=0.000)。(2)CRT:治疗前后比较,治疗组治疗后各时间点CRT较治疗前均降低,差异均有统计学意义(t_(7 d)=6.842,t_(1个月)=6.991,t_(2个月)=4.693,均P=0.000;t_(3个月)=2.797,P=0.006);对照组治疗后7 d、1个月CRT较治疗前均降低,差异均有统计学意义(t_(7 d)=6.108,t_(1个月)=5.92,均P=0.000),而治疗后2个月、3个月CRT较治疗前差异均无统计学意义(P>0.05)。治疗组的CRT下降幅度均大于对照组,组间比较均有统计学意义(t7 d=17.692,t1个月=18.416,t2个月=20.315,t3个月=28.451,均P=0.000)。(3)中医证候积分:治疗前后比较,治疗组治疗后中医证候积分较治疗前降低,差异有统计学意义(t=2.587,P=0.010),对照组治疗�OBJECTIVE To evaluate the clinical efficacy of Xiaozhong Granule combined with Conbercept in the treatment of diabetic macular edema(DME).METHODS A total of 216 patients(216 eyes)with DME who met the inclusion criteria diagnosed from January 2016 to June 2018 were included.The syndrome was spleen and kidney Yang deficiency and stasis obstructing eye collateral.They were randomly divided into the treatment group and the control group,with 108 cases(108 eyes)in each group.The control group was treated with a combination of placebo and Conbercept,while the treatment group was treated with Xiaozhong Granule combined with Conbercept.The best corrected visual acuity(BCVA)and central retinal thickness(CRT)of the subjects were measured before treatment and seven days,one month,two months,and three months after treatment respectively.The TCM syndrome scores of the subjects were evaluated and statistically analyzed before and three months after treatment.RESULTS There were no statistically significant differences in BCVA,CRT,and TCM syndrome scores between the two groups before treatment(P>0.05).(1)BCVA:The BCVA of the treatment group were significantly improved at each time point after treatment when compared to those before treatment,with statistically significant differences(t_(7d)=2.678,P=0.008;t_(1mon)=3.087,P=0.002;t_(2mon)=3.132,P=0.002;t_(3mon)=2.100,P=0.037).The BCVA of the control group were significantly increased seven days and one month after treatment when compared to those before treatment,respectively,and the differences were statistically significant(t_(7d)=2.652,P=0.009;t_(1mon)=2.966,P=0.003).There were no significant change in BCVA at two months and three months after treatment when compared to those before treatment(P>0.05).When compared between the two groups after treatment,the BCVA increase in the treatment group were greater than those in the control group,and the differences were statistically significant(t_(7d)=2.130,P=0.035;t_(1mon)=5.383,t_(2mon)=10.715,t_(3mon)=29.024,all P=0.000).(2)CRT:The C

关 键 词：消肿颗粒 康柏西普 糖尿病黄斑水肿 血管内皮生长因子 

分 类 号：R276.7[医药卫生—中医五官科学]