抗疣驻景方对肝肾不足型早、中期年龄相关性黄斑变性的双盲随机对照试验  

Kangyou Zhujing Prescription on early and middle age-related macular degeneration with syndrome of deficiency of both liver and kidney:A double-blind randomized controlled trial

作　　者：王诗惠[1] 孙宏睿 宋剑涛[1] 亢泽峰[1] 宋柯[1] 许超[1] 戴乐舒 WANG Shi-hui;SUN Hong-rui;SONG Jian-tao;KANG Ze-feng;SONG Ke;XU Chao;DAI Le-shu(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：《中华中医药杂志》2023年第2期886-890,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：首都卫生发展科研专项项目(No.2016-2-4183)。

摘　　要：目的:评价抗疣驻景方对于肝肾不足型早、中期年龄相关性黄斑变性患者的有效性及安全性,为年龄相关性黄斑变性的治疗提供高等级循证证据和新的治疗方法。方法:采用双盲随机对照临床试验,纳入2017年9月至2019年12月在中国中医科学院眼科医院门诊确诊的早、中期年龄相关性黄斑变性肝肾不足型患者120例,根据随机数表法分为试验组和对照组,每组60例。试验组口服抗疣驻景方颗粒剂,对照组口服抗疣驻景方安慰剂,服药6个月,随访6个月。记录治疗前,治疗后及治疗后6个月时的视力、中医证候评分和安全性指标。试验过程中受试者及研究者均不知受试者所处分组,盲法的实施依靠信封法完成。结果:共纳入受试者120例(120只眼),去除脱落病例后,共统计104例(104只眼),试验组55例(55只眼),对照组49例(49只眼)。治疗后试验组视力总有效率为78.18%(43/55),显著高于对照组的20.41%(10/49)(P<0.05);治疗后6个月时,试验组视力总有效率为72.73%(40/55),显著高于对照组的18.37%(9/49)(P<0.05)。治疗后,试验组中医证候评分总有效率为81.82%(45/55),显著高于对照组的20.41%(10/49)(P<0.01),试验组各中医证候积分均显著低于对照组(P<0.01)。整个研究过程中未发生不良事件。结论:抗疣驻景方针对肝肾不足型早、中期年龄相关性黄斑变性患者,可提高视功能、改善中医证候,治疗有效,临床应用安全。Objective:To evaluate the effectiveness and safety of Kangyou Zhujing Prescription for patients with early and middle age-related macular degeneration(AMD),and to provide high-level evidence-based evidence and new treatment methods for the treatment of AMD.Methods:A double-blind randomized controlled clinical trial was used.A total of 120patients with early and mid-stage AMD with liver and kidney deficiency in the outpatient clinic of the Eye Hospital of the Chinese Academy of Chinese Medical Sciences from September 2017 to December 2019 were included.According to random numbers table,subjects were divided into the experimental group and the control group,each with 60 cases.The experimental group took the Kangyou Zhujing Prescription granules orally,and the control group took the Kangyou Zhujing Prescription placebo orally,both for 6 months.After taking the medicine the subjects were followed up for 6 months.The vision,traditional Chinese medicine(TCM)syndrome scores and safety indicators at baseline,after the treatment and 6-month after the treatment were recorded.During the experiment,neither the subject nor the researcher knew the group of the subject,and the blind method was implemented by the envelope method.Results:A total of 120 cases(120 eyes)were included.After the dropout cases were removed,a total of 104 cases(104 eyes)were counted,55 cases(55 eyes)in the experimental group and 49 cases(49 eyes)in the control group.After the treatment,the effective rate of vision in experimental group was 78.18%(43/55),which was significantly highered than the 20.41%(10/49)in control group(P<0.05);At 6-month follow-up,the effective rate of vison improvement experimental group was 72.73%(40/55),which was significantly highered than the 18.37%(9/49)in control group(P<0.05).After the treatment,the effective rate of the TCM syndrome score improvement experimental group was 81.82%(45/55),which was significantly highered than 20.41%(10/49)in the control group(P<0.01).The total syndrome of experimental group was lowered than

关 键 词：抗疣驻景方 年龄相关性黄斑变性 视功能 中医证候 肝肾不足型 双盲 随机对照试验 

分 类 号：R774.5[医药卫生—眼科]