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抗疣驻景方对肝肾不足型早、...黄斑变性的双盲随机对照试验_王诗惠.pdf

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1、中华中医药杂志(原中国医药学报)2023年2月第38卷第2期 CJTCMP,February 2023,Vol.38,No.2 886 6 徐济民.缺血性心脏病诊断的命名及标准国际心脏病学会和协会/世界卫生组织临床命名标准化专题组的联合报告.国外医学:心血管疾病分册,1979(6):365-3667 中华医学会心血管病学分会,中华心血管病杂志编辑委员会.中国心力衰竭诊断和治疗指南2018.中华心血管病杂志,2018,46(10):760-7898 毛静远,朱明军.慢性心力衰竭中医诊疗专家共识.中医杂志,2014,55(14):1258-12609 赵冬琰,胡菱,李滢,等.益心活血法对气虚血瘀型

2、慢性心力衰竭患者的影响.中国老年保健医学,2020,18(3):3-610 谢娜,戴小华.益气活血法治疗慢性心力衰竭研究进展.安徽中医药大学学报,2019,38(2):94-9611 张玥,谷玉红,王居新.补阳还五汤联合西药治疗慢性心力衰竭(气虚血瘀)随机平行对照研究.实用中医内科杂志,2019,33(2):25-2812 张悦晨.加味补阳还五汤对气虚血瘀型慢性心力衰竭患者生活质量的临床研究.济南:山东中医药大学,202013 赵齐飞,李红蓉,尹玉洁,等.芪苈强心胶囊治疗慢性心力衰竭作用机制研究进展.天津中医药,2019,36(4):313-31814 冯所远.慢性心衰患者标准化“金三角”治疗

3、前后凝血功能的监测.血栓与止血学,2018,24(1):65-66,6915 史文静,周华.戎靖枫温补心阳和肾阳方对心力衰竭大鼠心功能和心肌磷酸腺苷含量的影响.中西医结合心脑血管病杂志,2012,10(9):1083-108516 胡元会,吴华芹,张百舜,等.心复康口服液对心梗后心衰大鼠心肌组织ATP ADP AMP影响的研究.辽宁中医杂志,2008,36(8):1141-114217 张安晶.心复康口服液对心梗后心衰大鼠心功能高能磷酸盐代谢影响的研究.北京:中国中医科学院,201318 Aura M,Raimondas K.Effect of physical training on ind

4、ices of platelet aggregation and fibrinogen concentration in patients with chronic heart failure.Medicina(Kaunas),2015,51(6):343-35019 邢亚彬,马爱霞.EQ-5D-5L中文版应用介绍.现代商贸工业,2013,25(1):177-179(收稿日期:2021年9月2日)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王诗惠,孙宏睿,宋剑涛,亢泽峰,宋柯,许超,戴乐舒(中国中医科学院眼科医院,北京 100040)摘要:目的:评价抗疣驻景方对于肝肾不

5、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1

6、04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)(P0.05);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)(P0.05)。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)(P0.01),试验组各中医证候积分均显著低于对照组(P0.01)。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,

7、治疗有效,临床应用安全。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;随机对照试验基金资助:首都卫生发展科研专项项目(No.2016-2-4183)临床报道 通信作者:宋剑涛,北京市石景山区鲁谷路33号中国中医科学院眼科医院,邮编:100040,电话:010-68688877E-mail:内文2.indd 8862023/2/28 10:36:50中华中医药杂志(原中国医药学报)2023年2月第38卷第2期 CJTCMP,February 2023,Vol.38,No.2 887 Kangyou Zhujing Prescription on early and

8、middle age-related macular degeneration with syndrome of deficiency of both liver and kidney:A double-blind randomized controlled trialWANG 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)Abstract:

9、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 controlle

10、d clinical trial was used.A total of 120 patients 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,subject

11、s 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 fo

12、llowed 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 i

13、mplemented 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

14、in experimental group was 78.18%(43/55),which was significantly highered than the 20.41%(10/49)in control group(P0.05);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(P0.05).After

15、 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(P0.01).The total syndrome of experimental group was lowered than that of control group(P0.01).No adverse events occurre

16、d during the entire study.Conclusion:Kangyou Zhujing Prescription is effective in improving visual function,improve TCM syndromes,and safe in clinical application.Key words:Kangyou Zhujing Prescription;Age-related macular degeneration;Vision;Traditional Chinese medicine syndromes;Syndrome of deficiency of both liver and kidney;Double blind;Randomized controlled trialFunding:Special Project on Research in Capital Health Development(No.2016-2-4183)年龄相关性黄斑变性(age-related macular degeneration,AMD)是中老

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