益气养阴化瘀通络方治疗糖尿病肾脏病Ⅳ期的临床研究  

Clinical study of Yiqi Yangyin Huayu Tongluo Formula in the treatment of stage Ⅳ diabetic kidneydisease

作　　者：马赟 赵炳武 裴国超[2] 高玉伟 王兴华 白璐 吴苏 王月华[4] 杨洪娟[3] 马金荣[2] 黄怀鹏 陈志强 MA Yun;ZHAO Bingwu;PEI Guochao;GAO Yuwei;WANG Xinghua;BAI Lu;WU Su;WANG Yuehua;YANG Hongjuan;MA Jinrong;HUANG Huaipeng;CHEN Zhiqiang(The First Affiliated Hospital of Hebei University of Chinese Medicine,Shijiazhuang 050000,China;Cangzhou Hospital of Integrated TCM-WM·Hebei,Cangzhou 061001,China;The First Hospital of Hebei Medical University,Shijiazhuang 050000,China;The Third Hospital of Hebei Medical University,Shijiazhuang 050000,China;Shijiazhuang Pingan Hospital,Shijiazhuang 050000,China)

机构地区：[1]河北中医药大学第一附属医院,石家庄050000 [2]河北省沧州中西医结合医院,沧州061001 [3]河北医科大学第一医院,石家庄050000 [4]河北医科大学第三医院,石家庄050000 [5]石家庄平安医院,石家庄050000

出　　处：《中华中医药杂志》2023年第11期5601-5605,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：河北省省级科技计划(No.20377711D)。

摘　　要：目的:观察益气养阴化瘀通络方对糖尿病肾脏病Ⅳ期气阴两虚、瘀血阻络证患者的临床疗效及炎症指标的影响。方法:采用多中心、随机双盲、安慰剂对照的研究方法,将126例糖尿病肾脏病Ⅳ期气阴两虚、瘀血阻络证患者分为观察组和对照组,每组63例。两组均采用常规西医治疗,对照组给予中药安慰剂口服,观察组给予益气养阴化瘀通络中药颗粒剂口服,共治疗24周。分别于治疗前后观察两组中医证候评分、24h尿蛋白定量(24 h UTP)、血肌酐(Scr)、血白蛋白(Alb)、糖化血红蛋白(HbA1c)、白介素-1β(IL-1β)、白介素-6(IL-6)、肿瘤坏死因子-α(TNF-α),判定中医证候疗效,记录终点事件发生率及不良反应。结果:观察组中医证候总有效率为69.84%(44/63),对照组为28.57%(18/63),观察组显著高于对照组(P<0.05)。观察组治疗后Alb显著高于治疗前(P<0.05),且显著高于对照组同期(P<0.05);观察组Scr升高值显著低于对照组(P<0.05);观察组治疗后24 h UTP、IL-1β、IL-6、TNF-α显著低于治疗前(P<0.05),且显著低于对照组同期(P<0.05)。观察组终点事件发生率3.64%(2/55),对照组终点事件发生率5.56%(3/54),差异无统计学意义。治疗过程中未见与试验药物相关且具有临床意义的不良反应。结论:益气养阴化瘀通络方可以改善糖尿病肾脏病Ⅳ期气阴两虚、瘀血阻络证患者临床症状,减少蛋白尿,延缓肾功能下降,其作用机制可能与抑制炎症介质分泌相关。Objective:To observe the clinical effect and inflammatory index of Yiqi Yangyin Huayu Tongluo Formula on patients with stage Ⅳ diabetic kidney disease with qi and yin deficiency and blood stasis blocking collaterals.Methods:A multicenter,randomized,double-blind,placebo-controlled study was conducted.A total of 126 patients with stage Ⅳ diabetic kidney disease were divided into control group and observation group,63 cases in each group.Both groups were treated with conventional western medicine.The control group was given traditional Chinese medicine placebo orally,while the observation group was given Yiqi Yangyin Huayu Tongluo traditional Chinese medicine granule orally for 24 weeks.Before and after treatment,the traditional Chinese medicine syndrome score,serum creatinine(Scr),serum albumin(Alb),glycosylated hemoglobin(HbAlc),interleukin-1β(IL-1β),interleukin-6(IL-6),tumor necrosis factor-α(TNF-α)and 24-hour urinary protein(24 h UTP)were observed in the two groups to determine the efficacy of traditional Chinese medicine syndrome,and the incidence of endpoint events and adverse reactions were recorded.Results:The total effective rate of traditional Chinese medicine syndrome was 69.84%(44/63)in the observation group and 28.57%(18/63)in the control group,the observation group was significantly higher than control group(P<0.05).The serum Alb of the observation group after treatment was significantly higher than that before treatment(P<0.05),and significantly higher than that of the control group at the same period(P<0.05).The increase of serum creatinine in the observation group was significantly lower than that in the control group(P<0.05).After treatment,the quantification of IL-1β,IL-6,TNF-α and 24 h UTP in the observation group were significantly lower than those before treatment(P<0.05),and significantly lower than those in the control group at the same period(P<0.05).The incidence of end-point events was 3.64%(2/55)in the observation group and 5.56%(3/54)in the control group,and the difference was

关 键 词：益气养阴化瘀通络 糖尿病肾脏病 蛋白尿 炎症 临床研究 双盲 随机对照试验 多中心 

分 类 号：R259[医药卫生—中西医结合] R277.5[医药卫生—中医内科学]