桃红四物汤外敷改善血液透析动静脉内瘘通畅性的随机、双盲、安慰剂对照临床研究
A randomized， double‑blind， placebo‑controlled clinical trial on the external application of Taohong Siwu Decoction to improve the arteriovenous fistula patency during hemodialysis
- 上海中医药杂志 2023年57卷第11期 页码：33-37
- 作者机构：
1.上海中医药大学附属岳阳中西医结合医院肾内科（上海 200437）
- 作者简介：
陈寅清，男，硕士研究生，住院医师，主要从事中西医结合治疗慢性肾脏病的临床与研究工作
韩世盛，副主任医师；E-mail：hanss8612@163.com
- 基金信息：上海市科委“科技创新行动计划”医学创新研究专项(20Y21902100)
DOI：10.16305/j.1007-1334.2023.2306077
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陈寅清,姚天文,卢嫣,等.桃红四物汤外敷改善血液透析动静脉内瘘通畅性的随机、双盲、安慰剂对照临床研究[J].上海中医药杂志,2023,57(11):33-37.
CHEN Yinqing,YAO Tianwen,LU Yan,et al.A randomized， double‑blind， placebo‑controlled clinical trial on the external application of Taohong Siwu Decoction to improve the arteriovenous fistula patency during hemodialysis[J].Shanghai Journal of Traditional Chinese Medicine,2023,57(11):33-37.
陈寅清,姚天文,卢嫣,等.桃红四物汤外敷改善血液透析动静脉内瘘通畅性的随机、双盲、安慰剂对照临床研究[J].上海中医药杂志,2023,57(11):33-37. DOI： 10.16305/j.1007-1334.2023.2306077.
CHEN Yinqing,YAO Tianwen,LU Yan,et al.A randomized， double‑blind， placebo‑controlled clinical trial on the external application of Taohong Siwu Decoction to improve the arteriovenous fistula patency during hemodialysis[J].Shanghai Journal of Traditional Chinese Medicine,2023,57(11):33-37. DOI： 10.16305/j.1007-1334.2023.2306077.
摘要
目的,2,评价桃红四物汤外敷改善血液透析动静脉内瘘（AVF）通畅性的临床疗效。,方法,2,采用随机、双盲、安慰剂对照临床研究方法，将84例行AVF术的慢性肾脏病5期患者随机分为治疗组、对照组，每组42例。治疗组给予桃红四物汤颗粒外敷，对照组给予桃红四物汤颗粒安慰剂外敷，两组疗程均为12个月。观察两组内瘘成熟时间，治疗90 d时比较两组内瘘成熟率，治疗结束后比较两组内瘘废弃率、内瘘通畅率、内瘘血流量及流出静脉内径；绘制Kaplan-Meier生存曲线，采用Log-rank检验比较组间内瘘通畅率与生存率差异；同时进行安全性评价。,结果,2,①试验过程中，治疗组脱落3例、对照组脱落1例，最终纳入80例病例，其中治疗组39例、对照组41例。②治疗组、对照组内瘘废弃率分别为5.13%和17.07%，内瘘通畅率分别为84.62%和78.05%，两组内瘘废弃率、内瘘通畅率比较，差异无统计学意义（,P,>,0.05）；生存分析结果显示，两组内瘘生存率差异有统计学意义（,P,<,0.05），内瘘通畅率差异无统计学意义（,P,>,0.05）。③治疗组、对照组90 d内瘘成熟率分别为92.31%、73.17%，两组内瘘成熟率比较，差异有统计学意义（,P,<,0.05）；两组内瘘成熟时间比较，治疗组早于对照组（,P,<,0.05）。④治疗后，治疗组内瘘血流量高于对照组，流出静脉内径大于对照组，差异有统计学意义（,P,<,0.05）。⑤两组不良反应发生率比较，差异无统计学意义（,P,>,0.05）。,结论,2,桃红四物汤外敷可有效提高血液透析AVF生存率与成熟率，增加内瘘血流量及流出静脉内径，对改善AVF预后具有积极意义。
Abstract
Objective,2,To assess the clinical efficacy of external application of Taohong Siwu Decoction （THSWD） in improving the patency of arteriovenous fistulas （AVF） in patients undergoing hemodialysis.,Methods,2,We conducted a randomized， double-blind， placebo-controlled clinical trial involving 84 patients with stage 5 chronic kidney disease who underwent AVF surgery. Participants were randomly assigned to either the treatment group， receiving external application of THSWD granules， or the control group， receiving placebo of THSWD granules for external application， with 42 patients in each group. The treatment duration for both groups was 12 months. We measured the maturation time of AVF， maturation rate after 90 days of intervention， and assessed abandonment rates， patency rates， blood flow， and outflow vein diameters of AVF post-treatment. Kaplan-Meier survival curves were generated and the Log-rank test was used to compare fistula patency and survival rates between two groups. Safety assessments were also conducted.,Results,2,①During the trial， 3 cases dropped out in the treatment group and 1 case dropped out in the control group， resulting in a final inclusion of 80 cases （39 in the treatment group and 41 in the control group）. ②The abandonment rates of AVF were 5.13% in the treatment group and 17.07% in the control group， with patency rates of 84.62% and 78.05%， respectively. No statistically significant difference was observed in abandonment or patency rates between the two groups （,P,>,0.05）. However， survival analysis indicated a statistically significant difference in the survival rate of AVF between the two groups （,P,<,0.05）， but no statistically significant difference in fistula patency rate （,P,>,0.05）. ③The 90-day AVF maturation rates were 92.31% in the treatment group and 73.17% in the control group， showing a statistically significant difference （,P,<,0.05）. The maturation time of AVF in the treatment group was shorter than that in the control group （,P,<,0.05）. ④After treatment， the treatment group exhibited higher fistula blood flow and larger outflow vein diameters than the control group， with statistically significant differences （,P,<,0.05）. ⑤There were no significant differences in the incidence of adverse events between the two groups （,P,>,0.05）.,Conclusions,2,External application of THSWD effectively improved the survival rate and maturation rate of AVF， increased blood flow rates and outflow vein diameters. This treatment approach holds significant potential for enhancing the prognosis of AVF.
关键词
慢性肾脏病肾衰竭血液透析动静脉内瘘桃红四物汤活血化瘀中医药疗法
Keywords
chronic kidney diseaserenal failurehemodialysisarteriovenous fistulaTaohong Siwu Decoctionpromoting blood circulation and resolving blood stasistraditional Chinese medicine therapy
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