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不同浓度聚多卡醇硬化剂治疗大隐静曲张的临床研究

发布时间:2018-06-27 18:39

  本文选题:下肢静脉曲张 + 聚多卡醇 ; 参考:《广州中医药大学》2017年硕士论文


【摘要】:目的:比较使用1%和3%两种不同浓度的聚多卡醇泡沫硬化剂治疗主干直径介于3~8mm的大隐静脉曲张的疗效和不良反应,为个体化选择泡沫硬化剂的浓度提供临床参考依据。方法:选择2015年9月至2016年03月我科收治的74位单纯大隐静脉曲张的患者,医师单盲将患者随机分为A组(1%聚多卡醇)和B组(3%聚多卡醇),在X射线透视引导下穿刺大隐静脉主干及局部侧支静脉行泡沫硬化治疗,并根据大隐静脉主干的直径大小将受试者分为三类:Ⅰ(3mm≤d5mm)、1Ⅱ(5mm≤d7mm)、Ⅲ(d≥7mm),于术后1周、1月、3月、6月、1年随访复查。分析对比使用两种不同浓度硬化剂(1%或3%)以及同种浓度硬化剂中不同直径类别组间的疗效差异。主要观察指标:血管闭塞率、反流消失率、临床成功率和不良反应;次要观察指标:CEAP分级、VCSS评分、CIVICQ评分、医疗费用和患者满意度。统计方法:两组均数比较用两独立样本t检验,率的比较用x2检验,重复测量数据选择重复测量方差分析,重复测量小样本计数资料选择Friedman检验,非正态两独立样本率的比较使用Mann-Whitney检验,非正态配对设计资料比较使用Wilicoxon非参数检验,二分类因变量的因素分析采用非条件logistic回归分析。结果:1两组患者一般资料比较均无明显性差异(P0.05)。A组泡沫硬化剂总用量和大隐静脉主干用量的平均值分别为(21.11±2.45)mL、(7.51±0.90)mL,而B组为(20.81±2.43)mL、(6.86±0.79)mL,两组间泡沫总用量的差异无统计学意义(t=0.525,P=0.6010.05),主干用量的差异有统计学意义(t=3.297,P=0.0020.01)。Ⅰ、Ⅱ、Ⅲ组的硬化剂用量组间差异均无统计学差异(p0.05)。2在术后1周、1月、3月、6月、1年共5个时间点内的随访中,A组的靶静脉闭塞率分别为62.2%、75.0%、88.2%、84.4%、80.6%,B组的靶静脉闭塞率分别为75.7%、89.2%、94.1%、84.8%、84.8%,两组在术后 1 周(Mann-Whitney U=489.5,P=0.0240.05)的闭塞率差异有统计学意义,余时间点无明显差异(P0.05)。3术后5个随访时间中,A组的大隐静脉反流消失率分别为75.7%、83.3%、91.2%、87.5%、83.9%,B 组的大隐静脉反流消失率分别为 83.8%、91.9%、97.0%、90.9%、84.8%,两组在术后 1 周和术后 1 月(Mann-Whitney U=457.5,484.0;P =0.008,0.0270.05)中有统计学差异,余时间点无明显差异(P0.05)。4术后5个随访时间中,A组的临床成功率分别为70.3%、69.4%、85.3%、87.5%、90.3%,B组的临床成功率分别为81.1%、89.2%、94.1%、90.9%、90.9%,两组在术后各时间点差异无统计学意义(P0.05)。5通过logistic多因素分析,硬化剂浓度、靶静脉直径分组与术后1年的靶静脉闭塞、静脉反流消失和临床成功情况均无明显相关性(P0.05)。6在术后3月和1年随访结果中,A、B两组的术后CEAP分级较术前改善,同一随访时间组间差异不显著(P0.05)。两组各时间点术后VCSS评分、CIVIQ评分均较术前明显降低,但同一时间点A、B组间差异无统计学意义(P0.05)。7 B组的治疗费用较A组高,其差异在统计学上有显著性(t=-22.601,P=0.0000.01);术后1月,B组的患者满意度较A组低,差异显著(χ2 =7.333,P =0.0070.01)。8两浓度组术后均不同程度地出现局部疼痛、色素沉着等不良反应,术后1周和1月B组疼痛发生率较A组高,差异均有统计学意义(Mann-Whitney U=397.0,444.0;P =0.001,0.0010.01);术后各随访时间段B组的色素沉着发生率与A组的差异均无统计学意义(P0.05)。结论:对于主干直径介于3~8mm的单纯大隐静脉曲张使用1%或3%浓度的聚多卡醇泡沫硬化剂进行硬化治疗,中期随访时间(术后1年)各疗效观察指标无明显差异,鉴于高浓度硬化剂可导致患者不良反应发生率高,并降低患者满意度,医师在临床应用中可选择低浓度硬化剂。
[Abstract]:Objective: To compare the efficacy and adverse reactions of 1% and 3% different concentrations of polyocele foam sclerosing agent in the treatment of large saphenous varices with the diameter of 3 ~ 8mm, and to provide a clinical reference for the individual selection of the concentration of the foam sclerosing agent. Methods: to select 74 simple great saphenous veins from September 2015 to 03 months of 2016. The patients were randomly divided into group A (1% polyocentol) and group B (3% polyocentol). The patients were treated by X ray fluoroscopy guided by the main trunk of the great saphenous vein and the local collateral vein for sclerotherapy, and the subjects were divided into three categories according to the diameter of the main trunk of the great saphenous vein: (3mm < d5mm), 1 II (5mm < d7mm), and III (D, or 7mm). 1 weeks, January, January, March, June, and 1 year follow-up review. Analysis and comparison of the differences between two different concentrations of sclerosing agents (1% or 3%) and the same concentration sclerosing agents in different types of diameter groups. Main observation indexes: vascular occlusion rate, reflux disappearance rate, clinical success rate and adverse reaction; secondary observation index: CEAP classification, VCSS score, CIVICQ evaluation Scores, medical expenses and patient satisfaction. Statistical methods: the two groups were compared with two independent samples t test, rate comparison with x2 test, repeated measurement data selection repeated measurement variance analysis, repeated measurement of small sample counting data to select Friedman test, non normal two independent sample rate comparison using Mann-Whitney test, non normal pairing The data were compared with Wilicoxon nonparametric test, and the two classification factors were analyzed by non conditional logistic regression analysis. Results: there was no significant difference in general data between the 1 groups and two groups (P0.05) the average value of the total dosage of foam sclerosing agent and the amount of major saphenous vein in the group.A were (21.11 + 2.45) mL and (7.51 + 0.90) mL, while the B group was (20.81 + 2.43) mL and (6.86 + 0.79) mL, there was no significant difference in the total amount of foam between the two groups (t=0.525, P=0.6010.05), and there was a significant difference between the dosage of the main trunk (t=3.297, P=0.0020.01). There was no statistical difference between the groups of group I, II, and group III (P0.05).2 at 1 weeks after the operation, in January, March, June, and 1 years in 5 time points. The rate of target vein occlusion in group A was 62.2%, 75%, 88.2%, 84.4%, 80.6%, and the occlusion rate of target vein in group B was 75.7%, 89.2%, 94.1%, 84.8%, 84.8%, respectively. There was significant difference in the occlusion rate in group two (Mann-Whitney U=489.5, P=0.0240.05) after operation, and there was no significant difference between the remaining time points (P0.05) during the 5 follow-up time after.3 operation, A group was big. The rate of disappearance of saphenous venous reflux was 75.7%, 83.3%, 91.2%, 87.5%, 83.9%. The rate of disappearance of great saphenous vein reflux in group B was 83.8%, 91.9%, 97%, 90.9%, 84.8%, respectively, and there were statistically significant differences between postoperative 1 weeks and postoperative (Mann-Whitney U=457.5484.0; P =0.008,0.0270.05) after operation, and there was no significant difference between the remaining time points (P0.05) during.4 postoperative 5 follow-up. The clinical success rates of group A were 70.3%, 69.4%, 85.3%, 87.5%, 90.3%, and B, respectively, and the clinical success rates were 81.1%, 89.2%, 94.1%, 90.9%, 90.9%, respectively, and there was no statistically significant difference between groups after the operation (P0.05).5 through logistic multifactor analysis, the concentration of sclerosing agent, the target vein diameter grouping and the occlusion of the target vein in 1 years after the operation, and the venous reverse. There was no significant correlation between flow disappearance and clinical success (P0.05).6 in the follow-up results of March and 1 years after operation. The CEAP classification of group A and B two was better than that before operation, and there was no significant difference between groups at the same follow-up time (P0.05). The VCSS score of the two groups at each time point was significantly lower than that before the operation, but the difference between the same time point A and the B group was no unification. The treatment cost of group P0.05.7 B was higher than that in group A, and the difference was statistically significant (t=-22.601, P=0.0000.01). In January after operation, the satisfaction of patients in group B was lower than that of A group, and the difference was significant (x 2 =7.333, P =0.0070.01) in the.8 two concentration group, with different degrees of local pain, pigmentation and other adverse reactions, 1 weeks and January postoperatively. The incidence of pain was higher than that in the A group (Mann-Whitney U=397.0444.0; P =0.001,0.0010.01), and there was no significant difference between the B group and the A group after the follow-up period (P0.05). Conclusion: the 1% or 3% concentration of polycala alcohol was used for the pure saphenous varices with the trunk diameter of 3 to 8mm. The sclerosing agent for sclerosing agent is treated with sclerotherapy, and there is no significant difference in the observation index of the curative effect in the middle period (1 years after operation). In view of the high concentration of sclerosing agent which can lead to the high incidence of adverse reactions and reduce the patient's satisfaction, the doctor can choose the low concentration sclerosing agent in the clinical application.
【学位授予单位】:广州中医药大学
【学位级别】:硕士
【学位授予年份】:2017
【分类号】:R654.4


本文编号:2074855

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