Clinical Study Of Sclerotherapy In The Treatment Of Great Saphenous Veins With Polidocanol Foam In Different Concentrations

Objective:To compare the efficacy and side effects of foam sclerotherapy of lower extremity varicose veins(trunk diameter 3-8mm)with 1%and 3%polidocanol foam(POL),which could provide reference for selecting the concentration of POL individual.Methods:From September 2015 to November 2016,74 patients with primary incompetent great saphenous veins(GSV)were randomized to treated with sclerotherapy using either 1%or 3%polidocanol foam in single blind,all of which were operated by puncturing the trunk or branch of GSV under the X ray.On the basis of the diameter of GSV,the volunteers were classified into three groups:Group I(3mm ≤ d<5mm),Group II(5mm≤d<7mm),Group III(d≥ 7mm).The follow-up results were assessed by ultrasound at 1 week,1 month,3 months,6 months,1 year,aiming to compare the clinical curative effect and adverse reactions between groups in different concentrations or in different diameters.The main outcomes concluded the occlusion of the trunk of GSV,the absence of GSV reflux,the clinical success,side effects.And the secondary outcomes were the scores of CEAP,VCSS,CIVIQ.Medical cost and patients’ satisfaction were assessed.Statistical method:t test was used for comparison between groups,x2 test for rates,the ANOVA for repeated measurement data,Mann-Whitney U test for non parameter paper,Friedman test for enumeration data with repeated measurement,Wilicoxon test for pairing data with non-normal distribution parameters,Logistic regression for the dichotomous variables.Results:1 Volunteer’s characteristics were no significant difference between the two groups(P>0.05).The mean value of total dosage and partial for trunk were 21.11ml(S.D.=2.45)and 7.51ml(S.D.=0.90)separately in Group A,20.81ml(S.D.=2.43)and 6.86(S.D.=0.79)in Group B.There is significant statistical difference between the two groups in dosage of trunk(t=3.297,P=0.002),but not in total dosage(t=0.525,P=0.601).There were no significant difference between groups of different diameters.2 Follow-up was carried out at the first week,the first month,the third months,the sixth months,the first year after the sclerotherapy.The occlusion rates were 62.2%,75.0%,88.2%,84.4%,80.6%respectively in Group A,and 75.7%,89.2%,94.1%,84.8%,84.8%in Group B,with significant difference in the occlusion rate between two groups after 1 week and 1 month(Mann-Whitney U=489.5,P=0.024<0.05).3 The absence rates of GSV reflux of Group A were 75.7%,83.3%,91.2%,87.5%,83.9%separately,and 83.8%,91.9%,97.0%,90.9%,84.8%in Group B,with significant difference between two groups after 1 week and 1 month(Mann=Whitney U=457.5,484.0,1187.0;P=0.008,0.027<0.05).4 The clinical success rates of Group A were 70.3%,69.40%,85.30,%,87.5%,90.30%separately,and 81.11%,89.2%,94.1%,90.9%,90,9%in Group B,with no significant difference between two groups at any time(P>0.05).5 The result of logistic regression analysis showed that the concentration of POL,trunk diameter had no statistically significant in effect on prognosis which include occlusion rate,absence of GSV reflux,clinical success(P>0.05).6 At 3 months and 1 year,the score of CEAP improved in both Group A and Group B comparing to preoperative,but no significant difference between groups at the same time(P>0.05).The score of CIVIQ and VCSS was decreased both in Group A and Group B comparing to that before operation,but no significantly difference between groups(P>0.05).7 The medical cost between Group A and Group B was statistical difference(t=-22.601,P=0.000<0.001),which means Group B was more expensive than Group A.Patients in Group A were more satisfied with their foam sclerotherapy than Group B at 1 month,with significant difference(x2=7.333,P =0.007<0.01).8 In both groups,side effects(local pain,pigmentation,etc.)were observed in different degrees.At 1 week and 1 month,Group B shows a significantly higher rate than Group A in local pain(Mann-Whitney U=397.0,444.0;P=0.001,0.001<0.01).There were no significant difference in pigmentation after operation between groups at any time(P>0.05).Conclusion:The outcomes above shows that 1%POL and 3%POL have the similar efficacy in foam sclerotherapy of GSV(trunk diameter 3-8mm)at 1 year.However,the side effects in Group B(3%POL)were higher than Group A(1%POL),which decrease the satisfaction from patients.Therefore,the POL in low concentration should be recommended to be used for sclerotherapy.