Basic And Clinical Research Of Foam Sclerotherapy In The Treatment Of Lower Extremity Varicose Veins And Venous Ulcers Through The Local Injection

PartⅠ Animal experimental study on the effect of intravenous blood vessel withLauromacrogol foam sclerosing agentObjective: To discuss the safety of local injection and the occlusion degree of the treatment of venous blood vessel in rabbits with the Lauromacrogol foam sclerosing agentMethod: 27 male New Zealand rabbits were selected as experimental animals with the weight 2.42 ± 0.21 kg, which were distributed into three groups according to the principle of random, they were lauromacrogol liquid group, Lauromacrogol foam group and saline group respectively. The study included a total of three groups of nine rabbits each. The dorsal rabbit ear vein was injected with 0.2 ml of the tested materials acconding to the different groups. Local compression was achieved for 24 hour after the injection.A futher distribution was 24 hours, 7 days and 1 month by the observation time. Animals were sacrificed at 24 hours, 7 days and 1 month after injection. HE staining was done to evaluate the general structure and and histopathological changes at different injection materials and different time points.Result: Obvious skin necrosis was not found in all groups after local injection. The volume of foam was a quarter of Lauromacrogol liquid. Vascular wilt was appeared in these two groups. The most serious intravascular inflammatory response is in 24 hours after injection, and it decreased in 7 days, no evidence of inflammation was found in 1month, the difference of inflammation severity score between these two groups at 24 h, 7d,1m was statistically significant: liquid group(F=111.50, P < 0.01), foam group(F=118.50,P < 0.01). There was no significantly diference of inflammatory score between these two groups at the time points 24 h, 7d and 1m, while the difference was found between these two groups and the saline group(P<0.01). Lumen obstruction was found in these two groups at 24 h, 7d and 1m. The most serious degree happened in 1m after injection. The difference of lumen obstruction degree between these two groups at 24 h, 7d, 1m was statistically significant: liquid group(F=12.20, P < 0.01), foam group(F=45.50, P < 0.01).There was no significantly difference of lumen obstruction degree between these two groups at the time points 24 h, 7d and 1m(P>0.05), while the difference was found between these two groups and the saline group(P<0.01). The proportion of hemosiderin appeared in the tissue surrounding the thrombus was 75.00%, the proportion of 16.67% was found in the tissue which no thrombus existed in 7d after injection. A significant association(kappa=0.57, P <0.01) was observed between the the presence of hemosiderin in the tissues adjacent to the vein and the presence of venous thrombus. There was no obvious change in gross tissue appearance and local tissue pathological in the inflammatory response, lumen obstruction and the presence hemosiderin among the saline group.Conclusion:1. Foam and liquid forms of domestic Lauromacrogol sclerosing agent all can induceaseptic inflammatory on vascular intimal, thus secondary to the mural thrombosis andvascular fibrosis, which eventually occlude the vessel. The volume of the sclerosis agentcan be reduce through the use of foam morphology for sclerotherapy.2. The presence of hemosiderin in the tissues adjacent to the vein can be induced bythrombus, so reducing the incidence of thrombus can avoid the occurrence of thisadverse reaction.Part Ⅱ The clinical study of foam sclerotherapy on the treatment for varicose veinsof the lower extremities with local injectionObjective: To discuss the rationality and clinical effect of the foam sclerotherapy of Lauromacrogol for varicose veins of the lower extremities with local injection.Method: The date of 67 patients(76 legs) with varicose veins who were treated with foam sclerotherapy under fluoroscopic guidance was collected from May 2011 to September 2013 in our hospital. We divided them into two groups according to the operation model. Group I: 25 patients(29 limbs) underwent catheter-directed foam sclerotherapy for the great saphenous combinated with local injection for varicose veins;Group Ⅱ: 42 patients(47 limbs) underwent foam sclerotherapy for the great saphenous by direct puncture combinated with local injection for varicose veins. All limbs were bandaged after operation. Some factors were compared among these two groups including the operating time, treatment costs, the improvement of clinical symptoms, the success rate of operation and the adverse reactions.Result: The age of two groups is ranged from 35 to 73 years old, the shortest course of disease was 2 years and the longest 30 years, the age and the course of disease did not differ between these two groups(P>0.05). There was no significant difference on the preoperative pathogenetic condition between the two groups(P>0.05). The average volume of foam sclerosing agent in each case was 41.80 ± 14.31ml(20 ~ 80ml). There was no significant difference in the volume of the two groups(P>0.05). There were significant differences in the treating time and hospitalization expenses(t= 22.19, 44.54;P<0.01). The clinical classification of the two groups were improved in 24-months follow up after the treatment, the difference was statistically significant between the preoperation and the postoperation, in group I(2χ =98.646,P<0.01) and grade II( χ2 =157.919,P<0.01), the difference of the clinical classification between these two groups in 3m, 6m, 12 m, 24 m after operation was not statistically significant(P>0.05). The rate of successful treatment of group I was 93.10%, and the partial success was 6.90%; the rate of successful treatment of group II was 91.49%, and the partial success was 8.51%. There was no significantdifference between the two groups on the clinical effect(Correcting2χ =0.000, P>0.05).There was no significant difference in the adverse reactions of postoperation between group I and group II(P>0.05), such as cough, chest pain, pigmentation and superficial phlebitis. All patients were able to walk immediately after treatment. Obvious abnormal varicose veins as well as the soreness and fatigue of lower extremity disappeared in all patients in 24-months follow up.Conclusion:1. The effect of lauromacrogol foam sclerosing agent in the treatment for varicose veinsof the lower extremities under the fluoroscopy was sure, other advantages includingminimally invasive, lower complication and outpatient treatment.2. Simple treatment, low cost and short operating time can be achieved by direct punctureon the great saphenous vein combined with local injection on varicose vein.Part III The Clinical study of foam sclerotherapy on the treatment for varicose ulcerof the lower extremities with local injectionObjective: To discuss the clinical efficacy of foam sclerotherapy of lauromacrogol in treatment for lower extremity varicose ulcer under fluoroscopic guidance.Method: The date of 30 patients(34 limbs) with varicose ulcer of lower extremity which were treated with foam sclerotherapy under fluoroscopic guidance was collected from February 2011 to June 2014 in our hospital, which including 21 males and 9 females,The average age was 63.56 ± 7.70 years old, which ranged from 44 to 77 years old. 26 cases had unilateral limb ulcer, 4 cases had bilateral limb ulcers, 3 cases had the history of surgery. The clinic efficacy was assessed according to clinical disease classification, the selective paracentesis was used to saphenous vein and varicose veins near the ulcer, and fluoroscopic-guided foam sclerotherapy was performed to the great saphenous vein,communicating vein and perforating vein. Compression and dressing were used after operation. The healing of the ulcer, the improvement of the Clinical symptoms and theadverse reactions were observed during the future 12 months.Result: All affected extremity were successfully treated by foam sclerotherapy under fluoroscopic guidance. The average volume of foam sclerosing agent in each ease was(43.88 ± 11.79)ml, which ranged from 20 ~ 65 ml. One ulcer recured after healing in the three week after operation with the surface of the burst and Partial solutions, which cured by compression in two weeks later. All ulcers achieved complete healing with no recurrence at the end of the 12-months’ follow-up, ulcer healing time ranged from 7 days to56 days, with mean time to healing of 32.5 days. The ulcer long dimension and the shortr dimension were(4.10 ± 1.80) and(2.90 ± 1.55)cm respectively before the treatment; and(3.50±1.53),(2.46±1.43)cm in the first week after the procedure,the difference between them was significant( t = 12.20, P<0.01; t = 13.79, P <0.01). The clinical classification of all the limbs were improved after the treatment(2χ= 226.117, P<0.01.). Pain, pigmentation and other adverse reactions are self-limiting. There were no serious complications such as deep vein thrombosis and pulmonary embolism during the period of follow-up.Conclusion:1. Multipoint puncture to injecting the foam sclerosing agent combined with compressiontherapy for the ulcer related varicose vein under fluoroscopic guidance can effectivelypromote ulcer healing, which is safe and a minimally invasive treatment, long-termefficacy remains to be further follow-up and observation.2. Fluoroscopic guidance technology can ensure the safety and thoroughness for thetreatment, which decreased the recurrence rate of the ulcer to a minimum degree. Inspite of the appearance of local adverse reactions, they were self-limiting, and therewere no severe local or systemic complications.