Panditray Siddharth, Acharya Sauvagini, Prusty Nilamadhab, Dany Subha Saumya
Department of ENT and Head Neck Surgery, VSSIMSAR, Burla, Odisha 768017 India.
Department of Dental Surgery, VIMSAR, Burla, Odisha 768017 India.
Indian J Otolaryngol Head Neck Surg. 2019 Oct;71(Suppl 1):566-573. doi: 10.1007/s12070-018-1410-8. Epub 2018 Jun 4.
Management of head and neck hemangiomas with oral propranolol versus oral itraconazole in conjugation with injection sodium tetra decyl sulphate. This prospective parallel clinical trial was done to check for the effectiveness of oral propranolol and oral itraconazole when used in conjugation with inj. sodium tetra decyl sulphate in treatment of head and neck haemangiomas in adult patients visiting department of ENT and head and neck surgery, VIMSAR, Burla. All the patients visiting the department with hemangioma (diagnosed clinically and by FNAC) were considered and only those who gave written informed consent and were according to our inclusion and exclusion criteria were included into the study as subjects. Dimension (length, width and hemi-circumference) of the haemangiomas were measured using disposable paper taper measures. Depth of the hemangioma was calculated based on formula and using that volume was calculated both at baseline and after 8 weeks of drug administration. Data so collected was entered into Microsoft Office Excel 2013 and statistical analysis was performed using SPSS Version 20.0. Descriptive statistics was calculated and student's test (paired and unpaired) was used to compare within the group (before and after) and between the groups respectively. Statistical significance was set at ≤ 0.05. Both the groups showed statistically significant volume reduction in the lesions [ < 0.018 (propranolo + sodium tetra decyl sulphate), < 0.025 (itraconazole + sodium tetra decyl sulphate)]. The mean decrease in volume in propranolol group was 91.92% and that in itraconazole group was 88.97%. There was no statistical difference between the final outcome of both the groups ( < 0.766) but 3 patients on propranolol had complete resolution while 1 patient on itraconazole had complete resolution of the lesion. Oral propranolol and itraconazole are both effective and safe in hemangioma in adults. The combination with inj. sodium tetra decyl sulphate has a (1) favorable impact on decreasing the overall duration of treatment. (2) Aiding in complete resolution of lesions (especially < 3 cm). Propranolol has an edge over itraconazole (more no of tumors had complete resolution).
口服普萘洛尔与口服伊曲康唑联合十四烷基硫酸钠治疗头颈部血管瘤。本前瞻性平行临床试验旨在检验口服普萘洛尔和口服伊曲康唑与十四烷基硫酸钠注射液联合使用时,对就诊于伯拉VIMSAR耳鼻喉科和头颈外科的成年患者头颈部血管瘤的治疗效果。所有因血管瘤前来科室就诊(临床诊断及细针穿刺抽吸活检确诊)的患者均被纳入考虑,只有那些签署书面知情同意书且符合我们纳入和排除标准的患者才被纳入本研究作为受试者。使用一次性纸锥测量血管瘤的尺寸(长度、宽度和半周长)。根据公式计算血管瘤的深度,并据此在基线和给药8周后计算体积。收集到的数据录入Microsoft Office Excel 2013,并使用SPSS 20.0版本进行统计分析。计算描述性统计量,并分别使用学生检验(配对和非配对)在组内(治疗前后)和组间进行比较。设定统计学显著性为≤0.05。两组病变体积均有统计学显著减小[普萘洛尔+十四烷基硫酸钠组P<0.018,伊曲康唑+十四烷基硫酸钠组P<0.025]。普萘洛尔组体积平均减小91.92%,伊曲康唑组为88.97%。两组最终结果无统计学差异(P<0.766),但普萘洛尔组有3例患者病变完全消退,伊曲康唑组有1例患者病变完全消退。口服普萘洛尔和伊曲康唑对成人血管瘤均有效且安全。与十四烷基硫酸钠注射液联合使用有以下作用:(1)对缩短总体治疗时间有积极影响。(2)有助于病变完全消退(尤其是<3 cm的病变)。普萘洛尔比伊曲康唑更具优势(更多肿瘤实现完全消退)。