Efficacy of Intralesional Bleomycin Alone and in Combination With Dexamethasone in Infantile Haemangiomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Decrease in size of lesion
研究概览
简要总结
Objective:
This study is intended to compare the outcome of intralesional bleomycin with dexamethasone versus the bleomycin alone in infantile haemangioma.
Materials and Methods:
This RCT was performed after the ethical approval at the pediatric surgery department of KEMU/Mayo hospital Lahore. 114 patients were enrolled in two groups A and B. Both groups contained 57 patients each. Group A was administered intralesional bleomycin with dexamethasone and group B was given intralesional bleomycin alone with a space of 4 weeks. Selection of patients was made according to inclusions and exclusion criteria.
详细描述
Introduction:
Infantile haemangioma (IH) is a common tumor found in children. The history of this tumor consists of an early phase of growth followed by slow resolution over a period of three to seven years but can extend up to 12 years. Therapeutic intervention is usually not required in infantile hemangiomas due to spontaneous regression. In about 10 to 15% of cases IH located in the perineal, airway or periocular areas, or hemangiomas associated with complications of ulceration, intervention is necessary. Another reason for intervention in these hemangiomas is the probability of scar formation with complete or incomplete spontaneous involution. Currently available treatment options for IH range from topical, intralesional, systemic and laser therapies to surgery based on the stage and presentation of the tumor. The choice of treatment must be carefully selected after comparing the merits and risks of each modality through a patient-specific approach.
OPERATIONAL DEFINITION:
Infantile Haemangioma: is a benign vascular proliferative disorder which has an early period of proliferation and then regresses spontaneously. They are found during the infancy and are considered medically benign lesions.
Efficacy: The desired effect obtained after giving a treatment is termed as efficacy. Efficacy of the treatment was measured in terms of reduction of the size of haemangioma which in turn was assessed by measuring length, width, height and volume every month to a period of one year. The decrease in size was graded on 5 point scale where 1= < 50% reduction, 2= 50-75%, 3= 75-90%, 4= >90% but < 100% and 5= 100%[17]. The complete flattening of haemangioma was considered as resolution of the lesion and at least the reduction in size of grade 2 results was labelled as the treatment being efficacious.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
participants were up to age of 12 years so they automatically got masked. outcome assessors were the teams of doctor working in outpatient department were also masked
入排标准
- 年龄范围
- 1 Month 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with haemangioma with size equal or more than 1 c
- •Less than 12 years and above 1 month of age.
排除标准
- •Patients with previous surgical procedure for haemangiomas
- •Patients with chronic respiratory conditions confirmed by history, symptoms and physical examination.
- •The diagnosed case of pulmonary fibrosis.
- •Patients sensitive to bleomycin proved upon giving a test dose
研究组 & 干预措施
Group A with intralesional injection of bleomycin with dexamethasone
Patients in the group A(n=57) were given intralesional bleomycin combined with dexamethasone and The intralesional dose of bleomycin was 1 mg/kg/dose but for haemangiomas on neck and face it was used as 0.5 mg/kg/dose and similarly intralesional dexamethasone was given as 0.8-1.6 mg/kg/dose. The Length, Width, Height and volume of haemangioma was measured in centimeters using a vernier calliper. The decrease in size was graded from 1-5 where 1=<50% decrease, 2=50-75%, 3=75-90%, 4=>90% but <100% and 5= 100% resolution. The data collection sheet included patent's age, sex, length, width, height, volume, site of haemangioma, dose of bleomycin, dexamethasone, clinical response being efficacious or non-efficacious as per operational definition and time taken to resolve for each patient.
干预措施: Comparison of intralesional injection of bleomycin alone and combined with injection dexamethasone (Drug)
Group B WITH INTRALESIONAL INJECTION OF BLEOMYCIN
Patients in the group B(n=57) intralesional bleomycin alone after taking aseptic and antiseptic measuresThe intralesional dose of bleomycin was 1 mg/kg/dose but for haemangiomas on neck and face it was used as 0.5 mg/kg/dose.The Length, Width, Height and volume of haemangioma was measured in centimeters using a vernier calliper. The decrease in size was graded from 1-5 where 1=<50% decrease, 2=50-75%, 3=75-90%, 4=>90% but <100% and 5= 100% resolution. The data collection sheet included patent's age, sex, length, width, height, volume, site of haemangioma, dose of bleomycin, dexamethasone, clinical response being efficacious or non-efficacious as per operational definition and time taken to resolve for each patient.
干预措施: Comparison of intralesional injection of bleomycin alone and combined with injection dexamethasone (Drug)
结局指标
主要结局
Decrease in size of lesion
时间窗: 1 year
The Length, Width, Height and volume of haemangioma was measured in centimeters using a vernier calliper. The decrease in size was graded from 1-5 where 1=\<50% decrease, 2=50-75%, 3=75-90%, 4=\>90% but \<100% and 5= 100% resolution.
次要结局
未报告次要终点
研究者
Muhammad Sharif
PROFESSOR
King Edward Medical University