Role of Propranolol as Compared to Bleomycin in Management of Hemangioma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Size Regression Efficacy Complications:
研究概览
简要总结
Infantile hemangiomas are widespread vascular tumours having incidence of 10% and most of them involute spontaneously. However, they are known to be located in proximity of vital organs and can have poor cosmetic and functional sequel if left untreated. A wide range of treatment options are available from expectant therapy to radical surgical excision. Propanolol has also been shown to be effective in treating infantile cutaneous hemangiomas. Similarly, anti-metabolite drugs as bleomycin has also shown promising results. Efficacy in terms of reduction in size of both treatments has been scarcely studied especially in Pakistan.
OBJECTIVE: To assess the efficacy of oral propranolol and intraleisonal bleomycin in the treatment of infantile cutaneous hemangioma in terms of size regression
详细描述
Material & Methods Study design: Randomised controlled trial Place of study: This is study was conducted in the department of paediatric surgery, children hospital, Pakistan institute of medical sciences, Islamabad Duration of study: 24 months
Number of patients:
Using the WHO sample size calculator with following statistical assumptions Confidence interval = 90% Alpha errors = 5% Anticipated population proportion in Group A = 85%9 Anticipated population proportion in Group B = 62.5%9 Sample size will be 45 cases in each study group. Total number of 90 cases will be required in this study Sampling technique: Probability sampling technique Sélection criteria Inclusion criteria
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6 month to 12 yr. of age presenting with infantile hemangioma anywhere on body 2. Both sex included 3. Previously not treated Exclusion criteria On the basis of history and clinical assessment;
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Patients with previous treatment of hemangioma.
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Patients who will be lost to follow up
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Patients who refused to be enrolled in this study
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Patients who experienced hypersensitivity to propranolol/Bleomycin during treatment or had previous known allergy to the drugs.
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Patients who had diagnosed Cardiac disease such as heart failure or AV block.
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Patients with diagnosed Pulmonary disease such as asthma or bronchiolitis.
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History of impaired renal or liver functions.
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Diabetes mellitus Collection procedure After approval of synopsis, researcher collected data after taking permission from hospital Ethical Committee. Patients were entertained through outdoor department. Patient was explained about the whole procedure. Brief history and clinical examination and investigations were recorded on a Performa. The patients who were diagnosed cases of any cardiac, pulmonary, renal or hepatic diseases were excluded from study based on history. Diagnosis was established on clinical grounds and Doppler ultrasonography of the hemangioma were done to confirm the diagnosis if needed. Size of hemangioma taken and any skin changes were noted.
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, Care Provider)
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6 month to 12 yr. of age presenting with infantile hemangioma anywhere on body
- •Both sex included
- •Previously not treated
排除标准
- •On the basis of history and clinical assessment;
- •Patients with previous treatment of hemangioma.
- •Patients who will be lost to follow up
- •Patients who refused to be enrolled in this study
- •Patients who experienced hypersensitivity to propranolol/Bleomycin during treatment or had previous known allergy to the drugs.
- •Patients who had diagnosed Cardiac disease such as heart failure or AV block.
- •Patients with diagnosed Pulmonary disease such as asthma or bronchiolitis.
- •History of impaired renal or liver functions.
- •Diabetes mellitus
研究组 & 干预措施
Propranolol
propranolol with a mean dose of 2mg/kg/day in 2 divided doses for a period of 6 months
干预措施: Bleomycin (Drug)
Bleomycin
Bleomycin 15mg diluted in 15 ml of Normal Saline along with a dosage of 0.5 mg/kg for a period of 6 months.
干预措施: Bleomycin (Drug)
结局指标
主要结局
Size Regression Efficacy Complications:
时间窗: 2 years
Objective To evaluate the efficacy of oral propranolol as compared to intralesional Bleomycin in management of cutaneous infantile hemangioma in terms of size change. Operational Definition Infantile Hemangiomas: These are vascular neoplasms which are lesions characterized by abnormal proliferation of endothelial cells and aberrant blood vessel architecture which proliferate after birth and are diagnosed clinically as cherry red vascular lesions. Complications: Propranolol: The known complications which could be present in group taking propranolol were hypotension, pulmonary symptoms as wheeze and precipitation of asthma and hypoglycemia. These findings were carefully looked for in the group taking propranolol. Bleomycin: The known complications which could be present in group taking bleomycin were Pulmonary symptoms as shortness of breath, bleeding and ulceration of lesions. These symptoms and signs were monitored in patients who were give intra-lesional bleomycin.
Size change
时间窗: 02 years
Size change: It is defined as change in size at three or six months compared to baseline size of hemangioma and represented in terms of percentage. Percentage size change = Size of hemangioma at 3 or 6 months x 100 Initial Size Left over Signs after treatment: defined as development of scar, hyperpigmentation or change in texture of skin at the location where hemangioma was previously present. Efficacy: The efficacy of propranolol and bleomycin will be evaluated for change in the size of the lesion, change in the colour of the lesion, epithelialisation in case of ulceration, complications following therapy, and signs of relapse after therapy. The outcome based on change in size will be graded as follows: I Complete involution, implying greater than 90percent response. II Response of change in size of 75 to 90percent III Response of change in size of 50 to 75percent. IV Response of change in size of 25 to 50 percent
次要结局
未报告次要终点
研究者
Ali Raza Chaudhry
Senior Registrar as principal investigator
Shaheed Zulfiqar Ali Bhutto Medical University