Intracystic bleomycin for cystic craniopharyngiomas in children.
Intracystic bleomycin for cystic craniopharyngiomas in children.
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DOI：
10.1002/14651858.cd008890.pub2
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发表时间：
2012
期刊：
影响因子：
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通讯作者：
Yuan Fang;Bo-wen Cai;Heng Zhang;Wen-ke Liu;Bo Wu;Jian Guo Xu;C. You
中科院分区：
文献类型：
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作者：
Yuan Fang;Bo-wen Cai;Heng Zhang;Wen-ke Liu;Bo Wu;Jian Guo Xu;C. You
颅咽管瘤是儿童时期最常见的累及下丘脑-垂体区的良性组织学肿瘤。囊性颅咽管瘤发生在90%以上的肿瘤。囊性颅咽管瘤的最佳治疗仍有争议。根治性切除术是肿瘤定位良好患者的首选治疗方法。当肿瘤定位不利时，大体全切除或部分切除后进行放射治疗是成人的主要治疗选择。然而，它有发病的风险，特别是对儿童。囊内博莱霉素已被用于延迟放疗或根治性切除术的使用，以降低发病率。明确博莱霉素囊内注射与其他治疗儿童囊性颅咽管瘤的利弊。方法我们检索了CENTRAL（科克伦图书馆2010年第4期）、MEDLINE/PubMed（1966年至2010年10月）和EMBASE/奥维德（1980年至2010年10月）的电子数据库，并使用预先指定的术语。此外，我们检索了相关文章和综述的参考文献列表、会议记录和正在进行的试验数据库。选择标准随机对照试验（RCT）、半随机试验或对照临床试验（CCT），比较囊内博莱霉素和其他治疗儿童（从出生到18岁）囊性颅咽管瘤的方法。数据收集和分析两位综述作者独立进行数据提取和“偏倚风险”评估。我们对二进制数据使用风险比（RR），对连续数据使用平均差（MD）。我们计划，如果其中一个治疗组没有发生任何事件，并且只有一项研究可用于结果，我们将使用Fischer精确检验。主要结果：我们无法确定任何研究中，治疗组之间的唯一差异是使用囊内博莱霉素。我们确定了一项比较囊内博莱霉素与囊内（32）P的RCT（n = 7例儿童）。该试验有很高的偏倚风险。无法评价生存率。没有证据表明囊肿缩小有显著差异（MD =-0.15，95%置信区间（CI）-0.69至0.39，P= 0.59），神经系统状态（Fisher精确P = 0.429），第三神经麻痹（Fischer精确P = 1.00），发热治疗组之间的不良反应（RR = 2.92，95% CI 0.73至11.70，P = 0.13）和总不良反应（RR = 1.75，95% CI 0.68至4.53，P = 0.25）。头痛和呕吐的发生率存在显着差异，有利于（32）P组（两种结果的Fischer精确P = 0.029）。专家结论：由于没有RCT、半随机试验或CCT在治疗儿童囊性颅咽管瘤时仅囊内博莱霉素的使用在治疗组之间存在差异，因此无法得出关于囊内博莱霉素在这些患者中的作用的明确结论。只有一个低功率RCT比较囊内博莱霉素与囊内（32）P治疗，但没有明确的结论，这些药物在儿童囊性颅咽管瘤的有效性。根据目前的证据，我们不能推荐囊内博莱霉素治疗儿童囊性颅咽管瘤。需要高质量的RCT。
BACKGROUND Craniopharyngiomas are the commonest benign histological tumours to involve the hypothalamo-pituitary region in childhood. Cystic craniopharyngiomas occur in more than 90% of tumours. The optimal treatment of cystic craniopharyngioma remains controversial. Radical resection is the treatment of choice in patients with favourable tumour localization. When the tumour localization is unfavourable, a gross-total or partial resection followed by radiotherapy is the main treatment option in adults. However, it presents risk of morbidity especially for children. Intracystic bleomycin has been utilized to potentially delay the use of radiotherapy or radical resection to decrease morbidity. OBJECTIVES To determine the benefits and harms of intracystic bleomycin versus other treatments for cystic craniopharyngiomas in children. SEARCH METHODS We searched the electronic databases of CENTRAL (The Cochrane Library 2010, Issue 4), MEDLINE/PubMed (from 1966 to Oct 2010), and EMBASE/Ovid (from 1980 to Oct 2010) with pre-specified terms. In addition, we searched reference lists of relevant articles and reviews, conference proceedings and ongoing trial databases. SELECTION CRITERIA Randomised controlled trials (RCTs) quasi-randomised trials or controlled clinical trials (CCTs) comparing intracystic bleomycin and other treatments for cystic craniopharyngiomas in children (from birth to 18 years). DATA COLLECTION AND ANALYSIS Two review authors independently performed the data extraction and the 'Risk of bias' assessment. We used risk ratio (RR) for binary data and mean difference (MD) for continuous data. We planned that if one of the treatment groups experienced no events and there was only one study available for the outcome, we would use the Fischer's exact test. MAIN RESULTS We could not identify any studies in which the only difference between the treatment groups was the use of intracystic bleomycin. We did identify a RCT comparing intracystic bleomycin with intracystic (32)P (n = 7 children). The trial had a high risk of bias. Survival could not be evaluated. There was no evidence of a significant difference in cyst reduction (MD = -0.15, 95% confidence interval (CI) -0.69 to 0.39, P= 0.59), neurological status (Fisher's exact P = 0.429), 3rd nerve paralysis (Fischer's exact P = 1.00), fever (RR = 2.92, 95% CI 0.73 to 11.70, P = 0.13) and total adverse effects (RR = 1.75, 95% CI 0.68 to 4.53, P = 0.25 ) between the treatment groups. There was a significant difference in favour of the (32)P group for the occurrence of headache and vomiting (Fischer's exact P = 0.029 for both outcomes). AUTHORS' CONCLUSIONS Since no RCTs, quasi-randomised trials or CCTs in which only the use of intracystic bleomycin differed between the treatment groups in the treatment of cystic craniopharyngiomas in children, no definitive conclusions could be made about the effects of intracystic bleomycin in these patients. Only one low-power RCT comparing intracystic bleomycin with intracystic (32)P treatment was available, but no definitive conclusions can be made about the effectiveness of these agents in children with cystic craniopharyngiomas. Based on the currently available evidence, we are not able to give recommendations for the use of intracystic bleomycin in the treatment of cystic craniopharyngiomas in children. High quality RCTs are needed.