Albavera-Hernández Cidronio, Rodríguez Jorge M, Idrovo Alvaro J
National Institute of Public Health, Mexican Social Security Institute.
Clin Rehabil. 2009 May;23(5):394-407. doi: 10.1177/0269215508099860. Epub 2009 Apr 23.
To assess the safety of botulinum toxin type A for children with cerebral palsy using data from randomized clinical trials.
A search was conducted of MEDLINE database for the period January 1990 to February 2008. A complementary search was carried out of references from previous reviews. From 122 articles, 20 randomized clinical trials were selected for the review.
Two authors independently assessed eligibility of the studies and methodological quality of those according to CONSORT guidelines. For each adverse effect, relative risk was calculated, and when more than one study reported adverse effects, a meta-analysis was carried out. Sensitivity analyses with different continuity corrections factors were performed when zero cases were reported in a study arm.
There were 882 participants in the 20 studies included in the meta-analysis. Six studies reported zero adverse effects. Thirty-five different adverse events were reported. Botulinum toxin type A use was related to respiratory tract infection, bronchitis, pharyngytis, asthma, muscle weakness, urinary incontinence, falls, seizures, fever and unspecified pain. Two deaths were reported in the study with higher person-time follow-up (relative risk (RR) 4.69, 95% confidence interval (CI) 0.23-95).
Botulinum toxin type A has a good safety profile during the first months of use. However the occurrence of adverse events is more frequent among children with cerebral palsy than individuals with other conditions. Severe adverse events are potentially related with the use of botulinum toxin type A, but data are sparse and additional study is required to clarify the causal relation.
利用随机临床试验数据评估A型肉毒杆菌毒素用于脑瘫患儿的安全性。
检索了MEDLINE数据库1990年1月至2008年2月期间的文献。对以往综述中的参考文献进行了补充检索。从122篇文章中，筛选出20项随机临床试验进行综述。
两位作者根据CONSORT指南独立评估研究的纳入资格和方法学质量。对于每种不良反应，计算相对风险，当有多项研究报告不良反应时，进行荟萃分析。当某一研究组报告的病例数为零时，使用不同连续性校正因子进行敏感性分析。
荟萃分析纳入的20项研究中有882名参与者。6项研究报告无不良反应。共报告了35种不同的不良事件。A型肉毒杆菌毒素的使用与呼吸道感染、支气管炎、咽炎、哮喘、肌肉无力、尿失禁、跌倒、癫痫发作、发热和不明原因疼痛有关。在随访人时较长的研究中报告了2例死亡（相对风险（RR）4.69，95%置信区间（CI）0.23 - 95）。
A型肉毒杆菌毒素在使用的最初几个月具有良好的安全性。然而，脑瘫患儿中不良事件的发生比其他疾病患者更频繁。严重不良事件可能与A型肉毒杆菌毒素的使用有关，但数据稀少，需要进一步研究以阐明因果关系。
