摘要
目的系统评价思密达与锡类散比较治疗小儿口腔溃疡的临床效果。方法计算机检索中国生物医学文献数据库、中国期刊全文数据库、中文科技期刊全文数据库和万方数字化期刊全文数据库中关于思密达和锡类散比较治疗小儿口腔溃疡的随机对照试验(RCT),同时追索纳入研究的参考文献,检索时间均从建库至2011年6月31日。由2名评价者独立对纳入研究的质量进行严格评价和资料提取后,采用RevMan 5.1软件进行Meta分析。结果最终纳入22个RCT,共1 489例患儿。Meta分析结果显示:与锡类散相比,思密达能显著提高总有效率[RR=1.38,95%CI(1.31,1.45),P<0.000 01]及缩短平均疗程[MD=–1.54,95%CI(–1.77,–1.31),P<0.000 01],其差异均有统计学意义。仅有3个研究报告了不良反应情况,均无不良反应发生。结论现有研究显示,思密达治疗小儿口腔溃疡安全有效。但鉴于纳入研究的局限性,基于GRADE标准的结局指标为中等质量、弱推荐,对本研究结果的可靠性尚需开展更多高质量、大样本的研究予以证实。
Objective To evaluate the clinical effectiveness of Smecta versus Xilei Powder in treatment of oral ulcer in children. Methods CBM, CNKI, VIP and WanFang Data were searched for the randomized controlled trials （RCTs） of Smecta versus Xilei Powder in treatment of oral ulcer in children from the date of their establishment to June 31, 2010. The bibliographies of the included studies were searched, too. Two reviewers evaluated the quality of the included RCTs and extracted data critically and independently, and then the extracted data were analyzed by using RevMan 5.1 software. Results Twenty-two RCTs involving 1 489 patients meeting the inclusion criteria. The results of meta-analyses showed that compared with Xilei Powder, Smecta could increase the total effective rate by 1.38 times （RR=l.38, 95%CI 1.31 to 1.45, P〈0.000 01） and decrease the average course of treatment （MD= -1.54, 95%CI -1.77 to -1.31, P〈0.000 01）, with significant differences. Only 3 RCTs mentioned adverse events, but no adverse events were reported. Conclusion The current evidence shows that Smecta is effective and safe in treatment of oral ulcer in children. Due to the limitations of the included RCTs, the quality of outcomes are moderate based on GRADE, which should be recommended by clinicians as ＂Weak Recommendation＂. More large-sample and high-quality RCTs are needed to confirm the reliability of this study.
出处
《中国循证医学杂志》
CSCD
2012年第3期326-333,共8页
Chinese Journal of Evidence-based Medicine
作者简介
曾宪涛,男(1984年-),住院医师,以口腔临床医学、临床流行病学及循证医学为主要研究方向;通讯作者:冷卫东,Email:lwd35@163.com
