木糖醇儿童局部用口服糖浆预防龋齿：一项疗效的双盲随机临床试验
Xylitol pediatric topical oral syrup to prevent dental caries: a double-blind randomized clinical trial of efficacy.
作者信息
Milgrom Peter, Ly Kiet A, Tut Ohnmar K, Mancl Lloyd, Roberts Marilyn C, Briand Kennar, Gancio Mary Jane
机构信息
Northwest Center to Reduce Oral Health Disparities, Department of Dental Public Health Sciences, School of Dentistry, University of Washington, Seattle, WA 98195-7475, USA.
出版信息
Arch Pediatr Adolesc Med. 2009 Jul;163(7):601-7. doi: 10.1001/archpediatrics.2009.77.
OBJECTIVES
To evaluate the effectiveness of a xylitol pediatric topical oral syrup to reduce the incidence of dental caries among very young children and to evaluate the effect of xylitol in reducing acute otitis media in a subsequent study.
DESIGN
Double-blind randomized controlled trial.
SETTING
Communities in the Republic of the Marshall Islands.
PARTICIPANTS
One hundred eight children aged 9 to 15 months were screened, and 100 were enrolled. Intervention Children were randomized to receive xylitol topical oral syrup (administered by their parents) twice a day (2 xylitol [4.00-g] doses and 1 sorbitol dose) (Xyl-2 x group) or thrice per day (3 xylitol [2.67-g] doses) (Xyl-3x group) vs a control syrup (1 xylitol [2.67-g] dose and 2 sorbitol doses) (control group).
MAIN OUTCOME MEASURES
The primary outcome end point of the study was the number of decayed primary teeth. A secondary outcome end point was the incidence of acute otitis media for reporting in a subsequent report.
RESULTS
Ninety-four children (mean [SD] age, 15.0 [2.7] months at randomization) with at least 1 follow-up examination were included in the intent-to-treat analysis. The mean (SD) follow-up period was 10.5 (2.2) months. Fifteen of 29 of the children in the control group (51.7%) had tooth decay compared with 13 of 32 children in the Xyl-3x group (40.6%) and eight of 33 children in the Xyl-2x group (24.2%). The mean (SD) numbers of decayed teeth were 1.9 (2.4) in the control group, 1.0 (1.4) in the Xyl-3x group, and 0.6 (1.1) in the Xyl-2x group. Compared with the control group, there were significantly fewer decayed teeth in the Xyl-2x group (relative risk, 0.30; 95% confidence interval, 0.13-0.66; P = .003) and in the Xyl-3x group (0.50; 0.26-0.96; P = .04). No statistical difference was noted between the 2 xylitol treatment groups (P = .22).
CONCLUSION
Xylitol oral syrup administered topically 2 or 3 times daily at a total daily dose of 8 g was effective in preventing early childhood caries.
目的
评估木糖醇儿童外用口服糖浆降低幼儿龋齿发病率的有效性，并在后续研究中评估木糖醇降低急性中耳炎发病率的效果。
设计
双盲随机对照试验。
地点
马绍尔群岛共和国的社区。
参与者
筛查了108名9至15个月大的儿童，100名儿童入组。干预措施：将儿童随机分为接受木糖醇外用口服糖浆（由其父母给药），每日两次（2剂木糖醇[4.00克]和1剂山梨醇）（Xyl-2x组）或每日三次（3剂木糖醇[2.67克]）（Xyl-3x组），与对照糖浆（1剂木糖醇[2.67克]和2剂山梨醇）（对照组）。
主要观察指标
研究的主要结局终点是乳牙龋坏数量。次要结局终点是后续报告中急性中耳炎的发病率。
结果
在意向性分析中纳入了94名至少进行了1次随访检查的儿童（随机分组时平均[标准差]年龄为15.0[2.7]个月）。平均（标准差）随访期为10.5（2.2）个月。对照组29名儿童中有15名（51.7%）患龋齿，而Xyl-3x组32名儿童中有13名（40.6%），Xyl-2x组33名儿童中有8名（24.2%）。对照组龋坏牙齿的平均（标准差）数量为1.9（2.4）颗，Xyl-3x组为1.0（1.4）颗，Xyl-2x组为0.6（1.1）颗。与对照组相比，Xyl-2x组的龋坏牙齿明显更少（相对风险，0.30；95%置信区间，0.13 - 0.66；P = 0.003），Xyl-3x组也更少（0.50；0.26 - 0.96；P = 0.04）。两个木糖醇治疗组之间未观察到统计学差异（P = 0.22）。
结论
每天以8克的总剂量局部使用2次或3次木糖醇口服糖浆对预防幼儿龋齿有效。
Zotero 插件