酪蛋白磷酸肽-无定型磷酸钙凝胶治疗釉质脱矿效果的系统评价

doi:10.7518/hxkq.2017.06.013

摘要/Abstract

摘要：

目的对有关酪蛋白磷酸肽（CPP）-无定形磷酸钙（ACP）凝胶对于釉质脱矿治疗的随机对照试验（RCT）进行系统评价，评价其治疗的效果。方法依照Cochrane系统评价员手册（5.1.0版本）指导进行分析，包含检索策略、纳入排除标准、数据提取及质量评价。通过计算机检索PubMed、Embase、Cochrane Library、中国知网（CNKI）、万方、维普（VIP）数据库，查找有关CPP-ACP的RCT，检索时间截至2016年9月。由2位研究者独立根据纳入与排除标准进行文献筛选、资料提取和质量评价后，对纳入研究进行系统评价。结果共纳入12个RCT，各文献中的实验设计、评价标准差异较大无法进行定量分析。结论尚无有力证据表明，CPP-ACP比常规含氟制剂存在优越性；但纳入研究数量、随访时间、设计存在局限性，且样本量较小，仍需更多高质量、长时间随访、大样本的RCT以进一步验证。

关键词: 酪蛋白磷酸肽-无定形磷酸钙, 随机对照试验, 系统评价, 白垩斑

Abstract:

Objective This study aims to assess the remineralization effect of casein phosphopeptide (CPP)-amorphous calcium phosphate (ACP) on enamel demineralization by performing system review of randomized controlled trials (RCT) involving the treatment of enamel demineralization with CPP-ACP. Methods The study was developed based on the Cochrane handbook for systematic reviews of interventions (Version 5.1.0) and included the following: search strategy, selection criteria, data extraction, and risk of bias assessment. We searched electronic databases such as PubMed, Embase, Cochrane Library, CNKI, Wanfang and VIP up to September 2016. RCT of treating enamel demineralization with CPP-ACP were included. Data extraction and domain-based risk of bias assessment were independently performed by two reviewers. Results Twelve RCTs were included. Because of the difference of experimental design and evaluation standards, the quantitative analysis can not be carried out. Conclusion There is no strong evidence that CPP-ACP is superior to con-ventional fluoride formulations in enamel remineralization. However, due to the limitations of sample size, follow-up time and study design, more high quality and large-sample RCT are needed to further verify the evidence.

Key words: casein phosphopeptide-amorphous calcium phosphate, randomized controlled trial, system review, white spot lesion

中图分类号:

R781.1

汪晓彤, 饶南荃, 谢静, 赵玉鸣, 葛立宏. 酪蛋白磷酸肽-无定型磷酸钙凝胶治疗釉质脱矿效果的系统评价[J]. 华西口腔医学杂志, 2017, 35(6): 629-635.

Xiaotong Wang, Nanquan Rao, Jing Xie, Yuming Zhao, Lihong Ge. Remineralization effect of casein phosphopeptide-amorphous calcium phosphate for enamel demineralization: a system review[J]. West China Journal of Stomatology, 2017, 35(6): 629-635.

图/表 3

表 1

纳入研究的基本特征

文献		氟暴露	研究设计	研究人群		评价方法	结果	不良反应及安全性
文献		氟暴露	研究设计	样本量	年龄/岁	评价方法	结果	不良反应及安全性
正畸后WSL	Bailey等^[4]	理想的水氟浓度,	随机双盲	45	12~19	ICDAS Ⅱ	Tooth Mousse^®组有更	与治疗相关或无关的
		每次就诊时用含氟	临床试验			临床计分	明显的病损减少趋势	非严重不良事件（39
		牙膏（1 000 mg·L^-1）					（无统计学差异）。	例）;可能与实验糊
		和含氟漱口水					12周时,基线2或3分	剂相关的轻微消化道
		（900 mg·L^-1）					的病损,Tooth Mousse^®	不适症状（1例）;
							组改善显著高于对照	相关联的或者严重不
							组	良反应（0）
	Beerens等^[10]	非氟化水;含氟	随机双盲	65	12~19	QLF图像	12周后,试验组与对	未提及
		牙膏	临床试验				照组均改善,无显著
							性差异
	Bröchner等^[5]	低水氟浓度（<	随机单盲	60	13~18	QLF测量法	4周后,QLF测量△F	无副作用或不良反应
		0.2 mg·L^-1）	临床试验				值以及病损都显著降	的报告
							低,试验组和对照组
							间无显著性差异
	Huang等^[6]	水氟浓度未	随机单盲	115	12~20	牙医、非专	8周时,试验组与对	未提及
		知,含氟牙膏	平行分组			业人士、患	照组无显著性差异
		（1 100 mg·L^-1）	试验			者根据照片
						记录进行目
						测评估
	Singh等^[7]	水氟浓度未	随机双盲	36	16~25	视诊;DIA-	6个月时,使用含氟	未提及
		知,含氟牙膏	临床试验			GNOdent	牙膏可以显著促进正
		（1 000 mg·L^-1）				scores	畸后WSL再矿化;额
							外使用 5%NaF或CPP-
							ACP没有叠加效果
	聂琳等^[8]	水氟浓度未知,含	随机临床	63	12~18	EDI	正畸治疗前和正畸结	未提及
		氟牙膏（0.14%）	对照试验				束后1个月两组EDI的
							差异无统计学意义,
							结束后3个月有试验
							组EDI显著低于对照
							组
	唐璐等^[9]	未知	随机双盲	20	10~17	根据照片进	2个月后,治疗前后	未提及
			临床试验			行EDI评价	B组EDI差值（CPP-
							ACP）大于A组
乳牙釉质脱矿	Memarpour等^[11]	水氟浓度相似	随机双盲	140	12~36	WSL尺寸;	12个月后,TM糊剂	组3、组4中没有出
		（<0.7 mg·L^-1）	平行临床			dmft指数	组WSL面积减小效果	现不良反应报告
			对照试验				最显著（63%）。但
							各组之间没有显著性
							差异
	Sitthisettapong等^[12]	水氟浓度<	随机双盲	296	2½~3½	QLF分析	1年时,两组的釉质	实验中无副作用或
		0.1 mg·L^-1,	安慰剂对				及牙本质龋坏数目、	不良反应报道
		含氟牙膏	照试验				dmfs均显著升高。组
		（1 000 mg·L^-1）					间无显著性差异
恒牙釉质脱矿	Aykut-Yetkiner等^[13]	水氟浓度未知,	随机单盲	60	13±0.68	拍照;	3个月后对照组的DI-	未提及
		含氟牙膏	临床对照			DIAGNOdent	AGNOdent读数显著
		（1 450 mg·L^-1）	试验			device	上升,实验有所降
							低,但无统计学意义
	Krithikadatta等^[14]	水氟浓度未知,膳	随机单盲	45	17~20	DIAGNOdent	30 d后, Tooth Mou-	未提及
		食和口腔卫生指导	对照试验			读数	sse^®和Tooth Mousse
							Plus^®再矿化效能相似,
							且显著优于漱口水
	Yazicioğlu等^[15]	水氟浓度未知,	随机单盲	42		视诊;影像	18个月后,CPP-ACP	未提及
		含氟牙膏	临床对照			学检查;	可以抑制釉质损伤脱
			试验			DIAGNOdent	矿,促进再矿化
						device

表 1

图 1

图 2

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