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The Differences and Connections Among Expert Evidence, Expert Opinion and Expert Consensus in the Development of Guidelines
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摘要:
专家证据、专家意见及专家共识在指南制订过程中常被提及并使用，但由于缺乏明确的定义和规范，导致三者在实际应用中存在混淆和误用现象。本文对专家证据、专家意见及专家共识在指南制订中的定义、现况，以及区别与联系进行梳理，以期为我国指南制订者提供参考。
Abstract:Expert evidence, expert opinion, and expert consensus are frequently mentioned and used in the process of guideline development. However, due to the lack of clear definitions and standards, there is confusion and misuse among the three in practice. This paper clarifies the meanings, current status, differences, and connections of expert evidence, expert opinion, and expert consensus in the development of guidelines, aiming to provide a reference for guideline developers in China.
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Keywords:
- clinical practice guideline /
- expert evidence /
- expert opinion /
- expert consensus
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刷牙是口腔主动健康的重要组成部分，是维护口腔健康最重要的方法之一。不良刷牙习惯会造成牙菌斑和牙结石堆积，从而引发牙周疾病，严重时可能引起牙齿松动和脱落[1]。此外，上述口腔健康问题也会增加心血管疾病和低度炎症的发生风险[2]，从而影响全身健康。血液指标能够反映全身健康状况，如红细胞沉降率(erythrocyte sedimentation rate，ESR)与青少年的认知能力相关[3]。因此，本研究分析青少年刷牙频率与血液指标的相关性，以期为进一步探究口腔健康是否对青少年全身健康产生影响提供依据。
1. 对象与方法
1.1 研究对象
本研究为横断面观察性研究，采用便利抽样法，以2023年6月5日于济宁市第七中学招募的2021级学生和2023年6月6日于济宁市体育训练中心招募的体育训练学生为研究对象，记录年龄、身高等信息。纳入标准：(1)年龄8~16岁；(2)愿意参加本研究。排除标准：(1)心、脑、肺、肾及运动系统等严重器质性病变者；(2)使用生长激素等直接影响生长发育药物者；(3)有精神病史者；(4)无法完成随访或顺应性差者。
本研究已获得北京协和医院伦理审查委员会批准(审批号：K3298)。研究对象及监护人均签署知情同意书。
1.2 研究方法
由纳入研究的青少年填写健康调查问卷，内容包括个人信息(姓名、年龄、身高、体质量)、生活习惯(吸烟、饮酒及每日刷牙频率)、生长发育情况(2022年身高及体质量)；由研究对象的母亲填写问卷中的出生及生长情况。由济宁医学院附属医院检验科对纳入研究的青少年进行血液指标检测，包括嗜酸性粒细胞百分比(eosinophil percentage，EOS%)、嗜酸性粒细胞计数(eosinophil count，EOS#)、嗜碱性粒细胞百分比(basophil percentage，BAS%)、嗜碱性粒细胞计数(basophil count，BAS#)、过氧化物歧化酶(superoxide dismutase，SOD)、胰岛素样生长因子1 (insulin-like growth factor 1，IGF-1)、尿酸(uric acid，UA)、红细胞(red blood cell，RBC)、血红蛋白(hemoglobin，HGB)、血小板(platelet，PLT)、白细胞(white blood cell，WBC)、淋巴细胞百分比(lymphocyte percentage，LYM%)、淋巴细胞计数(lymphocyte count，LYM#)、胰岛素(insulin, INS)、白蛋白(albumin，ALB)和总蛋白(total protein，TP)。根据每日刷牙频率将纳入研究的青少年分为3组，分别为≤1次组、2次组和≥3次组。
1.3 统计学处理
采用SPSS 27.0软件进行数据统计分析。符合正态分布的计量资料以均数±标准差表示，组间比较采用方差分析；非正态分布的计量资料以中位数(四分位数)表示，组间比较使用Kruskal-Wallis秩和检验。计数资料以频数(百分数)表示，组间比较采用卡方检验。将≤1次组、2次组和≥3次组进行哑变量处理，以≤1次组为参照进行回归分析。采用单因素线性回归分析刷牙频率与血液指标的相关性，自变量为刷牙频率，因变量为血液指标。以单因素回归分析中P＜0.05的血液指标为因变量，刷牙频率与相关协变量[体质量指数(body mass index，BMI)、年龄、性别、吸烟、WBC、LYM%、LYM#、INS、ALB、TP]为自变量，进行多因素线性回归分析并对性别进行亚组分析，鉴于≥3次组研究对象偏少，将2次组和≥3次组合并后进行敏感性分析。以P＜0.05为差异具有统计学意义。
2. 结果
2.1 一般资料
共361名青少年参与本研究，剔除无效问卷以及未进行血液指标检测的56名青少年，最终共305名青少年(济宁市第七中学167名、济宁市体育训练中心138名)纳入分析，有效率为84.49%。其中男性192名(62.95%)，女性113名(37.05%)。每日刷牙≤1次者123名(40.33%)，每日刷牙2次者164名(53.77%)，每日刷牙≥3次者18名(5.90%)。组间比较显示，三组在性别、IGF-1和UA方面差异具有统计学意义(P均＜0.05)，详见表 1。
表 1 305名青少年一般资料Table 1. General information of 305 adolescents项目 ≤1次组(n=123) 2次组(n=164) ≥3次组(n=18) P值 年龄[M(P25, P75), 岁] 13.50(12.92, 14.25) 13.33(12.92, 13.83) 13.42(12.92, 14.77) 0.555 女性[n(%)] 32(26.02) 72(43.90) 9(50.00) 0.004 身高(x±s, cm) 169.91±11.34 167.89±10.93 169.80±10.79 0.329 体质量(x±s, kg) 66.05±18.99 62.44±16.27 61.89±19.02 0.203 收缩压(x±s, mm Hg) 120.15±13.03 118.25±13.69 114.17±12.90 0.175 舒张压(x±s, mm Hg) 72.28±9.72 71.69±9.86 70.17±10.03 0.667 心率(x±s, 次/min) 85.98±16.97 88.48±13.91 88.00±16.61 0.391 吸烟[n(%)] 15(12.20) 16(9.76) 5(27.77) 0.056 饮酒[n(%)] 22(17.89) 31(18.90) 5(27.77) 0.561 BMI[M(P25, P75), kg/m2] 21.35(19.20, 24.37) 20.90(18.13, 23.75) 20.41(17.83, 24.26) 0.291 EOS%(x±s, %) 2.12±1.57 1.73±1.26 1.95±1.07 0.065 EOS#(x±s, ×109/L) 0.15±0.10 0.12±0.10 0.14±0.08 0.138 BAS%(x±s, %) 0.51±0.23 0.45±0.21 0.46±0.17 0.071 BAS#(x±s, ×109/L) 0.04±0.02 0.03±0.02 0.03±0.01 0.129 SOD(x±s, U/mL) 224.49±14.13 228.21±13.84 225.94±16.82 0.087 IGF-1 (x±s, μg/L) 279.44±64.99 300.33±62.19 270.39±72.71 0.010 UA(x±s, μmol/L) 360.41±75.73 349.46±82.98 307.11±70.59 0.028 LYM%(x±s, %) 36.04±8.64 36.19±7.86 36.28±7.91 0.985 LYM#(x±s, ×109/L) 2.50±0.61 2.51±0.66 2.55±0.56 0.946 RBC (x±s, ×1012/L) 5.13±0.43 5.11±0.40 4.98±0.29 0.369 HGB(x±s, g/L) 145.29±10.78 145.42±11.16 140.33±14.77 0.184 PLT(x±s, ×109/L) 312.58±70.04 300.04±64.26 289.28±50.61 0.171 WBC(x±s, ×109/L) 7.18±1.90 7.10±1.81 7.14±1.38 0.928 BMI(body mass index)：体质量指数；EOS%(eosinophil percentage)：嗜酸性粒细胞百分比；EOS#(eosinophil count)：嗜酸性粒细胞计数；BAS%(basophil percentage)：嗜碱性粒细胞百分比；BAS#(basophil count)：嗜碱性粒细胞计数；SOD(superoxide dismutase)：过氧化物歧化酶；IGF-1(insulin-like growth factor 1)：胰岛素样生长因子1；UA(uric acid)：尿酸；LYM%(lymphocyte percentage)：淋巴细胞百分比；LYM#(lymphocyte count)：淋巴细胞计数；RBC(red blood cell count)：红细胞；HGB(hemoglobin)：血红蛋白；PLT(platelet)：血小板；WBC(white blood cell)：白细胞 2.2 刷牙频率与血液指标的单因素线性回归分析
结果表明，每日刷牙2次与EOS%、EOS#、BAS%和BAS#均呈显著负相关(β均＜0, P均＜0.05)，与SOD、IGF-1均呈显著正相关(β均＞0, P=0.028, P=0.007)；每日刷牙≥3次与UA呈显著负相关[β(95% CI)：-0.16(-0.27~-0.04), P=0.008]，见表 2。
表 2 青少年刷牙频率与血液指标的单因素线性回归分析Table 2. Univariate linear regression analysis of brushing frequency and blood indicators in adolescents血液指标 ≤1次组 2次组 ≥3次组 β(95% CI) β(95% CI) P值 β(95% CI) P值 EOS% Ref. -0.14(-0.26~-0.02) 0.020 -0.03(-0.15~0.09) 0.624 EOS# Ref. -0.12(-0.23~0.00) 0.050 -0.01(-0.13~0.10) 0.834 BAS% Ref. -0.14(-0.25~-0.02) 0.023 -0.06(-0.17~0.06) 0.336 BAS# Ref. -0.12(-0.24~0.00) 0.043 -0.03(-0.15~0.09) 0.605 SOD Ref. 0.13(0.01~0.25) 0.028 0.02(-0.09~0.14) 0.683 IGF-1 Ref. 0.16(0.05~0.28) 0.007 -0.03(-0.15~0.08) 0.576 UA Ref. -0.07(-0.18~0.05) 0.249 -0.16(-0.27~-0.04) 0.008 LYM% Ref. 0.01(-0.11~0.13) 0.878 0.01(-0.11~0.13) 0.906 LYM# Ref. 0.01(-0.11~0.13) 0.845 0.02(-0.10~0.14) 0.754 RBC Ref. -0.05(-0.28, 0.19) 0.703 -0.36(-0.85~0.14) 0.159 HGB Ref. 0.01(-0.22~0.25) 0.924 -0.44(-0.94~0.06) 0.082 PLT Ref. -0.19(-0.42~0.05) 0.112 -0.35(-0.85~0.14) 0.163 WBC Ref. -0.50(-0.28~0.19) 0.699 -0.02(-0.52~0.48) 0.929 EOS%、EOS#、BAS%、BAS#、SOD、IGF-1、UA、LYM%、LYM#、RBC、HGB、PLT、WBC：同表 1 2.3 刷牙频率与血液指标的多因素线性回归分析
多因素线性回归分析显示，每日刷牙2次与BAS%呈显著负相关(β＜0, P=0.042)，与SOD、IGF-1均呈显著正相关(β均＞0, P=0.036, P=0.012)；每日刷牙≥3次与UA呈显著负相关(β＜0, P=0.026)，见图 1。亚组分析显示，男性每日刷牙2次与IGF-1呈显著正相关(β＞0, P=0.044)，女性每日刷牙≥3次与UA呈显著负相关(β＜0, P=0.014)，见图 2。敏感性分析显示，回归系数的方向无显著改变，但由于组间样本量变化，BAS%和UA的显著性结果有所改变，见图 3。
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图 1 青少年刷牙频率与血液指标的多因素线性回归分析EOS%、EOS#、BAS%、BAS#、SOD、IGF-1、BMI、WBC、UA、LYM%、LYM#：同表 1；INS(insulin)：胰岛素；ALB(albumin)：白蛋白；TP(total protein)：总蛋白Figure 1. Multivariate linear regression analysis of brushing frequency and blood indicators in adolescents![]()
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3. 讨论
研究表明，刷牙频率、刷牙持续时间不仅与口腔健康问题具有相关性且同样影响全身健康[4]。针对4537名年龄为35~64岁人群开展的5年纵向研究表明，每日刷牙≤1次与肥胖相关，且夜间不刷牙与高血糖之间存在显著关联[5]。另一项评估刷牙方法与心血管功能相关性的研究表明，低刷牙频率和短时间刷牙会导致心血管功能显著降低[6]。刷牙对中年人代谢综合征(metabolic syndrome，MetS)影响的研究表明，每日刷牙频率较多的中年人群MetS患病率显著降低[7]。
中国居民口腔健康指南推荐，每天至少刷牙2次，但目前尚缺乏每日刷牙频率≥3次的相关研究，而此频率对于实施群体口腔卫生教育和干预较为重要，因此本研究根据每日刷牙频率分为3组(≤1次组、2次组、≥3次组)，并对纳入研究的青少年刷牙频率对血液指标的影响进行单因素线性回归分析。结果表明，青少年刷牙频率与EOS%、EOS#、BAS%和BAS#呈显著负相关。嗜酸性粒细胞失调会造成多种全身性疾病，包括嗜酸性肉芽肿性多血管炎和高嗜酸性粒细胞综合征(hypereosino-philic syndrome，HES)[8]，此外，嗜酸性粒细胞水平也与头颈部鳞状细胞癌患者的预后相关[9]。有研究表明，接受口腔鳞状细胞癌手术治疗患者的外周血嗜酸性粒细胞在术后早期减少与疾病复发几率增加有关[10]。嗜碱性粒细胞是丰度最低的白细胞亚群[11]，其不仅参与过敏反应，还与狼疮性肾炎和类风湿关节炎等自身免疫性疾病的病理生理学反应相关[12]。
本研究多因素线性回归分析结果表明，青少年刷牙频率与BAS%呈显著负相关，与SOD呈显著正相关。SOD能够维持体内生物氧化剂产生和清除之间的动态平衡，在抗肿瘤、抗辐射和抗衰老过程中发挥一定作用[13]。SOD还可通过降低活性氧(reactive oxygen species，ROS)水平，同时调节细胞信号转导抑制炎症反应，从而在肺部疾病、皮肤炎症性疾病、哮喘、糖尿病相关疾病和关节炎等的治疗中发挥重要作用[14-15]。因此，刷牙频率可能通过影响上述血液指标进而与全身健康产生关联。本研究根据既往文献及临床经验确定需排除的混杂因素，如口腔急性炎症病变期间，血液中炎症指标升高，同时研究对象可能更注重口腔卫生，造成刷牙频率变化；此外口腔环境与营养物质的吸收具有一定的相关性，不同营养状况的人群刷牙频率可能不同，而ALB等血液指标可直接反映受试者近期营养状况[11, 13, 16-20]。
青少年时期不同性别之间的性激素分泌水平具有差异，目前已有研究表明性激素水平会对血液指标产生一定影响[21-24]。因此，本研究选择性别进行亚组分析，结果表明男性青少年刷牙频率与IGF-1呈正相关。青春期人体内IGF-1水平的增加能够显著促进生长发育[19, 25]，IGF-1可作用于神经系统，在中枢神经系统的发育和成熟中发挥至关重要的作用[26]。本研究证实，刷牙频率影响血液中IGF-1水平，提示刷牙频率可能与青少年生长发育具有一定相关性。此外，IGF-1水平可能具有性别差异，有研究表明，男性和女性青少年血清IGF-1峰值分别为13岁和11岁，同年龄段男性血清IGF-1水平高于女性，发育情况与血清IGF-1水平呈正相关[27]。另有研究表明，年龄≤50岁成年女性血清IGF-1水平高于成年男性，年龄＞50岁的男女血清IGF-1水平差异无统计学意义[28]，这种性别差异可能与本研究中男性青少年刷牙频率与IGF-1具有相关性有关。此外，本研究显示，女性青少年刷牙频率与UA水平呈负相关。UA同样是影响全身健康的重要因素，其具有促炎、促氧化作用，可能导致心脏代谢疾病，UA升高与高血压之间的相关性在儿童和青少年人群中表现明显。高尿酸血症是高血压、代谢综合征、2型糖尿病、冠状动脉疾病、心肌梗死、卒中、心力衰竭和慢性肾脏病发展的预测因素[29]，高尿酸血症患者血压升高的机制涉及氧化应激等方面[30]。研究显示，UA水平具有性别差异，绝经前女性明显低于男性[31]。此外，在女性人群中，牙周炎患者较非牙周炎人群的UA水平和高尿酸血症患病率更高，而在男性人群中无此差异[32]，这与本研究结论一致。
本研究局限性：(1)为横断面研究，不能很好地阐明刷牙频率和血液指标的因果关系。(2) 缺乏全面的口腔健康相关信息，无法充分考虑某些口腔疾病对血液指标的影响。(3)刷牙频率与全身健康的关系仅凭借既往研究得出，本研究未采集相关数据。(4)本研究未设计严格的概率抽样方法，使用方便抽样法可能对研究数据的代表性造成一定影响。(5)研究对象的年龄分布为8~16岁，不能完全代表青少年群体。未来应扩大研究群体范围，同时对其进行长期随访，以进一步探究刷牙频率变化对血液指标以及全身健康的影响。
4. 小结
综上所述，本研究通过对青少年刷牙频率与血液指标的相关性进行分析，发现刷牙频率与血液中EOS%、EOS#、BAS%、BAS#和UA呈负相关，而与血液中SOD和IGF-1呈正相关。本研究证实刷牙频率与多项影响全身健康的血液指标具有相关性，提示口腔健康与全身健康可能存在潜在关联，为未来进一步分析口腔健康对全身健康的影响提供了新的研究方向。
作者贡献：朱迪负责论文设计、初稿撰写；罗旭飞、王子君、史乾灵、李昊东、王晔参与论文修订；陈耀龙负责研究设计指导和论文审校。利益冲突：所有作者均声明不存在利益冲突志谢：感谢香港浸会大学中国EQUATOR中心马艳芳对于本文撰写提供的帮助。 -
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图 1 临床实践指南中专家证据、专家意见及专家共识的应用与关联
Figure 1. The application and interrelation of expert evidence, expert opinion, and expert consensus in clinical practice guidelines
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图 1 临床实践指南中专家证据、专家意见及专家共识的应用与关联
Figure 1. The application and interrelation of expert evidence, expert opinion, and expert consensus in clinical practice guidelines
表 1 国内外指南制订机构/组织的指南制订手册中专家证据相关内容
Table 1 The contents related to expert evidence in guideline development manuals of domestic and international guideline development institutions/organizations
机构 年份 专家证据相关内容 WHO[19] 2014 在缺乏严格研究证据的情况下，病例报告和国家或个人经验汇编可能作为形成(有条件)推荐意见的基础，但必须明确记录方法及其局限性 GIN[20] 2014 确定搜集其他证据和未发表数据的方法(如从指南专家组成员处获取建议、咨询利益相关者) NICE[21] 2015 专家证据是通过选定的专家证人，采用与征集证据相同的方式获取的可分析数据；专家证据应采用与研究证据相同的方式进行分析和报告 中华医学会[5] 2022 当证据质量低或缺乏直接证据时，需考虑专家意见和专家证据在其中发挥的作用 WHO(World Health Organization)：世界卫生组织；GIN(Guidelines International Network)：国际指南协作网；NICE(National Institute for Health and Care Excellence)：英国国家健康与临床优化研究所 
下载: 导出CSV
表 1 国内外指南制订机构/组织的指南制订手册中专家证据相关内容
Table 1 The contents related to expert evidence in guideline development manuals of domestic and international guideline development institutions/organizations
机构 年份 专家证据相关内容 WHO[19] 2014 在缺乏严格研究证据的情况下，病例报告和国家或个人经验汇编可能作为形成(有条件)推荐意见的基础，但必须明确记录方法及其局限性 GIN[20] 2014 确定搜集其他证据和未发表数据的方法(如从指南专家组成员处获取建议、咨询利益相关者) NICE[21] 2015 专家证据是通过选定的专家证人，采用与征集证据相同的方式获取的可分析数据；专家证据应采用与研究证据相同的方式进行分析和报告 中华医学会[5] 2022 当证据质量低或缺乏直接证据时，需考虑专家意见和专家证据在其中发挥的作用 WHO(World Health Organization)：世界卫生组织；GIN(Guidelines International Network)：国际指南协作网；NICE(National Institute for Health and Care Excellence)：英国国家健康与临床优化研究所
下载: 导出CSV
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