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预防性人乳头瘤病毒疫苗中国临床应用指南(2025版)
详细信息Preventive Human Papilloma Virus Vaccine Guidelines for Clinical Use in China(2025 edition)
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摘要:
预防性人乳头瘤病毒(human papilloma virus，HPV)疫苗接种是预防HPV感染的有效方法，可降低HPV感染相关疾病的发生。目前国内外临床试验及真实世界研究均表明，预防性HPV疫苗接种是安全的，具有很好的免疫原性、保护效力和保护效果。优先推荐9~26岁女性接种HPV疫苗，重点是9~14岁女孩；同时，推荐27~45岁女性和9~26岁男性接种，倡导男女共防。对于HPV感染或细胞学异常人群、HPV相关病变治疗史人群、遗传易感人群、子宫颈癌发病高风险生活方式人群，以及免疫功能低下人群均推荐预防性HPV疫苗接种。接种HPV疫苗后仍应定期进行子宫颈癌筛查。
Abstract:Prophylactic human papilloma virus (HPV) vaccination is an effective strategy to prevent HPV infection and reduce the incidence of HPV-related diseases.Current clinical trials and real-world studies globally have demonstrated that prophylactic HPV vaccines are safe, immunogenic, and exhibit robust protective efficacy and effectiveness.Priority vaccination is recommended for females aged 9-26 years, with a focus on girls aged 9-14 years.Additionally, vaccination is advised for females aged 27-45 years and males aged 9-26 years to promote gender-neutral prevention strategies.Prophylactic HPV vaccination is also recommended for high-risk and special populations, including individuals with HPV infection or cytological abnormalities, those with a history of HPV-related lesions, genetically susceptible populations, individuals with high-risk lifestyle behaviors associated with cervical cancer, and immunocompromised patients.Regular cervical cancer screening remains essential post-vaccination.
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Keywords:
- human papilloma virus /
- vaccines /
- clinical application /
- high-risk /
- special populations
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慢性认知障碍及其主要亚型阿尔茨海默病(Alzheimer's disease, AD)可造成进行性加重的记忆力、注意力、定向力、执行功能、视空间、语言等多个方面认知损害，导致患者生活能力逐渐下降。数据显示，我国65岁以上人群中认知障碍发病率为12.1/人年，AD发病率为8.2/人年，给社会和家庭造成了沉重负担[1]。早期识别、及时就诊是慢性认知障碍患者得以早期治疗和延缓病情进展的关键。
西藏自治区处于高原地区，具有独特的地理环境、文化传统和民族构成。流行病学调查显示，西藏地区的AD患病率高于平原地区[2]。为提高疾病的早诊早治率，需开展基于“知-信-行”连续过程的健康宣教。本研究旨在调查西藏自治区居民对认知障碍疾病的知晓度，了解其对于认知障碍疾病的认识水平和关注程度。在此基础上，进一步分析影响居民对该类疾病认知度的因素，以期为后续开展科普宣教及临床工作奠定基础，并为制定针对性公共卫生政策和干预措施提供依据。
1. 对象与方法
1.1 调查对象
2024年4—12月对西藏自治区常住居民开展问卷调查。纳入标准：年龄≥18岁的西藏自治区常住居民。排除标准：(1)截至调查日期，在西藏自治区居住时间不足半年(180 d)；(2)由于明显错误、前后矛盾等所致的无效问卷。本研究已通过西藏自治区人民医院伦理审查委员会批准(审号：ME-TBHP-24-KJ-022)，研究对象均知情同意。
1.2 调查内容
由于西藏自治区幅员辽阔，地广人稀，因此采用线上问卷调查为主，辅以医务人员在社区义诊时发放问卷二维码，以提高研究效率和人群覆盖面。调查问卷通过问卷星网站(www.wjx.cn)进行设计，问卷首页显著位置展示经批准的知情同意书, 调查者知情同意后方可填写问卷，并线上提交。问卷内容包括性别、年龄、文化程度、职业、居住地等人口学信息(匿名，不含个人可识别信息)，以及认知障碍疾病相关信息，如知晓度、就诊意愿、是否接触过认知障碍患者等。
1.3 质量控制
(1) 为尽量减少由于受教育程度和语言因素造成的偏倚，在问卷设计方面，力求语言简洁明了、通俗易懂，避免使用过于专业或生僻的词汇，以确保不同文化程度的被调查对象均可较好地理解问卷内容。同时，通过社区义诊等多种渠道进行问卷推广，如被调查者有需要，工作人员可协助其阅读，以尽可能地涵盖不同文化程度的研究对象。(2)问卷题目为必答题形式，填写完整后方可成功提交，以保障数据完整性。前后关联题目间在问卷设计时即设置逻辑关联，避免前后矛盾。(3)所获得的问卷数据经过查重核对，避免重复数据。
1.4 检验效能估算
采用G*Power软件进行检验效能估算，并设定以下参数：效应大小f2=0.15(中效应)，显著性水平α=0.05，样本量为313，预测变量数目为7。经计算统计效能为0.999 85，表明本研究具有99.99%的概率可正确拒绝虚无假设并发现显著效应，统计效能极高，可确保研究结果的可靠性。
1.5 统计学处理
采用SAS 9.4软件进行统计学分析。正态分布计量资料(年龄)以均数±标准差表示，组间比较采用方差分析；计数资料以频数(百分数)表示，组间比较采用卡方检验或Fisher精确概率法。采用有序Logistic回归模型分析疾病知晓度的影响因素。以P＜0.05为差异具有统计学意义。
2. 结果
2.1 一般临床资料
收集问卷327份，剔除14份(被调查者未达西藏自治区居住时间13份，自我报告曾被诊断为认知障碍1份)，最终纳入313份有效问卷。被调查者平均年龄为(42.0±11.9)岁；男性108人(34.5%)，女性205人(65.5%)；主要来自拉萨市(78.6%，246/313)，同时涵盖西藏自治区其他主要地级市，包括日喀则市(5.8%，18/313)，昌都市(5.8%，18/313)，山南市(3.8%，12/313)，那曲市(2.6%，8/313)例，林芝市(2.2%, 7/313)，阿里地区(1.3%，4/313)；藏族及其他少数民族206人(65.8%)，汉族107人(34.2%)；受教育程度为高中及以下50人(16.0%)，大学及以上263人(84.0%)；职业为医务工作者179人(57.2%)，非医务工作者134人(42.8%)；居住地为城市289人(92.3%)，农村24人(7.7%)。
2.2 不同疾病知晓度人群特征分布
313人对认知障碍疾病相关知识知晓度方面：“不知晓”“部分知晓”“知晓良好”者分别占比7.3%(23/313)、75.7%(237/313)、16.9%(53/313)。组间比较显示，3组年龄、民族、受教育程度、是否为医务工作者、是否接触过认知障碍患者差异具有统计学意义(P均＜0.05)，藏族及其他少数民族、受教育程度为高中及以下、非医务工作者、未接触过认知障碍患者的居民中，对认知障碍疾病“不知晓”的比例更高(表 1)。
表 1 不同知晓度人群分布特征Table 1. The characteristics of the participants with different levels of awareness指标 总体(N=313) 不知晓(n=23) 部分知晓(n=237) 知晓良好(n=53) F/χ2值 P值 年龄(x±s，岁) 42.0±11.9 49.8±16.0 41.2±11.4 42.1±10.8 5.68 0.004 性别[n(%)] 2.00 0.367 男 108(34.5) 11(47.8) 80(33.8) 17(32.1) 女 205(65.5) 12(52.2) 157(66.2) 36(67.9) 民族[n(%)] 12.91 ＜0.001 藏族及其他少数民族 206(65.8) 23(100) 150(63.3) 33(62.3) 汉族 107(34.2) 0(0) 87(36.7) 20(37.7) 受教育程度[n(%)] 20.45 ＜0.001 高中及以下 50(16.0) 11(47.8) 35(14.8) 4(7.6) 大学及以上 263(84.0) 12(52.2) 202(85.2) 49(92.5) 职业[n(%)] 34.54 ＜0.001 医务工作者 179(57.2) 2(8.7) 134(56.5) 43(81.1) 非医务工作者 134(42.8) 21(91.3) 103(43.5) 10(18.9) 居住地[n(%)] 1.24 0.523 城市 289(92.3) 20(87.0) 219(92.4) 50(94.3) 农村 24(7.7) 3(13.0) 18(7.6) 3(5.7) 接触过认知障碍患者[n(%)] 20.25 ＜0.001 是 112(35.8) 3(13.0) 77(32.5) 32(60.4) 否 201(64.2) 20(87.0) 160(67.5) 21(39.6) 出现相关症状时就诊态度[n(%)] 31.59 ＜0.001 无就诊意愿，认为属于自然衰老 53(16.9) 10(43.5) 37(15.6) 6(11.3) 无就诊意愿，对治疗效果缺乏预期 7(2.2) 1(4.3) 6(2.5) 0(0) 有就诊意愿，持观望等待态度 91(29.1) 1(4.3) 75(31.6) 15(28.3) 有就诊意愿，表示需早诊早治 141(45.0) 6(26.1) 104(43.9) 31(58.5) 态度不明确 21(6.7) 5(21.7) 15(6.3) 1(1.9) 在被问及若有相关症状是否会就诊时，无就诊意愿者60人(19.2%，60/313)，其中53人(16.9%，53/313)认为认知下降属于自然衰老正常现象，7人(2.2%，7/313)表示对治疗效果缺乏预期。有就诊意愿者232人(74.1%)，其中仅141人(45.0%，141/313)表示需进行早诊早治，91人(29.1%，91/313)持观望等待态度，表示等症状明显后再就诊。就诊意愿者态度不明确者21人(6.7%，21/313)。不同知晓度被调查者就诊意愿分布存在显著差异，知晓良好组早期就诊比例更高(表 1)。
在认知障碍疾病症状方面，知晓度由高至低依次为记忆力下降(94.2%，295/313)、语言能力下降(81.8%，256/313)、视空间方向分辨力下降(79.6%，249/313)、时间定向力下降(76.4%，239/313)、执行功能下降(74.4%，233/313)、精神行为异常(61.0%，191/313)，见图 1。
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图 1 313名被调查者对认知障碍疾病症状的知晓度Figure 1. Awareness of cognitive disorders disease symptoms among 313 participants考虑到医务工作者具有专业的医学知识，可能对疾病的认知度不同于一般居民，而非医务工作者对一般居民更有代表性，因此在非医务工作者中进行亚组人群特征描述(表 2)。结果显示，非医务工作者对认知障碍疾病相关知识“不知晓”“部分知晓”“知晓良好”者分别占比15.7%(21/134)、76.9%(103/134)、7.5%(10/134)。采用卡方检验对该亚组人群的疾病知晓度进行组间比较，发现民族具有统计学差异(P=0.006)，藏族及其他少数民族居民“不知晓”的比例更高。
表 2 非医务工作者中不同知晓度人群分布特征Table 2. The characteristics of the participants with different levels of awareness among non-medical workers指标 总计(N=134) 不知晓(n=21) 部分知晓(n=103) 知晓良好(n=10) F/χ2值 P值 年龄(x±s，岁) 45.0±12.4 49.3±16.2 44.0±11.6 47.3±11.2 1.83 0.164 性别[n(%)] 0.48 0.819 男 53(39.6) 9(42.9) 41(39.8) 3(30.0) 女 81(60.5) 12(57.1) 62(60.2) 7(70.0) 民族[n(%)] 8.47 0.006 藏族及其他少数民族 105(78.4) 21(100) 75(72.8) 9(90.0) 汉族 29(21.6) 0(0) 28(27.2) 1(10.0) 受教育程度[n(%)] 5.44 0.084 高中及以下 39(29.1) 10(47.6) 28(27.2) 1(10.0) 大学及以上 95(70.9) 11(52.4) 75(72.8) 9(90.0) 居住地[n(%)] 1.48 0.621 城市 119(88.8) 18(85.7) 91(88.3) 10(100) 农村 15(11.2) 3(14.3) 12(11.7) 0(0) 接触过认知障碍患者[n(%)] 4.48 0.111 是 35(26.1) 3(14.3) 27(26.2) 5(50.0) 否 99(73.9) 18(85.7) 76(73.8) 5(50.0) 出现相关症状时就诊态度[n(%)] 10.85 0.210 无就诊意愿，认为属于自然衰老 38(28.4) 8(38.1) 26(25.2) 4(40.0) 无就诊意愿，对治疗效果缺乏预期 4(3.0) 1(4.8) 3(2.9) 0(0) 有就诊意愿，持观望等待态度 31(23.1) 1(4.8) 29(28.2) 1(10.0) 有就诊意愿，表示需早诊早治 46(34.3) 6(28.6) 36(35.0) 4(40.0) 态度不明确 15(11.2) 5(23.8) 9(8.7) 1(10.0) 2.3 认知障碍疾病知晓度的影响因素
采用有序Logistic回归模型进一步探究居民对认知障碍疾病知晓度的影响因素。以认知障碍疾病知晓度按照有序分类变量作为因变量(“不知晓”=1，“部分知晓”=2，“知晓良好”=3)，分析认知障碍知晓度的影响因素。根据表 1有显著性差异的变量以及临床意义，纳入模型的自变量包括年龄、性别、民族、受教育程度、职业、居住地、是否接触过认知障碍患者。结果表明，受教育程度、职业、是否接触过认知障碍患者对认知障碍疾病知晓度有显著影响。受教育程度为高中及以下(OR=2.82, 95% CI：1.18~6.75，P=0.020)、非医务工作者(OR=4.03, 95% CI：2.00~8.14，P＜0.001)、未接触过认知障碍患者(OR=2.95, 95% CI：1.64~5.32，P＜0.001)与较低的疾病知晓度相关(表 3)。进一步按职业分层进行亚组分析，发现在非医务工作者中，受教育程度为高中及以下(OR=3.00, 95% CI：1.10~8.15，P=0.031)、未接触过认知障碍患者(OR=3.13, 95% CI：1.14~8.60，P=0.027)与较低的疾病知晓度相关；在医务工作者中，未接触过认知障碍患者(OR=3.40, 95% CI：1.61~7.20，P=0.001)与较低的疾病知晓度相关(表 4)。
表 3 认知障碍疾病知晓度影响因素的有序Logistic回归模型Table 3. Cumulative Logistic regression model for factors affecting awareness of cognitive disorders指标 β SE Wald OR值 95% CI P值 年龄(连续变量) -0.009 0.013 0.48 0.99 0.97~1.02 0.491 性别(与女性为参照) 0.165 0.145 1.29 1.39 0.79~2.46 0.257 民族(以藏族及其他少数民族为参照) -0.084 0.148 0.32 0.85 0.74~1.51 0.571 教育程度(以大学及以上为参照) 0.519 0.222 5.45 2.82 1.18~6.75 0.020 职业(以医务工作者为参照) 0.697 0.179 15.17 4.03 2.00~8.14 ＜0.001 居住地(以农村为参照) 0.042 0.270 0.02 1.09 0.38~3.14 0.878 接触过认知障碍患者(以是为参照) 0.541 0.150 13.02 2.95 1.64~5.32 ＜0.001 表 4 职业分层亚组分析认知障碍知晓度影响因素Table 4. Subgroup analysis of occupational stratification on factors affecting awareness of cognitive disorders指标 β SE Wald OR值 95% CI P值 非医务工作者 年龄(连续变量) -0.002 0.021 0.01 1.00 0.96~1.04 0.919 性别(与女性为参照) 0.270 0.218 1.54 1.71 0.73~4.02 0.215 民族(以藏族及其他少数民族为参照) -0.398 0.277 2.05 0.45 0.15~1.34 0.152 受教育程度(以大学及以上为参照) 0.549 0.255 4.64 3.00 1.10~8.15 0.031 居住地(以农村为参照) -0.325 0.354 0.84 0.52 0.13~2.09 0.358 接触过认知障碍患者(以是为参照) 0.571 0.257 4.93 3.13 1.14~8.60 0.027 医务工作者 年龄(连续变量) -0.014 0.018 0.59 0.99 0.95~1.02 0.441 性别(与女性为参照) 0.127 0.198 0.41 1.29 0.59~2.80 0.521 民族(以藏族及其他少数民族为参照) 0.042 0.184 0.05 1.09 0.53~2.24 0.819 教育程度(以大学及以上为参照) 0.053 0.407 0.02 1.11 0.23~5.48 0.897 居住地(以农村为参照) 0.433 0.378 1.31 2.38 0.54~10.48 0.252 接触过认知障碍患者(以是为参照) 0.612 0.191 10.23 3.40 1.61~7.20 0.001 3. 讨论
本研究通过问卷调查对西藏自治区常住居民对认知障碍疾病认知度进行了调查，结果显示：共收集313份有效问卷，“不知晓”“部分知晓”“知晓良好”者分别占比7.3%(23/313)、75.7%(237/313)、16.9%(53/313);有序Logistic回归模型显示，受教育程度为高中及以下(OR=2.82, 95% CI：1.18~6.75，P=0.020)、非医务工作者(OR=4.03, 95% CI：2.00~8.14，P＜0.001)、未接触过认知障碍患者(OR=2.95, 95% CI：1.64~5.32，P＜0.001)与较低的疾病知晓度相关。按职业分层进行亚组分析后发现，受教育程度为高中及以下(OR=3.13, 95% CI：1.14~8.60，P=0.027)与非医务工作者较低的疾病知晓度相关；未接触过认知障碍患者(OR=3.40, 95% CI：1.61~7.20，P=0.001) 与医务工作者较低的疾病知晓度相关。
造成慢性认知功能障碍的常见疾病包括AD、脑小血管病、帕金森综合征等。此类疾病起病隐匿，病情进展缓慢，早期症状相对较轻，随病程延长症状进行性加重，可对患者日常生活能力造成严重损害，早期识别和积极防治有助于延缓病情进展，提高患者生活质量[3-4]。目前，临床可通过生物标志物检测，如采用正电子发射断层显像或脑脊液检测β淀粉样蛋白、磷酸化Tau蛋白的方法，在症状早期甚至症状前期进行AD诊断[4]。在早期诊断的基础上，可进行针对病因的调节治疗，目前多个针对β淀粉样蛋白抗体的药物已在国内外获批[5]。因此，提高民众对疾病的知晓度，有助于使患者和家属觉察到疾病的早期表现，从而实现早诊和早治，是延缓疾病进展的关键环节[6]。既往研究缺乏针对西藏居民对认知障碍疾病认知度的相关报道。本研究调查了西藏自治区常住居民对认知障碍疾病的知晓度，结果发现“不知晓”“部分知晓”“知晓良好”者分别占比7.3%、75.7%、16.9%，该数据低于既往国内其他地区的报道(总知晓率91.5%)[7]。本研究中仅45.0%的被调查者对该病具有早期诊治意愿，其重要原因是与疾病知晓度较低有关。
西藏自治区居民对认知障碍疾病知晓度低可能由多方面原因造成。宏观层面：(1)地理与信息流通因素：西藏自治区处于我国西南边疆，交通相对不便，可能导致与外界的信息交流受限。认知障碍疾病防治理念更新和知识传播速度相对较慢，使得民众缺乏了解疾病的渠道。(2)文化与观念因素：西藏自治区居民尤其是藏族同胞有独特的文化传统和观念，可能对疾病的认知和态度有所不同，误认为认知障碍是衰老的自然现象，而不是一种需要关注和治疗的疾病。(3)医疗资源与服务可及性：西藏地区医疗资源相对不够充足，科普宣教活动能力有待提升，这可能影响民众对疾病的早期发现和诊断，进而降低对认知障碍的知晓度。
在个体层面，本研究发现实际生活经历(接触过认知障碍患者)和知识性提高(受教育程度、是否从事医务工作)是对认知障碍知晓度有显著影响的因素，这符合一般认知。有接触过认知障碍患者的实际生活经历，了解疾病症状和漫长疾病进程对患者及其照护者造成的痛苦，可使居民更直观地认识该疾病。既往研究显示，多层次的健康教育模式和综合干预是提高人群认知障碍知识水平的有效手段[8]。结合本调查结果可知，健康教育及科普宣传的侧重点应通过展示生动的临床案例，采用更直观的体现方式，使公众更加深入地了解疾病，从而提高知晓度和早期就诊率。例如，可通过影视剧、组织患者和照护者座谈会、开展社区分享活动等，展示患者的症状、治疗过程和康复情况，让更多的人了解患者的实际生活，从而提高其对疾病的关注度和认知度。
此外，本调查显示知识性提高有助于提升疾病的知晓度。在代表一般民众医学知识水平的非医务工作者中，除上述接触过认知障碍患者的实际生活经历外，提升教育水平是提高疾病知晓度的重要手段。可通过社区宣传、媒体报道、健康讲座等方式，普及认知障碍疾病的早期症状、预防方法和治疗手段。此外，虽然医务工作者的知晓度较一般居民高，但作为医学的实践者和医学知识的传播者，需在临床工作中识别或转诊认知障碍患者，仍有高达76.0%的医务工作者对认知障碍处于“不知晓或部分知晓”状态，这显著低于既往北京市对272名医护人员的调查结果(AD知识测评合格率为80.7%)[9]，因此西藏自治区的医务工作者对认知障碍疾病的知晓度仍有待提高。除加强专业培训外，还可建立激励机制，鼓励其在临床工作中积极开展健康教育，并对在该方面表现突出的医务工作者进行表彰和奖励，以提高他们的积极性和主动性。
本研究存在一定的局限性。首先，参与调查者中城市人口比例较高，以拉萨市为主，为尽量减少地域偏倚，本研究也纳入了除拉萨市之外的其他主要地级市(日喀则市、昌都市、山南市、那曲市、林芝市、阿里地区)，但限于西藏自治区地广人稀，难以联系到广大农牧区居民参加调查。鉴于本研究发现疾病知晓度与受教育程度呈显著负相关，农牧区居民较城市居民教育水平低，如农牧区居民参与调查，预计知晓度将更低。其次，本研究以线上问卷调查为主，可能对被调查者文化程度具有一定要求，从而造成一定的选择偏倚。未来可进一步扩大调查覆盖人群，包括农牧区、偏远地区和不同职业的群体，以获得更具代表性的数据。同时，可采用多种调查方法，如问卷调查结合现场访谈的定量和定性研究，以深入了解不同人群对认知障碍疾病的认知和态度。
综上，西藏自治区居民对认知障碍疾病的知晓度有待提升，受教育程度为高中及以下、非医务工作者、未接触过认知障碍患者是疾病知晓度较低的危险因素。政府应加大对认知障碍疾病防治的投入，提高医疗服务的可及性；医疗机构可加强专业培训和科研创新，提高疾病早期诊断和治疗水平；社会组织可开展志愿服务和宣传活动，提高公众对认知障碍疾病的认识和关注；公众应积极参与健康教育活动，提高自我保健意识和能力。相信在政府、医疗机构、社会组织和公众的共同努力下，居民对认知障碍疾病的知晓度将会得到明显提升。
志谢：: 感谢各学(协)会专家给予的大力支持。执笔专家：李明珠(北京大学人民医院)、赵方辉(中国医学科学院肿瘤医院)、尹如铁(四川大学华西第二医院/华西妇产儿童医院)、王新宇(浙江大学医学院附属第一医院)、丛青(复旦大学附属妇产科医院)、李双(华中科技大学医学院附属同济医院)、殷爱军(山东大学齐鲁医院)、宋坤(山东大学齐鲁医院)、隋龙(复旦大学附属妇产科医院)、孔北华(山东大学齐鲁医院)、马丁(华中科技大学同济医学院附属同济医院)、魏丽惠(北京大学人民医院)专家委员会成员 (按姓氏笔画排序)：王建六(北京大学人民医院)、王临虹(中国疾病预防控制中心)、王晓黎(海南省妇幼保健院)、尤志学(南京医科大学第一附医院/江苏省人民医院)、毕蕙(北京大学第一医院)、曲芃芃(天津市中心妇产科医院)、乔友林(中国医学科学院肿瘤医院)、向阳(中国医学科学院北京协和医院)、刘继红(中山大学肿瘤防治中心)、李静然(北京大学人民医院)、李亚里(解放军总医院第一医学中心)、李克敏(四川大学华西第二医院)、李隆玉(江西省妇幼保健院)、林仲秋(中山大学孙逸仙纪念医院)、杨帆(中山大学肿瘤防治中心)、吴小华(复旦大学附属肿瘤医院)、吴鹏(华中科技大学同济医学院附属协和医院)、沈丹华(北京大学人民医院)、张国楠(四川省肿瘤医院/四川省第二人民医院)、张淑兰(中国医科大学附属盛京医院)、狄文(上海交通大学医学院附属仁济医院)、胡尚英(中国医学科学院肿瘤医院)、郄明蓉(四川大学华西第二医院)、余楠(华中科技大学医学院附属同济医院)、周琦(重庆大学附属肿瘤医院/重庆市肿瘤医院)、姜桦(复旦大学附属妇产科医院)、赵超(北京大学人民医院)、赵昀(北京大学人民医院)、郝敏(山西医科大学第二医院)、高雨农(北京大学肿瘤医院)、郭瑞霞(郑州大学第一附属医院)、崔恒(北京大学人民医院)、梁志清(重庆医科大学附属妇女儿童医院)、程文俊(南京医科大学第一附属医院/江苏省人民医院)、薛凤霞(天津医科大学总医院)利益冲突：所有指南制订参与者均声明不存在利益冲突 -
表 1 推荐类别
Table 1 Recommended categories
推荐类别 证据等级和共识程度 1类 基于高级别证据，专家意见高度一致 2A类 基于高级别证据，专家意见基本一致；基于低级别证据，专家意见高度一致 2B类 基于低级别证据，专家意见基本一致；基于高级别证据，专家意见存在争议 3类 不论基于何种级别证据，专家意见明显分歧 
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表 2 我国国家药品监督管理局批准上市的HPV疫苗(截至2025年1月)
Table 2 HPV vaccines approved by the State Drug Administration of China(as of January 2025)
项目 双价HPV疫苗
(大肠杆菌)双价HPV疫苗
(毕赤酵母)双价HPV吸附疫苗
(杆状病毒)四价HPV疫苗
(酿酒酵母)九价HPV疫苗
(酿酒酵母)全球/中国境内上市时间 -/2019年 -/2021年 2007/2016年 2006/2017年 2014/2018年 覆盖HPV型别 16/18 16/18 16/18 6/11/16/18 6/11/16/18/31/33/45/52/58 佐剂 氢氧化铝 磷酸铝 AS04佐剂系统 无定形羟基磷酸硫酸铝 无定形羟基磷酸硫酸铝 预防HPV感染相关疾病(中国批准) HPV 16/18感染引起的子宫颈癌、AIS, CIN2/3、CIN1；HPV 16/18持续感染 HPV 16/18感染引起的子宫颈癌、AIS及CIN2/3 HPV 16/18感染引起的子宫颈癌、AIS、CIN2/3、CIN1 HPV 16/18感染引起的子宫颈癌、AIS、CIN2/3、CIN1；以及男性HPV 16/18引起的AIN、肛门癌、HPV 6/11引起的AGW和AIN HPV 16/18/31/33/45/52/58感染引起的子宫颈癌、AIS、CIN2/3、CIN1及HPV持续感染 接种对象及方案 9~45岁女性: 3剂次(0, 1, 6月) 9~30岁女性: 3剂(0, 2, 6月) 9~45岁女性: 3剂次(0, 1, 6月) 9~45岁女性, 9~26岁男性: 3剂次(0, 2, 6月) 9~45岁女性: 3剂次(0, 2, 6月) 9~14岁: 2剂次(0, 6月) 9~14岁: 2剂次(0, 6月) 9~14岁: 2剂次(0, 6月) 9~13岁女性: 2剂次(0, 6月) 9~14岁: 2剂次(0, 6~12月) HPV(human papilloma virus)：人乳头瘤病毒；AIS(adenocarcinoma in situ)：原位腺癌；CIN(cervical intraepithelial neoplasia)：子宫颈上皮内瘤变；AIN(anorectal intraepithelial neoplasia)：肛门上皮内瘤变；AGW (anogenital warts)：肛门生殖器疣；接种方式为肌内注射，首选上臂三角肌
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表 3 一般人群和特殊人群HPV疫苗接种的推荐级别
Table 3 Recommended levels of HPV vaccination for general and special populations
人群类别 推荐级别 一般人群 9~26岁女性 优先推荐 9~26岁男性 推荐 27~45岁女性 推荐 特殊人群 HPV感染/细胞学异常的适龄女性 推荐 妊娠期女性 不推荐 哺乳期女性 谨慎推荐 有HPV相关病变治疗史的适龄女性 推荐 遗传易感人群 推荐 子宫颈癌发病高风险生活方式的适龄女性* 优先推荐 免疫功能低下的适龄女性# HIV感染者 优先推荐 自身免疫性疾病患者: 系统性红斑狼疮、风湿性关节炎、结缔组织病、干燥综合征、桥本甲状腺炎等 推荐 糖尿病患者 推荐 肾衰竭接受血液透析患者 与临床医生共同探讨 器官/骨髓移植术后长期服用免疫抑制剂和恶性肿瘤患者 与临床医生共同探讨 HPV: 同表 2；*建议首次性暴露前或尽早接种；#全身脏器功能差、病情不乐观、预期寿命有限者，不推荐
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