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Article(id=1239268420324225743, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239268417962832543, articleNumber=null, orderNo=null, doi=10.14109/j.cnki.xyylc.2024.07.08, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1669737600000, receivedDateStr=2022-11-30, revisedDate=null, revisedDateStr=null, acceptedDate=1712678400000, acceptedDateStr=2024-04-10, onlineDate=1773394215899, onlineDateStr=2026-03-13, pubDate=1721836800000, pubDateStr=2024-07-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773394215899, onlineIssueDateStr=2026-03-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773394215899, creator=13701087609, updateTime=1773394215899, updator=13701087609, issue=Issue{id=1239268417962832543, tenantId=1146029695717560320, journalId=1205117082300743687, year='2024', volume='43', issue='7', pageStart='481', pageEnd='560', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773394215336, creator=13701087609, updateTime=1773394445099, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1239269381725810851, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239268417962832543, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1239269381725810852, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239268417962832543, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=523, endPage=528, ext={EN=ArticleExt(id=1239268420575883998, articleId=1239268420324225743, tenantId=1146029695717560320, journalId=1205117082300743687, language=EN, title=International experience and Chinese exploration of regulatory model of gene therapy drugs, columnId=1207314215644270693, journalTitle=Chinese Journal of New Drugs and Clinical Remedies, columnName=Policy and Management, runingTitle=null, highlight=null, articleAbstract=

As a new therapeutic modality, gene therapy drugs (GTDs) play a therapeutic role and also have many risks, which brings challenges to the regulation of GTDs. The United States (US) and the European Union (EU) have established a relatively perfect system in terms of the regulatory body, regulatory basis and listing regulation, which is worthy of China’s reference. China’s regulation of GTDs still exists in the regulatory basis level is not detailed, the regulatory content is not mature and transparent, the main body of the regulatory implementation and the body of the responsibility is not clear enough and other issues. It is suggested that our country can learn from the advanced experience of the US and the EU, divide and control the risk of GTDs, set up an expert technical team, establish an advisory committee, and strengthen international communication and exchange, so as to improve the regulatory system of GTDs and enhance the safety of such drugs in China.

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作为一种新的治疗方式，基因治疗药物（GTDs）在发挥治疗作用的同时也存在诸多风险，这给GTDs的监管带来了挑战。对此，美国和欧盟均在监管主体、监管依据和上市监管方面建立了比较完善的体系，值得我国借鉴。我国对于GTDs的监管还存在着监管依据层次不够细致、监管内容不够成熟透明、监管执行主体和责任主体还不够清晰等问题。建议我国可借鉴美国和欧盟的先进经验，对GTDs的风险进行划分和控制，组建专家技术团队，成立咨询委员会，加强国际沟通和交流，从而完善我国GTDs监管体系，提高此类药物的安全性。

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袁妮
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关晓岩，女，硕士在读，主要从事卫生经济与卫生政策评估的研究，E-mail：

袁妮，女，副教授，博士，主要从事医疗保障政策、药物经济学、药物政策的研究，E-mail：

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关晓岩，女，硕士在读，主要从事卫生经济与卫生政策评估的研究，E-mail：

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关晓岩，女，硕士在读，主要从事卫生经济与卫生政策评估的研究，E-mail：

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IRB：机构审查委员会，CTGTAC：细胞、组织和基因治疗咨询委员会

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ATMPs：先进治疗产品，CAT：先进疗法委员会，CHMP：人用药品委员会，IND：新药临床试验申请，PRAC：药物警戒风险评估委员会，BLA：生物制品许可申请，RMP：药物警戒和风险管理计划

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发文时间政策名称
2021年7月《关于征求ICH指导原则<S12:基因治疗产品的生物分布研究>意见的通知》
2021年12月《基因治疗产品长期随访临床研究技术指导原则（试行）》
2021年12月《基因治疗产品非临床研究与评价技术指导原则（试行）》
2021年12月《基因修饰细胞治疗产品非临床研究技术指导原则（试行）》
2022年6月《免疫细胞治疗产品药学研究与评价技术指导原则（试行）》
2022年6月《体内基因治疗产品药学研究与评价技术指导原则（试行）》
2023年4月《基因治疗血友病临床试验设计技术指导原则》
2023年12月《细胞和基因治疗产品临床相关沟通交流技术指导原则》
2024年1月《罕见病基因治疗产品临床试验技术指导原则》
2024年1月《重组腺相关病毒载体类体内基因治疗产品临床试验申请药学研究与评价技术指导原则》
), ArticleFig(id=1239268427681035235, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239268420324225743, language=CN, label=表1, caption=

2020—2024年国家药品监督管理局药品审评中心（CDE）发布的基因治疗药物（GTDs）相关文件

, figureFileSmall=null, figureFileBig=null, tableContent=
发文时间政策名称
2021年7月《关于征求ICH指导原则<S12:基因治疗产品的生物分布研究>意见的通知》
2021年12月《基因治疗产品长期随访临床研究技术指导原则（试行）》
2021年12月《基因治疗产品非临床研究与评价技术指导原则（试行）》
2021年12月《基因修饰细胞治疗产品非临床研究技术指导原则（试行）》
2022年6月《免疫细胞治疗产品药学研究与评价技术指导原则（试行）》
2022年6月《体内基因治疗产品药学研究与评价技术指导原则（试行）》
2023年4月《基因治疗血友病临床试验设计技术指导原则》
2023年12月《细胞和基因治疗产品临床相关沟通交流技术指导原则》
2024年1月《罕见病基因治疗产品临床试验技术指导原则》
2024年1月《重组腺相关病毒载体类体内基因治疗产品临床试验申请药学研究与评价技术指导原则》
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基因治疗药物监管模式的国际经验与中国探索
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关晓岩 1 , 常翰玉 2 , 王美琪 1 , 梁广盛 3 , 袁妮 1
中国新药与临床杂志 | 政策与管理 2024,43(7): 523-528
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中国新药与临床杂志 | 政策与管理 2024, 43(7): 523-528
基因治疗药物监管模式的国际经验与中国探索
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关晓岩1 , 常翰玉2, 王美琪1, 梁广盛3, 袁妮1
作者信息
  • 1.大连医科大学公共卫生学院，辽宁 大连　116044
  • 2.兰州大学第一医院 医保管理处，甘肃 兰州　730013
  • 3.中国福利会国际和平妇幼保健院，上海　200030

    • 关晓岩，女，硕士在读，主要从事卫生经济与卫生政策评估的研究，E-mail：

    袁妮，女，副教授，博士，主要从事医疗保障政策、药物经济学、药物政策的研究，E-mail：

通讯作者:

袁妮
International experience and Chinese exploration of regulatory model of gene therapy drugs
Xiao-yan GUAN1 , Han-yu CHANG2, Mei-qi WANG1, Guang-sheng LIANG3, Ni YUAN1
Affiliations
  • 1.School of Public Health, Dalian Medical University, Dalian LIAONING 116044, China
  • 2.Department of Medical Insurance, the First Hospital of Lanzhou University, Lanzhou GANSU 730013, China
  • 3.The International Peace Maternity and Child Health Hospital, SHANGHAI 200030, China
出版时间: 2024-07-25 doi: 10.14109/j.cnki.xyylc.2024.07.08
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摘要
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作为一种新的治疗方式，基因治疗药物（GTDs）在发挥治疗作用的同时也存在诸多风险，这给GTDs的监管带来了挑战。对此，美国和欧盟均在监管主体、监管依据和上市监管方面建立了比较完善的体系，值得我国借鉴。我国对于GTDs的监管还存在着监管依据层次不够细致、监管内容不够成熟透明、监管执行主体和责任主体还不够清晰等问题。建议我国可借鉴美国和欧盟的先进经验，对GTDs的风险进行划分和控制，组建专家技术团队，成立咨询委员会，加强国际沟通和交流，从而完善我国GTDs监管体系，提高此类药物的安全性。

基因治疗  /  监管  /  罕见病  /  生物制品  /  新药临床试验申请

As a new therapeutic modality, gene therapy drugs (GTDs) play a therapeutic role and also have many risks, which brings challenges to the regulation of GTDs. The United States (US) and the European Union (EU) have established a relatively perfect system in terms of the regulatory body, regulatory basis and listing regulation, which is worthy of China’s reference. China’s regulation of GTDs still exists in the regulatory basis level is not detailed, the regulatory content is not mature and transparent, the main body of the regulatory implementation and the body of the responsibility is not clear enough and other issues. It is suggested that our country can learn from the advanced experience of the US and the EU, divide and control the risk of GTDs, set up an expert technical team, establish an advisory committee, and strengthen international communication and exchange, so as to improve the regulatory system of GTDs and enhance the safety of such drugs in China.

genetic therapy  /  regulation  /  rare disease  /  biological products  /  investigational new drug application
关晓岩, 常翰玉, 王美琪, 梁广盛, 袁妮. 基因治疗药物监管模式的国际经验与中国探索. 中国新药与临床杂志, 2024 , 43 (7) : 523 -528 . DOI: 10.14109/j.cnki.xyylc.2024.07.08
Xiao-yan GUAN, Han-yu CHANG, Mei-qi WANG, Guang-sheng LIANG, Ni YUAN. International experience and Chinese exploration of regulatory model of gene therapy drugs[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (7) : 523 -528 . DOI: 10.14109/j.cnki.xyylc.2024.07.08
正文
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近年来，随着基因治疗领域快速发展，基因治疗药物（gene therapy drugs，GTDs）也在研发上取得了巨大进展，为罕见病、恶性肿瘤、感染性疾病等的治疗带来了新的希望[1]。截至2024年1月，全球已有54款GTDs获批上市（DNA疫苗和mRNA疫苗不计入在内）[2]。尽管GTDs应用潜能巨大，但因其研发技术含量高、制造工艺复杂、质量控制严格、个体化程度高、贮存和运输条件苛刻等问题[3]，使得其安全性和有效性存在诸多未知的风险，例如，用作基因治疗载体的腺相关病毒（adeno-associated virus，AAV）被发现高剂量注射后可能具有严重毒性[4]，这给GTDs的监管带来了挑战。本研究拟梳理美国和欧盟GTDs的监管体系，以期为完善我国GTDs的监管体系、提高GTDs的安全性提供有益借鉴。
GTDs概念的界定
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基因治疗是指将外源正常基因导入靶细胞，以纠正或治疗因基因缺陷或基因表达异常引起的疾病[5]。GTDs是指经过药品监管机构批准的用于治疗人体相关疾病的基因类产品[6]，以核酸类药物居多，包括DNA药物、RNA药物等。在美国，GTDs按照生物制品进行管理，而欧盟则将其按先进治疗产品（advanced therapy medicinal products，ATMPs）进行监管。
美国GTDs监管体系
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1　监管主体
在美国，GTDs是由美国食品和药物管理局（Food and Drug Administration，FDA）下设的生物制品评估和研究中心（the Center for Biologics Evaluation and Research，CBER）负责监管。
2　监管依据
美国GTDs的监管依据主要由法律、法规、指南3个层级构成。法律主要包括《美国公共卫生服务法案》（Public Health Service Act，PHS Act）和《联邦食品、药品和化妆品法案》，法律的强制性程度最高；法规主要包括《美国联邦法规》（第21章A、C、D、F、L分章）[7]；同时，辅以相应的行业指南，如《罕见病的人类基因治疗（工业指南）》和《使用人类基因治疗产品后的长期随访（工业指南）》等[3]，上述指南对GTDs提交新药上市申请所需信息、非临床研究信息、临床试验安全性和药品质量监管等作出了相应规定。
3　上市监管
美国对药品监管实行风险分类管理。根据产品的复杂程度和安全性等因素，FDA将细胞和基因治疗类产品分为低风险（PHS Act 361产品）和高风险（PHS Act 351产品）两类[3]。GTDs属于高风险产品，GTDs的上市申请须严格按照药品监管要求提交新药临床试验申请（investigational new drug application，IND）和生物制品许可申请（biologics license application，BLA），并由CBER统一负责审批[8]。FDA建议申请人进行新药临床试验之前可召开IND预备会（pre-meeting IND），与FDA讨论新药研发的可行性、临床试验的安全性等信息，之后再提交IND。FDA将从产品的药学特性层面对提交的IND进行评估，如果发现临床研究设计和试验结果可能存在有效性和安全性的担忧，FDA会将该药物的信息送至细胞、组织和基因治疗咨询委员会（Advisory Committee on Cell，Tissue and Gene Therapy，CTGTAC），由其再次审查GTDs的安全性及有效性，进而决定是否批准申请人进行临床试验；同时，由机构审查委员会（Institutional Review Boards，IRB）辅助进行伦理监督[9]（图1）。
对于BLA，FDA也建议申请人在提交BLA前召开BLA预备会（pre-meeting BLA），之后再提交BLA。BLA提交的时间范围限制在120 d内，申请人需要提供有关药物疗效和安全性的证据信息，再由FDA组织内部多学科领域专家对申请人提交的BLA进行上市前审查，此外，还需要申请人提供正在进行的Ⅲ期临床试验的疗效和安全性作为附加信息进行考虑。另外，申请人可以依照FDA有关药物快速通道、孤儿药认定以及突破性疗法认证的规定来提交相关材料，从而获得药物快速通道、孤儿药认定或者突破性疗法认证等资质。1997年，FDA重新修订的《食品、药物和化妆品法》增加了新的506B部分（21U.S.C.356b），为药物上市后研究的监管提供了额外的依据。美国药品审评与研究中心（Center for Drug Evaluation and Research，CDER）还会制定上市后药物警戒计划，包括临床试验受试者的长期随访研究、患者自愿登记和不良事件报告等药物警戒常规工作，以确保药品使用环节的安全性（图2）。
欧盟GTDs监管体系
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1　监管主体
GTDs属于ATMPs，由欧洲药品管理局（European Medicines Agency，EMA）集中授权，并按照规定的单一程序进行授权审批上市。EMA下设的先进疗法委员会（Committee for Advanced Therapies，CAT）是专为ATMPs设立的监管和咨询机构，由来自多学科领域的专家组成，负责对ATMPs的安全性、有效性和质量进行审查[10]。
2　监管依据
与美国监管层级略有不同，欧盟的监管依据分为法律、法规、指南/指导原则和指令4个层次[3]。法律层面主要有《医药产品法》2001/83/EC和《医疗器械法》93/42/EEC；法规包括《先进技术治疗医药产品法规》等；指南/指导原则包括《指导前沿治疗药品进行探索性和确证性临床试验的指南草案》等；指令则更加细致地对相关安全性问题作出了规定，如《人体细胞组织可溯源技术标准、副作用警告与处理、保藏、配送的技术要求》等。4个层级的监管依据主要对ATMPs的监管类别、监管委员会的职责设定、药品市场授权的管理规范等作出了相应规定。此外，欧盟还出台了一系列针对GTDs的非临床研究、临床研究、患者长期随访研究、市场授权和风险管理的指南和指令。
3　上市监管
申请人在GTDs上市的任何阶段都可以向EMA寻求研究设计的最佳指导，以提高药物疗效和安全性研究的可靠性[11]。EMA为ATMPs提供的科学建议和专门针对孤儿药提供的协助计划可帮助开发者在药物上市前进行科学的研究，以便药物能够顺利通过上市评估。在评估过程中，CAT会首先根据ATMPs的质量、安全性和有效性准备一份意见草案，然后发送给人用药品委员会（Committee for Medicinal Products for Human Use，CHMP），由CHMP根据该意见决定是否提交欧盟委员会进行审理[12]，最终再交由欧盟委员会决定该IND是否获批。此外，CHMP还负责初步评估欧盟范围内的BLA，以及评估现有BLA的更改等工作[13]。为了尽快满足患者获得新药的需求，欧盟也出台了加速审批政策——如果CHMP认为该药对公共卫生或治疗创新具有重大意义，则该申请药物可获得加速审评资格。EMA规定，评估一份上市许可申请的最长时间为210 d，如果申请药物证据和数据充足，时间可以缩短到150 d。但任何加速评估申请人都应在提交BLA前2~3个月提出。EMA建议申请人在提交BLA前6~7个月召开pre-meeting BLA会议，为加速评估做准备[12]。会议上，申请人可以与EMA、CAT、CHMP和其他有关委员会，如药物警戒风险评估委员会（Pharmacovigilance Risk Assessment Committee，PRAC）的相关专家讨论加速评估的相关事项，并展示申请过程中的数据信息和风险管理计划。
与所有药物一样，GTDs在获得EMA批准上市后也要对其安全性和有效性继续进行监测，EMA会为开发者提供科学支持，帮助其设计药物警戒和风险管理计划（risk management plan，RMP），以监测药物的安全性[14]。CHMP参考PRAC的药品上市后安全性数据管理要求对GTDs进行药物警戒管理，并在必要时向欧盟委员会建议更改药物的BLA。另外，针对附条件批准的药品，申请人还需要每年向EMA提交药品疗效和安全性的随访数据，一旦发现风险大于获益，EMA有权及时撤回该药的BLA（图3）。
我国GTDs监管体系
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1　监管主体
GTDs在我国由国家药品监督管理局（National Medical Products Administration，NMPA）和国家卫生健康委员会共同管理[3]。前者主要负责GTDs的安全性、有效性审查和临床试验审批；后者负责监管由研究者发起的临床试验和药品获得上市批准后的临床应用环节[3]。另外，医疗机构的伦理委员会则负责对临床试验的受试者进行保护，确保研究者的具体实施过程符合伦理规范，避免非产品本身问题造成的安全性风险[15]。
2　监管依据
2020年来，NMPA的药品审评中心（Center For Drug Evaluation, CDE）陆续发布了多部GTDs的研究指导原则（表1），反映出我国对GTDs的监管日渐重视，特别是2021年12月发布的3个指导原则分别从长期随访临床研究和非临床研究层面对GTDs相关研究的规范性进行了指导，也为降低GTDs的不良事件发生风险、获取GTDs的长期安全性和有效性信息、积累GTDs研发和监管经验提供了依据。2023—2024年，CDE发表的相关指导原则主要集中在细胞和基因治疗产品，特别是罕见病GTDs，这显示出国家对罕见病GTDs上市的关注和支持。
3　上市监管
NMPA是我国基因治疗产品的行政主管部门，负责对全国基因治疗产品进行全面监管，其中GTDs由CDE负责审批。CDE主要负责药物临床试验申请、产品上市申请、补充上市信息申请和境外生产药品再注册申请等的审评。为了激励医药企业研发创新药物的积极性，2020年，NMPA在新版《药品注册管理办法》中规定了加快药品上市注册的4个特殊通道——突破性治疗药物、附条件批准、优先审评审批及特别审批[16]，除特别审批程序外，GTDs均可通过其他3个特殊通道进行申请，这极大地提高了GTDs类新药的上市审批效率。另外，在药品研发和上市过程中，CDE等部门会组织相关专家给予申请人一定程度的技术交流指导，以缩短审批时限，优先满足患者未被满足的临床用药需求。申请人可以在药品临床试验过程中，在药品上市的任何阶段与药品监督部门就重大问题开展技术交流。
美国和欧盟GTDs监管体系对比及其对我国的启示
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通过对美国和欧盟GTDs产品监管体系进行梳理可以发现：监管主体方面，两种监管体系均有着明确的监管主体，分别由FDA和EMA两个主体下设机构CBER和CAT对GTDs进行监管。监管依据方面，美国的监管依据包括法律、法规、指南3个层级，欧盟的监管依据则包括法律、法规、指南/指导原则和指令4个层级。在监管模式方面，美国和欧盟均具有流程清晰、任务明确的上市前、上市中、上市后监管模式，美国的主要制度包括pre-meeting IND、pre-meeting BLA、伦理审查、风险分类管理、加速审批通道、上市后安全监测系统等；欧盟与美国大体相同，主要制度包括GTDs上市过程中的全程指导（如提供科学建议和协助计划等）、pre-meeting BLA、加速审批通道、上市后安全监测系统、RMP等。
目前，我国对GTDs的监管依据仅包括法律和指导原则两个层级，整体监管体系存在着监管依据层次不够细致、监管内容不够成熟明确、监管执行主体和责任主体还不够清晰等问题。在GTDs的风险管理方面，我国尚未出台具体的管理办法，在GTDs药物上市过程中，我国也尚未建立pre-meeting IND等专家咨询、指导制度。通过总结美国和欧盟针对GTDs的监管经验，综合我国实际情况，笔者提出如下优化建议。
1　完善GTDs的风险管理
美国制定了基于风险的备案管理制度，被划分为高风险的GTDs，需经过严格审核后方可上市销售；欧盟的RMP则通过一系列规定将药物上市后的风险降低到最小，尤其着重于对重要风险的监管，包括已存在的风险、潜在的风险和存在缺失信息的风险等，其中，缺失信息导致的风险还需要监测药品长期使用的安全性。我国监管体系目前没有对GTDs按风险等级进行划分，哪些药物可以按药品申报注册、哪些药物必须按医疗技术监管并没有明确的界定，缺乏统一的监管与制度约束，亟需出台相配套的法律法规对GTDs的安全和风险进行划分。建议我国监管部门可针对GTDs全生命周期中的风险类别进行划分和控制，从而保证GTDs的安全性和有效性。
2　组建GTDs专家技术团队
在美国，上市前的pre-meeting IND和pre-meeting BLA制度分别针对临床试验申请人和市场授权申请人给予相应的技术指导和帮助；欧盟则在GTDs研发、上市的全过程中为申请人提供科学建议和协助计划。我国CDE也会在药品临床试验和上市的过程中给予相应的技术交流指导，但尚无具体的专家指导团队以及规范的申报流程。鉴于GTDs的特殊性，对其安全性的监管应当比传统药品更为重视。因此，建议我国有关部门组建专门针对GTDs的专家技术团队，给予GTDs开发者在药品注册全过程中的指导和帮助，从而保障GTDs的安全、顺利审批上市。
3　成立专门监管GTDs的咨询委员会
美国和欧盟均由生物学家和医药专家等组建了专门的委员会对GTDs的临床研究项目进行安全性、技术性和操作性审查，以保障GTDs的临床研究和上市工作顺利开展。我国《药品注册管理办法》中也提出，CDE须建立专家咨询制度，成立专家咨询委员会，在审评、核查、检验、通用名称核准等过程中就重大问题听取专家意见，充分发挥专家的技术支撑作用。我国目前已经建立了干细胞临床研究专家委员会，但尚无针对GTDs的专家委员会。建议可尽快成立针对GTDs的临床研究专门机构或咨询委员会，辅助相关监管部门提供更有效力的审查和审批工作，以促进GTDs的研发上市，满足更多未被满足患者的治疗需求。
4　加强国际沟通和交流
我国对于GTDs的监督管理还不够成熟，各级药品监管部门对于该医疗领域的了解还不够，监管工作有必要借鉴先进经验。此外，制药企业也有必要积极总结行业内的质量标准，帮助药品监管部门和卫生部门完善现有标准和法规，在保证产品质量和安全性的同时加快产品研发上市速度，抢占国际市场。2023年6月，ICH宣布成立细胞和基因治疗讨论组，负责制订该领域的协调路线图。我国GTDs相关标准若能与这些国际标准进行统一和协调，将有助于减少我国基因治疗产业研发人力和物力的资源浪费。虽然我国GTDs的获批数量低于发达国家，产品种类与治疗领域也较为集中，但研发管线数量已跻身第一梯队，潜力可观[17]。未来我国可进一步加深与发达国家的交流合作，完善我国GTDs的监管制度，明确监管过程中的主体责任，将责任落实到具体的组织部门，加大监管和鼓励创新的力度，以推动我国基因治疗产业的持续健康发展。
基金
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  • 2022年度辽宁省教育厅基本科研项目(LJKMR20221296)
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2024年第43卷第7期
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doi: 10.14109/j.cnki.xyylc.2024.07.08
  • 接收时间：2022-11-30
  • 首发时间：2026-03-13
  • 出版时间：2024-07-25
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  • 收稿日期：2022-11-30
  • 录用日期：2024-04-10
基金
2022年度辽宁省教育厅基本科研项目(LJKMR20221296)
作者信息
    1.大连医科大学公共卫生学院，辽宁 大连　116044
    2.兰州大学第一医院 医保管理处，甘肃 兰州　730013
    3.中国福利会国际和平妇幼保健院，上海　200030

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袁妮
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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