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患者对生物类似药的认知:一项系统评价

Patients' Perceptions of Biosimilars: A Systematic Review.

作者信息

Wu Qiyou, Wang Zhitao, Wang Xin, Yu Hui, Sun Jing

机构信息

School of Health Policy and Management, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, Fujian, China.

出版信息

BioDrugs. 2023 Nov;37(6):829-841. doi: 10.1007/s40259-023-00620-7. Epub 2023 Sep 7.

Abstract

OBJECTIVE

To systematically summarize and evaluate the findings of existing studies about patients' perceptions of biosimilars by assessing their attitudes and knowledge.

METHODS

We conducted a systematic review of published studies concerning patients' perceptions of biosimilars, using databases of China National Knowledge Infrastructure, SinoMed, Web of Science, PubMed, Embase, and Cochrane Library. Two independent reviewers screened a total of 2197 Chinese or English papers published between 1 January 2018, and 1 October 2022. We assessed the quality of the included studies by applying the Joanna Briggs Institute appraisal tools.

RESULTS

Forty-three studies were included in the review, with the majority originating from Europe (n = 22) and North America (n = 10). Of these studies, 37 were cross-sectional quantitative studies, three were quasi-experimental studies, and the remaining three were qualitative studies based on semi-structured interviews. The sample sizes of the included studies ranged from 9 to 6554 patients. Twenty-two out of 31 studies investigating patients' acceptance of biosimilars found that most participants expressed satisfaction with treatment using biosimilars. However, doubts about the clinical effects and regulatory approval pathway could negatively influence patients' attitudes. The majority of patients understood the economic advantages of biosimilars; however, some incorrectly connected lower prices with lower quality. Patients generally lacked knowledge about biosimilars. There were 6-51% of participants who were familiar with biosimilars, and 25-58% thought they did not know enough about biosimilars. Physicians, pharmacists, medicines agencies, academia, and patient associations were identified as the main sources of information on biosimilars for patients. Healthcare providers not informing or advising patients about switching may hinder patients from acquiring enough knowledge.

CONCLUSIONS

The majority of patients expressed satisfaction with treatment using biosimilars, but limited knowledge continued to impede their perceptions. Doubts about the clinical effects and regulatory approval pathway were identified as major factors that negatively influenced patients' attitudes towards biosimilars, while the impact of a price advantage was mixed. It is essential to maintain a focus on educating healthcare professionals about biosimilars, including their clinical outcomes and the regulatory pathway, which equips them to provide comprehensive and informed guidance to patients.

摘要

目的

通过评估患者对生物类似药的态度和知识,系统总结和评价现有关于患者对生物类似药认知的研究结果。

方法

我们利用中国知网、中国生物医学文献数据库、科学网、PubMed、Embase和Cochrane图书馆等数据库,对已发表的有关患者对生物类似药认知的研究进行了系统综述。两名独立评审员共筛选了2018年1月1日至2022年10月1日期间发表的2197篇中文或英文论文。我们应用乔安娜·布里格斯研究所的评估工具评估纳入研究的质量。

结果

该综述纳入了43项研究,其中大多数来自欧洲(n = 22)和北美(n = 10)。在这些研究中,37项为横断面定量研究,3项为准实验研究,其余3项为基于半结构化访谈的定性研究。纳入研究的样本量从9名至6554名患者不等。在31项调查患者对生物类似药接受度的研究中,有22项发现大多数参与者对使用生物类似药进行治疗表示满意。然而,对临床效果和监管审批途径的疑虑可能会对患者的态度产生负面影响。大多数患者了解生物类似药的经济优势;然而,一些患者错误地将较低的价格与较低的质量联系起来。患者普遍缺乏关于生物类似药的知识。有6% - 51%的参与者熟悉生物类似药,25% - 58%的参与者认为他们对生物类似药了解不足。医生、药剂师、药品机构、学术界和患者协会被确定为患者获取生物类似药信息的主要来源。医疗保健提供者未告知或建议患者换药可能会阻碍患者获得足够的知识。

结论

大多数患者对使用生物类似药进行治疗表示满意,但知识有限继续妨碍他们的认知。对临床效果和监管审批途径的疑虑被确定为对患者对生物类似药态度产生负面影响的主要因素,而价格优势的影响则喜忧参半。必须持续关注对医疗保健专业人员进行生物类似药方面的教育,包括其临床结果和监管途径,使他们能够为患者提供全面且信息充分的指导。

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