Health technology assessment in traditional Chinese medicine in China: current status, opportunities, and challenges

Objectives:The widespread usage of traditional Chinese medicine(TCM)and the government's emphasis on TCM in China have created a positive macro-environment and great opportunities to develop and strengthen health technology assessment(HTA)in TCM.Over the past ten years,a series of policies have been issued by the government to promote the application of HTA and the development of TCM in China.This study reviews the concepts and characteristics of TCM,summarizes the current status of HTA in TCM,and analyzes the opportunities and challenges faced by HTA development in TCM with respect to deepening of healthcare reforms.Methods:Literature review and website searches were used to acquire information regarding the basic theories of TCM and the current status,opportunities,and challenges for HTA in TCM.Results:The number of articles on HTA in TCM rose substantially,especially those published in China National Knowledge Infrastructure(CNKI).With the optimistic policy environment and huge market demand for TCM,the development of HTA in TCM is expected to flourish in China.However,HTA in TCM also faces numerous challenges such as the absence of a clinical efficacy evaluation system for TCM and insufficient basic research evidence and qualified personnel.Conclusions:TCM has unique characteristic that distinguishes it from Western medicine.Currently,it is important to take all measures to address the existing main challenges and thereby take advantage of the present opportunities to develop and improve HTA in TCM.

Hospital-based health technology assessment:The next frontier for traditional Chinese medicine hospitals

Hospital-based health technology assessment(HB-HTA)is highly valuable in the application of hospital medical technology,cost control,improvement of medical quality,and protection of medical safety,and its use is increasing daily globally.However,in China,HB-HTA is still in its infancy,and it is yet to be adopted in traditional Chinese medicine(TCM).Therefore,this article introduces the application and development of HB-HTA,as well as discusses the current situation of TCM and related future development strategies to provide ideas and references for the development of HB-HTA in TCM.We conclude and recommend that all major stakeholders,including the state,health departments,and hospital leaders,support and promote the exploration and development of HB-HTA in TCM hospitals and integrative medicine hospitals.We also suggest the utilization of existing talents and introduction of other necessary talents to promote better and faster organizational development,as well as suggest the formation of a national and internationally recognized HB-HTA guidance manual and toolkit for TCM hospitals based on both the national HTA guidelines and the evaluation of TCM hospitals pilot projects.Moreover,we recommend that HB-HTA pilot study should be executed with Chinese patent medicine as the starting point to form the implementation process and framework in the TCM arena.

Health technology assessment in China: challenges and opportunities

Objectives:Economic growth and rapid development of health technology in China have created opportunities to strengthen health technology assessment (HTA) capacity.Over the time,HTA institutions have been established to conduct HTA related work.This study reviewed the current status of HTA in China and analysed the challenges of HTA development in the context of health reform under'new normal'economy.Methods:Literature review and webpage searches were used to document the development of HTA in China.An institutional survey has also been conducted to collect information on the HTA research institutions in China.Results:The number of articles and research projects on HTA were rising and are continuing to rise.HTA development has made substantial progress in China in terms of growing number of research institutions and qualified HTA workforce.However,HTA has notable weaknesses such as low capacity for conducting HTA research,limited experience in HTA researchers,and lack of knowledge translation.Conclusion:Currently,the translation of HTA findings to policy-making is limited and the integration of HTA in the policy-making processes is still in its infancy.The HTA development in China has had opportunities due to demands of health care,health insurance,and health technology as a result of health reform.Capacity building and institutionalization of HTA are urgently needed for further development of HTA in China.

Shaoma Zhijing granule for children with tic disorders: A rapid health technology assessment

Objective:To rapidly assess the effectiveness,safety,economy,and applicability of Shaoma Zhijing granule(SZG)for the treatment of children with tic disorders(TD),and provide currently available best evidence for decision-makers of health policies.Methods:We conducted a rapid health technology assessment(RHTA)to explore the value of SZG.A systematic literature search in eight literature databases and on three clinical trial registration platforms was performed.The literature was screened according to eligibility criteria.The screening process and data extraction were conducted by two reviewers,and the quality of the literature was also assessed.The results were summarized,analyzed,and presented in tables or figures.Results:A total of five randomized controlled trials(RCTs)were included in this study,of which one was published in English(in the Journal of Child Psychology and Psychiatry)and four in Chinese journals.The overall risk of bias for the five RCTs was evaluated as“some concerns.”SZG monotherapy or in combi-nation with tiapride was better than tiapride alone in improving traditional Chinese medicine(TCM)syndromes and tic symptoms,with a daily cost of¥67.50e107.22.Adverse events were mainly related to the digestive,respiratory,and neurological systems,but all were mild.Conclusion:Overall,the current RHTA of published,peer-reviewed literature has located a small body of evidence evaluating the use of SZG for the treatment of TD in children.SZG has effects on improving TCM syndromes and tic symptoms;the daily cost is¥67.50e107.22;and all adverse events are mild.High-quality studies with long-term follow-up should be conducted,so as to provide local evidence and consistently guide and improve scientific decision-making.

Can health technology assessments assist the global campaign against poverty?

Although a key tenant of the Sustainable Development Goals is to achieve universal health coverage,the global drug gap persists-cver a third of the global population lack access to essential medicines.Without access to affordable drugs,people have worse health outcomes,higher medical expenses,and productivity loss,pushing them into poverty.Health technology assessments(HTAs)offer an opportunity to decrease the global drug gap and increase access to essential medicines by overcoming barriers to medicine access.These barriers include drug procurement,drug affordability for payers and patients,a patienfs ability to obtain essential medicines,and health system capacity.Using HTAs can therefore close the global drug gap by increasing access to affordable essential medicines.In turn,people have better health outcomes,spend less money on medical care,and can have better productivity.Ultimately,use of HTAs can lift the population out of poverty and force fewer people into poverty by creating better health outcomes at affordable prices.

基于HB-HTA的医疗新技术准入评估体系研究

医疗新技术准入评估是医疗技术纳入临床应用前的重要一环,对保证医疗服务质量和医疗安全具有关键性作用。但在准入评估具体实践过程中,还存在着准入理论框架不完善、评估指标体系不健全等问题。以卫生政策及法律法规为战略支撑,借鉴医院卫生技术评估(Hospital-based Health Technology Assessment,HB-HTA)的理论和方法,综合考虑评估主体、评估客体、评估内容等核心要素,从技术特性、安全性、有效性、经济性、适用性等维度进行指标体系设计,构建引进型医疗新技术准入评估框架,以期为医疗机构医疗技术准入管理提供理论框架和循证基础。

HTA在发达国家医保体系中的发展及对我国的启示

本文对英国、美国、法国、德国、瑞典和加拿大六个发达国家的卫生技术评估(HTA)在医疗保健体系中的发展进行了深入探讨。HTA作为提高医疗决策科学性、经济性和公平性的重要工具,已在上述国家得到广泛应用。这些国家的实践展示了综合评估方法、多方参与、平衡公私部门角色、地方自主性和强调临床及成本效益的重要性。我国作为全球人口大国,面临着医疗资源有限、医保支出不断增加等挑战,借鉴并本土化这些国家的HTA经验有望提升我国医保部门医疗决策的质量,促进整个体系的公平和可持续发展。本文旨在为我国的医疗保健政策制定者、研究人员和从业人员提供关于国际最佳实践经验的深入洞察,为国内外学术界和政策制定者提供有价值的参考。

Mini-HTA在医院医疗器械评价中的分析与探讨

随着医疗器械在健康卫生领域发挥的作用越来越大,医疗设备的合理配置已成为医院面临的重大难题。本文通过检索中国期刊全文数据库(CNKI)和Pub Med数据库,深入研究医院医疗器械管理相关文献,就国内外医院对医疗器械卫生技术评估的现状进行分析与探讨。

基于全面质量管理理论构建城市医疗集团HB-HTA小组的论证

结合我国城市医疗集团需求特点,基于全面质量管理理论,以上海市第六人民医院的实践为例,对组建城市医疗集团HB-HTA小组过程要素:团队建设、运行机制、评估项目与资源、研究方法与工作程序、文化与制度环境以及报告评估与转化等进行论证,为以医联体为单位推动HB-HTA发展路径的形成提供参考。

基于Mini-HTA的医疗设备准入评估方法改进研究

目的:探究改进基于微型卫生技术评估(Mini-HTA)的医疗设备准入评估方法,提升医院Mini-HTA应用水平。方法:通过分析Mini-HTA在医院医疗设备准入评估应用中的局限性,引入层次分析法(AHP)和绩效评价法进行改进,提出评估因素设计改进思路。以医院新引进的磁共振系统准入评估为例,对比改进的Mini-HTA评估方法评估效果。结果:AHP的引入提高了Mini-HTA规范性,绩效评价法提供了后期的证据支持,评估因素设计改进可提高模型实用性及准确性。新引进的磁共振系统后期绩效评价证据与改进的Mini-HTA模型准入评估结果吻合。结论:改进后的Mini-HTA适用于医疗设备准入评估,能够有效帮助医疗机构决策者在医疗设备准入以及卫生资源配置等方面做出更优质的决策。

HTA在我国医保决策中的应用思考

HTA在我国医保决策领域的应用虽处于起步阶段,但由于学科特点与医保决策需求的高度契合性,未来将有很大的实践应用空间。我国医保管理体系与国外不同,不能盲目照搬国外模式,需要在不断的实践摸索中探索一条具有我国特色的医保HTA应用之路。医保HTA的长久持续发力离不开政府部门在机制化建设方面的久久为功,医保部门可以结合国家医保药品目录调整等改革任务,为HTA的体系建设进行积极探索,逐步形成中国医保HTA发展模式。本文介绍了卫生技术评估作用、概念和国际实践经验,并提出了对卫生技术评估在我国医保决策应用中的相关思考。

Establishing the Reliability and Validity of Health in Motion^©Automated Falls Screening Tool

Introduction: Blue Marble Health Company has created a digital fall risk screening tool (Health in Motion©) that can be used by means of self-report (touch/mouse) or by means of motion capture (Microsoft Kinect Sensor). Health in Motion©consists of automated versions of the Fall Risk Question-naire, 30-Second Chair Stand Test, and the One Leg Stance Test. Methods: We compared the three methods (self-report, sensor, and clinical standard measurement) using stopwatch and observation in 15 community-dwelling older adults, aged 63 - 80 years old. Each version was completed three times each in random order, for a total of nine trials. Results: Health in Motion©falls screening tool accessible via self-report and sensor is a valid and reliable automated at-home self-assessment for falls risk. Conclusion: Results support the use of Health in Motion©falls screening tools as viable alternatives to standard falls risk assessments for use by older adults at home.

地诺孕素治疗子宫内膜异位症的快速卫生技术评估

目的:快速评价地诺孕素治疗子宫内膜异位症的有效性、安全性和经济性,旨在为临床药物选择和决策提供循证依据。方法:计算机检索PubMed、Embase、Cochrane Library、中国知网、SinoMed、万方数据、国内外卫生技术评估(HTA)机构官方网站及相关数据库,收集地诺孕素治疗子宫内膜异位症的HTA报告、系统评价/Meta分析和药物经济学研究,检索时限均为建库起至2023年9月。资料提取和质量评价后,对纳入研究的结果进行描述性分析。结果:共纳入9篇系统评价(Meta分析)、2篇药物经济学研究。Meta分析文献质量偏低,经济学研究质量较好。有效性方面,与无治疗相比,地诺孕素可以显著降低术后复发率、盆腔疼痛(VAS)评分,提高妊娠率及有效率;地诺孕素与促性腺激素释放激素激动剂(GnRHa)、复方口服避孕药(COC)在复发率方面疗效相当;在复发率、妊娠率方面,地诺孕素优于达那唑,孕三烯酮以及米非司酮。安全性方面,与安慰剂对比,地诺孕素阴道出血、头痛的发生率显著增高,骨质丢失情况无差异;地诺孕素阴道出血发生率显著高于GnRHa,但潮热、骨质丢失的发生率低于GnRHa。经济性方面,与GnRHa比较,地诺孕素更具有成本-效益优势;而与COC比较,地诺孕素不具有经济性。结论:地诺孕素治疗子宫内膜异位症具有良好的有效性和安全性;经济性优于GnRHa,但劣于COC。

乌司他丁治疗急性胰腺炎的快速卫生技术评估

目的本文通过对乌司他丁(UTI)进行快速卫生技术评估(HTA),评价UTI治疗急性胰腺炎(AP)的有效性、安全性及经济性。方法计算机检索PubMed、Embase、the Cochrane Library、中国知网、万方数据库、中国生物医学文献数据库和HTA机构官方网站,收集UTI在AP方面的系统评价(SR)/Meta分析、经济学评价及HTA报告,检索时限为建库至2024年4月。由2名研究者根据纳排标准独立进行筛选、质量评价和数据提取,采取描述性分析方式对数据进行分析汇总。结果共纳入19篇研究,包括15篇SR/Meta分析和4篇经济学研究,未检索到HTA报告。UTI联合治疗AP较单独常规治疗在提高总有效率、缩短淀粉酶恢复时间、减少腹痛腹胀缓解时间、降低病死率及缩短平均住院天数等方面均具有明显优势,和其他阳性药物(甲磺酸加贝酯、奥曲肽、生长抑素)相比疗效相当或基本一致,安全性良好。就目前纳入的研究而言,UTI对比其他阳性药物具有明显经济学优势。结论UTI在治疗AP方面安全有效,具有经济学优势。

金水宝胶囊治疗肾脏疾病的快速卫生技术评估

目的:运用快速卫生技术评估(HTA)方法,对金水宝胶囊治疗肾脏疾病的有效性、安全性和经济性进行综合评价,为临床提供循证依据佐证用药。方法:检索PubMed、the Cochrane Library等外文数据库和万方数据库、中国知网、维普数据库、中国生物医学文献数据库等中文数据库,国际卫生技术评估机构网络、英国国家卫生与临床优化研究所、加拿大药物和卫生技术局等机构的官方网站及相关数据库,获取金水宝胶囊治疗肾脏疾病的系统评价/Meta分析、HTA报告以及药物经济学研究,检索时限均为建库至2023年6月。根据纳入与排除标准筛选文献、提取资料、评价质量,并对结果进行定性分析。结果:纳入系统评价/Meta分析13篇(11篇涉及糖尿病肾病,2篇涉及慢性肾衰竭),未检索到药物经济学研究和HTA报告。结果显示,金水宝胶囊联合常规治疗/血管紧张素转换酶抑制剂(ACEI)/血管紧张素Ⅱ受体阻断剂(ARB)用于肾脏疾病,临床总有效率优于对照组,在降低血肌酐、血尿素氮、24 h尿蛋白定量、尿微量蛋白排泄率、尿微量白蛋白/尿肌酐、三酰甘油、胱抑素C、尿中N-乙酰-β-D氨基葡萄糖苷酶和提高肌酐清除率方面具有优势;同时,不良反应发生率低且均为轻症,无严重不良事件发生,安全性良好。结论:金水宝胶囊在治疗肾脏疾病中的有效性和安全性较好,未来需要进一步开展药物经济学研究。

艾多沙班治疗癌症相关静脉血栓栓塞症的快速卫生技术评估

目的评价艾多沙班治疗癌症相关静脉血栓栓塞症(CAVTE)的有效性、安全性及经济性。方法采用计算机检索PubMed、The Cochrane Library、CRD Web、中国知网(CNKI)、万方(WanFang)数据库及国内外卫生技术评估(HTA)机构的官方网站,检索时限为自建库起至2023年8月31日。由2名评价者根据纳入与排除标准独立筛选文献并提取数据,采用HTA checklist、AMSTAR2量表或CHEERS 2022量表对纳入文献进行质量评价,采用描述性分析法对提取的研究内容进行分析和总结。结果共检索到相关文献514篇,最终纳入9篇系统评价/Meta分析、4篇药物经济学研究。研究结果显示,在有效性方面,艾多沙班治疗CAVTE,减少静脉血栓栓塞症复发的疗效优于华法林(P<0.05),与低分子肝素(LMWH)、利伐沙班、阿哌沙班的疗效相当(P>0.05);减少肺栓塞复发的疗效与LMWH相当(P>0.05);减少深静脉血栓形成复发的疗效优于LMWH(P<0.05)。在安全性方面,艾多沙班发生大出血的风险高于LMWH(P<0.05),与华法林、阿哌沙班、利伐沙班相当(P>0.05);发生临床相关非大出血的风险低于华法林(P<0.05),与LMWH、阿哌沙班、利伐沙班相当(P>0.05);发生临床相关出血的风险高于LMWH(P<0.05),低于利伐沙班(P<0.05),与阿哌沙班相当(P>0.05)。在经济性方面,国外的研究结果显示,艾多沙班较LMWH治疗CAVTE具有成本-效用优势。结论艾多沙班治疗CAVTE的有效性和安全性均较好,国外的研究提示经济性良好,但缺乏国内的药物经济学研究。

尿毒清颗粒治疗慢性肾脏病的快速卫生技术评估

目的:通过快速卫生技术评估(HTA)的方法,评价尿毒清颗粒治疗慢性肾脏病(CKD)的有效性、安全性和经济性,为临床提供循证依据。方法:检索PubMed、the Cochrane Library、中国生物医学文献数据库、中国知网、万方数据库和维普数据库等数据库(检索时限至2024年2月1日),纳入有关尿毒清颗粒治疗慢性肾脏病的HTA报告、系统评价、Meta分析和药物经济学研究,评价纳入文献的质量,定性分析结果。结果:13篇Meta分析被纳入研究,未检索到HTA报告和药物经济学研究。结果显示,联合应用尿毒清颗粒治疗CKD,其临床有效率优于其他治疗方案(其中病例数最多的研究结果显示,RR=1.37,95%CI=1.24~1.51,P<0.001),可提高内生肌酐清除率、肾小球滤过率、血红蛋白水平,并在降低血清肌酐、血清尿素氮、尿白蛋白排泄率、24 h尿蛋白、血清总胆固醇、血清三酰甘油、胱抑素C等指标水平方面有优势,同时,安全性较好,不良反应发生率低。结论:联合应用尿毒清颗粒在CKD的治疗中具有较好的有效性和安全性,未来有必要进一步开展药物经济学研究,补充其治疗CKD的经济学评价证据。

基于医院卫生技术评估的5种二肽基肽酶4抑制剂的临床应用情况

目的通过医院卫生技术评估(HB-HTA)对5种二肽基肽酶4抑制剂(DPP-4i)(西格列汀、维格列汀、沙格列汀、利格列汀和阿格列汀)进行评估,为医疗机构药品的遴选、临床的合理安全使用提供依据。方法通过HB-HTA,依照百分制评分体系,参考药品说明书、临床指南和文献,从安全性、有效性、经济型、创新性、适宜性和可及性等方面分别对5种DPP-4i进行评估。结果西格列汀、维格列汀、沙格列汀、利格列汀和阿格列汀得分分别为85.0、75.0、77.0、80.0、78.5分。评分差异主要在安全性、经济性、适宜性和可及性方面。西格列汀综合得分最高。结论HB-HTA评估DPP-4i结果比较合理,为医院药品遴选、安全合理使用提供依据。

4种治疗糖尿病周围神经病变补气活血类中成药的卫生技术评估

目的为临床选择糖尿病周围神经病变(DPN)治疗用补气活血类中成药提供参考。方法参考《医疗机构中成药遴选专家共识(第一版)》,结合临床实际,制订药物卫生技术评估细则,参考药品说明书、临床指南和文献,对4种中成药的安全性、有效性、经济性、适宜性、创新性、可及性、传承性进行评分,并计算总分。结果通心络胶囊、木丹颗粒、糖脉康颗粒、芪蛭降糖胶囊的评分分别为74.5分、72分、64.5分、57分。结论临床在选择治疗DPN的补气活血类中成药时,相对于糖脉康颗粒、芪蛭降糖胶囊,建议优先使用木丹颗粒、通心络胶囊。

替雷利珠单抗一线治疗晚期非小细胞肺癌的快速卫生技术评估

目的评价替雷利珠单抗(TIS)一线治疗晚期非小细胞肺癌(NSCLC)的有效性、安全性和经济性。方法计算机检索PubMed、Embase、Cochrane Library、CNKI、WanFang Data、SinoMed数据库和卫生技术评估(HTA)相关网站,搜集TIS一线治疗晚期NSCLC的HTA报告、系统评价/Meta分析和药物经济学研究,检索时限均从建库至2024年4月30日。由2名研究者独立筛选文献、提取资料和质量评价,并采用定性描述方法进行快速卫生技术评估。结果共纳入9篇文献,包括系统评价/Meta分析7篇,药物经济学研究2篇。有效性方面,与化疗(CT)相比,TIS+CT可提高晚期NSCLC患者的无进展生存期(PFS)和客观缓解率(ORR),可提高任何程序性细胞死亡受体配体-1(PD-L1)表达情况、伴或不伴肝转移、年龄≥65岁或<65岁、有吸烟病史的晚期NSCLC患者的PFS;与CT相比,TIS+CT可提高晚期非鳞状NSCLC患者的PFS,可提高PD-L1≥50%的晚期非鳞状NSCLC患者的PFS;与CT相比,TIS+CT可提高PD-L1为1%~49%、PD-L1≥50%、男性、年龄≥65岁、有吸烟史、ECOG评分1分、ⅢB期和Ⅳ期晚期鳞状NSCLC患者的PFS。安全性方面,与卡瑞利珠单抗+CT和阿替利珠单抗+贝伐珠单抗+CT相比,TIS+CT可降低严重不良反应发生率。经济学方面,对于无表皮生长因子受体突变和渐变淋巴瘤激酶重排的非鳞状NSCLC,与CT相比,TIS+CT在中国具有一定的成本-效果优势。亚组分析结果显示,在PD-L1表达≥50%、肝转移和有吸烟史的非鳞状NSCLC患者中,一线TIS+CT方案的生存益处更大。结论TIS+CT一线治疗晚期NSCLC具有较好的有效性、安全性和经济性。