Clinical research report on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions(2022)

Objective:The paper is to comprehensively summarize and analyze the basic situation and methodological quality of clinical randomized controlled trials(RCTs)of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions published in 2022,to provide evidence and reasonable suggestions for the advancement of clinical research and the formulation of policies and guidelines.Methods:The Evidence Database System of clinical evidence-based evaluation of traditional Chinese medicine was searched,and data from China National Knowledge Infrastructure(CNKI),PubMed,and other databases were supplemented.The search duration was from January 1,2022,to December 31,2022.RCTs of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were included as the source of clinical evidence,and published information,sample size,intervention,control measures,treatment course,methodological quality,and key link report were analyzed and evaluated.Results:A total of 1,464 RCTs of traditional Chinese patent medicines were included,which comprised 667 types of traditional Chinese patent medicines;“traditional Chinese patent medicines+Western medicine vs.Western medicine”was the most widely used intervention and control setting,involving 417 RCTs(28.48%).A total of 245 RCTs of traditional Chinese classic famous prescriptions were included,comprising 55 types of traditional Chinese classic famous prescriptions.“Decoction+conventional treatment vs.conventional treatment”was the most widely used intervention and control setting,with 87 RCTs(35.51%).Published RCTs on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were limited by the study design and implementation.Most“allocation concealment”and“blinding of patients and personnel”were rated as medium to high risk.There are insufficient reports on key research links such as experimental registration and ethical approval.Conclusions:The number of RCTs on traditional Chinese patent medicines has decreased in 2022,but there has been a slight improvement in the research quality and impact.There are relatively few studies on traditional Chinese classic famous prescriptions.Measures must be taken to improve clinical trial design,implementation,and reporting.Methodological experts should be invited to provide professional technical guidance on the trial design.In the research implementation process,attention should be paid to quality control,particularly the standardization of the randomized execution.

Research on Technology Development of Traditional Chinese Medicine Extraction Based on Patent Information

Objective To understand the development status of traditional Chinese medicine extraction technology,so as to provide a reference for enterprises and scientific research institutions to determine the direction of technological innovation.Besides,the government can formulate scientific and technological innovation strategies.Methods Based on patent information,statistical methods were applied to analyze the development of traditional Chinese medicine extraction technology.Then,the core technology was identified by constructing a patent citation network.Finally,the main path analysis method was applied to discover the technological evolution path.Results and Conclusion The extraction technology of traditional Chinese medicine is still in the growth stage.At present,its R&D is based on enterprises,supplemented by scientific research institutions.The core technologies are ultrasonic extraction and enzymatic extraction.The main path represented by enzymatic extraction technology reveals the evolution process of traditional Chinese medicine extraction technology.Based on this,relevant suggestions are put forward.Firstly,technological innovation cooperation should be strengthened to explore new models of achievement transformation and cooperation.Secondly,key enterprises of technology clusters should be cultivated to accelerate breakthroughs in core technologies.Thirdly,combined technologies can achieve high-efficiency enzyme-assisted extraction and open up new ways of extracting traditional Chinese medicine.Fourthly,traditional techniques should be improved to develop innovative modern techniques.

Ultrasonic Nebulization Extraction Coupled with Gas Chromatography-Mass Spectrometry for Analysis of Volatile Components in Traditional Chinese Patent Medicine

The ultrasonic nebulization extraction（UNE） was developed and applied to the extraction of volatile components from traditional Chinese patent medicine Xiaoyao Pills. Several parameters of ultrasonic nebulization extraction including the sample particle size, solvent volume, extraction time and ultrasonic power were studied and selected. As a result, 2.4 g of sample with particle size of 80 mesh was extracted with 15 mL of n-hexane for 20 min at an ultrasonic power of 35 W. The volatile components were analyzed by gas chromatography-mass spectrometry （GC-MS） under the optimal conditions and 57 compounds were identified. The precision, repeatability and stability of the proposed method were also studied. Compared with ultrasonic-assisted extraction（UAE） and hydrodistillation（HD） extraction, the proposed method is more efficient, faster and easier to be operated at room temperature with smaller sample and energy consumption. It is suggested that the ultrasonic nebulization extraction can be used as a novel alternative method for the extraction of volatile components from traditional Chinese patent medicine.

Analysis of the rule of medication of compound Chinese traditional patent medicine for digestive system tumors based on data mining

Objective:Based on the data mining method,explore the medication rules of Chinese patent medicines for the treatment of digestive system tumors.Method:Based on the"Chinese Traditional Medicine Prescription Database"in https://db.yaozh.com/,collect Chinese patent medicines for the treatment of digestive system tumors,establish an Excel table,and use the ancient and modern medical case cloud platform(V2.2.1)to perform frequency statistics,association rules,and drugs on the data Clustering and complex network analysis.Results:A total of 36 Chinese patent medicines for the treatment of digestive system tumors were screened.The medicinal properties were mainly warm and cold,the taste was bitter and sweet,and the meridians were mainly liver and spleen meridians.High frequency Chinese medicine include Astragalus,Scutellaria-barbata,Ginseng,Curcuma,Triangle,Atractylodes,Hedyotis diffusa,etc.Correlation analysis obtained 17 drug combinations,High-frequency drug pairs include Scutellaria-barbata-Astragalus,Ginseng-Astragalus,Curcuma-Astragalus,Scutellaria-barbata-Curcuma,etc.Cluster analysis found 3 types of drugs.The core drug network is composed of 27 drugs,and the core compatibility network consists of 3 groups of drugs.Conclusion:The Chinese patent compound medicine for the treatment of digestive system tumors has the characteristics of combining cold and warming,replenishing and reducing treatment,and treating the liver and spleen at the same time.The medicine is mainly used to replenish qi and invigorate the spleen,promote blood circulation and remove blood stasis,and clear away heat and detoxification.Replenish qi,nourish yin,invigorate blood,and detoxify are mainly compatible with each other,reflecting the pathogenesis characteristics of"deficiency,stasis,and toxin"in digestive system tumors.Data mining can provide references for the prescription and compatibility of Chinese patent medicines.

Quality Control for Traditional Medicines–Chinese Patent Medicines

Ji Shen: Dr.Ma Shuangcheng,Director of Institutes for Control of Chinese Traditional Medicines and Ethnic Medicine,National Institutes for Food and Drug Control,is a long-term researcher on the quality standards of Chinese materia medica,Chairman Member of the Risk Assessment of the Pharmacopoeia of People's Republic of China ,and is also the Director Member of the Professional Committee of Drug Risk,China Pharmaceutical Association,and the Director Member of the Directors Committee of Chinese Materia Medica Quality and Safety.He has long been engaged in the control of the quality and safety of Chinese materia medica,and has also been included in the National 10000 Talent Plan.Let's invite Dr.Ma to give a report.Thank you.

Partial response to Chinese patent medicine Kangliu pill for adult glioblastoma: A case report and review of the literature

BACKGROUND Glioblastoma is the most common type of brain tumor and is invariably fatal,with a mean survival time of 8-15 mo for recently diagnosed tumors,and a 5-year survival rate of only 7.2%.The standard treatment for newly diagnosed glioblastoma includes surgery followed by concurrent chemoradiotherapy and further adjuvant temozolomide.However,the prognosis remains poor and longterm survival is rare.This report aimed to demonstrate a new therapeutic strategy for the treatment of glioblastoma.CASE SUMMARY A patient was referred to the Department of Neurosurgery with an intracranial space-occupying lesion with a maximum diameter of approximately 5 cm.The tumor was compressing functional areas,and the patient accordingly underwent partial resection and concurrent chemoradiotherapy.The imaging and pathological findings were consistent with a diagnosis of glioblastoma with oligodendroglioma differentiation(World Health Organization IV).The patient was finally diagnosed with glioblastoma.However,the patient discontinued treatment due to intolerable side effects,and was prescribed Kangliu pill(KLP)7.5 g three times/d,which he has continued to date.Significant shrinkage of the tumor(maximum diameter reduced from about 3.5 to about 2 cm)was found after 3 mo of KLP therapy,and the tumor was further reduced to about 1 cm after 3 years.The patient’s symptoms of headache,limb weakness,and left hemiplegia were relieved,with no side effects.CONCLUSION KLP has been a successful intervention for glioblastoma, and the current caseindicates that traditional Chinese medicine may offer effective alternativetherapies for glioblastoma.

Clinical practice guideline on traditional Chinese medicine in the treatment of influenza (2021)

Influenza is a serious public health problem that endangers the health of the global human population.Traditional Chinese medicine(TCM)is rich in theory and practical experience regarding the treatment of influenza,and TCM treatments have shown good curative effects,but there is a dearth of standardized clinical guidance.It is necessary to formulate a clinical practice guide based on evidence-based medicine.To this end,the Specialty Committee of Emergency,China Association of Chinese Medicine(Beijing,China)organized a team of clinical experts,methodological experts,and other multidisciplinary experts to develop a guideline with integrated research methods in the first place of TCM.This guide includes 23 recommendations.The prescription section contains 16 recommendations,including 5 recommendations for mild cases,5 recommendations for severe cases,3 recommendations for critical cases,and 4 recommendations for the recovery period;the portion covering proprietary Chinese medicines forms a total of 7 recommendations.This guide aims to provide the best evidence for clinicians and related practitioners to make decisions about influenza diagnosis and treatment in Chinese medicine.

Efficacy and safety of Yangxue Qingnao Granules in treatment of migraine:A systematic review and meta-analysis

BACKGROUND Yangxue Qingnao Granules(YXQN)is a Chinese patent medicine that has been commonly used in the clinical treatment of migraine.AIM To assess the efficacy and safety of YXQN alone for the treatment of migraine.METHODS We searched 10 databases to identify relevant randomized controlled trials(RCTs)published before September 2022.Two review authors independently searched and screened the literature,extracted the data,and assessed the methodological quality of the studies using criteria from ROB 2.0,and analyzed the data using Review Manager 5.4 software.RESULTS A total of 12 RCTs including 767 participants with migraine met the selection criteria.We divided these studies into comparisons of YXQN with placebo,routine treatment drugs,and other Chinese patent medicines.The meta-analysis showed the following:(1)Efficacy:The YXQN group outperformed the placebo group[relative risk(RR)=0.29,95%confidence interval(95%CI):0.15–0.43,P<0.00001],routine treatment group(RR=0.18,95%CI:0.09–0.27,P<0.0001),and Chinese patent medicine group(RR=0.27,95%CI:0.13–0.41,P<0.001);(2)frequency of headache:There was a significant difference between YXQN vs placebo[mean difference(MD)=-1.25,95%CI:-1.60 to-0.90,P<0.00001],routine treatment drugs(MD=-0.85,95%CI:-1.15 to-0.56,P<0.00001),and Chinese patent medicine(MD=-0.91,95%CI:-1.35 to-0.46,P<0.0001);(3)headache duration:We found great heterogeneity between studies,with no differences between YXQN and placebo(MD=-0.61,95%CI:-1.53 to-0.31,P=0.19)and routine treatment drugs(MD=-0.22,95%CI:-0.89 to 0.46,P<0.53).YXQN was more effective than other Chinese patent medicines in reducing headache duration(MD=-1.24,95%CI:-1.70 to-0.77,P<0.00001);and(4)headache severity:There was no significant difference between YXQN vs placebo(MD=-1.67,95%CI:-3.52 to 0.19,P=0.08),routine treatment drugs(MD=-0.53,95%CI:-2.02 to 0.96,P=0.68),and other Chinese patent medicines(MD=-0.49,95%CI:-2.83 to 1.85,P=0.68).Mild gastrointestinal adverse reactions were reported in three cases.CONCLUSION This study revealed that YXQN is effective and safe for treatment of migraine.

Prescribing Chinese patent medicines without traditional Chinese medicine training is now banned in China

On July 1, 2019, the website of the National Health Commission of the People’s Republic of China issued the “Notice on printing and distributing the first batch of national key monitoring and rational drugs (chemicals and biological products)”(National Health Office Medical Letter [2019] No. 558)[1], where the third article stipulates:“Other types of physicians, after not less than one year of systematically studying Chinese medicine professional knowledge and passing the examination, in accordance with the basic principles of syndrome differentiation, can issue prescriptions for Chinese patent medicine”.

Based on the national patent database to explore the rule of traditional Chinese medicine in the treatment of hyperlipidemia

Objective:To explore the medication law of traditional Chinese medicine compound patent for hyperlipidemia,and to provide reference for the research and development of traditional Chinese medicine new drugs for clinical treatment of hyperlipidemia.Methods:All compound TCM patents related to the treatment of hyperlipidemia were searched and extracted from the national patent database(http://epub.sipo.gov.cn)from the establishment of the database to 10st,March 2021.The data was established by the TCM Inheritance Support System(V2.5)and Microsoft Excel 2010 Softwore,and used to conduct TCM syndromes,frequency statistics,four nature and five flavors of traditional Chinese medicine,meridian attribution statistics.IBM SPSS statistics 20 software was used for drug clustering analysis,IBM SPSS modeler 18.2.2 software was used for association rules and web visualization analysis.Results:Totally 284 compound TCM patents were included,involving 577 kinds of Chinese medicine,and the most common syndrome was Yin deficiency of liver and kidney syndrome(74 times,accounting for 26.06%).The most ten common Chinese materiamedica was Hawthorn,Salvia miltiorrhiza,Alismaorientalis,Cassia seed,Polygonummultiflorum,Licorice,Poriacocos,chinese rhubarb,dried tangerine peel,Radix Paeoniae Alba.The top three appeared frequently in drug categories were tonifying deficiency medicine,activating blood-circulation and dissipating blood-stasis medicine,and heat-clearing medicine,respectively.The top two of its drug properties were warm and cold;the top three drug tastes were sweet,bitterness and pungent;the top two meridians were liver and spleen meridian,respectively.Seven drug groups were obtained by cluster analysis,and 16 were obtained by association rule analysis,including 5 drug pairs and 11 three drug groups.Conclusion:Through the data mining of the patent of traditional Chinese medicine compound prescription for regulating and treating hyperlipidemia,it is concluded that the fundamental pathogenesis of the disease is deficiency of viscera function and obstruction of phlegm and blood stasis.The clinical methods are tonifying the liver and kidney,activating blood circulation and removing stasis,resolving phlegm and removing dampness.Traditional Chinese medicine is mostly used for tonifying deficiency,activating blood circulation,removing stasis,resolving phlegm and removing dampness.This paper provides a reference for the research and development of traditional Chinese medicine for hyperlipidemia.

Analysis and Suggestions on Patent Application Status for Traditional Chinese Medioine Cosmetics

From the perspective of patent application, the development process of traditional Chinese medicine （TCM） cos- metics was summarized. The legal status, regional distribution, applicants, and function distribution of patent applica- tions for TCM cosmetics in China were primarily analyzed. Suggestions on the future development of TCM cosmetics were given, and it was pointed out that it should pay more attention to intellectual property protection, as well as in- heriting TCM theory, only then TCM cosmetics can get an edge over the competition at home and abroad.

日本汉方药物的妊娠期和哺乳期风险评估及对我国中成药的影响

目的:通过对日本汉方药物的药品说明书进行妊娠期和哺乳期风险分析,评估日本汉方药物的用药风险及其对于我国中成药妊娠期风险评估的影响,为进一步开展我国中成药的妊娠期和哺乳期风险评估提供借鉴及参考。方法:针对日本医药品与医疗器械局平台收集及整理的148种医用日本汉方药物相关药品说明书,分析妊娠期和哺乳期相关表述,评估具有用药风险的日本汉方药物及中药组分。结合我国《中华人民共和国药典:一部》(2020年版)、《中药药物警戒》和《中药药性论》等中药典籍,对日本汉方药物可能存在的妊娠期潜在风险进行评估。基于日本汉方药物妊娠期风险中药组分,对我国505种中成药进行妊娠期风险评估,分析其对我国中成药妊娠期风险的影响。结果:日本148种日本汉方药物中,存在妊娠风险的药物共39种。妊娠期风险的中药组分包括大黄、牡丹皮、附子、桃仁、牛膝、芒硝和红花,主要为自身毒性及对于流产、早产的影响。哺乳期风险日本汉方药物中,因含有大黄而易引起新生儿腹泻的药物共18种。根据我国典籍评估,日本汉方药物具有潜在风险共93种。依据日本汉方药物风险组分,我国505种中成药中具有妊娠期潜在风险的药物共59种,占345种未标注妊娠期禁忌药物种类的17.1%。结论:日本汉方药物基于妊娠期和哺乳期风险的中药组分对其日本汉方药物成药风险进行评估,其特殊人群的风险表述方法对我国中成药发展具有一定的借鉴意义。

基于数据挖掘探讨专利中药复方治疗原发性痛经的组方规律

目的基于数据挖掘研究中药复方专利治疗原发性痛经的用药及配伍规律,为临床治疗原发性痛经提供参考。方法检索国家知识产权局专利数据库中治疗原发性痛经的中药复方专利数据,借助Excel Office 2021和Origin 2021进行描述性分析,结合IBM SPSS Modeler和R4.3.1进行Aprior关联规则和聚类分析,运用Cytoscape 3.9.1软件计算相关拓扑学属性值并构建核心复杂网络。结果最终纳入治疗原发性痛经的中药复方专利共165项,涉及中药466味,总频次1775味,高频药物包括当归(78次,47.27%)、延胡索(64次,38.79%)、川芎(57次,34.55%)、香附(56次,33.94%)、白芍(47次,28.48%)等;药物类别以活血止痛药(171次,9.63%)、补血药(154次,8.68%)、活血调经药(140次,7.89%)为主;聚类分析得到3类药物组合,核心药物组合为当归-川芎-香附-延胡索;经关联规则分析得到五灵脂-延胡索等二项关联规则3条,白芍-川芎-当归等三项关联规则24条,白芍-川芎-甘草-当归等四项关联规则3条。结论中药复方专利治疗原发性痛经以养血活血、调经止痛为主,同时配伍行气、温里等个体化的辨证诊治。

中成药治疗肾性贫血及其临床研究现状

目的分析并梳理中成药治疗肾性贫血的临床研究,以期为临床实践和未来研究方向提供参考。方法系统检索8个中英文数据库,收集中成药治疗肾性贫血的临床研究。采用描述性总结与图表结合的形式对结果进行展示。结果共纳入60篇研究,其中首篇关于中成药治疗肾性贫血的临床研究发表于2000年,绝大部分研究发表于近5年。研究类型最多的是随机对照试验,占比90%。关于透析依赖性肾性贫血的研究40篇,研究对象2916例;非透析依赖性肾性贫血研究2篇,研究对象174例;未提及透析或者非透析依赖的肾性贫血研究有18篇,研究对象1279例。临床研究中干预措施的对比形式主要是中成药联合西药与单用西药的对比。纳入的研究中有40篇将“血红蛋白的变化”设定为一项结局指标,其次是“总有效率”(35篇)。结论现阶段治疗肾性贫血的中成药种类繁多,其有效性和安全性尚待进一步研究。此外,临床研究的结局指标不一致,无法保证研究的科学性和严谨性。

现代化中医药专利保护的制度困境与出路--基于对中医药特点与专利保护适应性的反思

符合西医药特点的专利保护制度在中医药现代化进程中难以适应。尽管现行专利制度已对涉及中药领域发明专利申请审查的特殊情形作出了具体规定,但在本土语境下据此保护主要根植于我国传统知识领域的中医药发明创造时,中医药的复杂性、整体性、道地性和时节性、差异性等特点仍未得到充分体现,并由此产生中医相关发明创造不具有专利适格性、专利审查缺乏一般性指导规则、申请文件难以通过合规性审查、申请主题的可专利性要求过高、关键性概念缺乏细化指导规则等问题。为此,可从专门审查标准的制定和商业秘密的补充保护两方面出发,寻求前述问题的具体解决方案,以应对中医药专利保护的适应性需求,从而完善中医药知识产权保护体系。

中医药类专利国际合作申请现状分析与建议

以中医药类专利跨国合作申请为切入点,探讨中医药国际科研合作现状、问题与需求,并提出建议。研究发现,在11192项中医药类国际专利申请中,单一申请人的国际专利为8239项,占总数量的73.62%;合作申请为2953项,其中76.53%为国内合作申请,剩余23.47%为跨国合作申请,以中国为主要技术来源的申请约占跨国合作申请的40.8%。跨国合作申请的主申请人主要为跨国药企,国内则以科研机构为主,企业占比较小。国内药企及科研院所在国际专利申请布局上倾向于单一申请,但总量较小,一方面与其研发实力较强有关,另一方面与专利保护有关。提出采取合作申请方式有助于我国在国际上的知识产权布局与保护。

A novel classification method for aid decision of traditional Chinese patent medicines for stroke treatment

Traditional Chinese patent medicines are widely used to treat stroke because it has good efficacy in the clinical environment. However, because of the lack of knowledge on traditional Chinese patent medicines, many Western physicians, who are accountable for the majority of clinical prescriptions for such medicine, are confused with the use of traditional Chinese patent medicines. Therefore, the aid-decision method is critical and necessary to help Western physicians rationally use traditional Chinese patent medicines. In this paper, Manifold Ranking is employed to develop the aid-decision model of traditional Chinese patent medicines for stroke treatment. First, 115 stroke patients from three hospitals are recruited in the cross-sectional survey. Simultaneously, traditional Chinese physicians determine the traditional Chinese patent medicines appropriate for each patient. Second, particular indicators are explored to characterize the population feature of traditional Chinese patent medicines for stroke treatment. Moreover, these particular indicators can be easily obtained by Western physicians and are feasible for widespread clinical application in the future. Third, the aid-decision model of traditional Chinese patent medicines for stroke treatment is constructed based on Manifold Ranking. Experimental results reveal that traditional Chinese patent medicines can be differentiated. Moreover, the proposed model can obtain high accuracy of aid decision.

A Systematic Review of RCTs and quasi-RCTs on Traditional Chinese Patent Medicines for Treatment of Chronic Hepatitis B

Traditional Chinese patent medicines (TCPMs) are widely used for treatment of chronic hepatitis B (CHB) in China. To estimate the overall effectiveness of TCPMs for CHB, we performed a systematic review of clinical reports designed as randomized controlled trials (RCTs). One hundred and thirty-eight available RCTs and quasi-RCTs on 62 TCPMs, involving 16,393 patients, were included. The methodological quality of these trials was generally "poor". Few trials (6.52%) reported the methods of randomization correctly. Another common problem was the lack of allocation concealment, proper blinding, and the reporting of lost cases and dropouts. Forty-two trials (30.43%) on 27 TCPMs reported some anti-viral effect of TCPMs. Others reported beneficial aspects, including improvements of liver function (79.71% of the studies), liver fibrosis (29.99%), and CHB symptoms (92.75%). Forty-one articles (29.71%) reported mild adverse events with TCPMs but these occurred infrequently. In summary, the outcome of the report on currently registered TCPMs may be biased due to poor methodology. The data from these trials, therefore, is too weak to use in forming a recommendation for treatment of CHB. Nevertheless, five drugs (Dan Shen agents, Da Huang Zhe Chong pill/capsule, Shuang Hu Qing Gan granule, Fu Zheng Hua Yu granule and Cao Xian Yi Gan capsule) appear to be more effective than the other TCPMs.

Value and influencing factors of valid Traditional Chinese Medicine compound prescription patents for mammary gland hyperplasia

OBJECTIVE: To explore the value and factors influencing the maintenance of valid Traditional Chinese Medicine compound prescription patents for the management of mammary gland hyperplasia. METHODS: The State Intellectual Property Office Patents Database, China Patent Information Center Patents Database, Soopat Patent Search Platform, and CNIPR Search Platform of Chinese and Foreign Patent Database were searched to identify Traditional Chinese Medicine compound prescription patents for mammary gland hyperplasia that had been maintained for at least 5 years. Logistic regression analysis was used to detect the factors influencing the maintenance of valid patents. RESULTS: From 1 January 1993 to 31 December 2019, a total of 1228, Traditional Chinese Medicine compound prescription patents for mammary gland hyperplasia were authorized. Of these applications, 381 patents were granted and only 176 patents were maintained for more than 5 years. The five independent variables assessed in this study all had significant explanatory functions. CONCLUSIONS: The maintenance of valid patents for Traditional Chinese Medicine compound prescriptions for treating mammary gland hyperplasia is of great importance. The maintenance of such patents depends on many factors, such as the concentration of effective herbs, number of dependent claims, provision of new dosage forms and detailed experimental data, and transfer of patent rights.

四磨汤口服液治疗功能性消化不良临床综合评价

目的以药品临床价值为导向,对四磨汤口服液治疗功能性消化不良开展临床综合评价,为四磨汤口服液的合理定价、合理用药以及药品目录遴选提供科学依据。方法基于当前可获得数据以及调研数据,围绕四磨汤口服液与两种对照药治疗功能性消化不良的有效性、安全性、经济性、创新性、适宜性和可及性6个维度开展临床综合评价。结果有效性方面,四磨汤口服液可提高临床有效率,药理作用机制明确。安全性方面,未见毒性反应,不良反应较轻,预后良好。经济性方面,日均费用略高于对照药,具有一定成本效果优势。创新性方面,获中国专利授权,并作为中药创新药上市。适宜性方面,方便服用,在药物技术特性和药品使用方面都具有较好的适宜性。可及性方面,医院覆盖较广,产能充足,患者负担较低,长期应用无较大环境风险。3种中成药的综合价值分数从高到低依次为四磨汤口服液(92.01分)>对照药A(85.11分)>对照药B(77.51分)。专家组推荐意见为A类(21/23),建议可直接转化为决策使用。结论四磨汤口服液治疗功能性消化不良的临床综合价值较高,可为药品合理定价、合理用药以及药品目录遴选提供参考依据。