Identification of Myocardial Scarring Using Contrast-Free Cardiac MRI in Patients With Autoimmune Rheumatic Diseases.

BACKGROUND: Late gadolinium enhancement (LGE) cardiac MRI is the method of choice in revealing the presence of myocardial scarring, but its availability remains limited in clinical practice. PURPOSE: To assess myocardial scarring in patients with autoimmune rheumatic diseases (ARDs) using contrast-free cardiac MRI with a radiomics model. STUDY TYPE: Retrospective. POPULATION: One hundred ninety-two patients (mean age, 41 years ± 15, 62 men) with or without ARDs, grouped into a training set of 153 patients and a testing set of 39 patients. FIELD STRENGTH/SEQUENCE: 3.0 T/ cine imaging with a balanced steady-state free precession sequence, T1 mapping with a modified Look-Locker inversion recovery sequence, and LGE imaging with a phase-sensitive inversion recovery gradient echo sequence. ASSESSMENT: LGE assessment was the reference standard for identifying myocardial scarring. Based on motion features extracted from cine images and tissue characterization features extracted from native T1 maps, a fully automated radiomics model with T1, cine MRI, or combined inputs was developed. STATISTICAL TESTS: Logistic regression model was used to detect myocardial scarring using contrast-free cardiac MRI parameters. Receiver operating characteristic curves were analyzed to assess the accuracy, sensitivity, and specificity in detecting myocardial scarring. Sensitivities of the models were further assessed in patients with various myocardial scarring proportions. Z-statistic and dice coefficient were assessed to compare the performance. P-values <0.05 were considered significant. RESULTS: The multivariable regression model exhibited an accuracy of 85.3%, a sensitivity of 93.5%, and a specificity of 50.0%. The radiomics model with T1 and cine MRI input exhibited an accuracy of 75.7%, a sensitivity of 60.9%, and a specificity of 85.5%. Moreover, the radiomics model showed a sensitivity of 90.9% among patients with >25% myocardial scarring. DATA CONCLUSIONS: The proposed radiomics model allowed for the identification of myocardial scarring similar to LGE, but on contrast-free cardiac MRI in patients with ARDs. EVIDENCE LEVEL: 3 TECHNICAL EFFICACY: Stage 1.

Coronary Artery Stent Evaluation by CTA: Impact of Deep Learning Reconstruction and Subtraction Technique.

BACKGROUND. Coronary CTA with hybrid iterative reconstruction (HIR) is prone to false-positive results for in-stent restenosis due to stent-related blooming artifact. OBJECTIVE. The purpose of this study is to assess the impact of deep learning reconstruction (DLR), subtraction images, and the combination of DLR and subtraction images on the diagnostic performance of coronary CTA for the detection of in-stent restenosis. METHODS. This prospective study included patients with coronary stents who underwent coronary CTA between March 2020 and August 2021. CTA used a technique with two breath-holds (noncontrast and contrast-enhanced acquisitions). Conventional and subtraction images were reconstructed for HIR and DLR. The maximum visible instent lumen diameter was measured. Two readers independently evaluated images for in-stent restenosis (≥ 50% stenosis). A simulated assessment of combined conventional and subtraction images was generated, reflecting assessment of conventional and subtraction images in the presence or absence of severe misregistration artifact, respectively. Invasive angiography served as reference standard. RESULTS. The study enrolled 30 patients (22 men and eight women; mean age, 63.6 ± 7.4 [SD] years) with a total of 59 stents; severe misregistration artifact was present for 32 stents. Maximum visible in-stent lumen diameter was higher for DLR than for HIR (2.3 ± 0.5 vs 2.1 ± 0.5 mm, p < .001), and among stents without severe misregistration artifact, it was higher for subtraction than conventional DLR (3.0 ± 0.5 vs 2.4 ± 0.5, p < .001). Among conventional CTA with HIR, conventional CTA with DLR, combination (conventional and subtraction) approach with HIR, and combination (conventional and subtraction) approach with DLR, the highest patient-level diagnostic performance measures were as follows: for reader 1, sensitivity was identical (62.5%), specificity was highest for combination with DLR (90.1%), PPV was highest for combination with DLR (71.4%), NPV was highest for combination with DLR (87.0%), and accuracy was highest for combination with DLR (83.3%); for reader 2, sensitivity was identical (50.0%), specificity was highest for combination with HIR or DLR (both 95.5%), PPV was highest for combination with HIR or DLR (both 80.0%), NPV was highest for combination with HIR or DLR (84.0%), and accuracy was highest for combination with HIR or DLR (both 83.3%). CONCLUSION. The combined DLR and subtraction technique yielded optimal diagnostic performance for detecting in-stent restenosis by coronary CTA. CLINICAL IMPACT. The described technique could guide patient selection for invasive coronary stent evaluation.

Arginine Expedites Erastin-Induced Ferroptosis through Fumarate.

Ferroptosis is a newly characterized form of programmed cell death. The fundamental biochemical feature of ferroptosis is the lethal accumulation of iron-catalyzed lipid peroxidation. It has gradually been recognized that ferroptosis is implicated in the pathogenesis of a variety of human diseases. Increasing evidence has shed light on ferroptosis regulation by amino acid metabolism. Herein, we report that arginine deprivation potently inhibits erastin-induced ferroptosis, but not RSL3-induced ferroptosis, in several types of mammalian cells. Arginine presence reduces the intracellular glutathione (GSH) level by sustaining the biosynthesis of fumarate, which functions as a reactive α,ß-unsaturated electrophilic metabolite and covalently binds to GSH to generate succinicGSH. siRNA-mediated knockdown of argininosuccinate lyase, the critical urea cycle enzyme directly catalyzing the biosynthesis of fumarate, significantly decreases cellular fumarate and thus relieves erastin-induced ferroptosis in the presence of arginine. Furthermore, fumarate is decreased during erastin exposure, suggesting that a protective mechanism exists to decelerate GSH depletion in response to pro-ferroptotic insult. Collectively, this study reveals the ferroptosis regulation by the arginine metabolism and expands the biochemical functionalities of arginine.

State of the Art: Quantitative Cardiac MRI in Cardiac Amyloidosis.

Cardiac amyloidosis (CA) is characterized by amyloid infiltration in the myocardial extracellular space, causing heart failure. Patients with CA are currently underdiagnosed. Cardiac involvement is significantly associated with the prognosis and treatment decision-making for CA. Early identification and accurate stratification are the crucial first step in patient management. Comprehensive cardiac MRI-based evaluation of the cardiac structure, function, and myocardial tissue characterization assesses cardiac involvement by tracing disease processes. Emerging quantitative tissue characterization techniques have introduced new measures that can identify early staged CA and monitor disease progression or response after treatment. Quantitative cardiac MRI is becoming an instrumental tool in understanding CA, which leads to changes in individualized patient care. This review aimed to discuss the quantitative cardiac MRI-based assessment of CA using established and emerging techniques. EVIDENCE LEVEL: 5 TECHNICAL EFFICACY: Stage 3.

The impact of deep learning reconstruction on image quality and coronary CT angiography-derived fractional flow reserve values.

OBJECTIVES: To explore the impact of deep learning reconstruction (DLR) on image quality and machine learning-based coronary CT angiography (CTA)-derived fractional flow reserve (CT-FFRML) values. METHODS: Thirty-three consecutive patients with known or suspected coronary artery disease who underwent coronary CTA and subsequent invasive coronary angiography were enrolled. DLR was compared with filtered back projection (FBP), statistical-based iterative reconstruction (SBIR), model-based iterative reconstruction (MBIR) Cardiac, and MBIR Cardiac sharp for objective image qualities of coronary CTA. Invasive fractional flow reserve (FFR) and quantitative flow ratio (QFR) were used as the reference standards. The diagnostic performances of different reconstruction approach-based CT-FFRML were calculated. RESULTS: A total of 182 lesions in 33 patients were enrolled for analysis. The image quality of DLR was superior to the others. There were no significant differences in the CT-FFRML values among these five approaches (all p > 0.05). Of the 182 lesions, 17 had invasive FFR results, and 70 had QFR results. Using FFR as a reference, MBIR Cardiac, MBIR Cardiac sharp, and DLR achieved equal diagnostic performance, slightly higher than the other reconstruction approaches (MBIR Cardiac, MBIR Cardiac sharp, and DLR: AUC = 0.82, FBP and AIDR: AUC = 0.78, all p > 0.05). Using QFR as a reference, the AUCs of FBP, SBIR, MBIR Cardiac, MBIR Cardiac sharp, and DLR were 0.83, 0.81, 0.86, 0.84, and 0.83, respectively (all p > 0.05). CONCLUSIONS: Our study showed that the DLR algorithm improved image quality, but there were no significant differences in the CT-FFRML values and diagnostic performance among different reconstruction approaches. KEY POINTS: • Deep learning-based image reconstruction (DLR) improves the image quality of coronary CTA. • CT-FFRML values and diagnostic performance of DLR revealed no significant differences compared to other reconstruction approaches.

[Series of group standards of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions].

Drug instructions,the statutory and technical documents recording effectiveness and safety information,are an important basis for guiding doctors,pharmacists,and patients to use drugs rationally,and their scientificity,standardization,and accuracy directly affect the medication safety of the public. The sections of adverse drug events,contraindications,precautions,warnings,and application for specific populations in drug instructions directly express safety information and measures for rational use of drugs. In the drug life cycle,marketing authorization holders( MAHs) need to update safety information in the instructions promptly to ensure the safety and effectiveness of clinical drug medication. At present,revising instructions is an important measure to control drug risks. In the drug life cycle,in order to standardize the revision of safety information in the instructions by MAHs and eliminate inexact terms such as " unclear",the Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,have been established under the guidance of Standardization Department,China Association of Chinese Medicine. Therefore,on the basis of the existing rules and regulations,the standardized technical procedures for revising instructions came into being to help clinical safe and rational medication of drugs,and implement the strategy of " Healthy China".

[Interpretation of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions].

Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,were proposed by Professor ZHANG Bing from Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,and underwent centralized management by Chinese Association of Chinese Medicine. They were officially released on July 23 and implemented on July 31,2021. The series of group standards consist of six sections,including general principles,adverse drug events,contraindications,precautions,application for special populations,and warnings. The section of general principles is comprised of holistic and programmatic expressions,which explain the general technical requirements for revising the marketed Chinese patent medicine instructions. The other five sections focus on information collection,screening,transformation,and illustration of specific items,forming a standardized revision technical process. This series of standards is the result of multiple rounds of research and the suggestions of more than 200 experts in different professional fields of " medicine-pharmacy-management-law-enterprise" have been gathered therein to reach a consensus. With the purposes of establishing standardized technical specifications for the revision of safety information in the marketed Chinese patent medicine instructions,guiding marketing authorization holders in revising the instructions,filling the gaps in the research of Chinese patent medicine instructions,promoting the deve-lopment of pharmaceutical care and academic research,and encouraging the rational and safe medication of Chinese patent medicine,the series of group standards is of great significance.

Fructus Ligustri Lucidi preserves bone quality through induction of canonical Wnt/ß-catenin signaling pathway in ovariectomized rats.

Fructus Ligustri Lucidi (FLL) has been preclinically and clinically used to treat musculoskeletal diseases. However, whether and how FLL affect the canonical Wnt/ß-catenin signaling in the management of osteoporosis remains largely unknown. To this end, ovariectomized (OVX) rats and primary osteoblasts were administrated with FLL aqueous extract and medicated serum, respectively. Supplement of FLL to OVX rats maintains bone quality by attenuating the reduction in bone mineral density, strength and microstructure. The maintenance may be associated with upregulating the expression of insulin-like growth factor-1, osteoprotegerin, phospho (p)-low-density lipoprotein receptor-related protein 6, p-glycogen synthase kinase 3 beta (GSK3ß), ß-catenin, Runx2 and c-Myc, and downregulating the expressions of sclerostin (SOST), dickkopf-related protein 1 (DKK1), GSK3ß and p-ß-catenin in rat femurs and tibias. In addition, the medicated serum promotes osteoblastic bone formation through activation of Wnt/ß-catenin signaling via inhibition of DKK1 and SOST overexpression. Salidroside may be one of the active ingredients in FLL that are beneficial for bone homeostasis. In summary, our results suggest that FLL may preserve bone quality through induction of canonical Wnt/ß-catenin signaling via inhibition of DKK1 and SOST overexpression. And FLL may offer a new source of the DKK1 or SOST inhibitors in protection against osteoporosis.

[Pre-searching during formulation of expert consensus on clinical application of Chinese patent medicines:Yanshen Jianwei Capsules as example].

The formulation of expert consensus on clinical application of Chinese patent medicines, in means of exploring the effective combination of experience and evidence to form a research method in line with the characteristics of Chinese patent medicines, is an important transitional stage for clinical researches on Chinese patent medicines. Pre-searching is a new step in the formulation of expert consensus on clinical application of Chinese patent medicines. Before steps of interview and investigation on clinical application, pre-searching is conducted to collect publications and literature on certain variety and similar Chinese patent medicines; the publications on related medical classics and formulas of this variety; the recommendation condition of this variety in clinical practice guidelines and expert consensus; and the medication regimens recommended in disease-specific guidelines. Pre-searching is designed to know about the advantages of certain variety of Chinese patent medicine as well as its potential problems recorded in the literature, which is helpful to find out the clinical positioning of Chinese patent medicines, develop reasonable clinical questions and provide ideas for formal literature searching. However, it is not the direct basis for developing clinical questions. Moreover, interviews and investigations are still needed to further clarify the clinical positioning of Chinese patent medicines and develop reasonable questions. This paper took expert consensus on clinical application of Yanshen Jianwei Capsules as an example to introduce the pre-searching process and methods used during formulation of expert consensus on clinical application of Chinese patent medicines, and to further discuss the role of pre-searching to facilitate the formulation of clinical questions on selection of participants, interventions, controls and outcomes.

[Technical specification for Instructions for Clinical Application of Chinese Patent Medicines in China Association of Chinese Medicine].

In order to solve the problems of confusion in clinical medication and imperfect instructions in Chinese patent medicines(CPMs), the Standardization Department of the China Association of Chinese Medicine and Center for Pharmacovigilance and Rational use of Chinese Medicine in Beijing University of Chinese Medicine jointly compiled the Instructions for Clinical Application of Chinese Patent Medicines(CPMs). As the interpretation and supplement of drug instruction information, it aims to guide clinical safety and rational use of CPMs. In addition, the technical specification for clinical application description of CPMs has been formulated, which covers the seven processes of "carding instructions, clinical investigation, data retrieval, data screening, evidence classification, path transformation and writing format". It will enable readers of Instructions for Clinical Application of Chinese Patent Medicines to understand the work behind the compilation.

[Consideration on establishing evaluation system of clinical practice guidelines in traditional Chinese medicine].

Standardization is the technical support for the development of traditional Chinese medicine(TCM), and the guidelines have become the main component of the core standards of TCM technology. With the rise and development of evidence-based medicine in China, more than 500 guidelines have been issued in China, and the number is still increasing, but the quality of guidelines still lags far behind the international level. Similarly, the formulation of evidence-based clinical practice guidelines for TCM has gradually attracted the attention of the industry, but the quality is not so good, and most guidelines are not really evidence-based guidelines. Only reliable guidelines can fully and effectively play the role of clinical guidance. In order to comprehensively improve the scientificity and credibility of the guidelines, guideline evaluation can be used as a means to improve the quality of the guidelines. For the development of traditional Chinese medicine, it has become an urgent task to establish a complete evaluation standard system of guidelines, especially the evaluation standard system that conforms to the technical characteristics of traditional Chinese medicine. In this paper, the advantages and limitations of a series of domestic and foreign guideline evaluation tools were systematically analyzed, and the thinking and difficulties to establish the evaluation system of TCM guidelines were put forward, with a purpose to further improve the quality of TCM clinical practice guidelines, so that they can be better applied in clinical practice to enhance the clinical efficacy of TCM and ensure the quality of medical services.

[Quality evaluation recommendation list and interpretation of traditional Chinese medicine clinical practice guidelines].

Based on the idea of establishing a complete guideline evaluation system applicable to the field of traditional Chinese medicine(TCM), the author believes that a complete guideline evaluation system of traditional Chinese medicine clinical practice should be divided into three parts: quality evaluation, clinical applicability evaluation and clinical application investigation. According to the different purposes, different evaluators, different evaluation methods and different evaluation time points in the guideline evaluation, the quality evaluation recommendation list, the clinical applicability evaluation recommendation list and the clinical application questionnaire were formed. Among them, the purpose of quality evaluation is to evaluate the methodological quality in the guideline development process, in order to measure whether the entire guideline development process is scientifically rigorous. The evaluators must be the methodologists with an evidence-based medicine background. Therefore, a logical, detailed and comprehensive guideline quality evaluation list will provide good evaluation tools for the TCM guideline formulation team and play an important role in promoting the quality and application of the guidelines. By referring to the internationally recognized development process and methods of evaluation tools, as well as the proof by authoritative TCM clinical experts and methodologists, the author worked out the quality evaluation list of clinical practice guidelines applicable to the field of TCM by considering the characteristics of TCM field. In this paper, the author introduces the whole list of quality evaluation recommendations, and interprets each item in details, hoping to provide reference for the standardization of TCM clinical practice guidelines in the future.

[Applicability evaluation recommendation list and interpretation of traditional Chinese medicine clinical practice guidelines].

The development of the guidelines should not only meet the rigorous methodological requirements, but also ensure the credibility or enforceability of the guideline recommendations when they are applied in clinical practice. Based on the idea of establi-shing a perfect guideline evaluation system applicable to the field of traditional Chinese medicine(TCM), the author believed that a complete evaluation system of clinical practice guidelines in the field of TCM shall be divided into three parts: quality evaluation, applicability evaluation and clinical application investigation. Among them, applicability evaluation refers to the evaluation of the degree of fit between the guideline and clinical practice, that is, whether the guidelines have good readability and clinical applicability to promote clinical application. The evaluators are clinical experts in the related fields of TCM. Therefore, a logical, detailed and comprehensive guideline quality evaluation list will provide good evaluation tools for the TCM guideline formulation team and play an important role in promoting the quality and application of the guidelines. Based on the internationally recognized development process and methods of evaluation tools, as well as the proof by authoritative TCM clinical experts and methodologists, the author worked out the quality evaluation list of clinical practice guidelines applicable to the field of TCM. In this paper, the author introduces the whole list of quality evaluation, and interprets each item in details, hoping to provide reference for the standardization of TCM clinical practice guidelines in the future.

[Current status,problems and countermeasures of construction of standardization system of traditional Chinese medicine].

At present,China has issued a series of standards relating to traditional Chinese medicine(TCM). The standard system has already taken shape,but there are still some problems,such as incomplete standard system,low standard quality,inadequate application,insufficient study strength and lack of talent. This paper makes a detailed analysis of current management and development of standardization of traditional Chinese medicine in the aspects of " management mechanism and system construction" and " standards".The problems existing in the standardization of TCM are analyzed in three aspects: quality and popularization,standard research and talent reserve. At the same time,some suggestions are put forward to solve the problems. First,we shall strengthen the management of top-level design; second,we shall guide the transformation of high-quality scientific and technological achievements to standards;third,we shall consolidate the basic research of standardization of TCM; fourth,we shall focus on cultivating standardized technical talents; and fifth,we shall strengthen the standard research and development work in key fields.

[Reporting standards for expert consensus on clinical practice of Chinese patent medicines of China Association of Chinese Medicine].

In 2018,Standardization Department of China Association of Chinese Medicine invited methodologists with the background of evidence-based medicine to discuss and draft a series of standards for expert consensus on clinical practice of Chinese patent medicines. These standards have been made by reference to the published standards for developing expert consensus and clinical practice guidelines. These standards were made based on full consideration of the current evidence status and the history of clinical practice of Chinese patent medicines. These standards were composed of four parts,namely information summary items,normative general items,normative technical items and information supplementary items,including cover,content,preface,introduction,title,scope,basic Information of Chinese patent medicine,suggestions for clinical application,safety,conflict of interest,appendix,and references,so as to provides reference for improving the quality of expert consensus-based compilation and enhancing the applicability of expert consensus.

[Guidance of instructions for compiling expert consensus on clinical practice of Chinese patent medicine of China Association of Chinese Medicine].

The expert consensus on clinical practice of Chinese patent medicines shall be regarded as the same with clinical practice guidelines,which shall be concise,readable and applicable. Therefore,a formal expert consensus is unable to contain the whole compilation process and the content of its important process documents. It is necessary to write instructions for continuation,expansion and publicity. In 2018 Standardization Department of China Association of Chinese Medicine invited methodologists with the background of evidence-based medicine drafted a series of standards for expert consensus on clinical practice of Chinese patent medicines,including the guidance for compilation the instructions. It will be useful for readers of expert consensus to understand the work behind the compilation,so as to make the compilation process more transparent and standardized. We proposed nine requirements for compilation the instructions,namely content and requirements,work overview,main technical content,compilation process,process and basis for handling major disagreements,expert consensus implementation requirements and measure suggestions,other issues need to be explained,appendix and format for instructions.

Fructus Ligustri Lucidi modulates estrogen receptor expression with no uterotrophic effect in ovariectomized rats.

BACKGROUND: Accumulating evidence suggests that Fructus Ligustri Lucidi (FLL) plays a beneficial role in preventing the development of osteoporosis. However, the effects of FLL on estrogen receptor (ER) α and ERß expressions remain unknown. Therefore, in the current study we attempted to probe into the effects of FLL on ERα and ERß expressions in femurs, tibias and uteri of ovariectomized (OVX) rats. METHODS: The OVX rats were orally administrated with FLL water extract (3.5 g/kg/day) for 12 weeks. The uteri, femurs, tibias and serum were harvested from rats. The serum levels of estrogen (E2), luteinizing hormone (LH) and follicle-stimulating hormone (FSH) were determined by ELISA. The expressions of ERα and ERß in the femurs and tibias as well as uteri were analysed by western blot and immunohistochemical staining. RESULTS: FLL treatment did not increase uterus relative weight in OVX rats. Further, FLL treatment increased ERα expression in the femurs and tibias, and enhanced ERß expression in the uteri of OVX rats. However, the resulted expression of ERα was stronger than that of ERß in OVX rats in response to FLL treatment. Meanwhile, administration with FLL to OVX rats increased FSH and LH but did not increase E2 level in the serum. CONCLUSION: FLL treatment shows tissue selection on ERα and ERß expressions in the femurs and tibias as well as uteri of OVX rats without uterotrophic effect, which may offer the scientific evidence of the efficiency and safety of its clinical application.

Radix Salviae miltiorrhizae improves bone microstructure and strength through Wnt/ß-catenin and osteoprotegerin/receptor activator for nuclear factor-κB ligand/cathepsin K signaling in ovariectomized rats.

Although radix Salviae miltiorrhizae (RSM) is reported to exhibit the antiosteoporotic effect in preclinical study, the underlying mechanism is unclear. To this end, ovariectomized (OVX) rats were employed with administration of RSM (5 g/kg) for 14 weeks. The disturbed serum levels of alkaline phosphatase (ALP), osteoprotegerin (OPG), tartrate-resistant acid phosphatase, and receptor activator of nuclear factor-κB ligand (RANKL) in OVX rats were improved by RSM treatment. Furthermore, supplement of RSM to OVX rats resulted in an increase in femoral bone mineral density and bone strength as well as an improvement in bone microstructures. Moreover, the decreased expression of phosphor (p)-LRP6, insulin-like growth factor-1(IGF-1), ALP, and OPG, as well as increased expression of RANKL and cathepsin K in the tibias and femurs of OVX rats were shifted by RSM treatment. Additionally, RSM reversed the decreased ratio of p-glycogen synthase kinase 3ß (GSK3ß) to GSK3ß and increased ratio of p-ß-catenin to ß-catenin in OVX rats. Altogether, it is suggestive that RSM improves bone quantity and quality by favoring Wnt/ß-catenin and OPG/RANKL/cathepsin K signaling pathways in OVX rats thereby suggesting the potential of this herb to be a novel source of antiosteoporosis drugs.

[Manual for the clinical experts consensus of Chinese patent medicine].

Chinese patent medicine is widely used in clinical practice, but improper use will not only weaken the efficacy of drugs, but even cause adverse consequences. Evidence-based medicine provides guidance for clinical practice based on the best available evidence, experience of experts and needs of patients. However, considering the situation of "insufficient evidence" or "very low quality" in Chinese medicine research, experts consensus is the main basis for clinical decision-making, but expert opinions on which the consensus depends are susceptible to various subjective biases. Therefore, a reliable and scientific consensus-making process is needed to maximally avoid bias on consensus. Unlike the clinical practice guidelines, there is no unified formulating process for consensus in the world today. This article learns from a set of formulating processes from some international consensus formulating institutions/associations, combined with the characteristics and current situation of traditional Chinese medicine, and draws up a set of standard process that is suitable for the clinical experts consensus on Chinese patent medicine, with the expect of providing evidence and reference for consensus makers, and then bringing evidence-based assistance for the clinical standardized application of Chinese patent medicines.

[Discussion on issues related to clinical experts consensus of Chinese patent medicine].

The promulgation of standardized documents on traditional Chinese medicine has promoted the formulation of industrial standards of traditional Chinese medicine, including clinical practice guidelines and clinical expert consensus. In order to adapt to the current research situation of "insufficient evidence" or "very low quality" when developing clinical practice guideline in the field of traditional Chinese medicine, the author has made a retrospective study on the development of guidelines and consensus, and found that the consensus is more suitable for the current research status of Chinese patent medicine, as the stage of lack of high-quality clinical evidence will remain for a long time. However, unlike clinical practice guidelines, domestic scholars and consensus makers have insufficient understanding of the clinical experts consensus. This article will introduce the origin and status of the clinical experts consensus, the differences between clinical experts consensus and the clinical practice guidelines, and the basic principles that should be followed in the formulation of the clinical experts consensus of Chinese patent medicine, expecting to provide theory basis and reference for the normative formulation of clinical experts consensus.