[Methods for traditional Chinese medicine syndrome-based efficacy evaluation: a review].

Traditional Chinese medicine(TCM) syndrome-based efficacy is an evaluation index which is unique to TCM and can reflect the advantages of TCM. The development of the methods and measurement tools for evaluating TCM syndrome-based efficacy can provide objective and quantitative evidence for the clinical efficacy evaluation of TCM and the development of new Chinese medicine preparations, being the exploration direction of innovative methods and technologies for evaluating TCM efficacy. The conventional evaluation methods are subjective and limited to the mitigation of symptoms and the improvement of physical signs, which make it difficult to form a unified evaluation standard. In addition, the evaluation methods lack unity, objectivity, and quantitative research. The scientific connotation, evaluation ideas and methods, and key technologies of the evaluation for the therapeutic effect on syndromes remain unclear, which leads to diverse evaluation modes, methods, and indexes. The syndrome-based efficacy scale provides a new idea for the objective quantification and standardization of TCM syndromes. This review systematically summarizes the methods and problems, introduces the research progress in the evaluation scales, and puts forward some thoughts on the characteristics of TCM syndrome-based efficacy evaluation, aiming to provide insights for the research in this field.

Hyperuricemia research progress in model construction and traditional Chinese medicine interventions.

Hyperuricemia (HUA), a severe metabolic disease derived from purine metabolism disorder, will lead to abnormally increased serum uric acid (SUA) levels in the body. Studies have shown that HUA is highly related to gout, hypertension, diabetes, coronary heart disease, chronic kidney diseases, and so on. Traditional Chinese medicine (TCM) shows excellent results in treating HUA because of its unique advantages of multi-metabolites and multi-targets. This article reports on the use of TCM components for uric acid (UA)-lowering activity with excellent efficacy and low side effects based on established HUA models. This work summarizes the advantages and limitations of various HUA disease models for efficacy evaluation. Applications of TCM in HUA treatment have also been discussed in detail. This paper reveals recent research progress on HUA in constructing evaluation models and systematic TCM interventions. It will provide a scientific reference for establishing the HUA model and suggest future TCM-related HUA studies.

Auricular acupressure combined with Tongtian oral liquid for acute attacks of migraine without aura: a single-center, retrospective study.

OBJECTIVE: To observe the effect of auricular acupressure combined with Tongtian Oral Liquid for immediate pain relief in patients with acute migraine without aura, and to analyze the risk factors that affect the number of acute attacks of migraine without aura. METHODS: This retrospective study analyzed data of 180 patients diagnosed with acute migraine without aura who were admitted to Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of Chinese Medicine). The patients were divided into an intervention group 1 (n=60), an intervention group 2 (n=60), and a control group (n=60) according to different treatment methods. The intervention group 1 received auricular acupressure + Tongtian oral liquid, the intervention group 2 received Jing point bloodletting + Tongtian oral liquid, and the control group received ibuprofen + flunarizine. Before treatment, 60 minutes and 120 minutes after treatment, the visual analogue scale (VAS) and the short-form McGill pain questionnaire (SF-MPQ) were used to score the pain in the three groups to evaluate the efficacy of immediate analgesia. Symptoms including fatigue, drowsiness, nausea, and vomiting after 2 hours of treatment were observed. The amount of ibuprofen used within 24 hours was calculated. The drug treatment was continued for one month. The frequency of migraine attacks was compared among the three groups. The relevant factors affecting the number of migraine attacks were analyzed. RESULTS: The VAS and SF-MPQ scores of the three groups were all decreased 120 minutes after treatment as compared with those before treatment (P<0.01). The decline rate in the intervention group 1 > that in intervention group 2 > that in control group (P<0.01). The immediate analgesic efficiency at 60 minutes, intervention group 1 > intervention group 2 > control group (100% vs. 76.67% vs. 56.67%, P<0.001). After 2 hours of treatment, more cases of fatigue and lethargy occurred in the control group (P<0.05). There was no significant difference in nausea and vomiting among the three groups (P>0.05). The 24-hour ibuprofen dosage and headache recurrence ratio, control group > intervention group 2 > intervention group 1 (P<0.05). The number of headache attacks within 30 days was significantly higher in the control group than in the intervention groups (P=0.012). There was no significant statistical difference between the two intervention groups (P=0.568). Regression analysis found that age (OR=1.036, 1.006-1.068), body mass index (OR=1.101, 1.008-1.201), hypertension (OR=2.879, 1.187-6.986), chronic gastritis (OR=2.839, 1.213-6.647), children with educational problems (OR=0.333, 0.164-0.676), and residual fatigue symptoms (OR=4.539, 1.828-11.271) affected the number of headache attacks within the one month of treatment. CONCLUSIONS: Auricular acupressure combined with Tongtian Oral Liquid can relieve the acute pain of migraine without aura and reduce the number of pain episodes. The curative effect of this combination is better than that of western medicine alone.

Tonghua Liyan granules in the treatment of Laryngopharyngeal reflux disease with stagnation of phlegm and qi syndrome: a randomized, double-blind, placebo-controlled study.

Background: Laryngopharyngeal reflux disease (LPRD) is an extraesophageal syndromic manifestation of gastroesophageal reflux disease (GERD). Despite the increasing incidence of and concern about LPRD, treatment with proton pump inhibitors (PPIs) is unsatisfactory. Here, LPRD was treated with Tonghua Liyan (THLY) granules in combination with PPIs to evaluate treatment efficacy and possible adverse reactions. Methods: Seventy-six LPRD patients with stagnation of phlegm and qi syndrome (SPQS) were randomly divided into an experimental group and a control group. The experimental group received THLY granules combined with rabeprazole capsules. The control group received THLY granule placebo combined with rabeprazole capsules. A parallel, randomized, double-blind, placebo-controlled clinical trial was conducted with these two groups. The treatment cycle was 8 weeks. The reflux symptom index (RSI), clinical symptom score, salivary pepsin content, reflux finding score (RFS) and gastroesophageal reflux disease questionnaire (GerdQ) were used to evaluate clinical efficacy. The final efficacy rate was evaluated according to the RSI and clinical symptom score. Results: Compared with those at baseline, all the indicators in the experimental group and control group significantly improved (p < 0.01). In terms of the RSI, clinical symptom score, and RFS, the experimental group had a higher degree of improvement (p < 0.05), and the overall efficacy rate was higher (p < 0.05). In terms of the salivary pepsin concentration and GerdQ, there was no significant difference between the test group and the control group (p > 0.05). Both groups of safety indicators showed no abnormalities and did not cause any allergic reactions in the body. Conclusion: Compared with PPIs alone, THLY granules combined with PPIs are more effective in the treatment of LPRD patients with SPQS in terms of symptoms and signs. This combination treatment, because of its higher clinical efficacy and lack of obvious adverse reactions, is worthy of clinical promotion and further in-depth study. Clinical Trial Registration: www.chictr.org.cn, identifier ChiCTR2100046614.

Chinmedomics: a potent tool for the evaluation of traditional Chinese medicine efficacy and identification of its active components.

As an important part of medical science, Traditional Chinese Medicine (TCM) attracts much public attention due to its multi-target and multi-pathway characteristics in treating diseases. However, the limitations of traditional research methods pose a dilemma for the evaluation of clinical efficacy, the discovery of active ingredients and the elucidation of the mechanism of action. Therefore, innovative approaches that are in line with the characteristics of TCM theory and clinical practice are urgently needed. Chinmendomics, a newly emerging strategy for evaluating the efficacy of TCM, is proposed. This strategy combines systems biology, serum pharmacochemistry of TCM and bioinformatics to evaluate the efficacy of TCM with a holistic view by accurately identifying syndrome biomarkers and monitoring their complex metabolic processes intervened by TCM, and finding the agents associated with the metabolic course of pharmacodynamic biomarkers by constructing a bioinformatics-based correlation network model to further reveal the interaction between agents and pharmacodynamic targets. In this article, we review the recent progress of Chinmedomics to promote its application in the modernisation and internationalisation of TCM.

Exploration of biomarkers for efficacy evaluation of traditional Chinese medicine syndromes of acute exacerbation of chronic obstructive pulmonary disease based on metabolomics.

Background: Traditional Chinese medicine (TCM) is effective for the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD); however, there is no objective index for the evaluation of TCM syndrome efficacy. This study aimed to screen biomarkers related to the efficacy of TCM syndrome using metabolomics. Methods: We recruited AECOPD patients with phlegm-heat congesting lung (PH)/phlegm-damp amassing lung (PD) syndrome and treated them with Chinese herbal medicine (Qingre Huatan or Zaoshi Huatan granules) in addition to conventional medicine for 7 days. Data on clinical symptoms and sign scores, modified British Medical Research Council (mMRC), COPD assessment test (CAT), and inflammation indicators, including white blood cell (WBC) count, percentage of neutrophil count (NEU%), and C-reactive protein (CRP), were collected before and after treatment to evaluate the therapeutic effect. Serum samples were collected before and after treatment for metabolomic analysis to screen differential metabolites. Results: A total of 69 patients with AECOPD were enrolled, including 41 and 28 patients in the PH and PD groups, respectively. The clinical symptoms and sign scores, CAT, mMRC, NEU%, and CRP levels after treatment were lower than those before treatment in both groups (p < 0.05). Serum metabolomics analysis showed that there were 13 differential metabolites in the PH group and 16 differential metabolites in the PD group before and after treatment (p < 0.05, variable importance projection (VIP) ≥ 1.00). In the PH group, lysophosphatidylcholine (LPC) (16:0), LPC (17:1), LPC (18:3), LPC (18:2), and LPC (17:0) negatively correlated with clinical symptoms and sign scores (p < 0.05); LPC (16:0), LPC (17:1), LPC (16:1), and LPC (17:0) negatively correlated with WBC (p < 0.05) and NEU% (p < 0.05); and LPC (16:0) negatively correlated with CRP levels. In the PD group, L-phenylalanine positively correlated with CRP levels (p < 0.05), and 2-methylbutyroylcarnitine positively correlated with clinical symptoms and sign (p < 0.05) and CAT scores (p < 0.05). DL-carnitine positively correlated with clinical symptoms and sign scores (p < 0.05). Conclusion: Serum metabolites may be potential indicators to objectively evaluate the efficacy of TCM syndromes; however, further large controlled trials are required to verify these findings.

Decoding active compounds and molecular targets of herbal medicine by high-throughput metabolomics technology: A systematic review.

Clinical experiences of herbal medicine (HM) have been used to treat a variety of human intractable diseases. As the treatment of diseases using HM is characterized by multi-components and multi-targets, it is difficult to determine the bio-active components, explore the molecular targets and reveal the mechanisms of action. Metabolomics is frequently used to characterize the effect of external disturbances on organisms because of its unique advantages on detecting changes in endogenous small-molecule metabolites. Its systematicity and integrity are consistent with the effective characteristics of HM. After HM intervention, metabolomics can accurately capture and describe the behavior of endogenous metabolites under the disturbance of functional compounds, which will be used to decode the bioactive ingredients of HM and expound the molecular targets. Metabolomics can provide an approach for explaining HM, addressing unclear clinical efficacy and undefined mechanisms of action. In this review, the metabolomics strategy and its applications in HM are systematically introduced, which offers valuable insights for metabolomics methods to characterizing the pharmacological effects and molecular targets of HM.

Management Approaches to Health and Safety at Work during Prevention Intervention Planning.

This work deals with a systematic review of the literature data concerning the theme of integrated approaches to occupational health and safety management, with particular reference to the programming of assistance plans, which guide companies' organizational choices by also addressing the principles of Total Worker Health. In the current regulatory framework on this issue, the UNI ISO 45001: 2018 standard "Occupational health and safety management systems-Requirements and guidance for use" (published on 12 March 2018)" assumes relevance, defining dynamic approaches to occupational health and safety management systems-paying particular attention to external contextual factors that may influence corporate organizational decisions. The adoption of these systems is not mandatory but allows companies to fulfill their duties in terms of health and safety at work through an organizational approach aimed at the awareness, involvement, and participation of all subjects of the company prevention system, progressing past the phase of mere technological and prescriptive approaches towards a holistic vision of prevention that places the person at the center of preventive actions. In this context, the role of institutional networks and socio-economic partnerships assumes particular importance via the activation of territorial assistance interventions to support companies aimed at improving risk management levels. To this end, the importance of verifying the effectiveness of assistance interventions emerges from the scientific debate using indicators such as quantitative indicators aimed at measuring the performance of all phases of an intervention, with particular attention to their effects in terms of the improved solutions developed.

[Exploration and consideration on establishing a core outcome set of Traditional Chinese Medicine clinical trials in distal radius fracture].

There are inconsistencies in treatment outcomes, measurement instruments, and criteria for assessing clinical effectiveness in studies related to distal radius fractures (DRF), resulting in potential biases and failing to provide high-quality clinical evidence. To address these challenges, international researchers have reached a consensus on developing the core outcome indicator set for distal radius fractures(COS-DRF). However, it's important to note that the existing COS-DRF framework could not reflect the unique characteristics of Traditional Chinese Medicine (TCM) treatment. Currently, there are no established standards for treatment outcomes and measurement instruments specific to TCM clinical research, nor has a COS-DRF been established for TCM clinical studies in China. In light of these gaps, our research team aims to construct a core set of treatment outcomes for TCM clinical research on distal radius fractures. This involves compiling a comprehensive list of treatment outcomes and measurement instruments, initially derived from a thorough literature review and expert consensus, which will then undergo further refinement and updates based on real-world clinical experiences, incorporating feedback from 2 to 3 rounds of expert consensus or Delphi questionnaire surveys. Our goal is to establish a COS-DRF or CMS-DRF that aligns with the principles and practices of TCM, and provide high-quality evidence for clinical practice.

Efficacy of the low dose apatinib plus deep hyperthermia as third-line or later treatment in HER-2 negative advanced gastric cancer.

Aim: To observe the efficacy of the low dose apatinib plus deep hyperthermia as third-line or later treatment for patients with human epidermal growth factor receptor 2 (HER-2) negative advanced gastric cancer. Methods: 80 eligible patients with HER-2 negative advanced gastric cancer admitted to Jingjiang People's Hospital Affiliated with Yangzhou University-from March 2021 to March 2022 were selected, and they were divided into the control group (n = 40, apatinib) and experimental group (n = 40, apatinib plus deep hyperthermia) on the basis of random number table method. The levels of serum carcinoembryonic antigen (CEA), carbohydrate antigen 199 (CA199), and vascular endothelial growth factor (VEGF) were monitored, and the efficacy of the two groups was analyzed by referring to Karnofsky performance status (KPS), overall survival (OS) and disease control rate (DCR) before and after treatment. Results: The levels of CEA, CA199, and VEGF in both groups were lower after treatment than before (p < 0.05), and lower (CEA: 8.85 ± 1.36 vs. 12.87 ± 1.23, CA199: 34.19 ± 4.68 vs. 50.11 ± 5.73, VEGF: 124.8 ± 18.03 vs. 205.9 ± 19.91) in the experimental group than in the control group (p < 0.05). The DCR and KPS of the patients in the experimental group were significantly higher (DCR: 62.50% vs. 40.00%; KPS: 83.25 ± 1.15 vs. 76.25 ± 1.17) than in the control group (p < 0.05). In survival analysis, patients with control group had shorter OS than the experimental group. (median 5.65 vs. 6.50 months; hazard ratio [HR], 1.63 [95% confidence interval (CI) 1.02-2.60], p = 0.0396). Conclusion: The application of low-dose apatinib plus deep hyperthermia for patients with HER-2 negative gastric cancer who failed second-line treatment should be a promising option.

[Improvement of high-quality evaluation criteria of Chinese patent medicines based on whole process control].

Chinese patent medicines(CPMs) are unique therapeutic drugs in China. Establishing and improving the evaluation criteria is an important measure to promote the high-quality development of CPMs. Based on the "evaluation criteria of high-grade CPMs with quality as the core index" established by our group in 2018, the "high-quality evaluation criteria for CPMs based on whole process control" was proposed in the present study in 2022. The scope of application and basic principles of the new criteria were clarified. A quality evaluation scoring table was established in the new criteria, including five parts: raw material selection, production process, quality control, efficacy evaluation, and brand building. The technical evaluation indexes involved have increased from 20% in the original criteria to 70% in the new criteria, and efficacy evaluation has been added in the new criteria. The subjective evaluation indicators account for a large proportion in the original criteria, which is prone to bias. The improved criteria overcome this shortcoming. It is expected that the new criteria as a basis can play a better role in the selection of high-quality products of CPMs, guide enterprises and institutions to participate actively in the evaluation and research of high-quality CPMs, and promote the high-quality development of CPMs.

Protocol to establish auxiliary diagnostic model for knee osteoarthritis functional testing equipment.

In China, 50% of Knee Osteoarthritis (KOA) patients will be treated with Traditional Chinese Medicine or a combination of Traditional Chinese and Western Medicine, which call for objective efficacy evaluation methods. The collection, processing and fusion of multi-source data were taken as the main methods, with 150 KOA patients and 100 healthy people as an example to design prospective clinical tests. Data were collected with tongue inspection APP, infrared instrument and channel instrument, etc. And the analysis, screening, fusion and modelling of multi-source data were conducted. The traditional clinical tests have been combined with the customized information platform in this study, which is convenient for clinical tests, medical follow-ups and timely feedback to statistical analysis of data.

[Analysis of acupoints selection rules and efficacy evaluation of acupuncture and moxibustion for allergic rhinitis].

OBJECTIVE: To explore the rules of acupoints selection of acupuncture and moxibustion in the treatment of allergic rhinitis (AR) by using data mining technology, as well as to compare the efficacy of different acupoints selection methods. METHODS: Papers about acupuncture and moxibustion for treating AR published from January 2002 to August 2022 was retrieved from Chinese and English databases including CNKI, Wanfang, VIP, SinoMed and PubMed by using keywords of "acupuncture", "moxibustion" and "allergic rhinitis". According to the inclusion and exclusion criteria, the collected literature was screened to establish the AR database. Frequency statistic analysis was conducted for detecting high-frequency acupoints and specific acupoints frequency, and the curative effects of different acupoints selection methods were compared. SPSS26.0 software was used for factor analysis, cluster analysis and QUEST decision tree model identification. RESULTS: A total of 289 papers were included, with 384 acupuncture prescriptions extracted. A total of 99 acupoints were involved with the application frequency of 2 430 times. Among them, the application frequency of Yingxiang (LI20) is the highest (296 times, 12.18%), followed by Yintang (GV24+) and Hegu (LI4), etc. The main invloved meridians are the Bladder Meridian of Foot-Taiyang, the Large Intestine Meridian of Hand-Yangming and the Governor Vessel. The involved specific acupoints with the highest frequency of application is the crossing acupoints. Nine common factors of acupoints combinations units were extracted by factor analysis, and two cluster prescriptions of acupoints combinations correlation were obtained by cluster analysis. Three decision paths of simplified acupoints selection were simulated by the decision tree, with LI20 as the dependent variable. CONCLUSION: In the treatment of AR with acupuncture and moxibustion, the regularities and characteristics of acupoints selection are as follows: 1) often selecting local acupoints and acupoint combinations along meridians, 2) focusing on combination of dispelling pathogenic factors with strengthening vital energy, 3) advocating diversification of acupoint matching methods. The combination of factor analysis, cluster analysis and QUEST decision tree application provides three directions for clinical acupoints selection of AR.

Medication Analysis of Traditional Chinese Medicine Diagnosis and Treatment Guidelines for Allergic Rhinitis Based on Clinical Efficacy Evaluation / 中国实验方剂学杂志

ObjectiveTo explore the role of efficacy evaluation methods in providing evidence for traditional Chinese medicine （TCM） clinical practice guidelines based on a demonstration study of clinical efficacy evaluation of TCM for allergic rhinitis （AR），aiming to enrich the sources of evidence for guideline development. MethodReal-world data of TCM medication for AR were collected and efficacy evaluation was carried out. SPSS 16.0 software was used to calculate the conformity of clinical syndromes，main prescriptions， and medications to the guidelines. Correlation analysis of efficacy and medications was performed according to guideline conformity to compare the differences in medications between real-world clinical applications and current guidelines. ResultA total of 198 cases were collected and the clinical medications were compared with the relevant guidelines for AR. It was found that the clinical syndrome conformity was above 70%，and in addition to the guideline syndrome，there were also syndromes in six meridians and other mixed syndromes in clinical practice. The guideline conformity of the main prescriptions used in clinical practice showed a positive correlation trend with efficacy. There were some differences between the commonly used drugs in clinical practice and those recommended by the guidelines. For example，for lung Qi deficiency and cold syndrome，drugs such as Angelicae Dahuricae Radix， Magnoliae Flos， and Schisandrae Chinensis Fructus were often used. For kidney Yang deficiency syndrome，drugs such as Atractylodis Macrocephalae Rhizoma and Ostreae Concha were often used. For spleen Qi deficiency and weakness syndrome，drugs such as Poria， Cinnamomi Ramulus， and Magnoliae Flos were used. For lung Qi deficiency and cold syndrome in children，drugs such as Chebulae Fructus， Cicadae Periostracum， Zingiberis Rhizoma， and Ginseng Radix et Rhizoma were used. For lung and spleen Qi deficiency syndrome，drugs such as Dioscoreae Rhizoma， Menthae Haplocalycis Herba， Amomi Fructus， and Zingiberis Rhizoma were used. There were also some differences in the commonly used drugs for adults and children. For example，for lung Qi deficiency and cold syndrome，adults often used Angelicae Dahuricae Radix， Magnoliae Flos， and Tribuli Fructus，while children often used Ginseng Radix et Rhizoma， Paeoniae Radix Alba， and Poria. For lung meridian hidden heat syndrome， adults often used Bupleuri Radix， Asari Radix et Rhizoma， Pinelliae Rhizoma， and Xanthii Fructus， while children often used Houttuyniae Herba， Menthae Haplocalycis Herba， Citri Reticulatae Pericarpium， and Massa Medicata Fermentata. ConclusionEffective medication regimens can be screened out based on efficacy evaluation methods，which can help supplement immediate， objective， and clinically relevant evidence of medication for the development of clinical practice guidelines in TCM from the perspective of clinical effectiveness.

Improvement of high-quality evaluation criteria of Chinese patent medicines based on whole process control / 中国中药杂志

Chinese patent medicines(CPMs) are unique therapeutic drugs in China. Establishing and improving the evaluation criteria is an important measure to promote the high-quality development of CPMs. Based on the "evaluation criteria of high-grade CPMs with quality as the core index" established by our group in 2018, the "high-quality evaluation criteria for CPMs based on whole process control" was proposed in the present study in 2022. The scope of application and basic principles of the new criteria were clarified. A quality evaluation scoring table was established in the new criteria, including five parts: raw material selection, production process, quality control, efficacy evaluation, and brand building. The technical evaluation indexes involved have increased from 20% in the original criteria to 70% in the new criteria, and efficacy evaluation has been added in the new criteria. The subjective evaluation indicators account for a large proportion in the original criteria, which is prone to bias. The improved criteria overcome this shortcoming. It is expected that the new criteria as a basis can play a better role in the selection of high-quality products of CPMs, guide enterprises and institutions to participate actively in the evaluation and research of high-quality CPMs, and promote the high-quality development of CPMs.

Ideas and Methods of Establishing an Efficacy Evaluation System for Heart Failure：Combining Syndrome in Traditional Chinese and Disease Western Medicine，based on Doctors-patients Shared Reported Outcomes and Using 1+N Model / 中医杂志

Establishing an efficacy evaluation system that conforms to the laws of traditional Chinese medicine （TCM） is one of the keys in the development of TCM. With certain progress in recent years， however， the clinical efficacy evaluation systems or consensus that has been formed are not widely adopted. The main reason is the lack of objectification and standardization of efficacy evaluation， and additionally fixed efficacy evaluation system cannot meet the needs of different clinical research purposes. This paper initially analyzed the development status of clinical efficacy evaluation of heart failure （HF）， and then discussed the specific methods， advantages and difficulties in constructing a TCM clinical efficacy evaluation system for HF using the 1+N model， guided by the idea of combining traditional Chinese and western medicine， disease and syndrome， and based on the shared reported clinical outcomes by doctors and patients. Establishing an efficacy evaluation system that combines disease and syndrome can build a bridge to connect TCM with western medicine； the shared reported clinical outcomes by doctors and patients can reflect the people-centered concept and holism concept in TCM； the 1+N efficacy evaluation model can meet the general clinical research need by constructing one core outcome set （“1”）， and can match different research purposes by adding numbers of other outcomes （“N”）. One difficulty in constructing the TCM efficacy evaluation system for HF is to unify the differentiation standard for TCM syndromes of HF and the standardization to diagnose HF firstly， and then distinguish between syndrome efficacy standards and syndrome diagnostic standards. By constructing a 1+N model-based efficacy evaluation system for HF that not only conforms to the characteristics of TCM itself but also embodies the evidence-based medicine concept in western medicine， it is expected to provide ideas for evaluating clinical efficacy of TCM.

Study on the efficacy evaluation criteria of randomized controlled trials of TCM in the treatment for edema / 国际中医中药杂志

Objective:To analyze the efficacy evaluation criteria of the existing TCM treatment for edema RCT research, and to provide reference for the construction of unified standards.Methods:The batabases CNKI, WanFang Data, VIP, CBM, Pubmed and Web of Science were retrieved. The randomized controlled trials for the treatment of edema of TCM research, from September 1, 1993 to July 31, 2022, were screened and included. The content of efficacy evaluation, performed statistics on evaluation standard, the curative effect evaluation indexes, as well as standard composition, usage were extracted. We analyzed the characteristics, application and problems of the existing efficacy evaluation criterion.Results:A total of 123 Chinese articles were included. The included literature involved nephrogenic edema, cardiogenic edema, idiopathic edema, apoplexy limb edema and other edema. In recent years, randomized controlled trials on the treatment of edema by TCM have mainly used four efficacy evaluation criteria. Of which the Guidelines for Clinical Research on New Chinese Medicines (Trial) in 2002 had the highest utilization rate of 29.27%. Secondly, the utilization rate of Standard for Diagnosis and Curative Effect of TCM Diseases and Syndromes was 21.14%. The rest of the criteria were used by less than 6%. While 39.02% of the literature did not use the standards or used self-designed standards. Among the composition of efficacy evaluation indices, the application rate of TCM syndrome or symptom efficacy index was the highest (91.87%), the utilization rate of the Minnesota Living with Heart Failure Questionnaire Indicators was only 4.88%; biochemical tests accounted for a large proportion of Western medical indicators, while the measurement of edema severity was rarely applied. Conclusions:At present, the evaluation criteria of edema curative effect are diversified and insufficiently popularized, which need to be further screened and improved. It is suggested to construct a TCM edema efficacy evaluation model based on the characteristics of edema syndrome, comprehensively evaluate the efficacy from multiple dimensions such as TCM syndromes, western medicine indicators, and quality of life, and improve the scientific indicators.

Discussion on Development Status of Traditional Chinese Medicine Dispensing Granules and Survival Strategy of Enterprises / 中国实验方剂学杂志

As an important complementary form of decoction pieces of traditional Chinese medicine（TCM）， TCM dispensing granules has the advantages of being free of decoction， easy to take， easy to carry and easy to be dispensed， which greatly improves the capacity of emergency services of TCM and is more in line with the needs of modern society. With the end of the pilot project of TCM dispensing granules， the market has been fully liberalized， the competition has been intensified， and it is in the transition period of switching between the new standard and the old one， and there are some problems such as the shortage of varieties， the change of specifications and the difference of quality， and the production enterprises are facing new opportunities and challenges. Based on this， the authors intend to systematically sort out the policies and regulations， enterprise layout and standard formulation since the pilot of TCM dispensing granules. In view of the problems in the post-pilot stage and from the perspective of survival and development of enterprises， it is suggested that enterprises should establish a quality control system for the whole industry chain of TCM dispensing granules to reduce process costs and increase enterprise competitiveness， further increase the investment in scientific research， overcome the key technical problems of difficult varieties， actively and orderly promote the research of national standards， in order to ensure the integrity of clinical formula varieties， and establish and improve the efficacy evaluation mechanism of TCM dispensing granules， build a consistency evaluation system between TCM dispensing granules and decoction pieces. Government departments should strengthen the guidance， fully mobilize the enthusiasm of scientific research institutions， enterprises and hospitals， and explore the establishment of "government-industry-study-research-application" mode to promote the development of TCM dispensing granule industry.

Screening of Clinical Efficacy Evaluation Indicators for Traditional Chinese Medicine Injections based on Mixed Method Research / 中医杂志

Currently， evidence on the efficacy and risk of traditional Chinese medicine （TCM） injections is seriously insufficient， and it is difficult to evaluate TCM injections comprehensively， truly and objectively using available efficacy evaluation indicators. Therefore， establishing a clinical efficacy evaluation system that can effectively reflect TCM injections is imperative. Core outcome set （COS） has played an important role in screening TCM efficacy evaluation indicators， however， there are still certain problems， such as large differences in efficacy indicators， non-standardization， and lack of featured and specific TCM indicators. Mixed method research （MMR） has the advantages of looking at problems from both quantitative and qualitative perspectives. It is thereby proposed to use COS and MMR integrated model to establish a clinical efficacy evaluation indicator system that not only fully considers the cha-racteristics of TCM injections， but also highlights the efficacy and advantages of TCM injections from the perspective of TCM intervention. Simultaneously， an indicator screening method using MMR to optimize COS research model is formulated， which can provide ideas for the research on efficacy evaluation indicators of TCM injections.

[Point-pricking method with fire needle for knee osteoarthritis: a randomized controlled trial].

OBJECTIVE: To observe the effects of point-pricking method with fire needle on the symptoms of knee joint and physio-psychological health in the patients with knee osteoarthritis (KOA). METHODS: Sixty six patients with KOA were randomly divided into a fire needling group (33 cases) and a filiform needling group (33 cases). The patients received the point-pricking method with fire needle in the fire needle group while the conventional acupuncture with filiform needle was provided in the filiform needling group. The basic health management was performed in both groups. The acupoints included bilateral Liangqiu (ST34), Xuehai (SP10), Dubi (ST35), Neixiyan (EX-LE4), Yanglingquan (GB34) and Zusanli (ST36) as well as Ashi points. The treatment was conducted twice a week for 6 weeks consecutively. Before and after treatment, the scores of Western Ontario and McMaster University Osteoarthritis Index (WOMAC), traditional Chinese medicine (TCM) symptoms and visual analogue score (VAS), the numbers of affected areas of knee joint pain and the scores of 12-item short-form health survey (SF-12) were assessed and the incidence of adverse effects was recorded. RESULTS: The score for pain, stiffness and function, as well as the total score of WOMAC were all reduced (P<0.05), the score of TCM symptoms, VAS score and the numbers of the affected areas of knee joint pain were lower (P<0.05) after treatment when compared with those before treatment within group. After treatment, the score of each domain of SF-12 (i.e. general health, physical function, role-physical, vitality, role-emotional, physical component summary and mental component summary) was higher in comparison to those before treatment in both groups (P<0.05), while the scores of bodily pain, mental health and social functioning in SF-12 were increased in the fire needling group (P<0.05). Compared with the filiform needling group, the score of joint function and the total score in WOMAC and VAS score were reduced remarkably (P<0.05), and general health score in SF-12 was more obviously increased (P<0.05) in the fire needling group after treatment. None adverse effects were found in either group. CONCLUSION: The point-pricking method with fire needle is safe and effective when compared with conventional acupuncture with filiform needle. In the aspects of improving knee joint function, relieving joint pain and advancing the quality of life, the point-pricking method with fire needle is superior to the conventional acupuncture with filiform needle.