Study on HBV-related acute-on-chronic liver failure risk factors and novel predictive survival model / 中华肝脏病杂志

Objective: To identify the predisposing factors, clinical characteristics, and risk factors of disease progression to establish a novel predictive survival model and evaluate its application value for hepatitis B virus-related acute-on-chronic liver failure. Methods: 153 cases of HBV-ACLF were selected according to the guidelines for the diagnosis and treatment of liver failure (2018 edition) of the Chinese Medical Association Hepatology Branch. Predisposing factors, the basic liver disease stage, therapeutic drugs, clinical characteristics, and factors affecting survival status were analyzed. Cox proportional hazards regression analysis was used to screen prognostic factors and establish a novel predictive survival model. The receiver operating characteristic curve (ROC) was used to evaluate predictive value with the Model for End-Stage Liver Disease (MELD) and the Chronic Liver Failure Consortium Acute-on-Chronic Liver Failure score (CLIF-C ACLF). Results: 80.39% (123/153) based on hepatitis B cirrhosis had developed ACLF. HBV-ACLF's main inducing factors were the discontinuation of nucleos(t)ide analogues (NAs) and the application of hepatotoxic drugs, including Chinese patent medicine/Chinese herbal medicine, non-steroidal anti-inflammatory drugs, anti-tuberculosis drugs, central nervous system drugs, anti-tumor drugs, etc. 34.64% of cases had an unknown inducement. The most common clinical symptoms at onset were progressive jaundice, poor appetite, and fatigue. The short-term mortality rate was significantly higher in patients complicated with hepatic encephalopathy, upper gastrointestinal hemorrhage, hepatorenal syndrome, and infection (P < 0.05). Lactate dehydrogenase, albumin, the international normalized ratio, the neutrophil-to-lymphocyte ratio, hepatic encephalopathy, and upper gastrointestinal bleeding were the independent predictors for the survival status of patients. The LAINeu model was established. The area under the curve for evaluating the survival of HBV-ACLF was 0.886, which was significantly higher than the MELD and CLIF-C ACLF scores (P < 0.05), and the prognosis was worse when the LAINeu score ≥ -3.75. Conclusion: Discontinuation of NAs and the application of hepatotoxic drugs are common predisposing factors for HBV-ACLF. Hepatic decompensation-related complications and infection accelerate the disease's progression. The LAINeu model can predict patient survival conditions more accurately.

Application of "major scientific issues and engineering technology difficulties in traditional Chinese medicine(2019-2021)" in national science and t echnology layout / 中国中药杂志

In order to judge the future development trend of science and technology, plan ahead and lay out the frontier technology fields and directions, China Association of Chinese Medicine(CACM) has launched consultation projects for collecting "major scienti-fic issues and engineering technology difficulties in traditional Chinese medicine(TCM)" for the industry for three consecutive years since 2019. Up to now, 18 projects have been selected as major issues for research, and some experience and achievements have been made. These projects have been applied in important scientific and technological work such as scientific and technological planning and deployment at all levels of national, local, and scientific research institutions, the selection and cultivation of major national scientific and technological projects, and the construction of innovation bases, giving full play to the role of the think tank advisory committee of CACM. This study reviewed the selection of major issues for the first time, systematically combed its application in the national layout of science and technology, and put forward the existing problems and improvement suggestions, aiming to provide new ideas for further improving the selection of major issues and research direction, providing a theoretical basis and decision support for the national scientific and technological layout in the field of TCM, and promoting scientific and technological innovation to facilitate the high quality development of TCM.

Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version) / 中国中药杂志

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.

Clinical Research on Treatment of Benign Prostatic Hyperplasia with Traditional Chinese Medicine： A Review / 中国实验方剂学杂志

Benign prostatic hyperplasia （BPH）， a common disease in urology and andrology， is mainly manifested as enlarged prostate glands， bladder outlet obstruction， and lower urinary tract symptoms（LUTS）， which seriously affects the quality of life of middle-aged and elderly men. This disease falls into the categories of "retention of urine" and "prostatic hypertrophy" in traditional Chinese medicine （TCM）. In recent years，many doctors have put forward their understandings of BPH based on academic classics and their clinical experience. Clinical research on the treatment of BPH with TCM has become increasingly abundant. The basic pathogenesis of BPH lies in the disturbance of Qi transformation in the bladder and poor blood circulation due to kidney Qi deficiency in the aged. The disease is located in the kidney and the bladder and is related to the dysfunction of the lung and the kidney. It is basically characterized by deficiency in origin and excess in superficiality. A large number of clinical research reports have proved that TCM is efficient in alleviating the clinical symptoms of BPH patients， improving their quality of life， reducing the volume of the prostate， and decreasing postoperative complications. In addition， the external treatment methods of TCM， such as acupuncture therapy， moxibustion， hot water bathing， acupoint application， anal suppository， and enema therapy， are also widely used in clinical practice， demonstrating the diverse ways of TCM in treating BPH. TCM and western medicine complement each other's advantages in the treatment of BPH， thus enhancing the clinical efficacy and reducing the occurrence of long-term complications. This study reviewed the etiology， pathogenesis， and treatment progress of BPH with TCM in recent years， and summarized the current research status. From three aspects of producing high-quality clinical research， standardizing the clinical diagnosis and treatment of TCM， and combining cutting-edge research to explore the mechanism of TCM， it provided suggestions for clinical research on the treatment of BPH with TCM to promote the development and application of TCM in the treatment of this disease.

Experimental Models of Benign Prostatic Hyperplasia： A Review / 中国实验方剂学杂志

Benign prostatic hyperplasia （BPH） model， as a carrier of BPH， is vital for exploring the pathogenesis of the disease and evaluating the efficacy of corresponding drugs. This paper reviewed the in vivo and in vitro models of BPH， the modeling principles and methods， and evaluation indicators， and analyzed the advantages and disadvantages of different types of models. At present， the BPH model is getting closer to the clinical characteristics of human BPH， providing powerful support for the evaluation of drug efficacy. Furthermore， the model has been developed towards cytology to allow further research on the pathogenesis of BPH. The relevant testing indicators reflect the core pathological changes of BPH from different levels， providing a guarantee for further exploring the pathogenesis of BPH and the development of prevention and control drugs. However， no model can fully simulate the natural development process of human BPH， and each model and evaluation criterion has its unique advantages and limitations. In terms of model evaluation， most BPH models are assessed based on benign prostate enlargement （BPE）， and there is still a lack of reliable models to simulate BPH progression and combine with bladder dysfunction. In terms of indicator evaluation， symptom-reflected behavioral indicators are absent in the replication of BPH models in animals. The study of the BPH model in traditional Chinese medicine （TCM） only focuses on the replication and investigation of the "disease" model， rather than the "syndromes" and "signs"， which cannot simulate the syndrome differentiation and treatment under the guidance of the TCM theory. In view of the above deficiencies， we should further improve the modeling method based on clinical characteristics， explore the multifactor composite models， especially those of disease-syndrome combination suitable for basic research of TCM， replicate the model closing to disease development， and optimize the evaluation indicators， which is of great theoretical and practical significance to develop drugs for effective prevention and control of BPH.

Expert Consensus on Sepsis Responding Specifically to Traditional Chinese Medicine / 中国实验方剂学杂志

To give full play to the therapeutic advantages of traditional Chinese medicine （TCM） in sepsis， clarify the entry point of integrated TCM and western medicine， further standardize the clinical treatment of TCM， develop a recognized and integrated treatment protocol of TCM and western medicine， and improve the clinical efficacy on sepsis，the Chinese Association of Chinese Medicine organized TCM and western medicine experts specialized in sepsis treatment to conduct in-depth discussions on the advantages of TCM and integrated TCM and western medicine in the treatment of sepsis based on the TCM etiology and pathogenesis of sepsis， a representative acute and critical disease. They emphasized the pathogenesis characteristics of asthenia of healthy Qi and sthenia of pathogenic factors and summarized the roles of Chinese medicine in correcting the imbalance of inflammatory response， improving blood coagulation dysfunction， and relieving organ damage. Furthermore， they proposed the treatment protocol with integrated TCM and western medicine， which is expected to provide references for actual clinical treatment and scientific research.

Expert Consensus on Rheumatic Immune Diseases Responding Specifically to Traditional Chinese Medicine / 中国实验方剂学杂志

In the clinical practice of rheumatic immune diseases in traditional Chinese medicine （TCM），it`s still unclear about the dominant diseases and breakthrough points. It`s urgent missions to formulate TCM diagnosis and treatment guidelines widely recognized and integrated by traditional Chinese medicine and Western medicine. In order to clarify the dominant diseases and breakthrough points in rheumatism，China association of Chinese medicine initiated a research group covering experts in the field of rheumatism of traditional Chinese medicine and Western medicine. Based on questionnaire survey and on-site discussion，experts had reached the following consensus. Evidence-based medicine research using modern medical methods and scientific methods should be carried out to provide objective clinical evidences. "Four mutuality" were put forward as the basis for the work of integrated traditional Chinese and Western medicine，that is the mutual communication using the exchangeable context，the mutual explanation using common theories，the mutual certification using common standards，and the mutual integration using common means. Key works should focus on solving refractory rheumatism in the future. In terms of dominant diseases and breakthrough points，this paper introduces 21 breakthrough points in 6 dominant diseases，including rheumatoid arthritis，ankylosing spondylitis，Sjogren's syndrome，hyperuricemia and gout，systemic lupus erythematosus and fibromyalgia syndrome. Advice on this discussion can provide valuable references for developing the treatment scheme of rheumatism with TCM and integrated Chinese and Western medicine and clinical practice and scientific research.

Exploration and practice of post-marketing survival benefit evaluation of Chinese patent medicine for cancer / 中国中药杂志

Traditional Chinese medicine(TCM) is an important feature of cancer treatment in China. The methods to tap the advantages of TCM, reasonably evaluate and accurately apply Chinese patent medicines have become current research hotspots and difficulties. TCM takes syndrome differentiation and treatment as the core, with the characteristics of overall regulation and multi-targets efficacy. Therefore, the post-marketing survival benefit evaluation of Chinese patent medicines for cancer is different from that in modern medicine. The primary treatment goals in cancer patients include to improve the disease control rate and prolong their survival time. At present, Chinese patent medicines for cancer patients are lacking indepth studies on survival benefit at the post-marketing stage. In addition, the characteristics of individualized treatment with TCM have also increased the complexity of clinical research on TCM. Therefore, it is of certain practical significance and necessity to evaluate the survival benefit of Chinese patent medicines for cancer after marketing. Based on this, in this paper, we first summarized the technical methodological means of survival benefit evaluation at this stage, and then explored the post-marketing survival benefit evaluation of Chinese patent medicines for cancer from three aspects: the evaluation of cancer treatment effect based on survival time and quality of life, treatment-related toxicity and the auxiliary effect of TCM, and the improvement effect for tumor-related symptoms. Based on the practices of early clinical researches, and according to the insufficient efficacy evaluation of current clinical research on Chinese patent medicines, this paper proposed to improve the evaluation system for clinical researches on Chinese patent medicines, establish the evaluation method with TCM characteristics, clarify the dominant population, lay a theoretical foundation for the evaluation of post-marketing survival benefits of Chinese patent medicines for cancer in the future, and promote the modernization process of TCM.

Chinese Expert's Perspectives on Andrological Diseases Responding Specifically to Traditional Chinese Medicine / 中国实验方剂学杂志

In recent years， the incidence rate of andrological diseases has shown a significant growth trend. Considering the unavailability of a perfect theoretical system for andrology in traditional Chinese medicine （TCM） and the complex pathogenesis despite of the limited types of andrological diseases， it is necessary to improve the clinical efficacy of andrological diseases so as to satisfy the needs of patients. Therefore， the China Association of Chinese Medicine （CACM） organized the andrologists of TCM and western medicine and the outstanding young clinicians to discuss the andrological diseases responding specifically to TCM or integrated TCM and western medicine， such as chronic prostatitis， male infertility， benign prostatic hyperplasia， erectile dysfunction， and premature ejaculation， determine their diagnostic criteria in western medicine， and standardize the specifications for TCM diagnosis and treatment based on syndrome differentiation， thus formulating recognized and integrated diagnosis and treatment protocols. Apart from proposing suggestions on the treatment of such andrological diseases with TCM and western medicine， the experts have also figured out the andrological diseases responding specifically to TCM， the optimal intervention time of TCM and western medicine， and the suitable measures including surgery. The resulting consensus helps to better guide the formulation of accurate， personalized， and optimized treatment plans in clinical practice and improve the diagnosis and treatment effects of andrological diseases by giving full play to the advantages of TCM， which will in turn contribute to further innovation and development of TCM.

Expert Consensus on Otorhinolaryngology Head and Neck Diseases Responding Specifically to Traditional Chinese Medicine / 中国实验方剂学杂志

Traditional Chinese medicine （TCM） and western medicine have their respective advantages and limitations in the diagnosis and treatment of common otorhinolaryngology head and neck diseases. Although the integrated TCM and western medicine exhibits definite curative effects， there is no consensus on the otorhinolaryngology head and neck diseases responding specifically to TCM or integrated TCM and western medicine， as well as the diagnosis and treatment schemes. The China Association of Chinese Medicine （CACM） thus organized the otorhinolaryngology head and neck specialists of both TCM and western medicine to discuss the etiology， pathogenesis， and clinical diagnosis and treatment methods of common otorhinolaryngology head and neck diseases with the results of multiple clinical trials taken into account. The acute pharyngitis， chronic pharyngolaryngitis， paraesthesia pharyngis， hysterical aphasia， allergic rhinitis， subjective tinnitus， and otogenic vertigo were confirmed to respond specifically to TCM or integrated TCM and western medicine. Then a mutually agreed diagnosis and treatment scheme and recommendation with integrated TCM and western medicine was formulated as a reference for clinical practice， thus benefiting more patients.

Neurological Diseases Responding Specifically to Traditional Chinese Medicine / 中国实验方剂学杂志

In recent years， the incidence of neurological diseases has been increasing year by year. To give full play to the advantages of traditional Chinese medicine （TCM） in the treatment of neurological disorders， identify the breakthrough point of integrating TCM with western medicine， and further standardize the clinical diagnosis and treatment of TCM， the China Association of Chinese Medicine organized neurologists in TCM and western medicine to carry out in-depth discussion on the neurological diseases responding specifically to TCM and integrated TCM and western medicine， such as stroke， headache， vertigo， multiple sclerosis， and epilepsy， aiming to formulate a well-recognized and integrated treatment protocol for TCM and western medicine and improve the efficacy of neurological disorders. Furthermore， the treatment suggestions of the corresponding diseases in TCM and western medicine were proposed to provide references for clinical practice and scientific research.

Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine：Membranous Nephropathy / 中国实验方剂学杂志

Traditional Chinese medicine （TCM） is a great treasure house， exhibiting unique advantages in the treatment of some difficult and critical diseases. The incidence rate of membranous nephropathy has increased year by year in recent years， and has become the first cause of primary glomerular diseases. However， its pathogenesis is not clear. Modern medicine often uses immunosuppressive therapy， but it often faces the problems of high side effects and high recurrence rate. The China Association of Chinese Medicine （CACM） invited clinical experts of TCM and western medicine to fully discuss membranous nephropathy， which was later confirmed to be one of the clinical diseases responding specifically to TCM. Apart from summarizing the pathogenesis and clinical diagnosis and treatment of membranous nephropathy in both TCM and western medicine， this paper also detailed TCM cognition， syndrome differentiation， and therapeutic schemes of membranous nephropathy， aiming to improve the clinical remission rate of membranous nephropathy and provide reference for its clinical treatment.

Obstetric Diseases Responding Specifically to Traditional Chinese Medicine / 中国实验方剂学杂志

In recent years， with the change in life style， social environment， and national childbearing policy， the proportion of high-risk pregnant women has increased significantly， triggering the spectrum of obstetric diseases to constantly change， which has brought new challenges to the diagnosis and treatment of obstetrics. Traditional Chinese medicine （TCM） has been proved effective in dealing with a variety of obstetric diseases， and various treatment methods are available， which can serve as alternative means for solving refractory obstetric diseases. However， most obstetric clinicians are currently less aware of the therapeutic effects of TCM， which has significantly hindered its participation in clinical treatment. Therefore， the China Association of Chinese Medicine （CACM） organized the outstanding young obstetricians of TCM and western medicine to discuss 15 obstetric diseases responding specifically to TCM or integrated TCM and western medicine， including hyperemesis gravidarum， threatened abortion， ectopic gestation， cough during pregnancy， pregnancy-induced hypertension syndrome， maternal-fetal ABO incompatibility， postpartum hypogalactia， residual pregnancy tissue in uterine cavity， puerperal infection， pantalgia after childbirth， hematoma/undesirable healing after caesarean section， postpartum urinary retention， ileus after cesarean section， pelvic floor dysfunction， and postnatal depression. The suggestions for their treatment with TCM or integrated TCM and western medicine were also proposed， aiming to provide patients with effective and personalized treatments in clinical practice and improve the diagnosis and treatment effects of obstetric diseases， thus benefiting the public. At the same time， more obstetrical clinicians are expected to understand the therapeutic effects and advantages of TCM and draw on the strengths of both TCM and western， thereby promoting the establishment of an obstetric diagnosis and treatment system with Chinese characteristics.

Reporting standards for expert consensus on clinical practice of Chinese patent medicines of China Association of Chinese Medicine / 中国中药杂志

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 / 中国中药杂志

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.

Manual for the clinical experts consensus of Chinese patent medicine / 中国中药杂志

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.

Progress in research of traditional Chinese medicine Citrus aurantium / 中国中药杂志

Citrus aurantium is one of the most common traditional Chinese medicines. In this paper, the chemical components, content determination and pharmacological actions of C. aurantium were summarized for the comprehensive utilization of its resources. Because of the complicated resources of C. aurantium, only one single component as index couldn't reflect the quality and effects and comprehensive evaluation which concluding multiple components should be established in the future quality control. In recent years, the pharmacological effects research of C. aurantium has made tremendous progress, and it is important to explore new drugs from the development and utilization of the active ingredient of C. aurantium. In recent years, the pharmacological effects research of C. aurantium has made tremendous progress, and it is important to explore new drugs from the development and utilization of the active ingredient of C. aurantium.

Studies and reports of impact indicators on big brand Chinese medicine cultivation / 中国中药杂志

Questionnaire survey was conducted among thirty traditional Chinese pharmaceutical companies nationwide. We studied the following factors and how they impose the significance on the culture of big brands, namely, the policies, the access to market, the specialty of the product, the foundation of research, the market, the salesmanship, the resource insurance of product and the security. And these could be referred when the enterprises cultivate the big brands. The findings show that interviewees and different firms hold various opinions on the factors of culture of the big brands. The policies and the access to market always attract the most attention for the enterprises, and whether the product is classified into the catalogue of health insurance or into the basic medicinal directory plays a pivotal role in the development of big brand. The uniqueness of the product can be regarded as a natural advantage, the construction of team of academic experts is more and more emphasized on the development of the product, and the security of the product deserves increasing attention.