Distribution of Traditional Chinese Medicine patterns in 324 cases with hepatitis B-related acute-on-chronic liver failure:a prospective,cross-sectional survey

OBJECTIVE： To determine the distribution of Tradi- tional Chinese Medicine （TCM） patterns in hepatitis B-related acute-on-chronic liver failure （HB-ACLF） in different stages for guiding clinical prescriptions and treatments. METHODS： A prospective, cross-sectional survey method was used in this study. A total of 324 cases with HB-ACLF in China were involved. RESULTS： The general frequency of TCM patterns in HB-ACLF were as follows： Heat Toxin Stagnation Pattern （134/324, 41.36%）, Damp-heat Obstruction Pattern （66/324, 20.37% ）, Yong Qi Deficiency Pat- tern （52/324, 16.05%）, and Liver and Kidney Yin De- ficiency Pattern （26/324, 8.02%）. In the early stage of HB-ACLE there was a remarkably higher percent- age of excessive patterns than those in the middle and late stage. The incidence of Heat Toxin Stagna- tion reached 58.57% （82/140） in the early stage, while it was 33.96% （36/106） in the middle stage and 20.51% （16/78） in the late stage. In the early stage of HB-ACLF, excessive patterns, such as the Heat Toxin Stagnation Pattern, were more preva- lent than those in the middle and late stages （P〈a＇= 0.003）. However, in the late stage of HB-ACLE defi- cient patterns, such as the Yang Qi Deficiency Pat- tern, were more prevalent than those in the early and middle stages. The Yang Qi Deficiency Pattern had a higher rate of 41.03% （32/78） in the late stage compared with that of 20.75% （22/106） in the middle stage and 8.57% （12/140, P〈a＇ =0.003） in the early stage. The distribution of the other pat- terns was not significant between the three stages （P〉0.003）. CONCLUSIONS： There are four major patterns of HI3-ACLF, including the Heat Toxin Stagnation Pat- tern, the Damp-heat Obstruction Pattern, the Yang Qi Deficiency Pattern, and the Liver and Kidney Yin Deficiency Pattern. The Heat Toxin Stagnation and Yang Qi Deficiency Patterns are the representative patterns in the early and late stages of HB-ACLF. In the middle stage of HB-ACLF, the TCM patterns vary in a complicated manner, with no significant differ- ence among the patterns. Treatment for HB-ACLF should vary with the different representative pat- terns in the early and late stages.

A Brief on Pain and Its Patterns in Chinese Medicine

Pain is the most common symptom in clinics.Therefore,the quality,time course and location of pain are important for the diagnosis and treatment.However,pain is very difficult to define,and it is one of the conditions poorly understood by the medical sciences.In Western medicine pain is often described in terms of a penetrating or tissue-destructive process and/or emotional reactions,but in Chinese medicine the pathogenesis and description of pain are different.It is described based on the theories and patho...

Correlation between Traditional Chinese Medicine symptom patterns and serum concentration of zinc,iron,copper and magnesium in patients with hepatitis B and associated liver cirrhosis

OBJECTIVE:To investigate the correlation between the patterns of Traditional Chinese Medicine(TCM)syndromes and the serum concentration of zinc,iron,copper and magnesium of patients with chronic hepatitis B(CHB) and hepatitis B virus(HBV)-induced liver cirrhosis.METHODS:A total of 86 patients were included in the study between March 1,2009 and January 1,2010.All were diagnosed with CHB or HBV-induced liver cirrhosis according to the diagnosis standard of the Chinese Medical Association.Fasting serum concentrations of zinc,iron,copper and magnesium were measured.Patients were classified into different patterns of TCM symptoms according to TCM theory and clinical experience.RESULTS:In the HBV-induced liver cirrhosis group,the mean zinc concentration in patients with the TCM pattern of stagnation of fluid-Dampness was lower than that in patients with obstruction of collaterals by Blood stasis(P < 0.034).In the CHB group,the mean magnesium concentration in patients with toxic Heat flourishing was significantly lower than that in those with Damp-Heat in the Liver and Gallbladder,and those with Liver depression and Spleen deficiency(P < 0.021).The concentrations of iron and copper showed little difference among the different TCM symptom patterns.CONCLUSION:The serum zinc and magnesium concentrations correlated with certain TCM patterns of symptoms in patients with HBV-induced liver cirrhosis and CHB.It may be helpful to interpret the pathogenic change in the TCM symptom patterns in liver cirrhosis and CHB,and also to conduct clinical treatment of the diseases based on identified TCM patterns.

Integration of Chinese Medicine with Western Medicine Could Lead to Future Medicine: Molecular Module Medicine

The development of an effective classification method for human health conditions is essential for precise diagnosis and delivery of tailored therapy to individuals. Contemporary classification of disease systems has properties that limit its information content and usability. Chinese medicine pattern classification has been incorporated with disease classification, and this integrated classification method became more precise because of the increased understanding of the molecular mechanisms. However, we are still facing the complexity of diseases and patterns in the classification of health conditions. With continuing advances in omics methodologies and instrumentation, we are proposing a new classification approach： molecular module classification, which is applying molecular modules to classifying human health status. The initiative would be precisely defining the health status, providing accurate diagnoses, optimizing the therapeutics and improving new drug discovery strategy. Therefore, there would be no current disease diagnosis, no disease pattern classification, and in the future, a new medicine based on this classification, molecular module medicine, could redefine health statuses and reshape the clinical practice.

Evidence-Based Chinese Medicine Clinical Practice Guideline for Stomach Pain in Hong Kong

Stomach pain in Chinese medicine（CM） is a very common disorder in clinical practice and it has been listed as one of the pilot three conditions in Hong Kong to develop evidence-based CM clinical practice guidelines（CM CPGs）. The aim of this stomach Pain CPG is to summarize the treatment methods of stomach pain with CM and evaluate reasonably, then to guide local licensed CM practitioners and provide beneficial reference for social medical decision makers and patients. In this manuscript, we defined stomach pain in CM and the category of chronic gastritis in Western medicine. The clinical manifestation, CM pattern classification, and CM intervention including herbal medicine treatment based on pattern differentiation, symptomatic treatment, acupuncture treatment, regulation and nursing were illustrated.

Pattern Classification of Enterovirus 71-Associated Hand, Foot, and Mouth Disease in Chinese Medicine: A Retrospective Study in 433 Cases

Objective： To determine whether patterns of enterovirus 71（EV71）-associated hand, foot, and mouth disease（HFMD） were classified based on symptoms and signs, and explore whether individual characteristics were correlated with membership in particular pattern. Methods： Symptom-based latent class analysis（LCA） was used to determine whether patterns of EV71-HFMD existed in a sample of 433 cases from a clinical data warehouse system. Logistic regression was then performed to explore whether demographic, and laboratory data were associated with pattern membership. Results： LCA demonstrated a two-subgroup solution with an optimal fit, deduced according to the Bayesian Information Criterion minima. Hot pattern（59.1% of all patients） was characterized by a very high fever and high endorsement rates for classical HFMD symptoms（i.e., rash on the extremities, blisters, and oral mucosa lesions）. Non-hot pattern（40.9% of all patients） was characterized by classical HFMD symptoms. The multiple logistic regression results suggest that white blood cell counts and aspartate transaminase were positively correlated with the hot pattern（adjust odds ratio=1.07, 95% confidence interval： 1.006–1.115; adjust odds ratio=1.051, 95% confidence interval： 1.019–1.084; respectively）. Conclusions： LCA on reported symptoms and signs in a retrospective study allowed different subgroups with meaningful clinical correlates to be defined. These findings provide evidence for targeted prevention and treatment interventions.

Deciphering Potential Correlations between New Biomarkers and Pattern Classification in Chinese Medicine by Bioinformatics:Two Examples of Rheumatoid Arthritis

Biological complexity and the need for personalized medicine means that biomarker development has become increasingly challenging.Thus,new paradigms for research need to be created that bring together a different classifier of individuals.One potential solution is collaboration between biomarker development and Chinese medicine pattern classification.In this article,two examples of rheumatoid arthritis are discussed,including a new biomarker candidate casein kinase 2 interacting protein 1(CKIP-1)and a micro RNA 214.The authors obtained a"snapshot"of pattern classification with disease in biomarker identification.Bioinformatics analyses revealed underlying biological functions of two biomarker candidates,in varying degrees,are correlated with Chinese medicine pattern of rheumatoid arthritis.The authors'initial attempt can provide a new window for studying the win-win potential correlation between the biomarkers and pattern classification in Chinese medicine.

Inter-observer Reliability of Indicators and Decision of Pattern Identification Using Diagnostic Flowchart with Traditional Korean Medicine

Objective： To evaluate the consistency of patterns and pattern identification（PI）, and the improvement in the diagnosis of blood stasis after the standard operating procedures（SOPs） were enhanced by using a diagnostic flowchart. Methods： A total of 358 subjects who were admitted by the Jaseng Hospital of Korean Medicine between June 2013 and December 2014 were included in the study. Each patient was independently diagnosed by two experts from the same department. In 2014, the SOPs included the use of a diagnostic flowchart for each indicator. Inter-observer consistency was assessed by simple percent agreement and by the kappa and AC1 statistics. Results： The improvements in inter-observer agreement for the indicators（for al patients） and PI were greater in 2014 than in 2013. In 2013, the j-value measure of agreement between the two experts ranged from ＂poor＂（κ=–0.051） to ＂good＂（κ=0.968）. The AC1 measure of agreement between the experts was generally high for the indicators and ranged from –0.010 to 0.978. In most cases, agreement was considerably lower when it was assessed by the j-values compared with the AC1 values. In 2014, the j-value measure of agreement on the indicators（for the subjects） general y ranged from poor to good, with the values ranging from –0.007 to 0.994. Moreover, the AC1 measure of agreement between the experts was general y high for al of the indicators and ranged from ＂moderate＂（AC1=0.408） to ＂excel ent＂（AC1=0.996）. Conclusions： In four examinations, there was moderate agreement between the clinicians on the PI indicators of blood stasis. To improve clinician consistency（e.g., in the diagnostic criteria used）, it is necessary to analyse the reasons for inconsistency and to improve clinician training.（Trial registration No. KCT0000916）

Effectiveness and safety of Xuefu Zhuyu oral liquid(血府逐瘀口服液)on Qi-stagnation and blood-stasis pattern in patients with stable angina,tension-type headache and primary dysmenorrhea:rationale and design of a master protocol

We present the rationale and design of a master protocol study that clarifies the effectiveness and safety of Chinese herbal formulas on Qi-stagnation and blood-stasis pattern(QBP).Three randomized controlled trials(RCTs)and real-world observational studies.Based on three registry cohorts of stable angina,tension-type headache and primary dysmenorrhea,patients with QBP will be enrolled in RCTs to receive either Xuefu Zhuyu(血府逐瘀,XFZY)oral liquid or a placebo,while patients with non-QBP will be enrolled in the observational studies and experience follow-up.1414 patients(RCTs:574;observational studies:840)will be recruited at seven centers in China over a 3-year period.The primary outcome is the visual analog scale of pain intensity.Adverse events will also be reported.The analysis will be undertaken separately in each sub-study,and then an overall analysis combining multiple subgroups will be performed to comprehensively investigate the effect of XFZY oral liquid.This study will provide high-quality evidence of XFZY oral liquid for QBP patients and show a paradigm of post-marketing evaluation of the effectiveness and safety for Chinese medicine following the notion of the pattern dominating different disease research models.

Short-Term Efficacy of Treating Hepatitis B Virus-Related Acute-on-Chronic Liver Failure Based on Cold Pattern Differentiation with Hot Herbs: A Randomized Controlled Trial

Objective： To evaluate the clinical efficacy and safety of Yinchen Zhufu Decoction（茵陈术附汤, YCZFD） in the treatment of acute-on-chronic liver failure caused by hepatitis B virus（HBV-ACLF） with cold pattern in Chinese medicine（CM）. Methods： This is a multi-center randomized controlled trial of integrative treatment of CM and Western medicine（WM） for the management of HBV-ACLF patients. A total of 200 HBV-ACLF patients with cold pattern were equally randomly assigned to receive YCZFD and WM（integrative treatment） or WM conventional therapy alone respectively for 4 weeks. The primary end point was the mortality for HBV-ACLF patients. Secondary outcome measures included Model for End-Stage Liver disease（MELD） score, liver biochemical function, coagulation function and complications. Adverse events during treatment were reported. Results： The mortality was decreased 14.28% in the integrative treatment group compared with WM group（χ^2=6.156, P=0.013）. The integrative treatment was found to significantly improve the MELD score（t=2.353, P=0.020）. There were statistically significant differences in aspartate transaminase, total bilirubin, indirect bilirubin, direct bilirubin and prothrombin time between the two groups（P〈0.05 or P〈0.01）. The complications of ascites（χ^2=9.033, P=0.003） and spontaneous bacteria peritonitis（χ^2=4.194, P=0.041） were improved significantly in the integrative treatment group. No serious adverse event was reported. Conclusions： The integrative treatment of CM and WM was effective and safe for HBV-ACLF patients with cold pattern in CM. The Chinese therapeutic principle ＂treating cold pattern with hot herbs＂ remains valuable to the clinical therapy.（Trial registration No. Chi CTR-TRC-10000766）

Standardization and Future Directions in Pattern Identification Research: International Brainstorming Session

An international brainstorming session on standardizing pattern identification（PI） was held at the Korea Institute of Oriental Medicine on October 1, 2013 in Daejeon, South Korea. This brainstorming session was convened to gather insights from international traditional East Asian medicine specialists regarding PI standardization. With eight presentations and discussion sessions, the meeting allowed participants to discuss research methods and diagnostic systems used in traditional medicine for PI. One speaker presented a talk titled ＂The diagnostic criteria for blood stasis syndrome： implications for standardization of PI＂. Four speakers presented on future strategies and objective measurement tools that could be used in PI research. Later, participants shared information and methodology for accurate diagnosis and PI. They also discussed the necessity for standardizing PI and methods for international collaborations in pattern research.