[Research and development strategy of new traditional Chinese medicine drugs for syndromes based on human use experience].

Chinese drug registration laws and regulations have always reserved a place for the new traditional Chinese medicine(TCM) drugs for syndromes, but so far no such new drugs have been approved for registration. This paper expounded on the relevant policies, regulations, and technologies of new TCM drugs for syndromes in China and pointed out that the application of the animal model of TCM syndromes to carry out pharmacodynamics research and clinical efficacy evaluation criteria of TCM syndromes were the main technical difficulties in the research and development of new TCM drugs for syndromes. Not all syndromes are suitable for developing new drugs, and the indications for new TCM drugs should be constant syndromes. Among the three research and development models of simple syndrome, syndrome-unified disease, and combined disease and syndrome, the research and development model of combined disease and syndrome is recommended. Clinical positioning is the key to new TCM drugs for syndromes. It is encouraged to conduct high-quality human use experience studies to determine the clinical positioning of new TCM drugs for syndromes, as well as the target population, dose, course of treatment, and initial therapeutic and safety, and apply for exemption from non-clinical effectiveness studies. Clinical trials of new TCM drugs for syndromes should take the target symptoms or signs as the main efficacy index and the efficacy of TCM syndromes as the secondary efficacy index. Clinical research program design should implement the "patient-centered" concept and introduce clinical outcome evaluation indicators. In the clinical safety evaluation, special conditions such as characteristic syndromes and changes should be considered. With the construction of the human use experience technology system and the promotion of the TCM registration and evaluation evidence system featuring the "combination of TCM theory, human use experience, and clinical trials", it is believed that many high-quality new TCM drugs for syndromes will be developed in the future.

Traditional Chinese medicine diagnostic prediction model for holistic syndrome differentiation based on deep learning.

Background: With the development of traditional Chinese medicine (TCM) syndrome knowledge accumulation and artificial intelligence (AI), this study proposes a holistic TCM syndrome differentiation model for the classification prediction of multiple TCM syndromes based on deep learning and accelerates the construction of modern foundational TCM equipment. Methods: We searched publicly available TCM guidelines and textbooks for expert knowledge and validated these sources using ten-fold cross-validation. Based on the BERT and CNN models, with the classification constraints from TCM holistic syndrome differentiation, the TCM-BERT-CNN model was constructed, which completes the end-to-end TCM holistic syndrome text classification task through symptom input and syndrome output. We assessed the performance of the model using precision, recall, and F1 scores as evaluation metrics. Results: The TCM-BERT-CNN model had a higher precision (0.926), recall (0.9238), and F1 score (0.9247) than the BERT, TextCNN, LSTM RNN, and LSTM ATTENTION models and achieved superior results in model performance and predictive classification of most TCM syndromes. Symptom feature visualization demonstrated that the TCM-BERT-CNN model can effectively identify the correlation and characteristics of symptoms in different syndromes with a strong correlation, which conforms to the diagnostic characteristics of TCM syndromes. Conclusions: The TCM-BERT-CNN model proposed in this study is in accordance with the TCM diagnostic characteristics of holistic syndrome differentiation and can effectively complete diagnostic prediction tasks for various TCM syndromes. The results of this study provide new insights into the development of deep learning models for holistic syndrome differentiation in TCM.

Clinical efficacy and safety of Guipi decoction combined with escitalopram oxalate tablets in patients with depression.

BACKGROUND: Depression is a widespread mental health condition that requires effective treatment. In the treatment of depression, traditional Chinese medicine (TCM) offers obvious advantages, fewer adverse reactions, and a lower recurrence rate. AIM: To evaluate the clinical benefits of Guipi decoction combined with escitalopram oxalate tablets for individuals with depression. METHODS: In total, 80 patients diagnosed as having depression were enrolled in the study and divided into either an experimental group or a control group. All of the patients were orally administered escitalopram oxalate tablets. Additionally, the experimental group received Jiajian Guipi decoction and reduced Governor vessel fumigation over 4 wk. TCM syndrome scores, Hamilton depression rating scale (HAM-D) scores, self-rating depression scale (SDS) scores, and Pittsburgh sleep quality index scores were measured for the two groups and compared before and after the treatment. The two groups were monitored for any adverse reactions. RESULTS: After 4 wk of treatment, both groups exhibited a significant reduction in TCM syndrome scores compared with their pre-treatment scores (P < 0.05). However, the experimental group exhibited significantly lower TCM syndrome scores than the control group (P < 0.05). Similarly, the post-treatment SDS and HAM-D-24 scores were significantly lower in both groups than the pre-treatment scores (P < 0.05), with the experimental group exhibiting lower scores than the control group (P < 0.05). The total treatment efficiency was significantly better in the experimental group (97.14%) than in the control group (77.78%) (P < 0.05). Furthermore, after 4 wk of treatment, the Pittsburgh sleep quality index scores for both groups were significantly lower than those before the treatment (P < 0.05), with the experimental group exhibiting lower scores than the control group (P < 0.05). The incidence of adverse reactions was significantly lower in the experimental group than in the control group (P < 0.05). CONCLUSION: The combination of Guipi decoction and escitalopram oxalate tablets was found to be an effective and safe treatment for depression. This combination could reduce TCM syndrome scores, improve depressive symptoms, and enhance sleep quality.

The Association Between Health-Related Behaviors and Traditional Chinese Medicine Syndromes in Type 2 Diabetes Mellitus Patients.

Background: Traditional Chinese medicine (TCM) has certain advantages in treating diabetes via TCM syndromes differentiation, and health-related behaviors can regulate TCM syndromes. This study aimed to identify the clusters of TCM syndromes in type 2 diabetes mellitus (T2DM) patients and to explore the association between health-related behaviors and those TCM syndromes clusters. Methods: This was a cross-sectional study of 1761 T2DM patients from the Ningxia Province. The TCM syndromes (11 TCM syndromes in total) scale was used to collect the syndrome information. Health-related behaviors, including smoking, alcohol use, tea drinking, the intensity of physical activity, sleep quality, and sleep duration, were collected via a face-to-face interview questionnaire. Latent profile analysis was employed to identify clusters of 11 TCM syndromes. Multinomial logistic regression was employed to examine the relationships between health-related behaviors and clusters of TCM syndromes. Results: TCM syndromes in T2DM patients were classified into three profiles using latent profile analysis: light, moderate, and heavy. Participants with poor health-related behaviors were more likely to have heavy 1.49 (95% CI: 1.12, 1.99) or moderate 1.75 (95% CI: 1.10, 2.79) profiles than those with good health-related habits. Smokers, tea drinkers, and those with poor sleep quality were more likely to have a moderate profile and heavy profile than a light profile. Compared with heavy physical activity, moderate activity 0.24 (95% CI: 0.07, 0.88) was negatively associated with a heavy profile. Conclusion: Results showed that most participants had light or moderate levels of TCM syndromes, and those with poor health-related behaviors were more likely to have heavy or moderate profiles. In the context of precision medicine, these results have important implications for understanding the prevention and treatment of diabetes via changing lifestyles and behaviors to regulate TCM syndromes.

PDMS-TiO2 composite films combined with LC-MS/MS for determination of phospholipids of urine in non-small cell lung cancer patients with traditional Chinese medicine syndromes.

Lung cancer is one of the most common malignant tumors in China. Most patients are already in the mid to advanced stages during the consultation and the survival rate is less than 23 % with a poor prognosis. Therefore, effective dialectical diagnosis of advanced cancer can guide individualized treatment to improve survival. Phospholipids are the building blocks of cell membranes and abnormal phospholipid metabolism is associated with plentiful diseases. Most studies of disease markers use blood as a sample. However, urine covers extensive metabolites that are produced during the body's metabolic processes. Therefore, the study of markers in urine can be used as a complement to improve the diagnosis rate of marker diseases. Moreover, urine is characterized by high water content, high polarity, and high inorganic salt, therefore the detection of phospholipids in urine is challenging. In this study, an original Polydimethylsiloxane (PDMS)-titanium dioxide (TiO2) composite film for sample pre-treatment coupled with the LC-MS/MS method for the determination of phospholipids in the urine with high selectivity and low matrix effects was prepared and developed. The extraction process was scientifically optimized by the single-factor test. After systematic validation, the established method was successfully applied to the accurate determination of phospholipid substances in the urine of lung cancer patients and healthy subjects. In conclusion, the developed method has great potential for the development of lipid enrichment analysis in urine and can be used as a beneficial tool for cancer diagnosis and Chinese medicine syndrome typing.

Distribution of Traditional Chinese Medicine Syndromes in 600 Patients with Alopecia Areata Based on Factor Analysis and Cluster Analysis / 中医杂志

ObjectiveTo explore the distribution of traditional Chinese medicine （TCM） syndromes of alopecia areata （AA）， and to provide reference for TCM clinical syndrome differentiation and classification of AA. MethodsAA patients who visited the specialized hairiness clinic of Beijing China-Japan Friendship Hospital were included. A questionnaire was developed including general information of the patients， history of hair loss （onset time， triggers and exacerbating factors， disease progression）， current symptoms （symptoms and signs）， medical history， personal history， family history， and hair microscopy examination results. The factor analysis and cluster analysis were used to determine the syndrome elements and to summarize the syndrome types. ResultsA total of 600 patients with AA were included， including 218 males （36.33%） and 382 females （63.67%）. Totally， 128 patients （21.33%） had a family history of hair loss， and 326 patients （54.33%） had a previous related underlying disease. The leading triggering and exacerbating factors of AA were tension and anxiety， accounting for 335 cases （55.83%） and 285 cases （47.50%）， respectively. The top 10 symptoms involved among patients were scalp oil， anxiety， irritability， dreaminess， fatigue， itching， tension， weakness and dandruff. The factor analysis showed that the factor rotation converged after 9 iterations， and finally obtained 12 common factors and 34 variables， with a cumulative contribution rate of 58.59%. In terms of disease location of AA， the main syndrome elements were liver， spleen and kidney， and the disease nature syndrome elements were mainly dampness-heat， qi stagnation， yin deficiency， qi deficiency， and blood deficiency. The clustering analysis of the 12 common factors showed that TCM syndromes could be summarized into four categories： internal retention of damp-heat， liver-kidney deficiency， qi and blood deficiency， and liver constraint and spleen deficiency. There were significant differences in the distribution of TCM syndromes in patients of different ages and genders （P＜0.001）. ConclusionThe main disease location of AA is in the liver， spleen， and kidney， with the liver being the key. The disease mechanism of AA is a deficiency-excess complex， initially manifested as excess and later becoming deficiency. The TCM syndromes mainly include four types which are internal retention of damp-heat， liver-kidney deficiency， qi and blood deficiency， and liver constraint and spleen deficiency.

Traditional Chinese Medicine Syndromes and Influencing Factors of Protein Energy Wasting in Chronic Kidney Disease Patients Undergoing Maintenance Hemodialysis：a Cross-sectional Study / 中医杂志

ObjectiveTo investigate the distribution of traditional Chinese medicine （TCM） syndrome types and influencing factors of protein-energy wasting （PEW） in chronic kidney disease （CKD） undergoing maintenance hemodialysis （MHD）. MethodsAccording to diagnostic criteria， 164 patients with MHD were divided into PEW group and non-PEW group. The clinical data of all patients were collected， including general information such as gender， age， height and weight， disease characteristics such as course， cormobidity， and haemodialysis duration， laboratory indicators such as blood routine， liver function， renal function， electrolyte， blood lipid， grip strength， and the four examinations. Logistic regression analysis was used to find the influencing factors of PEW by taking the clinical indicators with significant differences between the two groups （P＜0.05） as the independent variables， diagnosis of PEW as the dependent variable， and normal values as the reference. ResultsOut of 164 patients with MHD， there were 96 （58.5%） cases in PEW group and 68 cases （41.5%） in non-PEW group. Compared to the non-PEW group，PEW group had increased age， ratios of bedrest， deep vein preservation， edema， and low grip strength， percentages of comorbidities type 2 diabetes， cardiovascular and cerebrovascular diseases，infections and anemia， and levels of alanine aminotransferase and permine amin aminotransferase， as well as decreased body mass index， self-care ratio，internal arteriovenous fistula， red blood cell count， hemoglobin， serum total protein， serum albumin levels （P＜0.05）. The PEW group had significantly higher frequency of poor appetite and digestion， abdominal distension， fear of cold and preference of warmth， weak breathing and fatigue， poor appetite， oliguria， nausea and vomiting than non-PEW group （P＜0.05）. The incidence of both yin and yang deficiency syndrome and damp-turbidity syndrome were significantly higher in the PEW group than the non-PEW group， while that of liver-kidney yin deficiency syndrome and stirring of wind syndrome were lower （P＜0.05）. Logistic regression analysis showed that low BMI （＜22 kg/m2）， inability to take care of oneself， low grip strength，low serum albumin （＜38 g/L）， infection， older age， fear of cold and cold limbs，and poor appetite were the risk factors of PEW in patients undergoing MHD （P＜0.05）. ConclusionThe root syndrome of MHD-PEW patients is both yin and yang deficiency， concurrent with damp-turbidity syndrome. Low BMI， low serum albumin， infection and older age may be the influencing factors of PEW in patients undergoing MHD.

[Effect of Shanhaidan Granules combined with tadalafil on erectile dysfunction: A multi-center clinical trial].

OBJECTIVE: To observe the clinical effect and safety of Shanhaidan Granules (SHDG) combined with tadalafil tablets (TT) in the treatment of ED. METHODS: In this open multi-center case-control clinical trial, we enrolled 247 ED patients according to the designed criteria, and treated them orally with SHDG at 10 g per time tid (n = 74), TT at 5 mg per time bid (n = 52), or SHDG + TT at the above doses (n = 121), all for 8 weeks. Before and after medication, we recorded the IIEF-6, erection hardness scores (EHS), traditional Chinese medicine syndromes (TCMS) scores, penile cavernous blood flow parameters and adverse reactions, and compared them between the 3 groups of patients. RESULTS: After 8 weeks of treatment, all the patients showed significantly increased IIEF-6, EHS and TCMS scores in comparison with the baseline (P < 0.05). The total effectiveness rates in the SHDG, TT and SHDG + TT groups were 60.8%, 67.3% and 69.4% respectively based on the IIEF-6 scores, remarkably higher in the TT and SHDG + TT groups than in the SHDG group (P < 0.05), and 40.5%, 32.7% and 63.6% respectively according to the TCMS scores, markedly higher in the SHDG and SHDG + TT groups than in the TT group (P < 0.05). Single-center data manifested significantly increased peak systolic velocity (PSV) of the penile artery in the SHDG + TT and TT groups (P < 0.05). The improvement values of relevant parameters were remarkably higher in the SHDG + TT group than in the TT and SHDG groups, so were IIEF-6 scores in the TT than in the SHDG group, and TCM syndromes in the SHDG than in the TT group. No medication-related adverse events were found in any of patients after treatment, except for some mild side effects including muscle soreness and gastrointestinal reactions in a few cases, all soon relieved, none with abnormalities in blood and urine routine tests or hepatic and renal function indicators. CONCLUSIONS: Shanhaidan Granules combined with tadalafil can significantly improve the erectile function and reduce TCM syndromes in ED patients, and therefore can be applied effectively and safely in clinical practice./.

Integrated DIA proteomics and lipidomics analysis on non-small cell lung cancer patients with TCM syndromes.

BACKGROUND: Lung cancer remains the leading cause of mortality from malignant tumors, non-small cell lung cancer (NSCLC) accounts for the majority of lung cancer cases, and individualized diagnosis and treatment is an effective trend. The individual characteristics of different traditional Chinese medicine (TCM) syndromes of NSCLC patients may be revealed by highly specific molecular profiles. METHODS: In this study, 10 NSCLC patients with Qi deficiency and Yin deficiency (QDYD) syndrome and 10 patients with Qi deficiency of lung-spleen (QDLS) syndrome in TNM stage III-IV as well as 10 healthy volunteers were enrolled. Aiming at the varied syndromes of NSCLC patients with "Yin deficiency" as the main difference, a proteomics research based on data-independent acquisition (DIA) was developed. Of the dysregulated proteins in NSCLC patients, lipid metabolism was significantly enriched. Thereafter, nontargeted lipidomics research based on UPLC-Q-TOF/MS was performed in 16 patients, with 8 individuals randomly selected from each syndrome group. Furthermore, the considerably different characteristics between the syndromes and pathological mechanisms of NSCLC were screened by statistical and biological integrations of proteomics and lipidomics and the differential metabolic pathways of the two similar syndromes were further explored. Besides, lipids biomarkers were verified by a clinically used anticancer Chinese medicine, and the level of key differential proteins in the two syndromes was also validated using ELISA. RESULTS: The results showed that glycerophospholipid metabolism, sphingolipid metabolism, glycolipid metabolism, and primary bile acid biosynthesis were altered in NSCLC patients and that glycerophospholipid metabolism was significantly changed between the two syndromes in lipidomics analysis. Among the proteins and lipids, ALDOC and lysophosphatidylcholine (LPCs) were revealed to have a strong relationship by statistical and biological integration analysis, and could effectively distinguish QDLS and QDYD syndromes. Notably, the patients with different syndromes had the most typical metabolic patterns in glycerophospholipid metabolism and glycolysis, reflecting the differences in the syndromes dominated by "Yin deficiency". CONCLUSIONS: ALDOC and LPCs could be employed for the differentiation of NSCLC patients with QDLS and QDYD syndromes, and "Yin deficiency" might be associated with glycerophospholipid metabolism and glycolysis pathway. The results provided a theoretical basis for "Syndrome differentiation" in TCM diagnosis. Moreover, the developed integrated strategy could also provide a reference for individualized diagnosis and treatment of other diseases.

Serum metabolic profiling of traditional Chinese medicine syndromes in patients with diarrhea-predominant irritable bowel syndrome.

OBJECTIVE: The clinical symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D) can be effectively improved by traditional Chinese medicine (TCM) treatment, based on the usage of specific therapies for different TCM syndromes. However, in the stage of diagnosis, the standard criteria for the classification of TCM syndrome were still deficient. Through serum metabolic profiling, this study aimed to explore potential biomarkers in IBS-D patients with different TCM syndromes, which can assist in diagnosis of the disease. METHODS: Serum samples were collected from healthy controls (30 cases), IBS-D patients with Liver-Stagnation and Spleen-Deficiency syndrome (LSSD, 30 cases), Yang Deficiency of Spleen and Kidney syndrome (YDSK, 11 cases) and Damp Abundance due to Spleen-Deficiency syndrome (DASD, 22 cases). Serum metabolic profiling was conducted by ultra-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry. The potential biomarkers were screened by orthogonal partial least square-discriminate analysis, while metabolic pathways undergoing alterations were identified by pathway enrichment analysis in MetaboAnalyst 4.0. RESULTS: Overall, 34 potential biomarkers were identified in LSSD group, 36 in YDSK group and 31 in DASD group. And the 13 metabolites shared by three groups were determined as the potential biomarkers of IBS-D. Glycerophospholipid metabolism was disturbed significantly in IBS-D patients, which may play a role in IBS-D through inflammation. What's more, three TCM syndromes have the specific potential biomarkers in glycerophospholipid metabolism. CONCLUSION: The serum metabolomics revealed that different TCM syndrome types in IBS-D may have different metabolic patterns during disease progression and glycerophospholipid metabolism was one of the pathways, whose metabolism was disturbed differently among three TCM syndromes in IBS-D. Therefore, the specific potential biomarkers in glycerophospholipid metabolism of three TCM syndromes in IBS-D can serve as the objective indicators, which can facilitate the TCM-syndrome objective classification of IBS-D.

Syndrome Differentiation and Treatment Regularity in Traditional Chinese Medicine for Type 2 Diabetes: A Text Mining Analysis.

Objective: The goal of this study was to systematically summarize and categorize the syndrome differentiation, medication rules, and acupoint therapy in the domestic traditional Chinese medicine (TCM) literature on type 2 diabetes mellitus (T2DM), such that guidelines and new insights can be provided for future practitioners and researchers. Methods: Taking randomized controlled trials (RCTs) on the treatment of T2DM in TCM as the research theme, we searched for full-text literature in three major clinical databases, including CNKI, Wan Fang, and VIP, published between 1990 and 2020. We then conducted frequency statistics, cluster analysis, association rules extraction, and topic modeling based on a corpus of medical academic words extracted from 3,654 research articles. Results: The TCM syndrome types, subjective symptoms, objective indicators, Chinese herbal medicine, acupuncture points, and TCM prescriptions for T2DM were compiled based on invigorating the kidney and Qi, nourishing Yin, and strengthening the spleen. Most TCM syndrome differentiation for T2DM was identified as "Zhongxiao" (the lesion in the spleen and stomach) and "Xiaxiao" (the lesion in the kidney) deficiency syndromes, and most medications and acupoint therapies were focused on the "Spleen Channel" and "Kidney Channel." However, stagnation of liver Qi was mentioned less when compared with other syndromes, which did not have symptomatic medicines. Conclusion: This study provides an in-depth perspective for the TCM syndrome differentiation, medication rules, and acupoint therapy for T2DM and provides practitioners and researchers with valuable information about the current status and frontier trends of TCM research on T2DM in terms of both diagnosis and treatment.

Serum metabolic profiling of traditional Chinese medicine syndromes in patients with diarrhea-predominant irritable bowel syndrome / 中西医结合学报

OBJECTIVE@#The clinical symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D) can be effectively improved by traditional Chinese medicine (TCM) treatment, based on the usage of specific therapies for different TCM syndromes. However, in the stage of diagnosis, the standard criteria for the classification of TCM syndrome were still deficient. Through serum metabolic profiling, this study aimed to explore potential biomarkers in IBS-D patients with different TCM syndromes, which can assist in diagnosis of the disease.@*METHODS@#Serum samples were collected from healthy controls (30 cases), IBS-D patients with Liver-Stagnation and Spleen-Deficiency syndrome (LSSD, 30 cases), Yang Deficiency of Spleen and Kidney syndrome (YDSK, 11 cases) and Damp Abundance due to Spleen-Deficiency syndrome (DASD, 22 cases). Serum metabolic profiling was conducted by ultra-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry. The potential biomarkers were screened by orthogonal partial least square-discriminate analysis, while metabolic pathways undergoing alterations were identified by pathway enrichment analysis in MetaboAnalyst 4.0.@*RESULTS@#Overall, 34 potential biomarkers were identified in LSSD group, 36 in YDSK group and 31 in DASD group. And the 13 metabolites shared by three groups were determined as the potential biomarkers of IBS-D. Glycerophospholipid metabolism was disturbed significantly in IBS-D patients, which may play a role in IBS-D through inflammation. What's more, three TCM syndromes have the specific potential biomarkers in glycerophospholipid metabolism.@*CONCLUSION@#The serum metabolomics revealed that different TCM syndrome types in IBS-D may have different metabolic patterns during disease progression and glycerophospholipid metabolism was one of the pathways, whose metabolism was disturbed differently among three TCM syndromes in IBS-D. Therefore, the specific potential biomarkers in glycerophospholipid metabolism of three TCM syndromes in IBS-D can serve as the objective indicators, which can facilitate the TCM-syndrome objective classification of IBS-D.

Efficacy of Qiju Dihuang decoction combined with sodium hyaluronate eye drops in the treatment of xerophthalmia after cataract surgery / 国际眼科杂志(Guoji Yanke Zazhi)

@#AIM: To explore the efficacy of Qiju Dihuang decoction combined with sodium hyaluronate eye drops in the treatment of xerophthalmia after cataract surgery.<p>METHODS: A total of 120 patients with xerophthalmia after cataract surgery admitted to our hospital were selected between January 2018 and January 2020, and randomly divided into control group and observation group, with 60 cases in each group. The control group was treated with sodium hyaluronate eye drops alone, and the observation group was given Qiju Dihuang decoction combined with sodium hyaluronate eye drops, and they were treated for 1mo. The clinical efficacy, Traditional Chinese Medicine(TCM)syndromes scores, tear film break-up time(BUT), Schirmer Ⅰ test(SⅠt), corneal fluorescein staining(FL)and quality of life \〖25-item National Eye Institute Visual Function Questionnaire(NEI-VFQ-25)\〗were compared between the two groups.<p>RESULTS:After treatment, the total effective rate of treatment was 93% in observation group and was 75% in control group(<i>P</i><0.05). After 1mo of treatment, the scores of TCM syndromes(dry eyes, foreign body sensation, photophobia, blurred vision), BUT, SⅠt and FL in the two groups were improved compared with those before treatment, and the TCM syndromes scores after treatment in observation group were lower than those in control group, the BUT time was longer than that in control group, the SⅠt level was higher than that in control group while the FL score was lower than that in control group(all <i>P</i><0.05). During 3mo of follow-up, the NEI-VFQ-25 scores(general health status, mobility impairment, visual impairment)in the two groups were increased compared with those before treatment, and the scores of dimensions of NEI-VFQ-25 during 3mo of follow-up in observation group were higher than those in control group(<i>P</i><0.05).<p>CONCLUSION: Qiju Dihuang decoction combined with sodium hyaluronate eye drops has exact efficacy in treating xerophthalmia after cataract surgery, and it can effectively alleviate the symptoms of ocular discomfort, improve tear film function, and promote the quality of life of patients.

Effect of Shanhaidan Granules combined with tadalafil on erectile dysfunction: A multi-center clinical trial / 中华男科学杂志

Objective@#To observe the clinical effect and safety of Shanhaidan Granules (SHDG) combined with tadalafil tablets (TT) in the treatment of ED.@*METHODS@#In this open multi-center case-control clinical trial, we enrolled 247 ED patients according to the designed criteria, and treated them orally with SHDG at 10 g per time tid (n = 74), TT at 5 mg per time bid (n = 52), or SHDG + TT at the above doses (n = 121), all for 8 weeks. Before and after medication, we recorded the IIEF-6, erection hardness scores (EHS), traditional Chinese medicine syndromes (TCMS) scores, penile cavernous blood flow parameters and adverse reactions, and compared them between the 3 groups of patients.@*RESULTS@#After 8 weeks of treatment, all the patients showed significantly increased IIEF-6, EHS and TCMS scores in comparison with the baseline (P < 0.05). The total effectiveness rates in the SHDG, TT and SHDG + TT groups were 60.8%, 67.3% and 69.4% respectively based on the IIEF-6 scores, remarkably higher in the TT and SHDG + TT groups than in the SHDG group (P < 0.05), and 40.5%, 32.7% and 63.6% respectively according to the TCMS scores, markedly higher in the SHDG and SHDG + TT groups than in the TT group (P < 0.05). Single-center data manifested significantly increased peak systolic velocity (PSV) of the penile artery in the SHDG + TT and TT groups (P < 0.05). The improvement values of relevant parameters were remarkably higher in the SHDG + TT group than in the TT and SHDG groups, so were IIEF-6 scores in the TT than in the SHDG group, and TCM syndromes in the SHDG than in the TT group. No medication-related adverse events were found in any of patients after treatment, except for some mild side effects including muscle soreness and gastrointestinal reactions in a few cases, all soon relieved, none with abnormalities in blood and urine routine tests or hepatic and renal function indicators.@*CONCLUSIONS@#Shanhaidan Granules combined with tadalafil can significantly improve the erectile function and reduce TCM syndromes in ED patients, and therefore can be applied effectively and safely in clinical practice./.

[Exploration on scientific connotation of TCM syndromes and recommended prescriptions against COVID-19 based on TCMTP V2.0].

Coronavirus disease 2019(COVID-19) has attracted great attentions from the whole world. Traditional Chinese medicine(TCM) has been widely used and shown satisfying efficacies in treating all stages of COVID-19. In this study, the molecular interaction networks of different stages of COVID-19(the early, severe, critical and recovery stage) were constructed using the links among symptoms-related genes collected from TCMIP V2.0(http://www.tcmip.cn/), an integrated pharmacology network-computing platform for TCM. Following the network topological feature calculation and functional enrichment analysis, we found that the molecular targets and pathways related with the "immune-inflammation system" were involved throughout all the stages of COVID-19. The severe stage and the critical period of COVID-19 were occupied by a large proportion of inflammatory factors and pathways, suggesting that there might be a cytokine storm in these periods, along with respiratory disorders, cardiopulmonary dysfunction, nervous system disorders, etc. Accordingly, the therapeutic targets and pathways hit by the recommended prescriptions against COVID-19 were also aimed to regulate the balance of immune-inflammation system, nutrient absorption and metabolism, abnormal energy metabolism, the cardio-pulmonary function, nerve system function, etc., which may be related to the therapeutic effects of these prescriptions in terms of several clinical symptoms, such as expiratory dyspnea, chest tightness and shortness of breath, abdominal distension and constipation, sweating and limb cold, dizziness, and irritability, etc. The above findings reflect the integrative actions of TCM characterizing by multiple-components, multiple-targets, multiple-pathways, and multiple-effects. This study systematically constructed the molecular networks of different TCM syndromes during the development and progression of COVID-19 and uncovered the biological basis for symptomatic treatment of TCM. Furthermore, our data revealed the pharmacological mechanisms and the scientific connotation of recommended prescriptions, which may provide supports for the prevention and treatment of COVID-19 using TCM.

Research progress on Traditional Chinese Medicine syndromes of diabetes mellitus.

With the improvement of people's living standard and the changes of environment, the incidence of diabetes mellitus (DM) is on the rise day by day, while clinical treatment mainly aims at lowering blood glucose, instead of fundamental prevention and treatment. What's worse, the measures of prevention and treatment of DM complications remain inadequate. Both Chinese and modern medicine have advantages and disadvantages in treating DM, therefore, it would be a worthy attempt to break through the bottleneck of DM treatment by combining the advantages of both, and explore the new measures to prevent and deal with DM from the perspective of the combination of Traditional Chinese Medicine (TCM) syndrome and modern medicine. In this paper, modern research methods and possible indicators of TCM syndromes of DM were expounded from clinical and basic research aspects, aiming to find specific biomarkers of TCM syndromes, and providing experimental supports for the diagnosis and treatment of DM and the verification of TCM theory.

Clinical Efficacy and Experiences of Lung-toxin Dispelling Formula No.1 Treating Patients of Corona Virus Disease 2019 Type Severe/type Extremely Severe / 中国实验方剂学杂志

Objective:To observe clinical efficacy of Lung-toxin dispelling formula No.1 treating patients of corona virus disease 2019(COVID-19) type severe/type extremely severe, and summarize experiences of diagnosis and treatment. Method:Collected and analyzed clinical informations of patients of COVID-19 type severe/type extremely severe, treated with Lung-toxin dispelling formula No.1, who were hospitalized in central hospital in Zhumadian and the first affiliated hospital of Henan university of traditional Chinese medicine from 31st January to 27th February. Result:All patients had positive epidemiological history, major symptoms were fever, cough, tachypnea, weakness and sore heavy muscles, combined with bad appetite and diarrhea. The median age was 59, median time from onset to getting worse was 9 days, ground glass opacity, lamellar, nodular high density shadow were mostly displayed in both lungs， lesions progressedfaster. After treatment with Lung-toxin dispelling formula No.1 combined with western medicine, the median time of PCR-NAD-test from positive to negative was 16 days, the median hospitalization days were 20 days, all patients were cured and discharged. Conclusion:Lung-toxin dispelling formula No.1 had certain clinical efficiency in treating patients of COVID-19 type severe/type extremely severe, further large sample clinical verification is needed.

Expression of Treg/Th17 Cells in Patients with HBV-ACLF in Different Traditional Chinese Medicine Syndrome " Yanghuang-Yinyanghuang-Yinhuang" / 中国实验方剂学杂志

Objective::To detect the expression levels of peripheral blood Treg/Th17 cells and related cytokines in patients with Hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF) with different traditional Chinese medicine (TCM) syndrome " Yanghuang-Yinyanghuang-Yinhuang" , in order to explore the cellular immunological characteristics of different TCM syndromes of liver failure. Method::The 32 cases of patients with HBV-ACLF in early, middle and late stages in line with the " Yanghuang-Yinyanghuang-Yinhuang" TCM syndrome grouping were selected. Flow cytometry was used to detect the frequency expression of Treg/Th17 cells in peripheral blood. The expression levels of interleukin-10(IL-10), transforming growth factor-β(TGF-β), interleukin-17A(IL-17A), tumor necrosis factor-α(TNF-α) and interleukin-23(IL-23) were detected by cytometric bead array (CBA). The expressions of transcription factor forkhead box P3(FoxP3) and retinoid-related orphan nuclear receptor-γt(ROR-γt) mRNA were detected by Real-time PCR. The SPSS 20.0 software was applied in data statistics and processing to analyze the expression characteristics of Treg/Th17 cells and related cytokines in patients with different TCM syndrome types of HBV-ACLF. Result::The patients with HBV-ACLF Yanghuang syndrome were mainly distributed in the early stage of liver failure, those with Yinyanghuang syndrome were mainly distributed in the middle stage, and those with Yinhuang syndrome were distributed in the late stage. From Yanghuang syndrome, Yinyanghuang syndrome to Yinhuang syndrome, the frequency of Treg and Th17 cells gradually increased, and the differences among the groups were statistically significant (P<0.05). From Yanghuang syndrome, Yinyanghuang syndrome to Yinhuang syndrome, Treg cytokines IL-10, TGF-β gradually increased, and the differences among the groups were statistically significant (P<0.05). Th17 cytokines IL-17A, TNF-α, IL-23 gradually increased, of which IL-17A were differences between Yanghuang syndrome and the Yinyanghuang syndrome, as well as Yanghuang syndrome and Yinhuang syndrome (P<0.05). From Yanghuang syndrome, Yinyanghuang syndrome to Yinhuang syndrome, the expression of FoxP3 was gradually decreased, while that of ROR-γt was gradually increased, and the differences among the groups were statistically significant (P<0.01). Conclusion::There is a certain correlation between the different course of early, middle and late stages of HBV-ACLF and the distribution of TCM syndromes. The frequency of Treg and Th17 cells and the correlation of IL-17A, TGF-β and IL-10 with TCM syndrome differentiation are related, suggesting that Treg and Th17 cells have a certain reference value for the diagnosis of patients with HBV-ACLF and the syndrome differentiation of TCM syndromes.

Research progress of correlation between genetic polymorphism and traditional Chinese medicine syndromes / 中国中西医结合急救杂志

Traditional Chinese medicine (TCM) syndromes have a certain genetic background. It is of great significance to study the essence of syndromes, and through genetic polymorphism research, the objectification of TCM syndromes can be realized. There are multiple relationships between genetic polymorphisms and TCM syndromes:including the relationship between internal factors and external manifestations, the relationship between macrocosmic view and microcosmic view, and the relationship between objectivity and subjectivity. This article reviews the current research progress on the correlation between genetic polymorphism and TCM syndromes in order to provide some ideas for the objectification of syndromes.

Effect of traditional Chinese medicine syndrome differentiation and standard bundle therapy in patients with septic shock / 中华危重病急救医学

Objective To evaluate an effective and feasible quantitative evaluation table of traditional Chinese medicine (TCM) syndrome differentiation, and to observe the effect of combination of TCM syndrome differentiation and standard bundle therapy in patients with septic shock. Methods A prospective randomized controlled trial was conducted. The septic shock patients with acute deficiency syndrome admitted to department of critical care medicine of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine from January 1st, 2016 to December 31st, 2017 were enrolled. The patients were randomly divided into control group and Shenfu group. The patients in both groups received early application of standardized bundle therapy; those in Shenfu group received 60 mL Shenfu injection infusion in addition for 7 days. The TCM syndrome score was evaluated by classification and scoring method of TCM symptoms. The circulation and tissue perfusion, severity of disease, organ function, inflammation response, adjuvant treatment and 28-day mortality were compared between the two groups. Results A total of 50 patients with septic shock were enrolled in the analysis, 25 in control group and 25 in Shenfu group. The markedly effective rate of TCM symptoms score in Shenfu group was significantly higher than that in control group [60.0% (15/25) vs. 16.0% (4/25), P < 0.01]. There was no significant difference in all parameters before treatment between the two groups. After treatment, the observation indexes of both groups were improved. Compared with control group, the mean arterial pressure (MAP) in Shenfu group increased more significantly [mmHg (1 mmHg = 0.133 kPa): 13.0 (2.5, 28.5) vs. 6.0 (0, 13.5)], the lactate (Lac) and procalcitonin (PCT) decreased more significantly [Lac (mmol/L): 0.8 (0.1, 3.7) vs. 0.5 (-0.6, 1.7), PCT (μg/L): 2.0 (0.7, 32.3) vs. 0 (-1.8, 3.8)], activated partial thromboplastin time (APTT) was shortened more significantly [s: 8.5 (0, 12.9) vs. 0 (-7.2, 10.0)], and interleukins (IL-2 receptor and IL-6) levels decreased more significantly [IL-2 receptor (ng/L):1 031.0 (533.0, 1 840.0) vs. 525.5 (186.0, 1 166.8), IL-6 (ng/L): 153.1 (21.4, 406.8) vs. 35.1 (16.3, 110.1)] with significant differences (all P < 0.05). There was no significant difference in the use time of vasoactive drugs, duration of mechanical ventilation, severity of the disease or 28-day mortality between the two groups. However, the use time of vasoactive drugs in Shenfu group was shorter than that in control group (days: 5.48±4.81 vs. 8.28±7.83), and the 28-day mortality was decreased [8.0% (2/25) vs. 20.0% (5/25)]. Conclusions TCM syndrome score is helpful to evaluate the effect of TCM syndrome differentiation and treatment, and it is effective and feasible in clinical application. Septic shock patients treated with TCM syndrome differentiation and treatment combined with standard bundle therapy were significantly improved in circulation, tissue perfusion, coagulation function and inflammation reaction.