Yin Deficiency Syndrome Research Articles

Effects of Chinese Medicine on Symptoms, Syndrome Evolution, and Lung Inflammation Absorption in COVID-19 Convalescent Patients during 84-Day Follow-up after Hospital Discharge: A Prospective Cohort and Nested Case-Control Study.

ObjectiveTo observe the changes of symptoms, Chinese medicine (CM) syndrome, and lung inflammation absorption during convalescence in patients with coronavirus disease 2019 (COVID-19) who had not totally recovered after hospital discharge and whether CM could promote the improvement process.MethodsThis study was designed as a prospective cohort and nested case-control study. A total of 96 eligible patients with COVID-19 in convalescence were enrolled from Beijing Youan Hospital and Beijing Huimin Hospital and followed up from the hospital discharged day. Patients were divided into the CM (64 cases) and the control groups (32 cases) based on the treatment with or without CM and followed up at 14, 28, 56, and 84 days after discharge. In the CM group, patients received the 28-day CM treatment according to two types of CM syndrome. Improvements in clinical symptoms, CM syndrome, and absorption of lung inflammation were observed.ResultsAll the 96 patients completed the 84-day follow-up from January 21 to March 28, 2020. By the 84th day of follow-up, respiratory symptoms were less than 5%. There was no significant difference in the improvement rates of symptoms, including fatigue, sputum, cough, dry throat, thirst, and upset, between the two groups (P>0.05). Totally 82 patients (85.42%) showed complete lung inflammation absorption at the 84-day follow-up. On day 14, the CM group had a significantly higher absorption rate than the control group (P<0.05) and the relative risk of absorption for CM vs. control group was 3.029 (95% confidence interval: 1.026–8.940). The proportions of CM syndrome types changed with time prolonging: the proportion of the pathogen residue syndrome gradually decreased, and the proportion of both qi and yin deficiency syndrome gradually increased.ConclusionsPatients with COVID-19 in convalescence had symptoms and lung inflammation after hospital discharge and recovered with time prolonging. CM could improve lung inflammation for early recovery. The types of CM syndrome can be transformed with time prolonging. (Registration No. ChiCTR2000029430)

Analysis of animal models of heart failure based on characteristics of clinical symptoms of traditional Chinese and Western medicine

The incidence of heart failure has increased year by year, with a negative impact on quality of life and life expectancy of patients. Reproduction of animal models that meet the characteristics of clinical symptoms is a prerequisite for conducting experimental studies relating to heart failure. Based on the characteristics of clinical symptoms of heart failure in traditional Chinese medicine(TCM) and Western medicine, the existing common animal models of heart failure were explored, and the clinical anastomosis of the existing animal models was analyzed based on the clinical diagnostic criteria of heart failure in TCM and Western medicine. After analysis and comparison, it can be seen that the existing modeling methods are mostly single-factor animal models, with certain gaps between the characteristics of clinical multi-factors and interactions that jointly lead to heart failure, and the modeling methods were mostly guided by Western medicine, with a lack of TCM pathogenic factors in the model process, which is different from the clinical diagnostic criteria of Chinese and Western medicine for heart failure. In terms of syndrome differentiation, heart failure is classified into heart and lung Qi deficiency syndrome, Qi and Yin deficiency syndrome, heart and kidney Yang deficiency syndrome, Qi deficiency and blood stasis syndrome, Yang deficiency and water flooding syndrome, phlegm-drinking obstructive lung syndrome, Yin and yang exhausted syndrome. The existing animal models mostly confused them, with no effective and recognized method for modeling at present. There are major limitations in studies of Chinese medicine. Therefore, based on clinical characteristics of heart failure in Chinese and Western medicine, this article analyzed the existing animal models, defined their advantages and disadvantages and application prospects, and then suggested further improving the corresponding animal models of heart failure and standardizing the model evaluation, so as to improve the clinical coincidence between animal models and Chinese and Western medicine, make heart failure animal models better serve scientific studies, and promote relevant mechanism studies, pathological change studies and drug screening.

Clinical application characteristics of Ciwujia Injection in treatment of 5 904 cases with cardiovascular disease in real world

To investigate the clinical characteristics and the rule of administration of Ciwujia Injection in patients with cardiovascular disease by correlation analysis and frequency analysis. The information of 5 904 patients who used Ciwujia Injection to treat cardiovascular disease for at least three times in the hospital information system(HIS) of 19 comprehensive tertiary hospitals nationwide. The frequency analysis method was used to analyze the higher frequency variables, and the algorithm of Apriori correlation analysis method was used to analyze the clinical characteristics and medication laws of Ciwujia Injection in treating patients with cardiovascular disease. Among the 5 904 patients, the median age of the patients was 70 years, and the number of patients between 65-75 years old was up to 2 096(35.5%). There were more women than men in terms of diagnosis and treatment, and the women at age of 45-65 and 65-75 years old were more than men. The top three diagnoses by Western medicine were coronary heart disease in 8 104 cases(65.66%), dyslipidemia in 2 515 cases(20.38%), and cardiac function grade Ⅱ-Ⅲ in 581 cases(4.71%), while the largest number of syndromes in traditional Chinese medicine(TCM) at discharge was 1 109(21.37%) in other type, followed by 739 cases(14.24%) of Qi deficiency and blood stasis syndrome, and 698(13.46%) of liver and kidney Yin deficiency syndrome. The most frequently used Western medicine in combined use was Nifedipine in 2 567 cases(7.21%), and most frequently used TCM was Compound Xianzhuli Liquid leachate in 766 cases(3.53%). From the results of pharmacological analysis, the frequency of using Ciwujia Injection + stasi-seliminating agent + calcium channel blocking drugs was highest when using 1 Chinese medicine combined with 1 or 2 Western medicines. In the use of 2 Chinese medicines combined with 1 Western medicine, Ciwujia Injection + heat-clearing agent + stasis-eliminating agent + calcium channel blocker was the most common. This study demonstrated that Ciwujia Injection was more common in middle-aged and elderly patients and more in women than men. Treatment should be based on different cardiovascular disease treatment guidelines to reduce complications caused by underlying diseases, and attention should be paid to the prevention and treatment of cardio-vascular disease risk factors such as hypertension, diabetes and abnormal lipid metabolism. According to the analysis of frequency distribution and association rules, it was concluded that Ciwujia Injection was mainly used in combination with calcium channel blockers and stasis-eliminating agents in the treatment of cardiovascular disease. In the treatment of cardiovascular diseases by Ciwujia Injection in combination with other Chinese and Western medicines, in order to avoid pharmacological changes and avoid affecting the efficacy of the drug, it is necessary to closely observe whether adverse reactions occur and ensure that the medication is safe and effective. This study provides a good reference for the follow-up clinical guidance of Ciwujia Injection.

A randomized controlled clinical trial study protocol of Liuwei Dihuang pills in the adjuvant treatment of diabetic kidney disease.

A large number of patients with diabetic kidney disease (DKD) approach traditional Chinese medicine (TCM) owing to discontent with standard treatments. Based on TCM theory and clinical experience, the syndrome of kidney yin deficiency is a common type of DKD. Liuwei Dihuang pills (LDPs) is a common prescription of a Chinese herbal formula for patients presenting this syndrome of DKD. However, well-established data supporting the efficacy and safety of LDP in DKD treatment are lacking. We have designed a double-blind, placebo-controlled, randomized trial. After a 2-week run-in period, 124 eligible participants with DKD will be assigned to either the experimental or the control group in a 1:1 ratio. Patients in the experimental group will receive LDP, while patients in the control group will receive a matched placebo. As the basic treatment in the 2 groups, metformin hydrochloride sustained-release tablets, for blood glucose control, and irbesartan tablets, for blood pressure regulation, will be provided. All participants will undergo 4 weeks of treatment and 12 weeks of follow-up. The primary outcome is the change in 24 hours urinary protein levels, measured from the baseline to the end of the treatment phase (week 24). The secondary outcomes to be assessed include the change in serum creatinine and estimated glomerular filtration rate, urinary albumin excretion rate, improvement of TCM syndromes and symptoms, fasting blood glucose and postprandial 2-hour blood glucose, blood lipids (total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol, from baseline to weeks 12 and 24. The results of this study will provide high-quality evidence of the effects of LDP in DKD treatment, which will provide an alternative treatment strategy in patients with DKD.

Pharmacodynamic and Metabolomics Studies on the Effect of Kouyanqing Granule in the Treatment of Phenol-Induced Oral Ulcer Worsened by Sleep Deprivation.

Oral ulcers are the most prevalent oral mucosal diseases globally, and no specific treatment schemes are currently available due to the complexity of oral ulcer diseases. Sleep deprivation increases the risk of a deterioration in oral health. Kouyanqing Granule (KYQG) has been used for decades in China to treat inflammatory diseases of the mouth and throat associated with the hyperactivity of fire due to yin deficiency syndrome. However, the mechanisms underlying the effects of KYQG in the treatment of oral ulcers are still unclear. The aims of this study were to investigate whether KYQG treatment could attenuate the symptoms of oral ulcers worsened by sleep deprivation and identify the involved metabolic pathways. First, we conducted chemical profiling of KYQG via UPLC–MS analysis. We then combined pharmacological and metabolomics approaches in a phenol-induced rat model of oral ulcers worsened by sleep deprivation. A total of 79 compounds were initially identified. Our observations showed that KYQG treatment induced a significantly higher healing rate in oral ulcers worsened by sleep deprivation. KYQG significantly reduced the levels of 5-HT and GABA in serum, and only decreased the 5-HT level in brain tissue after phenol injury followed by sleep deprivation. Moreover, KYQG administration significantly suppressed systemic inflammation by inhibiting TNF-α, IL-1β, IL-6, IL-18, and MCP-1. Immunohistochemical analysis further revealed that KYQG inhibited IL-6 expression in buccal mucosa tissues. KYQG treatment also significantly decreased the serum levels of ACTH, CORT, IgM, and 8-OHdG. Serum metabolomics analysis showed that a total of 30 metabolites showed significant differential abundances under KYQG intervention, while metabolic pathway analysis suggested that the altered metabolites were associated with the dysregulation of eight metabolic pathways. Taken together, our results indicated that KYQG attenuates the symptoms of oral ulcers worsened by sleep deprivation probably through the regulation of the neuroimmunoendocrine system, oxidative stress levels, and tryptophan metabolism. This study also provides a novel approach for addressing the increased health risks resulting from sleep deficiency using an herbal medicine formula.

Study on traditional Chinese medicine common syndrome characteristic of coronavirus disease 2019 based on latent structure combined with system clustering analysis

To investigate traditional Chinese medicine (TCM) common syndrome characteristic of coronavirus disease 2019 (COVID-19), thus providing evidence for clinical differentiation. The COVID-19 TCM treatment plan and syndrome related literature published before February 24, 2020 was searched and a database was established. TCM common syndrome characteristics of COVID-19 were analyzed by the method of latent structure and system clustering combined with frequency and constituent ratio, which were conducted by Lantern 5.0 and SPSS 20.0. Forty-two literatures about treatment plans, and 212 syndromes records were enrolled. Latent structure model was established based on 53 symptoms with frequency over 10, and 14 latent variables and 7 syndromes were concluded by comprehensive clustering, including syndrome of pathogenic heat invading lung, internal block and outward desertion, syndrome of dampness heat accumulating lung, syndrome of Qi and Yin deficiency, syndrome of epidemic virus closing lung, syndrome of cold dampness closing lung and syndrome of Qi deficiency of lung and spleen. Factor analysis was conducted for 53 symptoms, which were reported more than 10 times, and 14 common factors were obtained. Symptoms with load coefficient over 0.3 were clustered and 6 syndromes were obtained, including syndrome of epidemic virus closing lung, syndrome of pathogenic heat invading lung, syndrome of Qi and Yin deficiency, internal block and outward desertion, syndrome of cold dampness closing lung, and syndrome of dampness heat accumulating lung. The literatures included 25 syndromes, and the syndromes with constituent ratio over 5% were internal block and outward desertion (14.62%), syndrome of epidemic virus closing lung (13.68%), syndrome of dampness heat accumulating lung (12.74%), syndrome of Qi deficiency of lung (10.85%), spleen and syndrome of cold dampness closing lung (8.50%), syndrome of Qi and Yin deficiency (8.50%), syndrome of pathogenic heat invading lung (8.02%) and syndrome of dampness repressing defensive Qi of lung (5.66%). Eighty-seven symptoms whose cumulative frequency was 2 838 were referred, including greasy fur (5.25%), fever (4.83%), red tongue (4.37%), rapid pulse (3.74%) and fatigue (3.46%). According to the results above, the common syndromes and their symptoms of COVID-19 were: (1) syndrome of pathogenic heat invading lung: fever, cough, throat-drying, headache, all of the body distressed and constipation, etc.; (2) syndrome of cold dampness closing lung: aversion to cold, all of the body distressed, nausea and vomiting, abdominal distention and loose stool, etc.; (3) syndrome of dampness heat accumulating lung: cough, sticky phlegm, anorexia, thirst without desire to drink and constipation, etc.; (4) syndrome of epidemic virus closing lung: fever, cough, yellow phlegm, wheezing, suffocation and purple lips, etc.; (5) internal block and outward desertion: coma, feel fidgety, suffocation, sweating and feel cold and purple lips, etc.; (6) syndrome of Qi and Yin deficiency: dry cough, sweating, fatigue, thirsty, feverish feeling in palms and soles and loose stool, etc.; (7) syndrome of Qi deficiency of lung and spleen: cough, wheezing, sweating, fatigue, nausea and vomiting, and loose stool, et al. The common syndromes of COVID-19 were syndrome of pathogenic heat invading lung, syndrome of cold dampness closing lung, syndrome of dampness heat accumulating lung, syndrome of epidemic virus closing lung, internal block and outward desertion, syndrome of Qi and Yin deficiency and syndrome of Qi deficiency of lung and spleen. This study could provide reference for clinical differentiation.

Real-world study on syndrome distribution and medication characteristics of colonic malignant tumors

In order to explore the characteristics of traditional Chinese medicine(TCM) syndromes and medications in patients with colonic malignant tumors in China, the clinical data of patients with colonic malignant tumors from the information system of 33 Grade-A tertiary hospitals in China from 2001 to 2016 were extracted and a descriptive analysis was conducted on their disease characteristics, syndrome distribution, drug characteristics and treatment status. A total of 22 691 patients with colonic malignancies nationwide were included in the analysis, with male to female ratio of 1.59∶1, median age of 62 years, susceptible age of 50-79 years. Postoperative patients with colonic malignant tumors accounted for 47.10%, and patients with liver metastases reached 36.02%. Among the 520 patients with colonic malignant tumors, the top three TCM syndromes were: spleen deficiency syndrome(21%), Qi and Yin deficiency syndrome(17%) and liver and stomach disharmony syndrome(15%). The most frequently used Western medicine for patients with colonic malignant tumors was anti-metabolite cytotoxicity(61.23%), most frequently used in combination with platinum-based cytotoxic drugs(support degree 42.40%).The top three Western medicines were oxaliplatin(42.26%), leucovorin injection(38.58%) and dexamethasone(34.67%). The most frequently used traditional Chinese medicine type was heat-clearing and detoxifying drugs(39.59%), most frequently used in combination with Qi replenishing and body resistance strengthening drugs(support degree 12.72%). The top three traditional Chinese medicines were compound Kushen Injection(14.62%), Shenqi Fuzheng Injection(10.18%) and Aidi Injection(6.48%). This study shows that spleen and Qi deficiency may be the dominant syndrome of colonic malignant tumor, and chemotherapy is one of the main treatment methods. Traditional Chinese medicine has shown unique advantages in alleviating the toxic and side effects of chemotherapy and preventing recurrence and metastasis, so integrated TCM and Western medicine can significantly improve the clinical efficacy.

Serum proteins TGFBI, PCSK9, and CCL14 are potential biomarkers for different traditional Chinese medicine syndromes of multidrug-resistant tuberculosis.

Patients with multidrug-resistant tuberculosis (MDR-TB) tend to have a long course of anti-TB treatment and severe side effects. Traditional Chinese Medicine (TCM) has a synergistic effect in attenuation of MDR-TB. However, the lack of objective biological standards to classify and diagnose MDR-TB TCM syndromes could result in less effective TCM treatment. Therefore, in this study, we identified differentially expressed proteins (DEPs) in serum of individuals with MDR-TB TCM syndromes by applying isobaric tags for relative and absolute quantification coupled with two-dimensional liquid chromatography-tandem mass spectrometry (iTRAQ-2DLC-MS/MS) method and bioinformatics analysis. The functional analysis of DEPs was also performed. Additionally, DEPs among three different TCM syndromes of MDR-TB were validated by enzyme-linked immunosorbent assay (ELISA). Finally, a receiver operating characteristic (ROC) curve was performed to estimate the diagnostic ability of DEPs. A total of 71 DEPs were identified in the three different MDR-TB TCM syndrome groups such as the pulmonary Yin deficiency (PYD) syndrome group, the Hyperactivity of Fire due to Yin deficiency (HFYD) syndrome group, and the deficiency of Qi and Yin (DQY) syndrome group. The results showed that the expression level of transforming growth factor-beta-induced protein ig-h3 (TGFBI) was lower in the PYD syndrome group (p = .002), the proprotein convertase subtilisin/kexin type 9 (PCSK9) was overexpressed in the HFYD syndrome group (p < .0001), and the C-C motif chemokine ligand 14 (CCL14) expression level was reduced in the DQY syndrome group (p = .004). Our study demonstrated that serum TGFBI, PCSK9, and CCL14 may serve as potential novel biomarkers for PYD syndrome, HFYD syndrome and DQY syndrome of MDR-TB, respectively. The study provides a biological basis for MDR-TB TCM syndromes classification and can be of great significance for the treatment of different TCM syndromes.

Study on syndrome differentiation based on pharmacology of syndrome management system - a case of Qi and Yin deficiency syndrome

Study on syndrome differentiation based on pharmacology of syndrome management system - a case of Qi and Yin deficiency syndrome

Zhibaidihuang Decoction Ameliorates Cell Oxidative Stress by Regulating the Keap1-Nrf2-ARE Signalling Pathway.

Zhibaidihuang decoction (ZBDHD) is a Chinese herbal formula, which is used in Chinese traditional medicine to treat symptoms of Yinxuhuowang (Yin deficiency and high fire) syndrome. This study elucidates the mechanism of ZBDHD on oral ulcers, one Yinxuhuowang syndrome. Simultaneously, some ingredients in ZBDHD were found and identified by ultraperformance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). A Ganjiangfuzirougui decoction- (GJD-) induced Yinxuhuowang syndrome SD rat model was used to demonstrate the efficiency of ZBDHD treatment. The oral mucosa of rat in the GJD group, stained with hematoxylin and eosin (H&E), showed epidermal shedding and inflammatory cell infiltration. And an alleviation efficiency of ZBDHD in GJD-induced pathological changes in the oral mucosa could be obtained. ZBDHD treatment restored the GJD-induced imbalance of metabolites, which were choline, glycocholic acid, and palmitoyl-L-carnitine (PALC). GJD stimulated the expression of NF-κB. And the overexpressed of NF-κB in mucosa of rat in the GJD group could be inhibited by ZBDHD treatment. Simultaneously, the optimal efficiency of ZBDHD treatment on the cellular ATP content, oxygen consumption rate (OCR), and superoxide dismutase (SOD) concentration was evaluated, in vitro assay. Compared to the control cells, the ATP content, OCR, and SOD activity in the ZBDHD-treated cells were significantly higher. For the mechanisms study, seven cytokines were screened with a Dual-Luciferase Reporter gene assay. In the ARE assay, the luciferase signal was stimulated significantly by ZBDHD. In cells, the transcription of nrf2, maf, and keap1, which were related to the ARE pathway, was elevated by ZBDHD treatment. Our study demonstrated that high-dose GJD could lead to Yinxuhuowang syndrome, such as oral ulcers, and the imbalance in serum metabolites. And ZBDHD can improve oral cell inflammation and the imbalance of metabolism by inhibiting NF-κB and enhancing the activity of the ARE signalling pathway to ameliorate oxidative stress in the cell. This study provides a theoretical basis for the clinical application of ZBDHD.

Insights from the Perspective of Traditional Chinese Medicine to Elucidate Association of Lily Disease and Yin Deficiency and Internal Heat of Depression.

Lily disease was first recorded in Synopsis of the Golden Chamber by Zhang Zhongjing. It is a disease of heart and lung internal heat by Yin deficiency, which belongs to the category of emotion disease in Chinese medicine. In recent years, researchers believe that lily disease and depression syndrome of Yin deficiency and internal heat have many similarities in etiology, pathogenesis, and clinical manifestations. This review summarizes the clinical symptoms, etiology, pathogenesis, and therapeutic medication of lily disease and modern Yin-deficient internal heat depression and discusses the relationship between them. Furthermore, the relationship between coronavirus disease 2019 (COVID-19) and lily disease was discussed from the etiology, pathogenesis, and treatment. It provides new ideas for the treatment of COVID-19 and the treatment of psychological problems after recovery.

Traditional Chinese Medicine-Guided Dietary Intervention for Male Youth Undergoing Drug Detoxification: A Randomized Controlled Trial.

Objective The aim of this study was to evaluate the effectiveness of traditional Chinese medicine- (TCM-) guided dietary interventions in improving yang-qi deficiency and yin-blood deficiency TCM syndromes according to the principles of TCM syndrome differentiation theory in male youths undergoing drug detoxification during the rehabilitation period who stayed in a compulsory isolation detoxification center. Methods Male youths undergoing drug detoxification who met the criteria to be included in the study were randomly divided into the intervention group (n = 62) and the control group (n = 61) according to a random number table in a 1 : 1 ratio. The intervention group received a TCM-guided diet, and the control group received routine food support. Over an intervention period of 3 months, we observed changes in the TCM syndrome element scores in the two groups before and after intervention. Results After 3 months, the qi deficiency, yin deficiency, blood deficiency, and yin-blood deficiency syndrome in the intervention group improved significantly (P values 0.009, 0.000, 0.005, and 0.001, respectively). In the control group, yang deficiency, qi deficiency, and yang-qi deficiency syndromes worsened significantly (P values 0.003, 0.032, and 0.009, respectively). The differences (post-pre) in yang deficiency, qi deficiency, yang-qi deficiency, yin deficiency, blood deficiency, and yin-blood deficiency syndromes between the two groups were statistically significant (P values 0.003, 0.003, 0.003, 0.001, 0.005, and 0.002, respectively). Conclusion A TCM-guided diet can delay the worsening of yang-qi deficiency syndrome symptoms and improve yin-blood deficiency syndrome and the prognosis of male youth undergoing drug detoxification during the rehabilitation period.

The type of Traditional Chinese Medicine syndrome predicts prognosis and chemotherapeutic outcomes in colorectal cancer

IntroductionIdentifying and targeting patients who can benefit from an intervention by determining the prognostic factors is increasingly important if effective healthcare is to be provided. This study analyzed whether Traditional Chinese Medicine (TCM) syndrome differentiation could be used to determine prognosis and chemotherapeutic efficacy in colorectal cancer (CRC) patients. MethodsA total of 470 patients registered on the CRC database between 2006 and 2010 and with detailed clinical data were categorised according to TCM syndrome differentiation. Patients with CRC were divided into spleen deficiency syndrome, stagnation of cold-heat syndrome, stasis position resistance syndrome, spleen-kidney yang deficiency syndrome, liver-kidney yin deficiency syndrome, dual deficiency of qi and blood syndrome. Kaplen-Meier method was used to calculate the cumulative survival curve of TCM syndrome types and the COX regression analysis further analyzed the correlation between TCM syndrome types and prognosis and chemotherapeutic efficacy. ResultsThe survival rate of patients with deficiency syndrome was higher than that of patients with excess syndrome, and the survival rate of patients with dual deficiency of qi and blood syndrome was higher than other types. The COX regression analysis model, single factor and multi-factor analysis confirmed that TCM syndrome type was an independent factor in predicting the prognosis of patients with CRC; excess syndrome patients can significantly prolong their overall survival through postoperative adjuvant chemotherapy. ConclusionsThe prognosis of CRC patients with deficiency syndrome was better than patients with excess syndrome. Patients with excess syndrome could benefit from postoperative adjuvant chemotherapy. Moreover, patients with deficiency syndrome have the best prognosis among the six TCM syndrome types.

Expert consensus statement on treatment of type 2 diabetes with Xiaoke Pills in clinical practice

Xiaoke Pills are Chinese and Western medicine compound preparations with effects of nourishing kidney and Yin,and supplementing Qi and promoting fluid. It is widely used in clinical treatment of type 2 diabetes( Qi and Yin deficiency syndrome),and continuously included in 2010,2013 and 2017 editions of Chinese prevention guide for type 2 diabetes. For the purpose of accurate positioning and rational use in clinic,it is necessary to further define the curative effect,indications,medication precautions and contraindications of Xiaoke Pills,in order to improve medication safety. This consensus was reached by reference of international clinical guidelines and expert consensus approach based on clinical evidence-based evidence,expert experience and standard specification. The evidence-based evaluation was oriented to clinical problems summarized by no less than 200 front-line clinical physicians in two rounds.GRADE system was adopted for quality classification and evaluation of the evidences,and then the nominal group method was used to form consensus recommendations or suggestions. This consensus defined the curative effect advantages,target users,dosage,administration method,contraindications and precautions of Xiaoke Pills,and provided valuable reference for the clinical use of the drug. Thisconsensus still needs to be updated and revised based on new clinical problems and evidence-based evidence in practical application in the future.

Chronic hepatitis B: dynamic change in Traditional Chinese Medicine syndrome by dynamic network biomarkers

BackgroundIn traditional Chinese medicine (TCM) clinical practice, TCM syndromes help to understand human homeostasis and guide individualized treatment. However, the TCM syndrome changes with disease progression, of which the scientific basis and mechanism remain unclear.MethodsTo demonstrate the underlying mechanism of dynamic changes in the TCM syndrome, we applied a dynamic network biomarker (DNB) algorithm to obtain the DNBs of changes in the TCM syndrome, based on the transcriptomic data of patients with chronic hepatitis B and typical TCM syndromes, including healthy controls and patients with liver-gallbladder dampness-heat syndrome (LGDHS), liver-depression spleen-deficiency syndrome (LDSDS), and liver-kidney yin-deficiency syndrome (LKYDS). The DNB model exploits collective fluctuations and correlations of the observed genes, then diagnoses the critical state.ResultsOur results showed that the DNBs of TCM syndromes were comprised of 52 genes and the tipping point occurred at the LDSDS stage. Meanwhile, there were numerous differentially expressed genes between LGDHS and LKYDS, which highlighted the drastic changes before and after the tipping point, implying the 52 DNBs could serve as early-warning signals of the upcoming change in the TCM syndrome. Next, we validated DNBs by cytokine profiling and isobaric tags for relative and absolute quantitation (iTRAQ). The results showed that PLG (plasminogen) and coagulation factor XII (F12) were significantly expressed during the progression of TCM syndrome from LGDHS to LKYDS.ConclusionsThis study provides a scientific understanding of changes in the TCM syndrome. During this process, the cytokine system was involved all the time. The DNBs PLG and F12 were confirmed to significantly change during TCM-syndrome progression and indicated a potential value of DNBs in auxiliary diagnosis of TCM syndrome in CHB.Trial registration Identifier: NCT03189992. Registered on June 4, 2017. Retrospectively registered (http://www.clinicaltrials.gov)

Clinical study on Duhuo-Xuduan decoction combined with massage in the treatment of lumbar intervertebral disc herniation with yin deficiency of liver and kidney type

Objective To explore the Duhuo-Xuduan decoction combined with massage in the treatment of lumbar intervertebral disc herniation with yin deficiency of liver and kidney type. Methods According to the random number table method, 67 patients were divided into the control group (n=33) and the study group (n=34). The patients in the control group were treated with traditional massage, while the patients in the study group were treated with Duhuo-Xuduan decoction on the basis of the control group. The groups were treated continuously for 4 weeks. After treatment, the total clinical effective rate of the two groups was counted. The Visual analogue scale (VAS) and Oswestry dysfunction index were measured before and after treatment. At the same time, the level of serum Aggrecan, bone morphogenetic protein 7 (BMP-7), P substance (SP), 5-hydroxytryptamine (5-HT), dopamine (DA) were detected respectively before and after treatment. In addition, the adverse reaction of the two groups were observed. Results The total clinical effective rate of the study group was 97.06% (33/34), significantly higher than 81.82% (27/33) of the control group, and the difference was statistically significant (χ2=4.157, P=0.041). After treatment, the VAS score, Oswestry dysfunction index and serum SP, 5-HT, DA of study group was significantly lower than those of the control group (t=13.175, 12.524, 14.481, 15.729, 14.391, all Ps<0.01), while the level of serum Aggrecan, and BMP-7 of study group was significantly higher than that of the control group (t=18.697, 16.222, all Ps<0.01). There were no serious adverse reactions during treatment in both groups. Conclusions The Duhuo-Xuduan decoction combined with massage can alleviate pain, improve dysfunction of the patients with lumbar intervertebral disc herniation with yin deficiency of liver and kidney type. It is speculated that its mechanism may be related to analgesia and promoting cartilage regeneration of injured lumbar intervertebral disc. Key words: Intervertebral disc displacement; Syndrome of yin deficiency of liver and kidney; Tui Na therapy; Duhuo-Xuduan decoction; Integrated Chinese traditional and western medicine therapy

From clinical appearance to accurate management in acute ischemic stroke patients: With the guidance of innovative traditional Chinese medicine diagnosis.

ObjectiveTo investigate the correlation between simplified classification and laboratory indicators in patients with acute ischemic stroke, also provide accurate evidences for simplified classification and guide clinical interventions and treatment.MethodsTwo hundred patients with acute ischemic stroke were classified into four types according to the characteristics of Traditional Chinese Medicine syndrome: phlegm‐heat syndrome, phlegm‐dampness syndrome, qi deficiency syndrome, and yin deficiency syndrome. The differences between the types of syndromes and the correlation between laboratory indicators and syndromes were analyzed.ResultsAmong the 200 patients with acute ischemic stroke, there were significant differences in the level of low‐density lipoprotein (LDL‐C) (p < .05) between patients with phlegm‐heat syndrome and other three types. There were significant differences in the levels of homocysteine (HCY) and fibrinogen (Fib) between patients with yin deficiency syndrome and other three types (p < .05). In addition, there were statistically significant differences in blood glucose (Glu), glycosylated hemoglobin (HBA1c), and total cholesterol (CHO) between phlegm‐heat syndrome and qi deficiency syndrome (p < .05). There were significant differences in the levels of Glu, HBA1c, D‐2 polymer (D‐D), and C‐reactive protein (CRP)s between patients with phlegm‐heat syndrome and phlegm‐dampness syndrome (p < .05). There were statistically significant differences in the levels of CRP and urea nitrogen between patients with yin deficiency syndrome and phlegm‐dampness syndrome and qi deficiency syndrome (p < .05).ConclusionsThe four‐type simplified classification of Integrated TCM and Western medicine in acute ischemic stroke has specific laboratory data to support. Simplified classification with TCM treatment and intervention of different patients improves the survival and treatment, which is an innovative, easy‐to‐master clinical diagnosis and treatment model.

Metabolic Profiling Analysis of Patients With Coronary Heart Disease Undergoing Xuefu Zhuyu Decoction Treatment.

Coronary heart disease (CHD) remains the leading cause of morbidity and mortality worldwide. Traditional Chinese medicine (TCM) is one of the effective complementary and alternative therapies used to improve the prognosis of CHD patients. Xuefu Zhuyu (XFZY) decoction, a classical traditional Chinese medication for regulating Qi and promoting blood circulation, has a clinical benefit in CHD; however, the underlying mechanism is not clear. Recently, it was found that the metabolites involved in amino acid metabolism and the tricarboxylic acid cycle were altered in CHD patients with Qi and Yin deficiency syndrome. To understand the material foundation of Qi, it is of great significance to study the differential metabolites involved in Qi during treatment of CHD with Qi-regulating and blood-promoting herbs. In this study, we investigated the metabolic profiles of serum in CHD patients by nontargeted metabolomics analysis to detect differential metabolites between the XFZY decoction group and placebo group. Ten CHD patients were enrolled and treated with placebo granules or XFZY decoction granules in a random and double-blind manner. Serum samples of all patients were evaluated by untargeted high-performance liquid chromatography with tandem mass spectrometry-based metabolomics. In total, 513 metabolites were detected in the serum of CHD patients, and six of these metabolites participating in seven metabolic pathways were significantly different between CHD patients treated with XFZY decoction and the placebo group. Among the six differential metabolites, FA (20:2)-H and tetracarboxylic acid (24:0), involved in fatty acid metabolism; cis-aconitic acid, which participates in the tricarboxylic acid cycle; 2-deoxy-D-glucose, involved in glucose metabolism; and N-acetylglycine, involved in amino acid metabolism, were decreased, whereas spermine, which participates in amino acid metabolism, was increased as compared with the placebo group. Our findings, combined with the perspective of biological functions, indicate that 2-deoxy-D-glucose and spermine might constitute the partial material foundation of Qi in CHD patients treated with XFZY decoction.

Correlation analysis of serum progesterone with clinical indicators and common traditional Chinese medicine syndrome types in male type 2 diabetic patients

To analyze the correlation of serum progesterone (PROG) level with blood biochemical parameters and common traditional Chinese medicine (TCM) syndromes in male patients with type 2 diabetes mellitus (T2DM). We collected the clinical data of 192 male patients with T2DM, who were admitted in the Department of Endocrinology, Nanjing Hospital of Chinese Medical Affiliated to Nanjing University of Chinese Medicine between January, 2018 and March, 2019. The general clinical data, C-peptide level, blood glucose level, glycated hemoglobin (HbA1c), HOMA, blood lipid level, and sex hormones were compared between the patients with normal PROG and elevated PROG levels and also between the patients with two common TCM syndromes, namely qi and Yin deficiency syndrome and damp- heat accumulation in the spleen syndrome. We further compared the sex hormones, C-peptide level, HOMA, HbA1c, and blood glucose level among the patients with the two TCM syndromes having normal or elevated PROG levels. Compared with those in patients with normal PROG level, BMI, C-peptide, HOMA-β, and HOMA2-IR were significantly lowered and HOMA-IS, E2, and T were significantly increased in patients with elevated PROG level; no statistical differences were found in age, disease duration, waist-to-hip ratio (WHR), smoking history, blood pressure, blood glucose, blood lipids, HbA1c, LH, FSH or PRL between the two groups. Compared with the patients with damp-heat accumulation syndrome group, the patients with qi and Yin deficiency syndrome were older and had a longer disease duration, a greater BMI, and higher levels of PROG, C-Peptide, HOMA-β, HOMA2-IR and HOMA-IS, but the smoking history, WHR, HbA1c, blood glucose, and sex hormone levels were comparable between the two groups. Among the 4 groups of patients with different PROG levels and TCM syndromes, significant differences were found in the levels of C-peptide, HOMA-β, HOMA-IS, HOMA2-IR, PROG, E2, T, LH and FSH, and the patients with qi and Yin deficiency syndrome as well as an elevated PROG level had the lowest C-peptide level, HOMA-β and HOMA2-IR and the highest HOMA-IS, PROG, E2, T, LH and FSH. An elevated PROG level is closely related to islet cell dysfunction and TCM syndrome types in male patients with T2DM.

Safety and Efficacy of Tianfoshen Oral Liquid in Non-Small Cell Lung Cancer Patients as an Adjuvant Therapy.

Ethnopharmacological Relevance As an important Chinese herb injection, Tianfoshen (TFS) oral liquid is widely used in Chinese non-small cell lung cancer (NSCLC) patients. Aim of the Study To evaluate the efficacy and safety of Tianfoshen (TFS) oral liquid plus chemotherapy in Chinese NSCLC patients with Qi and Yin deficiency syndrome, an observational study was conducted in Beijing Friendship Hospital between August 2012 and July 2016. Patients, enrolled in this study, were diagnosed with NSCLC and were treated with Cisplatin in combination with Paclitaxel/Navelbine/Gemcitabine/Docetaxel as a first-line treatment, or Pemetrexed for recurrent patients. The primary endpoint was the improvement of traditional Chinese medicine syndrome and objective response rate in patients. The secondary endpoint was the occurrence of drug-related adverse events. Results A total of 108 patients were included in this study and underwent the safety and efficacy assessments. Compared to the baseline, the total scores of traditional Chinese medicine (TCM) syndrome after 3 or 8/9 weeks of TFS treatment were statistically significant (P<0.0001), and the clinical efficiency rate was 36.11% and 50.93%, respectively. The objective response rate (ORR) and disease control rate (DCR) of TFS group were slightly higher than those of without-TFS group, although the comparison was not statistically significant. The incidence of common adverse events related to TFS was 7.41% whereas the incidence of serious adverse events was 0.93%. Conclusions As an adjuvant therapy of chemotherapy, TFS showed an acceptable tolerability profile in the clinical practice of Chinese NSCLC patients with Qi and Yin deficiency syndrome, but it seems to have no effect on the ORR and DCR.