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

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

[Personality characteristics of erectile dysfunction patients with different traditional Chinese medicine syndromes].

OBJECTIVE: To explore the correlation between personality characteristics and traditional Chinese medicine (TCM) syndromes in ED patients. METHODS: We collected the general demographic data from 97 ED patients with different types of TCM syndromes, including the syndromes of liver-qi depression, fear-induced kidney injury, vital gate fire declination, heart and spleen deficiency, downward diffusion of damp-heat, yin-deficiency and fire-hyperactivity, and blood vessel stasis and obstruction. Using the Eysenck Personality Questionnaire (EPQ), we analyzed the personality types of the patients by comparing their EPQ scores with those of the adult males in the national norm group. RESULTS: Statistically significant differences were found between the ED patients and the males in the national norm group in the EPQ scores on neuroticism (11.97 ± 5.58 vs 4.61 ± 2.93, P < 0.01) and extraversion-introversion (10.06 ± 3.66 vs 7.38 ± 2.85, P < 0.01). Different personality types were significantly associated with the TCM syndrome types of the ED patients (P < 0.01), choleric temperament and melancholic temperament correlated with the syndrome of liver-qi depression (P < 0.01), and sanguine temperament with that of fear-induced kidney injury (P < 0.01). CONCLUSION: TCM syndrome differentiation has underlying correlations with personality characteristics. It is clinically feasible to divide ED into more subtypes based on correlation of the TCM syndrome differentiation with personality characteristics of the patient.

[Application of metabonomics in study of traditional Chinese medicine syndrome:a review].

Syndrome is a nonlinear "internal-excess external-deficiency", "dynamic spatial-temporal" and "multi-dimensional" complex system and thus only by using a versatile method can the connotation be expounded. Metabonomics, which is dynamic, holistic, and systematic, is consistent with the overall mode of traditional Chinese medicine(TCM)(holistic view and syndrome differentiation and treatment). Therefore, metabonomics is very important for the research on the differentiation, material basis, and metabolic pathways of syndromes, and efficacy on syndromes. This study reviewed the application of metabonomics in the study of TCM syndromes in recent years, which is expected to objectify the research on TCM syndromes.

[Biological connotation of four traditional Chinese medicine syndromes of rheumatoid arthritis based on "disease-syndrome-symptom" association network].

The present study explored the biological connotation of traditional Chinese medicine(TCM) syndromes of rheumatoid arthritis(RA) from the "disease-syndrome-symptom" association network. RA patients with four TCM syndromes(dampness-heat obstruction, phlegm-stasis obstruction, Qi-blood deficiency, and liver and kidney deficiency), three for each type, were assigned as the RA TCM syndrome group, and three healthy volunteers as the normal control group. The differential gene sets of four syndromes were screened out through transcriptome expression profiling and bioinformatics mining. The relevant gene sets of syndrome-related clinical symptoms were collected from TCMIP v2.0(http://www.tcmip.cn/). The "disease-syndrome-symptom" association networks of four RA syndromes were established by using the intersection genes of syndrome-related differential genes and symptom-related genes, and the key network target genes of each syndrome were screened out and the corresponding biological functions were mined through topological feature calculation and enrichment analysis. The genes associated with clinical symptoms such as vasculitis, joint pain, and fever in the damp-heat obstruction syndrome ranked the top, and the key network target genes of this syndrome were most significantly enriched in the pathways related to material and energy metabolism and thermal reaction biological processes. The clinical symptom-related genes of the phlegm-stasis obstruction syndrome were most significantly enriched in the pathways related to "immunity-inflammation", nervous system regulation, and sensory response. The clinical symptoms such as hypoglycemia, hypotension, weight loss, palpitation, and arrhythmia in Qi-blood deficiency syndrome were predominant, and its key network target genes were most significantly enriched in the pathways related to the nervous system and "immunity-inflammation" response. The abnormal symptoms in the liver and kidney in the liver and kidney deficiency syndrome were commonly seen, and its key network target genes were most significantly enriched in the "immunity-inflammation" regulatory pathways, and liver and kidney development and metabolic response. In conclusion, the differences and connections of the biological basis between different TCM syndromes of RA are in line with the theoretical interpretation of TCM on the etiology and pathogenesis of RA. This study summarized the objective essence of syndromes to a certain extent from the "disease-syndrome-symptom" association network and is expected to provide a theoretical basis for the discovery of serum biomarkers of RA syndromes.

[Research progress of change of platelet in blood stasis syndrome and effect of traditional Chinese medicine].

The traditional Chinese medicine(TCM) syndrome of blood stasis refers to blood stagnation in meridians and viscera, with the main symptoms of pain, mass, bleeding, purple tongue, and unsmooth pulse. Cardiovascular and cerebrovascular diseases are among the major chronic diseases seriously harming the health of the Chinese. Among the coronary heart disease and stroke patients, most demonstrate the blood stasis syndrome. Platelet is considered to be one of the necessary factors in thrombosis, which closely relates to the TCM syndrome of blood stasis and the occurrence of cardiovascular and cerebrovascular diseases. The clinical and laboratory research on platelet activation and aggregation has been paid more and more attention. Its purpose is to treat and prevent blood stasis syndrome. In this study, the authors analyzed the research on the dysfunctions of platelets in blood stasis syndrome, biological basis of TCM blood stasis syndrome, and the effect of blood-activating stasis-resolving prescriptions on platelets, aiming at providing a reference for exploring the mechanism of platelet intervention in the treatment of TCM blood stasis syndrome and the pathways and targets of Chinese medicine in the prevention and treatment of the syndrome.

[Selection principles and analysis of common prescriptions in clinical practice guidelines of traditional Chinese medicine--case example of migraine].

In this study, common prescriptions were retrieved from existing data in multiple ways to determine the selection principle of common formulas in traditional Chinese medicine(TCM) clinical practice guidelines. Taking the selection of common prescriptions in the clinical practice guidelines of TCM for migraine as an example, we searched common prescriptions for migraines from National Essential Medicine List, the National Drug Catalog for Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance, Chinese Pharmacopoeia, three teaching materials and two clinical practice guidelines, and we also electronically searched CNKI, VIP, WanFang about famous clinical experience for migraine published from 1990 to 2019. At the same time, 32 prescriptions commonly used by experts in the clinical questionnaire survey were collected to summarize and analyze the TCM clinically applicable syndrome types and medication rules of the included prescriptions and medicines. From the National Essential Medicine List, the National Drug Catalog for Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance, Chinese Pharmacopoeia, we got 12 Chinese patent medicines. From the teaching materials, we got 9 prescriptions. From the clinical practice guidelines, we got 8 prescriptions. We got 3 prescriptions from the experience of famous experts and got 4 prescriptions from experts in the clinical questionnaire survey. A total of 24 prescriptions were included from the above results. External wind syndrome, syndrome of blood stasis and brain blocking, and syndrome of liver Yang transforming into wind were the common syndrome types in the treatment of migraine. Chuanxiong Rhizoma and Angelicae Dahuricae Radix were the most common Chinese herbs in the prescriptions. Chuanxiong Rhizoma-Angelicae Dahuricae Radix was the most common drug pair for the treatment of migraine. By retrieving the data such as the famous clinical experience and teaching materials, we systematically summarized the prescriptions in the treatment of migraine in this study, which can provide a basis for the selection of traditional Chinese medicines in clinical practice guidelines.

[Distribution of traditional Chinese medicine syndrome types of male infertility in Chengdu area].

OBJECTIVE: To explore the distribution characteristics of the traditional Chinese medicine (TCM) syndrome types of male infertility in Chengdu area, China, in order to provide some objective evidence for the clinical treatment and studies of male infertility. METHODS: We collected the clinical data on 500 cases of male infertility treated in the outpatient and inpatient departments of the Affiliated Hospital of Chengdu University of Chinese Medicine and Chengdu Hospital for Reproduction, Women and Children from January to December 2017. Based on the results of examinations using the four diagnostic methods of TCM, namely, observation, auscultation and olfaction, interrogation, and palpation, we differentiated the TCM syndromes of the patients and analyzed the distribution characteristics of the syndrome types. RESULTS: Analysis of the baseline characteristics and the results of Chi-square test showed statistically significant differences in the distribution of the frequency of sexual intercourse, body mass index, history of urinary tract infection, testis volume, testicular texture, vas deferens and varicocele among the 500 patients (P < 0.05). As for the distribution of the TCM syndrome types, 115 cases (23.0%) were diagnosed with the unlicensed discernible type of syndrome, 109 (21.8%) with kidney-yang deficiency, 36 (7.2%) with kidney-essence deficiency, 30 (6.0%) with both kidney-yang deficiency and liver-qi stagnation, 30 (6.0%) with both kidney-yang deficiency and spleen-asthenia with excessive dampness, 28 (5.6%) with kidney-yin deficiency, 20 (4.0%) with spleen-asthenia and excessive dampness, 19 (3.8%) with liver-qi stagnation, 19 (3.8%) with phlegm dampness obstruction, 19 (3.8%) with kidney-yang and kidney-essence deficiency, 16 (3.2%) with downward damp-heat, 11 (2.2%) with both kidney-yin and kidney-yang deficiency, 10 (2.0%) with qi-stagnation and blood stasis, and 38 (7.6%) with other types of syndromes. CONCLUSIONS: The main TCM syndrome types of male infertility in Chengdu area include kidney-yang deficiency, kidney-yang deficiency with liver-qi stagnation, and kidney-yang deficiency with spleen-asthenia and excessive dampness. The distribution and influencing factors of the syndrome types need to be further explored and clarified by more large-sample and high-quality studies.

[New method for evaluating pharmacodynamics of traditional Chinese medicine compounds based on its moderate regulation and principle of balanced adjustment of immunity under pan-immunomic].

For the basic research on the traditional Chinese medicine(TCM), objective syndrome of traditional Chinese medicine and evaluation criteria of traditional Chinese medicine compounds are hardly to break though. While, the modern immunology points out that the body is a counterbalance state and immune imbalance is the root of sickness. The thinking mode of treating diseases in traditional Chinese medicine is also "balance", considering disease is the result of bias which present the imbalance of "Yin counters Yang", "exterior counters interior", "cold counters heat" and "weak counters strong". The Chinese herbal compound formula preparation was applied on disease therapy based on theory of Chinese medicine, which was confirmed by long period clinical application. It is composed of multi-compounds and has the characteristic of multi-targeting. Integrative medicine has spawned pan-immunomics, and the evaluation of immune function (immune balance) has become an important basis for diagnosis and treatment models of integrative medicine. In addition, balance is the core idea of whole-systemic conception of traditional Chinese medicine. Therefore, we speculate that immune balance under pan-immunomic can bridge the traditional Chinese medicine and modern integrative medicine and is the important basis for objective syndrome of traditional Chinese medicine and evaluation criteria of traditional Chinese medicine compounds. According to the bridging theory, we attempt to utilize informatics and statistical methods to construct an evaluation system for pharmacodynamics of traditional Chinese medicine based on its moderate regulation and the balanced adjustment of immunity under pan-immunomic, which further reveal the scientific essence of the whole-systemic view of traditional Chinese medicine. This research brings out a new valuable strategy and provides a theoretical basis for accelerating the transformation of traditional Chinese medicine, especially the exploitation of Chinese herbal compound formula, and constructing the new drug innovation and review system for traditional Chinese medicine. Besides as a reference for traditional Chinese medicine objective syndrome and pharmacodynamics of traditional Chinese medicine compounds, the evaluation system can screen the immunity of sub-health population also. With the continuous accumulation of clinical sample and data, the evaluation system will be more accurate and intelligent.

[Regression analysis of serum bone metabolic markers and traditional Chinese medicine syndromes in patients with CKD-MBD].

To analyze the interdependent relationship between serum bone metabolic markers and traditional Chinese medicine (TCM) syndromes in patients with chronic kidney disease (stages 3 and 4)-related mineral and bone disorder (CKD-MBD), in order to provide the objective basis for exploring the rules of TCM syndrome differentiation in patients with CKD-MBD. The retrospective survey was conducted to collect 105 cases with CKD (stages 3 and 4)-MBD. General clinical indexes, frequency of TCM syndromes and distribution of TCM syndrome type were investigated. Furthermore, serum bone metabolic markers, including calcium (Ca2+), phosphonium (P3+), intact parathyroid hormone (iPTH), alkaline phosphatase (ALP), procollagen type 1 amino-N-terminal propeptide (P1NP) and ß-crosslaps (ß-CTX) were analyzed, respectively. Meanwhile, bone mineral density (BMD) was assessed. And then, the multivariate regression analysis was performed for serum bone metabolic markers and TCM syndromes. The results showed that the general clinical features of the 105 patients included old age, hypertension, fracture, loss of bone mass and mild abnormalities of serum bone metabolic markers. High-frequency TCM syndromes were related to Yang deficiency in Spleen and Kidney, Qi deficiency in Spleen and Kidney and blood stasis. Moreover, Yang deficiency in Spleen and Kidney and blood stasis were found as the most frequent characteristics of the distribution of TCM syndromes type. The clinical characteristics of patients with the syndrome type of Yang deficiency in Spleen and Kidney were probably old age, increase in TCM syndrome scores and abnormalities in iPTH and P1NP. In addition, the interdependent relationship between abnormality in Ca2+ and syndromes of hair loss, tooth shake and sexual dysfunction, abnormality in P3+ and syndromes of aches in waist and knees, abnormality in iPTH and syndromes of soreness and weakness in waist and knees, lassitude, fatigue and extreme chilliness, abnormality in ALP and syndromes of loose stools, abnormality in P1NP and syndromes of fear of chills, tendency of warmth and loose stools, and abnormality in ß-CTX and syndromes of chills and pain in waist and knees. In general, among the 105 cases with CKD (stages 3 and 4)-MBD were clinically characterized by mild changes in serum bone metabolic markers; And their main TCM syndrome was the deficiency in spleen and kidney. Serum bone metabolic markers with mild changes have an interdependent relationship with main TCM syndromes, and can be considered as an objective syndrome factor of TCM syndrome differentiation.