Objective To develop the evidence base for the"Guidelines for the Diagnosis and Treatment of Integrated Traditional Chinese and Western Medicine for Female Menopausal Syndrome"(hereafter referred to as"the guideline"),aiming to provide effective evidence to support the formulation of recommendation statements.Methods Based on Internationally recognized methods and standards for evidence-based guideline development,the PICO(population,intervention,comparison,outcome)framework was used to construct clinical questions.A systematic literature search was conducted across domestic and international databases to identify studies published before 30 July,2022,focusing on the treatment of menopausal syndrome with integrated Chinese and Western medicine.Studies were se-lected based on predefined inclusion and exclusion criteria.Data extraction and synthesis were performed using ReviewManager 5.3software,and the quality of evidence was assessed employing the GRADE(Grading of Recommendations,Assessment,Development and Evaluation)methodology.Results A total of 143322 articles were retrieved,with 92studies ultimately included.These studies encom-passed treatment interventions such as classical formulas,Chinese patent medicines,and distinctive therapies.The evidence from these studies was synthesized and graded,resulting in an overview of evidence pertinent to both foundational and clinical questions.Conclusion The construction process of the evidence body in this guideline is an exploratory practice of evidence-based traditional Chinese medicine.This article reviews the important steps involved,with a view to providing a reference for the development/revision of clinical practice guidelines for traditional Chinese medicine.

Objective Based on the"preventive treatment of disease"theory and real-world data,this study aimed to evaluate the clinical efficacy of Yangyin Shugan Formula in patients with ovarian dysfunction characterized by the syndrome of kidney deficiency and liver depression at different stages and to provide evidence for optimizing the timing of traditional Chinese medicine(TCM)in premature ovarian insufficiency(POI)management.Methods Ovarian dysfunction patients under 40 years old characterized by syndrome of kidney deficiency and liver depression,registered in the outpatient electronic medical records of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine from January 2020 to December 2023,were stratified into three groups:subclinical POI,POI,and premature ovarian failure(POF)groups.The therapeutic outcomes of the three groups of patients were compared,including TCM syndrome total response rates,menstrual total response rates/normalization(cured)rates,base follicle-stimulating hormone(FSH)total response rate/normalization rates and anti-Müllerian hormone(AMH)levels.Results A total of 307 patients meeting the research criteria were included(97 cases in subclinical POI group,112 cases in POI group,and 98 cases in POF group).The TCM syndrome total response rates ranked as subclinical POI group(98.97%,96/97)>POI group(95.54%,107/112)>POF group(83.67%,82/98),with the POF group was lower than that of the subclinical POI and POI groups(P<0.017);while the difference of the subclinical POI group with the POI group was not significant.Menstrual total response rates ranked as subclinical POI group(97.22%,70/72)>POI group(72.32%,81/112)>POF group(51.02%,50/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017);normalization rates ranked as subclinical POI group(90.28%,65/72)>POI group(54.46%,61/112)>POF group(26.53%,26/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017).FSH total response rates ranked as subclinical POI group(89.69%,87/97)>POI group(81.25%,91/112)>POF group(60.20%,59/98),while POF group was lower than that of the other two groups(P<0.017),and the difference of the subclinical POI group with the POI group was not significant.Normalization FSH rates ranked as subclinical POI group(71.13%,69/97)>POI group(53.57%,60/112)>POF group(16.33%,16/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017).Compared with before treatment,the FSH levels in all three groups decreased after treatment(P<0.01).The reduction of FSH in the POF and POI groups were better than that in the subclinical P OI group(P<0.017).No significant difference was observed in the reduction of FSH between the POI and POF groups.Post-treatment AMH elevation observed in the subclinical POI and POI groups(P<0.01).Conclusion Yangyin Shugan Formula improves the menstrual conditions and TCM syndromes across all the stages.It also improves elevated FSH levels across all the stages and has a specific effect on normalizing FSH and menstruation.Yangyin Shugan Formula increases the AMH levels of patients with subclinical POI and POI,highlighting the applicability of TCM in staged preventive management.

This article outlines the formulation process of the local standard of Traditional Chinese Medicine Chronic Disease Management Guideline for Menopausal Women with Emotional Disorders(DB44/T 2547-2024;hereafter referred to as the"Guideline").By analyzing its structural framework and content,this study elucidates the TCM-specific chronic disease management strategies incorporated in the Guidelines,aiming to supply references to the development of similar standards and provide guidance for TCM chronic disease management practices.The development for the Guideline involved a multi-dimensional evidence collection process,including literature review,summary of expert experience,and expert consultations.By employing a multi-dimensional evidence-based approach,the Guideline has effectively integrated diverse evidence sources,and ensures the standard formulation being scientific and precise.The Guideline proposes the requirements for TCM-specific chronic disease management of menopausal women with emotional disorders firstly.By incorporating TCM lifestyle regulation,TCM emotional management,TCM dietary therapy,medication guidance,exercise therapies,and distinctive external treatments,the Guideline has developed into a comprehensive TCM chronic disease management system for prevention,treatment,rehabilitation and health preservation.The integrated approach effectively reduces the recurrence of emotional disorder and enhances quality of life of the patients.

Objective Based on the"preventive treatment of disease"theory and real-world data,this study aimed to evaluate the clinical efficacy of Yangyin Shugan Formula in patients with ovarian dysfunction characterized by the syndrome of kidney deficiency and liver depression at different stages and to provide evidence for optimizing the timing of traditional Chinese medicine(TCM)in premature ovarian insufficiency(POI)management.Methods Ovarian dysfunction patients under 40 years old characterized by syndrome of kidney deficiency and liver depression,registered in the outpatient electronic medical records of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine from January 2020 to December 2023,were stratified into three groups:subclinical POI,POI,and premature ovarian failure(POF)groups.The therapeutic outcomes of the three groups of patients were compared,including TCM syndrome total response rates,menstrual total response rates/normalization(cured)rates,base follicle-stimulating hormone(FSH)total response rate/normalization rates and anti-Müllerian hormone(AMH)levels.Results A total of 307 patients meeting the research criteria were included(97 cases in subclinical POI group,112 cases in POI group,and 98 cases in POF group).The TCM syndrome total response rates ranked as subclinical POI group(98.97%,96/97)>POI group(95.54%,107/112)>POF group(83.67%,82/98),with the POF group was lower than that of the subclinical POI and POI groups(P<0.017);while the difference of the subclinical POI group with the POI group was not significant.Menstrual total response rates ranked as subclinical POI group(97.22%,70/72)>POI group(72.32%,81/112)>POF group(51.02%,50/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017);normalization rates ranked as subclinical POI group(90.28%,65/72)>POI group(54.46%,61/112)>POF group(26.53%,26/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017).FSH total response rates ranked as subclinical POI group(89.69%,87/97)>POI group(81.25%,91/112)>POF group(60.20%,59/98),while POF group was lower than that of the other two groups(P<0.017),and the difference of the subclinical POI group with the POI group was not significant.Normalization FSH rates ranked as subclinical POI group(71.13%,69/97)>POI group(53.57%,60/112)>POF group(16.33%,16/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017).Compared with before treatment,the FSH levels in all three groups decreased after treatment(P<0.01).The reduction of FSH in the POF and POI groups were better than that in the subclinical P OI group(P<0.017).No significant difference was observed in the reduction of FSH between the POI and POF groups.Post-treatment AMH elevation observed in the subclinical POI and POI groups(P<0.01).Conclusion Yangyin Shugan Formula improves the menstrual conditions and TCM syndromes across all the stages.It also improves elevated FSH levels across all the stages and has a specific effect on normalizing FSH and menstruation.Yangyin Shugan Formula increases the AMH levels of patients with subclinical POI and POI,highlighting the applicability of TCM in staged preventive management.

Objective To develop the evidence base for the"Guidelines for the Diagnosis and Treatment of Integrated Traditional Chinese and Western Medicine for Female Menopausal Syndrome"(hereafter referred to as"the guideline"),aiming to provide effective evidence to support the formulation of recommendation statements.Methods Based on Internationally recognized methods and standards for evidence-based guideline development,the PICO(population,intervention,comparison,outcome)framework was used to construct clinical questions.A systematic literature search was conducted across domestic and international databases to identify studies published before 30 July,2022,focusing on the treatment of menopausal syndrome with integrated Chinese and Western medicine.Studies were se-lected based on predefined inclusion and exclusion criteria.Data extraction and synthesis were performed using ReviewManager 5.3software,and the quality of evidence was assessed employing the GRADE(Grading of Recommendations,Assessment,Development and Evaluation)methodology.Results A total of 143322 articles were retrieved,with 92studies ultimately included.These studies encom-passed treatment interventions such as classical formulas,Chinese patent medicines,and distinctive therapies.The evidence from these studies was synthesized and graded,resulting in an overview of evidence pertinent to both foundational and clinical questions.Conclusion The construction process of the evidence body in this guideline is an exploratory practice of evidence-based traditional Chinese medicine.This article reviews the important steps involved,with a view to providing a reference for the development/revision of clinical practice guidelines for traditional Chinese medicine.

Objective Based on the real-world data,we aimed to study the clinical efficacy and safety of Yangyin Shugan(method of nourishing yin and soothing liver)Decoction,an empirical prescription of famous traditional Chinese medicine(TCM)practitioners,in the treatment of premature ovarian insufficiency(POI)with pattern of kidney deficiency and liver depression.Methods A total of 618 POI patients with pattern of kidney deficiency and liver depression who registered in the outpatient electronic medical record system of Guangdong Provincial Hospital of Chinese Medicine were collected from January 2020 to December 2023.After 1:1 propensity matching,a total of 222 patients with POI who met the criteria were included and assigned to a Yangyin Shugan Decoction group(treated with Yangyin Shugan Decoction only)and a hormone control group(hormone treatment only),with 111 cases in each group.Age,age at menarche,marriage status,duration,times of pregnancy,times of miscarriage,menstrual total score,total score of TCM syndrome,basal serum follicle-stimulating hormone(bFSH),and anti-Müllerian hormone(AMH)were recorded and compared.After 3 to 4 months of treatment,the clinical efficacy between the two groups include TCM syndromes,menstrual,bFSH,and menstrual normalization rates during the follow-up period(3 months after discontinuation of medication)were compared.Additionally,comparisons were also made before and after treatment for the total score of TCM syndrome and scores of individual symptom,menstrual total score and scores of indicator,bFSH level,and AMH levels in both groups.Results(ⅰ)The total effective rate of the TCM syndrome in the Yangyin Shugan Decoction group and hormone control group were 85.59%and 52.25%,respectively;the total effective rate of menstrual were 54.95%and 90.99%,respectively;the menstrual normalization rate during the follow-up period were 31.53%and 9.01%,respectively;and regarding bFSH efficacy,the total effective rate were 70.27%and 27.03%,respectively,and the normalization rate of bFSH were 35.14%and 9.01%,respectively.The differences between the two groups were statistically significant(P<0.01).(ⅱ)The bFSH value in the Yangyin Shugan Decoction group decreased after treatment compared to before treatment(P<0.01),while the bFSH value in the hormone control group showed no change before and after treatment.The AMH value increased after treatment compared to before treatment in Yangyin Shugan Decoction group(P<0.01),while the AMH value in the hormone control group showed no change before and after treatment.The difference of bFSH and AMH between the two groups after treatment was statistically significant(P<0.01).(ⅲ)After treatment,the total score of TCM syndrome and the scores of individual symptom in the Yangyin Shugan Decoction group were lower than those before treatment(P<0.01);the total score of TCM syndrome,scores of hot flushes and sweating,hyposexuality,and insomnia in the hormone control group were lower than those before treatment(P<0.01).After treatment,the total score of TCM syndrome and the scores of individual symptom in the Yangyin Shugan Decoction group were lower than those in the hormone control group(P<0.01).(ⅳ)After treatment,the menstrual total score,scores of menstrual cycle,period,menstrual flow,and menstrual blood color in the Yangyin Shugan Decoction group were lower than those before treatment(P<0.01);the menstrual total score,score of menstrual cycle,period,and menstrual flow in the hormone control group were lower than those before treatment(P<0.01);after treatment,the menstrual total score and menstrual cycle score in the hormone control group were better than those in the Yangyin Shugan Decoction group(P<0.01).(ⅴ)No adverse reactions were observed in the Yangyin Shugan Decoction group and 29 cases of adverse reactions were observed in the hormone control group.Conclusion Yangyin Shugan Decoction can effectively improve TCM syndrome in POI patients with pattern of kidney deficiency and liver depression;downregulate the elevated bFSH level,increase the low AMH level,and effectively improve ovarian function,even continue to maintain menstruation after drug withdrawal.In the real world,Yangyin Shugan Decoction got satisfactory efficacy and good safety in the treatment of POI,which deserves clinical promotion and application.

Objective Based on the real-world data,we aimed to study the clinical efficacy and safety of Yangyin Shugan(method of nourishing yin and soothing liver)Decoction,an empirical prescription of famous traditional Chinese medicine(TCM)practitioners,in the treatment of premature ovarian insufficiency(POI)with pattern of kidney deficiency and liver depression.Methods A total of 618 POI patients with pattern of kidney deficiency and liver depression who registered in the outpatient electronic medical record system of Guangdong Provincial Hospital of Chinese Medicine were collected from January 2020 to December 2023.After 1:1 propensity matching,a total of 222 patients with POI who met the criteria were included and assigned to a Yangyin Shugan Decoction group(treated with Yangyin Shugan Decoction only)and a hormone control group(hormone treatment only),with 111 cases in each group.Age,age at menarche,marriage status,duration,times of pregnancy,times of miscarriage,menstrual total score,total score of TCM syndrome,basal serum follicle-stimulating hormone(bFSH),and anti-Müllerian hormone(AMH)were recorded and compared.After 3 to 4 months of treatment,the clinical efficacy between the two groups include TCM syndromes,menstrual,bFSH,and menstrual normalization rates during the follow-up period(3 months after discontinuation of medication)were compared.Additionally,comparisons were also made before and after treatment for the total score of TCM syndrome and scores of individual symptom,menstrual total score and scores of indicator,bFSH level,and AMH levels in both groups.Results(ⅰ)The total effective rate of the TCM syndrome in the Yangyin Shugan Decoction group and hormone control group were 85.59%and 52.25%,respectively;the total effective rate of menstrual were 54.95%and 90.99%,respectively;the menstrual normalization rate during the follow-up period were 31.53%and 9.01%,respectively;and regarding bFSH efficacy,the total effective rate were 70.27%and 27.03%,respectively,and the normalization rate of bFSH were 35.14%and 9.01%,respectively.The differences between the two groups were statistically significant(P<0.01).(ⅱ)The bFSH value in the Yangyin Shugan Decoction group decreased after treatment compared to before treatment(P<0.01),while the bFSH value in the hormone control group showed no change before and after treatment.The AMH value increased after treatment compared to before treatment in Yangyin Shugan Decoction group(P<0.01),while the AMH value in the hormone control group showed no change before and after treatment.The difference of bFSH and AMH between the two groups after treatment was statistically significant(P<0.01).(ⅲ)After treatment,the total score of TCM syndrome and the scores of individual symptom in the Yangyin Shugan Decoction group were lower than those before treatment(P<0.01);the total score of TCM syndrome,scores of hot flushes and sweating,hyposexuality,and insomnia in the hormone control group were lower than those before treatment(P<0.01).After treatment,the total score of TCM syndrome and the scores of individual symptom in the Yangyin Shugan Decoction group were lower than those in the hormone control group(P<0.01).(ⅳ)After treatment,the menstrual total score,scores of menstrual cycle,period,menstrual flow,and menstrual blood color in the Yangyin Shugan Decoction group were lower than those before treatment(P<0.01);the menstrual total score,score of menstrual cycle,period,and menstrual flow in the hormone control group were lower than those before treatment(P<0.01);after treatment,the menstrual total score and menstrual cycle score in the hormone control group were better than those in the Yangyin Shugan Decoction group(P<0.01).(ⅴ)No adverse reactions were observed in the Yangyin Shugan Decoction group and 29 cases of adverse reactions were observed in the hormone control group.Conclusion Yangyin Shugan Decoction can effectively improve TCM syndrome in POI patients with pattern of kidney deficiency and liver depression;downregulate the elevated bFSH level,increase the low AMH level,and effectively improve ovarian function,even continue to maintain menstruation after drug withdrawal.In the real world,Yangyin Shugan Decoction got satisfactory efficacy and good safety in the treatment of POI,which deserves clinical promotion and application.

Objective:To explore the role of insulin-like growth factor binding protein 1 (IGFBP1) in the diagnosis and prognosis of nasopharyngeal carcinoma (NPC), and to search for molecular markers that can be used for the diagnosis of NPC.Methods:A retrospective analysis was conducted on 150 NPC patients (treated from April 2014 to May 2015) at the Cancer Hospital Affiliated to Shantou University Medical School, and clinical baseline data were collected from 143 healthy individuals (normal control group) during the same period. The serum IGFBP1 concentration was detected using enzyme-linked immunosorbent assay (ELISA) in 112 nasopharyngeal carcinoma patients and 109 normal controls in the training cohort, and was validated in the validation cohort (38 nasopharyngeal carcinoma patients and 34 normal controls). The diagnostic value of serum IGFBP1 in nasopharyngeal carcinoma was evaluated using the receiver operating characteristic curve (ROC).Results:Compared to the normal control group, the expression level of serum IGFBP1 in nasopharyngeal carcinoma patients was higher in the training and validation queues (all P<0.05). In the training queue, the area under the ROC curve was 0.768 (95% CI: 0.706-0.830), with diagnostic specificity and sensitivity of 90.83% and 48.21%, respectively. In the validation queue, the area under the ROC curve was 0.798 (95% CI: 0.697-0.899), with diagnostic specificity and sensitivity of 97.06% and 31.58%, respectively. The predictive values for positive cases in both cohorts were greater than 80%, while the predictive values for negative cases were greater than 50%. The diagnostic threshold for serum IGFBP1 in both cohorts was 1 077 ng/ml. Conclusions:IGFBP1 has practical value as a molecular marker for the diagnosis of nasopharyngeal carcinoma.

Objective:To investigate the serum level of insulin-like growth factor binding protein 7 (IGFBP7) in patients with gastric cancer and its diagnostic significance.Methods:A total of 100 gastric cancer patients (gastric cancer group) including 49 patients with early gastric cancer (early gastric cancer group) , who were hospitalized in Sun Yat-sen University Cancer Center from May to December 2019 were selected as the research subjects, and 94 physical examination subjects during the same period were selected as the normal control group. The levels of serum IGFBP7 were detected by enzyme-linked immunosorbent assay. At the same time, the laboratory carcinoembryonic antigen (CEA) test results were collected. The relationships between the level of serum IGFBP7 and the clinicopathological features of gastric cancer patients were analyzed. The diagnostic value was evaluated by receiver operating characteristic (ROC) curve.Results:The level of serum IGFBP7 in the gastric cancer group was (1.595±0.159) ng/ml, and that in the normal control group was (1.850±0.328) ng/ml, with a statistically significant difference ( t=-0.26, P<0.001) , and among them, the level of serum IGFBP7 in the early gastric cancer group was (1.601±0.153) ng/ml, and there was a statistically significant difference compared with the normal control group ( t=-0.26, P<0.001) . The level of serum CEA in the gastric cancer group was 2.230 (2.043) ng/ml, and that in the normal control group was 1.805 (1.020) ng/ml, with a statistically significant difference ( U=0.45, P=0.004) , and among them, the level of serum CEA in the early gastric cancer group was 2.220 (1.780) ng/ml, and there was a statistically significant difference compared with the normal control group ( U=0.53, P=0.002) . There were no significant correlations between IGFBP7 and CEA level ( χ2=0.36, P=0.547) , age ( χ2=0.16, P=0.688) , gender ( χ2=0.97, P=0.326) , depth of invasion ( χ2=0.30, P=0.585) , lymph node metastasis ( χ2=0.17, P=0.684) , distant metastasis ( χ2=0.09, P=0.767) and TNM stage ( χ2=0.38, P=0.537) . ROC curve analysis showed that the area under the curve (AUC) of IGFBP7 for gastric cancer diagnosis was 0.84 (95% CI: 0.78-0.89) , the AUC of CEA for gastric cancer diagnosis was 0.62 (95% CI: 0.54-0.70) , and there was a statistically significant difference ( Z=4.33, P<0.001) . The AUC of IGFBP7 combined with CEA for gastric cancer diagnosis was 0.85 (95% CI: 0.79-0.90) . Compared with CEA alone, there was a statistically significant difference ( Z=4.97, P<0.001) . Compared with IGFBP7 alone, there was no statistically significant difference ( Z=1.41, P=0.159) . The AUC of IGFBP7 in the diagnosis of early gastric cancer was 0.84 (95% CI: 0.78-0.91) , the AUC of CEA in the diagnosis of early gastric cancer was 0.66 (95% CI: 0.56-0.75) , and there was a statistically significant difference ( Z=3.11, P=0.002) . The AUC of IGFBP7 combined with CEA in the diagnosis of early gastric cancer was 0.85 (95% CI: 0.78-0.91) . Compared with CEA alone, there was a statistically significant difference ( Z=3.54, P<0.001) . Compared with IGFBP7 alone, there was no statistically significant difference ( Z=1.19, P=0.232) . Conclusion:The serum IGFBP7 level of gastric cancer patients is lower than that of normal controls. Compared with CEA, serum IGFBP7 has better diagnostic value for gastric cancer.

Objective To investigate the expression change of cytokines in peripheral blood and intestinal mucosa in the patients with diarrhea post-infectious irritable bowel syndrome(PI-IBS) and its relation with clinical symptoms scores.Methods Thirty outpatients and inpatients with diarrhea PI-IBS(observation group) and contemporaneous 30 individuals undergoing physical examination(control group) in the Hainan Provincial People's Hospital from January to December 2013 were selected.The peripheral blood mononuclear cells(PBMC) were separated and cultured.Then the levels of IFN-y and IL-10 in peripheral blood and cell culture supernatant fluid were detected by ELISA.The colonic mucosal tissue was taken by coloscopy.Then colonic mucosal IFN-γ and IL-10 protein expression was detected by immunohistochemistry staining.Furthermore,the correlationship between the level change of IFN-γ and IL-10 with clinical symptom score was analyzed by using the Spearman correlation method.Results Peripheral blod IL-10 and IFN-γ levels had no statistical difference between the two groups(P＞0.05).Compared with the control group,in PBMC seperation and cuture,the IFN-γ level in the observation group was increased and IL-10 level was decreased,the difference was statistically signifieant(P＜0.01).The intestinal main symptom score in the observation group had the positive correlation with IFN-γ expression level of PBMC culture supernatant fluid and colonic mucosal IFN-γ expression level(r=0.45,0.94,P＜0.01),and had the negative correlation with IL-10 expression level(r=-0.52,-0.79,P＜0.01).Conclusion The unbalance of IFN-γ and IL-10 level could be involved in the pathogenesis of diarrhea PI-IBS,which can serve as the observation indicators of disease activity.