The number of investor initiated trial(IIT)in the field of traditional Chinese medicine(TCM)in China has been increasing year by year,but there are still many problems about their scientific validity.Scientific review is the top priority of IIT management,which is of great significance to improve the quality of IIT.Considering the characteristics of IIT in the field of TCM,randomized controlled trials and discuss common methodological problems in the scientific review process of IIT are focused on,such as non-standard placebo setting,unclear research hypothesis or improper selection of hypothesis test type,inappropriate sample size estimation methods,insufficient characteristics of TCM in outcome measures,unreasonable statistical analysis methods,etc.At the same time,corresponding solutions are proposed to increase the scientific and credibility of IIT,thus improving the research quality of IIT in TCM.

Objective:To explore the formulation patterns and potential targets of traditional Chinese medicine (TCM) in the treatment of pneumoconiosis using data mining, network pharmacology, and Mendelian randomization (MR) .Methods:In November 2023, prescription data for TCM compound treatments of pneumoconiosis from the past five years were retrieved from the China National Knowledge Infrastructure (CNKI), Wanfang, and VIP databases. The formulation patterns of TCM for pneumoconiosis were analyzed based on drug frequency, association rules, and cluster analysis, followed by the identification of core drugs. Network pharmacology and MR analysis were then applied to determine the potential targets for pneumoconiosis treatment.Results:A total of 100 TCM prescriptions were included, involving 182 herbs, with 15 high-frequency herbs. A total of 24 strong association rules were identified, including 16 herbs. Cluster analysis identified three groups of drug combinations. The core drug combination, "Astragalus Root-Codonopsis Root-Tangkuei-Chinese Magnolia Vine Fruit-Danshen Root-Prepared Rehmannia Root" was determined, which interacted with 47 common targets associated with pneumoconiosis. Further protein-protein interaction (PPI) analysis identified 18 core targets, and MR analysis confirmed that Caspase-3 (CASP3) and Cathepsin B (CTSB) were risk factors for pneumoconiosis ( OR=1.35, 1.44; P=0.038, 0.038) . Conclusion:The core drug combination for the treatment of pneumoconiosis with TCM is "Astragalus Root-Codonopsis Root-Tangkuei-Chinese Magnolia Vine Fruit-Danshen Root-Prepared Rehmannia Root". The medication mainly focuses on tonifying lung qi, moistening dryness and stopping coughing, circulating blood and transforming stasis, which are supplemented with herbs for nourishing yin and moistening dryness, warming yang and dissipating cold. Finally, the key targets for treating pneumoconiosis are screened out, providing an important basis for the development of therapeutic drugs for it.

Objective To investigate the relationship of C-reactive protein-albumin-lymphocyte(CALLY)index,serum autotaxin and serine protease 2(PRSS2)with postoperative recurrence and metastasis in gastric cancer patients.Methods A total of 188 patients who underwent radical gastrectomy for gastric cancer from December 2019 to December 2021 were selected as the research subjects.According to the postoperative situation,they were divided into the recurrence and metastasis group(n=72)and the non-recurrence and metastasis group(n=116).C reactive protein(CRP)was detected by immunoturbidimetry,albumin was detected by bromocresol green method,lymphocyte count was detected by blood routine analyzer,and CALLY index was calculated.Enzyme-linked immunosorbent assay was used to detect serum levels of autotaxin and PRSS2,and Spearman/Pearson correlation analysis was used to analyze the correlation between CALLY index,serum autotaxin,PRSS2 levels and clinical data.Multivariate logistic regression was used to analyze the influencing factors of recurrence and metastasis in patients with gastric cancer after radical resection,and receiver operating characteristic(ROC)curve was used to analyze the predictive value of CALLY index,serum autotaxin and PRSS2 levels for recurrence and metastasis in patients with gastric cancer after radical resection.Kaplan-Meier method was used to analyze the relationship between CALLY index,serum autotaxin,PRSS2 levels and postoperative recurrence and metastasis.Results Compared with the non-recurrence and metastasis group,the recurrence and metastasis group had a higher proportion of patients with TNM stage Ⅲ,Borrmann type Ⅲ-Ⅳ,lymphovascular invasion,neoadjuvant therapy and postoperative chemotherapy,higher serum levels of autotaxin and PRSS2,and lower CALLY index(P<0.01).TNM stage,Borrmann type,lymphovascular invasion,neoadjuvant therapy and postoperative chemotherapy were negatively correlated with CALLY index,and positively correlated with serum autotaxin and PRSS2 levels,while serum autotaxin and PRSS2 levels were negatively correlated with CALLY index(P<0.01).TNM stage,Borrmann type,lymphovascular invasion,CALLY index,autotaxin and PRSS2 were the influencing factors of recurrence and metastasis in patients with gastric cancer after radical resection(P<0.05,P<0.01).The area under the curve(AUC)of CALLY index,autotaxin and PRSS2 for predicting recurrence and metastasis was 0.962,which was significantly larger than that of CALLY index,autotaxin and PRSS alone(P<0.01).The 3-year recurrence and metastasis rate of patients with low CALLY index expression[56.52%(52/92)]was higher than that of patients with high CALLY index expression[20.83%(20/96)](P<0.01).The 3-year recurrence and metastasis rate of patients with high expression of autotaxin[49.47%(47/95)]was higher than that of patients with low expression[26.88%(25/93)](P<0.01).The 3-year recurrence and metastasis rate of patients with high PRSS2 expression[47.87%(45/94)]was higher than that of patients with low PRSS2 expression[28.72%(27/94)](P<0.01).Conclusion The CALLY index decreases,and serum autotaxin and PRSS2 increase in patients with postoperative recurrence and metastasis of gastric cancer.The combined prediction of the three factors demonstrates higher predictive performance for postoperative recurrence and metastasis.

Objective:To compare the clinical and radiological outcomes between the ankle dislocation exposure versus the traditional posterolateral approach exposure in the treatment of complex posterior ankle malunion.Methods:This retrospective study analyzed the 50 patients (50 feet) with posterior ankle malunion who had been treated at Department of Foot and Ankle Orthopedics, Foshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine from May 2015 to June 2023. This cohort included 18 males and 32 females, with an age of (46.2±12.0) years. The duration from injury to surgery averaged 7.0 (4.0, 12.2) months. The patients were divided into 2 groups based on the surgical exposure methods: an ankle dislocation group (22 cases) in which the posterior ankle malunion was exposed by ankle dislocation before reduction and fixation, and a traditional posterolateral approach group (28 cases) in which the posterior ankle malunion was exposed by the traditional posterolateral approach before reduction and fixation. Evaluation indices included operative time, ankle arthritis grading, incidence of complications, as well as pre-operative and last follow-up recordings of distal tibial articular angle and joint step-off, visual analogue scale (VAS) pain score, and ankle-hindfoot score of American Orthopaedic Foot and Ankle society (AOFAS).Results:There was no significant difference in the baseline data between the 2 groups, indicating comparability ( P>0.05). The average follow-up was (39.4±17.9) months. The operative time in the dislocation group [(95.8±9.9) min] was significantly shorter than that in the posterolateral approach group [(121.9±14.3) min] ( P<0.05). The step-off on the distal tibial articular surface at the last follow-up in the dislocation group [0.3 (0.0, 0.9) mm] was significantly lower than that in the posterolateral approach group [1.0 (0.3, 1.1) mm] ( P<0.05). The grading of ankle arthritis was significantly worse in the posterolateral approach group than that in the dislocation group ( P<0.05). There were no differences in distal tibial articular angle, VAS pain score, AOFAS ankle-hindfoot score, or postoperative complications between the 2 groups at the last follow-up ( P>0.05). Conclusions:Both ankle dislocation exposure and traditional posterolateral approach exposure yield satisfactory clinical and radiological outcomes in patients with complex posterior ankle malunion. However, the ankle dislocation exposure offers a novel method for direct visualization of the malunion on multiple planes, which is more advantageous for restoration of the anatomical consistency of the distal tibial articular surface.

Objective To investigate the current status of home medicine cabinet management and unmet needs for home-based pharmaceutical services among elderly hypertensive patients in Hubei Province,and to provide evidence for optimizing home pharmaceutical care models.Methods From July 2022 to March 2023,310 elderly hypertension patients across Hubei Province were enrolled.Pharmacists conducted home visits to administer structured questionnaires capturing demographics and blood pressure control rates,perform medication categorization and quality assessments of home medicine cabinets and document cabinet management issues in real-time.Results Among 290 valid questionnaires,binary logistic regression revealed better blood pressure control in non-working and non-smoking individuals.Medicine cabinet audits identified three critical issues:failure to separate Chinese and chemical medicines,duplicate medications with similar ingredients and missing original packaging.Post-intervention,all cabinets demonstrated proper medication categorization and storage compliance.Conclusions Significant medication safety hazards exist in elderly hypertensive patients'home medicine cabinets.Pharmacist-led home interventions effectively cleared substandard medications and improved medication safety.Future home pharmaceutical services should focus on optimizing cabinet management protocols,enhancing medication safety awareness and personalizing pharmaceutical care to ensure precise and effective home-based medication management.

Objective:To explore the formulation patterns and potential targets of traditional Chinese medicine (TCM) in the treatment of pneumoconiosis using data mining, network pharmacology, and Mendelian randomization (MR) .Methods:In November 2023, prescription data for TCM compound treatments of pneumoconiosis from the past five years were retrieved from the China National Knowledge Infrastructure (CNKI), Wanfang, and VIP databases. The formulation patterns of TCM for pneumoconiosis were analyzed based on drug frequency, association rules, and cluster analysis, followed by the identification of core drugs. Network pharmacology and MR analysis were then applied to determine the potential targets for pneumoconiosis treatment.Results:A total of 100 TCM prescriptions were included, involving 182 herbs, with 15 high-frequency herbs. A total of 24 strong association rules were identified, including 16 herbs. Cluster analysis identified three groups of drug combinations. The core drug combination, "Astragalus Root-Codonopsis Root-Tangkuei-Chinese Magnolia Vine Fruit-Danshen Root-Prepared Rehmannia Root" was determined, which interacted with 47 common targets associated with pneumoconiosis. Further protein-protein interaction (PPI) analysis identified 18 core targets, and MR analysis confirmed that Caspase-3 (CASP3) and Cathepsin B (CTSB) were risk factors for pneumoconiosis ( OR=1.35, 1.44; P=0.038, 0.038) . Conclusion:The core drug combination for the treatment of pneumoconiosis with TCM is "Astragalus Root-Codonopsis Root-Tangkuei-Chinese Magnolia Vine Fruit-Danshen Root-Prepared Rehmannia Root". The medication mainly focuses on tonifying lung qi, moistening dryness and stopping coughing, circulating blood and transforming stasis, which are supplemented with herbs for nourishing yin and moistening dryness, warming yang and dissipating cold. Finally, the key targets for treating pneumoconiosis are screened out, providing an important basis for the development of therapeutic drugs for it.

Objective To investigate the relationship of C-reactive protein-albumin-lymphocyte(CALLY)index,serum autotaxin and serine protease 2(PRSS2)with postoperative recurrence and metastasis in gastric cancer patients.Methods A total of 188 patients who underwent radical gastrectomy for gastric cancer from December 2019 to December 2021 were selected as the research subjects.According to the postoperative situation,they were divided into the recurrence and metastasis group(n=72)and the non-recurrence and metastasis group(n=116).C reactive protein(CRP)was detected by immunoturbidimetry,albumin was detected by bromocresol green method,lymphocyte count was detected by blood routine analyzer,and CALLY index was calculated.Enzyme-linked immunosorbent assay was used to detect serum levels of autotaxin and PRSS2,and Spearman/Pearson correlation analysis was used to analyze the correlation between CALLY index,serum autotaxin,PRSS2 levels and clinical data.Multivariate logistic regression was used to analyze the influencing factors of recurrence and metastasis in patients with gastric cancer after radical resection,and receiver operating characteristic(ROC)curve was used to analyze the predictive value of CALLY index,serum autotaxin and PRSS2 levels for recurrence and metastasis in patients with gastric cancer after radical resection.Kaplan-Meier method was used to analyze the relationship between CALLY index,serum autotaxin,PRSS2 levels and postoperative recurrence and metastasis.Results Compared with the non-recurrence and metastasis group,the recurrence and metastasis group had a higher proportion of patients with TNM stage Ⅲ,Borrmann type Ⅲ-Ⅳ,lymphovascular invasion,neoadjuvant therapy and postoperative chemotherapy,higher serum levels of autotaxin and PRSS2,and lower CALLY index(P<0.01).TNM stage,Borrmann type,lymphovascular invasion,neoadjuvant therapy and postoperative chemotherapy were negatively correlated with CALLY index,and positively correlated with serum autotaxin and PRSS2 levels,while serum autotaxin and PRSS2 levels were negatively correlated with CALLY index(P<0.01).TNM stage,Borrmann type,lymphovascular invasion,CALLY index,autotaxin and PRSS2 were the influencing factors of recurrence and metastasis in patients with gastric cancer after radical resection(P<0.05,P<0.01).The area under the curve(AUC)of CALLY index,autotaxin and PRSS2 for predicting recurrence and metastasis was 0.962,which was significantly larger than that of CALLY index,autotaxin and PRSS alone(P<0.01).The 3-year recurrence and metastasis rate of patients with low CALLY index expression[56.52%(52/92)]was higher than that of patients with high CALLY index expression[20.83%(20/96)](P<0.01).The 3-year recurrence and metastasis rate of patients with high expression of autotaxin[49.47%(47/95)]was higher than that of patients with low expression[26.88%(25/93)](P<0.01).The 3-year recurrence and metastasis rate of patients with high PRSS2 expression[47.87%(45/94)]was higher than that of patients with low PRSS2 expression[28.72%(27/94)](P<0.01).Conclusion The CALLY index decreases,and serum autotaxin and PRSS2 increase in patients with postoperative recurrence and metastasis of gastric cancer.The combined prediction of the three factors demonstrates higher predictive performance for postoperative recurrence and metastasis.

Objective To investigate the current status of home medicine cabinet management and unmet needs for home-based pharmaceutical services among elderly hypertensive patients in Hubei Province,and to provide evidence for optimizing home pharmaceutical care models.Methods From July 2022 to March 2023,310 elderly hypertension patients across Hubei Province were enrolled.Pharmacists conducted home visits to administer structured questionnaires capturing demographics and blood pressure control rates,perform medication categorization and quality assessments of home medicine cabinets and document cabinet management issues in real-time.Results Among 290 valid questionnaires,binary logistic regression revealed better blood pressure control in non-working and non-smoking individuals.Medicine cabinet audits identified three critical issues:failure to separate Chinese and chemical medicines,duplicate medications with similar ingredients and missing original packaging.Post-intervention,all cabinets demonstrated proper medication categorization and storage compliance.Conclusions Significant medication safety hazards exist in elderly hypertensive patients'home medicine cabinets.Pharmacist-led home interventions effectively cleared substandard medications and improved medication safety.Future home pharmaceutical services should focus on optimizing cabinet management protocols,enhancing medication safety awareness and personalizing pharmaceutical care to ensure precise and effective home-based medication management.

The number of investor initiated trial(IIT)in the field of traditional Chinese medicine(TCM)in China has been increasing year by year,but there are still many problems about their scientific validity.Scientific review is the top priority of IIT management,which is of great significance to improve the quality of IIT.Considering the characteristics of IIT in the field of TCM,randomized controlled trials and discuss common methodological problems in the scientific review process of IIT are focused on,such as non-standard placebo setting,unclear research hypothesis or improper selection of hypothesis test type,inappropriate sample size estimation methods,insufficient characteristics of TCM in outcome measures,unreasonable statistical analysis methods,etc.At the same time,corresponding solutions are proposed to increase the scientific and credibility of IIT,thus improving the research quality of IIT in TCM.

Objective:To compare the clinical and radiological outcomes between the ankle dislocation exposure versus the traditional posterolateral approach exposure in the treatment of complex posterior ankle malunion.Methods:This retrospective study analyzed the 50 patients (50 feet) with posterior ankle malunion who had been treated at Department of Foot and Ankle Orthopedics, Foshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine from May 2015 to June 2023. This cohort included 18 males and 32 females, with an age of (46.2±12.0) years. The duration from injury to surgery averaged 7.0 (4.0, 12.2) months. The patients were divided into 2 groups based on the surgical exposure methods: an ankle dislocation group (22 cases) in which the posterior ankle malunion was exposed by ankle dislocation before reduction and fixation, and a traditional posterolateral approach group (28 cases) in which the posterior ankle malunion was exposed by the traditional posterolateral approach before reduction and fixation. Evaluation indices included operative time, ankle arthritis grading, incidence of complications, as well as pre-operative and last follow-up recordings of distal tibial articular angle and joint step-off, visual analogue scale (VAS) pain score, and ankle-hindfoot score of American Orthopaedic Foot and Ankle society (AOFAS).Results:There was no significant difference in the baseline data between the 2 groups, indicating comparability ( P>0.05). The average follow-up was (39.4±17.9) months. The operative time in the dislocation group [(95.8±9.9) min] was significantly shorter than that in the posterolateral approach group [(121.9±14.3) min] ( P<0.05). The step-off on the distal tibial articular surface at the last follow-up in the dislocation group [0.3 (0.0, 0.9) mm] was significantly lower than that in the posterolateral approach group [1.0 (0.3, 1.1) mm] ( P<0.05). The grading of ankle arthritis was significantly worse in the posterolateral approach group than that in the dislocation group ( P<0.05). There were no differences in distal tibial articular angle, VAS pain score, AOFAS ankle-hindfoot score, or postoperative complications between the 2 groups at the last follow-up ( P>0.05). Conclusions:Both ankle dislocation exposure and traditional posterolateral approach exposure yield satisfactory clinical and radiological outcomes in patients with complex posterior ankle malunion. However, the ankle dislocation exposure offers a novel method for direct visualization of the malunion on multiple planes, which is more advantageous for restoration of the anatomical consistency of the distal tibial articular surface.