Barrett's esophagus(BE),a precancerous state of esophageal adenocarcinoma,poses a major challenge for prevention and treatment owing to its complex mechanism of inflammation-cancer transformation and the lack of effective clinical treatment and torsion strategies.Building upon the"preventing disease progression"theory,this study aimed to address the critical clinical challenge of intercepting the pathological progression during the inflammation-cancer transformation of BE by proposing an innovative"two critical nodes-three stages"pathomechanism framework.The pathogenesis of BE originates from liver depression and qi stagnation.The pathological progression evolves through two critical nodes:liver depression transforming into heat and heat transforming into blood stasis,representing a three-stage evolutionary pattern of qi stagnation,heat transformation,and blood stasis formation.Acidic bile salts,acting as a pathogenic toxin,permeate the entire process and catalyze carcinogenesis.Based on this understanding,the therapeutic principles of"treatment from the liver"and"truncation and torsion"were established,emphasizing stage-specific interventions.For the qi stagnation stage,treatment focuses on soothing the liver and regulating qi,as well as moistening,harmonizing,and descending the qi.This is achieved by combining modified Chaihu Shugan Powder with Xuanfu Daizhe Decoction,while using pungent and drying herbs cautiously and supplementing them with light and floral herbs.In the heat transformation stage,the strategy aims to clear the liver and drain heat while protecting yin and harmonizing the stomach,employing modified Huaganjian combined with Yiguanjian and supplemented with Jinlingzi Powder to clear depressed fire.For the blood stasis formation stage,treatment involves activating blood and resolving stasis,combined with supporting healthy qi and removing toxins.This is achieved using a modified Gexia Zhuyu Decoction,supplemented with Liujunzi Decoction,and additions such as Radix Salviae Miltiorrhizae and turtle carapace to disperse nodules and reduce masses.This theoretical framework establishes a diagnostic and therapeutic model characterized by the integration of disease mechanisms with pathology and the mutual reference of macro-level signs with micro-level indicators.It provides a comprehensive clinical practice pathway,complete with principles,methods,formulas,and herbs,for the stage-specific interception of inflammation-cancer transformation in BE using traditional Chinese medicine.

Barrett's esophagus(BE),a precancerous state of esophageal adenocarcinoma,poses a major challenge for prevention and treatment owing to its complex mechanism of inflammation-cancer transformation and the lack of effective clinical treatment and torsion strategies.Building upon the"preventing disease progression"theory,this study aimed to address the critical clinical challenge of intercepting the pathological progression during the inflammation-cancer transformation of BE by proposing an innovative"two critical nodes-three stages"pathomechanism framework.The pathogenesis of BE originates from liver depression and qi stagnation.The pathological progression evolves through two critical nodes:liver depression transforming into heat and heat transforming into blood stasis,representing a three-stage evolutionary pattern of qi stagnation,heat transformation,and blood stasis formation.Acidic bile salts,acting as a pathogenic toxin,permeate the entire process and catalyze carcinogenesis.Based on this understanding,the therapeutic principles of"treatment from the liver"and"truncation and torsion"were established,emphasizing stage-specific interventions.For the qi stagnation stage,treatment focuses on soothing the liver and regulating qi,as well as moistening,harmonizing,and descending the qi.This is achieved by combining modified Chaihu Shugan Powder with Xuanfu Daizhe Decoction,while using pungent and drying herbs cautiously and supplementing them with light and floral herbs.In the heat transformation stage,the strategy aims to clear the liver and drain heat while protecting yin and harmonizing the stomach,employing modified Huaganjian combined with Yiguanjian and supplemented with Jinlingzi Powder to clear depressed fire.For the blood stasis formation stage,treatment involves activating blood and resolving stasis,combined with supporting healthy qi and removing toxins.This is achieved using a modified Gexia Zhuyu Decoction,supplemented with Liujunzi Decoction,and additions such as Radix Salviae Miltiorrhizae and turtle carapace to disperse nodules and reduce masses.This theoretical framework establishes a diagnostic and therapeutic model characterized by the integration of disease mechanisms with pathology and the mutual reference of macro-level signs with micro-level indicators.It provides a comprehensive clinical practice pathway,complete with principles,methods,formulas,and herbs,for the stage-specific interception of inflammation-cancer transformation in BE using traditional Chinese medicine.

In July 2023， the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products （hereinafter referred to as the Measures）. This article interprets the main content of the Measures， and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction. It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code “YB” letter， and the drug standard code and numbering rules would be included in the next round of amendments to the Measures. It is necessary to clarify the construction goals of the information system for drug standards at the same time， and build a national drug standard data-sharing platform based on the basic framework of user interface layer， computing processing layer， and data storage layer. Digital drug standards will be free， and access and download services for the public will be provided.

Gastroesophageal reflux related cough is located in the lung and stomach.The basic pathogenesis is the inversion of stomach qi and the lung loss propagating and descending.In view of the above,based on the theory of"relevance of lung and stomach",this article analyzed the modern mechanism of"relevance of lung and stomach"in gastroesophageal reflux related cough,which included"microinhalation"theory,"esophagus-bronchial reflex"theory,and"airway neurogenic inflammation"theory.This article also put forward the TCM disease name of"gastric cough",and the treatment methods of"simultaneous treatment of lung and stomach"and"treatment of cough from stomach",which would provide new ideas for the theoretical and mechanism research of TCM treatment of gastroesophageal reflux related cough.

Objective:To evaluate the efficacy and safety of mosapride citrate dispersible tablet (MP) combined with Shugan Jieyu capsule (SGJY) in the treatment of functional dyspepsia (FD).Methods:From April 2018 to January 2019, FD patients from 10 hospitals including Renji Hospital, Shanghai Jiaotong University School of Medicine, Luohe Hospital of Traditional Chinese Medicine, the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Handan Hospital of Traditional Chinese Medicine and Nanshi Hospital of Nanyang were selected for a randomized, double-blind, placebo-controlled trial. The patient health questionnaire-9 (PHQ-9) and generalized anxiety disorder-7 (GAD-7) were used to assess depression and anxiety in FD patients, respectively. According to the random number table method, 200 FD patients who met the inclusion criteria were randomly divided into SGJY+ MP group and placebo+ MP group, with 100 patients in each group, and all the patients were given oral MP. The patients of the SGJY+ MP group and the placebo+ MP group were given oral SGJY or placebo on the basis of MP, respectively. The patients of both groups were treated continuously for 6 weeks. Total FD symptom scores, PHQ-9 and GAD-7 scores, as well as efficiency and safety were evaluated after treatment. Independent samples t-test and chi-square test were used for statistical analysis. Results:A total of 193 patients were included into the full analysis set with 94 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group. A total of 183 patients completed the 6-week trial, including 89 cases in the SGJY+ MP group and 94 cases in the placebo+ MP group. A total of 198 patients were included in the safety analysis set, including 99 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group.After treatment, the total FD symptom scores of the SGJY+ MP group and the placebo+ MP group were both lower than those of baseline before treatment (3.71±3.06 vs. 11.79±5.18 and 4.17±3.69 vs. 11.19±5.05), and the differences were both statistically significant ( t=-24.87 and -23.27, both P<0.001). The efficacy of the SGJY+ MP group was higher than that of the placebo+ MP group (86.5%, 77/89 vs. 74.5%, 70/94), and the difference was statistically significant ( χ2=4.69, P=0.030). The efficacy of patients with moderate-to-severe anxiety and depression in the SGJY+ MP group was both higher than that of patients in the placebo+ MP group (10/10 vs. 3/7, 85.0%, 17/20 vs. 8/14), and the differences were statistically significant ( χ2=5.66 and 5.33, P=0.017 and 0.010). The efficacy of patients with postprandial distress syndrome (PDS) subtype in the SGJY+ MP group was higher than that of patients in the placebo+ MP group (93.0%, 53/57 vs. 76.5%, 39/51), and the difference was statistically significant (χ 2=5.82, P=0.016). The PHQ-9 scores of patients with depression in both SGJY+ MP and placebo+ MP groups were lower than those at baseline before treatment (3.63±2.76 vs. 7.87±2.24 and 3.35±2.51 vs. 7.63±2.25), and the differences were statistically significant ( t=-14.88 and -15.87, both P<0.001). There was no significant difference in proportion of depressed patients with a ≥50% reduction in PHQ-9 scores from baseline value between the SGJY+ MP group and the placebo+ MP group (60.2%, 50/83 vs. 62.8%, 54/86; χ2=0.05, P=0.825). The GAD-7 scores of anxious patients both the SGJY+ MP group and the placebo+ MP group were lower than the baseline value before treatment (3.27±2.57 vs. 7.09±2.08 and 3.86±2.49 vs. 6.84±1.66), and the differences were statistically significant ( t=-13.30 and -11.47, both P<0.001). The proportion of anxious patients with a ≥50% reduction in GAD-7 scores from baseline in the SGJY+ MP group was higher than that of the placebo+ MP group (54.4%, 43/79 vs. 36.5%, 27/74), and the difference was statistically significant ( χ2=4.53, P=0.033). There were no serious adverse events in both the SGJY+ MP group and the placebo+ MP group during the treatment. There were no significant differences in the incidence of adverse events and adverse reactions during the treatment between the SGJY+ MP group and the placebo+ MP group (7.1%, 7/99 vs. 5.1%, 5/99, and 3.0%, 3/99 vs. 3.0%, 3/99, respectively; both P>0.05). Conclusion:SGTY can safely and effectively improve the efficacy of the prokinetic drugs in the treatment of FD symptoms, especially in FD patients with PDS subtype or with moderate-to-severe anxiety and with depression.

Objective:To evaluate the efficacy and safety of mosapride citrate dispersible tablet (MP) combined with Shugan Jieyu capsule (SGJY) in the treatment of functional dyspepsia (FD).Methods:From April 2018 to January 2019, FD patients from 10 hospitals including Renji Hospital, Shanghai Jiaotong University School of Medicine, Luohe Hospital of Traditional Chinese Medicine, the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Handan Hospital of Traditional Chinese Medicine and Nanshi Hospital of Nanyang were selected for a randomized, double-blind, placebo-controlled trial. The patient health questionnaire-9 (PHQ-9) and generalized anxiety disorder-7 (GAD-7) were used to assess depression and anxiety in FD patients, respectively. According to the random number table method, 200 FD patients who met the inclusion criteria were randomly divided into SGJY+ MP group and placebo+ MP group, with 100 patients in each group, and all the patients were given oral MP. The patients of the SGJY+ MP group and the placebo+ MP group were given oral SGJY or placebo on the basis of MP, respectively. The patients of both groups were treated continuously for 6 weeks. Total FD symptom scores, PHQ-9 and GAD-7 scores, as well as efficiency and safety were evaluated after treatment. Independent samples t-test and chi-square test were used for statistical analysis. Results:A total of 193 patients were included into the full analysis set with 94 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group. A total of 183 patients completed the 6-week trial, including 89 cases in the SGJY+ MP group and 94 cases in the placebo+ MP group. A total of 198 patients were included in the safety analysis set, including 99 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group.After treatment, the total FD symptom scores of the SGJY+ MP group and the placebo+ MP group were both lower than those of baseline before treatment (3.71±3.06 vs. 11.79±5.18 and 4.17±3.69 vs. 11.19±5.05), and the differences were both statistically significant ( t=-24.87 and -23.27, both P<0.001). The efficacy of the SGJY+ MP group was higher than that of the placebo+ MP group (86.5%, 77/89 vs. 74.5%, 70/94), and the difference was statistically significant ( χ2=4.69, P=0.030). The efficacy of patients with moderate-to-severe anxiety and depression in the SGJY+ MP group was both higher than that of patients in the placebo+ MP group (10/10 vs. 3/7, 85.0%, 17/20 vs. 8/14), and the differences were statistically significant ( χ2=5.66 and 5.33, P=0.017 and 0.010). The efficacy of patients with postprandial distress syndrome (PDS) subtype in the SGJY+ MP group was higher than that of patients in the placebo+ MP group (93.0%, 53/57 vs. 76.5%, 39/51), and the difference was statistically significant (χ 2=5.82, P=0.016). The PHQ-9 scores of patients with depression in both SGJY+ MP and placebo+ MP groups were lower than those at baseline before treatment (3.63±2.76 vs. 7.87±2.24 and 3.35±2.51 vs. 7.63±2.25), and the differences were statistically significant ( t=-14.88 and -15.87, both P<0.001). There was no significant difference in proportion of depressed patients with a ≥50% reduction in PHQ-9 scores from baseline value between the SGJY+ MP group and the placebo+ MP group (60.2%, 50/83 vs. 62.8%, 54/86; χ2=0.05, P=0.825). The GAD-7 scores of anxious patients both the SGJY+ MP group and the placebo+ MP group were lower than the baseline value before treatment (3.27±2.57 vs. 7.09±2.08 and 3.86±2.49 vs. 6.84±1.66), and the differences were statistically significant ( t=-13.30 and -11.47, both P<0.001). The proportion of anxious patients with a ≥50% reduction in GAD-7 scores from baseline in the SGJY+ MP group was higher than that of the placebo+ MP group (54.4%, 43/79 vs. 36.5%, 27/74), and the difference was statistically significant ( χ2=4.53, P=0.033). There were no serious adverse events in both the SGJY+ MP group and the placebo+ MP group during the treatment. There were no significant differences in the incidence of adverse events and adverse reactions during the treatment between the SGJY+ MP group and the placebo+ MP group (7.1%, 7/99 vs. 5.1%, 5/99, and 3.0%, 3/99 vs. 3.0%, 3/99, respectively; both P>0.05). Conclusion:SGTY can safely and effectively improve the efficacy of the prokinetic drugs in the treatment of FD symptoms, especially in FD patients with PDS subtype or with moderate-to-severe anxiety and with depression.

Objective To study stress distributions of the cartilage around the hip joint in stress environment of complete gait cycle, and explore the optimal correction angle of bone block in curved periacetabular osteotomy (CPO), so as to provide theoretical references for clinical operation. Methods Based on CT scans from a healthy volunteer and a patient with development dysplasia of hip (DDH), the three-dimensional (3D) model including pelvis and proximal femur was reconstructed. The cortical bone and cancellous bone were distinguished by dividing the masks, and the material attributes were assigned to the finite element model. A total of 100 different postoperative models were obtained by simulating CPO in DDH model, by adjusting lateral center edge angle (LCEA) and anterior center edge angle (ACEA). According to hip joint stresses in complete gait cycle, the model was loaded respectively, and stress changes of normal, preoperative and postoperative acetabular cartilage were analyzed and compared. ResultsThe minimum peak contact stresses of acetabular cartilage of DDH patient at heel landing phase, start phase of single leg support, mid phase of single leg support, end phase of single leg support and double support phase after simulated CPO operation were 5.273, 6.128, 7.463, 6.347, 6.582 MPa, which were decreased by 2.159, 2.724, 2.249, 2.164, 2.119 MPa,respectively, compared with those before operation. The contact area between femoral head and acetabulum was significantly increased after operation, but it was still smaller than that of normal volunteers. Conclusions The optimal correction angle of LCEA and ACEA can be obtained by using finite element method, and the simulation of CPO surgery on different patients is of great significance to improve surgical accuracy and efficiency.

【Objective】 Tostudy the effect of sex-differentiated human IgG samples on Dendritic cells (DC) secretion of inflammation-related factors and explore the effect of residual sex hormones in IgG products (such as IVIg) on the secretion of IL-6 by DC. 【Methods】 According to the standard IVIg production process, the company was entrustedto prepare sex-differentiated plasma purified IgG samples, and two sex-differentiated IgG samples with different sex ratios (male to female ratio1: 0, 0: 1) were obtained. The samples and referenceswere treated with human DC (induced by THP-1 cells) respectively. After 24 h of culture, the chemokines (CCL2, CCL3, CCL4), adhesion molecule (ICAM-1) and inflammatory cytokines (IL-1, IL-6, IL-10, IL-12p70, IFN-) in the cell supernatant were detected, The effects of different samples on the secretion of inflammation-related factors by DC were compared. The effect of sex hormone residues on the anti-inflammatory ability of IgG products was preliminarily explored uing sex hormones and sex hormone receptor blockers. 【Results】 The samples in each group significantly inhibitedthe secretion of chemokines (CCL2, CCL3, CCL4) and the adhesion molecule (ICAM-1) by mature DC (compared with the PBS group, P<0.05), but significantly promoted the secretion of inflammatory cytokines (IL-1a/b, IL-6, IL-10, IL-12p70), compared with the PBS group(P<0.05). The results of sex hormone residues showed that therewere residues of estradiol (E2) and testosterone (TSTO) in sex-differentiated IgG samples and IVIg products. The experimental results of IVIg and sex hormone/sex hormone receptor blockers showed that residual E2 may promote the secretion of IL-6 by DC, which may be achieved through the E2 receptor ERb. 【Conclusion】 There are differences in the effect of IgG samples prepared from combined plasma with different sex ratios on the secretion of cytokines by DC, which may be related to the residual E2 in the products. The residual sex hormones in IVIg may promote the production and secretion of IL-6 through the sex hormone receptor ERb expressed in DC, and TSTO may have a collaboration effect to enhance the secretion-promoting effect of IL-6 by E2. This study provides a theoretical basis for whether sex hormone residues need to be considered in the quality control indicators of IVIg products.

Objective In order to simulate different angles of acetabular blocks that need to be adjusted during operation, the optimal angle was determined through analyzing the contact stress and contact area of cartilage around the hip joint, so as to provide an individual scheme for acetabular osteotomy. Methods The finite element models for development dysplasia of hip (DDH) and normal pelvis were established to investigate morphological characteristics of the acetabulum and the causes of stress concentration. To simulate osteotomy for the DDH model, a total of 20 postoperative osteotomy models were obtained through the combination of different angles for anterior rotation and lateral rotation of acetabular blocks, and the differences in optimal results of the models during simulated one legged-standing were compared and analyzed. Results The maximum contact pressure of acetabular cartilage in normal model was 7.85 MPa. The maximum contact pressure of acetabular cartilage in DDH model was 13.42 MPa. The optimal contact pressure after simulated osteotomy decreased to 8.49 MPa, and the contact distribution was improved more significantly. Conclusions Changing the anterior rotation angle can significantly improve the contact pressure distribution and size, as well as stay away from the preoperative lesion area, which has a positive impact on postoperative outcomes. Personalized osteotomy plan based on actual situation of each patient before the operation is crucial for the surgical effect.

Objective To explore the influence of different model scopes on acetabular stress distribution and optimal osteotomy result in preoperative planning of Bernese acetabular osteotomy. Methods Two patients with hip dysplasia were established according to different model ranges. Model 1 included the affected hip and femur, and Model 2 included the complete pelvis and affected femur. Compare and analyze the acetabular cartilage contact pressure, area and distribution of the two models under single-leg standing conditions, and simulate osteotomy. Results Compared with Model 1 before surgery, Model 2 had higher contact pressure, smaller contact area and closer distribution to the meniscus edge of acetabulum. Compared with 11 postoperative plans, the variation amplitude of contact pressure and the optimal osteotomy angle for Model 1 were all smaller than those of Model 2. Conclusions The preoperative analysis result of the model with affected hip bone and femur would underestimate the degree of stress concentration and misjudge the location of stress concentration, and the obtained optimal osteotomy rotation angle would be relatively small. The research findings provide certain theoretical basis for preoperative planning and modeling of osteotomy.