ObjectiveTo investigate the effect and mechanism of modified Sini San in ameliorating intestinal mucosal barrier by observing its effects on short chain fatty acids （SCFAs） and high mobility group protein B1 （HMGB1）/receptor of advanced glycation end products （RAGE） signaling pathways in chronic stress rats. MethodsThe 50 male SD rats were randomly divided into control group，model group，low-dose modified Sini San group （7.34 g·kg^-1·d^-1），high-dose modified Sini San group （14.68 g·kg^-1·d^-1），and Fructo-oligosaccharides group （3.15 g·kg^-1·d^-1），with 10 rats in each group. Except for the control group，all other groups were subjected to chronic unpredictable stress/social isolation to create a chronic stress model for 6 weeks. After 4 weeks of modeling，each treatment group was given corresponding drugs by gavage for 2 weeks while modeling. The control group and model group were given the same volume of physiological saline. The effects of Modified Sini San on behaviors，body weight，Bristol score in feces and fecal moisture content in chronic stress rats were observed. Hematoxylin and eosin （HE） staining was used to observe the pathological changes in the cecum. The content of SCFAs in the cecal contents of rats were detected by Gas chromatography-mass spectrometry （GC-MS）. Immunohistochemistry and Western blot were used to detect the expression of HMGB1/RAGE pathway related proteins in cecal tissue. The levels of ZO-1，Occludin，and Claudin-1 in the cecal tissue were detected by enzyme linked immunosorbent assay （ELISA）. ResultsCompared with the model group，the sucrose preference rate，total distance traveled and the number of grid crossings in the open field test of rats in the low-dose modified Sini San group were obviously increased （P<0.05， P<0.01），and the immobility time in the open field test and the immobility time in the forced swimming test of rats in the low-dose and high-dose modified Sini San groups were obviously reduced （P<0.05， P<0.01）. Meanwhile，the Bristol score and fecal moisture content of rats in the low and high dose groups of modified Sini San were obviously increased （P<0.05）. The low-dose group of modified Sini San had intact mucosal layer structure in the cecal tissue and reduced infiltration of inflammatory cells. The content of SCFAs in the cecal contents increased，with a obviously increase in the content of acetic acid，propionic acid，butyric acid，and isovaleric acid （P<0.05， P<0.01） and the expression levels of HMGB1，RAGE，Toll-like receptor 2（TLR2），Toll-like receptor 4（TLR4），tumor necrosis factor-α（TNF-α），and nuclear factor kappa-B p65（NF-κB p65） proteins in cecal tissue were significantly decreased （P<0.05， P<0.01） in low-dose group of modified Sini San. Meanwhile，the contents of ZO-1，Occludin，and Claudin-1 in the cecal tissue were obviously increased （P<0.01） in low-dose group of modified Sini San. ConclusionModified Sini San can improve the function of intestinal mucosal barrier in chronic stress rats by increasing the content of SCFAs in the intestine and inhibiting the HMGB1/RAGE pathway.

ObjectiveThis paper aims to investigate and evaluate the staged efficacy and safety of the representative empirical prescription of the “Zhu Ke Jiao” theory， Qijia Rougan prescription， combined with entecavir in the treatment of hepatic fibrosis in chronic hepatitis B. MethodsA multicenter randomized controlled clinical study was conducted， and 101 patients diagnosed with chronic hepatitis B-related hepatic fibrosis （CHB-HF） who met the diagnosis and inclusion criteria were randomly assigned to an observation group （Qijia Rougan prescription + entecavir） and a control group （entecavir）. The treatment duration was 24 weeks. Liver stiffness measurement （LSM）， fibrosis-4 index （FIB-4）， portal vein diameter， hepatitis B serology， biochemical indicators， hepatic fibrosis markers in serum ［hyaluronic acid （HA）， laminin （LN）， procollagen Ⅲ peptide （PⅢP）， and type Ⅳ collagen （Ⅳ-C）］， and traditional Chinese medicine syndrome scores were used as efficacy evaluation indicators. Efficacy assessments and explorations of different staged subgroups of Qijia Rougan prescription were conducted according to LSM values based on the Metavir pathological staging standard. ResultsA total of 98 cases were included for statistical analysis， with 49 cases in the observation group and 49 in the control group. The general data of the patients in both groups were comparable. Compared with the same group before treatment， the observation group showed a significant reduction in LSM and FIB-4 （P<0.01）， as well as notable improvements in LN， Ⅳ-C， and various TCM syndrome scores （P<0.05， P<0.01）. When compared to the control group after treatment， the observation group demonstrated significant improvements in LSM， FIB-4， and various TCM syndrome score indicators （P<0.05， P<0.01）， indicating that the observation group performed better than the control group. Subgroup analysis of the regression of hepatic fibrosis stages showed that compared to the same group before treatment， the observation group had better improvement in regression of stages F2 and F3 （P<0.05）. When compared to the control group after treatment， the observation group exhibited superior improvement in regression of stage F3 （P<0.05）. No adverse events occurred in either group during the treatment period. ConclusionCompared with entecavir alone， the combination of Qijia Rougan prescription and entecavir significantly improves the degree of hepatic fibrosis and clinical TCM symptoms in patients. The optimal intervention period is primarily during stage F3， which is a potential “interception” point of the “Zhu Ke Jiao” theory.

To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines； further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly； replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.

Objective: To compare quality control (relative purity and specific activity) and process control [plasminogen (Pg) antigen recovery and potency recovery] indexes of samples before and after adding the Q chromatography step to the full chromatography process of human Pg, thereby determining whether the addition of this step could improve Pg recovery by affinity chromatography. Methods: A Q chromatography step was added before the Pg affinity chromatography in the original Pg chromatography process. The loading solution, flow through solution and eluate of Q chromatography and Pg affinity chromatography were collected. The potency of coagulation factor Ⅱ (FⅡ), Ⅶ (FⅦ), Ⅷ (FⅧ), Ⅸ (FⅨ), and Ⅹ(FⅩ) were detected by the coagulation method, the total protein content was detected by the BCA method, and the Pg potency was detected by the chromogenic substrate method. The content of specific plasma proteins was detected by immunoturbidimetry, the potency recovery of coagulation factors was calculated, and the flow direction of coagulation factors was analyzed. The recovery of different plasma protein antigens were calculated, and the distribution of impurity proteins was analyzed. The relative purity and specific activity of Pg, antigen content, and potency recovery in the target fractions were calculated and compared with the original process indicators, so as to determine the effect of adding Q chromatography on the original process. Furthermore, the reproducibility after process modification was assessed. Results: 100% of FⅡ, FⅩ, and FⅨ, 87.81% of FⅧ, and 40.44% of FⅦ in filtered plasma were removed by Q chromatography. The residual FⅦ (53.26%) and FⅧ (13.30%) in Q flow-through fraction were completely removed by Pg affinity chromatography. In both the original process (without Q-chromatography) and the modified process (with Q-chromatography), non-target plasma proteins mainly existed in the flow-through fraction of Pg affinity chromatography. The antigen recovery of IgM, ceruloplasmin (CER), and fibronectin (FNC) in Q-chromatography flow-through fraction were reduced. In contrast, antigen recovery of other plasma proteins [IgG, IgA, Pg, albumin (AlB), alpha-1-antitrypsin (AAT), and fibrinogen (Fg)] were all >90%, which were consistent with the protein composition and proportion in the original affinity chromatography loading solution. Compared with the recovery rate of Pg antigen in the original process (74.4%), the total recovery of Pg antigen in the modified process was significantly increased (89.97%). Compared with the recovery of IgG (97.48%) and Fg (95.32%) in the Pg affinity flows-through fraction of the original process, the modified process resulted in a slight reduction in the recovery of IgG (94.60%), while the recovery of Fg was not affected (95.05%). The potency recovery rate, specific activity, and relative purity of Pg after Q chromatography were 99.3%, 0.016 U/mg, and 0.15%. These values were the same as those of Pg affinity chromatography loading solution by the original process, indicating that introduction of Q chromatography did not affect subsequent Pg affinity chromatography. Compared with the recovery of Pg antigen in three batches of the original process (66.49±1.02)%, the recovery of Pg antigen in the affinity chromatography eluent of the modified process [five batches; (77.43±4.43)%] was significantly improved. Furthermore, the potency recovery was (86.80±4.28)%, the relative purity was (81.99±1.25)%, the specific activity was (8.679±1.073)U/mg, and the process was reproducible. Conclusion: The addition of Q chromatography could improve the recovery of Pg affinity chromatography in the full chromatography process.

Objective:To analyze the application effects and safety of continuous negative pressure drainage devices in postoperative drainage of congenital microtia reconstruction of auricle.Methods:A retrospective study was conducted, including 1 211 patients with congenital microtia treated at the Plastic Surgery Hospital of Chinese Academy of Medical Sciences and Peking Union Medical College from January 2018 to August 2021. All patients underwent auricular reconstruction surgery and were divided into two groups based on the type of negative pressure drainage device used. The study group consisted of 624 patients [315 males and 309 females, aged 6-24 (15.1±2.2) years], while the control group consisted of 587 patients [286 males and 301 females, aged 5-23 (14.7±2.3) years]. The study group used a novel negative pressure drainage ball, while the control group used a conventional negative pressure syringe for drainage. The preoperative and postoperative 1, 7 days scores of the modified Yale preoperative anxiety scale (mYPAS) and the quality of life scores postoperative 3 days (including functional activity, self-image, psychological health, satisfaction and pain) were compared between the two groups. All patients were followed up at 4, 8, 12, and 16 weeks postoperatively to compare the surgical scar area between the two groups. The incidence of adverse reactions within 12 weeks after surgery in two groups were recorded.Results:There was no significant difference in preoperative mYPAS scores between the two groups ( P=0.897). The mYPAS scores at 1 and 7 days after surgery were lower than the preoperative scores in both groups (all P<0.05), and the study group had significantly lower mYPAS scores at all time points than those of the control group (all P<0.001). The study group had higher scores in functional activity, self-image, psychological health, and satisfaction than those of the control group (all P<0.001), and a lower pain score than that of the control group ( P<0.001). Follow-up at 4, 8, 12, and 16 weeks showed that the surgical scar area was significantly smaller in the study group at all time points than in the control group (all P<0.001). The incidence of adverse reactions within 12 weeks after surgery was 9.0% (56/624) in the study group, which was lower than the 19.4% (114/587) in the control group ( P<0.001). Conclusion:The use of continuous negative pressure drainage devices in congenital microtia reconstruction of auricle is more effective and can reduce the incidence of postoperative adverse reactions.

Objective:To observe and assess the clinical value of electrophysiology of ocular surface in the diagnosis and treatment of blepharospasm in Meige syndrome (MS).Methods:A single-center, cross-sectional study. A total of 413 patients diagnosed with MS and undergoing surgical treatment at the Henan Provincial Meige Syndrome Diagnosis and Treatment Center of the Henan Provincial Third People′s Hospital from May 2022 to December 2023 were included as the MS group. A total of 110 age- and gender-matched spouses of patients and community volunteers were selected as the control group. The bioelectricity detection program of the electrooculogram was used; the frequency bandwidth was set at 0.3 to 300.0 Hz. Surface electrodes were employed to record the surface electrophysiological manifestations of the corrugator supercilii muscle and the lower orbicularis oculi muscle, as well as the conditions and temporal characteristics of spasm waves. Based on the amplitude and waveform of the electrophysiology of ocular surface signals, it can be classified into 0-4 grades. The blepharospasm was divided into conditionally induced type, spastic type, reverse spastic type, and oro-ocular elicited type. All patients were treated with neural circuit occlusion, and the postoperative follow-up time was 4.1 (0.5-19.0) months. The distribution of different grades of electrophysiology of ocular surface in the MS and control group at baseline were observed, as well as within the MS group at the last follow-up visit. Additionally, the blepharospasm grades in the MS group were also assessed. The comparison of the distribution of the number of eyes with different grades of electrophysiology of ocular surface between groups was conducted using the Mann-Whitney U test. Results:At baseline, in the MS group, the number of cases with corrugator supercilii muscle amplitudes and morphologies graded from 0 to 4 were as follows: 15 (3.60%, 15/413) for grade 0, 95 (23.00%, 95/413) for grade 1, 142 (34.38%, 142/413) for grade 2, 127 (30.75%, 127/413) for grade 3, and 34 (8.24%, 34/413) for grade 4. In the control group, the corresponding numbers of individuals were 82 (74.54%, 82/110) for grade 0, 24 (21.82%, 24/110) for grade 1, 4 (3.64%, 4/110) for grade 2, 0 (0.00%, 0/110) for grade 3, and 0 (0.00%, 0/110) for grade 4. For the orbicularis oculi muscle, there were 35 cases (8.47%) in grade 0, 124 cases (30.03%) in grade 1, 150 cases (36.32%) in grade 2, 90 cases (21.79%) in grade 3, and 14 cases (3.39%) in grade 4 in the MS group. In the control group, there were 86 cases (78.18%) in grade 0, 24 cases (21.82%) in grade 1, and 0 cases in grades 2, 3, and 4. There were statistically significant differences in the distribution of the number of eyes with different electrophysiology of ocular surface grading of the corrugator supercilii muscle and the orbicularis oculi muscle between the MS and control group ( Z=-14.51, -13.86; P<0.001). Meanwhile, there were statistically significant differences in the distribution of the number of eyes with different electrophysiology of ocular surface grading of the corrugator supercilii muscle and the orbicularis oculi muscle between preoperation and at the last follow-up in the MS group ( Z=-16.52, -17.36; P<0.001). In the MS group, there were 61 (14.77%, 61/413), 306 (74.09%, 306/413), 27 (6.54%, 27/413) and 19 (4.60%, 19/413) cases of blepharospasm conditionally induced type, spasm type, reverse spasm type and oro-ocular elicited type, respectively. Conclusion:The electrophysiology of the ocular surface can objectively reflect the activity of periocular neuromuscular.

Oral squamous cell carcinoma(OSCC)is a malignant lesion originating from the oral mucosal squamous epithelium,account-ing for over 80％of oral and maxillofacial malignancies.Key etiological factors include tobacco,alcohol abuse,and betel quid chewing.In China,its incidence has shown an overall upward trend,posing a significant threat to public health.OSCC exhibits high local invasive-ness,making early diagnosis critical for improving prognosis.Its clinical management requires close multidisciplinary collaboration among oral and maxillofacial surgery,head and neck surgery,radiation oncology,medical oncology,reconstructive surgery,radiology,patholo-gy,and nutritional support teams.Given the increasing disease burden of OSCC and rapid development of multidisciplinary collaborative models,an expert panel has formulated this integrated management consensus based on evidence-based medicine and extensive deliber-ation.Centered on the'Prevention-Screening-Diagnosis-Treatment-Rehabilitation'framework,the consensus provides comprehensive guidance for the entire disease course of OSCC patients,aiming to standardize clinical practice.

Objective:To investigate the feasibility of the bortezomib, lenalidomide, and dexamethasone (VRD) regimen combined with autologous hematopoietic stem cell transplantation (auto-HSCT) in patients with multiple myeloma (MM) and renal impairment, analyze treatment efficacy and renal responses stratified based on renal dysfunction severity, and explore the prognostic significance of early renal response and its affecting factors.Methods:This retrospective study, conducted at the First Affiliated Hospital of Soochow University, categorized 316 patients with newly diagnosed MM (NDMM) from August 2018 to October 2022 based on renal function for analysis of clinical characteristics, treatment response, and prognosis. Continuous variables were compared using t-tests or Mann-Whitney U tests, categorical variables utilizing Chi-square tests, survival outcomes employing Kaplan-Meier and Log-rank tests, and renal response predictors with logistic regression.Results:Patients were stratified based on baseline estimated glomerular filtration rate (eGFR) : normal [≥90 ml·min -1· (1.73 m 2) -1, n=160], mild [≥60 ml·min -1· (1.73 m 2) -1 to <90 ml·min -1· (1.73 m 2) -1, n=55], moderate [≥30 ml·min -1· (1.73 m 2) -1 to <60 ml·min -1· (1.73 m 2) -1, n=39], and severe impairment [<30 ml·min -1· (1.73 m 2) -1, n=62]. Moderate and severe renal impairment correlated with advanced International Staging System/Revised International Staging System classification, lower hemoglobin levels, frailty, and higher light-chain/IgD subtype prevalence ( P<0.05). Despite younger age ( P=0.001) and higher transplant rates ( P=0.041) in severe cases, overall response rates ( ORR: 93.7% ; ≥VGPR: 82.9% ) were comparable across groups ( P>0.05). Among 24 dialysis-dependent patients at diagnosis, 11 (45.8% ) achieved dialysis independence after induction [median: 3.0 (0.5–4.0) months], including 10 undergoing auto-HSCT. In 89 evaluable patients [baseline eGFR <50 ml·min -1· (1.73 m 2) -1], renal ORR (RORR) was 70.8% [rapid complete response: 31.5% ; rapid partial response: 11.2% ; rapid minimal response (RMR) : 28.1% ]. Renal response predicted better survival (overall survival: HR=0.36, 95% CI: 0.13–0.99, P=0.049). Moderate-to-severe renal impairment was associated with increased transplant-related adverse events and delayed engraftment ( P<0.05) ; however, auto-HSCT significantly improved outcomes after 33.5-month median follow-up (range: 2–65 months). Multivariate analysis identified 1q21+ ( OR=3.58, 95% CI: 1.17–11.02, P=0.026) and light-chain subtype ( OR=2.86, 95% CI: 1.08–7.69, P=0.036) as independent predictors of poor renal response. Conclusion:VRD regimen plus auto-HSCT demonstrates robust efficacy in NDMM, including patients with renal impairment, with a 70.8% RORR and manageable toxicity. Achieving ≥RMR correlates with superior prognosis, whereas 1q21+ and light-chain subtype independently predict inferior renal response.

The Occupational Classification Dictionary of the People's Republic of China (2015 Edition) has added a new occupation type, Medical Nursing Assistants, aiming to meet the strong demand for medical care in the context of the aging population in China.In order to standardize the services of medical nursing assistants for the elderly in home and community settings and contribute to healthy aging, the National Health Commission issued the " Service Standards for Medical Nursing Assistants of Older Adults in Home and Community" ( WS/ T 803—2022) on September 28, 2022.The standards regulate the service processes, service items and requirements, as well as service evaluation and improvement for elderly medical nursing assistants.The interpretation of the standard's formulation background, the compilation process, and the standard's content are as follows.