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 explore the application value of emergency temporal body surface positioning for single drain dual-target thalamic hematoma ventricular drainage in the treatment of thalamic hemorrhage breaking into ventricle with hydrocephalus.Methods A retrospective analysis was conducted on 223 patients with thalamic hemorrhage breaking into the ventricles with hydrocephalus,including a study group of 115 cases who underwent emergency single drain dual-target thalamic hematoma ventricular drainage surgery with temporal body surface positioning,and a control group of 108 cases who underwent emergency ventricular drainage first and then underwent stereotactic thalamic hematoma drainage surgery after the condition stabilized.Compare the differences in postoperative complications and treatment outcomes between two groups of patients,and evaluate the application value of temporal surface positioning for single drain dual-target thalamic hematoma ventricular drainage surgery in the treatment of thalamic hemorrhage breaking into the ventricle with hydrocephalus.Results The postoperative rebleeding rates,hematoma clearance and death were 5.2％,87.5％±7.3％and 13.9％in the study group and 4.7％,90.2％±8.5％and 15.7％in control group,respectively.There was no significant difference between the two groups(P＞0.05).The tube time,postoperative intracranial infection,Shunt dependent hydrocephalus,effective treatment and favorable prognosis of and the control group were(75.5±18.4)h,3.5％,19.1％,53.9％and 51.3％in the study group and(130.8±22.9)h,13.9％,35.1％,38.7％and 38.0％,respectively.The difference between the two groups was statistically significant(P＜0.05).Conclusion Body surface landmark-guided emergency single drain dual-target thalamic hematoma ventricular drainage surgery for the treatment of thalamic hemorrhage breaking into the ventricle with hydrocephalus is safe and reliable,and can improve the patient's prognosis.

T cell infiltration and proliferation in tumor tissues are the main factors that significantly affect the therapeutic outcomes of cancer immunotherapy. Emerging evidence has shown that interferon-gamma (IFNγ) could enhance CXCL9 secretion from macrophages to recruit T cells, but Siglec15 expressed on TAMs can attenuate T cell proliferation. Therefore, targeted regulation of macrophage function could be a promising strategy to enhance cancer immunotherapy via concurrently promoting the infiltration and proliferation of T cells in tumor tissues. We herein developed reduction-responsive nanoparticles (NPs) made with poly (disulfide amide) (PDSA) and lipid-poly (ethylene glycol) (lipid-PEG) for systemic delivery of Siglec15 siRNA (siSiglec15) and IFNγ for enhanced cancer immunotherapy. After intravenous administration, these cargo-loaded could highly accumulate in the tumor tissues and be efficiently internalized by tumor-associated macrophages (TAMs). With the highly concentrated glutathione (GSH) in the cytoplasm to destroy the nanostructure, the loaded IFNγ and siSiglec15 could be rapidly released, which could respectively repolarize macrophage phenotype to enhance CXCL9 secretion for T cell infiltration and silence Siglec15 expression to promote T cell proliferation, leading to significant inhibition of hepatocellular carcinoma (HCC) growth when combining with the immune checkpoint inhibitor. The strategy developed herein could be used as an effective tool to enhance cancer immunotherapy.

Objective:To investigate the application value of fluorescence imaging in single-port thoracoscopic anatomic segmentectomy.Methods:The clinical data of 280 patients (145 patients with fluorescence method and 135 patients with modified inflation-deflation method) who underwent thoracoscopic anatomic segmentectomy were retrospectively studied in the Anhui Chest Hospital from June 2020 to June 2021. There were 113 patients in the simple segmentectomy group and 167 patients in the complex segmentectomy group. The baseline data of the fluorescence method and the modified inflation-deflation method in the complex segmentectomy group were corrected by propensity score matching, and the perioperative results were compared between the groups.Results:There were no significant differences in segmental resection time, intraoperative blood loss, postoperative drainage, postoperative pain, postoperative extubation time, length of hospital stay, incidence of complications and cost of hand-holding between the fluorescence method and the modified method of the simple segmentectomy group.In the complex segmentectomy group, the time of segmental resection with the fluorescence method was significantly shorter than that with the modified inflation-deflation method( P<0.05), and other indexes had no significant difference. Conclusion:Fluorescence method single-port thoracoscopic anatomic segmentectomy has the same perioperative safety and short-term efficacy as modified inflation-deflation method, which can significantly shorten the operative time and improve the operative efficiency in complex anatomic segmentectomy.

Changes in structure of oral solid dosage forms (OSDF) elementally determine the drug release and its therapeutic effects. In this research, synchrotron radiation X-ray micro-computed tomography was utilized to visualize the 3D structure of enteric coated pellets recovered from the gastrointestinal tract of rats. The structures of pellets in solid state and in vitro compendium media were measured. Pellets in vivo underwent morphological and structural changes which differed significantly from those in vitro compendium media. Thus, optimizations of the dissolution media were performed to mimic the appropriate in vivo conditions by introducing pepsin and glass microspheres in media. The sphericity, pellet volume, pore volume and porosity of the in vivo esomeprazole magnesium pellets in stomach for 2 h were recorded 0.47, 1.55 × 10⁸ μm³, 0.44 × 10⁸ μm³ and 27.6%, respectively. After adding pepsin and glass microspheres, the above parameters in vitro reached to 0.44, 1.64 × 10⁸ μm³, 0.38 × 10⁸ μm³ and 23.0%, respectively. Omeprazole magnesium pellets behaved similarly. The structural features of pellets between in vitro media and in vivo condition were bridged successfully in terms of 3D structures to ensure better design, characterization and quality control of advanced OSDF.

Objective:To study the clinicopathological features, diagnosis, treatment and prognosis of patients with solid pseudopapillary neoplasm of the pancreas (SPN).Methods:From Jan 2008 to Dec 2017, 112 pathology confirmed SPN patients who underwent surgical treatment at the Fourth Hospital of Hebei Medical University were followed up. The clinicopathological characteristics and diagnosis were analyzed.Results:Most SPN patients were young women, the ratio of male to female is 1∶7. SPN patients have no typical clinical symptoms. The preoperative diagnostic accuracy of SPN was 57.14% with imaging examination. Pathological diagnosis depends mainly on immunohistochemical staining. All patients underwent surgical resection. Follow-up ranged from 4 to 123 months. The mean follow-up time was 49 months. All patients were doing well and no recurrence or metastasis was found.Conclusions:SPN is a rare tumor with low malignant potential. Surgical resection is effective.

The three-dimensional (3D) liver and tumor segmentation of liver computed tomography (CT) has very important clinical value for assisting doctors in diagnosis and prognosis. This paper proposes a tumor 3D conditional generation confrontation segmentation network (T3scGAN) based on conditional generation confrontation network (cGAN), and at the same time, a coarse-to-fine 3D automatic segmentation framework is used to accurately segment liver and tumor area. This paper uses 130 cases in the 2017 Liver and Tumor Segmentation Challenge (LiTS) public data set to train, verify and test the T3scGAN model. Finally, the average Dice coefficients of the validation set and test set segmented in the 3D liver regions were 0.963 and 0.961, respectively, while the average Dice coefficients of the validation set and test set segmented in the 3D tumor regions were 0.819 and 0.796, respectively. Experimental results show that the proposed T3scGAN model can effectively segment the 3D liver and its tumor regions, so it can better assist doctors in the accurate diagnosis and treatment of liver cancer.
Humans ; Image Processing, Computer-Assisted ; Liver Neoplasms/diagnostic imaging* ; Tomography, X-Ray Computed

Objective To evaluate the diagnostic efficiency and prognostic value of 18F-fluorodeoxyglucose (FDG) PET/CT for response assessment after treatment in patients with diffuse large B-cell lymphoma (DLBCL) when using the Deauville criteria and International Harmonization Project (IHP) criteria.Methods A total of 212 patients (119 males,93 males,average age:59.6(10-88) years) with DLBCL from February 2010 to June 2018 were analyzed.All subjects underwent restaging PET/CT after treatment.Images were evaluated with the IHP criteria,Deauville score of 3-5 (DC3) and Deauville score of 4-5 (DC4).The diagnostic efficiency of the 3 criteria for treatment effect was assessed and follow-up results were used as the gold standard.Spearman rank correlation analysis was used.Progression-free survival (PFS) and overall survival (OS) were analyzed by Kaplan-Meier analysis and Cox proportional hazards model.Results The positive predictive value and accuracy of DC4 for treatment effect evaluation were 96.8％(61/63) and 94.3％(200/212),those of IHP criteria were 75.3％(67/89) and 87.7％(186/212)respectively,and those of DC3 were 82.9％ (68/82) and 92.0％ (195/212) respectively.IHP criteria results and Deauville scores were correlated(rs =0.926,P＜0.05).The 2-year PFS rates in IHP-,DC3-and CD4-positive groups were 78.7％,76.5％ and 69.8％,respectively,and those in IHP-,DC3-and CD4-negative groups were significantly higher (95.6％,94.7％,97.2％;x2=14.415,18.293 and 26.920,all P＜0.05).The similar results were found for OS rates (x2 =9.597,11.149 and 17.416,all P＜0.05).The 2-year PFS rates in Deauville score of 1,2,3,4,5 groups were 95.3％,91.7％,93.3％,88.9％ and 55.6％ respectively (x2 =48.199,P＜0.05).Cox-regression analysis showed significant correlation between Deauville criteria and 2-year PFS rate (P＜0.05).Conclusions PET/CT with DC4,DC3 and IHP criteria have high predictive values for treatment outcome,and DC4 is the best.Cox regression analysis shows significant risk of progression by Deauville criteria.

Objective To assess the effects of two different managements of typeⅢsupracondyla humeral fractures in children: open reduction vs closed reduction and pinning. Methods Relevant articles were identified by using several database (Pubmed Medline, EMbase, cochranelibrary, CBM, CNKI, wanfang data). Control studies comparing closed reduction with percutaneous pinning and open reduction with pinning were analyzed.Results There was no significant difference in the carrying angle according to criteria of Flynn(OR=0.92,P=0.760).There was no significant difference in the functional results according to criteria of Flynn(OR=1.77, P=0.557).There was no significant difference in the ulnar nerve injury(OR=1.10,P=0.332).However, there was a obvious tendency to excellent and good results in the closed reduction group. Conclusions We recommend that closed reduction with percutaneous pinning should be performed first unless some special circumstances are present, for example:complex fractures and failed closed reduction.