In this study, the pre-market regulatory requirements for typical Class Ⅱ wound dressings, as well as the status of testing and post-market adverse events monitoring, were reviewed from the perspective of the whole lifecycle of medical devices. Additionally, the regulatory requirements for wound dressings in China, the United States, and the European Union were compared. Supplementary research was also conducted on Class Ⅰ and Ⅱ liquid and paste dressing products. Furthermore, this study analyzed the issues in the registration and application of typical Class Ⅱ wound dressings and provided regulatory recommendations, aiming to offer technical references for the review and approval, inspection and testing, and post-market supervision of wound dressing products.
Bandages/standards* ; United States ; China ; Humans ; European Union

Eight new diterpenoids, Isodons A-H (1-8), comprising seco-abietane and abietane-type structures, together with 13 known analogues (9-21), were isolated from Isodon lophanthoides (Buch.-Ham. ex D. Don) Hara. The compounds (+)-3/(-)-3, (+)-4/(-)-4, and (+)-5/(-)-5 were identified as three enantiomeric pairs. The planar structures and absolute configurations of 1-8 were determined through high-resolution electrospray ionization mass spectrometry (HR-ESI-MS), 1D & 2D nuclear magnetic resonance (NMR) spectroscopy, electronic circular dichroism (ECD) calculations, and X-ray diffraction crystallography. A cholesterol 7α-hydroxylase (Cyp7a1) luciferase reporter assay revealed significant anti-cholestatic activities for compounds 1, (+)-4, 6, 7, 12-14, and 16. Additionally, compound 6 demonstrated anti-cholestatic effects through the farnesoid X receptor (FXR)-associated signaling pathways in vitro and in vivo. These findings suggest potential applications for I. Lophanthoides in pharmaceutical development.
Abietanes/pharmacology* ; Molecular Structure ; Animals ; Isodon/chemistry* ; Humans ; Diterpenes/pharmacology* ; Plant Extracts/chemistry*

Traumatic supraorbital fissure syndrome (TSOFS) is a symptom complex caused by nerve entrapment in the supraorbital fissure after skull base trauma. If the compressed cranial nerve in the supraorbital fissure is not decompressed surgically, ptosis, diplopia and eye movement disorder may exist for a long time and seriously affect the patients′ quality of life. Since its overall incidence is not high, it is not familiarized with the majority of neurosurgeons and some TSOFS may be complicated with skull base vascular injury. If the supraorbital fissure surgery is performed without treatment of vascular injury, it may cause massive hemorrhage, and disability and even life-threatening in severe cases. At present, there is no consensus or guideline on the diagnosis and treatment of TSOFS that can be referred to both domestically and internationally. To improve the understanding of TSOFS among clinical physicians and establish standardized diagnosis and treatment plans, the Skull Base Trauma Group of the Neurorepair Professional Committee of the Chinese Medical Doctor Association, Neurotrauma Group of the Neurosurgery Branch of the Chinese Medical Association, Neurotrauma Group of the Traumatology Branch of the Chinese Medical Association, and Editorial Committee of Chinese Journal of Trauma organized relevant experts to formulate Chinese expert consensus on the diagnosis and treatment of traumatic supraorbital fissure syndrome ( version 2024) based on evidence of evidence-based medicine and clinical experience of diagnosis and treatment. This consensus puts forward 12 recommendations on the diagnosis, classification, treatment, efficacy evaluation and follow-up of TSOFS, aiming to provide references for neurosurgeons from hospitals of all levels to standardize the diagnosis and treatment of TSOFS.

Objective:To explore the factors affecting the prognosis of severe pediatric acute respiratory distress syndrome (ARDS) after receiving extracorporeal membrane oxygenation (ECMO) support.Methods:It was a multicenter prospective observational study. A total of 95 children with severe ARDS who were treated with ECMO salvage therapy from January 2018 to December 2022 in 9 pediatric ECMO centers in China were enrolled in the study. The general data, disease severity, organ function, comprehensive treatment and prognosis were recorded, and they were divided into survival group and death group according to the outcome at discharge. T test, chi-square test, multivariate Logistic regression and mixed linear model were used to analyze the relationship among baseline before ECMO treatment, some important indicators (pediatric critical scores, platelet count, albumin, fibrinogen, etc) during ECMO treatment and prognosis. Results:Among the 95 children with severe ARDS who received ECMO, 55 (58%) were males and 40 (42%) were females, aged 36.9 (0.5, 72.0) months. Twelve children (13%) were immunodeficient. Sixty-eight (72%) children were treated with venous artery (VA) mode and 27 (28%) with venous vein (VV) mode. The discharge survival rates of overall, VA, and VV mode children were 51% (48/95), 47% (32/68), and 59% (16/27), respectively. The number of immunodeficient children in the death group was higher, and there were lower pediatric critical scores, platelet count, albumin, fibrinogen and arterial oxygen partial pressure/fraction of inspired oxygen (PaO 2/FiO 2), higher ventilator driving pressure (ΔP), oxygenaion index (OI), and longer ARDS duration before ECMO (all P<0.05). There were no statistically significant differences in other indicators, including age, gender, weight, and ECMO mode among different prognostic groups (all P>0.05). High ΔP, high OI, low P/F, and low albumin were high-risk factors affecting prognosis(all P<0.05). After further grouping, it was found that ΔP≥25 cmH 2O (1 cmH 2O=0.098 kPa), P/F≤67 mmHg (1 mmHg=0.133 kPa) and OI≥35 were the thresholds for predicting poor prognosis ( P<0.05). From 24 h after ECMO, there were significant differences in ΔP, P/F and OI between the dead group and the survival group (all P<0.05), and the differences gradually increased with the ECMO process. The platelet level was significant from 7 days after ECMO ( P<0.05) and gradually expanded. Blood lactate levels showed a significant difference between the 2 groups on before and after ECMO ( P<0.05) and gradually increased from 24 h after ECMO. Conclusions:The risk factors affecting the prognosis of severe ARDS in ECMO include high ΔP, high OI, low P/F and low albumin purification therapy before ECMO. The gradual decrease of ΔP, OI and increase of P/F from 24 h of ECMO predicted a good prognosis, while the gradual increase of lactate after ECMO application showed a poor prognosis.

Objective:To study the teaching effect of traditional teaching combined with virtual simulation teaching in pharmaceutical content analysis using high performance liquid chromatography (HPLC).Methods:The students in two parallel classes of grade 2016 were divided into experimental group (44 students) and control group (38 students). Taking the content analysis and its related analytical methodology of Metronidazole by HPLC as an example, the experimental group adopted the traditional offline teaching combines with virtual simulation teaching, and the control group adopted the traditional offline teaching. The teaching effects of the two groups were compared. SPSS 22.0 was used to conduct independent-samples t-test. Results:According to the mid-term test results, the experimental group was superior to the control group in practical operation assessment [(17.98±6.75) vs. (14.03±5.92)], and the difference was statistically significant ( P < 0.05). But there were no differences between the two groups in the scores of theory, discussion report and presentation. There was no significant difference in the final exam scores between the two groups. Conclusion:The ability of practical training and the teaching effect can be improved by the teaching method of traditional offline teaching combined with virtual simulation. Through the training of this project, students have mastered the operation of HPLC, the content determination of pharmaceutical preparations, the verification of analytical methods, data processing, and the writing of analytical reports, and have certain practical analysis ability.

The inconsistency of diagnostic criteria for malnutrition has confused clinicians since the 1980s. After the implementation of disease diagnosis related group payment (DRG) in China's public hospitals, the diagnosis of malnutrition and the correct documentation of nutrition-related diagnosis on the front sheet of medical records are related to the correct classification of the disease group and the medical insurance payment. Therefore, the reliable diagnostic criteria for malnutrition, especially disease-related malnutrition, is urgently needed in clinical practice. In September 2018, The global leadership Iinitiative on malnutrition (GLIM) diagnostic criteria consensus was launched. GLIM aimed to provide the explicit and unified diagnostic criteria for malnutrition in adult hospitalized patients. However, GLIM criteria was based on the voting by nutritional experts and was merely a consensus in nature. The clinical validity of GLIM criteria needs prospective verification, i.e., to demonstrate that patients with malnutrition as per GLIM criteria could have improved clinical outcomes with reasonable nutritional interventions. In November 2020, the article titled Nutritional support therapy after GLIM criteria may neglect the benefit of reducing infection complications compared with NRS 2002 was published on the journal Nutrition. It was the first study comparing nutritional risk screening 2002 (NRS 2002) and GLIM malnutrition diagnostic criteria among Chinese patients for the indication of nutritional support therapy. The clinical effectiveness of the two tools was retrospectively verified as well. Here we discussed the key points of this retrospective study, including the critical research methods, to inform the currently ongoing prospective validation of the GLIM malnutrition diagnostic criteria (the item of reduced muscle mass not included).

Objective To develop an evidence-based,localized practice protocol for the interhospital transfer of critically ill children.Methods Through a comprehensive evidence summary and semi-structured interviews,a preliminary inter-hospital transfer practice protocol for critically ill children was formulated.A panel of 31 experts from 12 hospitals in China participated in 2 rounds of expert correspondence between May and July 2022,facilitating meticulous revision of the protocol entries.Results The response rate for both rounds of questionnaires was 100%,and the expert authority coefficients ranged from 0.926 to 0.931.In the second round of consultation,the coefficient of variation for the importance score of each entry ranged from 0.036 to 0.226,and the Kendall's W was determined to be 0.201(P＜0.001).Additionally,the coefficient of variation for the feasibility score of each entry fell within the range of 0.070 to 0.314,with Kendall's W of 0.124(P＜0.001).Ultimately,the final interhospital transfer protocol for critically ill children comprised 8 level Ⅰ entries,16 level Ⅱ entries,and 75 level Ⅲ entries.Conclusion The interhospital transfer protocol constructed in this study is grounded in scientific evidence and exhibits practical feasibility.It serves as a valuable reference for organizing and implementing interhospital transfers of critically ill children.

Desmoid-type fibromatosis is a rare benign tumor with invasive growth, which can occur in all parts of the body, mostly in the abdominal wall, and also in the abdomen and skeletal muscle. This paper reports a case of right ureteral stenosis caused by pelvic desmoid-type fibromatosis. Pelvic tumor resection, ileocecal resection and ureterovesical replantation were performed. The patients were followed up for 18 months without local recurrence and distant metastasis.

BACKGROUND/OBJECTIVES: This study aimed to investigate cancer-specific survival (CSS) and associated risk factors in elderly gastric cancer (EGC) patients. SUBJECTS/METHODS: EGC patients (≥ 70 yrs) who underwent curative gastrectomy between January 2013 and December 2017 at our hospital were included. Clinicopathologic characteristics and survival data were collected. Receiver operating characteristic (ROC) analysis was used to extract the best cutoff point for body mass index (BMI). A Cox proportional hazards model was used to determine the risk factors for CSS. RESULTS: In total, 290 EGC patients were included, with a median age of 74.7 yrs. The median follow-up time was 31 (1–77) mon. The postoperative 1-yr, 3-yr and 5-yr CSS rates were 93.7%, 75.9% and 65.1%, respectively. Univariate analysis revealed risk factors for CSS, including age (hazard ratio [HR] = 1.08; 95% confidence interval [CI], 1.01–1.15), intensive care unit (ICU) admission (HR = 1.73; 95% CI, 1.08–2.79), nutritional risk screening (NRS 2002) score ≥ 5 (HR = 2.33; 95% CI, 1.49–3.75), and preoperative prognostic nutrition index score < 45 (HR = 2.06; 95% CI, 1.27–3.33). The ROC curve showed that the best BMI cutoff value was 20.6 kg/m 2 . Multivariate analysis indicated that a BMI ≤ 20.6 kg/m 2 (HR = 2.30; 95% CI, 1.36–3.87), ICU admission (HR = 1.97; 95% CI, 1.17–3.30) and TNM stage (stage II: HR = 5.56; 95% CI, 1.59–19.43; stage III: HR = 16.20; 95% CI, 4.99–52.59) were significantly associated with CSS. CONCLUSIONS Low BMI (≤ 20.6 kg/m2 ), ICU admission and advanced pathological TNM stages (II and III) are independent risk factors for CSS in EGC patients after curative gastrectomy. Nutrition support, better perioperative management and early diagnosis would be helpful for better survival.