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

This article explores the MRI-guided proton therapy(MRiPT)integrated technology,which is magnetic resonance imaging-guided radiation therapy.By precisely controlling dose distribution,MRiPT has the potential to enhance the efficacy of radiotherapy.This article reviews the development of MRiPT,analyzes its potential for clinical application,and discusses technical challenges and potential solutions.MRiPT technology offers significant advantages in improving treatment precision and reducing side effects,especially showing exceptional potential in the treatment of complex tumors.This article concludes by looking forward to the future development of MRiPT technology,emphasizes the importance of optimizing electromagnetic compatibility and reducing inter-system interference.

Background/Aims: The aim of this study was to analyze the chronological changes in postoperative complications in surgical ulcerative colitis patients over the past decade in China and to investigate the potential parameters that contributed to the changes. Methods: Ulcerative colitis patients who underwent surgery during 2008–2017 were retrospectively enrolled from 13 hospitals in China. Postoperative complications were compared among different operation years. Risk factors for complications were identified by logistic regression analysis. Results: A total of 446 surgical ulcerative colitis patients were analyzed. Fewer short-term complications (24.8% vs. 41.0%, P=0.001) and more laparoscopic surgeries (66.4% vs. 25.0%, P<0.001) were found among patients who received surgery during 2014–2017 than 2008–2013. Logistic regression suggested that independent protective factors against short-term complications were a higher preoperative body mass index (odds ratio [OR], 0.870; 95% confidence interval [CI], 0.785–0.964; P=0.008), laparoscopic surgery (OR, 0.391; 95% CI, 0.217–0.705; P=0.002) and elective surgery (OR, 0.213; 95% CI, 0.067–0.675; P=0.009). The chronological decrease in short-term complications was associated with an increase in laparoscopic surgery. Conclusions Our data revealed a downward trend of short-term postoperative complications among surgical ulcerative colitis patients in China during the past decade, which may be due to the promotion of minimally invasive techniques among Chinese surgeons.

The anterior cruciate ligament (ACL) injury is a common sports injury that has a significant impact on knee function and patients′ mobility. With the popularity of national fitness campaign in China, the incidence of ACL injury is increasing year by year. Currently, there still lacks clinical standards or guidelines on how to choose appropriate treatment methods, surgical plans and rehabilitation protocols for ACL injury. In order to timely reflect the new treatment concept of ACL injury, standardize its diagnosis and treatment and improve the curative effect, the Sports Medicine Society of Chinese Research Hospital Association and the Editorial Board of Chinese Journal of Trauma organized domestic orthopedic and sports medicine experts to formulate the "clinical evidence-based guideline for the diagnosis and treatment of anterior cruciate ligament injury (2022 version)" based on the level of evidence-based medicine and in compliance with the principle of scientificity, practicability and advancement. The present guideline includes 12 recommendations for the diagnosis, treatment and rehabilitation of ACL injury in order to provide guidance and assistance for the clinical diagnosis and treatment of ACL injury in China.

Objective:To evaluate the effect of definitive radiotherapy with different doses on overall survival (OS) and identify the prognostic factors of patients with non-metastatic esophageal squamous cell carcinoma (ESCC).Methods:Clinical data of 2 344 ESCC patients treated with definitive radiotherapy (RT) alone or chemoradiotherapy from 2002 to 2016 in 10 hospitals were collected and analyzed retrospectively. After the propensity score matching (PSM)(1 to 2 ratio), all patients were divided into the low-dose group (equivalent dose in 2 Gy fractions, EQD 2Gy<60 Gy; n=303) and high-dose group (EQD 2Gy≥60 Gy; n=606) based on the dose of radiation. Survival analysis was conducted by Kaplan- Meier method. Multivariate prognostic analysis was performed by Cox′s regression model. Results:The median follow-up time was 59.6 months. After the PSM, the 1-, 3- and 5-year overall survival (OS) rate was 66.5%, 34.7%, 27.2% in the low-dose group, 72.9%, 41.7% and 34.7% in the high-dose group, respectively ( P=0.018). The 1-, 3-and 5-year progression-free survival rate was 52.2%, 27.2%, 23.1% in the low-dose group, 58.3%, 38.1% and 33.9% in the high-dose group, respectively ( P=0.001). The outcomes of univariate analysis indicated that cervical/upper esophagus location, early (stage Ⅱ) AJCC clinical stage, node negative status, tumor length ≤5 cm, receiving intensity-modulated radiation therapy (IMRT), receiving concurrent chemotherapy and EQD 2Gy≥60 Gy were closely associated with better OS (all P<0.05). Multivariable analysis demonstrated that tumor location, regional lymph node metastasis, concurrent chemotherapy and EQD 2Gy were the independent prognostic factors for OS (all P<0.05). Conclusion:Three-dimensional conformal or IMRT with EQD 2Gy≥60 Gy yields favorable survival outcomes for patients with locally advanced ESCC.

Objective To investigate the social function, adverse reaction and medication adherence of paliperidone, amisulpride, and olanzapine in patients with first episode schizophrenia.Methods A total of 96 patients with first episode of schizophrenia was randomly divided into three groups, with reference to random numbers, among which there were 32 in paliperidone group, 32 cases in amisulpride group, and 32 in olanzapine group.All the patients in all groups were assessed with negative and positive scale (PANSS), personal and social performance scale (PSP), drug attitude inventory (DAI) at baseline and the end of 6 months.Results (1) There was no significant difference in the therapeutic effect between three groups (P ＞ 0.05);(2) The scores of PSP and DAI were increased in three groups after treatment, and the difference was statistically significant compared to that before treatment (P ＜ 0.05).Conclusions Three drugs have similar efficacy in the treatment of first-episode schizophrenia, and there is no significant difference in improving medication compliance and social function.

Objective To evaluate the survival and prognostic factors of esophageal cancer treated with definitive ( chemo ) radiotherapy by applying novel radiation techniques including three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiotherapy (IMRT). Methods Clinical data of 2762 patients with non-operated esophageal squamous cell carcinoma who underwent definitive ( chemo ) radiotherapy from 2002 to 2016 in 10 hospitals were retrospectively analyzed.The prognostic factors were also identified and analyzed. Results The median follow-up time was 60. 8 months. The 1-, 2-, 3-and 5-year overall survival (OS) of all patients was 71. 4％,48. 9％,39. 3％,and 30. 9％,respectively.The 1-,2-,3-and 5-year progression-free survival (PFS) was 59.5％,41.5％,35.2％,and 30％,respectively.The median survival was 23 months.The median time to progression was 17. 2 months.Multivariate analysis demonstrated that age, primary tumor location, clinical stage, tumor target volume, EQD2 and treatment mode were the independent prognostic factors for OS.Primary tumor location,clinical stage,tumor target volume and EQD2 were the independent prognostic factors for PFS. Conclusions In this first large-scale multi-center retrospective analysis of definitive ( chemo) radiotherapy for esophageal squamous cell carcinoma in China, the 5-year OS of patients with esophageal squamous cell carcinoma is significantly improved by 3DCRT, IMRT combined with chemotherapy drugs. However, the findings remain to be validated by prospective clinical trials with high-level medical evidence.

Objective To understand the current prevalence of clonorchiasis in Jiangxi Province. Methods A survey was performed according to the scheme of the 3rd Principal Human Parasites of Jiangxi Province. Based on the ecological regions,a stratified cluster sampling method was applied by the economic and geographic situation. In rural areas,the investigation of C. si?nensis was carried out together with the soil?transmitted helminths investigation,and in the urban areas,the random cluster sam?pling method was applied for the C. sinensis investigation. There were 92 survey sites from 32 counties. The eggs of C. sinensis in stool were examined by Kato?Katz technique,and health knowledge was also investigated by questionnaires in some people at the same time. Results A total of 23 606 sample residents were investigated,and 138 were found infected with C. sinensis, with the infection rate of 0.58%. Light infection was found in most of them. Totally 124 C. sinensis infected persons focused in Xinfeng County,and only a few of infected people scattered in the other counties. In Xinfeng County,851 residents were investi?gated. Among them,the infected people were found in all the age groups except the 0?year age group. The highest infection rate appeared in the 70? years group(24.00%). The male infection rate was 20.29%,which was higher than that of the female (6.25%),showing a statistically significant difference(P<0.01). The infection rate was highest in the population who received high school or technical secondary school education(31.48%). For the occupation distribution,the infection rate was highest in public officers(39.39%). The questionnaire survey showed that the infection rate in the populations in Xinfeng County who had the history of eating raw fish or raw shrimp was 33.15%. Conclusions The distribution of C. sinensis infection presents a region?al aggregation in Xinfeng County,but in other areas,the distribution is sporadic. It is necessary to continue to carry out the para?sitic disease screening,and in Xinfeng County,it is necessary to strengthen the comprehensive prevention and control interven?tion.

Objective: To evaluate the diagnostic value and feasibility of narrow-band imaging in detection of recurrent nasopharyngeal carcinoma (NPC). Methods: One thousand three hundred and sixty-four NPC patients who had completed NPC treatment were enrolled. All patients were followed-up with imaging, serological examination of EB virus and nasopharyngeal endoscopy(WL and NBI mode), in which (1) both white light (WL) and NBI modes were done; (2) positive endoscopic patients were given nasopharyngeal biopsy; (3) using histologic finding as criterion standard, the sensitivity, specificity, accuracy and Yonden′s index of two modes were compared. Kappa index was used to evaluate the consistency between the two modes and pathological results respectively; (4) the positive rates of WL and NBI in patients with early recurrent (stage Ⅰ+ Ⅱ) were compared. Results: A total of 265 cases were suspected as having recurrent lesions by endoscopy in WL mode and 68 cases of them were pathologically diagnosed as having NPC; and 82 cases were suspected as having recurrent lesions by endoscopy in NBI mode and 74 cases of them were pathologically diagnosed as having NPC. The sensitivity, specificity, accuracy and Yonden′s index of WL mode were 91.89%, 0, 25.09% and -0.0811, respectively, with a kappa of -0.045; the sensitivity, specificity, accuracy and Yonden′s index of NBI mode were 100.00%, 95.94%, 97.05% and 0.9594, respectively. Conclusion NBI has higher sensitivity, specificity, early diagnosis rate and Yonden′s index than WL.

Objective To explore the immune mechanism of negative results of immune tests of schistosomiasis japonica pa?tients. Methods Totally 142 schistosomiasis patients(positive stool examinations)of Poyang Lake region were tested by ELI?SA method,and the ROC curve was applied to determine the high and low response of the patients. The levels of cellular immu?nity and cytokines of high and low responders were compared. Results Totally eight schistosomiasis patients were found as low responders. Besides SWAP?IgA(t= -1.588,P > 0.1),the levels of isotype antibodies were significantly lower in the low re?sponders compared with those in the high responders(t = -14.517 to -2.866,all P < 0.05). In the low responders,the propor?tion of CD3+T was increased;and the proportions of CD4+T,CD8+T,CD4+CD25+Treg,and the ratio of CD4+/CD8+ were all de?creased,but all of them were not significant(t = -1.72 to 0.974,all P > 0.05)compared with those in the high responders. The differences of IFN?γ and IL?10 between the high and low responders were both not significant(t= -2.426 to 0.216,all P >0.05). Conclusions There is a significant difference between the high and low responders only in the levels of isotype antibod?ies. One of the reasons of low response in the immune tests is the much lower antibody level after the antigen?antibody compound is completely formulated.