OBJECTIVE To provide reference for optimizing or formulating unified evaluation methods for evidence and recommendation in expert consensus on off-label use of drugs. METHODS Retrieved from CNKI， Wanfang data， VIP， CBM， PubMed and Web of Science， Chinese expert consensuses on off-label use of drugs involving evaluation methods for evidence and recommendations were collected from the inception to August 1， 2024. After screening the literature and extracting relevant data， descriptive statistical analysis was conducted. RESULTS & CONCLUSIONS Among the 32 articles included， 14 articles （43.8%） used Micromedex’s Thomson grading system， only 7 articles （21.9%） considered economic factors when forming recommendations， 10 articles （31.3%） reported the conflicts of interest； only 2 articles （6.3%） involved experts in the field of evidence-based medicine methodology. There were differences in the sources of evidence， factors considered in forming recommendations， and the grading standards for evidence and recommendations among different expert consensus evidence evaluation methods. There were also differences in evidence levels and recommendation strength of the same drug off-label use in different expert consensus. It is recommended that in future consensus-building processes， greater attention should be paid to potential conflicts of interest among participants， collaboration with methodological experts should be enhanced， and efforts should be expedited to establish unified standards for evaluating evidence and recommendation methodologies.

Animal experiments are essential tools in biomedical research, serving as a bridge between basic research and clinical trials. Systematic reviews and meta-analyses (SRs/MAs) of animal experiments are crucial methods for integrating evidence from animal experiment, which can facilitate the translation of findings into clinical research, reduce translational risks, and promote resource integration in basic research. With the continuous development of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology, its application in SRs/MAs of animal experiments has gained increasing attention. This article first outlines the principles and specific applications of the GRADE methodology in SRs/MAs of animal experiments, including qualitative descriptive systematic reviews, meta-analyses, and network meta-analyses. It then deeply analyzes the misuse of the GRADE methodology in practice, including incorrect evidence grading, improper classification of evidence, misapplication in qualitative systematic reviews, inconsistencies between the documentation of the upgrading and downgrading process and results, and inappropriate use for making recommendations. Furthermore, this article comprehensively discusses the factors influencing the grading of evidence certainty in SRs/MAs of animal experiments, including the impact of bias risk, indirectness, inconsistency, imprecision, and publication bias on evidence downgrading, as well as the role of large effect sizes and cross-species consistency in evidence upgrading. Finally, in response to the issues discussed, improvement strategies are proposed, including further research and optimization of the GRADE methodology for SRs/MAs of animal experiments, the development of reporting guidelines tailored to the characteristics of SRs/MAs in animal experiment research, and enhanced professional training for researchers in the GRADE methodology. This article aims to improve the quality of evidence in SRs/MAs of animal experiments, strengthen their reliability in clinical decision-making, and promote the more efficient translation of findings from animal experiment research into clinical practice.

OBJECTIVE To explore the effect of superoxide dismutase （SOD） administration on the malignant behavior of PLC/PRF/5 liver cancer cells， and analyze the correlation between SOD and alpha-fetoprotein （AFP） expression， to provide new ideas for targeting AFP with SOD as a drug for hepatocellular carcinoma. METHODS Normal human liver cells L-02， AFP- negative human liver cancer cells HLE， and AFP-positive human liver cancer cells PLC/PRF/5 were used as experimental cells. Western blot assay and SOD activity detection kit were used to detect the expression of AFP， SOD and activity of SOD in cells before and after changing AFP expression； the effects of different concentrations of SOD [0 （control）， 0.188， 0.375， 0.75， 1.5， 3 U/mL] administration on the migration and proliferation of PLC/PRF/5 cells were detected using cell scratch assay and CCK-8 assay. The effects of SOD overexpression on the expression of malignant biological behavior-related proteins AFP and sarcoma virus protein （Src） in PLC/PRF/5 cells were detected using Western blot. RESULTS Compared with L-02 group and HLE group， the expression levels of SOD1 and SOD2， and SOD activity in PLC/PRF/5 cells were significantly reduced （P＜0.05）. After down-regulating AFP expression in PLC/PRF/ 5 cells， compared with PLC/PRF/5 group， the expression levels of SOD1 and SOD2， as well as SOD activity， were significantly increased in the PLC/PRF/5-shAFP group （low-expression） （P＜0.05）. After 48 hours of SOD treatment， compared with control group， the scratch healing rates of PLC/PRF/5 cells in the 0.375， 0.75， 1.5 and 3 U/mL SOD groups were significantly reduced （P＜0.05）； after 72 hours of SOD treatment， compared with control group， the scratch healing rates of PLC/PRF/5 cells in the 0.375， 0.75， and 1.5 U/mL SOD groups were significantly reduced （P＜0.05 or P＜0.01）. Compared with control group， proliferation rates of PLC/PRF/5 cells were significantly reduced in the 0.375， 0.75， 1.5 and 3 U/mL SOD groups （P＜0.05 or P＜0.01）. Compared with the PLC/PRF/5 group before up-regulating SOD1 and SOD2 expression， the expression levels of AFP and Src in the PLC/PRF/5-oeSOD1 and PLC/PRF/5-oeSOD2 groups （over-expression） after up-regulating SOD1 and SOD2 expression were significantly reduced （P＜0.05）. CONCLUSIONS A certain concentration of SOD can inhibit malignant behavior such as migration and proliferation of PLC/PRF/5 cells， and the expression level and activity of SOD are negatively correlated with AFP.

At present, there is no effective drug treatment for obstructive sleep apnea hypopnea syndrome (OSAHS). It is usually treated by mechanical ventilation through a ventilator. In this paper, a non-invasive bi-level breathing therapy system suitable for home scenarios is developed. The system supports single-level and bi-level positive airway pressure therapies, and introduces the function of inspiratory synchronous trigger based on flow monitoring to enhance the synchrony of patient-ventilator synchronization. The test results show that the performance indicators of the system meet expectations. Each ventilation mode can operate normally and can meet the requirements for the use of home non-invasive ventilators.
Humans ; Sleep Apnea, Obstructive/therapy* ; Equipment Design ; Noninvasive Ventilation/instrumentation* ; Respiration, Artificial

Objective To conduct preliminary evaluation of the reliability and safety of pancreatic duct-to-jejunum stent-bridging internal drainage as a supplementary approach to pancreaticojejunostomy in central pancreatectomy.Methods The clinical data of 28 patients who underwent robotic central pancreatectomy performed by our team between January 2021 and November 2024 were retrospectively collected,and and follow-up of postoperative endocrine and exocrine functions was performed.Based on the methods of digestive tract reconstruction adopted,the patients were divided into a conventional pancreaticojejunostomy group and a pancreatic duct-to-jejunum stent-bridging internal drainage group(PancreaticoJejunal-Stent bridge group).The operative time,digestive tract reconstruction time,and short-term complications were compared between the two groups.Results Among patients undergoing robotic central pancreatectomy,the digestive tract reconstruction time was shorter(t=5.168,P<0.001)in the PancreaticoJejunal-Stent bridge group([31.1±6.3]min)than that in the conventional pancreaticojejunostomy group([49.7±8.9]min)(t=5.168,P<0.001).The total operative time was(172.7±64.6)min in the PancreaticoJejunal-Stent bridge group and(200.1±52.7)min in the conventional pancreaticojejunostomy group,showing no statistically significant difference(t=1.215,P=0.235).In the PancreaticoJejunal-Stent bridge group,one patient developed a postoperative biochemical fistula,and 14 patients developed grade B pancreatic fistulas.Among the 14 patients with grade B pancreatic fistulas,1 case was complicated by fistula-related intra-abdominal infection,and 13 cases had drainage tube retention time of more than 21 days.In the conventional pancreaticojejunostomy group,2 patients developed postoperative biochemical fistulas,and 11 patients developed grade B pancreatic fistulas.Among the 11 patients with grade B pancreatic fistulas,1 case was complicated by fistula-related intra-abdominal infection,and 1 case was complicated by fistula-related intra-abdominal bleeding and infection.No postoperative gastroparesis,pancreatitis,or grade C pancreatic fistulas occurred in either group.There were no statistically significant differences between the two groups in overall postoperative complication rate(P=0.522),postoperative pancreatic fistula rate(P=0.583),intra-abdominal infection rate(P=0.583),or bleeding rate(P=0.464).Conclusion Pancreatic duct-to-jejunum stent-bridging internal drainage optimizes the anastomosis between the distal end of the pancreas and the jejunum during central pancreatectomy,shortens digestive tract reconstruction time,and reduces surgical complexity without increasing the risk of short-term severe postoperative complications.This approach is safe and feasible.

Objective To investigate the food allergy situation of children in Changping District of Beijing,and to explore the influence of allergic family history,gender and mode of delivery on food allergy in children,the distribution of food allergy in different age groups,the types of food allergy that are easy to cause in this area,and the comorbidities of food allergy.Methods A total of 515 children aged 0 to 14 years who were admitted to the general pediatric outpatient and emergency department and inpatient of Beijing Changping Hospital from April to November 2023.Using immunoblotting to detect specific immunoglobulin E in the serum of pediatric patients,and using SPSS 26.0 statistical software to perform binomial tests on gender and delivery mode non parameters;Using custom Excel functions to statistically analyze the family history of allergies,the number of people in different age groups,and the frequency of allergic foods in each group;Use a self-made mini program to statistically analyze the combination of comorbid allergic diseases.Results ① The number of male children with food allergies(306 cases)was higher than that of female children(209 cases),and the difference was statistically significant(P＜0.05).(2)There were 109 cases of pediatric patients with parents who had no history of allergic diseases,accounting for 21.17％of the total cases;There were a total of 406 cases where at least one parent had a family history of allergies,accounting for 78.83％of the total cases.Among them,228 cases(44.27％)had one parent with a history of allergies,and 178 cases(34.56％)had both parents with a history of allergies.③ Among 515 children with positive food allergens,there were 10 cases(1.94％)in infancy,37 cases(7.19％)in early childhood,235 cases(45.63％)in preschool,192 cases(37.28％)in school age,and 41 cases(7.96％)in adolescence.The highest positivity rate for food allergens is in milk(444 times),followed by egg white(70 times),cashew nuts(57 times),crab(37 times),beef(26 times),mango(24 times),shrimp(21 times),pineapple(6 times),and shellfish(1 time).Milk protein is the most common allergen in all age groups.(4)Among 515 children with food allergies,399 cases were single food allergies,accounting for 77.47％;116 cases of multiple food allergies(2 or more types of food allergies),accounting for 22.53％.⑤ The most common comorbidity of food allergies is food allergy related gastrointestinal diseases combined with allergic rhinitis,with a total of 267 cases;Secondly,there were 192 cases of allergic rhinitis combined with chronic cough,and 124 cases of food allergy related gastrointestinal diseases combined with chronic cough.Conclusion Milk is the main allergen of food allergy in people of age 14 and under,and gastrointestinal symptoms are the most common in children with food allergy.

Objective To investigate the effect of intrarectal local anesthesia (IRLA) with heated oxybuprocaine gel on pain during transrectal ultrasound guided prostate biopsy (TRUSPB).Methods A total of 150 cases patients who underwent TRUSPB in Huzhou Central Hospital from January to June 2023 were prospectively taken into.The patients were randomly divided into group A (routine group),group B (oxybuprocaine gel for IRLA at room temperature) and group C (oxybuprocaine gel for IRLA at 40℃),with 50 cases in each group.Nurses who were unaware of the anesthesia type used visual analog scale (VAS) to score the pain level of patients at each stage (VAS Ⅰ:when the ultrasound probe was inserted into the rectum;VAS Ⅱ:during the biopsy;VAS Ⅲ:30 minutes after biopsy),and the incidence of complications after biopsy were compared.Results The VAS Ⅱ score of group C was lower than that of group A and group B,and the difference was statistically significant (P<0.05).There was no statistically significant difference (P>0.05) in the VAS Ⅰ,VAS Ⅲ scores,and incidence of complications after biopsy among the three groups.There was no allergic reaction to oxybuprocaine gel.Conclusion In TRUSPB,IRLA with heated oxybuprocaine gel can effectively control pain without increasing incidence of complications.

Objective To summarize the current research status and cutting-edge trends of the off-label drug use in China,with a view to providing reference for researchers in this field.Methods CNKI and SinoMed databases were searched to collect research of the off-label drug use in China,and used Microsoft Excel 2021,the R software Bibliometric,and VOSviewer 1.6.18 to visualize the time and trend of publication,province,issuing authors and units,journals,keywords,and topic evolution of the included studies.Results 1 475 papers were included in the research.A total of 2 808 authors from 31 provinces,cities and regions had conducted relevant studies on over-the-counter medication,with an overall increasing trend in the number of publications.Among them,Guangdong province published the most studies related to this field,the Straits Pharmacy Journal and China Pharmacy published the most studies in this field.Proprietary Chinese medicines,antimicrobials,antitumor drugs,and other drugs were the research hotspots.In addition,the patients in pediatrics,outpatient emergency,obstetrics and gynecology,psychiatry and other departments as a special sick population,the clinical use of medication exists in the overspecification situation was also a future research trend.Conclusion At present,research in this field focuses more on OLDU for special populations,special diseases,special drugs,etc.In the future,researchers should conduct evidence-based evaluation of drugs on the basis of more high-quality evidence in order to seek the best evidence for guiding the clinical use of medication.At the same time,drug administration and medical institutions should also develop standardized management policies and systems to promote the rational and safe use of medication in healthcare institutions.

Objective To explore the effect of high-intensity ultrasound focused ablation in the treatment of ⅡB cesarean scar Pregnancy.Methods A total of 365 patients in our hospital from January 2019 to December 2021 which were ⅡB Cesarean Scar Pregnancy were selected as the research objects.The research objects were divided into the experimental group pretreated by high-intensity ultrasound ablation(186 cases)and the control group without treatment(179 cases)to compare the levels of intraoperative blood loss,postoperative vaginal bleeding time,human chorionic gonadotropin(HCG)decline rate after the operation,success rate of operation and other indicators.Results The amount of intraoperative blood loss and postoperative vaginal bleeding time in the experimental group were less than those in the control group(P<0.05),and the decrease rate of blood HCG in the experimental group was higher than that in the control group(P<0.05).There was significant difference in the success rate of operation between the experimental group and the control group(P<0.05).There was no significant difference in menstrual volume between the experimental group and the control group(P>0.05),but the control group had prolonged menstruation,and the incidence of postoperative complications between the experimental group and the control group have no statistical significance.Conclusion High-intensity focused ultrasound ablation can effectively reduce intraoperative blood loss in patients of type ⅡB cesarean scar pregnancy,reduce the application of invasive methods such as laparoscopy,can be promoted as a pretreatment method for type ⅡB cesarean scar pregnancy.