The assessment of adverse drug events is an important basis for clinical safety evaluation and post-marketing risk control of drugs,and its causality assessment is gaining increasing attention.The existing methods for assessing the causal relationship between drugs and the occurrence of adverse reactions can be broadly classified into three categories:global introspective methods,standardized methods,and probabilistic methods.At present,there is no systematic introduction of the operational details of the various methods in the domestic literature.This paper compares representative causality assessment methods in terms of definition and concept,methodological steps,industry evaluation and advantages and disadvantages,clarifies the basic process of determining the causality of adverse drug reactions,and discusses how to further improve the adverse drug reaction monitoring and evaluation system,with a view to providing a reference for drug development and pharmacovigilance work in China.

BackgroundMajor depressive disorder is one of the most disabling mental diseases. Currently， medication in combination with physiotherapy and psychotherapy remains the most commonly used treatment modality for the disease， whereas only a few randomized controlled studies have been conducted on physiotherapy， and even fewer studies have focused on medication combined with physiotherapy. ObjectiveTo explore the efficacy and safety profile of repetitive transcranial magnetic stimulation （rTMS） versus modified electroconvulsive therapy （MECT） in combination with antidepressants in the treatment of major depressive disorder， so as to provide an optimized treatment plan for patients with major depressive disorder. MethodsPatients with major depressive disorder （n=335） hospitalized in Shandong Daizhuang Hospital from January 1， 2019 to April 30， 2023 were included， all of whom met the diagnostic criteria of the International Classification of Diseases， tenth edition （ICD-10）. Depending on their disease condition， patients were subjected to either MECT in combination with drugs （n=141） or rTMS in combination with drugs （n=194） after admission. Depressive symptoms were assessed using Hamilton Depression Scale-24 item （HAMD-24） at the baseline and the end of the 1^st， 2^nd， 3^rd and 4^th week of treatment， and the adverse reactions were documented in patient's medical records. ResultsAnalysis of variance on HAMD-24 revealed a significant effect of time （F=3.081， P=0.042）， but no effect of group （F=1.023， P=0.313）， and the interaction effect between the time and the groups was not statistically significant （F=1.642， P=0.191）. No statistical difference was reported between two groups in response rate and full remission rate （P>0.05）. Throughout the course of treatment， 58 cases （41.13%） of recent memory impairment and 74 cases （52.48%） of headache or neck muscle pain occurred in MECT combined with drugs group， and 27 cases （13.92%） in rTMS combined with drugs group experienced headache or head skin discomfort. ConclusionAntidepressants in combination with rTMS or MECT show equivalent efficacy in the treatment of major depressive disorder， while rTMS combined with antidepressants demonstrates a superior safety profile compared to MECT.

BACKGROUND:The landing error scoring system test is a standard for assessing the risk of non-contact injuries and has not yet been developed for Chinese college soccer programs. OBJECTIVE:To establish a test evaluation standard for the landing error scoring system to provide a basis for evaluating the risk of non-contact injuries in college soccer students. METHODS:A prospective cohort study was designed in which 219 athletes from 10 college soccer teams were tested with the standard landing error scoring system,and the subjects were followed up by questionnaires and medical examinations for non-contact injuries of the lower extremities and trunk for 1 year after testing to determine sex differences and assessment criteria for the landing error scoring system test indicators. RESULTS AND CONCLUSION:The total score of the landing error scoring system was(8.22±1.65)points for 219 subjects,(8.29±1.74)for males and(8.07±1.44)for females,with no significant difference between males and females(P>0.05).Within 1 year after the test,the overall injury rate of 219 subjects was 10.05%and the morbidity rate was 15.98%;the injury rate of male subjects with non-contact injury of the lower limbs and trunk was 12.75%and the morbidity rate was 20.13%;the injury rate of female subjects with non-contact injury of the lower limbs and trunk was 4.29%and the morbidity rate was 7.14%.There were no significant differences in the injury rate between men and women(P<0.05).The total score of the landing error scoring system was higher in the injury group than in the non-injury group[(9.50±1.14)vs.(8.08±1.64),P<0.01];for male subjects,the total score of the landing error scoring system was higher in the injury group than in the non-injury group[(9.63±1.12)vs.(8.09±1.73),P<0.01].The area under the curve for the total score of the landing error scoring system was 0.773(P=0.000),which had a diagnostic value for the risk of non-contact injury of the lower extremities and trunk in male subjects,with a best cut-off point of 8.5,sensitivity of 0.842,specificity of 0.623,positive likelihood ratio of 2.233,negative likelihood ratio of 0.254,relative risk factor of 8.400,and odds ratio of 8.816;the total score of the landing error scoring system was not applicable for assessing the risk of non-contact injury of the lower extremities and trunk in female subjects.To conclude,the landing error scoring system test can be used as a criterion to assess the risk of non-contact injury to the lower extremity and trunk in Chinese college male soccer players,with an optimal cut-off point of 8.5.The risk of non-contact injury to the lower extremity and trunk is 8.40 times higher in male athletes with a landing error scoring system test score of≥8.5 than in male athletes with a score of<8.5.

Objective:To explore the research hotspots and effective promotion paths of post market surveillance and supervise of medical consumables with non-active medical devices.Methods:Data mining methods were used to collect related journal literatures and documents from the websites of China regulatory institutions and the China National Knowledge Infrastructure(CNKI),order sub item data of medical device adverse event reports,extract the MeSH element words of literatures and documents,perform bibliometric analysis and visual display.Results:The number of medical devices adverse event reports in China has been increasing year by year,reaching 694 866 in 2022,in the four statistical years from 2019 to 2022,the number of reports on non-active medical devices and IVD reagents also showed a parallel increasing trend,accounting for about 65.00% of the total number of adverse event reports on medical devices in the year.The bibliometric analysis of journal literature shows that research in this field has received varying degrees of participation from regulatory institutions,universities,medical institutions,and enterprises.Regulatory institutions have contributed 46 articles,accounting for 56.79% of the total number of articles,followed by 28 articles from universities.The co-occurrence analysis shows that hot topic is focused in 5 clusters:quality management,risk management,international experiences discussion and adverse event surveillance and re-evaluation and real-world research.China regulatory institutions attach great importance to post market surveillance and supervise,and have issued more than 20 relevant documents since 2006,focusing on specific topics and gradually deepening around safety and effectiveness.Conclusion:The post market surveillance and supervise of medical devices,especially medical consumables based on non-active medical devices,need to be promoted synchronously in three dimensions:regulatory institutions,medical institutions,and enterprises.Universities,research institutes,and industry organizations should work in coordinating to strengthen the collection,identification,and active surveillance of risk signals based on adverse event surveillance,safety evaluation based on risk management,and conducting real-world research,research and develop risk control and corrective and preventive measures.

Objective To investigate the effect of varying ureteral wall thickness(UWT)at the site of ureteral stones on the clinical efficacy of ureteroscopic lithotripsy(URL).Methods The clinical data of 164 patients with ureteral stones in our hospital were retrospectively analyzed.According to different UWT,the patients were divided into the mild thickening group(84 cases,UWT<3.16 mm),the moderate thickening group(31 cases,UWT 3.16 to 3.49 mm),and the severe thickening group(49 cases,UWT>3.49 mm),and the differences of clinical related indicators among the three groups were compared.Results The incidence of postoperative renal colic and leukocyte disorder in the mild thickening group and the moderate thickening group were lower than those in the severe thickening group,and the differences were statistically significant(P<0.05).The postoperative catheterization time in the mild thickening group and the moderate thickening group were shorter than that in the severe thickening group,and the incidences of secondary lithotripsy,residual stones and stone return to kidney in the mild thickening group and the moderate thickening group were lower than those in the severe thickening group,with statistically significant differences(P<0.05).The length of hospital stay and hospitalization cost in the mild thickening group and the moderate thickening group were shorter/less than those in the severe thickening group,with statistically significant differences(P<0.05).Conclusion With the increase of UWT(especially when UWT>3.49 mm),the incidence of postoperative complications and hospitalization cost of URL increase to varying degrees,and the surgical efficacy decreases.In clinical work,UWT measurement holds potential value in predicting the surgical efficacy and complications of URL.

Objective To study the anti-reflux effect of conical gastric stump embedding in radical resection of esophageal cancer.Methods A total of 60 patients who planned to undergo radical resection of esophageal cancer in our hospital from June 2020 to June 2022 were selected as the study objects,and the patients were divided into the observation group and the control group by random number table method,with 30 cases in each group.Patients in both groups underwent laparoscopic radical resection of esophageal cancer and esophagogastric end-to-side mechanical anastomosis.The observation group adopted the conical gastric stump embedding technique after esophagogastric end-to-side mechanical anastomosis.The perioperative related indexes,postoperative complications and gastroesophageal reflux of patients in the two groups were compared.The postoperative anti-reflux effect was evaluated by reflux disease questionnaire(RDQ)score and 24-hour intraesophageal pH monitoring.Results The operation time and digestive tract reconstruction time of patients in the observation group were longer than those in the control group(P<0.05),while there was no statistically significant difference in the amount of intraoperative bleeding,the number of lymph node dissection,the first exhaust time,or the postoperative hospital stay of patients between the two groups(P>0.05).There was no statistically significant difference in the overall incidence of postoperative complications between the two groups(P>0.05).The severity of postoperative gastroesophageal reflux of patients in the observation group was lighter than that in the control group,and the difference was statistically significant(P<0.05).The RDQ score,24-hour reflux frequency,>5 minutes reflux frequency,pH<4 time,and longest reflux time of patients in the observation group was significantly lower/less/shorter than those in the control group(P<0.05).Conclusion The conical gastric stump embedding technique is safe and feasible in the radical resection of esophageal cancer.Although the operation time and digestive tract reconstruction time are slightly prolonged,it does not increase the perioperative risks,which can significantly reduce the occurrence and severity of postoperative gastroesophageal reflux of patients,and achieve a good anti-reflux effect.

Sucrose synthase plays a crucial role in the plant sugar metabolism pathway by catalyzing the production of uridine diphosphate (UDP)-glucose, which serves as a bioactive glycosyl donor for various metabolic processes. In this study, a sucrose synthase gene named CtSus was cloned from Cistanche tubulosa, a traditional Chinese medicine known for its rich content of diverse glycosides, based on transcriptome analysis results. The open reading frame of CtSus was 2 418 bp long encoding 805 amino acids. Sequence analysis revealed conserved domains associated with the plant sucrose synthase family at both the N-terminal and C-terminal regions of CtSus protein. Phylogenetic analysis demonstrated that CtSus shares a close evolutionary relationship with sucrose synthases from other plants within the same order. Functional identification of CtSus was performed through whole-cell catalysis coupling with UGT71BD1, a characterized glycosyltransferase enzyme. The results showed that the introduction of CtSus significantly enhanced the conversion rate of glycosylation catalyzed by UGT71BD1. The soluble expression of CtSus in Escherichia coli was further achieved using the pCold^TM TF expression vector. In vitro enzymatic assay indicated the activity of CtSus to catalyze the formation of UDP-glucose in the presence of sucrose and UDP. Real-time quantitative-polymerase chain reaction results showed that the expression patterns of CtSus gene in different parts of C. tubulosa and the suspension cell cultures of C. tubulosa under drought stress correlated with the accumulation patterns observed for phenylethanol glycosides, respectively. Furthermore, key amino acids and their interactions between enzyme and substrate were explored based on protein structure prediction and molecular docking results. Overall, our findings identify a sucrose synthase CtSus responsible for the supply of the active glycosyl donor UDP-glucose during the biosynthesis of glycoside products in C. tubulosa and have also provided a gene element that can be utilized in engineering strain construction for glycoside products production.

OBJECTIVE: To investigate the effectiveness of percutaneous pedicle screw fixation combined expandable tubular retractor in the treatment of patients with spinal metastases. METHODS: In the study, 12 patients of spinal metastases treated with percutaneous pedicle screw fixation combined expandable tubular retractor in our hospital were retrospectively reviewed between June 2017 and October 2019. Among the 12 patients, 9 were males and 3 were females; the median age was 62.5 years [(65.1±2.9) years]. The decompression segment of 7 patients was located at the lower thoracic spine (including 1 patient with incomplete paraplegia) and the decompression segment of 5 patients was located at the lumbar spine; Tomita score was 6.0±0.6. Perioperative data of the patients were reviewed. Visual analog scale (VAS score), Karnofsky score, and Eastern Cooperative Oncology Group (ECOG) score were compared before and after surgery. The patient's survival, adjuvant treatment, and internal fixation failure were observed in the follow-up period. RESULTS: All the 12 patients had a successful operation with percuta-neous pedicle screw fixation combined expandable tubular retractor. The average operative time, blood loss, and blood transfused of the patients were (247.0±14.6) min, (804.2±222.3) mL and (500.0±100.0) mL, respectively. The average amount of drainage was (240.8±79.3) mL. Drainage tubes were pulled out early postoperative [(3.2±0.3) d], allowing early mobilization. The patients discharged (7.8±0.8) d postoperative. All the patients were followed up for 6-30 months, and the average overall survival time was (13.6±2.4) months. During the follow-up period, 2 patients experienced screw displacement, the internal fixation was stable after conservative treatment and no revision surgery was performed. The VAS of the patients was 7.1±0.2 before surgery, which decreased to 2.3±0.1 and 2.8±0.4 at 3 and 6 months after surgery (P < 0.05). The Karnofsky score of the patients was 59.2±1.9 before surgery, which increased to 75.0±1.9 and 74.2±3.1 at 3 and 6 months after surgery (P < 0.05). The ECOG of the patients was 2.3±0.2 before surgery, which decreased to 1.7±0.1 and 1.7±0.2 at 3 and 6 months after surgery (P < 0.05). CONCLUSION For selected patients with spinal metastases, minimally invasive surgical treatment of spinal metastases (percutaneous pedicle screw internal fixation combined with expandable tubular retractor) can effectively relieve the clinical symptoms and improve the quality of life, with satisfactory clinical outcome.
Male ; Female ; Humans ; Middle Aged ; Pedicle Screws ; Treatment Outcome ; Spinal Neoplasms/surgery* ; Quality of Life ; Retrospective Studies ; Fracture Fixation, Internal ; Lumbar Vertebrae/surgery* ; Thoracic Vertebrae/surgery* ; Spinal Fusion ; Spinal Fractures/surgery*

Hip fracture is considered as the most severe osteoporotic fracture characterized by high disability and mortality in the elderly. Improved surgical techniques and multidisciplinary team play an active role in alleviating prognosis, which places higher demands on perioperative nursing. Dysfunction, complications, and secondary impact of anaesthesia and surgery add more difficulties to clinical nursing. Besides, there still lack clinical practices in perioperative nursing for elderly patients with hip fracture in China. In this context, led by the Orthopedic Nursing Committee of Chinese Nursing Association, the Expert consensus on clinical practice in perioperative nursing for elderly patients with hip fracture ( version 2023) is developed based on the evidence-based medicine. This consensus provides 11 recommendations on elderly patients with hip fracture from aspects of perioperative health education, condition monitoring and inspection, complication risk assessment and prevention, and rehabilitation, in order to provide guiding advices for clinical practice, improve the quality of nursing and ameliorate the prognosis of elderly patients with hip fracture.

Objective:To investigate the phylogenetic and antigenic characteristics of hemagglutinin (HA) gene of influenza B/Victoria lineage (BV) viruses in Beijing during the 2021-2022 influenza surveillance season, and to analyze whether the circulating BV viruses match the vaccine strain.Methods:Pharyngeal swab specimens from influenza like-illness (ILI) cases in the 2021-2022 influenza surveillance season were collected from surveillance network labs in Beijing and cultured in MDCK cells and chicken embryo to isolate BV viruses. Nucleic acids of the viruses were extracted, and the HA gene was amplified and sequenced. The nucleotide and amino acid sequence identity of the HA gene was analyzed using MEGA5.0 software. A phylogenetic tree of HA gene was constructed using the maximum likelihood method. The N-glycosylation sites in HA were predicted online. Three-dimensional structure of HA was constructed using SWISS-MODEL homologous modeling. Hemagglutination inhibition (HI) test was performed to analyze the antigenicity of BV viruses.Results:A total of 402 BV viruses were collected and 58 strains with full-length HA gene sequences were chosen for further analysis. Compared with the HA gene of this year′s vaccine strain (B/Washington/02/2019), there were 27 amino acid mutations, 11 of which were located in four different antigenic determinants. The phylogenetic analysis revealed that three subgroups of 1A.3, 1A.3a1, and 1A.3a2 co-circulated in Beijing with 54 strains (54/58, 93.10%) clustered to the Clade 1A.3a2, two strains (2/58, 3.45%) clustered to the Clade 1A.3a1, and two strains (2/58, 3.45%) in the same subgroup (Clade 1A.3) as the vaccine component BV strain in 2021-2022. Compared with the vaccine strain (B/Washington/02/2019), two BV strains had an additional N-glycosylation site at residue 197, while the other 56 strains showed no change in N-glycosylation sites. Antigenic analysis showed that 35 BV strains (35/58, 60.34%) were antigenically similar to the vaccine strain and 23 strains (23/58, 39.66%) were low-response strains.Conclusions:Three subgroups of BV viruses co-circulated in Beijing during the 2021-2022 influenza surveillance season. The predominant subgroup was Clade 1A.3a2 (93.10%), showing a certain genetic distance with the vaccine strain (B/Washington/02/2019). Nearly 40% (39.66%) of the viruses were low-response strains. This study indicated that continuous monitoring of the variations of influenza epidemic strains and timely providing laboratory basis for screening vaccine component strains were the basic technical guarantee for coping with influenza pandemic.