OBJECTIVE To provide a reference for improving the drug patent linkage system. METHODS Data on drug names， drug types， abbreviated new drug application （ANDA） acceptance numbers， registration classifications， and applicant names were obtained from the patent certifications and patent information disclosure modules of China’s patent information registration platform for marketed drugs. The data collection period was from July 4， 2021， to September 30， 2023. The analysis focused on the annual distribution of patent certifications for the ANDA varieties included in the statistics， the proportion of different registration classifications， the details of the type Ⅳ certifications， the remaining validity periods of the corresponding patents for the type Ⅲ certifications， and the number of manufacturers for the same variety. RESULTS Among the ANDA varieties analyzed， type Ⅰ certifications predominated （accounting for 86.53%）， while types Ⅱ， Ⅲ and Ⅳ certifications each accounted for approximately 4% to 5%. In the three registration classifications， type Ⅰ certifications in registration classification 3 accounted for as high as 98.55%， and in registration classification 4， type Ⅰ certifications accounted for 79.65%， while types Ⅱ， Ⅲ and Ⅳ certifications each accounted for around 7%. In terms of the detailed type of the Ⅳ certifications， type Ⅳ of article 2 certifications had a large proportion （79.23%） and showed a slight upward trend， whereas the challenges of type Ⅳ of article 1 certifications were few. The remaining validity period of the patents corresponding to type Ⅲ certifications was excessively long， with a median of 18 months. The proportion of the same variety with fewer than 5 manufacturers was 36.44%， while those with more than or equal to 20 manufacturers accounted for 14.75%. CONCLUSIONS The ANDA system in China has been orderly integrated with the drug patent linkage system in practice. It is recommended to optimize aspects such as patent certifications registration and objection mechanisms， the effective approval dates for ANDA with type Ⅲ certifications， and incentive measures for type Ⅳ of article 1 certifications， thereby further standardizing the ANDA process and guiding the high-quality development of generic drugs.

AIM:To analyze the occurrence and clinical characteristics of adverse drug reactions(ADR)induced by four programmed cell death pro-tein 1(PD-1)inhibitors according to literature re-ports,and to provide reference for clinical safe medication.METHODS:PubMed,CNKI,and Wan-fang,and other databases were searched to collect case reports of adverse reactions caused by four PD-1 inhibitors,including camrelizumab,sintilimab,toripalimab,and tislelizumab.RESULTS:A total of 105 eligible literature reports were retrieved from the databases at home and abroad(as of June 1,2022),including 42 reports on camrelizumab with 47 patients,29 reports on sintilimab with 30 pa-tients,21 reports on toripalimab with 24 patients and 13 reports on tislelizumab with 15 patients.Among them,there were 76 males(65.5％)and 40 females(34.5％),with a gender ratio of 1.9:1.0.The age range was between 29 to 84 years old,and the onset of ADR mainly occurred within 4 months af-ter the first use of PD-1 inhibitors.Immune-related adverse reactions were mainly manifested as skin and its attachment(41 cases,34.5％),endocrine sys-tem(25 cases,21.0％),and cardiovascular system(22 cases,18.5％).Most patients improved after symptomatic and supportive treatment.CONCLU-SION:Immune-related adverse effects(irAEs)may occur at any time during treatment with the four PD-1 inhibitors,among these the skin system is most frequently affected,followed by the cardiovas-cular and endocrine systems.This suggests the im-portance of individualized drug administration and stringent control over indications in clinical prac-tice.Close monitoring throughout immunotherapy is essential to minimize or prevent irAEs,thus en-suring patient safety in medication usage.

Objective:To compare the accuracy and efficacy of robot assisted and navigation assisted pedicle screw fixation.Methods:Retrospective analysis of 764 patients with lumbar spine disorders who underwent internal fixation treatment at the Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, from June 2017 to April 2023 were performed. They were divided into the Renaissance group (212 cases), the Tinavi group (301 cases), and the S8 navigation group (251 cases), according to the method of assisted placement of pedicle screws. The operation time, fluoroscopy time, X-ray radiation dose, intra-operative blood loss, accuracy of screw placement, screw revision rate, pain visual analogue scale (VAS), Oswestry disability index (ODI) and postoperative infection rate were compared among the three groups.Results:922 screws were placed in the Renaissance group, 1,260 screws in the Tinavi group, and 1,044 screws in the S8 navigation group. The accuracy of clinically acceptable pedicle screw placement was 92.08% (849/922), 99.68% (1,256/1,260), and 99.43% (1,038/1,044) in the three groups, respectively, with the Renaissance group being smaller than the Tinavi group and the S8 group (χ 2=90.334, P<0.001; χ 2=68.446, P<0.001), and the Tinavi group and the S8 group had no statistically significant difference (χ 2=0.380, P=0.537). The operation time of the three groups was 173.64±62.23 min, 177.11±60.85 min, 176.02±60.93 min, and the intraoperative blood loss was 118.16±58.26 ml, 121.84±55.91 ml, 123.62±59.84 ml, respectively, and the differences between the groups were not statistically significant ( P>0.05). The fluoroscopy time of the three groups was 8.73±2.92 s, 10.67±2.85 s, and 11.31±2.89 s, and the X-ray radiation doses were 18.83±7.41 μSv, 20.40±7.60 μSv, and 22.88±7.47 μSv, respectively, with statistically significant differences between the groups and the two comparisons ( P<0.05). All patients were given follow-up for 3-30 months. Three cases in the postoperative Renaissance group underwent screw revision for nerve root irritation due to screw penetration of the pedicle cortex, and none of the other two groups underwent screw revision. Postoperatively, one case in the Renaissance group and one case in the Tinavi group had superficial infections, which were cured after prolonged antibiotic use. At 3 months postoperatively, the VAS scores for leg pain in the Renaissance group, the Tinavi group, and the S8 navigation group were 3.52±1.14, 3.59±1.12, and 3.39±1.16, and the VAS scores for back pain were 3.54±1.14, 3.57±1.12, and 3.51±1.15, respectively; the ODI scores were 12.48%±4.53%, 12.01%±4.57%, and 12.28%±4.60%, and none of the differences between the groups were statistically significant ( P>0.05). Conclusion:The accuracy of screw placement by the Tinavi robot was comparable to that of the S8 navigation, and both were superior to that of the Renaissance robot; the fluoroscopy time and radiation dose of the Renaissance robot were smaller than those of the Tinavi robot, which was smaller than that of the S8 navigation. The early efficacy of robotics and navigation-assisted pedicle screw internal fixation for lumbar spine disorders is similar.

Objective:To evaluate the quality of critical patient handover practice between emergency room and intensive care unit (ICU) nurses, and to provide a basis for structured handover process.Methods:From March to July 2023, a total of 223 pairs of nurses in emergency room and ICU (including EICU) of 5 Class 3 Grade A general hospitals in Suzhou were selected as the research objects by using cross-sectional survey method and convenience sampling method. Self-designed general information questionnaire and Patient Handover Practice Quality Scale were used to investigate the included 223 pairs of nurses in emergency room and ICU on the current situation of handover time and quality.Results:A total of 211 pairs of nurses were included, including 286 females (67.8%) and 136 males (32.2%). The average age of emergency department nurses was (27.31 ± 2.17) years old, and ICU nurses was (26.96 ± 3.04) years old. The total scores of the patient handover practice Quality Scale for nurses in the emergency room and ICU were (45.25 ± 6.26) and (43.55 ± 7.19) points respectively, and the scores of the information transmission dimension were (20.47 ± 5.43) and (17.66 ± 3.45) points. The scores of common understanding dimension were (7.59 ± 2.31) and (8.58 ± 2.46) points. The scores of work atmosphere dimension were (7.93 ± 2.11) and (8.39 ± 2.29) points. The scores of handover situation dimension were (5.33 ± 1.30) and (5.70 ± 1.53) points, and the differences were statistically significant ( t values were - 6.35-4.22, all P<0.05). There were statistically significant differences in the scores of handover practice quality between emergency room nurses and ICU nurses according to specialization, education background, working years and job category ( t values were - 4.91-2.56, all P<0.05). Conclusions:Emergency room nurses and ICU nurses have different requirements and expectations for handover procedures, so it is necessary to build a structured handover practice framework and carry out personalized handover practice training, in order to achieve the consistency of handover content and improve the quality of critical patients handover practice.

Objective To analyze the relationships of carotid plaque characteristics and hemorheology with disease classification and severity in elderly patients with ischemic stroke. Methods A total of 240 elderly patients with ischemic stroke were selected as observation group, and were further divided into different groups based on disease classification [complete anterior circulation infarction (TACI), partial anterior circulation infarction (PACI), posterior circulation infarction (POCI), lacunar infarction (LACI)] and severity of the disease (mild, moderate, and severe); another 60 elderly healthy individuals with physical examinations were selected as control group. The characteristics of carotid artery plaques [carotid intima-media thickness (IMT), number of plaques, maximum length of plaques, and nature of plaques]as well as hemorheology indexes[erythrocyte sedimentation rate (ESR), hematocrit (HCT), plasma fibrinogen (Fib), plasma viscosity, and whole blood viscosity]were measured in all the cases, and the relationships of carotid plaque characteristics and hemorheology with disease classification and severity were analyzed. Results The IMT, the number of plaques, maximum diameter of plaques, ESR, HCT, Fib, plasma viscosity, and whole blood viscosity in the observation group were significantly higher than those in the control group (P < 0.05); the IMT, the number of plaques, and maximum diameter of plaques in the LACI group were significantly lower than those in the TACI, PACI, and POCI groups, while the ratios of stable plaques were significantly higher (P < 0.05); the ESR, HCT, Fib, plasma viscosity, and whole blood viscosity in the LACI group were significantly lower than those in the TACI, PACI, and POCI groups (P < 0.05); the IMT, the number of plaques, and maximum diameter of plaques in the mild group were significantly lower than those in the moderate and severe groups, the ratio of stable plaques was significantly higher than that in the moderate and severe groups, the IMT, the number of plaques, and maximum diameter of plaques in the moderate group were significantly lower than those in the severe group (P < 0.05); the ESR, HCT, Fib, plasma viscosity, and whole blood viscosity in the mild group were significantly lower than those in the moderate and severe groups, and the above indicators in the moderate group were significantly lower than those in the severe group (P < 0.05). Conclusion The characteristics of carotid artery plaques and hemorheology in elderly patients with ischemic stroke are related to the classification and severity of the disease, and the status of carotid artery plaques and hemorheological abnormalities in elderly patients with TACI, PACI, and POCI types of ischemic stroke are more severe than those of patients with LACI type.

Objective:To compare the clinical efficacies of O-arm combined with CT three-dimensional navigation system assisted screw placement versus manual screw placement in treating lower cervical fracture and dislocation.Methods:A retrospective cohort study was used to analyze the clinical data of 41 patients with lower cervical fracture and dislocation, who were treated in Honghui Hospital, Xi′an Jiaotong University from May 2021 to February 2022. The patients included 26 males and 15 females, aged 31.5-48.6 years [(41.5±15.0)years]. The injured segments were C 3 in 3 patients, C 4 in 12, C 5 in 13, C 6 in 10 and C 7 in 3. Nineteen patients were treated with cervical pedicle screws by O-shaped arm combined with CT three-dimensional navigation system (navigation group, 76 screws) and 22 by bare hands (traditional group, 88 screws). The total operation time, effective operation time, single nail placement time, single screw correction times, screw distance from anterior cortex, intraoperative blood loss, intraoperative fluoroscopic radiation dose, incision length and length of hospital stay were compared between the two groups, and the height of intervertebral space, Cobb angle, interbody slip distance and American Spinal injury Association (ASIA) grade were compared before operation and at 3 days after operation. Visual analogue score (VAS), Japanese Orthopedic Association (JOA) score, and neck dysfunction index (NDI) were evaluated before operation, at 3 days, 3 months after operation and at the last follow-up. Accuracy of screw placement and incidence of complications (adjacent facet joint invasion, infection, screw loosening) were detected as well. Results:All the patients were followed up for 11.1-13.9 months [(12.5±1.4)months]. The total operation time, intraoperative blood loss, intraoperative fluoroscopic radiation dose and incision length in the navigation group were more or longer than those in the traditional group (all P<0.05). The effective operation time, single nail placement time, single nail correction times and screw distance from anterior cortex in the navigation group were markedly less or smaller than those in the traditional group (all P<0.05). There was no significant difference in the length of hospital stay between the two groups ( P>0.05). There were significant improvements in the height of intervertebral space, Cobb angle and interbody slip distance between the two groups at 3 days after operation (all P<0.05). There was no significant difference in the height of intervertebral space, Cobb angle, interbody slip distance or ASIA grade between the two groups before operation or at 3 days after operation (all P>0.05). Compared with pre-operation, the VAS, JOA score and NDI were significantly improved in both groups at 3 days, 3 months after operation and at the last follow-up (all P<0.05), with further improvement with time. There was no significant difference in VAS between the two groups before operation or at 3 months after operation (all P>0.05), but it was markedly lower in the navigation group compared with the traditional group at 3 days after operation and at the last follow-up (all P<0.05). There were no significant differences in JOA score or NDI between the two groups before operation or at 3 days and 3 months after operation (all P>0.05), but both were lower in the navigation group compared with the traditional group at the last follow-up (all P<0.05). The accuracies of placement of grade 0 and grade 0+1 screws were 92.0% (70/76) and 96.6% (73/76) in the navigation group, respectively, which were markedly higher than 88.7% (78/88) and 93.5% (82/88) in the traditional group (all P<0.05). The rates of adjacent facet joint invasion of A, B, and C degrees were 71.2% (54/76), 28.8% (22/76) and 0% (0/76) in the navigation group, respectively, while the invasion rates were 60.5% (53/88), 32.3% (28/88) and 7.3% (7/88) in the traditional group ( P<0.05). No screw loosening was noted in the navigation group, but the screw loosening rate was 9.1% (8/88) in the traditional group ( P<0.01). Conclusion:Compared with manual screw placement, O-arm combined with CT three-dimensional navigation system assisted screw placement for lower cervical fracture and dislocation has the advantages of shorter effective operation time, quicker screw placement, stronger screw holding force, better cervical stability, slighter postoperative pain, higher screw placement accuracy, and lower facet joint invasion and screw loosening rates.

Objective:To analyze the application effect of discharge planning based on enhanced recovery after surgery (ERAS) in patients with osteoporotic thoracolumbar fracture (OTLF).Methods:A retrospective cohort analysis was made on clinical information of 230 OTLF patients treated in Honghui Hospital of Xi′an Jiaotong University from January to December 2020, including 44 males and 186 females, aged 53-92 years [(72.0±9.9)years]. A total of 115 patients receiving conventional nursing intervention from January to June 2020 were enrolled in regular nursing group and 115 patients receiving discharge planning intervention based on ERAS from July to December 2020 were enrolled in discharge planning group. The length of hospital stay, readiness for hospital discharge scale (RHDS) at 4 hours before discharge, caregiver preparedness scale (CPS) on admission and at 4 hours before discharge, discharge rate before 12∶00, Chinese osteoporosis quality of life short questionnaire (COQOL) on admission and at 6 months after surgery, and re-fracture rate were compared in the two groups.Results:The patients were followed up for 6 months, except for 3 patients lost to follow up in discharge planning group and 4 patients in regular nursing group. The length of hospital stay was (2.8±0.6)days in discharge planning group and (2.6±0.7)days in regular nursing group ( P>0.05). The RHDS in discharge planning group was significantly greater at 4 hours before discharge when compared with regular nursing group [(103.0±8.3)points vs. (95.3±9.5)points] ( P<0.01). The two groups had no significant difference in CPS at admittance ( P>0.05), but a significantly greater CPS was found in discharge planning group at 4 hours before discharge when compared with regular nursing group [(28.9±3.5)points vs. (24.3±4.8)points] ( P<0.01). The discharge rate before 12∶00 in discharge planning group was significantly higher when compared with regular nursing group [27.7%(31/115) vs. 15.3%(17/115)] ( P<0.05). The COQOL was similar at admittance between the two groups ( P>0.05), but a significantly lower score was found in discharge planning group than that in regular nursing group [(21.6±6.2)points vs. (26.6±6.9)points] ( P<0.01). A significantly lower re-fracture rate was found in discharge planning group at 6 months after surgery when compared with regular nursing group [4.5%(5/112) vs. 12.6%(14/111)] ( P<0.05). Conclusion:For OTLF patients, discharge planning based on ERAS is superior to regular nursing in improving the readiness for hospital discharge, caregiver preparedness, quality of life and management of beds, and lowering re-fracture rate.

【Objective】 To learn the production efficient of platelet components among prefecture-level blood stations in China, to provide supporting data for those blood stations to optimize the production mode of platelet components and continuously improve production efficiency and supply capacity. 【Methods】 The data from 2017 to 2020 was obtained from 24 prefecture-level blood stations who were the members of the practice comparison network for blood institutes in China. The collection units of apheresis platelets, the number of dual-collections of apheresis platelets and plasma, the average apheresis units of one platelet apheresis procedure, the discarded rate of apheresis platelets, the amount of expired apheresis platelets and the amount of apheresis platelets issued were collected. For concentrated platelets, the prepared amount of platelet concentrates and the amount of expired platelet concentrates were collected; both the quantity of qualified and issued concentrated platelets were submitted for statistical analysis.The total output and efficiency of platelet components were calculated based on the collected data. 【Results】 The average annual growth rate of apheresis platelets collection in 24 prefecture-level blood stations was 12.23%, accounting for 99.80% of the total platelet output; the average collection unit of one platelets apheresis procedure was 1.75; from 2019 to 2020, only 5 blood stations performed dual-collection of platelet and plasma during one apheresis procedure; the discarded rate of apheresis platelets was 0.28%, of which 0.007% was due to expiration. A total of 1 621.2 therapeutic units of concentrated platelets were prepared, and 13.03% of them was discarded due to the expiration. The production efficiency of platelet components was 97.56%, of which the production efficiency of apheresis platelets was 97.61% and the production efficiency of concentrated platelets was 74.43%. 【Conclusion】 There are large regional differences in the supply capacity of platelet components in prefecture-level blood stations. Apheresis platelets are the main resource of platelet components product, and the collection capacity is increasing over the years with the characteristics of high production efficiency and low expiration scrapping rate. However, the preparation of concentrated platelets are still limited with relatively low production and high expiration discarded rate.

Objective:To build a health education scheme related to discharge planning for adolescent idiopathic scoliosis surgery patients, and provide systematic and standardized health education related to discharge planning for adolescent idiopathic scoliosis surgery patients.Methods:From January to June 2021, through literature review and semi-structured interviews, the first draft of health education scheme for discharge planning of adolescent idiopathic scoliosis surgery patients was formulated. The Delphi method was used to conduct 2 rounds of consultation with 15 experts, and the final version of the health education scheme for the discharge plan was determined according to the expert consultation.Results:The effective recovery rates of the 2 rounds of expert consultation questionnaires were both 100.0%, the coefficients of expert authority were 0.93 and 0.94, and the Kendall's harmony coefficients of expert opinions were 0.251 and 0.273 ( P<0.01) . Finally, the health education program was constructed according to the health needs of patients and caregivers at 7 time periods including admission day, 1 day before surgery, operation day, postoperative day 1, 1 day before discharge, discharge day and 1 week after discharge, including 7 first-level items, 24 second-level items, and 78 third-level items. Conclusions:The health education scheme related to the discharge plan for adolescent idiopathic scoliosis surgery patients constructed in this study is scientific and reasonable in design, comprehensive, reliable and clinically practical. It is of great significance for the effective implementation of the discharge plan for adolescent idiopathic scoliosis surgery patients .

Objective:To investigate optimal antiplatelet therapy options based on the CYP2C19 genotype in elderly patients with acute coronary syndrome(ACS).Methods:Elderly patients with ACS admitted to our hospital from January 2018 to March 2019 were enrolled and received CyP2C19 gene testing.Patients with the intermediate metabolic genotype of CYP2C19 were randomly divided into two groups: the Ticagrelor group and the double-dose Clopidogrel group.After a one-year follow-up, the risk of bleeding and incidences of cardiovascular events in the two groups were analyzed.Results:468 elderly patients meeting the criteria, 214 had the intermediate metabolic genotype of CYP2C19, accounting for 45.7% of the total, and were randomly divided into the ticagrelor treatment group( n=107)and the double-dose Clopidogrel treatment group( n=107). There were significant differences between the Ticagrelor treatment group and the double-dose Clopidogrel treatment group in incidences of minor bleeding, massive hemorrhage, recurrent angina and recurrent acute myocardial infarction(11.2% vs.22.4%, 2.8% vs. 9.4 %, 4.7% vs.13.1%, 3.7% vs. 11.2%, P<0.05). The double-dose Clopidogrel group not only had a higher risk of cardiovascular events, but also a higher risk of bleeding. Conclusions:For elderly ACS patients with the intermediate metabolic genotype of CYP2C19, a standard dose of ticagrelor is recommended.