OBJECTIVE To mine and analyze the adverse drug events （ADE） signals of two camptothecin topoisomerase 1 inhibitors， i.e. irinotecan and topotecan， and to provide reference for clinical medication safety. METHODS Based on the U.S. Food and Drug Administration Adverse Event Reporting System （FAERS） database， ADE report data for the aforementioned two drugs were extracted from January 1， 2004 to March 31， 2023. After processing the data， signal mining was conducted by using the reporting odds ratio in conjunction with the Bayesian confidence propagation neural network， followed by analysis. RESULTS A total of 14 738 relevant ADE reports were screened， among which 11 483 were associated with irinotecan and 3 255 with topotecan. The ADE reports for irinotecan were predominantly male， whereas for topotecan， they were predominantly female； the age of patients using the two drugs mainly concentrated in 45-＜75 years old. A total of 847 signals were detected， involving 24 system organ classes （SOCs）. Among them， 565 signals of irinotecan were detected， involving 24 SOCs， primarily concentrating on gastrointestinal disorders， general disorders and administration site conditions， blood and lymphatic system disorders； the most frequently reported ADE was diarrhea， and the ADE with the strongest signal intensity was cholinergic syndrome. A total of 282 signals of topotecan were detected， involving 22 SOCs， primarily concentrating on general disorders and administration site conditions， investigations， blood and lymphatic system disorders， and gastrointestinal disorders； the most frequently reported ADEs were death and anemia， and the ADE with the strongest signal intensity was febrile bone marrow aplasia. ADE signals for irinotecan such as metastatic colorectal cancer， peripheral sensory neuropathy， steatohepatitis， and those for topotecan such as iris atrophy， retinal degeneration， vitreous hemorrhage， were not documented in their respective drug instruction. CONCLUSIONS ADEs of irinotecan and topotecan primarily involve the digestive and hematologic systems， warranting close clinical monitoring. Cholinergic syndrome caused by irinotecan should be concerned. In addition， patients receiving irinotecan should also be monitored for ADE such as metastatic colorectal cancer， peripheral sensory neuropathy， steatohepatitis， and proteinuria； for patients using topotecan， enhanced surveillance of ocular diseases is recommended to ensure medication safety.

Objective:To compare the efficacy of percutaneous vertebroplasty (PVP) under enhanced regional and conventional anesthesia for multisegmental acute symptomatic osteoporotic thoracolumbar fractures (m-ASOTLF).Methods:A retrospective cohort study was conducted to analyze the data of 91 patients with m-ASOTLF who were admitted to Honghui Hospital of Xi′an Jiaotong University from January 2021 to December 2022, including 36 males and 55 females, aged 55-80 years [(67.4±7.3)years]. According to American Society of Anesthesiologists (ASA) classification system, 18 patients were classified as grade I, 52 grade II, and 21 grade III. Injured segments included T 6-T 10 in 23 patients, T 11-L 2 in 47 and L 3-L 5 in 21. All the patients were treated with PVP, among whom 45 were given enhanced regional anesthesia (enhanced anesthesia group) and 46 regional conventional anesthesia (conventional anesthesia group). The following indicators were compared between the two groups: the operation time, intraoperative bleeding, intraoperative heart rate, intraoperative mean arterial pressure (MAP), number of intraoperative fluoroscopies, and total amount of bone cement injected; the visual analogue scale (VAS) and Oswestry dysfunction index (ODI) before surgery, at 1 day, 1 month after surgery and at the last follow-up; the mini-mental state examination (MMSE) before surgery, at 1, 6, and 12 hours after surgery; the anterior vertebrae height (AVH), middle vertebrae height (MVH), and vertebral kyphosis angle (VKA) before and at 1 day after surgery; the incidence of complications such as bone cement leakage. Results:All the patients were followed up for 12-20 months [(15.8±2.6)months]. There were no significant differences between the two groups in the operation time, intraoperative bleeding, intraoperative heart rate, intraoperative MAP, number of intraoperative fluoroscopies or total amount of bone cement injected ( P>0.05). No significant differences were found between the two groups in VAS or ODI before surgery and at the last follow-up ( P>0.05). The VAS scores in the enhanced anesthesia group were (2.5±0.4)points and (1.8±0.3)points at 1 day and 1 month postoperatively respectively, which were both lower than (3.5±0.4)points and (2.0±0.5)points in the conventional anesthesia group ( P<0.01). The ODI values in the enhanced anesthesia group were 39.8±3.3 and 26.5±5.0 at 1 day and 1 month postoperatively respectively, which were both lower than 43.8±7.5 and 30.3±6.4 in the conventional anesthesia group ( P<0.01). The VAS and ODI at all postoperative time points decreased in both groups compared with those before surgery, with significant differences among those at all postoperative time points ( P<0.05). There was no significant difference between the two groups in the MMSE scores before, at 1, 6, and 12 hours after surgery ( P>0.05). The MMSE scores at 1 and 6 hours postoperatively were lower than that preoperatively in both groups ( P<0.05), and it was increased at 6 hours compared with that at 1 hour postoperatively ( P<0.05). There was no significant difference between the MMSE scores at 12 hours postoperatively and preoperatively in both groups ( P>0.05). The differences between the two groups in AVH, MVH, or VKA preoperatively were not statistically significant ( P>0.05). The AVH and MVH at 1 day postoperatively in the enhanced anesthesia group were (22.4±4.2)mm and (22.7±3.7)mm respectively, which were both higher than those in the conventional anesthesia group [(19.3±3.7)mm and (20.1±6.3)mm] ( P<0.05 or 0.01); the VKA at 1 day postoperatively in the enhanced anesthesia group was (13.9±3.7)°, which was lower than that in the conventional anesthesia group (15.8±4.1)° ( P<0.05). The AVH, MVH, and VKA in both groups were all improved at 1 day postoperatively compared with those preoperatively ( P<0.05). The incidence of bone cement leakage in the enhanced anesthesia group was 6.7% (3/45), which was lower than 21.7% (10/46) in the conventional anesthesia group ( P<0.05). Conclusion:Compared with conventional regional anesthesia, PVP under enhanced regional anesthesia for m-ASOTLF has more advantages in early postoperative pain relief, improvement of spinal function, restoration of vertebral height and reduction of bone cement leakage.

Objective:To test and evaluate the reliability and clinical effectiveness of osteoporotic thoracolumbar fracture (OTLF) scoring and classification system.Methods:A multicenter retrospective case series study was conducted to analyze the clinical data of 530 OTLF patients admitted to 8 hospitals including Honghui Hospital Affiliated to Xi'an Jiaotong University from January 2021 to June 2022. There were 212 males and 318 females, aged 55-90 years [(72.6±10.8)years]. There were 4 patients with grade C and 18 with grade D according to American Spinal Injury Association (ASIA) classification. According to the osteoporotic thoracolumbar injury classification and severity (OTLICS) score, all patients had an OTLICS score over 4 points and required surgical treatment. Among them, 410 patients had acute symptomatic OTLF (ASOTLF), including 24 patients with type I, 159 type IIA, 47 type IIB, 31 type IIC, 136 type IIIA, 8 type IIIB, 2 type IV (absence of neurological symptoms) and 3 type IV (presence of neurological symptoms), and 120 patients had chronic symptomatic OTLF (CSOTLF), including 62 patients with type I, 21 type II, 17 type III, 3 type IV (reducible under general anesthesia), 9 type IV (not reducible under general anesthesia), 1 type V (reducible under general anesthesia), 5 type V (presence of neurological symptoms), and 2 type V (not reducible under general anesthesia). Surgical procedures included percutaneous vertebroplasty (PVP), positional repositioning plus PVP, percutaneous kyphoplasty (PKP), posterior open reduction combined with bone graft fusion and bone cement augmented screw internal fixation, posterior open reduction combined with decompression, bone graft fusion and bone cement augmented screw internal fixation, and posterior open reduction combined with osteotomy and orthopedics, bone graft fusion and bone cement augmented screw internal fixation. A weighted Kappa was used to test the interobserver and intraobserver reliability of the OTLICS score, the ASOTLF classification, and the CSOTLF classification. The visual analog scale (VAS), Oswestry disability index (ODI), ASIA classification were compared before, at 1 month after surgery and at the last follow-up. Incidence of postoperative complications was observed.Results:The percentage of mean interobserver agreement for OTLICS staging was 93.4%, with a mean confidence Kappa value of 0.86, and the percentage of mean intraobserver agreement was 93.0%, with a mean confidence kappa value of 0.86. The percentage of mean interobserver agreement for ASOTLF staging was 94.2%, with a mean confidence Kappa value of 0.84, and the percentage of mean intraobserver agreement was 92.5%, with a mean confidence Kappa value of 0.83. The percentage of mean interobserver agreement for CSOTLF subtyping was 91.9%, with a mean confidence Kappa value of 0.80, and the percentage of mean intraobserver agreement was 91.3%, with a mean confidence Kappa value of 0.81. All the patients were followed up for 6-12 months [(9.0±2.1)months]. The VAS and ODI scores were significantly lower in patients with ASOTLF and CSOTLF classifications at 1 month after surgery and at the last follow-up than those before surgery (all P<0.05). The VAS scores in patients with ASOTLF types IIA, IIB, IIC, IIIA, and IV were significantly lower at the last follow-up than that at 1 month after surgery; the ODI scores in patients with ASOTLF types I, IIA, IIB, IIIA, IIIB and IV were significantly lower at the last follow-up than those at 1 month after surgery. The VAS scores in patients with CSOTLF types II, III, IV, and V were significantly lower at the last follow-up than those at 1 month after surgery, and the ODI scores in patients with all CSOTLF types were significantly lower at the last follow-up than those at 1 month after surgery (all P<0.05). Two patients with ASIA grade C recovered to grade D, and the rest recovered to grade E at the last follow-up ( P<0.01). No major vessel or nerve injury or internal fixation failure was found during follow-up. There were 18 patients with cement leakage, none of whom showed relevant clinical symptoms. There were 35 patients with new vertebral fractures, all of whom recovered well after symptomatic treatment. Conclusions:The OTLICS score, ASOTLF classification and CSOTLF classification have a high degree of reliability. Application of stepwise treatment for patients with different levels of injury according to the scoring and classification system can reduce pain, promote recovery of the spinal function, and reduce complications, which is of some significance in guiding the selection of clinical treatment.

Diffuse idiopathic skeletal hyperostosis(DISH) is a kind of ankylosing spinal disease, which usually occurs in the middle-aged and elderly. It is mainly manifested as ossification and calcification of ligaments and tendon attachment points. It is a bone disease that mainly involves the spine but is not accompanied by severe intervertebral disc degeneration or sacroiliac joint and intervertebral facet joint ankylosis. DISH combined with thoracolumbar fracture has a high rate of delayed diagnosis and neurological deterioration, so this kind of fracture should be diagnosed and treated in time. However, there are different conclusions on the choice of treatment methods and postoperative efficacy, and there are still disputes in some academic aspects.The author consulted the relevant literature and reviewed the treatment methods of DISH combined with thoracolumbar fracture in order to provide reference for the clinical treatment of this kind of fracture.

Objective:To investigate the risk factors associated with the occurrence of proximal junctional kyphosis (PJK) after posterior long-segment internal fixation for type IV chronic symptomatic osteoporotic thoracolumbar fracture (CSOTLF) in the elderly.Methods:A case-control study was used to analyze the clinical data of 95 elderly patients with type IV CSOTLF treated in Honghui Hospital affiliated to Xi′an Jiaotong University from January 2013 to June 2018, including 32 males and 63 females, aged from 60 to 85 years［(67.4±6.5) years］. Injured segments were T 11 in 17 patients, T 12 in 37, L 1 in 30 and L 2 in 11. All patients were treated with posterior long-segment internal fixation and divided into PJK group ( n=30) and non-PJK group ( n=65) according to whether PJK occurred after surgery. Univariate analysis was performed for the correlation of the following indices with the incidence of postoperative PJK, including general information such as gender, age, body mass index (BMI), bone mineral density (BMD), history of smoking, cause of injury, comorbidities, injury segments, American Spinal Injury Association (ASIA) classification and time from injury to surgery, preoperative imaging data such as posterior junctional angle (PJA), sagittal vertical axis (SVA), pelvic incidence-lumbar lordosis difference (PI-LL), pelvic tilt (PT) and sacral slope (SS), basic surgical data such as posterior ligament complex (PLC) injury, location of upper instrumented vertebrae (UIV), location of lower instrumented vertebrae (LIV) and number of fixed segments. Multifactorial Logistic regression analysis was used to measure the independent risk factors associated with the occurrence of postoperative PJK. Results:Univariate analysis showed that the incidence of postoperative PJK was correlated with age, BMI, BMD, preoperative PJA, preoperative SVA, preoperative PI-LL, PLC injury, location of UIV, location of LIV and number of fixed segments (all P<0.05), rather than gender, history of smoking, cause of injury, comorbidities, injury segments, ASIA classification, time from injury to surgery, preoperative PT and preoperative SS (all P>0.05). Multifactorial Logistic regression analysis showed that age ≥70 years ( OR=32.28, 95% CI 3.83-272.29, P<0.01), BMI>28.0 kg/m 2 ( OR=7.88, 95% CI 1.63-37.99, P<0.01), BMD T value<-3.5 SD ( OR=20.84, 95% CI 2.36-183.93, P<0.01), preoperative PI-LL>20° ( OR=13.30, 95% CI 1.54-113.87, P<0.05) and PLC injury ( OR=13.98, 95% CI 1.37-142.34, P<0.05) were significantly associated with the occurrence of postoperative PJK. Conclusions:Age≥70 years, BMI>28 kg/m 2, BMD T value<-3.5 SD, preoperative PI-LL>20° and PLC injury are independent risk factors for the incidence of PJK after posterior long-segment internal fixation in elderly patients with type IV CSOTLF. Attention should be paid to soft tissue protection and sagittal balance restoration of the spine intraoperatively and weight control and anti-osteoporosis treatment postoperatively.

Objective:To compare the efficacy of forceful reduction percutaneous pedicle screw and ordinary percutaneous pedicle screw in the treatment of osteoporotic thoracolumbar burst fracture with kyphosis.Methods:A retrospective cohort study was conducted to analyze the clinical data of 566 patients with osteoporotic thoracolumbar burst fracture with kyphosis admitted to Honghui Hospital, Xi ′an Jiaotong University from January 2015 to December 2018, including 191 males and 375 females, with age range of 48-79 years [(61.7±10.7)years]. Fracture segments were located at T 11 in 134 patients, T 12 in 154, L 1 in 160, and L 2 in 118. All fractures were type IIIA according to the acute symptomatic osteoporotic thoracolumbar fracture classification (ASOTLF). The thoracolumbar osteoporotic fracture severity score assessment system (TLOFSAS) score was ≥5 points. A total of 275 patients underwent forceful reduction and percutaneous pedicle screw internal fixation (forceful reduction screw group), and 291 patients underwent common percutaneous pedicle screw internal fixation (common screw group). The operation time, intraoperative blood loss, times of X-ray exposure on patients and measures documented before operation, at 3 days after operation and at 2 years after operation including anterior height ratio of the injured vertebrae, sagittal Cobb angle of the injured vertebrae, Japanese Orthopaedic Association (JOA) score and visual analog scale (VAS) were compared between the two groups. Moreover, degree of correction of Cobb angle at 3 days after operation, loss of correction of Cobb angle at 2 years after operation and postoperative complications were observed. Results:All patients were followed up for 25-34 months [(29.9±3.4)months]. The operation time, intraoperative blood loss and times of X-ray exposure on patients in forceful reduction screw group were (69.4±10.2)minutes, (60.3±13.1)ml and (26.8±3.7)times, less than (80.6±11.9)minutes, (80.7±15.4)ml and (30.4±3.4)times in common screw group (all P<0.01). There was no significant difference in anterior height ratio of the injured vertebrae between the two groups before operation and at 3 days after operation (all P>0.05). The anterior height ratio of the injured vertebrae in forceful reduction screw group was (95.5±2.3)% at 2 years after operation, significantly higher than (85.4±1.7)% in common screw group ( P<0.01). There was no significant difference in sagittal Cobb angle of the injured vertebrae between the two groups before operation ( P>0.05). The sagittal Cobb of the injured vertebrae in forceful reduction screw group at 3 days and 2 years after operation were (7.9±1.6)° and (8.8±1.5)°, lower than (10.6±1.1)° and (12.3±1.2)° in common screw group ( P<0.05 or 0.01). There were no significant difference in JOA score and VAS between the two groups before operation, at 3 days and at 2 years after operation (all P>0.05). The degree of correction of Cobb angle in forceful reduction screw group was (19.4±2.5)°, higher than (17.3±2.6)° in common screw group ( P<0.05). The loss of correction of Cobb angle in forceful reduction group was less than that in common screw group at 2 years after operation, but the difference was not statistically significant ( P>0.05). The incidence of postoperative complications in forceful reduction screw group was 12.4% (34/275), compared to 14.1% (41/291) in common screw group ( P>0.05). There were no complications such as iatrogenic nerve injury, fracture or loosening of internal fixator or leakage of bone cement in the spinal canal in both groups. Conclusions:For osteoporotic thoracolumbar burst fracture with kyphosis, forceful reduction and percutaneous pedicle screw internal fixation can significantly shorten operation time, reduce intraoperative blood loss and times of X-ray exposure on patients, restore height of the injured vertebrae, correct kyphosis and maintain reduction height of the injured vertebrae in contrast with conventional percutaneous pedicle screw internal fixation.

Objective:To investigate the efficacy of flexion-lateral curvature-supination reduction combined with primary anterior surgery for the treatment of lower cervical dislocation with unilateral facet inter-locking.Methods:A retrospective analysis was performed in the 32 patients who had been admitted to Department of Spine Surgery, Honghui Hospital for lower cervical dislocation with unilateral facet interlocking from November 2015 to October 2018. According to their treatments, they were divided into 2 groups. In the emergency group treated by flexion-lateral curvature-supination reduction combined with primary anterior surgery, there were 13 males and 3 females, aged from 24 to 63 years. In the traction group treated by cranial traction reduction combined with secondary anterior surgery, there were 12 males and 4 females, aged from 20 to 64 years. The operation time, intraoperative blood loss, hospital stay, bone graft fusion, American Spinal Injury Association (ASIA) grade and Japanese Orthopaedic Association (JOA) score were compared between the 2 groups.Results:There was no significant difference in the preoperative general data between the 2 groups, showing they were comparable ( P<0.05). All patients were followed up from 26 to 40 months. The hospital stay for the emergency group [(7.2±1.2) d] was significantly shorter than that for the traction group[(10.9±1.2) d] ( P<0.05). There was no significant difference in the operation time, blood loss, ASIA grade or JOA score between the 2 groups ( P>0.05). All patients achieved osseous fusion of intervertebral space. Conclusion:Compared with traditional methods, flexion-lateral curvature-supination reduction combined with primay anterior surgery shows no significant difference in the recovery of neurological function but leads to a shorter hospital stay.

Objective:To explore the clinical effects of unilateral secondary puncture percutaneous vertebroplasty (PVP) in the treatment of type ⅡA acute symptomatic osteoporotic thoracolumbar fractures (ASOTLF).Methods:A retrospective case-control study was conducted to analyze the clinical data of 193 patients with type ⅡA ASOTLF who had been admitted to Department of Spine Surgery, Honghui Hospital from February 2016 to October 2018. They were 71 males and 122 females, aged from 65 to 90 years [average, (73.9±4.3) years]. The segments injured were T10 in 21 cases, T11 in 27 cases, T12 in 44 cases, L1 in 48 cases, L2 in 29 cases, L3 in 14 cases, and L4 in 10 cases. Of them, 85 received unilateral secondary puncture PVP (observation group) and 108 did not (control group). The clinical effects were evaluated by comparing between the 2 groups the operation time, bone cement injection volume, intraoperative blood loss, hospital stay, and visual analogue scale (VAS) for back pain, spinal Oswestry disability index (ODI), anterior height of the injured vertebral body (AH) and kyphosis angle (KA) of the injured vertebra before operation, at 3 days after operation and the last follow-up. The bone cement leakage and fracture of adjacent vertebral body were observed.Results:All patients were followed up for 12 to 24 months (average, 15.8 months). There was no significant difference in the preoperative general data between the 2 groups, showing they were comparable ( P>0.05). The operation time and bone cement injection volume [(36.2±1.4) min and (5.5±0.7) mL] in the observation group were significantly longer or more than those in the control group [(32.3±1.7) min and (4.0±0.7) mL] ( P<0.05). There was no significant difference in the hospital stay or intraoperative blood loss between the 2 groups ( P>0.05). The VAS, ODI, AH and KA at 3 days after operation and the last follow-up were significantly improved compared with those before operation in both groups ( P<0.05). There was no significant difference in VAS, ODI, AH or KA between the 2 groups before operation or at 3 days after operation ( P>0.05). However, the VAS, ODI, AH and KA at the last follow-up in the observation group [(2.2±0.8) points, 19.2%±5.8%, (2.90±0.21) cm, and 12.2°±1.5°] were better than those in the control group [(3.1±0.9) points, 22.8%±5.3%, (2.41±0.15) cm, and 13.3°±1.2°]. There was no significant difference between the 2 groups in the incidence of postoperative bone cement leakage or that of adjacent vertebral fracture ( P>0.05). Conclusions:In the treatment of type ⅡA ASOTLF, unilateral secondary puncture PVP can result in satisfactory clinical effects, because it effectively promotes dispersion of bone cement and prevents re-collapse of the vertebra operated but does not increase the risks of bone cement leakage and adjacent vertebral fracture.

Spinal tuberculosis is one of the common causes of severe kyphosis. The formation of spinal tuberculosis kyphosis is multi-factors, including age at the time of infection, the cumulative number of segments, the height of vertebral body loss before treatment, and "spine danger signs" . Although the use of anti-tuberculosis drugs has achieved good results, for patients with spinal tuberculosis cured by drug treatment, the kyphosis will continue to progress and gradually develop into a severe kyphosis. Then there are a series of problems such as appearance, psychology, rib-pelvic impingement, cardiopulmonary dysfunction, and nerve and spinal cord compression. The X-ray signs of the height of the vertebral body loss and "spine danger signs" before treatment can help predict the severity of future deformities. Therefore, a comprehensive understanding of the formation of kyphosis of spinal tuberculosis and individualized selection of surgical methods according to the specific conditions of the disease as soon as possible can effectively prevent the formation of kyphosis and reduce the incidence of neurological damage and delayed paralysis.

Objective:To conduct a Meta-analysis of the efficacy and safety of laparoscopy-assisted pylorus-preserving gastrectomy(LPPG) and laparoscopy-assisted distal gastrectomy(LDG) in early gastric cancer(EGC).Methods:Searched Web of Science, Cochrane library, Embase, Chinese Biomedical Medical Database, CNKI, Wanfang Database to identify all qualified studies comparing LPPG and LDG in EGC. The retrieval time was from the database establishment to October 2020. Measurement data with normal distribution were represented as ( Mean± SD). Comparing two groups by mean difference(MD) with 95% confidence interval(CI) for contious outcomes and odds ratio(OR) with 95% CI for dichotomous data.The RevMan software was used to analyze the perioperative outcome. Results:A total of 10 studies were included, with a total of 1613 patients, 624 in the LPPG group and 989 in the LDG group. Operation time, intraoperative blood loss, postoperative anal exhaust time, hospital stay, and overall complication rate of LPPG were similar to LDG.Compared with the LDG group, the LPPG group had fewer lymph node dissections ( MD=-2.51, 95% CI: -4.31~-0.71, P=0.006), longer postoperative gastric tube indwelling time ( MD=1.05, 95% CI: 0.31~1.80, P=0.006), and a higher incidence of delayed gastric emptying ( P<0.01). There was no statistically significant difference between the two groups in terms of other perioperative complications. Conclusion:LPPG is a safe and feasible surgical method for the treatment of EGC, and can be used as an alternative to LDG.