1.Phase Ⅲ, multicenter, randomized comparative study of LY01005 and Zoladex ? for patients with premenopausal breast cancer
Xiying SHAO ; Qingyuan ZHANG ; Zhaofeng NIU ; Man LI ; Jingfen WANG ; Zhanhong CHEN ; Ruizhen LUO ; Guangdong QIAO ; Jianguo WANG ; Liyuan QIAN ; Ronghua YANG ; Zhendong CHEN ; Jian WANG ; Yumin YAO ; Jianghua OU ; Tao SUN ; Qiao CHENG ; Yongsheng WANG ; Jian HUANG ; Hongying ZHAO ; Wuyun SU ; Zhong OUYANG ; Yu DING ; Lilin CHEN ; Sumei YANG ; Mengsheng CUI ; Aimin ZANG ; Enxiang ZHOU ; Peizhi FAN ; Jing ZHANG ; Qiang LIU ; Yuee TENG ; Hui LI ; Jianyun NIE ; Jin YANG ; Xiaojia WANG ; Zefei JIANG
Chinese Journal of Oncology 2025;47(4):340-348
Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.
2.Study of the dynamic management for equipment in operating room based on MCDA method
Yu QIAO ; Jing WANG ; Mengmeng YIN ; Fei YU
China Medical Equipment 2025;22(7):130-135
Objective:To construct a management model for equipment in operating room on the basis of multi-criteria decision analysis(MCDA)method,and optimize management strategies and implement dynamic management.Methods:The dynamic monitoring and management for the operation and management of equipment in operating room was realized through combined the process of multi-criteria decision-making and the data platform of equipment in operating room,and construct the MCDA's framework for equipment in operating room.A total of 40 used equipment from operating room at Beijing Friendship Hospital Affiliated to Capital Medical University during January and December 2023 were selected as the research objects.The conventional management method was applied in 20 equipment during January and June 2023,and the management model(MCDA management method)of equipment in operating room was applied in 20 equipment during June to December 2023.The operational qualities of equipment,failure rates and qualification rates of sampling,and the scores of management effectiveness between two kinds management methods were compared.A self-designed survey questionnaire for satisfaction was adopted to investigate the satisfactions of managers,who used equipment in operating room,for the equipment that received clinical managements of two kinds of management methods.Results:The average rate of opening equipment,the increased extent of average cost-benefit and the increased extent of average social benefit of these equipment in operating room were respectively(91.58±3.36)%,(7.02±1.69)%and(7.25±1.36)%in using MCDA management method,all of which were higher than those in using conventional management method.However,the average transferring rate of MCDA management method was(7.69±1.54)%,which was lower than that of conventional management method,and the differences of them were all statistically significant(t=19.466,9.732,14.558,20.969,P<0.05).The failure rate of the equipment in operating room,which were managed by the MCDA method,was lower than that of these equipment were managed by the conventional method,while the pass rate of random inspection of equipment were managed by the MCDA methods was higher than those were managed by the conventional method,and the differences were statistically significant(x2=10.157,7.619,P<0.05).The scores of safety performance,speed of maintenance,cleaning quality and the speed of replacing equipment of adopting MCDA management method were all higher than those of adopting conventional management method,and the differences were statistically significant(t=17.952,15.149,13.527,10.474,P<0.05).The satisfaction rates of the managers of using equipment for adopting MCDA management method in the rationality of the process of medical equipment,the feasibility of the system,and the effectiveness of quality were all higher than those for adopting conventional management method,and the differences were significant(x2=5.454,6.667,5.963,P<0.05).Conclusion:The management of management model based on MCDA method for equipment in operating room can enhance the operational quality and management level for equipment,and reduce the operating risk and the incidence of adverse events in equipment,and improve the satisfactions of managers in using equipment.
3.Research progress on serrated polyposis syndrome
Jing QIAO ; Ze WANG ; Yinglong HUANG
Clinical Medicine of China 2025;41(4):311-315
Serrated polyposis syndrome (SPS), characterized by multiple serrated polyps on the colorectum, is associated with a high risk of colorectal cancer. Serrated polyps eventually develop into colorectal cancer through a serrated pathway. In addition, the flat shape of serrated polyps and the mucus cap on the surface make them easy to miss the diagnosis under endoscopy, which is the main cause of intercolonic cancer. Therefore, the increased risk of colorectal cancer makes it necessary for patients with SPS to be accurately diagnosed, comprehensively managed, and appropriately treated and monitored. In recent years, the WHO has updated the diagnostic criteria and follow-up monitoring of SPS, and the research on the molecular genetic characteristics of SPS has also advanced.
4.Advances in DNA methylation of brain-derived neurotrophic factor and depression
Zi-yun LIAO ; Meng-yu WANG ; Jing-yi QIAO ; Run ZHANG ; Pei-dong LIU ; Xin-wang CHEN
Chinese Pharmacological Bulletin 2025;41(5):825-829
Depression is a heterogeneous mental disorder in which the interaction between genetic susceptibility and environ-mental factors plays a key role in its pathogenesis.Although the specific mechanisms of the disease still need to be thoroughly studied and elucidated,there is now a broad consensus that epi-genetic markers have a central influence on its mechanism of ac-tion.DNA methylation of brain-derived neurotrophic factor(BD-NF)is not only regarded as a promising epigenetic biomarker of pathology,but may also help predict the efficacy of antidepres-sants.In this paper we reviewed the gene structure of BDNF and its DNA methylation regulation mechanism,and also analyzed the changes of DNA methylation of this factor in depression pa-tients and animal models,aiming to provide new ideas and theo-retical support for clinical research.
5.Effects of Qingre Qudu Decoction for fumigation combined with three-gap drainage on wound healing and serum inflammatory factors in patients with acute perianal abscess
Wei YANG ; Bin XIAO ; Jing QIAO ; Man WANG ; Xi ZHANG ; Shuai JIANG ; Sizhu LI ; Lili YANG ; Jiamin HANG ; Heng JIA
International Journal of Traditional Chinese Medicine 2025;47(7):908-912
Objective:To explore the effects of Qingre Qudu Decoction for fumigation combined with three-gap drainage on wound healing and serum inflammatory factors in patients with acute perianal abscess.Methods:Randomized controlled trial was conducted. A total of 117 patients with acute perianal abscess in the hospital were enrolled as the observation objects between August 2022 and May 2024. According to random number table method, they were divided into observation group (59 cases) and control group (58 cases). Both groups received three-gap drainage therapy. On basis of three-gap drainage, control group was given potassium permanganate, while observation group was given Qingre Qudu Decoction for fumigation. All patients were treated for 14 d. The growth of granulation tissue and wound secretions before and after treatment was evaluated. VAS scale was used to evaluate the degree of incision pain, and Wexner score was used to assess incontinence; ELISA was used to detect serum activator A (ACTA), immunoturbidimetry was used to detect serum CRP, and radioimmunoassay was used to detect serum IL-6 levels. The occurrence of complications and abscess recurrence during treatment was recorded, and clinical efficacy was evaluated.Results:The total effective rate of the observation group was 96.61% (57/59), while that of the control group was 82.76% (48/58), with statistical significance ( χ2=6.10, P=0.014). After treatment, scores of granulation tissue growth and wound secretions in observation group, and scores of VAS and Wexner incontinence in observation group were lower than those in the control group ( t=9.66, 5.00, 7.98, 3.65, P<0.001), and wound healing time was shorter than that in control group ( t=8.41, P<0.001). After treatment, levels of serum ACTA, CRP and IL-6 in observation group were lower than those in control group ( t=15.30, 2.08, 19.34, P<0.01 or P<0.05). The incidence of postoperative complications in the observation group was 6.78% (4/59), while in the control group it was 27.59% (16/58), with statistical significance ( χ2=8.93, P=0.003). Conclusion:Qingre Qudu Decoction for fumigation combined with three-gap drainage can relieve postoperative incision pain, inhibit inflammatory response, accelerate the recovery of wound and promote the recovery of anal function and improve clinical efficacy.
6.Pulsatilla saponin D inhibits invasion and metastasis of triple-negative breast cancer cells through multiple targets and pathways
Qiao CHU ; Xiaona WANG ; Jiaying XU ; Huilin PENG ; Yulin ZHAO ; Jing ZHANG ; Guoyu LU ; Kai WANG
Journal of Southern Medical University 2025;45(1):150-161
Objective To explore the mechanism by which Pulsatilla saponin D(PSD)inhibits invasion and metastasis of triple-negative breast cancer(TNBC).Methods The public databases were used to identify the potential targets of PSD and the invasion and metastasis targets of TNBC to obtain the intersection targets between PSD and TNBC.The"PSD-target-disease"interaction network was constructed and protein-protein interaction(PPI)analysis was performed to obtain the core targets,which were analyzed for KEGG pathway and GO functional enrichment.Molecular docking study of the core targets and PSD was performed,and the therapeutic effect and mechanism of PSD were verified using Transwell assay and Western blotting in cultured TNBC cells.Results Network pharmacology analysis identified a total of 285 potential PSD targets and 26 drug-disease intersection core targets.GO analysis yielded 175 entries related to the binding of biomolecules(protein,DNA and RNA),enzyme activities,and regulation of gene transcription.KEGG analysis yielded 46 entries involving pathways in cancer,chemical carcinogenesis-receptor activation,microRNAs in cancer,chemical carcinogenesis-reactive oxygen species,PD-L1 expression and PD-1 checkpoint pathway in cancer.Molecular docking showed high binding affinities of PSD to MTOR,HDAC2,ABL1,CDK1,TLR4,TERT,PIK3R1,NFE2L2 and PTPN1.In cultured TNBC cells,treatment with PSD significantly inhibited cell invasion and migration and lowered the expressions of MMP2,MMP9,N-cadherin and the core proteins p-mTOR,ABL1,TERT,PTPN1,HDAC2,PIK3R1,CDK1,TLR4 as well as NFE2L2 expressionin the cell nuclei.Conclusion The inhibitory effects of PSD on TNBC invasion and metastasis are mediated by multiple targets and pathways.
7.Study on risk factors of colorectal adenomatous polyps and construction and validation of prediction model
Kui DONG ; Jie WU ; Jing YAN ; Haitao LIU ; Jun WANG ; Guan'en QIAO
The Journal of Practical Medicine 2025;41(6):838-845
Objective To identify risk factors for colorectal adenomatous polyps using logistic regression analysis,construct a prediction model based on these identified factors,and subsequently evaluate the performance of the model.Methods Encompassed 1,023 patients who underwent large intestine polyp resection at the First Hospital of Handan between January 2017 and January 2022.Among these patients,676 had adenomatous polyps(adenomatous polyp group)and 347 had non-adenomatous polyps(non-adenomatous polyp group).We collected data on basic information,medical history,colonoscopy results,and polyp pathology.By comparing the two groups,we identified significant differences in various indicators,which were selected as candidate factors for model construction.Patients were randomly divided into a training set and a validation set at an 8∶2 ratio.Using the training set data,we constructed a risk prediction model and developed a nomogram using R Studio software to visually present the model.Finally,we internally validated the model using the validation set.The model's discrimination ability was evaluated using the ROC curve,its accuracy was assessed via the calibration curve,and its clinical utility was evaluated through decision curve analysis(DCA).Results Significant differences were observed between the two groups in terms of age,drinking habits,family history of colorectal cancer,hyperlipid-emia,history of cholecystectomy,HP infection,and history of appendectomy(P<0.05).These variables were included in the model construction.A total of 818 participants were randomly assigned to the training set,while 205 were allocated to the validation set.Multivariate logistic regression analysis on the training set confirmed that age(OR=1.021,95%CI:1.006~1.036,P=0.006),alcohol consumption(OR=3.440,95%CI:2.251~5.257,P<0.001),first-degree relatives with colorectal cancer(OR=3.775,95%CI:1.881~7.577,P<0.001),hyperlipidemia(OR=3.428,95%CI:2.443~4.808,P<0.001),history of cholecystectomy(OR=3.916,95%CI:1.756~8.735,P<0.001),Helicobacter pylori(HP)infection(OR=3.292,95%CI:2.309~4.693,P<0.001),and history of appendectomy(OR=3.819,95%CI:2.002~7.286,P<0.001)were independent risk factors for adenomatous polyps.Consequently,a prediction model for large intestine adenomatous polyps was developed using the formula P=1/(1+e-Y),where Y=0.020×age+1.328×first-degree relatives with colorectal cancer+1.235×alcohol consumption+1.232×hyperlipidemia+1.365×cholecystectomy+1.192×HP infection+1.340×appendectomy-1.995.The model demonstrated good performance with AUC values of 0.763(95%CI:0.729~0.797)for the training set and 0.769(95%CI:0.644~0.787)for the validation set.The calibration curve indicated a good fit,and decision curve analysis showed that the model could achieve positive net benefit across a wide range of threshold probabilities,confirming its clinical utility.Conclusions Age,alcohol consumption,a family history of colorectal cancer in first-degree relatives,hyperlipidemia,cholecystectomy,HP infection,and appendectomy were identified as independent risk factors for adenomatous polyps.A prediction model incorporating these risk factors holds significant practical value for predicting the occurrence of colorectal adenomatous polyps.
8.Anesthesia effect of different concentration of sevoflurane combined with propofol regimen and patient's immune function observation during hepatic resection for primary hepatocellular carcinoma
Jing XU ; Xue QIAO ; Yuming SUN ; Bo WANG
Journal of Clinical Surgery 2025;33(2):191-195
Objective To investigate the anesthesia effects of different concentrations of sevoflurane combined with propofol during primary liver cancer resection surgery,as well as the changes in immune function in patients.Methods Using single-blind method,120 cases of primary hepatocellular carcinoma admitted to the Third Affiliated Hospital of Naval Military Medical University from January 2023 to September 2023 were prospectively selected as the study subjects,and the patients were randomly(using the randomized numerical table method)included in the control group(60 cases)and the observation group(60 cases).During hepatic cancer resection,the control group was given 0.5 alveolar minimum effective concentration(MAC)sevoflurane combined with propofol target-controlled infusion anesthesia,and the observation group was given 1.0 MAC sevoflurane combined with propofol target-controlled infusion anesthesia,and both groups were observed for 3 d postoperatively.The perioperative related indexes,the sedation and quality of awakening in the immediate moment of extubation,15 min after extubation,and 30 min after extubation,the cognitive function before and at 1 and 3 d postoperatively,vital signs before induction of anesthesia,after induction of anesthesia,at the moment of intubation,at the end of surgery,immune function before and 1 d postoperative,and adverse reactions during the observation period were compared between the two groups.Results The time for extubation,recovery of spontaneous respiration,recovery of orientation,and awakening in the observation group were(11.25±1.69)min,(9.76±1.34)min,(69.23±3.35)min,and(10.13±1.43)min,and the control group were(14.57±2.28)min,(13.55±2.76)min,(73.44±4.52)min,(14.26±2.25)min,all of which were shorter in the observation group than in the control group(P<0.05).The Ramsay sedation score at the immediate moment of extubation was(4.16±0.22)in the observation group,and(3.21±0.10)in the control group;the standardized(Aldrete)score in the awakening room of the observation group at the immediate moment of extubation,and 15 min after extubation were(9.56±0.12)and(9.77±0.20),respectively,and the control group was(9.02±0.13),respectively,(9.05±0.17)points;the scores of the brief mental state examination(MMSE)scale in the observation group were(26.23±1.12)points and(25.17±0.98)points in the control group in the 1 d postoperative period,which were higher than those of the control group(P<0.05).The heart rate(HR)at the moment of intubation and at the end of operation in the observation group were(73.08±4.10)beats/min,(75.27±6.03)beats/min,and the mean arterial pressure(MAP)was(81.56±4.49)mmHg and(86.07±5.48)mmHg,respectively,and in the control group the HR was(75.47±5.78)beats/min,(77.91±6.79)beats/min,and the MAP was(85.22±5.08)mmHg and(88.25±6.01)mmHg in the observation group,respectively,which were lower than those in the control group(P<0.05).The whole blood natural killer(NK)cells,CD4+and CD4+/CD8+in the observation group at 1 d postoperatively were(35.62±5.54)%,(50.09±3.32)%,and(1.42±0.25),the control group were(24.12±4.09)%,(43.17±4.20)%,and(1.20±0.19),the observation group was higher than the control group(P<0.05);whole blood CD8+was(26.55±3.02)%in the observation group and(28.71±4.45)%in the control group,the observation group was lower than the control group(P<0.05).The total incidence of adverse reactions during the observation period was 16.67%in the observation group and 5.00%in the control group,which was higher than the control group(P<0.05).Conclusion Compared with 0.5 MAC sevoflurane combined with propofol target-controlled infusion anesthesia,1.0 MAC sevoflurane combined with propofol target-controlled infusion anesthesia had less effect on hemodynamics and immune function in patients undergoing resection for primary hepatocellular carcinoma,and it could improve the quality of patients'awakening,cognitive function,and promote postoperative recovery,and the anesthesia was more effective,but it had more adverse effects.
9.Comparative efficacy of early versus delayed reconstruction of anterior cruciate ligament ruptures under arthroscopy
Jiankang ZENG ; Yingjia ZHOU ; Jiahuan LI ; Fei TAN ; Peijie LI ; Jiangming ZHANG ; Kai ZHANG ; Jing WANG ; Yongjie QIAO ; Shuo YE ; Chenpo DANG ; Shenghu ZHOU
Chinese Journal of Trauma 2025;41(6):572-579
Objective:To compare the efficacy of early versus delayed reconstruction of anterior cruciate ligament (ACL) ruptures under arthroscopy.Methods:A retrospective cohort study was conducted to analyze the clinical data of 260 young adults with ACL ruptures admitted to 940th Hospital of Joint Logistic Support Force of PLA from January 2022 to June 2024, including 171 males and 89 females, aged 18-45 years [(25.6±5.9)years]. Left knee was involved in 127 patients, while the right in 133 patients. All the patients underwent arthroscopic ACL reconstruction with autologous tendon grafts, of whom 130 patients were treated within 3 months after injury (early reconstruction group) but other 130 treated at 3 months after injury (delayed reconstruction group). The operative duration and intraoperative bleeding were compared between the two groups. The incidence of medial meniscus (MM) and lateral meniscus (LM) tears and the incidence of corresponding types of tears were recorded intraoperatively in the two groups. Tegner score and Lysholm score preoperatively, at 3 months postoperatively, and at the last follow-up were detected. Visual analogue scale (VAS) scores at 3 months postoperatively and at the last follow-up and postoperative complication rate were compared between the two groups.Results:All the patients were followed up for 6-15 months [(9.1±3.2)months]. There were no significant differences in operative duration or intraoperative bleeding between the two groups ( P>0.05). The incidence of MM tears in the early reconstruction group was 22.3% (29/130), lower than 34.6% (45/130) in the delayed reconstruction group ( P<0.05). There was no significant difference in the incidence of LM tears between the two groups ( P>0.05). The incidence of MM bucket-handle tears in the early reconstruction group was 2.3% (3/130), lower than 9.2% (12/130) in the delayed reconstruction group ( P<0.05), while no significant difference in the incidence of other types of meniscus tears was found between the two groups ( P>0.05). There were no significant differences in Tegner score or Lysholm score preoperatively between the two groups ( P>0.05). At 3 months postoperatively and at the last follow-up, the Tegner scores in the early reconstruction group were (7.4±1.3)points and (8.6±0.7)points, higher than (6.4±1.5)points and (7.9±0.6)points in the delayed reconstruction group and the Lysholm scores were (82.1±7.1)points and (90.7±3.8)points in the early reconstruction group, higher than (79.5±6.8)points and (86.3±4.0)points in the delayed reconstruction group ( P<0.01). There were no significant differences in VAS scores between the two groups at 3 months postoperatively or at the last follow-up ( P>0.05). The postoperative complication rate was 8.5% (11/130) in the early reconstruction group and 12.3% (16/130) in the delayed reconstruction group ( P>0.05). Conclusion:For young patients with ACL rupture, arthroscopic reconstruction within 3 months after injury can reduce the incidence of MM tear and bucket-handle tear and improve knee function without increasing the incidence of other complications when compared with delayed reconstruction at 3 months after injury.
10.Expert consensus on intraoperative repositioning for patients with spine fracture and dislocation (version 2025)
Dongmei BIAN ; Ke SUN ; Ningbo CHEN ; Caixia BAI ; Miao WANG ; Yafeng QIAO ; Fei WANG ; Hong WANG ; Feng TIAN ; Mei YAN ; Meng BAI ; Linjuan ZHANG ; Liyan ZHAO ; Yaqing CUI ; Xue JIANG ; Leling FENG ; Ning NING ; Junqin DING ; Lan WEI ; Yonghua ZHAI ; Yu ZENG ; Zengmei ZHANG ; Jiqun HE ; Fenggui BIE ; Hong CHEN ; Zengyan WANG ; Li LI ; Li ZHANG ; Yaying ZHOU ; Bing SHAO ; Ying WANG ; Caixia XIE ; Yanfeng YAO ; Jingjing AN ; Wen SHI ; Xiongtao LIU ; Xiaoyan AN ; Ning NAN ; Lan LI ; Xiaohui GOU ; Qiaomei LI ; Xiuting WU ; Yuqin ZHANG ; Jing LIU ; Fusen XIANG ; Xu XU ; Na MEI ; Jiao ZHOU ; Shan FAN ; Qian WANG ; Shuixia LI
Chinese Journal of Trauma 2025;41(2):138-147
Spine fracture and dislocation are common traumatic spinal conditions that often require surgical intervention due to compromised spinal stability. Surgical approaches include anterior, posterior, and combined anterior-posterior spinal procedures. According to the specific surgical requirements, patients may be placed in the prone position or repositioned between prone and supine positions during surgery. Intraoperative repositioning has become an essential step in patient positioning. However, during repositioning, patients with spinal fracture and dislocation are at increased risk for complications such as hemodynamic instability, nerve injury, and pressure injuries to the skin and soft tissue. Notably, due to the instability of the spinal cord, even minor manipulations can further exacerbate the damage, potentially leading to severe outcomes like paraplegia. Although the current clinical guidelines provide instructive recommendations for standard position, there remains no specific protocols for intraoperative repositioning in patients with spine fracture and dislocation. With a concern for the lack of clinical studies on positioning techniques, risk prevention, and operational norms for special patients, no applicable guidelines or standards are available. A consensus was required to provide clinical reference, meet the requirements of surgical treatment, and minimize the safety risks of patients caused by improper placement of positions. Professional Committee of Operating Room Nursing of Shaanxi Nursing Association organized experts in nursing management and operating room nursing from major hospitals across China to formulate Expert consensus on intraoperative repositioning for patients with spinal fracture and dislocation ( version 2025). The consensus provides 11 recommendations covering pre-repositioning preparation, intraoperative maneuvers, and post-repositioning observation, aiming to provide references for clinical standardization of the intraoperative repositioning process and protection of patients′ safety.

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