1.Feasibility study of ethmoidal foramen in the medial wall of the orbit based on 10 μm ultra-high resolution CT
Xiwen WANG ; Ping WANG ; Yongxian ZHANG ; Yue KANG ; Yue SHI ; Yunfu LIU ; Zhaohui LIU
Chinese Archives of Otolaryngology-Head and Neck Surgery 2024;31(10):647-651
OBJECTIVE To investigate the feasibility of ultra-high resolution CT(U-HRCT)in demonstrating and evaluating ethmoidal foramen in the medial wall of the orbit.METHODS Nine cadavers(18 side orbits)fixed in 10%buffered formalin were enrolled and underwent U-HRCT and multislice helical CT(MSCT).Subjective and objective evaluations of image quality were performed by two experienced radiologists independently.Anterior,middle,and posterior ethmoidal foramen(AEF,MEF,and PEF)were recorded and the distance among them was measured.RESULTS The results of subjective and objective evaluations were not significant differences between evaluators and consistency was strong.CNR of U-HRCT and MSCT were 43.09±8.87 and 11.04±0.66 and SNR were 2.13±1.45 and 0.55±0.13,respectively.CNR and SNR of U-HRCT were significantly higher than MSCT(P<0.05).Objective scores of the U-HRCT and MSCT groups were 10.00 points(9.00 points,10.00 points)and 6.00 points(5.75 points,7.00 points).Objective scores of the U-HRCT were higher than MSCT(P<0.05).All eighteen AEF were shown by U-HRCT and MSCT.Among 18 PEF showed by U-HRCT,17 of them demonstrated by MSCT,and no significant difference was found in the display rate between groups(P>0.05).Nine MEF(7 single hole and 2 double holes)were found by U-HRCT,but only 2 of them were shown by MSCT.The MEF display rate of U-HRCT was higher than MSCT(P<0.05).The distance from MEF to AEF,from MEF to PEF,and from AEF to PEF were(9.43±1.13)mm,(4.75±1.09)mm,(14.18±1.14)mm,respectively.CONCLUSION U-HRCT is better to evaluate ethmoidal foramen than MSCT.It could be used to show the number and position of ethmoidal foramen before surgery to avoid complications.
2.Pyrotinib Combined with Vinorelbine in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer: A Multicenter, Single-Arm, Prospective Study
Kuikui JIANG ; Ruoxi HONG ; Wen XIA ; Qianyi LU ; Liang LI ; Jianhao HUANG ; Yanxia SHI ; Zhongyu YUAN ; Qiufan ZHENG ; Xin AN ; Cong XUE ; Jiajia HUANG ; Xiwen BI ; Meiting CHEN ; Jingmin ZHANG ; Fei XU ; Shusen WANG
Cancer Research and Treatment 2024;56(2):513-521
Purpose:
This study aims to evaluate the efficacy and safety of a new combination treatment of vinorelbine and pyrotinib in human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) and provide higher level evidence for clinical practice.
Materials and Methods:
This was a prospective, single-arm, phase 2 trial conducted at three institutions in China. Patients with HER2-positive MBC, who had previously been treated with trastuzumab plus a taxane or trastuzumab plus pertuzumab combined with a chemotherapeutic agent, were enrolled between March 2020 and December 2021. All patients received pyrotinib 400 mg orally once daily plus vinorelbine 25 mg/m2 intravenously or 60-80 mg/m2 orally on day 1 and day 8 of 21-day cycle. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included the objective response rate (ORR), disease control rate (DCR), overall survival, and safety.
Results:
A total of 39 patients were enrolled. All patients had been pretreated with trastuzumab and 23.1% (n=9) of them had accepted trastuzumab plus pertuzumab. The median follow-up time was 16.3 months (95% confidence interval [CI], 5.3 to 27.2), and the median PFS was 6.4 months (95% CI, 4.0 to 8.8). The ORR was 43.6% (95% CI, 27.8% to 60.4%) and the DCR was 84.6% (95% CI, 69.5% to 94.1%). The median PFS of patients with versus without prior pertuzumab treatment was 4.6 and 8.3 months (p=0.017). The most common grade 3/4 adverse events were diarrhea (28.2%), neutrophil count decreased (15.4%), white blood cell count decreased (7.7%), vomiting (5.1%), and anemia (2.6%).
Conclusion
Pyrotinib plus vinorelbine showed promising efficacy and tolerable toxicity as second-line treatment in patients with HER2-positive MBC.
3.Comparative efficacy of awake prone positioning combined with standardized nursing care and standardized nursing care in the prevention of early postoperative pulmonary complications in elderly patients with hip fracture
Liu SHI ; Yucheng GAO ; Hao WANG ; Wang GAO ; Cheng ZHANG ; Tian XIE ; Min LIU ; Xiwen ZHANG ; Yingjuan LI ; Chuwei TIAN ; Chunhua DENG ; Hui CHEN ; Yunfeng RUI
Chinese Journal of Trauma 2023;39(11):1014-1021
Objective:To compare the effectiveness of awake prone positioning (APP) care combined with standardized nursing and standardized nursing care in the prevention of early postoperative pulmonary complications (PPCs) in elderly patients with hip fracture.Methods:A retrospective cohort study was conducted to analyze the clinical data of 84 elderly patients with hip fracture Admitted to Zhongda Hospital Affiliated to Southeast University from February 2021 to August 2021. There were 31 males and 53 females, aged 67-96 years [(82.3±6.3)years]. Fracture types were femoral neck fracture ( n=45) and intertrochanteric fracture ( n=39). Surgical procedures included closed reduction internal fixation ( n=39), hip hemiarthroplasty ( n=35), and total hip arthroplasty ( n=10). Among them, 42 patients received standardized nursing care and APP intervention (APP combined with standardized nursing care group), while the remaining 42 patients received standardized nursing care only (standardized nursing care group). The incidence rate of PPCs (including pneumonia, respiratory failure, pleural effusion, atelectasis and pulmonary edema) within 30 postoperative days, arterial oxygen pressure (PaO 2), arterial carbon dioxide pressure (PaCO 2), arterial oxygen saturation (SaO 2) on the 4th postoperative day, difference in PaO 2 between the 4th postoperative day and emergency visit, clinical pulmonary infection score (CPIS) on the 4th postoperative day, and number of adverse events related to APP were compared between the two groups. Results:All the patients were followed up for 30-90 days [(86.1±16.5)days]. The incidence rates of PPCs and type 1 postoperative respiratory failure in the APP combined with standardized nursing care group were 16.7% (7/42) and 4.8% (2/42), and were 35.7% (15/42) and 21.4% (9/42) in the standardized nursing care group (all P<0.05). The PaO 2 and SaO 2 on the 4th postoperative day, and difference in PaO 2 between the 4th postoperative day and emergency visit were (82.0±8.8)mmHg, 0.96±0.01, and 3.2 (-1.9, 8.0)mmHg in the APP combined with standardized nursing care group, and were (74.3±12.1)mmHg, 0.94±0.03, and -7.6 (-17.2, 1.1)mmHg in the standardized nursing care group (all P<0.01). The CPIS on the 4th postoperative day was 2.0 (1.0, 3.0)points in the APP combined with standardized nursing care group and 4.0 (1.0, 7.0)points in the standardized nursing care group ( P<0.05). No statistically significant differences were observed in the incidence of pneumonia, type I respiratory failure, pleural effusion, atelectasis and pulmonary edema within 30 postoperative days, as well as PaCO 2 on the 4th postoperative day between the two groups (all P>0.05). None of the patients experienced adverse events related to APP. Conclusion:For elderly patients with hip fracture, compared with standardized nursing care, application of APP combined with standardized nursing care can significantly decrease the incidence rate of early PPCs, especially type I respiratory failure, and improve postoperative oxygenation.
4.Risk factors of preoperative hypoxemia in geriatric patients with hip fracture
Yucheng GAO ; Liu SHI ; Wang GAO ; Tian XIE ; Xiwen ZHANG ; Min LIU ; Xiangxu CHEN ; Cheng ZHANG ; Wenbin FAN ; Xueliang CUI ; Yulei QIAN ; Yingjuan LI ; Hui CHEN ; Yunfeng RUI
Chinese Journal of Trauma 2022;38(5):436-443
Objective:To investigate the risk factors for preoperative hypoxemia in geriatric patients with hip fracture.Methods:A case-control study was used to analyze the clinical data of 99 geriatric patients with hip fracture admitted to Zhongda Hospital affiliated to Southeast University between November 2020 and August 2021. There were 29 males and 70 females, aged 67-96 years [(82.6±6.2)years]. The patients were divided into hypoxemia group ( n=51) and non-hypoxemia group ( n=48) using partial arterial partial pressure of oxygen (PaO 2)<80 mmHg while breathing room air at emergency as the reference standard. The two groups were compared in terms of sex, age, fracture types, body mass index (BMI), American Society of Anesthesiologists (ASA) classification, pulmonary diseases diagnosed by preoperative chest CT [atelectasis, pleural effusion, chronic obstructive pulmonary disease (COPD)], time from injury to visit, New York Heart Association (NYHA) classification, Barthel index, KATZ index, modified Medicine Research Council (mMRC) dyspnea scale, numeric rating scale (NRS), smoking, drinking, comorbidities (hypertension, diabetes mellitus, Parkinson′s disease, Alzheimer′s disease, cerebral infarction, coronary atherosclerotic heart disease), body temperature, blood routine test at first examination (erythrocyte count, leukocyte count, C-reactive protein, hemoglobin), biochemistry (serum albumin, blood glucose, blood creatinine, blood urea nitrogen), electrolyte (serum potassium, serum sodium), and other related examinations [D-dimer, brain natriuretic peptide (BNP), lactic acid]. Univariate analysis was performed to the correlation of those indicators with preoperative hypoxemia. Multivariate Logistic regression analysis was used to identify the independent risk factors for preoperative hypoxemia in geriatric patients with hip fracture. Results:Differences in sex, age, fracture types, BMI, pulmonary diseases diagnosed by preoperative chest CT, time from injury to visit, Barthel index, KATZ index, NRS, smoking, drinking, comorbidities, body temperature, first laboratory results of erythrocyte count, biochemistry, electrolyte and other related examinations were not statistically significant between the two groups (all P>0.05). The two groups showed statistical differences in ASA classification, NYHA classification, mMRC dyspnea scale, leukocyte count at first examination, C-reaction protein and hemoglobin (all P<0.05). Univariate analysis indicated that ASA classification, NYHA classification, mMRC dyspnea scale, leukocyte count at first examination and C-reaction protein were correlated with the occurrence of preoperative hypoxemia in geriatric patients with hip fracture (all P<0.05). Multivariate Logistic regressions analysis indicated that higher mMRC dyspnea scale ( OR=2.30, 95% CI 1.10-4.81, P<0.05), higher leukocyte count at first examination ( OR=1.24, 95% CI 1.05-1.45, P<0.05), higher level of C-reaction protein ( OR=1.02, 95% CI 1.01-1.03, P<0.05) and higher level of hemoglobin ( OR=1.04, 95% CI 1.01-1.07, P<0.05) were significantly correlated with the occurrence of preoperative hypoxemia in geriatric patients with hip fracture. Conclusion:Higher mMRC dyspnea scale, higher leukocyte count, higher level of C-reaction protein and higher level of hemoglobin are independent risk factors for preoperative hypoxemia in geriatric patients with hip fracture.
5.Cost-effectiveness of primary prophylaxis with PEG-rhG-CSF in early-stage breast cancer patients receiving chemotherapy in China
Wen XIA ; Shusen WANG ; Hao HU ; Feili ZHAO ; Fei XU ; Ruoxi HONG ; Kuikui JIANG ; Zhongyu YUAN ; Yanxia SHI ; Kun ZHAO ; Jiajia HUANG ; Cong XUE ; Xiwen BI ; Qianyi LU ; Xin AN ; Jingmin ZHANG
Chinese Journal of Oncology 2020;42(10):861-867
Objective:To evaluate the cost effectiveness of primary prophylaxis (PP) with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF), PP with recombinant human granulocyte colony stimulating factor (rhG-CSF) and no prophylaxis in women with early-stage breast cancer in China.Methods:Two phase Markov models were constructed for a hypothetical cohort of patients aged 45 with stage Ⅱ breast cancer. The first phase modelled costs and outcomes of 4 cycles docetaxel combined with cyclophosphamide [TC×4, febrile neutropenia (FN) risk>20%] chemotherapy, which assumptions based on literature reviews, including FN rates [base-case (deterministic sensitivity analysis range), 0.29 (0.24-0.35)] and related events [FN case-fatality, 3.4 (2.7-4.1)]. Second phase modelled the long term survival which was link with the relative dose intensity (RDI) [mortality hazard ratio ( HR) of RDI < 85% vs ≥85%, 1.45 (1.00-2.32)]. Clinical effectiveness, therapeutic costs, and economic utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences. Results:Compared to rhG-CSF PP and no prophylaxis, the cost of PEG-rhG-CSF PP increased to 5 208.19 RMB and 5 222.73 RMB, respectively. The quality-adjusted life-years (QALYs) enhanced to 0.066 and 0.297, respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79 146.3 RMB and 17 558.77 RMB per QALY, which were both below the willingness to pay (WTP) threshold of three times GDP per capita (18, 000 RMB) recommended by the WHO. Sensitivity analysis suggested that the more clinically effective the primary prophylaxis with PEG-rhG-CSF is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. And the lower the mortality HR of RDI<85% vs ≥85% is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. Conclusion:Although the cost of PP PEG-rhG-CSF is higher, considering the additional benefits, the administrating of PP PEG-rhG-CSF is likely to be a cost-effective alternative to PP rhG-CSF and no prophylaxis in patients with early stage breast cancer whose FN risks are more than 20% in China.
6.Cost-effectiveness of primary prophylaxis with PEG-rhG-CSF in early-stage breast cancer patients receiving chemotherapy in China
Wen XIA ; Shusen WANG ; Hao HU ; Feili ZHAO ; Fei XU ; Ruoxi HONG ; Kuikui JIANG ; Zhongyu YUAN ; Yanxia SHI ; Kun ZHAO ; Jiajia HUANG ; Cong XUE ; Xiwen BI ; Qianyi LU ; Xin AN ; Jingmin ZHANG
Chinese Journal of Oncology 2020;42(10):861-867
Objective:To evaluate the cost effectiveness of primary prophylaxis (PP) with pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF), PP with recombinant human granulocyte colony stimulating factor (rhG-CSF) and no prophylaxis in women with early-stage breast cancer in China.Methods:Two phase Markov models were constructed for a hypothetical cohort of patients aged 45 with stage Ⅱ breast cancer. The first phase modelled costs and outcomes of 4 cycles docetaxel combined with cyclophosphamide [TC×4, febrile neutropenia (FN) risk>20%] chemotherapy, which assumptions based on literature reviews, including FN rates [base-case (deterministic sensitivity analysis range), 0.29 (0.24-0.35)] and related events [FN case-fatality, 3.4 (2.7-4.1)]. Second phase modelled the long term survival which was link with the relative dose intensity (RDI) [mortality hazard ratio ( HR) of RDI < 85% vs ≥85%, 1.45 (1.00-2.32)]. Clinical effectiveness, therapeutic costs, and economic utilities were estimated from peer-reviewed publications and expert opinions in case of unavailability of published evidences. Results:Compared to rhG-CSF PP and no prophylaxis, the cost of PEG-rhG-CSF PP increased to 5 208.19 RMB and 5 222.73 RMB, respectively. The quality-adjusted life-years (QALYs) enhanced to 0.066 and 0.297, respectively. Accordingly, the incremental cost effectiveness ratios (ICERs) are 79 146.3 RMB and 17 558.77 RMB per QALY, which were both below the willingness to pay (WTP) threshold of three times GDP per capita (18, 000 RMB) recommended by the WHO. Sensitivity analysis suggested that the more clinically effective the primary prophylaxis with PEG-rhG-CSF is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. And the lower the mortality HR of RDI<85% vs ≥85% is, the more cost-effective primary prophylaxis with PEG-rhG-CSF will be. Conclusion:Although the cost of PP PEG-rhG-CSF is higher, considering the additional benefits, the administrating of PP PEG-rhG-CSF is likely to be a cost-effective alternative to PP rhG-CSF and no prophylaxis in patients with early stage breast cancer whose FN risks are more than 20% in China.
7.Pedigree analysis of DYNC1H1 p. P776L mutation in a family with spinal muscular atrophy
Xiaojuan WANG ; Haichang MA ; Hongzhi GUAN ; Xiwen GENG ; Shujian LI ; Yingying SHI ; Huiqin LIU ; Lingzhi QIN ; Gang LIU ; Wei LI
Chinese Journal of Neurology 2018;51(12):949-954
Objective To analyze the clinical and electrophysiological features in a family with spinal muscular atrophy (SMA), and assess the probable causative gene mutations for the family. Methods To identify the nosogenesis of the proband with weakness and atrophy in the double lower proximal limbs, clinical data of his 12 family members were collected, and the proband and his mother were selected for clinical examinations, including laboratory tests, electromyogram (EMG), F-wave, H-reflex, X-ray of the spine and double lower limbs, brain and spinal cord magnetic resonance imaging, etc. Moreover, human whole exome sequencing was performed on blood sample from the proband, then its deleterious effects were assessed according to the Standards and guidelines for the interpretation of sequence variants, a joint consensus recommendation of the American College of Medical Genomics (ACMG) and the Association for Molecular Pathology (AMP). Subsequently, the strong pathogenic mutation was validated by Sanger sequencing. Results Familial investigation showed seven of 12 family members presented with weakness in the double lower proximal limbs. Among them, three had the main manifestation of atrophy in the double lower proximal limbs, one had high arched foot as the main presentation, and the others had weakness in the double lower proximal limbs. EMG studies showed the abnormal results in the anterior horn of the spinal cord. The strong pathogenic mutation in DYNC1H1 gene (exon8, c.2327C>T, p.P776L) was identified from the proband according to ACMG and AMP guidelines. Sanger sequencing revealed six patients had this variant and it was passed mainly from his maternal grandmother. Conclusions A pathogenic mutation of the DYNC1H1 p.P776L in six Chinese pedigrees which cosegregated with SMA was identified. There existed individual differences in clinical presentations. This finding may have important implications for the study of SMA in Chinese patients.
8.Frameless stereotactic ventriculoperitoneal shunt
Zhonghua WU ; Bin WANG ; Xiwen SHI ; Ming LI ; Yu LI ; Yongming LI
Chinese Journal of Neuromedicine 2017;16(4):419-421
Objective To explore the clinical efficacy of simple frameless stereotactic ventricle peritoneal shunt.Methods Retrospective analysis was performed in 128 patients with hydrocephalus,admitted to and performed ventriculoperitoneal shunt in our hospital from March 2012 to March 2016:simple frameless stereotactic ventricle peritoneal shunt was performed in 47,traditional occipital horn puncture in 23,and traditional triangle puncture in 58.The respective end of shunt tube placement position and recent end shunt tube adjustment were analyzed retrospectively.Results Inappropriate position was achieved in one patient performed simple frameless stereotactic biopsy,and no recent change or reset the shunt pipe was performed.In patients accepted traditional pillow angle puncture,head end improper placement happened in 5 patients,adjustment of recent tip was performed in 3.In patients accepted traditional triangle puncture,incorrect triangle needle tip was placed in 20 patients,and recent change or reset the head end shunt was performed in 7.Conclusion Simple frameless stereotactic puncture is effective in shunt placement of head end,which can lower the head end shunt recent change or reset the risk.
9.Clinical analysis of early lumbar drainage combined with antibiotic therapy in ventricular peritoneal shunt infection
Zhonghua WU ; Bin WANG ; Xiwen SHI
Chinese Journal of Neuromedicine 2016;15(6):614-616
Objective To explore the effectiveness of early lumbar pool drainage combined with antibiotics treatment in remedying ventricle peritoneal shunt infection and the problems needed to be paid attention during the process of treatment.Methods Twenty-two patients with infection after ventricle peritoneal shunt,admitted to our hospital from January 2008 to June 2015,were given lumbar pool drainage combined with antibiotics treatment,including 16 with early lumbar pool drainage combined with antibiotics treatment (3-7 d of infection) and 6 with late lumbar pool drainage combined with antibiotics treatment (8-10 d of infection).The clinical data and treatment efficacy were retrospectively analyzed.Results Bacterial culture of cerebrospinal fluid in the 22 patients indicated negative results in 5,coagulase negative staphylococcus in 10,staphylococcus aureus in two,enterococcus in two and klebsiella bacillus in three;the cure rate of patients with staphylococcus aureus was the lowest (0%);after lumbar pool drainage combined with antibiotics treatment,the cure rate of these patients reached to 72.7% (16/22);the infection of the left 6 patients could not be controlled,and therefore ventriculoperitoneal shunt was removed.The cure rate in patients with early treatment was better than that in patients with late treatment (88% vs.33%).Conclusion Early lumbar drainage combined with antibiotics can effectively control the ventricle peritoneal shunt infection,avoid risk of second operation and save economic burden.
10.Treatment strategies of medulla oblongata cavernous malformations
Rongjun QIAN ; Zhixiao LI ; Jiadong ZHANG ; Xiwen SHI
Chinese Journal of Neuromedicine 2016;15(9):932-935
Objective To discuss the strategies and efficacies of surgical treatment in medulla oblongata cavernous malformations.Methods The clinical and follow-up data of 9 patients with medulla oblongata cavernous malformations,admitted to our hospital from October 201 1 to February 2015,were retrospectively analyzed.Five patients underwent surgical treatment:posterior midline transcerebellomedullary fissure approach was used in 4,far-lateral transcondylar approach in one,and all cavernous malformations were excised completely.Conservative treatment and regular observation were done in 4 patients.Follow-up was performed for 10-40 months.Results Symptoms improved after surgery in 4 patients;postoperative hemiplegia appeared in one,and at the end of follow-up,the muscle strength of hemiplegic limbs recovered to level Ⅳ.Minor re-hemorrhage was noted in one of the 4 patients with conservative treatment at the end of the follow-up,and no changes were noted in the rest patients.Karnofsky Performance Scale scores were 82.2 ±6.7,which were significantly increased as compared with those before treatment (73.3±11.2,P<0.05).Conclusion After strict preoperative evaluation,surgical treatment is a feasible way,enjoying good prognosis in medulla oblongata cavernous malformations;but,patients with deep site,small malformations or no obvious bleeding symptoms should not be operated.

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