1.Safety evaluation of sintilimab in combination with chemotherapy for the treatment of cholangiocarcinoma
Hao ZHONG ; Hang LIN ; Yaxin LU ; Haiyan MAI
China Pharmacy 2025;36(4):482-485
OBJECTIVE To assess the safety profile of sintilimab in combination with chemotherapy for the treatment of cholangiocarcinoma. METHODS The data of patients with cholangiocarcinoma from January 1st, 2021 to December 31st, 2022 were collected and divided into control group (29 cases) and observation group (18 cases) based on different medication regimens. Patients in the control group were treated with Gemcitabine hydrochloride for injection+Cisplatin for injection or Oxaliplatin for injection, the observation group was treated with Sintilimab injection based on the control group. Patients in each group underwent blood routine, liver and kidney function, biochemical and other examinations before and after each treatment cycle to observe the occurrence of adverse drug reactions. The correlation of adverse drug reactions with drugs was evaluated with Naranjo’s scale. RESULTS The correlation between blood toxicity and drug use was deemed “probable” in both groups; however, the observation group exhibited a significantly higher score, indicating a stronger correlation. In the control group, hepatotoxic reactions were classified as “suspicious” whereas in the observation group, they were categorized as “probable”. The correlation of gastrointestinal symptoms between the two groups was considered “possible”. Systemic symptoms, skin toxicity, musculoskeletal toxicity, endocrine toxicity and renal toxicity were all classified as having a “suspicious” correlation with drug use. The total incidence of blood toxicity in the observation group was significantly higher than control group (P=0.014). There was no statistically significant difference in the total incidences of hepatotoxic, gastrointestinal symptoms, systemic symptoms, skin toxicity, musculoskeletal toxicity, endocrine toxicity, renal toxicity, or the incidence of grade 3 or higher blood toxicity, hepatotoxic between the two groups (P>0.05). For the patients experiencing adverse drug reactions, the symptoms were alleviated following drug discontinuation or symptomatic supportive treatment. No fatalities occurred during the treatment period. CONCLUSIONS Sintilimab combined with chemotherapy may significantly increase the risk of blood toxicity in patients with cholangiocarcinoma, especially thrombocytopenia, but the adverse reactions are within a controllable range, and the overall safety is good.
2.Introduction and enlightenment of the Recommendations and Expert Consensus for Plasm a and Platelet Transfusion Practice in Critically ill Children: from the Transfusion and Anemia Expertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB)
Lu LU ; Jiaohui ZENG ; Hao TANG ; Lan GU ; Junhua ZHANG ; Zhi LIN ; Dan WANG ; Mingyi ZHAO ; Minghua YANG ; Rong HUANG ; Rong GUI
Chinese Journal of Blood Transfusion 2025;38(4):585-594
To guide transfusion practice in critically ill children who often need plasma and platelet transfusions, the Transfusion and Anemia Expertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB) developed Recommendations and Expert Consensus for Plasma and Platelet Transfusion Practice in Critically Ill Children. This guideline addresses 53 recommendations related to plasma and platelet transfusion in critically ill children with 8 kinds of diseases, laboratory testing, selection/treatment of plasma and platelet components, and research priorities. This paper introduces the specific methods and results of the recommendation formation of the guideline.
3.Clinical guidelines for indications, techniques, and complications of autogenous bone grafting.
Jianzheng ZHANG ; Shaoguang LI ; Hongying HE ; Li HAN ; Simeng ZHANG ; Lin YANG ; Wenxing HAN ; Xiaowei WANG ; Jie GAO ; Jianwen ZHAO ; Weidong SHI ; Zhuo WU ; Hao WANG ; Zhicheng ZHANG ; Licheng ZHANG ; Wei CHEN ; Qingtang ZHU ; Tiansheng SUN ; Peifu TANG ; Yingze ZHANG
Chinese Medical Journal 2024;137(1):5-7
4.Simulated Microgravity can Promote the Apoptosis and Change Inflammatory State of Kupffer Cells
Ge JUN ; Liu FEI ; Nie HONGYUN ; Yue YUAN ; Liu KAIGE ; Lin HAIGUAN ; Li HAO ; Zhang TAO ; Yan HONGFENG ; Xu BINGXIN ; Sun HONGWEI ; Yang JIANWU ; Si SHAOYAN ; Zhou JINLIAN ; Cui YAN
Biomedical and Environmental Sciences 2024;37(10):1117-1127
Objective In this study,we analyzed the transcriptome sequences of Kupffer cells exposed to simulated microgravity for 3 d and conducted biological experiments to determine how microgravity initiates apoptosis in Kupffer cells. Methods Rotary cell culture system was used to construct a simulated microgravity model.GO and KEGG analyses were conducted using the DAVID database.GSEA was performed using the R language.The STRING database was used to conduct PPI analysis.qPCR was used to measure the IL1B,TNFA,CASP3,CASP9,and BCL2L11 mRNA expressions.Western Blotting was performed to detect the level of proteins CASP3 and CASP 9.Flow cytometry was used to detect apoptosis and mitochondrial membrane cells.Transmission electron microscopy was used to detect changes in the ultrastructure of Kupffer cells. Results Transcriptome Sequencing indicated that simulated microgravity affected apoptosis and the inflammatory state of Kupffer cells.Simulated microgravity improved the CASP3,CASP9,and BCL2L11 expressions in Kupffer cells.Annexin-V/PI and JC-1 assays showed that simulated microgravity promoted apoptosis in Kupffer cells.Simulated microgravity causes M1 polarization in Kupffer cells. Conclusion Our study found that simulated microgravity facilitated the apoptosis of Kupffer cells through the mitochondrial pathway and activated Kupffer cells into M1 polarization,which can secrete TNFA to promote apoptosis.
5.Oral anti-coagulants use in Chinese hospitalized patients with atrial fibrillation
Jing LIN ; Deyong LONG ; Chenxi JIANG ; Caihua SANG ; Ribo TANG ; Songnan LI ; Wei WANG ; Xueyuan GUO ; Man NING ; Zhaoqing SUN ; Na YANG ; Yongchen HAO ; Jun LIU ; Jing LIU ; Xin DU ; Louise MORGAN ; C. Gregg FONAROW ; C. Sidney SMITH ; Y.H. Gregory LIP ; Dong ZHAO ; Jianzeng DONG ; Changsheng MA
Chinese Medical Journal 2024;137(2):172-180
Background::Oral anti-coagulants (OAC) are the intervention for the prevention of stroke, which consistently improve clinical outcomes and survival among patients with atrial fibrillation (AF). The main purpose of this study is to identify problems in OAC utilization among hospitalized patients with AF in China.Methods::Using data from the Improving Care for Cardiovascular Disease in China-Atrial Fibrillation (CCC-AF) registry, guideline-recommended OAC use in eligible patients was assessed.Results::A total of 52,530 patients with non-valvular AF were enrolled from February 2015 to December 2019, of whom 38,203 were at a high risk of stroke, 9717 were at a moderate risk, and 4610 were at a low risk. On admission, only 20.0% (6075/30,420) of patients with a diagnosed AF and a high risk of stroke were taking OAC. The use of pre-hospital OAC on admission was associated with a lower risk of new-onset ischemic stroke/transient ischemic attack among the diagnosed AF population (adjusted odds ratio: 0.54, 95% confidence interval: 0.43–0.68; P <0.001). At discharge, the prescription rate of OAC was 45.2% (16,757/37,087) in eligible patients with high stroke risk and 60.7% (2778/4578) in eligible patients with low stroke risk. OAC utilization in patients with high stroke risk on admission or at discharge both increased largely over time (all P <0.001). Multivariate analysis showed that OAC utilization at discharge was positively associated with in-hospital rhythm control strategies, including catheter ablation (adjusted odds ratio [OR] 11.63, 95% confidence interval [CI] 10.04–13.47; P <0.001), electronic cardioversion (adjusted OR 2.41, 95% CI 1.65–3.51; P <0.001), and anti-arrhythmic drug use (adjusted OR 1.45, 95% CI 1.38–1.53; P <0.001). Conclusions::In hospitals participated in the CCC-AF project, >70% of AF patients were at a high risk of stroke. Although poor performance on guideline-recommended OAC use was found in this study, over time the CCC-AF project has made progress in stroke prevention in the Chinese AF population.Registration::ClinicalTrials.gov, NCT02309398.
6.Analysis of factors influencing the efficacy and prognosis of surgical treatment for primary malignant pelvic bone tumors
Weifeng LIU ; Lin HAO ; Zhuoyu LI ; Tao JIN ; Yang SUN ; Yongkun YANG ; Yuan LI ; Fajun YANG ; Feng YU ; Qing ZHANG ; Xiaohui NIU
Chinese Journal of Oncology 2024;46(4):344-353
Objective:To analyze the prognostic factors and the influence of surgical margin to prognosis.Methods:A retrospective analysis was performed for 208 pelvic tumors who received surgical treatment from January 2000 to December 2017 in our instituition. Survival analysis was performed using the Kaplan-Meier method and Log rank test, and impact factor analysis was performed using Cox regression models.Results:There were 183 initial patients and 25 recurrent cases. According to Enneking staging, 110 cases were stage ⅠB and 98 cases were stage ⅡB. 19 lesions were in zone Ⅰ, 1 in zone Ⅱ, 15 in zone Ⅲ, 29 in zone Ⅰ+Ⅱ, 71 in zone Ⅱ+Ⅲ, 29 in zone Ⅰ+Ⅳ, 35 in zone Ⅰ+Ⅱ+Ⅲ, 3 in zone Ⅰ+Ⅱ+Ⅳ, and 6 in zone Ⅰ+Ⅱ+Ⅲ+Ⅳ. Surgical margins including Intralesional excision in 7 cases, contaminated margin in 21 cases, marginal resection in 67 cases, and wide resection in 113 cases. Local recurrence occurred in 37 cases (17.8%), 25 cases were performed by reoperation and 12 cases received amputation finally. The 5-year recurrence rate of marginal resection was higher than wide resection ( P<0.05), and the recurrence-free survival rate of marginal resection was lower than wide resection ( P<0.05). There was significant differences in recurrence rate and recurrence-free survival rate between R0 and R1 resection ( P<0.05). 92 cases were not reconstructed and 116 cases were reconstructed after pelvic surgery. At the last follow-up, 63 patients (30.3%) died, and the 5-year, 10-year and 15-year survival rates were 70.4%, 66.8% and 61.3%, respectively. The 5-year survival rate of stage ⅠB and ⅡB tumor was 90.4% and 46.8%, respectively. There were 29 cases had postoperative wound complications (13.8%), 1 case with pelvic organ injury. The final function was evaluated in 132 patients, with an average MSTS score of 25.1±3.6. Cox multivariate analysis showed that surgical staging, R0/R1 margin and metastasis were independent prognostic factors for pelvic tumors. Conclusions:The safe surgical margin is the key factor for recurrence-free of pelvic tumor. The survival rate of stage ⅡB pelvic tumors was significantly lower than that of stage ⅠB tumors. Wound infection is the main postoperative complication. Surgical staging, R0/R1 margin and metastasis were independent prognostic factors of pelvic tumors.
7.Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults (version 2024)
Qingde WANG ; Yuan HE ; Bohua CHEN ; Tongwei CHU ; Jinpeng DU ; Jian DONG ; Haoyu FENG ; Shunwu FAN ; Shiqing FENG ; Yanzheng GAO ; Zhong GUAN ; Hua GUO ; Yong HAI ; Lijun HE ; Dianming JIANG ; Jianyuan JIANG ; Bin LIN ; Bin LIU ; Baoge LIU ; Chunde LI ; Fang LI ; Feng LI ; Guohua LYU ; Li LI ; Qi LIAO ; Weishi LI ; Xiaoguang LIU ; Hongjian LIU ; Yong LIU ; Zhongjun LIU ; Shibao LU ; Yong QIU ; Limin RONG ; Yong SHEN ; Huiyong SHEN ; Jun SHU ; Yueming SONG ; Tiansheng SUN ; Yan WANG ; Zhe WANG ; Zheng WANG ; Hong XIA ; Guoyong YIN ; Jinglong YAN ; Wen YUAN ; Zhaoming YE ; Jie ZHAO ; Jianguo ZHANG ; Yue ZHU ; Yingjie ZHOU ; Zhongmin ZHANG ; Wei MEI ; Dingjun HAO ; Baorong HE
Chinese Journal of Trauma 2024;40(2):97-106
Ankylosing spondylitis (AS) combined with lower cervical fracture is often categorized into unstable fracture, with a high incidence of neurological injury and a high rate of disability and morbidity. As factors such as shoulder occlusion may affect the accuracy of X-ray imaging diagnosis, it is often easily misdiagnosed at the primary diagnosis. Non-operative treatment has complications such as bone nonunion and the possibility of secondary neurological damage, while the timing, access and choice of surgical treatment are still controversial. Currently, there are no clinical practice guidelines for the treatment of AS combined with lower cervical fracture with or without dislocation. To this end, the Spinal Trauma Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults ( version 2024) in accordance with the principles of evidence-based medicine, scientificity and practicality, in which 11 recommendations were put forward in terms of the diagnosis, imaging evaluation, typing and treatment, etc, to provide guidance for the diagnosis and treatment of AS combined with lower cervical fracture.
8.Expert consensus on the diagnosis and treatment of osteoporotic proximal humeral fracture with integrated traditional Chinese and Western medicine (version 2024)
Xiao CHEN ; Hao ZHANG ; Man WANG ; Guangchao WANG ; Jin CUI ; Wencai ZHANG ; Fengjin ZHOU ; Qiang YANG ; Guohui LIU ; Zhongmin SHI ; Lili YANG ; Zhiwei WANG ; Guixin SUN ; Biao CHENG ; Ming CAI ; Haodong LIN ; Hongxing SHEN ; Hao SHEN ; Yunfei ZHANG ; Fuxin WEI ; Feng NIU ; Chao FANG ; Huiwen CHEN ; Shaojun SONG ; Yong WANG ; Jun LIN ; Yuhai MA ; Wei CHEN ; Nan CHEN ; Zhiyong HOU ; Xin WANG ; Aiyuan WANG ; Zhen GENG ; Kainan LI ; Dongliang WANG ; Fanfu FANG ; Jiacan SU
Chinese Journal of Trauma 2024;40(3):193-205
Osteoporotic proximal humeral fracture (OPHF) is one of the common osteoporotic fractures in the aged, with an incidence only lower than vertebral compression fracture, hip fracture, and distal radius fracture. OPHF, secondary to osteoporosis and characterized by poor bone quality, comminuted fracture pattern, slow healing, and severely impaired shoulder joint function, poses a big challenge to the current clinical diagnosis and treatment. In the field of diagnosis, treatment, and rehabilitation of OPHF, traditional Chinese and Western medicine have accumulated rich experience and evidence from evidence-based medicine and achieved favorable outcomes. However, there is still a lack of guidance from a relevant consensus as to how to integrate the advantages of the two medical systems and achieve the integrated diagnosis and treatment. To promote the diagnosis and treatment of OPHF with integrated traditional Chinese and Western medicine, relevant experts from Orthopedic Expert Committee of Geriatric Branch of Chinese Association of Gerontology and Geriatrics, Youth Osteoporosis Group of Orthopedic Branch of Chinese Medical Association, Osteoporosis Group of Orthopedic Surgeon Branch of Chinese Medical Doctor Association, and Osteoporosis Committee of Shanghai Association of Integrated Traditional Chinese and Western Medicine have been organized to formulate Expert consensus on the diagnosis and treatment of osteoporotic proximal humeral fracture with integrated traditional Chinese and Western medicine ( version 2024) by searching related literatures and based on the evidences from evidence-based medicine. This consensus consists of 13 recommendations about the diagnosis, treatment and rehabilitation of OPHF with integrated traditional Chinese medicine and Western medicine, aimed at standardizing, systematizing, and personalizing the diagnosis and treatment of OPHF with integrated traditional Chinse and Western medicine to improve the patients ′ function.
9.Reliability and Validity of the SGGC-Net-Based Motion Capture System for Analyzing Walking Gait
Lin ZHU ; Pengcheng DONG ; Peixin SHEN ; Hao CHEN ; Jiande SUN ; Qipeng SONG
Journal of Medical Biomechanics 2024;39(2):305-311
Objective The reliability and validity of the SGGC-Net-based motion capture system(SGGC-Net system)and SIMI system for parsing walking gait were compared using a three-dimensional(3D)motion capture system(Vicon)with marker points as a reference standard.Methods Thirty healthy college students were recruited,and their gait characteristics while walking on a treadmill were analyzed.Kinematic data were collected using the Vicon system,and video data were collected synchronously using four cameras to obtain the right shoulder,elbow,hip,knee,and ankle joint angles.Reliability was assessed using intraclass correlation coefficients(ICCs)with 95%confidence intervals and standard error of measurement(SEM).Validity was assessed using multiple correlation coefficients(MCCs)and root mean square errors(RMSEs).Results The ICCs of the maximum and minimum 3D coordinate angles of the upper and lower limb joints of the SGGC-Net system ranged from 0.798-0.990 with an SEM of 0.04°-0.95°,and the ICCs of the SIMI system ranged from 0.650-0.967,with an SEM of 0.31°-1.24°.The ICCs of the SGGC-Net system were higher than those of the SIMI system for all joint angles except for the minimum hip and maximum knee angles.Compared to the joint angle curves derived from the SIMI system,the MCCs of the curves derived from the SGGC-Net system ranged from 0.945-0.996,with RMSEs of 1.44°-4.65°,and the multiple correlation coefficients of the SIMI system ranged from 0.815-0.986,with RMSEs of 2.56°-9.99°.The MCCs of the SGGC-Net system were greater than those of the SIMI system at all angles except for the ankle joint.The RMSEs of the SGGC-Net system were smaller than those of the SIMI system at all angles except for the ankle joints.Conclusions The SGGC-Net system has better reliability and validity than the SIMI system in most of the variables,and it has better repeatability and accuracy in analyzing walking gait.It can be applied to motion capture environments without marker points,such as technical analysis of athletes'movements and clinical gait analysis of special populations.
10.The value of magnetic resonance imaging and pathological multi parameters in predicting the efficacy of neoadjuvant chemotherapy for advanced breast cancer
Zhengtong WANG ; Fan ZHAO ; Chongchong LI ; Yueqin CHEN ; Zhanguo SUN ; Hao YU ; Zhitao SHI ; Lin CHEN ; Weiwei WANG
Journal of Chinese Physician 2024;26(9):1343-1349
Objective:To explore the value of conventional magnetic resonance imaging (MRI), diffusion weighted imaging (DWI), diffusion kurtosis imaging (DKI) sequence and pathological examination in predicting the efficacy of neoadjuvant chemotherapy (NAC) in advanced breast cancer.Methods:The clinical data of 65 cases of advanced breast cancer with NAC confirmed by pathology in the Affiliated Hospital of Jining Medical University from March 2022 to May 2023 were retrospectively analyzed, including 20 cases in the pathological complete remission (pCR) group and 45 cases in the non pCR group; All patients underwent routine MRI, DWI, DKI examinations and pathological analysis. The clinical pathological data, routine MRI features, apparent diffusion coefficient (ADC) values, mean kurtosis coefficient (MK), and mean diffusion coefficient (MD) between the two groups were analyzed; We compared the differences in various parameters between two groups and plotted receiver operating characteristic (ROC) curves to compare their diagnostic efficacy of NAC in breast cancer.Results:There were significant differences in molecular typing, estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (Her-2) and Ki-67 between pCR group and non pCR group (all P<0.05). In pCR group, Her-2 overexpression type and triple negative breast cancer (TNBC) type breast cancer were more common. ER and PR were mostly negative, Her-2 was mostly positive, and Ki 67 was mainly positive. The difference in tumor T2WI signal between the pCR group and the non pCR group was statistically significant ( P<0.05), with the pCR group showing mostly moderate/low T2WI signal. The ADC and MD values of the pCR group were lower than those of the non pCR group, while the MK value of the pCR group was higher than that of the non pCR group, and the differences were statistically significant (all P<0.001). The area under the ROC curve (AUC) for predicting the efficacy of NAC using a clinical pathological model was 0.829, which was higher than the AUC of molecular subtypes, ER, PR, Her-2, and Ki-67 ( Z=3.008, 2.697, 2.815, 2.131, 2.376, all P<0.05); The AUC of the DKI+ DWI predicting the efficacy of NAC was 0.934, which was higher than that of the DWI single sequence model, and the difference in type was statistically significant ( Z=2.396, P=0.017). The diagnostic efficacy of the DKI+ DWI model was higher than that of the single parameter ADC, MD, and MK, and the differences were statistically significant ( Z=2.396, 2.219, 2.161, all P<0.05); The AUC of the combined imaging and pathology model was 0.983, and its diagnostic efficacy was higher than that of the conventional MRI feature model, pathology model, DWI model, and DKI model, with statistically significant differences ( Z=5.877, 2.961, 3.240, 2.264, all P<0.05). Conclusions:The results of pathology, conventional MRI, DWI and DKI parameters of pCR and non pCR breast cancer patients are significantly different, and the combined model is better than the single model in predicting the efficacy of NAC.

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