1.Expert consensus on clinical application of parenteral direct thrombin inhibitors in perioperative period
Mingyu JIANG ; Yuan BIAN ; Lizhu HAN ; Qinan YIN ; Fengjiao KANG ; Anhua WEI ; Danjie ZHAO ; Lin WANG ; Ying SHAO ; Li TANG ; Yi WANG ; Shuhong LIANG ; Huijuan LIU ; Guirong XIAO ; Yue LI
China Pharmacy 2026;37(6):689-699
OBJECTIVE To form an expert consensus on the clinical application of parenteral direct thrombin inhibitors (DTIs) in patients during the perioperative period. METHODS Led by Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital (the Affiliated Hospital of UESTC), a multidisciplinary working group was established. Through literature review and the Delphi method, clinical questions related to the rational perioperative use of parenteral DTIs were identified. A structured design was adopted using the “Population-Intervention-Comparison-Outcome” framework; systematic searches were conducted in CNKI, Medline, Embase and other databases. Relevant evidence from randomized controlled trials and cohort studies was included and synthesized. Evidence quality was assessed using the Grades of Recommendations Assessment,Development and Evaluation (GRADE) approach, and recommendations were formulated through multiple rounds of Delphi surveys and expert consensus meetings. RESULTS &CONCLUSIONS Seven recommendations (each with an expert consensus rate exceeding 90%) on the use of parenteral DTIs in perioperative patients were developed. These recommendations specify drug selection, dosing ranges, key monitoring points, and safety management strategies for parenteral DTIs in various scenarios, including the perioperative period of ventricular assist device implantation, the perioperative period of cardiac surgery, perioperative patients with lower-extremity atherosclerotic disease, the perioperative period of percutaneous coronary intervention in patients with acute coronary syndrome, the perioperative period of carotid artery stenting in patients with carotid stenosis, the perioperative period of patients with right heart thrombosis, and patients who develop related thrombosis and dysfunction after a central venous catheter insertion. In addition, warning and management pathways for perioperative bleeding and thrombotic events were proposed. This expert consensus, which is formulated based on the best available evidence, provides evidence-based guidance for standardized and individualized use of parenteral DTIs in perioperative period.
2.Clinicopathological and genetic features of hyalinizing trabecular tumor of the thyroid
Danjie HU ; Yanli LUO ; Yiwei ZHAO ; Yuxia XIE ; Xuling SU ; Keyang SUN ; Zhiyan LIU
Chinese Journal of Pathology 2025;54(10):1050-1054
Objective:To analyze the cytological, histological, immunohistochemical, and molecular pathological features of hyalinizing trabecular tumor (HTT).Methods:Clinical and pathological data of the HTT cases diagnosed at Shanghai Sixth People′s Hospital affiliated to Shanghai Jiao Tong University School of Medicine between 2020 and 2024 were collected and analyzed. HE staining, special staining, immunohistochemical staining, and next-generation sequencing were performed on all cases.Results:Among the 10 HTT patients, 4 were male and 6 were female. The age at onset ranged from 29 to 85 years, with a median age of 49 (35,61) years. The maximum tumor diameter ranged from 0.3 to 5.3 cm. Cytologically, the smears were hypercellular and showed tumor cells arranged in nested clusters with visible basement membrane-like material. The nuclei were oval with finely granular chromatin, and nuclear pseudoinclusions were readily identifiable. Histologically, the tumors were well demarcated. The tumor cells were arranged in a paraganglioma-like pattern, exhibiting typical nuclear features of papillary thyroid carcinoma and psammoma bodies. Yellow bodies were observed in the cytoplasm. The stroma was rich in hyalinized material, which was periodic acid-Schiff stain (PAS)-positive. Immunohistochemically, the tumor cells showed diffuse expression of TTF-1 and focal expression of thyroglobulin. Aberrant immunoreaction with Ki-67 was present in the cytoplasm and membrane of the tumor cells. Molecular testing was performed on 8 cases. The PAX8-GLIS3 gene fusion was detected in 7 cases. Among these fusion-positive cases, 4 exhibited additional genetic abnormalities: one concurrent TSHR point mutation (p.D617H); one concurrent HRAS point mutation (p.Q61R); one concurrent LRP1B point mutation (p.S1752L), SUGCT point mutation (p.K137), and TERT point mutation (p.P785L); one concurrent MTOR mutation (7528+27A>T) and FLT3 mutation (p.E77K). The key initiating factors for thyroid carcinoma, including the BRAF V600E mutation and RET rearrangements, were absent in all cases tested.Conclusions:Cellular pleomorphism, yellow bodies and basement membrane-like material constitute important cytological and histological features for the differential diagnosis of HTT. Immunophenotypically, thyroglobulin may show focal expression, while Ki-67 is typically localized in the tumor cell membrane and cytoplasm. This study also demonstrates that PAX8-GLIS3 fusion is a characteristic molecular abnormality in HTT, although cases with wild type of GLIS gene may also present. Although rare, HTT may harbor point mutations in HRAS and TSHR, and other uncommon genetic alterations.
3.Principles of managing wards for patients with internal radionuclide contamination
Fan BAI ; Chao YANG ; Lei ZHU ; Minghao LIU ; Danjie LIU ; Xiaoxin LIU ; Shanshan GUO ; Jianan WANG
Chinese Journal of Radiological Health 2025;34(3):444-449
Based on current national policies, regulations, standards, relevant literature, and departmental experience regarding the protection against radionuclides in China, this study provides a brief overview of key issues in the management of hospital wards for patients with internal radionuclide contamination. The discussion covers the detection of internal contamination, general requirements for internal radionuclide contamination wards, and inpatient management. In addition, the study explores in depth the daily responsibilities, protective measures, and management protocols for both healthcare staff and patients within such wards. This article summarizes a framework for the construction of internal radionuclide contamination wards, along with specific plans and detailed role-based guidelines. These results provide a reference for the management of hospital wards for patients with internal radionuclide contamination.
4.Effect of postoperative radiotherapy after complete resection in patients with stage ⅢA-N2 non-small cell lung cancer: A propensity score matching analysis
Zhengshui XU ; Minxia ZHU ; Jiantao JIANG ; Shiyuan LIU ; Jia CHEN ; Danjie ZHANG ; Jianzhong LI ; Liangzhang SUN ; Shaomin LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(07):1006-1012
Objective To evaluate the value of postoperative radiotherapy (PORT) in patients with stage ⅢA-N2 non-small cell lung cancer who received complete resection and chemotherapy. Methods Patients with stage ⅢA-N2 non-small cell lung cancer who received complete resection and chemotherapy were chosen from the SEER Research Plus Database [17 Registries, November 2012 Submission (2000-2019)]. The patients were divided into a PORT group and a non-PORT group according to whether the PORT was used. To balance baseline characteristics between non-PORT and PORT groups, R software was used to conduct a propensity score matching (PSM) with a ratio of 1 : 1 and a matching tolerance of 0.01. Both the Cox regression analysis and Kaplan-Meier survival analysis were conducted to evaluate the value of PORT in terms of overall survival (OS) and disease-specific survival (DSS). Results In total, 2468 patients with stage ⅢA-N2 non-small cell lung cancer were enrolled, including 1078 males and 1390 females with a median age of 65 (58-71) years. There were 1336 patients in the PORT group, and 1132 patients in the non-PORT group. Cox regression analysis showed that PORT was not significantly associated with OS (multivariate analysis: HR=1.051, 95%CI 0.949-1.164, P=0.338) and DSS (multivariate analysis: HR=1.094, 95%CI 0.976-1.225, P=0.123). No statistical difference was found in the OS or DSS between non-PORT group and PORT group after PSM analysis (P>0.05). Conclusion PORT does not have a survival benefit for patients with stage ⅢA-N2 non-small cell lung cancer who received complete resection and chemotherapy.
5.Clinicopathological and genetic features of hyalinizing trabecular tumor of the thyroid
Danjie HU ; Yanli LUO ; Yiwei ZHAO ; Yuxia XIE ; Xuling SU ; Keyang SUN ; Zhiyan LIU
Chinese Journal of Pathology 2025;54(10):1050-1054
Objective:To analyze the cytological, histological, immunohistochemical, and molecular pathological features of hyalinizing trabecular tumor (HTT).Methods:Clinical and pathological data of the HTT cases diagnosed at Shanghai Sixth People′s Hospital affiliated to Shanghai Jiao Tong University School of Medicine between 2020 and 2024 were collected and analyzed. HE staining, special staining, immunohistochemical staining, and next-generation sequencing were performed on all cases.Results:Among the 10 HTT patients, 4 were male and 6 were female. The age at onset ranged from 29 to 85 years, with a median age of 49 (35,61) years. The maximum tumor diameter ranged from 0.3 to 5.3 cm. Cytologically, the smears were hypercellular and showed tumor cells arranged in nested clusters with visible basement membrane-like material. The nuclei were oval with finely granular chromatin, and nuclear pseudoinclusions were readily identifiable. Histologically, the tumors were well demarcated. The tumor cells were arranged in a paraganglioma-like pattern, exhibiting typical nuclear features of papillary thyroid carcinoma and psammoma bodies. Yellow bodies were observed in the cytoplasm. The stroma was rich in hyalinized material, which was periodic acid-Schiff stain (PAS)-positive. Immunohistochemically, the tumor cells showed diffuse expression of TTF-1 and focal expression of thyroglobulin. Aberrant immunoreaction with Ki-67 was present in the cytoplasm and membrane of the tumor cells. Molecular testing was performed on 8 cases. The PAX8-GLIS3 gene fusion was detected in 7 cases. Among these fusion-positive cases, 4 exhibited additional genetic abnormalities: one concurrent TSHR point mutation (p.D617H); one concurrent HRAS point mutation (p.Q61R); one concurrent LRP1B point mutation (p.S1752L), SUGCT point mutation (p.K137), and TERT point mutation (p.P785L); one concurrent MTOR mutation (7528+27A>T) and FLT3 mutation (p.E77K). The key initiating factors for thyroid carcinoma, including the BRAF V600E mutation and RET rearrangements, were absent in all cases tested.Conclusions:Cellular pleomorphism, yellow bodies and basement membrane-like material constitute important cytological and histological features for the differential diagnosis of HTT. Immunophenotypically, thyroglobulin may show focal expression, while Ki-67 is typically localized in the tumor cell membrane and cytoplasm. This study also demonstrates that PAX8-GLIS3 fusion is a characteristic molecular abnormality in HTT, although cases with wild type of GLIS gene may also present. Although rare, HTT may harbor point mutations in HRAS and TSHR, and other uncommon genetic alterations.
7.Efficacy and Safety of Guselkumab in the Treatment of Moderate-to-severe Plaque Psoriasis :A Systematic Re- view
Xin LIU ; Xiaoyan ZHONG ; Changjing XU ; Danjie ZHAO ; Qingze FAN ; Bin YU ; Yilan HUANG
China Pharmacy 2020;31(10):1266-1271
OBJECTIVE:To systematically evaluate the efficacy and safety of guselkumab in the treatment of moderate-to- severe plaque psoriasis ,and to provide evidence-based reference for the clinical treatment. METHODS :Retrieved from PubMed , Embase,Cochrane Library ,CNKI,VIP,Wanfang database during inception to Oct. 2019,randomized controlled trials (RCTs) about guselkumab versus placebo/positive control in the treatment of moderate-to-severe plaque psoriasis were collected. After literature screening and data extraction ,quality evaluation was performed by using the bias risk evaluation tool recommended by the Cochrane System evaluator manual 5.1.0. Meta-analysis was performed by using Stata 16.0 software. RESULTS :Eight RCTs with a total of 3 488 patients were included. The results of Meta-analysis indicated that the proportion of patients who achieved 90% reduction or more from baseline of psoriasis area and severity index (PASI)in guselkumab group was significantly higher than that placebo group [RR =26.72,95%CI(15.98,44.70),P<0.001],adaliumumab group [RR =1.45,95%CI(1.32,1.59), P<0.001] and secukinumab group (P<0.000 1). The proportion of patients with Investigator ’s Global Assessment (IGA)score of 0 or 1 in guselkumab group was significantly better than placebo group [RR =11.15,95% CI(8.22,15.14),P<0.001] and adaliumumab group [RR =1.27,95%CI(1.19,1.35),P<0.001]. The proportion of patients with IGA score of 0,the proportion of patients who achieved 75% reduction or more from baseline of PASI ,dermatology life qu ality index score of 0 or 1 in guselkumab group were signifi cantly superior than placebo group and adaliumumab gr oup,the proportion of patients who achieved 100% reduction from baseline of PASI in guselkumab group Lewx- was significantly superior than placebo group (P<0.05), inn@outlook.com there was no significant difference compared with adaliumumab group (P>0.05). There was no statistical significance in the proportion of patients with IGA score of and other secondary outcome indicators between guselkumab and secukinumab group (P>0.05). In the safety indicators as total incidence rate of ADR ,rate of withdrawl due to ADR ,etc. ,there was no statistical significance between guselkumab and placebo/ adalimumab groups (P>0.05). CONCLUSIONS :Guselkumab is superior to placebo ,adaliumumab and secukinumab in improving the symptoms of moderate-to-severe plaque psoriasis with good safety .
8.Efficacy and Safety of Peficitinib for Treating Rheumatoid Arthritis :A Systematic Review
Xin LIU ; Changjing XU ; Xiaoyan ZHONG ; Danjie ZHAO ; Bin YU ; Yilan HUANG
China Pharmacy 2020;31(7):859-864
OBJECTIVE:To systematically evaluate the efficacy and safety of pe ficitinib for treating rheumatoid arthritis (RA),and to provide evidence-based reference for the clinical treatment of RA. METHODS :Retrieved from PubMed ,Embase, The Cochrane Library ,CJFD,VIP and Wanfang database during from their establishment to September 2019,randomized controlled trials (RCTs)about the efficacy and safety of Peficitinib (trial group )versus placebo (control group )in the treatment of RA were collected. The risk of bias assessment tool provided in Cochrane System Evaluator Manual 5.1.0 was used to evaluate the quality after data extracted from clinical studies which met the inclusion criteria. Meta-analysis of the efficacy [the proportion of patients who met the American College of Rheumatology 20% improvement criteria (ACR20),ACR50,ACR70,the proportion of the patients with 28 joint disease activity index <2.6 calculated by erythrocyte sedimentation rate (DAS28-ESR<2.6),the proportion of patients with 28 joint disease activity index <2.6 calculated by C-reactive protein (DAS28-CRP<2.6),etc.] and safety(incidence of total ADR )was performed by using Stata 16 statistical software. RESULTS :Totally 5 RCTs were included , 药学。E-mail:hyl3160131@163.com 5.11),P<0.001],150 mg[RR=3.52,95%CI(1.78,6.96),P< 0.001]},ACR70{total [RR =2.51,95%CI(1.52,4.14),P<0.001],100 mg[RR=3.50,95%CI(1.62,7.58),P=0.001],150 mg [RR=4.59,95%CI(1.47,14.30),P=0.009]},DAS28-ESR<2.6{total [RR =4.83,95%CI(3.20,7.28),P<0.001],100 mg[RR= 5.37,95%CI(2.68,10.77),P<0.001],150 mg[RR=7.44,95%CI(3.78,14.65),P<0.001]} and DAS 28-CRP<2.6{total [RR =3.41, 95%CI(2.65,4.39),P<0.001],100 mg[RR=4.00,95%CI(2.67,5.99),P<0.001],150 mg[RR=4.45,95%CI(2.99,6.63),P< 0.001]} in trial group were significantly higher than control group ,with statistical significance. In term of safety ,there was no statistical significance in the incidence of total ADR [RR =1.05,95% CI(0.94,1.16),P=0.395] between 2 groups. CONCLUSIONS:For the treatment of RA ,100 mg or 150 mg peficitinib once per day is superior to placebo in terms of ACR 20, ACR50 and ACR 70,DAS28-ESR<2.6,DAS28-CRP<2.6; the adverse events are mild and tolerable and it may be a new treatment option for RA.
9.Establishment and verification of fluctuation of reference intervals for biochemistry parameters in routine physical examina-tion
Bo YUE ; Manjiao LIU ; Dahai TANG ; Jialei HE ; Mengjie JIANG ; Xiaoqiang WEI ; Danjie LI ; Shangzhen ZHANG
Chinese Journal of Clinical Laboratory Science 2018;36(6):418-421
Objective To establish and verify the fluctuation of reference intervals for biochestry parameters in routine physical exami-nation. Methods The results of biochemistry parameters,i.e., total protein (TP), albumin (Alb), total bilirubin (T-Bil), alanine aminotransferase (ALT), glucose (Glu), urea (Urea), creatinine (Cr), uric acid (UA), triacylglycerol (TG) and total cholesterol ( TC) from 2 089 healthy subjects in routine physical examination during consecutive 2014, 2015 and 2016 were randomly collected, in which all the results were within the reference range. The ratio (λ1) of the results of 2015 to those of 2014, and ratio (λ2) of the re-sults of 2016 to those of 2015 were calculated. λ1was analyzed statistically to establish the fluctuation of reference interval (CIλ). CIλ was verified by λ2.The personalized reference interval (CIp) was established by multiplying each result of 2015 and the upper and low-er limits of CIλ. The CIpwas verified by the results of 2016. The ratios of CIpto the upper and lower limits of conventional reference in-terval were calculated. Results The values of CIλwere as follows: TP: 0.91 to 1.08, Alb: 0.91 to 1.08, T-Bil: 0.58 to 1.74, ALT:0.49 to 1.99, Glu: 0.84 to 1.20, Urea: 0.67 to 1.50, Cr: 0.82 to 1.22, UA: 0.77 to 1.32, TG: 0.51 to 1.98 and TC: 0.80 to 1.26. Compared with conventional reference interval, the ratio of the upper and lower limits of CIp was lessened. Conclusion The personal-ized reference interval (CIp) which may increase the sensitivity of conventional reference intervals was established and verified.
10.Establishment and verification of personalized reference interval of blood cells
Bo YUE ; Manjiao LIU ; Dahai TANG ; Jialei HE ; Mengjie JIANG ; Xiaoqiang WEI ; Danjie LI ; Shangzhen ZHANG
Chinese Journal of Clinical Laboratory Science 2017;35(2):107-110
Objective To establish and verify the personalized reference interval of blood cells.Methods The results of blood cells from 2 089 health subjects in 2014,2015 and 2016 were collected.The ratio of the later results to the previous results was defined as the fluctuation (λ).The ratio (λ1) of the results of 2015 to the results of 2014 was calculated and λ1 was analyzed statistically to establish the fluctuation reference interval (CIλ).The ratio (λ2) of the results of 2016 to the results of 2015 was calculated.λ2 was used to verify λ2.The personalized reference interval (CIp) was established by multiplying each result of 2015 and CIλ.CIp was verified by results of 2016.The ratio of the upper and lower limits of CIp was calculated.The ratio of the upper and lower limits of the reference interval (WS/T 405) was calculated.Results The values of CIλ were as follows:WBC (0.66 to 1.53),L(0.67 to 1.51),M (0.50 to 2.00),N(0.56 to 1.78),E(0.4 to 2.51),PLT(0.76 to 1.32),RBC(0.92 to 1.12),Hb(0.92 to 1.11),Hct(0.91 to 1.12),MCV(0.95 to 1.07),MCH(0.95 to 1.05)and MCHC(0.94 to 1.06).The validation tests of CIλ and CIp showed that both CIλ and CIp were suitable for this laboratory.Compared with the reference interval of professional criteria,the ratio of the upper and lower limits of the CIp was smaller than that of traditional criteria.Conclusion CIp for this laboratory was established and verified.Compared with traditional criteria,CIp should be more personalized and highly sensitive.

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