1.Expert consensus on the clinical application of parenteral direct thrombin inhibitors in special populations
Xin YAO ; Yuan BIAN ; Lizhu HAN ; Qinan YIN ; Yang LEI ; Zimeng WAN ; Luyao HUANG ; Danjie ZHAO ; Yu YAN ; Qin LI ; Baorong HU
China Pharmacy 2026;37(8):965-975
OBJECTIVE To form an expert consensus addressing clinical issues regarding the use of parenteral direct thrombin inhibitors (DTIs) in special populations. METHODS Led by the Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital(the Affiliated Hospital of UESTC), a multidisciplinary working group was formed comprising experts from multiple fields, including clinical pharmacy, cardiac surgery, obstetrics, pediatrics and evidence-based medicine. Through literature review and the Delphi method, clinical questions regarding the efficacy and safety of parenteral DTIs used in special populations were identified. A structured design was adopted using the “Population-Intervention-Comparison-Outcome” (PICO) framework;systematic searches were conducted in CJFD, PubMed, Embase and other databases. Relevant evidence from randomized controlled trials,cohort studies and systematic reviews were included and synthesized. Evidence quality was assessed using the Grading of Recommendations Assessment,Development and Evaluation (GRADE) approach, and recommendations were formulated through three rounds of Delphi surveys and expert consensus meetings. RESULTS &CONCLUSIONS Seven clinical questions were ultimately selected (with a consensus rate exceeding 90%), resulting in the formulation of seven recommendations on the use of parenteral DTIs in special populations, including children, pregnant women, patients with hepatic or renal impairment, patients with mesenteric venous thrombosis, and individuals with thrombophilia. These recommendations clarify the preferred agents, dosing ranges, monitoring parameters, and safety management strategies for parenteral DTIs in these special populations. 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 special populations.
2.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.
3.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.
4.Research progress on risk of major adverse cardiovascular events associated with Janus kinase inhibitors in treatment of immune-mediated inflammatory diseases
Danjie ZHAO ; Yuan BIAN ; Qi'nan YIN ; Yi WANG ; Peng TANG ; Lizhu HAN
Adverse Drug Reactions Journal 2025;27(1):44-49
Janus kinase inhibitors (JAKi) are a kind of small molecule targeted drugs used to treat a variety of immune-mediated inflammatory diseases by inhibiting the excessive response of a variety of cytokines. Currently, JAKi has shown good clinical efficacy, but it also has risk of major adverse cardiovascular events (MACE). The specific mechanism of JAKi-caused MACE is still unclear. This paper reviews the pharmacological molecular mechanisms and classification of JAKi and the research progress of MACE related to the JAKi (tolvaptan, baricitinib, ruxolitinib, upadacitinib, and abrocitinib) that have been approved for marketing in China. The risk factors that lead to MACE, including age, combined cardiovascular disease and inflammatory diseases, types of JAKi, dosage forms, and treatment duration are analyzed, so as to provide reference for the clinical rational use of JAKi and better prevention of MACE related to JAKi.
5.Research progress on risk of major adverse cardiovascular events associated with Janus kinase inhibitors in treatment of immune-mediated inflammatory diseases
Danjie ZHAO ; Yuan BIAN ; Qi'nan YIN ; Yi WANG ; Peng TANG ; Lizhu HAN
Adverse Drug Reactions Journal 2025;27(1):44-49
Janus kinase inhibitors (JAKi) are a kind of small molecule targeted drugs used to treat a variety of immune-mediated inflammatory diseases by inhibiting the excessive response of a variety of cytokines. Currently, JAKi has shown good clinical efficacy, but it also has risk of major adverse cardiovascular events (MACE). The specific mechanism of JAKi-caused MACE is still unclear. This paper reviews the pharmacological molecular mechanisms and classification of JAKi and the research progress of MACE related to the JAKi (tolvaptan, baricitinib, ruxolitinib, upadacitinib, and abrocitinib) that have been approved for marketing in China. The risk factors that lead to MACE, including age, combined cardiovascular disease and inflammatory diseases, types of JAKi, dosage forms, and treatment duration are analyzed, so as to provide reference for the clinical rational use of JAKi and better prevention of MACE related to JAKi.
6.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.Risk factor analysis of non-acute symptomatic portal vein thrombosis after endoscopic gastric variceal injection
Danjie SHEN ; Xiaoxian QIAN ; Jian WANG ; Feng LI ; Qingqing FANG ; Juan ZHAO ; Wei CHEN ; Ying CHEN ; Yi TIAN ; Siyao CHEN
Journal of Chinese Physician 2021;23(3):338-342
Objective:To analyze the incidence and risk factors of non-acute symptomatic portal vein thrombosis (PVT) after endoscopic gastric variceal injection (GVI) in the treatment of liver cirrhosis with gastric variceal bleeding (GVB).Methods:66 patients with GVB who were treated with GVI for the first time from July 2017 to October 2019 in Minhang Hospital Affiliated to Fudan University were retrospectively analyzed. The data of gender, age, preoperative Child-Pugh grade, preoperative platelet count, preoperative plasma D-dimer concentration, preoperative splenic length, preoperative portal vein velocity, preoperative splenic vein velocity, preoperative portal vein diameter, preoperative splenic vein diameter, treatment times, total number of injection points, total dose of sclerosing agent and tissue adhesive agent were collected. The patients were divided into PVT group and non-PVT group according to the occurrence of non-acute symptomatic PVT within one year after GVI. Univariate analysis was performed first, and then the factors with P<0.2 were included in the binary logistic regression model to screen the risk factors of PVT after GVI. Results:There were 25 cases (37.88%) in PVT group and 41 cases (62.12%) in non-PVT group. There were significant differences in D-dimer concentration, spleen length, Child-Pugh grade and total dose of sclerosing agent between the two groups ( P<0.05). The D-dimer concentration ( OR=2.319, 95% CI:1.359-3.956), spleen length ( OR=1.044, 95% CI:1.007-1.081) and total dose of sclerosing agent ( OR=1.075, 95% CI:1.004-1.152) were independent risk factors for PVT ( P<0.05). Conclusions:Preoperative D-dimer concentration, spleen length and total dose of sclerosing agent can predict the risk of PVT after GVI. In order to reduce the risk of PVT after GVI, the dose of sclerosing agent should be reduced as much as possible.
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.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 .
10.Metastatic status of lymph nodes in patients of distal gastric carcinoma
Ruiting LIU ; Xiangming CHE ; Lin FAN ; Wei ZHAO ; Guanghui WANG ; Danjie ZHANG ; Jien HE ; Zijing LIN
Chinese Journal of General Surgery 2010;25(5):345-348
Objective To investigate lymph node metastases in distal gastric cancer and its clinical significance. Methods From June 2006 to December 2007, 129 distal gastric cancer patients underwent radical gastrectomy with lymphadenectomy. Dissected lymph nodes were collected in groups, and histopathological studies were performed to detect lymph node metastasis. The relationship between lymph node metastasis and tumor parameters such as diameter, location, infiltrating depth, histological category,Borrmann typing was evaluated. Results Lymph node metastases was found in 80 out of 129 patients (62%). A total of 3295 lymph nodes were harvested with an average of 25.54 lymph nodes per patient,among those 889 lymph nodes were identified with metastasis. The metastasis rate was 18.60%, 48. 84%,37. 98%, 38. 76%, 44. 19%, 31.01%, 10. 85%, 14. 73%, 4. 65%, 1.55% and 0. 78% respectively in No. 1, No. 3, No. 4d, No. 5, No. 6, No. 7, No. 8a, No. 9, No. 11 p, No. 12a, No. 14v lymph node group.No. 3 and No. 6 group nodes were moat frequently invaded by metastasis. Conclusion This study provides the regular pattern of lymph node metastasis in distal gastric carcinoma patients undergoing radical gastrectomy and perigastric lymphadectomy which helps to guide lymphadectomy in terms of less trauma and favorite prognosis.

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