1.Pharmaceutical care for a case of severe dermal toxicity induced by durvalumab
Liulian JI ; Zhengbi QIN ; Pengcheng LIU ; Xiaowen DENG ; Lili LIU ; Lijuan YAO ; Tingting LIU ; Pingchen GU
China Pharmacy 2026;37(1):88-91
OBJECTIVE To provide references for the accurate identification and management of immune-related cutaneous adverse events (irCAEs) caused by durvalumab, and ensuring safe clinical drug use. METHODS Clinical pharmacists participated in the diagnosis and treatment process of a patient with gallbladder cancer who developed irCAEs caused by durvalumab. The clinical pharmacists systematically reviewed the patient’s past medical history and medication history, and assisted physicians in assessing the association between adverse drug reactions and administered drugs. Meanwhile, the clinical pharmacists conducted a graded assessment of the adverse reaction, proposed recommendations such as discontinuing durvalumab and adjusting the administration regimen of glucocorticoids, assisted physicians in restarting immunotherapy, and carried out medication education and other pharmaceutical care. RESULTS The occurrence of irCAEs in this patient was “highly likely” related to durvalumab and was classified as severe. The physicians adopted the clinical pharmacist’s opinion, and after symptomatic treatment, the patient’s skin symptoms improved, and discharged with medication. After the completion of glucocorticoid therapy for the patient, the physician restarted immunotherapy with tislelizumab, and no related adverse reactions occurred again in the patient. CONCLUSIONS Durvalumab can cause irCAEs such as severe skin maculopapular rash. In clinical practice, it is crucial to promptly identify and discontinue suspicious drugs, immediately implement effective symptomatic treatment measures, and actively resume immunotherapy to ensure the continuity and safety of the patient’s treatment.
2.Value of decreased carbohydrate antigen 19-9 kinetics for patients with advanced biliary or pancreatic cancers
Yiyin Zhang ; Ying Dai ; Ziran He ; Ziting Qu ; Lili Lu ; Qingbo Zhu ; Xiaowen Qi ; Kangsheng Gu
Acta Universitatis Medicinalis Anhui 2025;60(4):712-718
Objective:
To investigate the value of decreased carbohydrate antigen 19-9(CA19-9) kinetics in predicting short-term outcomes and determining prognosis among advanced biliary or pancreatic cancer patients receiving first-or second-line therapy in the real world.
Methods :
Eighty-nine patients were retrospectively collected with advanced biliary or pancreatic cancer, especially on the CA19-9 dynamics and decline rates at different time points. This study evaluated the association of CA19-9 changes with clinicopathological features, short-term response to antitumor therapy, and survival outcomes.
Results :
The enrolled patients recorded baseline CA19-9 levels ranging from 1.20 to 65 706.40 U/ml, with a median of 303.11 U/ml. There was no statistical correlation between baseline CA19-9 levels and gender, age, body mass index, primary tumor site, hepatic metastases, pulmonary metastases, lymph node metastases, peritoneal metastases, performance status, treatment lines, and combinations of drug types. Baseline CA19-9 levels were not associated with systemic immunoinflammatory index, prognostic nutritional index, and total bilirubin. A 25% or 50% decrease in CA19-9 after 2-3 therapy courses indicated short-term efficacy in reaching tumor objective remission or disease control. Both combinations of multiple drug types and a 25% decline in CA19-9 after one course of treatment were independent prognostic factors that affected the longer progression-free survival of patients receiving first or second line of treatment.
Conclusion
Decreased CA19-9 kinetics has specific values in predicting the efficacy and prognosis of advanced biliary or pancreatic cancer.
3.Clinical Efficacy and Safety of Qingyusan Capsules in Treatment of Ulcerative Colitis with Syndrome of Large Intestine Dampness-heat
Xiaowen LIU ; Sizhen GU ; Danbo DOU ; Shigui XUE ; Yini TANG ; Gan CAI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(14):114-121
ObjectiveTo evaluate the efficacy and safety of Qingyusan capsules in the long-term treatment of mild to moderate active ulcerative colitis (UC) with the syndrome of large intestine dampness-heat. MethodA randomized, controlled design was adopted, and 88 patients with mild to moderate UC and syndrome of large intestine dampness-heat were randomized into a Qingyusan (Qingyusan capsules, 0.8 g·d-1) group and a control (mesalazine, 0.4 g·d-1) group, with 44 patients in each group. Three and one patients dropped out in the control and Qingyusan groups, respectively, during the 32 weeks of treatment. The clinical remission rate, mucosal healing rate, and modified Mayo score, TCM symptom score, and short inflammatory bowel disease questionnaire (SIBDQ) score before and after treatment were compared between the two groups. The colonoscopic and pathological changes were observed, and the clinical safety was compared between the two groups. ResultAfter treatment, the clinical remission rate and mucosal healing rate in the Qingyusan group were 72.1% (31/43) and 74.4% (32/43), respectively, which were higher than those [26.8% (11/41) and 41.5% (17/41), respectively] in the control group (χ2=17.200, χ2=10.843, respectively, both P<0.01). The treatment in both groups decreased the modified Mayo score, partial Mayo score, and TCM symptom score (P<0.05), and the decreases in the Qingyusan group were higher than those in the control group (P<0.01). After treatment, the SIBDQ scores in both groups increased (P<0.05), and the increase was more pronounced in the Qingyusan group than in the control group (P<0.01). There was no difference in the incidence of adverse events between the two groups. ConclusionThe clinical efficacy of Qingyusan capsules is remarkable in the long-term treatment of UC with the syndrome of large intestine dampness-heat. Particularly, Qingyusan capsules demonstrates advantages in inducing and maintaining clinical remission, promoting mucosal healing, alleviating TCM symptoms, and enhancing the survival quality of patients, with high safety.
4.Value of unenhanced CT combined with clinical features in predicting adnexal torsion in women
Xiaowen GU ; Lu JIANG ; Lei CUI ; Xiaoxia WU ; Jibin ZHANG ; Ying FEI
Chinese Journal of Clinical Medicine 2024;31(6):951-958
Objective To investigate the value of unenhanced CT combined with clinical features in predicting adnexal torsion in women with abdominal pain and an adnexal mass. Methods A retrospective selection of patients with abdominal pain and an adnexal mass underwent operation in 2 tertiary hospitals from January 2018 to September 2023. The torsion group (n=53) and non-torsion group (n=53) were matched in a 1∶1 ratio. 15 CT signs of adnexal masses were reviewed independently by two radiologists using a double-blind method. The high-risk factors were screened using multivariate logistic regression analysis. The diagnostic values of high-risk factors for adnexal torsion were assessed using receiver operating characteristic (ROC) curves. Results According to the surgical and pathological results, the most common adnexal mass in torsion group was mature cystic teratoma (32.1%), and the most common mass in the non-torsion group was adnexal abscess (20.8%). The age, fever rate, white blood cell count, location of mass, thickened fallopian tube rate, and pelvic effusion rate were not statistically different between the two groups, the nausea and vomiting and remaining CT signs were significant different between the two groups (P<0.05). Multivariate logistic analysis showed that nausea and vomiting (OR=4.886), navel sign (OR=22.733), and whirl sign (OR=43.462) were independently associated with adnexal torsion (P<0.05). The area under the curve (AUC) of nausea and vomiting, navel sign, and whirl sign were 0.717, 0.802, and 0.840, respectively; AUC of the combination of all three was 0.877 with 92.45% of sensitivity, 84.91% of specificity, 85.96% of positive predictive value, 91.84% of negative predictive value, and 88.68% of accuracy. Conclusions For women with abdominal pain and an adnexal mass, nausea and vomiting, navel sign, and whirl sign are help of predicting adnexal torsion, and combination value of all three is best.
5.Risk factors analysis of blood type unexpected antibody in large sample of inpatients
Xiaowen GU ; Yue WANG ; Jinnguo YOU
Chinese Journal of Blood Transfusion 2023;36(8):701-704,705
【Objective】 To observe and analyze the detection results of blood type unexpected antibody and its risk factors in inpatients, so as to provide reference for promoting the safety of clinical blood transfusion. 【Methods】 Clinical data of 22 800 inpatients were collected retrospectively and unexpected antibody screening was performed by microcolumn gel method and saline method. According to the screening results, the inpatients were divided into positive group (n = 62) and negative group (n = 22 738). Clinical data of the two groups were collected and analized by univariate analysis, and specificity identification of unexpected antibody was performed in the positive group. The specific distribution characteristics of antibody were statistically analyzed, and the risk factors of unexpected antibody were analyzed by binary logistic regression. 【Results】 Among the 22 800 inpatients, the yield rate of unexpected antibody was 0.27% (62/22 800), with Rh, MNS, Lewis, Kidd blood group antibody, mixed antibody, autoantibodies and others accounted for 40.32% (25/62), 14.52% (9/62), 6.45%(4/62), 1.61%(1/62), 20.97%(13/62), 6.45%(4/62) and 9.68%(6/62), respectively. Univariate analysis showed that there were significant differences in gender, age, pregnancy history, blood transfusion history, blood transfusion frequency and disease type between the positive group and the negative group by chi-square test (χ2 = 11.142, 6.994, 12.453, 4.762, 5.493, 92.381, all P<0.05), while there was no significant difference in nationality (χ2 = 3.719, P>0.05 ) . Binary logistic regression analysis showed that female, age >60 years old, with history of blood transfusion, number of blood transfusion >3 times, history of pregnancy, solid tumor and blood diseases, severe internal medical diseases were independent risk factors for unexpected antibody(P<0.05) . 【Conclusion】 For patients who need blood transfusion, especially those with the above risk factors, conducting unexpected antibodies screening and identification before transfusion, avoiding corresponding antibodies and selecting antigen-negative blood for cross-matching were suggested to ensure the effectiveness and safety of clinical blood transfusion.
6.Optimization of molding process and physical fingerprint of Shuangye pipa granules based on QbD concept
Xiaowen MAO ; Zhirong GU ; Yuanyuan WANG ; Bin GE
China Pharmacy 2023;34(21):2608-2612
OBJECTIVE To optimize the molding process of Shuangye pipa granules based on the concept of quality by design (QbD) and analyze its physical fingerprint. METHODS The dry extract of Shuangye pipa granules was used as the main drug. The retention rate of total flavonoid, moisture absorption rate, dissolution rate, angle of repose and molding rate of the granules were selected as evaluation indexes. The single-factor test combined with the entropy weight method and Box-Behnken response surface design was used to optimize the molding process, and validation test was conducted. The physical fingerprints of 10 batches of Shuangye pipa granules prepared by the optimal process were comprehensively analyzed by eight secondary physical indexes (relative homogeneity, moisture, moisture absorption rate, Hausner ratio, angle of repose, bulk density, tap density and porosity). RESULTS The optimal molding process of Shuangye pipa granules was as follows: soluble starch-maltodextrin-mannitol was 1∶1∶1 (m/m/m), 95% ethanol was as wetting agent and the amount of it was 37%, the drug-assisted ratio was 1∶0.8 (m/m), the drying temperature was 59 ℃, drying time was 28 min. The results of 3 validation tests showed that the average comprehensive score was 0.879 6, the RSD of which with prediction value (0.881 9 score) was 1.97%. The similarity between the physical fingerprints of 10 batches of Shuangye pipa granules and the control physical fingerprint was higher than 0.99. CONCLUSIONS The optimized molding process of Shuangye pipa granules is stable and feasible, and the physical property of Shuangye pipa granules is stable and controllable.
7.Differential diagnosis and treatment of chylothorax and pseudochylothorax after lung cancer surgery
Jie YANG ; Zhuopeng WU ; Weiquan GU ; Jun YE ; Shengli YANG ; Fei WANG ; Ye XIAO ; Xiaowen ZHANG ; Ning ZHAO ; Lingling WU ; Dongsheng LIU
Chinese Journal of Thoracic and Cardiovascular Surgery 2022;38(8):481-486
Objective:To explore the differential diagnosis and different treatment methods of chylothorax and pseudochylothorax after lung cancer surgery.Methods:Clinical data of 1 584 surgical patients with non-small cell lung cancer from January 2016 to December 2021 were analyzed, 21 cases of chylothorax and 8 cases of pseudochylothorax were identified and analyzed to compare the differences in pleural fluid chyle test, pleural effusion biochemical values, total cholesterol, triglycerides, total cholesterol/triglyceride ratio, leukocyte count, bacterial culture and treatment.Results:The incidence of chylothorax after lung cancer surgery was 1.3%, and the incidence of pseudochylothorax was 0.5%; 80.9%% of chylothorax on the right side was significantly higher than 19.1% of chylothorax on the left side, and the difference was statistically significant( P<0.05). Pseudochylothorax occurred on the right side(100%). The difference between chylothorax and pseudochylothorax in pleural fluid tests for cholesterol and triglyceride was statistically significant( P<0.05), the leukocyte count was significantly higher in pseudochylothorax than chylothorax, and the difference was statistically significant( P<0.05). The differences in drainage before treatment, postoperative drainage time and postoperative hospitalization time between the two groups were statistically significant( P<0.05). The success rate was 61.9% in 13 cases of chylothorax treated conservatively and 38.1% in 8 cases of thoracic duct clamping; all cases of pseudochylothorax were treated conservatively with a success rate of 100%. Conclusion:In naddition to pleural fluid chyle test and pleural effusion biochemical values, total cholesterol, triglyceride and total cholesterol to triglyceride ratio in pleural fluid should be tested to identify chylothorax and pseudochylothorax, high triglyceride in pleural fluid diagnosed as chylothorax; Pseudochylothorax is diagnosed with a cholesterol/triglyceride ratio >1 in the pleural fluid, pseudochylothorax is usually treated conservatively. Chylothorax is treated conservatively and surgically according to different conditions. If the drainage flow is greater than 800 ml/day for 3 consecutive days or if it causes serious electrolyte disorders, it is recommended to perform thoracoscopic-assisted thoracic duct clamping via right-sided approach.
8.Research progress in the effect of placental growth factor on pregnancy
International Journal of Biomedical Engineering 2020;43(2):166-170
Placental growth factor (PLGF) is isolated and purified from human placental complementary DNA (cDNA) library, and syncytiotrophoblast cells are the main synthesis site. PLGF can bind to tyrosinase receptors located in trophoblast cells and vascular endothelial cells, and regulate trophoblast cell proliferation through autocrine and paracrine regulation of angiogenesis, respectively. PLGF plays an extremely important role in the formation and development of the placenta during pregnancy. The abnormal secretion of PLGF is closely related to the occurrence and progression of pregnancy complications (such as pregnancy complicated with diabetes, hypertension in pregnancy, preeclampsia, etc.). In this paper, the structure, receptor, biological activity of PLGF and its relationship with normal pregnancy and pregnancy complications were reviewed to provide references for clinical guidance and auxiliary diagnosis of pregnancy complications.
9.Related factors of urinary incontinence among patients with surgery for lumbar disc herniation
Juan SHAN ; Jing ZHANG ; Haiyan GU ; Lei PENG ; Xiaowen QI ; Cuihong ZHANG ; Fanglei XU
Chinese Journal of Modern Nursing 2019;25(11):1405-1408
Objective? To explore the related factors of urinary incontinence among patients with surgery for lumbar disc herniation (LDH). Methods? From 1st June 2017 to 31st May 2018, we selected 336 medical records of LDH patients with surgical therapy at a ClassⅢ Grade A hospital and a ClassⅡGrade A hospital in Shanghai by convenience sampling. Single factor analysis and multiple factors analysis were used to patients' basic data, diagnosis, segments of LDH, symptoms, complications, types of surgery, types of anesthesia, laboratory examination, patient-controlled analgesia and indwelling urinary catheters. Results? A total of 336 medical records of LDH patients were investigated with 29.5% for the incidence of urinary incontinence. Multiple factors analysis showed that the independent risk factors of patients with surgery for LDH included 9 factors involving the childbearing history, complications (diabetes, heart disease, cerebral infarction, lumbar spinal stenosis), symptoms (constipation and urinary tract infection), indwelling urinary catheters and indwelling days (P<0.05). Conclusions? The incidence of urinary incontinence of patients with surgery for LDH is high and is related to many factors. Medical staff should carry out screening in time and early intervention for high-risk patients according to related factors to reduce the incidence of urinary incontinence.
10. An experimental study of CD4 targeted chimeric antigen receptor modified T cell with anti-lymphoma activity
Guanghua CHEN ; Haiwen HUANG ; Yi WANG ; Huiwen LIU ; Liangjing XU ; Xiao MA ; Shengli XUE ; Xuefeng HE ; Ying WANG ; Bin GU ; Caixia LI ; Huiying QIU ; Xiaowen TANG ; Zhengming JIN ; Miao MIAO ; Aining SUN ; Depei WU
Chinese Journal of Hematology 2018;39(2):148-152
Objective:
To study the specific killing effect of CD4 membrane protein targeted chimeric antigen receptor modified T (CAR-T) cell.
Methods:
The second generation CD4 targeted chimeric antigen receptor containing 4-1BB costimulation domain was insert into lentiviral vector through recombinant DNA technology. Lentivirus was prepared and packaged by 293T cells with four plasmids. Beads activated T cells were transduced with lentivirus and the transduction efficiency was checked with Protein L and flow cytometry. T cell subsets and IFN-γ concentrations were detected with probe-tagged antibody and cytometric bead assay.
Results:
①The transduction efficiency of activated T cells with prepared lentivirus were 50.0%-70.0%. A subset of CD8+ T cell acquired dim expression of CD4 membrane protein after activation. CD4+T cell and CD8+CD4dim T cell were gradually killed by CD4 targeted CAR-T post lentivirus transduction. ②The kill efficacy of CD4 targeted CAR-T cell and control T cell toward KARPAS 299 T cell at an E∶T ratio of 8∶1 for 24 h was (96.9±2.1)% and (11.2±3.1)%, CAR-T cell has a higher killing efficacy than control T cell (


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