1.Survey on the perception and current status of drug risk management in medical institutions
Xuelin SUN ; Mingqing XING ; Zixuan ZHANG ; Wenjing ZHAO ; Dongfang QIAN ; Yan LIANG ; Li XU ; Pengfei JIN ; Yatong ZHANG
China Pharmacy 2025;36(1):7-12
OBJECTIVE To know about the perception and current status of drug risk management among pharmacists in Chinese medical institutions, providing insights and recommendations for enhancing the drug risk management system in medical institutions. METHODS A questionnaire survey was conducted across 28 provinces, cities, and autonomous regions; stratified radom sampling was employed to study the population of medical workers and pharmaceutical professionals in medical institutions nationwide. The survey included information on the survey population, the current status of drug risk management implementation in medical institutions, the cognition, definition and process of drug risk management related concepts, and the content and mode of drug risk management work in medical institutions. Finally, suggestions were collected from various medical institutions on the system construction of drug risk management. Descriptive statistical analysis was adopted to summarize the obtained data. RESULTS A total of 446 questionnaires were collected in this survey, including 420 valid questionnaires and 26 invalid questionnaires. The questionnaire collection rate was 100%,and the effective rate was 94.17%. 51.19% of the respondents No.2020YFC2009001)。 based their understanding of drug risk management on Management Measures for Adverse Drug Reaction Reports and Monitoring, while 87.38% recognized the need for drug risk management throughout the drug use process. 63.33% of the participants stated that their medical institutions had dedicated positions related to drug risk management, with the highest proportion (72.17%) was in third-grade class A medical institutions. 66.43% reported implementing risk management across all drug use stages. Suggestions for the development of drug risk management systems in medical institutions by the research participants focused on enhancing guiding documents, clarifying concepts, establishing information-sharing mechanisms. CONCLUSIONS The overall awareness of drug risk management in China’s medical institutions is high, with practices in place across various stages in multiple forms. However, there remains a need to strengthen institutional documents, management regulations, system development, and information-sharing mechanisms to improve collaborative governance, improve drug management levels, and ensure patient safety.
2.Serum levels of ANGPTL4 and NLRP3 in patients with severe traumatic brain injury and their diagnostic value for secondary massive cerebral infarction
Yongli WANG ; Jinbao XU ; Hao LUO ; Zhijia GUO ; Pengfei ZHAO
International Journal of Laboratory Medicine 2024;45(2):219-223
Objective To explore the changes of serum angiopoietin-like protein 4(ANGPTL4)and NOD-like receptor protein 3(NLRP3)levels after traumatic brain injury(TBI)and their diagnostic value for sec-ondary massive cerebral infarction.Methods A total of 100 TBI patients admitted to the hospital from Au-gust 2019 to August 2021 were enrolled as the TBI group,meantime,100 healthy people in the hospital were enrolled as the control group.The serum levels of ANGPTL4 and NLRP3 were detected by enzyme-linked im-munosorbent assay(ELISA).The clinical characteristics of TBI patients with and without secondary massive cerebral infarction were compared.Receiver operating characteristic(ROC)curve was applied to analyze the serum levels of ANGPTL4 and NLRP3 on their diagnostic value for TBI patients with secondary massive cere-bral infarction.Multivariate Logistic regression analysis was applied to analyze the factors affecting the occur-rence of secondary massive cerebral infarction in TBI patients.Results The serum ANGPTL4 level in TBI group was lower than that in the control group,and the serum NLRP3 level was higher than that in the con-trol group(P<0.05).There were obvious differences in proportion of brain hernia,proportion of subarach-noid hemorrhage,serum levels of ANGPTL4 and NLRP3 between patients with secondary massive cerebral infarction and patients without secondary massive cerebral infarction(P<0.05).ROC curve analysis showed that the area under the curve(AUC)of serum ANGPTL4 and NLRP3 in diagnosing secondary massive cere-bral infarction in TBI patients was 0.792 and 0.812 respectively,with sensitivity of 77.80%and 83.30%re-spectively,and specificity of 86.60%and 64.60%respectively.The sensitivity,the specificity and AUC of the combined detection were 83.30%,82.90%and 0.867 respectively.Multivariate Logistic regression analysis showed that serum NLRP3 level was a risk factor for TBI patients with secondary massive cerebral infarction(P<0.05).After treatment,it was found that serum ANGPTL4 level increased and NLRP3 level decreased in TBI patients(P<0.05).Conclusion The serum level of ANGPTL4 in TBI patients decreases,while the level of NLRP3 increases,and the level of ANGPTL4 in the serum of patients with secondary massive cerebral in-farction decreases and the level of NLRP3 increases,both of them are of great significance in the diagnosis of secondary massive cerebral infarction in TBI patients.
3.Evaluation of corpus callosum absence and intracranial accompanying abnormalities via prenatal MRI
Ting WANG ; Guangmin LI ; Lili SHI ; Pengfei SONG ; Yang ZHAO ; Surong LI
Journal of Practical Radiology 2024;40(4):531-534,571
Objective To evaluate the absence of corpus callosum(ACC)and intracranial accompanying abnormalities in fetus via prenatal MRI.Methods A total of 61 cases of fetal ACC diagnosed by prenatal MRI were analyzed retrospectively.The types and numbers of intracranial accompanying abnormalities were observed,and the probability of accompanying abnormalities was counted.According to whether the corpus callosum was completely absent,all cases were divided into complete ACC and partial ACC.Statistical differences of probability of accompanying abnormalities between the two groups were analyzed.Results A total of 54.1%(33/61)patients were complicated with other intracranial abnormalities,among which the most common was cerebral cortical dysplasia,accounting for 26.2%(16/61).The probability of complete ACC and partial ACC complicated with other intracranial abnormalities was 63.4%(26/41)and 35.0%(7/20),respectively,and there was statistical difference in intracranial abnormalities between complete ACC and partial ACC(χ2=4.37,P=0.037).The probability of complete ACC and partial ACC complicated with cerebral cortical dysplasia was 39.0%(16/41)and 5.0%(1/20),respectively,and there was statistical difference in cerebral cortical dysplasia between complete ACC and partial ACC(χ2=7.74,P=0.005).Conclusion MRI can accurately diagnose the fetal ACC and intracranial accompanying abnormalities.Complex ACC is more common than isolated ACC.Compared with partial ACC,complete ACC is more likely to be complicated with other intracranial abnormalities,and cerebral cortical dysplasia is the most common,which provides reliable diagnostic basis for fetal prognosis in clinical practice.
4.Overview of in vitro skin models of transdermal drug delivery systems
Yan LIU ; Xiaolei HU ; Kehong XU ; Hairong ZHAO ; Xiumei WU ; Zizhong YANG ; Chenggui ZHANG ; Yu ZHAO ; Pengfei GAO
Chinese Journal of Comparative Medicine 2024;34(2):122-128
Skin modeling of transdermal drug delivery system refers to experimental models that mimic the structure and function of human skin to explore and evaluate absorption,penetration,and efficacy of medicines in transdermal drug delivery.It provides an alternative to traditional human skin experiments and reduces the use of human skin in medical research,which is convenient,controllable,and cost effective.For skin models of transdermal drug delivery systems,this article introduces commonly used animal skin models,artificial skin models,and recombinant human skin models from the perspective of the transdermal absorption pathway of medicines,and analyzes their advantages,disadvantages,and applications so provide references the research and development of transdermal formulations and topical therapies.
5.3D printed metal augment or tibial prosthesis for reconstruction of large bone defects in total knee arthroplasty and revision surgery
Pengfei HU ; Haobo WU ; Jisheng RAN ; Jiapeng BAO ; Lifeng JIANG ; Weiping CHEN ; Xiang ZHAO ; Shigui YAN ; Lidong WU
Chinese Journal of Orthopaedics 2024;44(4):243-249
Objective:To investigate the clinical efficacy of 3D printed metal augment or tibial prosthesis for reconstruction of large bone defects in total knee arthroplasty (TKA) and knee revision surgery.Methods:A total of 7 patients (7 knees) with TKA or knee revision who were admitted to the Department of Orthopaedics of the Second Affiliated Hospital of Zhejiang University School of Medicine with large bone defects from July 2018 to December 2023 were retrospectively analyzed, including 4 patients with TKA and 3 patients with knee revision. There were 3 males and 4 females, aged 58.7±7.6 years (range, 54-68 years), 3 patients with left knee and 4 patients with right knee. All the patients had bone defects in the knee joint (AORI type III), 2 cases had bone defects only in the femur, 4 cases had bone defects only in the tibia, and 1 case had bone defects in both the tibia and femur, which were treated with personalized reconstruction using 3D printing. Hip-knee-ankle angles, American Knee Society score (KSS) before and after surgery were compared, and postoperative complications were observed.Results:All patients successfully completed the operation, and the operation time was 189.3±35.5 min (range, 125-240 min). Complex TKA was performed in 4 cases with surgical times of 175, 195, 210, and 240 min, and revision surgery was performed in 3 cases with surgical times of 125, 180, and 200 min, respectively. Intraoperative blood loss was 114±24.4 ml (range, 100-150 ml). Five cases used 3D printed metal augment, and two used 3D printed one-piece tibial components. All patients were followed up for 2, 2, 5, 6, 7, 20, 57 months, respectively. The KSS of the five patients at 3 months postoperatively were 56, 61, 66, 56, and 56 points, respectively, greater than the preoperative scores of 35, 44, 36, 27, and 41 points. The KSS functional scores of the five patients at 3 months postoperatively were 45, 45, 45, 30, and 45 points, respectively, which were greater than the preoperative scores of 30, 30, 15, 20, and 20 points. The hip-knee-ankle angle was 181.8°±3.4° (range, 177.9° to 188.0°) at the final follow-up and 175.8°±12.4° (range, 153.3° to 192.1°) before surgery, with no significant difference ( t=-1.230, P=0.242). At the final follow-up, the 3D printed component was well integrated with the bone surface, the prosthesis was securely positioned, and the force lines of the lower limbs were normal. There were no postoperative complications such as poor wound healing, infection, fat liquefaction, nerve injury, deep vein thrombosis of lower limbs, knee joint stiffness, periprosthesis infection and loosening. Conclusion:Using 3D printed metal augment or tibial prosthesis to reconstruct the huge bone defect in TKA and revision has a satisfactory early clinical effect, satisfactory joint function and good surgical safety.
6.Progresses in imaging researches of transverse sinus stenosis
Yuejiao LIU ; Heyu DING ; Xiaoyu QIU ; Chihang DAI ; Pengfei ZHAO ; Zhenchang WANG
Chinese Journal of Medical Imaging Technology 2024;40(1):121-124
Transverse sinus is an important pathway of intracranial venous reflux,which is also crucial for maintaining cerebral circulation and stabilizing intracranial pressure.Transverse sinus stenosis(TSS)is the most common variation of transverse sinus,which might lead to changes in sinus hemodynamics and pressure and closely related to idiopathic intracranial hypertension,pulsatile tinnitus and chronic headache.The progresses in imaging researches of transverse sinus stenosis were reviewed in this article.
7.Clinical observation of levosimendan in the treatment of septic shock combined with myocardial depression
Fang XIONG ; Chao LIU ; Kexiang ZHANG ; Qilong ZHOU ; Hua LU ; Jianguo CHEN ; Xi YUE ; Jianxin ZHAO ; Pengfei PAN
China Pharmacy 2024;35(20):2517-2521
OBJECTIVE To explore the effects of levosimendan on cardiac function, hemodynamics and prognosis of patients with septic shock complicated with myocardial depression, and evaluate the safety of levosimendan. METHODS Patients with septic shock complicated with myocardial depression who were admitted to the Department of Critical Care Medicine of Chongqing University Three Gorges Hospital from April 2021 to August 2023, underwent adequate fluid resuscitation, had a mean arterial pressure (MAP) ≥65 mmHg, and received pulse indicator continuous cardiac output (PiCCO) monitoring were enrolled. The patients were randomly divided into dobutamine group and levosimendan group according to a random number table, with 20 patients in each group. Both groups received intravenous infusion of Norepinephrine bitartrate injection at a dose of 0.1-2.0 μg/(kg·min). On this basis, the dobutamine group additionally received intravenous infusion of Dobutamine hydrochloride injection at a dose of 5- 10 μg/(kg·min) for 3 to 7 days, while the levosimendan group additionally received intravenous infusion of Levosimendan injection at a dose of 0.1-0.2 μg/(kg·min) for 24 hours. Heart rate (HR) and hemodynamic parameters [systolic blood pressure, diastolic blood pressure, MAP, central venous pressure (CVP)], PiCCO monitoring parameters [cardiac function index (CFI), cardiac index (CI), stroke volume index (SVI), extravascular lung water index, global end-diastolic volume index, pulmonary vascular permeability index (PVPI), global ejection fraction (GEF), systemic vascular resistance index, left ventricular contractility index], and prognosis indicators [death within 3 days after administration, mechanical ventilation time,intensive care unit (ICU) stay time, 28-day mortality rate] were compared between the two groups before treatment and at 24 and 72 hours after treatment. Adverse reactions were E-mail:recorded for both groups. RESULTS Compared with before treatment in the same group, CFI, CI and GEF at 24 hours after treatment, CI and GEF at 72 hours after treatment in the dobutamine group, as well as SVI at 24 hours after treatment and SVI and GEF at 72 hours after treatment in the levosimendan group were significantly increased; PVPI at 72 hours after treatment in the dobutamine group was significantly decreased (P<0.05). Compared with the dobutamine group during the same period, patients in the levosimendan group had significantly lower HR and significantly higher CVP at 24 hours after treatment (P<0.05). Within 3 days after administration, there were no deaths in either group; there were no statistically significant differences in mechanical ventilation time, ICU stay time, 28-day mortality rate, or the incidence of adverse reactions between the two groups (P>0.05). CONCLUSIONS For patients with septic shock complicated with myocardial depression who have undergone adequate fluid resuscitation and have a MAP of ≥65 mmHg, levosimendan is comparable to dobutamine in improving cardiac function and hemodynamic parameters, without affecting patients’ prognosis or increasing the risk of adverse reactions such as hypotension.
8.Efficacy of PD-1 inhibitors combined with nab-paclitaxel and cisplatin in the neoadjuvant treatment of locally advanced hypopharyngeal squamous cell carcinoma
Qi FANG ; Pengfei XU ; Fei CAO ; Zheng ZHAO ; Xinrui ZHANG ; Di WU ; Chunyan CHEN ; Zhiming LI ; Fei HAN ; Xuekui LIU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2024;59(7):750-757
Objective:To assess the efficacy of neoadjuvant treatment with PD-1 (programmed cell death protein 1) inhibitors combined with paclitaxel (albumin-conjugated) and cisplatin (TP regimen) for locally advanced hypopharyngeal squamous cell carcinoma and laryngeal organ function preservation.Methods:Data of 53 patients, including 51 males and 2 females, aged 38-70 years old, who were diagnosed with locally advanced hypopharyngeal squamous carcinoma confirmed by histology and enhanced CT at the Cancer Prevention and Control Center of Sun Yat-sen University during the initial treatment from January 1, 2019 to January 15, 2023, were retrospectively analyzed. All patients received neoadjuvant therapy with PD-1 inhibitors combined with albumin-bound paclitaxel (260 mg/m 2) and cisplatin (60 mg/m 2) for 3 to 4 cycles. The main outcome measures were larynx dysfunction-free survival (LDFS), overall survival (OS), and progression-free survival (PFS). Survival curves were plotted using the Kaplan-Meier method, and Cox multifactorial analysis was further performed if Cox univariate analysis was statistically significant. Results:The overall efficiency was 90.6% (48/53). The 1-year and 2-year LDFS rates were 83.8% (95% CI: 74.0% to 94.8%) and 50.3% (95% CI: 22.1% to 91.6%), the 1-year and 2-year OS rates were 95.2% (95% CI: 88.9% to 100.0%) and 58.2% (95% CI: 25.6% to 81.8%), and the 1-year and 2-year PFS rates were 83.9% (95% CI: 74.2% to 94.9%) and 53.5% (95% CI: 32.1% to 89.1%). Adverse events associated with the neoadjuvant therapy were mainly myelosuppression (45.3%), gastrointestinal reactions (37.7%) and hypothyroidism (20.8%). Conclusion:The neoadjuvant treatment of locally advanced hypopharyngeal squamous cell carcinoma using PD-1 inhibitors combined with paclitaxel and cisplatin can provide with a higher survival rate with a improved laryngeal organ function preservation rate.
9.Transverse sinus blood flow characteristics of pulsatile tinnitus with dehiscent sigmoid plate based on 4D flow MRI
Chihang DAI ; Heyu DING ; Han LYU ; Xiaoyu QIU ; Xiaoshuai LI ; Rong ZENG ; Guopeng WANG ; Zhenghan YANG ; Shusheng GONG ; Zhenchang WANG ; Pengfei ZHAO
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2024;59(9):897-901
Objective:To investigate the hemodynamic characteristics of transverse sinus with sigmoid sinus wall dehiscence (SSWD) of pulsatile tinnitus (PT) based on 4D flow MRI.Methods:Retrospective analysis was performed on all patients admitted to Beijing Friendship Hospital, Capital Medical University from January 2019 to January 2021 for dehiscent sigmoid plate pulsatile tinnitus. A total of 26 patients (sides) who met the criteria and underwent 4D flow MRI were included. A total of 26 subjects (46 sides), matched 1∶1 according to gender and age, were included in the normal healthy control group. Nonparametric rank sum test, Student′s t test, and ANOVA were performed by SPSS 19.0 software. Binary Logistic regression was applied to the data with statistical significance. Results:There were more patients with dominant drainage on the affected side in PT group than in control group (73.1% vs. 42.3%). The incidence of transverse with a focal intraluminal filling defect and tapered stenosis was higher than that in control group (21.7% vs. 69.2%; 17.4% vs. 42.3%). Average through-plane velocity and maximum through-plane velocity in PT group were higher than those in control group [(33.75±13.88) cm/s vs. (15.84±7.21) cm/s; (93.19±33.55) cm/s vs. (40.40±14.40) cm/s]. The middle part and proximal end of Flow avg (ml/s) in PT group were larger than those in control group [4.69 (2.87; 5.62) ml/s vs. 2.76 (1.67; 4.99) ml/s; 3.41 (2.16; 5.47) ml/s vs. 2.67 (1.68; 4.41) ml/s]. In control group, the velocity of transverse sinus changed relatively gently, while in PT group, the velocity of proximal sinus increased significantly. Binary Logistic regression showed that SSWD PT was independently correlated with proximal maximum flow velocity [ OR=1.086(1.029-1.146), P=0.003]. Conclusion:4D flow MRI showed that the dominant drainage and higher velocity at the proximal end of the transverse sinus might be an important hemodynamic characteristics of dehiscent sigmoid plate pulsatile tinnitus.
10.Selection of inner ear fenestration strategy and surgical effect of patients with oval window atresia accompanied by facial nerve aberration
Zhongrui CHEN ; Ruowei TANG ; Jing XIE ; Jingying GUO ; Pengfei ZHAO ; Zijing YANG ; Guopeng WANG ; Shusheng GONG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2024;59(9):902-908
Objective:To summarize the clinical features and postoperative efficacy of patients with oval window atresia accompanied by facial nerve aberration.Methods:The clinical data of patients with congenital middle ear malformation with facial nerve aberration admitted to our hospital from January 2015 to March 2023 were retrospectively analyzed. There were 97 cases (133 ears) in total. Among them, 39 patients (44 ears) had complete follow-up data, including 27 male patients and 12 females, aged 7-48 years old, with an average age of 17.8 years old. Of these, 14 cases (16 ears) were patients combined with facial nerve aberration, and 25 cases (28 ears) were without facial nerve aberration. The results of imaging examination, pure-tone audiometry, selection of surgical strategy, intraoperative findings and postoperative hearing improvement were summarized and analyzed. The malformations of malleus, incus, stapes, oval window and facial nerve were recorded. Prism 9 software was used to statistically analyze the mean bone conductance and air-bone gap of patients before and after surgery.Results:All the 14 patients (16 ears) with middle ear malformation accompanied by facial nerve aberration and oval window atresia showed poor hearing and no facial palsy since childhood. High resolution CT (HRCT) examination of temporal bone, pure tone audiometry and Gelle test were performed before surgery. The malformations of malleus, incus, stapes, oval window and facial nerve were recorded. Preoperative high-resolution CT (HRCT) examination of temporal bone found 12 ears with 4 or more deformities, accounting for 75.00%, in the group of patients with facial nerve malformation. The preoperative average bone conductive threshold was (15.3±10.4) dB and the average air-bone gap was (46.3±10.6) dB in pure-tone audiometry (0.5, 1, 2, 4kHz). According to the different degrees of facial nerve and ossicle malformation, we performed three different hearing reconstruction strategies for the 14 patients (16 ears) with facial nerve aberration and oval window atresia, including 7 ears of incus bypass artificial stape implantation, 7 ears of Malleostapedotomy (MS) and 2 ears of Malleus-cochlear-prothesis (MCP). After 3 months to 18 months of follow-up, all patients showed no facial paralysis. The postoperative mean bone conductive threshold was (15.7±7.9) dB and air-bone gap was (19.8±8.5) dB. There were significant differences in mean air-bone gap before and after operation ( t=7.766, P<0.05), and there was no significant difference between the mean bone conductive threshold before and after surgery ( t=0.225, P=0.824). There was no significant difference of mean reduction of air-bone gap between patients with and without facial nerve aberration ( t=1.412, P=0.165). There was no significant difference between the three hearing reconstruction strategies. There was no significant displacement of the Piston examined by U-HRCT. Conclusion:For patients of middle ear malformation whose facial nerve cover the oval window partially, incus bypass artificial stape implantation or Malleostapedotomy (MS) can be selected according to the specific condition of auditory ossis malformation, and for patients whose facial nerve completely covers the oval window area, Malleus-cochlear-prothesis (MCP) can be selected. Three types of stapes surgery are safe and reliable for patients with oval window atresia accompanied by facial nerve aberration. There was no significant difference in efficacy between them. Preoperative HRCT assessment of middle ear malformation is effective. There is no significant difference of surgical effect with or without facial nerve aberration. The U-HRCT can be used to evaluate the middle ear malformation before surgery and the Piston implantation status after surgery. Due to the risks of surgery, those who do not want to undergo surgery can choose artificial hearing AIDS, such as hearing aid, vibrating soundbridge, bone bridge or bone-anchored hearing aid.

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