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.Improvement effects and mechanism of Xiangsha yiwei tang on gastric mucosal injury in rats with chronic atrophic gastritis
Pengfei XIA ; Di JIN ; Jin LIANG ; Yi YU ; Jinjun DU ; Zhanyong JIN ; Jun FANG ; Xia YANG ; Huiwu LIU
China Pharmacy 2025;36(11):1311-1316
OBJECTIVE To investigate the improvement effects and mechanism of Xiangsha yiwei tang on gastric mucosal injury in rats with chronic atrophic gastritis (CAG). METHODS Rats were randomly assigned into normal control group, model group, Xiangsha yiwei tang low-, medium- and high-dose groups (6, 12, 18 g/kg, calculated by crude drug), and high-dose group of Xiangsha yiwei tang+740 Y-P [Xiangsha yiwei tang 18 g/kg+transforming growth factor β1/phosphatidyl inositol 3 kinase/ protein kinase B(TGF-β1/PI3K/Akt) pathway activator group 740 Y-P 10 mg/kg], with 18 rats in each group. Rats in each group were administered the corresponding drugs via oral gavage or injection, once daily, for 4 consecutive weeks. Gastric mucosal blood flow, the levels of serum gastrointestinal hormones [including motilin (MTL), gastrin (GAS), and pepsinogen (PP)], as well as inflammatory cytokines [including tumor necrosis factor- α (TNF- α), interleukin-1β (IL-1β), IL-6] in rats were measured. Pathological damage to gastric mucosal tissue was observed in rats; the apoptotic rate of gastric mucosal cells was detected. The expressions of TGF-β1/PI3K/Akt signaling pathway-related proteins and apoptosis-related proteins [including B-cell lymphoma-2 (Bcl-2) and Bcl-2-associated X protein (Bax)] in the gastric mucosal tissues of rats were assessed. RESULTS Compared with normal control group, model group had abnormal gastric mucosal tissue structure, with shedding of gastric mucosal epithelial cells, and prominent infiltration of inflammatory cells. Gastric mucosal blood flow, the serum levels of MTL, GAS, PP, and Bcl-2 protein expression were lowered significantly, while serum levels of TNF-α, IL-1β and IL-6, apoptosis rate, protein expressions of Bax and TGF-β1, the phosphorylations of PI3K and Akt were increased significantly (P<0.05). Compared with model group, Xiangsha yiwei decoction groups exhibited attenuated histopathological injuries in gastric mucosal tissues, reduced inflammatory cell infiltration, and significant improvements in the aforementioned quantitative parameters (P<0.05). Compared with high-dose group of Xiangsha yiwei tang, high-dose group of Xiangsha yiwei decoction combined with 740 Y-P exhibited significantly aggravated histopathological injuries in gastric mucosal tissues, and the aforementioned quantitative parameters were markedly reversed (P<0.05). CONCLUSIONS Xiangsha yiwei tang can alleviate gastric mucosal damage in CAG rats, and its mechanism of action is related to the inhibition of TGF-β1/PI3K/Akt signaling pathway.
3.Network meta-analysis of triple therapy for the prevention and treatment of acute nausea and vomiting caused by emetogenic chemotherapy drugs with moderate and high risk
Tian ZHANG ; Ting LI ; Yatong ZHANG ; Yang WANG ; Pengfei JIN
China Pharmacy 2024;35(6):750-757
OBJECTIVE To evaluate the efficacy of the triple therapy of 5-HT3 receptor antagonists, neurokinin-1 receptor antagonists and dexamethasone (referred to as “triple therapy”) in the prevention and treatment of acute nausea and vomiting caused by moderately and highly emetogenic chemotherapy drugs. METHODS Retrieved from PubMed, Embase, the Cochrane Library, CNKI and Wanfang data, randomized controlled trials (RCTs) about triple therapy or 5-HT3 receptor antagonist combined with dexamethasone (referred to as “dual therapy”) were collected during the inception to May 2023. After literature screening, data extraction and literature evaluation, network meta-analysis was performed by using Stata 16.0 software. RESULTS A total of 59 RCTs were included, involving 23 418 patients and 15 interventions. Results of network meta-analysis showed that fosaprepitant + palonosetron + dexamethasone (FPD) was most effective in terms of acute nausea and vomiting control rate, followed by fosaprepitant + granisetron + dexamethasone (FGD) and aprepitant + ramosetron + dexamethasone (AMD). In terms of acute nausea control rate, FPD was the most effective, followed by aprepitant + palonosetron + dexamethasone (APD) and FGD. In terms of acute vomiting control rate, FPD was the most effective, followed by FGD and APD. CONCLUSIONS Fosaprepitant + palonosetron + dexamethasone is better than other triple therapy or dual therapy in preventing acute nausea and vomiting caused by moderately and highly emetogenic chemotherapy drugs.
4.Current situation analysis and suggestions on clinical pharmacy undergraduate internship education in China
Weihang CAO ; Jianchun LI ; Pengfei JIN
China Pharmacy 2024;35(8):1011-1015
OBJECTIVE To provide a reference for the improvement of the clinical pharmacy undergraduate internship education in China. METHODS The status of clinical pharmacy undergraduate internship education in China was briefly summarized, and suggestions on its future development based on advanced methods of domestic and abroad were provided. RESULTS & CONCLUSIONS In China, undergraduate students of clinical pharmacy were required to undergo hospital internships for no less than 42 weeks. The internship took place in both pharmacy and clinical departments in hospitals. Students’ performance was usually assessed at the end of the internship. The mainstream teaching patterns included on-site teaching, simulation teaching, case-based discussion teaching, medical and pharmaceutical joint teaching, team-based teaching, academic exchange, and so on. The form of assessment had also shifted from final evaluations to more dynamic formats. The clinical pharmacy undergraduate internship education in China can adopt teaching models such as the layered teaching approach, establish pre-internship assessment or training, and encourage interns to participate in social pharmacy practice and directly interact with patients, etc., so as to improve the effect of internship.
5.Serum miR-211 and miR-202 Expression Levels in Alzheimer's Disease Patients and Their Correlation with Cognitive Function,Anxiety and Depression
Pengfei WANG ; Changying CHEN ; Yujuan JIN ; Anlong SUN
Journal of Modern Laboratory Medicine 2024;39(2):129-134
Objective To analyze the expression levels of serum microRNA(miR)-211 and miR-202 in patients with Alzheimer's disease and their correlation with cognitive function,anxiety and depression.Methods A total of 90 patients with Alzheimer's disease admitted to Hebei Yanda Hospital from March 2019 to March 2022 were selected as the research group.According to the Clinical Dementia Rating(CDR)score,the patients were grouped into mild group(n=24),moderate group(n=48)and severe group(n=18).Another 90 healthy individuals who underwent physical examination were collected as the control group.The expression levels of miR-211 and miR-202 in serum were compared.Pearson method and Spearman method were used to analyze serum miR-211 and miR-202 and their correlation with cognitive function,anxiety and depression.Logistic regression analysis was used to analyze the influencing factors of Alzheimer's disease.Results The expression levels of serum miR-211(0.59±0.16,1.01±0.31)and miR-202(0.35±0.10,1.00±0.32)were significantly reduced in the research group and control group,with significant differences(t=11.422,18.393,all P<0.05).Serum miR-211(0.73±0.21,0.62±0.17,0.32±0.08)expression levels,miR-202(0.51±0.15,0.33±0.10,0.19±0.04)expression levels,mini-mental state examination(MMSE)score(22.54±1.41 score,19.35±1.01 score,16.23±1.00 score)and Montreal cognitive assessment(MoCA)score(25.35±2.60 score,18.59±1.32 score,16.59±1.24 score)in the mild,moderate and severe groups gradually decreased,and the differences were statistically significant(F=32.006,46.917,163.048,163.703,all P<0.05).Compared with mild group,the serum miR-211,miR-202,MMSE and MoCA scores of severe group and moderate group were reduced,and the differences were statistically significant(t=3.685~25.375,all P<0.05).The mild,moderate and severe groups had a gradual increase in Hamilton anxiety scale(HAMA)score(12.34±1.27 score,20.59±2.09 score and 31.29±2.19 score)and Hamilton depression scale(HAMD)score(14.35±2.13 score,23.89±2.20 score and 35.35±1.21 score),and the differences were statistically significant(F=496.059,553.939,all P<0.05).According to Pearson correlation analysis,miR-211 was positively correlated with miR-202(r=0.651,P<0.05).According to Spearman correlation analysis,miR-211 and miR-202 were positively correlated with MMSE and MoCA(r=0.539~0.585,all P<0.05)and negatively correlated with HAMA and HAMD(r=-0.651~-0.539,all P<0.05).Logistic regression analysis showed that the low expression of miR-211[OR(95%CI):5.321(1.648~17.180)]and miR-202[OR(95%CI):3.158(1.989~5.012)]were risk factors for Alzheimer's disease(P<0.05).Conclusion The serum expression levels of miR-211 and miR-202 in patients with Alzheimer's disease were reduced,indicating miR-211 and miR-202 were closely related to cognitive function,anxiety and depression.
6.Application of seamless phase Ⅱ/Ⅲ design in vaccine clinical trials
Qian LIU ; Lairun JIN ; Pengfei JIN ; Fengcai ZHU ; Jingxin LI
Chinese Journal of Epidemiology 2024;45(4):602-607
The seamless phase Ⅱ/Ⅲ design integrates independent phase Ⅱ and phase Ⅲ clinical trials into a continuous, phased adaptive clinical trial design. Compared with traditional independent phase Ⅱ and phase Ⅲ clinical trials, the seamless design offers significant advantages in accelerating drug or vaccine development and improving clinical trial efficiency. Currently, the application of this design in anti-tumor drug research is becoming increasingly mature, and it is gradually expanding to clinical trials of vaccines, including the 9-valent human papillomavirus vaccine, sabin strain inactivated polio vaccine, and others. This paper aims to clarify the seamless phase Ⅱ/Ⅲ design concept and offer valuable insights into its implementation. It accomplishes this by presenting a clinical trial example featuring a phase Ⅱ/Ⅲ seamless design for a 9-valent human papillomavirus vaccine. The article delves into the specific considerations and potential challenges related to implementing the seamless design, aiming to provide valuable insights for optimizing vaccine clinical trials within our country.
7.Rapid health technology assessment of ulinastatin in the treatment of acute pancreatitis
Zihui ZHENG ; Zinan ZHAO ; Feng GAO ; Wenying LI ; Han YUAN ; Baige ZHANG ; Liping YANG ; Pengfei JIN
China Pharmacy 2024;35(21):2676-2683
OBJECTIVE To conduct rapid health technology assessment (HTA) of ulinastatin (UTI), and to evaluate the efficacy, safety and cost-effectiveness of UTI in the treatment of acute pancreatitis (AP). METHODS Retrieved from PubMed, Embase, the Cochrane Library, CNKI, Wanfang database, CBM and official websites of HTA institutions, the systematic review (SR)/meta-analysis, economic evaluation and HTA reports of UTI in the treatment of AP were collected from the inception to Apr. 2024. Two researchers independently conducted screening, quality evaluation and data extraction according to the admission and exclusion criteria, and descriptive analysis was adopted to analyze and summarize the data. RESULTS A total of 19 studies were included, involving 15 SR/meta-analysis and 4 economic studies, and no HTA report was retrieved. In the treatment of AP, UTI showed clear advantages over conventional treatment alone in terms of improving the overall effective rate, shortening the recovery time of amylase, reducing the time required to relieve abdominal pain and distension, lowering the mortality rate, and decreasing the average hospital stay. Compared to other positive drugs (carbendate mesylate, octreotide, somatostatin, etc.), its efficacy is similar, with a favorable safety profile. As far as the current research was concerned, UTI had obvious economic advantages over other positive drugs. CONCLUSIONS UTI is safe and effective in the treatment of AP, and has economic advantages.
8.Differences in Chemical Composition of Polygonatum cyrtonema Rhizome Before and After Processing Based on UPLC-Q-Exactive Orbitrap MS Analysis
Cuijiao REN ; Yangfei DING ; Jingji LI ; Shuaishuai LI ; Pengfei LI ; Wei ZHANG ; Hongsu ZHAO ; Fengqing XU ; Chuanshan JIN ; Junling LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):183-189
ObjectiveUltra performance liquid chromatography-quadrupole-electrostatic field orbitrap high resolution mass spectrometry(UPLC-Q-Exactive Orbitrap MS) was used to analyze the differences in chemical components between raw products and wine-processed products of Polygonatum cyrtonema rhizome. MethodUPLC-Q-Exactive Orbitrap MS was used to analyze the chemical compositions of P. cyrtonema rhizome before and after processing, and the effective response ions were extracted after raw data processing, and the differential compounds before and after processing were screened combined with multivariate statistical analysis and according to the conditions of variable importance in the projection(VIP) value>1, P<0.05, fold change(FC)>2 or FC<0.5, based on the retention time, quasi-molecular ions, fragment ions and other information, the components were identified in combination with the control products and the literature, and the significant difference compounds were identified by clustering thermal analysis and relative quantitative analyzed, in order to clarify the change rule of the main components in P. cyrtonema rhizome before and after processing. ResultA total of 72 differential constituents between raw products and wine-processed products were identified, including 15 alkaloids, 12 organic acids, 12 amino acids, 6 flavonoids, 4 saccharides and 23 others. There were a total of 18 significantly different components, among which 13 compounds, including L-malic acid, lactic acid and 9,12,13-trihydroxy-10-octadecenoic acid, showed an increasing trend in content after wine processing, 5 compounds such as trans-3-indoleacrylic acid, L-arginine, D-tryptophan, showed a decreasing trend after processing. ConclusionThe chemical components of P. cyrtonema rhizome are significantly different before and after processing, mainly organic acids, saccharides, amino acids, flavonoids and alkaloids, which can lay the foundation for the in-depth study of the processing mechanism of Polygonati Rhizoma.
9.Redefining the role of surgical resection in pancreatic cancer with liver oligometastases
Chinese Journal of Digestive Surgery 2024;23(5):667-675
Pancreatic cancer is an aggressive malignancy with a poor prognosis. Compre-hensive treatment based on surgical resection can improve prognosis of patients to a great extent. However, a significant challenge had arisen as patients were often diagnosed with distant metas-tases, predominantly liver metastases. Traditionally, patients presenting with metastatic pancreatic cancer have been considered unresectable, leading to palliative systemic chemotherapy as the standard treatment. With the establishment of multiagent chemotherapy protocols in recent years, the feasi-bility of conversion surgery in selected patients with liver oligometastasis following preoperative chemotherapy was reported. Nonetheless, the understanding of pancreatic cancer with liver oligo-metastases remains limited among most physicians, leaving the treatment paradigm of these patients ambiguous. In this review, the authors attempt to define liver oligometastases in pancreatic cancer, assess the safety and oncologic outcome of surgical resection, and explore feasible strategies for conversion surgery from the perspective of biological resectability.
10.Analysis and summary of clinical characteristics of 289 patients with paroxysmal nocturnal hemoglobinuria in Zhejiang Province
Gaixiang XU ; Weimei JIN ; Baodong YE ; Songfu JIANG ; Chao HU ; Xin HUANG ; Bingshou XIE ; Huifang JIANG ; Lili CHEN ; Rongxin YAO ; Ying LU ; Linjie LI ; Jin ZHANG ; Guifang OUYANG ; Yongwei HONG ; Hongwei KONG ; Zhejun QIU ; Wenji LUO ; Binbin CHU ; Huiqi ZHANG ; Hui ZENG ; Xiujie ZHOU ; Pengfei SHI ; Ying XU ; Jie JIN ; Hongyan TONG
Chinese Journal of Hematology 2024;45(6):549-555
Objective:To further improve the understanding of paroxysmal nocturnal hemoglobinuria (PNH), we retrospectively analyzed and summarized the clinical characteristics, treatment status, and survival status of patients with PNH in Zhejiang Province.Methods:This study included 289 patients with PNH who visited 20 hospitals in Zhejiang Province. Their clinical characteristics, comorbidity, laboratory test results, and medications were analyzed and summarized.Results:Among the 289 patients with PNH, 148 males and 141 females, with a median onset age of 45 (16-87) years and a peak onset age of 20-49 years (57.8% ). The median lactic dehydrogenase (LDH) level was 1 142 (604-1 925) U/L. Classified by type, 70.9% (166/234) were classical, 24.4% (57/234) were PNH/bone marrow failure (BMF), and 4.7% (11/234) were subclinical. The main clinical manifestations included fatigue or weakness (80.8%, 235/289), dizziness (73.4%, 212/289), darkened urine color (66.2%, 179/272), and jaundice (46.2%, 126/270). Common comorbidities were hemoglobinuria (58.7% ), renal dysfunction (17.6% ), and thrombosis (15.0% ). Moreover, 82.3% of the patients received glucocorticoid therapy, 70.9% required blood transfusion, 30.7% used immunosuppressive agents, 13.8% received anticoagulant therapy, and 6.3% received allogeneic hematopoietic stem cell transplantation. The 10-year overall survival (OS) rate was 84.4% (95% CI 78.0% -91.3% ) . Conclusion:Patients with PNH are more common in young and middle-aged people, with a similar incidence rate between men and women. Common clinical manifestations include fatigue, hemoglobinuria, jaundice, renal dysfunction, and recurrent thrombosis. The 10-year OS of this group is similar to reports from other centers in China.

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