1.International experience and enlightenment of patient engagement in drug regulation
Jingjing WU ; Kaixin ZENG ; Yufei YANG ; Mengyan TIAN ; Fangzheng DONG ; Yimeng ZHANG ; Jun LI ; Ningying MAO
China Pharmacy 2025;36(8):908-913
OBJECTIVE To provide suggestions for improving the path and system construction of patient engagement in drug regulation in China. METHODS By reviewing initiatives and experiences from the United States (U. S.), European Union (EU), and Japan in promoting patient engagement, this study summarizes the roles and contributions of patients in the entire drug regulatory process internationally. Combining China’s current progress and challenges in patient engagement, specific proposals are formulated to refine regulatory pathways and institutional systems. RESULTS & CONCLUSIONS With growing global emphasis on patient engagement as a regulatory strategy, countries or regions such as the U.S., EU, and Japan have established clear policies, designated oversight agencies, and developed diversified pathways for patient engagement. Patients contribute to regulatory processes through advisory meetings, direct decision-making roles, and leveraging lived experiences and expertise to optimize drug evaluation and monitoring. In contrast, China’s patient engagement remains primarily limited to clinical value- oriented drug development, lacking formal policy guidance. It is recommended that China, based on its existing policy system, further strengthen the construction of a safeguard system for patient engagement, improve the capacity building and pathway models for patient participation in pharmaceutical regulation, and promote the continuous development of patient engagement in pharmaceutical regulation in our country.
2.Nodule candidate detection algorithm based on deep learning
Caidi ZHANG ; Yueyang LI ; Fangzheng CUI ; Haichi LUO ; Zhongxuan GU
Chinese Journal of Medical Physics 2024;41(9):1177-1184
A nodule candidate detection algorithm based on 3DSCANet utilizing deep learning techniques is proposed to improve nodule candidate detection performance.The algorithm employs a strengthen coordinate attention(SCA)module which improves upon the basic coordinate attention mechanism to enable it to extract three-dimensional(3D)features,and incorporates adaptive convolution to extract cross-channel features,thereby enhancing the feature extraction capability of the SCA mechanism.Additionally,a method to convert 3D rectangular anchor boxes into 3D spheres is proposed,along with the introduction of a sphere based intersection over union loss function(SIoUX)to fully leverage the morphological characteristics of lung nodules which are spherical in shape.During the experimental phase,the method is tested on the LUNA16 dataset using ten-fold cross-validation,and it achieves an average recall rate of 0.94.
3.Lung nodule classification algorithm based on multi-dimensional fusion
Hongqun DU ; Yueyang LI ; Fangzheng CUI ; Haichi LUO ; Zhongxuan GU
Chinese Journal of Medical Physics 2024;41(11):1428-1436
A novel algorithm based on multi-dimensional fusion is proposed for classifying lung nodules.Based on the algorithm for reducing false positives of pulmonary nodules,the optimization is carried out by introducing a high-level feature enhancement soft activation mapping module after obtaining features by the multi-scale feature fusion module to improve the classification ability.To address the imbalance of different nodule data in the actual classification,a balanced mean square error loss is adopted to improve the training effect of the model.A three-dimensional and two-dimensional model fusion method is used to further improve the classification performance.The experiment conducted on a Private Lung dataset proves that the proposed model has a classification accuracy of 93.8%,outperforming the existing methods.
4.Association of microsatellite instability with clinicopathological features and prognosis of colon cancer patients
Chentong YUAN ; Zhaopeng LI ; Fangzheng YANG ; Shengnan WANG ; Yancheng SONG ; Yu LI
Chinese Journal of General Surgery 2023;38(6):412-417
Objective:To investigate the relationship between microsatellite instability (MSI) , and clinicopathological features ,prognosis in patients with stage Ⅱ and Ⅲ colon cancer.Methods:Patients undergoing surgical resection for stage Ⅱ and Ⅲ colonic tumor in the Affiliated Hospital of Qingdao University from Dec 2016 to Nov 2018 were enrolled. All the 292 patients were with stage Ⅱ and Ⅲ colon cancer and MSI status. Propensity score matching method was used to match the two groups of patients according to 1:1. χ 2 analysis, Logistic Regression and COX regression was used to analyse the relationship between MSI status, the clinicopathological features and prognosis. Results:The risk of MSI-H in young patients ( OR=0.340, 95% CI: 0.126~0.921, P=0.034), right-sided colon cancer ( OR=7.985, 95% CI: 3.040-20.973, P<0.001), mucinous adenocarcinoma ( OR=4.285, 95% CI: 1.495-12.284, P=0.007), poorer differentiation ( OR=4.848, 95% CI: 1.597-14.716, P=0.005), N0 staging ( OR=0.235 , 95% CI: 0.077-0.719, P=0.011) increased . The total OS of colon cancer patients in the MSS group (66.7%) and the MSI-H group (86.9%) were statistically different( P=0.003). The MSI status ( HR=0.367, 95% CI: 0.151-0.891, P=0.027) is an independent factor affecting the prognosis of patients. Conclusions:In stage Ⅱ and Ⅲ colon cancer, patients with MSI-H have a better prognosis. MSI status is prognosis relevant factor for colon cancer patients.
5.Incidence and risk factors of postoperative delirium in liver transplantation recipients: a Meta-analysis
Xu HU ; Fangzheng JIANG ; Baiqiang LI ; Donghua ZHANG ; Tao JIANG ; Ying ZUO ; Jiajie TANG ; Guizhu LIU ; Fang WANG
Chinese Journal of Organ Transplantation 2023;44(6):346-353
Objective:To clarify the incidence and the related risk factors of postoperative delirium in liver transplantation (LT) recipients to provide rationales for early identification of delirium and constructing the related models.Methods:The authors used the "肝移植""移植术""肝移植手术""肝脏移植""移植肝""谵妄""谵语""危险因素""相关因素""影响因素"and "liver transplantation""liver transplant""delirium""delirious""delirium confusion""risk factors""relevant factors""root cause analysis"as the Chinese and English keywords, searching Wanfang data, China Biomedical Literature Database, CNKI, PubMed, Embase, Web of Science, Cochrane Library, BMJ and the literature for the incidence or risk factors of postoperative delirium in LT recipients. The researchers independently performed literature screening, methodological evaluation and data extraction. And RevMan 5.4 and State16.0 software were employed for data processing.Results:A total of 19 articles involving 5003 samples were retrieved and 22 risk factors identifies. Meta-analysis showed that the incidence of POD was 23%(1151/5003). The statistically significant risk factors included preoperative blood ammonia concentration >46 mmol/L ( OR=3.51, 95% CI: 1.53-8.09, P<0.001), model for end-stage liver disease (MELD) score >15 points ( OR=4.24, 95% CI: 2.51-7.16, P<0.001), preoperative hepatic encephalopathy ( OR=3.00, 95% CI: 2.09-4.31, P<0.001), preoperative dosing of diuretics ( OR=2.36, 95% CI: 1.38-4.04, P<0.001), history of alcoholism ( OR=3.16, 95% CI: 1.06-9.40, P=0.040), longer anhepatic period ( OR=1.04, 95% CI: 1.03-1.06, P<0.001) and elevated aspartate transaminase concentration at Day 1 post-operation ( OR=1.33, 95% CI: 1.15-1.53, P<0.001). Conclusions:Preoperative blood ammonia concentration >46 mmol/L, MELD score >15, hepatic encephalopathy, dosing of diuretic, a history of alcoholism, longer anhepatic period and elevated aspartate transaminase at Day 1 post-operation are risk factors for postoperative delirium after LT. Postoperative reintubation is not a risk factor for postoperative delirium.
6.Efficacy and safety of 125I intraluminal irradiation combined with lenvatinib in treatment of progressive extrahepatic cholangiocarcinoma
Xingshu ZHU ; Pengfei CHEN ; Mengfan ZHANG ; Fangzheng LI ; Jinwei CHEN ; Wenguang ZHANG ; Xuhua DUAN ; Jianzhuang REN ; Xinwei HAN
Journal of Clinical Hepatology 2023;39(10):2406-2412
ObjectiveTo investigate the efficacy and safety of 125I intraluminal irradiation combined with lenvatinib in the treatment of progressive extrahepatic cholangiocarcinoma. MethodsA retrospective analysis was performed for 25 patients with progressive extrahepatic cholangiocarcinoma who attended Department of Interventional Radiology, The First Affiliated Hospital of Zhengzhou University, from January 2018 to November 2021, and according to the treatment modality, they were divided into combination group with 13 patients (125I intraluminal irradiation combined with lenvatinib) and control group (125I intraluminal irradiation alone). The two groups were compared in terms of technical success rates, changes in liver function, stent patency, survival time, and incidence rates of adverse events. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Wilcoxon rank-sum test was used for comparison of continuous data with skewed distribution between two groups; the Fisher’s exact test was used for comparison of categorical data between groups. The Kaplan-Meier method and the log-rank test were used to evaluate survival time and stent patency. ResultsAll patients had successful implantation of biliary stents and 125I particles, with a technical success rate of 100%. After 1 month of treatment, both groups had significant improvements in the serum levels of total bilirubin, direct bilirubin, alanine aminotransferase, and aspartate aminotransferase (all P<0.05). There were significant differences between the control group and the combination group in the duration of stent patency (7.0 months vs 9.5 months, P=0.022) and median survival time (11.5 months vs 15.6 months, P=0.008). There were no intolerable adverse events in the combination group during treatment. ConclusionCompared with 125I intraluminal irradiation alone, 125I intraluminal irradiation combined with lenvatinib has better efficacy and is a safe and effective treatment regimen for progressive extrahepatic cholangiocarcinoma.
7.Advances of long non-coding RNA encoded micro-peptides.
Jianfeng PAN ; Fangzheng SHANG ; Rong MA ; Min WANG ; Youjun RONG ; Lili LIANG ; Shuran NIU ; Yanbo LI ; Yunpeng QI ; Yanjun ZHANG ; Jinquan LI
Chinese Journal of Biotechnology 2022;38(9):3194-3214
Long non-coding RNA (lncRNA) refers to non-coding RNA longer than 200 nt, with one or more short open reading frames (sORF), which encode functional micro-peptides. These functional micro-peptides often play key roles in various biological processes, such as Ca2+ transport, mitochondrial metabolism, myocyte fusion, cellular senescence and others. At the same time, these biological processes play a key role in the regulation of body homeostasis, diseases and cancers development and progression, embryonic development and other important physiological processes. Therefore, studying the potential regulatory mechanisms of micro-peptides encoded by lncRNA in organisms will help to further elucidate the potential regulatory processes in organisms. Furthermore, it will provide a new theoretical basis for the subsequent targeted treatment of diseases and improvement of animal growth performance. This review summarizes the latest research progress in the field of lncRNA-encoded micro-peptides, as well as the progress in the fields of muscle physiological regulation, inflammation and immunity, common human cancers, and embryonic development. Finally, the challenges of lncRNA-encoded micro-peptides are briefly described, with the aim to facilitate subsequent in-depth research on micro-peptides.
Animals
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Humans
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Neoplasms/therapy*
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Open Reading Frames
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Peptides/chemistry*
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RNA, Long Noncoding/genetics*
8.The application of transjugular liver biopsy in patients with unexplained liver disease
Wenguang ZHANG ; Xianwei QI ; Jingqiang ZHANG ; Zhenhua TIAN ; Pengfei CHEN ; Xueliang ZHOU ; Fangzheng LI ; Yong NIU ; Jianzhuang REN ; Xinwei HAN
Chinese Journal of Hepatobiliary Surgery 2022;28(9):651-655
Objective:To investigate the clinical value of transjugular liver biopsy (TJLB) in patients with unexplained liver disease complicated with massive ascites or coagulopathy.Methods:A retrospective analysis was performed from patients underwent TJLB in the First Affiliated Hospital of Zhengzhou University, Zhoukou Central Hospital, Shangqiu First People's Hospital and Jincheng People's Hospital from March 2015 to January 2022 due to unexplained liver disease complicated with massive ascites or coagulopathy. A total of 37 patients were included, including 21 males and 16 females, aged (53.5±11.9) years. According to different puncture points, the patients were divided into two groups: transhepatic right vein TJBL and transhepatic middle vein TJBL. The obtained liver tissue sampling effect, puncture times, complications were analyzed.Results:The success rate of TJLB was 97.3%(36/37). Thirty-six patients were able to obtain more than three segments of liver tissue and obtain histological diagnosis, and the pathological diagnosis rate was 100.0%(36/36). The number of puncture times, the amount of hepatic tissue and the number of portal areas in the right hepatic vein group (21 cases) were (3.7±0.9), (3.7±0.7) and (6.5±0.9) respectively, and those in the middle hepatic vein group (15 cases) were (3.7±0.7), (3.7±0.7) and (6.3±0.8) respectively. There were no significant differences between the two groups (all P>0.05). Conclusion:TJLB is safe and feasible for patients with unexplained liver disease complicated with massive peritoneal effusion and coagulopathy. Good liver tissue specimens can be obtained by TJLB from both right hepatic vein and middle hepatic vein.
9.Observation of short-term efficacy of bronchial arterial chemoembolization combined with anlotinib for treatment of advanced non-small cell lung cancer
Wenhui WANG ; Xuhua DUAN ; Hao LI ; Manzhou WANG ; Fangzheng LI ; Pengfei CHEN ; Wenze XU ; Jianzhuang REN ; Xinwei HAN
Cancer Research and Clinic 2021;33(12):908-912
Objective:To observe the short-term efficacy and safety of bronchial arterial chemoembolization (BACE) combined with anlotinib for treatment of advanced non-small cell lung cancer (NSCLC).Methods:The clinical data of 14 patients with advanced NSCLC in the First Affiliated Hospital of Zhengzhou University from June 2018 to March 2019 were retrospectively analyzed. The short-term efficacy and adverse reactions of BACE combined with anlotinib hydrochloride were evaluated.Results:All patients successfully received BACE treatment twice. The median follow-up time was 19 months (8-26 months). The objective response rate (ORR) of patients at 1, 3 and 6 months after the first treatment was 100.0% (14/14), 71.4% (10/14) and 57.1% (8/14), and the disease control rate (DCR) was 100.0% (14/14), 92.8% (13/14) and 78.6% (11/14), respectively. The median progression-free survival (PFS) time was 9.5 months (95% CI 9.0-17.3 months), and the 6-month and 12-month PFS rates were 78.6% and 28.6%, respectively. The median overall survival (OS) time was 19.0 months (95% CI 18.4-23.1 months), and the 6-month and 12-month OS rates were 100.0% and 85.7%, respectively. Anlotinib hydrochloride-related adverse reactions included hand-foot syndrome [42.9% (6/14)], fatigue [35.7% (5/14)], hypertension [35.7% (5/14)], oral mucositis [28.6% (4/14)], hemoptysis [28.6% (4/14)], elevated aminotransferases [21.4% (3/14)] and diarrhea [14.3% (2/14)]. There were no grade ≥3 adverse reactions. Conclusion:BACE combined with anlotinib is safe and effective for treatment of advanced NSCLC, and the short-term clinical efficacy is satisfactory.
10.Clinical value of emergency endovascular embolization in the interventional treatment for oral hemorrhage caused by carcinoma
Fan TANG ; Pengfei CHEN ; Fangzheng LI ; Donglin KUANG ; Jiaxing WANG ; Li WAN ; Xinwei HAN ; Jianzhuang REN ; Xuhua DUAN
Chinese Journal of Stomatology 2021;56(4):370-373
To evaluate the clinical value of emergency endovascular embolization in the interventional treatment for oral hemorrhage caused by carcinoma, 32 patients with oral hemorrhage caused by carcinoma, who received emergency endovascular embolization due to unsatisfactory hemostatic effect of conventional conservative treatment in the First Affiliated Hospital of Zhengzhou University from January 2014 to December 2019, were included in this study and their clinical data, laboratory data and imaging information were retrospectively analyzed. There were 16 males and 16 females, aged (60.6±13.6) years (34-88 years). Technical successful rate of emergency endovascular embolization, immediate successful rate of controlling hemorrhage, blood pressure before and after operation, hemoglobin before and after operation, postoperative complications and recurrence rate of oral hemorrhage were statistically analyzed. Results showed that technical successful rate of operation and immediate successful rate of controlling oral hemorrhage are both 100% (32/32). Recurrent oral hemorrhage occurred in 4 patients (13%). The hemorrhagic shock symptoms of all patients were significantly improved after interventional therapy. After operation, local swelling happened in 34% (11/32) patients and intermittent local pain happened in 22% (7/32) within 24 hours; the swelling and the pain gradually disappeared from 2nd to 5th days. Mild complications of transient fever happened in 9% (3/32) patients and disappeared spontaneously in the short term. No serious complications such as blindness, cerebrovascular accident or central nervous system disturbance occurred in all patients after operations. During the whole follow-up period (1 to 12 months), a total of 8 patients died. The causes of death were progression and metastasis of carcinoma ( n=4), heart failure ( n=2), severe pneumonia ( n=1) and respiratory failure caused by recurrent oral hemorrhage ( n=1). Owing to the remarkable short-term curative effect, repeatable operation, low recurrence rate of oral hemorrhage and low incidence of complications, emergency endovascular embolization can be used in the clinical therapy and application of oral hemorrhage caused by carcinoma.

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