1.Current status of registration of radiopharmaceutical clinical trials
Jiancai WU ; Mengmeng WANG ; Qiaoling LIU ; Da ZHANG ; Danhua LU ; Huamei WANG ; Ziqiao LEI
Chinese Journal of Radiological Medicine and Protection 2025;45(8):790-794
Objective:To analyze the status of registration of clinical trials of radiopharmaceuticals in China, and to provide reference for the development and clinical application of radiopharmaceuticals.Methods:By searching the clinical trial registration and information disclosure platform of the Center for Drug Evaluation of the National Medical Products Administration (NMPA), the data on clinical trials of radiopharmaceuticals registered from 2014 to 2024 were collected and analyzed for trial design, administered dose, common indications, and geographical distribution.Results:A total of 77 clinical trials were included. The Compound Annual Growth Rate for the number of projects from 2014 to 2024 was 40%. Diagnostic radiopharmaceuticals were predominantly based on 18F and 99Tc m, while therapeutic radiopharmaceuticals primarily utilized 177Lu and 90Y. All indications were concentrated in the field of oncology. Regarding trial design, non-randomized (71.4%), open-label (89.6%), and single-arm (66.2%) trials accounted for the highest proportions. Geographical distribution showed Beijing (29 trials), Shanghai (18 trials), and Jiangsu province (14 trials) as the regions with the highest concentration of clinical trials. Conclusions:Radiopharmaceutical clinical trials in China have shown rapid growth. However, research remains predominantly focused on oncology, with a relatively high proportion of early-stage trials. In order to fully utilize the potentials of radiopharmaceuticals and improve the quality of clinical trials, nuclear medicine researches should broaden therapeutic applications, implement prudently administerd dose in clinical trials, and implement optimized radiation protection procedures across all clinical trial centers.
2.Clinical efficacy of advanced esophageal cancer treated with esophageal stent placement by endoscopic distance measurement and blind push insertion(182 cases)
Hongqing QIU ; Danhua ZHOU ; Yaping LU
China Journal of Endoscopy 2025;31(7):86-90
Objective To investigate the clinical efficacy of placing a covered esophageal stent by blind pushing method under endoscopic distance measurement in the treatment of advanced esophageal cancer.Method Clinical data of 182 patients with advanced esophageal cancer who were treated by the above method from January 2014 to December 2023 were retrospectively analyzed,and the situations of operation time,patient comfort,accuracy of stent placement,postoperative bleeding,and postoperative chest pain were observed.Result All 182 patients with advanced esophageal cancer were successfully implanted with the covered esophageal stent by the blind pushing method under endoscopic distance measurement.The average placement time was(11.0±4.0)min,and the position of the stent was within 0.5 cm of the expected position.The patients could eat semi-liquid food within 6 h after the operation.No obvious symptoms such as nausea,vomiting and choking cough occurred during the implantation process.Postoperative bleeding was observed in 25 patients(13.7%).No intravenous anesthesia was required,no perforation occurred after the operation,the incidence of postoperative chest pain was documented at 82.4%.The dysphagia problem of the patients was significantly alleviated.Conclusion The endoscopic distance measurement and blind push insertion demonstrate advantages of procedural simplicity,accurate positioning,reducing procedure-related complications,and minimal patient discomfort in patients with advanced esophageal carcinoma and obstruction,establishing its clinical applicability as a novel approach for esophageal stent placement.
3.Clinical efficacy of advanced esophageal cancer treated with esophageal stent placement by endoscopic distance measurement and blind push insertion(182 cases)
Hongqing QIU ; Danhua ZHOU ; Yaping LU
China Journal of Endoscopy 2025;31(7):86-90
Objective To investigate the clinical efficacy of placing a covered esophageal stent by blind pushing method under endoscopic distance measurement in the treatment of advanced esophageal cancer.Method Clinical data of 182 patients with advanced esophageal cancer who were treated by the above method from January 2014 to December 2023 were retrospectively analyzed,and the situations of operation time,patient comfort,accuracy of stent placement,postoperative bleeding,and postoperative chest pain were observed.Result All 182 patients with advanced esophageal cancer were successfully implanted with the covered esophageal stent by the blind pushing method under endoscopic distance measurement.The average placement time was(11.0±4.0)min,and the position of the stent was within 0.5 cm of the expected position.The patients could eat semi-liquid food within 6 h after the operation.No obvious symptoms such as nausea,vomiting and choking cough occurred during the implantation process.Postoperative bleeding was observed in 25 patients(13.7%).No intravenous anesthesia was required,no perforation occurred after the operation,the incidence of postoperative chest pain was documented at 82.4%.The dysphagia problem of the patients was significantly alleviated.Conclusion The endoscopic distance measurement and blind push insertion demonstrate advantages of procedural simplicity,accurate positioning,reducing procedure-related complications,and minimal patient discomfort in patients with advanced esophageal carcinoma and obstruction,establishing its clinical applicability as a novel approach for esophageal stent placement.
4.Current status of registration of radiopharmaceutical clinical trials
Jiancai WU ; Mengmeng WANG ; Qiaoling LIU ; Da ZHANG ; Danhua LU ; Huamei WANG ; Ziqiao LEI
Chinese Journal of Radiological Medicine and Protection 2025;45(8):790-794
Objective:To analyze the status of registration of clinical trials of radiopharmaceuticals in China, and to provide reference for the development and clinical application of radiopharmaceuticals.Methods:By searching the clinical trial registration and information disclosure platform of the Center for Drug Evaluation of the National Medical Products Administration (NMPA), the data on clinical trials of radiopharmaceuticals registered from 2014 to 2024 were collected and analyzed for trial design, administered dose, common indications, and geographical distribution.Results:A total of 77 clinical trials were included. The Compound Annual Growth Rate for the number of projects from 2014 to 2024 was 40%. Diagnostic radiopharmaceuticals were predominantly based on 18F and 99Tc m, while therapeutic radiopharmaceuticals primarily utilized 177Lu and 90Y. All indications were concentrated in the field of oncology. Regarding trial design, non-randomized (71.4%), open-label (89.6%), and single-arm (66.2%) trials accounted for the highest proportions. Geographical distribution showed Beijing (29 trials), Shanghai (18 trials), and Jiangsu province (14 trials) as the regions with the highest concentration of clinical trials. Conclusions:Radiopharmaceutical clinical trials in China have shown rapid growth. However, research remains predominantly focused on oncology, with a relatively high proportion of early-stage trials. In order to fully utilize the potentials of radiopharmaceuticals and improve the quality of clinical trials, nuclear medicine researches should broaden therapeutic applications, implement prudently administerd dose in clinical trials, and implement optimized radiation protection procedures across all clinical trial centers.
5.Psychological experience of nursing assistants of elderly patients with disability and mental disorders: a qualitative study
Gang ZENG ; Weiye CAO ; Aixiang XIAO ; Xingxiao HUANG ; Rong GUI ; Danhua HE ; Wen WANG ; Li LU
Chinese Journal of Modern Nursing 2024;30(2):161-166
Objective:To explore the real work experience and needs of nursing assistants of elderly patients with disability and mental disorders, and provide reference for relevant institutions to develop a reasonable support system and promote their physical and mental health.Methods:From October to November 2022, purposive sampling was used to select nursing assistants of elderly patients with disability and mental disorders from the Affiliated Brain Hospital of Guangzhou Medical University as the research subject. The phenomenological method was used to conduct in-depth interviews, recordings, and transcripts of 12 nursing assistants. The Colaizzi analysis program was used to analyze, organize, refine, and summarize.Results:A total of five themes were extracted, including multiple emotional experiences, lack of rest and relaxation, insufficient professional identity and external support, lack of care knowledge and skills, heavy workload and poor treatment.Conclusions:Accompanying management institutions and hospitals need to strengthen their attention to nursing assistants, reduce their physical and mental burden, attach importance to skill training, increase welfare benefits, enhance professional identity, and improve the quality of care.
6.Osteosarcoma with bone metastasis or pulmonary metastasis show distinct genomic manifestations
Zhenyu CAI ; Yanchun SHE ; Lu XIE ; Han WANG ; Zhiye DU ; Yuan LI ; Tingting REN ; Jie XU ; Xin SUN ; Kunkun SUN ; Danhua SHEN ; Xiaodong TANG ; Wei GUO
Chinese Journal of Orthopaedics 2023;43(9):581-590
Objective:To investigate the genomic manifestation and pathogenesis of osteosarcoma with different relapse pattens, which were respectively initially presented with bone metastasis or pulmonary metastasis.Methods:From May 1, 2021 to October 1, 2021, 38 fresh tumor specimens and some paraffin-embedded specimens of high-grade osteosarcoma were collected in Peking University People's Hospital, including 29 males and 9 females, aged 19.6±2.2 years (range, 6-61 years). Among the 38 cases, 12 cases had initial bone metastasis (group A) and 26 cases had initial lung metastasis (group B), of which 15 cases (40%, 15/38) had paired specimens of primary and metastatic lesions. Based on Illumina NovaSeq 6000, we analyzed whole-exome sequencing (WES) as well as transcriptome for osteosarcoma with paired samples in different relapse patterns. During all their treatment courses, we also collected their paired samples to reveal these tumors' evolution. We sought to redefine disease subclassifications for osteosarcoma based on genetic alterations and correlate these genetic profiles with clinical treatment courses to elucidate potential evolving cladograms.Results:We found that osteosarcoma in group A mainly carried single-nucleotide variations (83%, 10/12), displaying higher tumor mutation burden [4.9 (2.8, 12.0) & 2.4 (1.4, 4.5), P=0.010] and neoantigen load [743.0 (316.5, 1,034.5) & 128.5 (49.0, 200.5), P=0.003], while those in group B mainly exhibit structural variants (58%, 15/26). The mutation spectrum showed that there was a significant difference in age-related gene imprinting 1 between the bone metastasis group and the lung metastasis group ( P=0.005). Samples were randomly selected from group A (3 patients) to investigate immunologic landscape by multiplex immunohistochemistry, from which we noticed tertiary lymphatic structure from one patient from group A. High conservation of reported genetic sequencing over time was found in their evolving cladograms. Conclusion:Osteosarcoma with mainly single-nucleotide variations other than structural variants might exhibit biological behavior predisposing toward bone metastases with older in age as well as better immunogenicity in tumor microenvironment.
7.Correlation between MLH1 methylation and distant metastasis of solid pseudopapillary tumor of pancreas
Ying ZHOU ; Liping LU ; Yiwen SUN ; Wenbing SUN ; Changyu YAO ; Jie HAN ; Shigang GUO ; Danhua SHEN
Chinese Journal of Hepatobiliary Surgery 2022;28(12):918-923
Objective:To investigate the significance of MLH1 protein expression and MLH1 gene methylation rate between metastatic solid pseudopapillary tumor of pancreas (SPT) and non-metastatic SPT, and to explore the correlation between MLH1 gene methylation and SPT metastasis.Methods:Twelve metastatic SPT patients admitted to Peking University People's Hospital, Rizhao Central Hospital and Chaoyang Central Hospital of Liaoning Province from January 2009 to May 2022 were studied retrospectively, including 3 males and 9 females, with a median age of 47 years old, ranging from 21 to 73 years old. Thirty non-metastatic SPT patients with clear diagnosis, clear medical history and complete follow-up data from pathological database of Peking University People's Hospital from January 2009 to May 2017 were selected as the control group, including 12 males and 18 females, with a median age of 42 years old, ranging from 34 to 69 years old. Clinical data such as gender, age and pathological data were collected. Immunohistochemical expression of MLH1 protein and methylation of MLH1 gene were detected by pathological paraffins.Results:There was no significant difference in general data between the two groups (all P>0.05). Among the 12 metastatic SPT patients, 4 cases metastasized to liver, 2 to spleen, 2 to lung, 2 to lymph nodes, 1 to mediastinum, and 1 to sacrum. Compared with the non-metastatic tissue, the MLH1 protein deletion in metastatic pancreatic lesions (metastatic SPT-P) and metastatic lesions (metastatic SPT-M) were increased [both 33.3%(4/12)], and the difference was statistically significant (both Chi square=5.00, both P=0.041). Compared with 0 (0/30) MLH1 gene methylation rate in non-metastatic SPT tissues, the methylation rate of MLH1 gene in metastatic SPT-M and metastatic SPT-P tissues [both 30% (3/10)] were higher, with statistical significance (both Chi square=0.96, both P=0.032). Conclusion:Compared with non-metastatic SPT, the loss rate of MLH1 protein expression and MLH1 gene methylation are increased in metastatic SPT. MLH1 methylation may occur before metastasis, which can be used as a predictor of SPT metastasis.
8.Application of the Micro-Teachermate platform combined with PBL in gynecology and obstetrics teaching
Mao CHEN ; Li HONG ; Suting LI ; Danhua LU ; Linlin WANG
Chinese Journal of Medical Education Research 2021;20(9):975-978
Objective:To illustrate the effectiveness of Micro-Teachermate platform combined with problem-based learning (PBL) in gynecology and obstetrics teaching.Methods:Students from different classes were randomly divided into experimental group and control group, and the general data of the two groups were compared. The two groups respectively adopted Micro-Teachermate platform combined with PBL and traditional lecture teaching methods. The class attendance rate and the scores of relevant chapters in the final examination were analyzed through statistical methods for assessing the enthusiasm of students and teaching quality in class in terms of the same content and the same class hours. A questionnaire survey was conducted to know students' evaluation of this teaching mode, evaluating its teaching effect and satisfaction comprehensively. SPSS 17.0 was used for t test and chi-square test. Results:There was no difference in general information between the two groups. The class attendance rate of the experimental group (274/279) was significantly higher than that of the control group (61/90), while the scores of the relevant chapters in the final exam were also significantly higher ( P<0.01). Questionnaire survey results among 93 students in the experimental group were taken back 93 valid questionnaires (the effective rate, 100%), showing that most of the students were very satisfied with this teaching mode (90/93) and hoped to apply it to more subjects teaching (89/93). Conclusion:The application of Micro-Teachermate platform combined with PBL in gynecology and obstetrics class teaching contributes to improve students' participating enthusiasm and can effectively improve the quality and efficiency of teaching. Most students highly recognize the teaching method, which is worth applying and popularizing.
9.Application of the Teachermate platform combined with PBL in gynecology and obstetrics teaching
Mao CHEN ; Li HONG ; Suting LI ; Danhua LU ; Linlin WANG
Chinese Journal of Medical Education Research 2020;19(12):E014-E014
Objective:To illustrate the effectiveness of Teachermate platform combined with problem-based learning (PBL) in gynecology and obstetrics teaching.Methods:Students from different classes were randomly divided into experimental group and control group, and the general data of the two groups were compared. The two groups respectively adopted Teachermate platform combined with PBL and traditional lecture teaching methods. The class attendance rate and the scores of relevant chapters in the final examination were analyzed through statistical methods for assessing the enthusiasm of students and teaching quality in class in terms of the same content and the same class hours. A questionnaire survey was conducted to know students' evaluation of this teaching mode, evaluating its teaching effect and satisfaction comprehensively.Results:There was no difference in general information between the two groups. The class attendance rate of the experimental group (274/279) was significantly higher than that of the control group (61/90) ( P=0.00), while the scores of the relevant chapters in the final exam were also significantly higher ( P=0.00). Questionnaire survey results among 93 students in the experimental group were taken back 93 valid questionnaires (the effective rate, 100%), showing that most of the students were very satisfied with this teaching mode (90/93) and hoped to apply it to more subjects teaching (89/93). Conclusion:The application of Teachermate platform combined with PBL in gynecology and obstetrics class teaching contributes to improve students' participating enthusiasm and can effectively improve the quality and efficiency of teaching. Most students highly recognize the teaching method, which is worth applying and popularizing.
10.Analysis of prognosis and pregnancy outcomes of fertility-preserving treatment for patients with stage Ⅰa, grade 2 endometrial cancer
Yiqin WANG ; Rong ZHOU ; Lijiang XU ; Meng XIA ; Qun LU ; Guoli LIU ; Danhua SHEN ; Gang WANG ; Mian HE ; Jianliu WANG
Chinese Journal of Obstetrics and Gynecology 2020;55(5):327-332
Objective:To investigate the efficacy and pregnancy outcome of fertility-preserving treatment for patients with stage Ⅰa, grade 2 endometrial cancer (EC).Methods:Clinical data was retrospectively collected for EC or atypical endometrial hyperplasia (AEH) patients treated in Peking University People's Hospital, Foshan First People's Hospital of Guangdong Province and First Affiliated Hospital of Sun Yat-sen University, from 2010 to 2019. Inclusion criteria for fertility-preserving treatment included: (1) Age ≤45 years. (2) EC with histological differentiation of G 1, G 2 or endometrial AEH. (3) EC disease should be stage Ⅰa, confined to the endometrium without myometrial invasion, lymph node or extrauterine metastasis. Treatment regimen: patients were given oral progestin therapy and endometrial pathology was evaluated every three months. Patients were divided into three groups as G 2 EC group, G 1 EC group and AEH group based on the histological differentiation. Oncological and pregnancy outcomes were compared among them. Results:(1) Totally 57 eligible patients were included in this study, including 11 cases with G 2 EC, 22 cases with G 1 EC, and 24 cases with AEH. (2) Oncological outcome: among the three groups of G 2 EC, G 1 EC and AH, the complete remission rates (9/11, 91% and 96%, respectively) and recurrence rates (3/9, 30% and 22%, respectively) were not significantly different (all P>0.05). Median remission time was significantly longer in the G 2 EC group than those in the other two groups (8, 6 and 4 months; P=0.046). Among 9 G 2 EC patients who recurred after complete remission, three patients relapsed at 7, 18 and 53 months, respectively. All 3 patients chose fertility-sparing treatment again, and all achieved complete remission after retreatment. (3) Pregnancy outcome: among the three groups, the assisted reproduction technology rates (4/8, 5/18 and 36%, respectively) and pregnancy rates (6/8, 5/18 and 36%, respectively) had no significant difference ( P>0.05). However, time interval to pregnancy was shorter in G 2 EC patientsthan the other two groups (4, 9 and 22 months, respectively; P=0.006). Conclusions:Fertility-preserving treatment for patients with stageⅠa, G 2 endometrial cancer, may obtain a relatively high remission rate and an acceptable pregnancy rate. However, further exploration is needed due to the limited number of cases.

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