1.Clinical value of serum calcitonin in the diagnosis,preoperative evaluation and postoperative follow-up of medullary thyroid cancer
Tingting LI ; Bing'e MA ; Chi HUANG ; Shuhang XU ; Xinping WU ; Jianhua WANG
Chinese Archives of Otolaryngology-Head and Neck Surgery 2024;31(1):7-12
OBJECTIVE To investigate the diagnostic efficacy of serum calcitonin(Ctn)in medullary thyroid cancer(MTC),the correlation between preoperative serum Ctn and clinicopathological features,and the risk factors affecting the progression of MTC disease during follow-up.METHODS The clinical data of 50 patients admitted to the Hospital of Integrated Traditional Chinese and Western Medicine of Nanjing University of Chinese Medicine from 2011 to 2022 were systematically reviewed,the ROC curve calculated the diagnostic efficacy of Ctn and CEA levels on MTC,and the risk factors for lymph node metastasis in the central region of MTC were analyzed in univariate and multivariate,and the survival curve without disease progression was drawn to predict risk factors.RESULTS The ROC curve yields the preoperative cut-off value of Ctn was 23.81 pg/ml and the cut-off value of CEA was 3.035 ng/ml for the diagnosis of MTC.The age of disease,tumor diameter,and preoperative serum Ctn and CEA levels in MTC patients were higher than those in non-MTC patients.Ctn≥289.62 pg/ml was an independent risk factor for central lymph node metastasis in MTC.The survival curve showed that invasion of the capsule,central region metastasis,and TNM stage above T2 were risk factors for predicting disease progression(P<0.05).Patients with MTC who have disease progression have higher preoperative Ctn.CONCLUSION Serum Ctn has important clinical value in the differential diagnosis,preoperative evaluation and postoperative follow-up of MTC.
2.Size discrepancy between ultrasonic and pathological measurement of solitary cN0M0 papillary thyroid microcar-cinoma
Yujie REN ; Yujiang LI ; Zheng ZENG ; Jianhua WANG ; Wenbo DING ; Xinping WU ; Chao LIU ; Shuhang XU
Journal of Surgery Concepts & Practice 2024;29(4):345-350
Objective To compare the size discrepancy between ultrasonic and pathological measurement of solitary cN0M0 papillary thyroid microcarcinoma(PTMC),and to explore their correlation with lymph node metastasis.Methods From April 2021 to January 2022,234 patients with solitary cN0M0 PTMC who received thyroid lobectomy or total thyroidectomy in the Department of Thyroid and Breast Surgery of Nanjing University of Chinese Medicine,Affiliated Hospital of Integrated Traditional Chinese and Western Medicine were analyzed retrospectively.The size discrepancy between ultrasonic and pathological measurement were compared,and the risk factors of central lymph node metastasis were analyzed.Results The mean of maximum diameter of PTMC measured by ultrasound was 6.8(range 5.6 to 8.4)mm,which was significantly bigger than that measured by pathology 5.0(range 4.0 to 7.0)mm(P=0.000).Of them,37.2%of the tumor size measured by ultrasound is consistent with pathology,61.1%of the tumor size measured by ultrasound is bigger than that measured by pathology,and only 1.7%of the tumor size measured by ultrasound is smaller than that measured by pathology.There was a linear correlation between the diameter measured by ultrasound and pathology.And the regression equation can be expressed as:pathological diameter=0.799×ultrasonic diameter-0.221.In addition,28.6%patients had central lymph node metastasis.Multivariate Logistic regression analysis showed that the diameter measured by pathology is a risk factor for central lymph node metastasis in patients(OR=17.845,95%CI:2.507-127.025,P=0.004),and the cutoff value is 5.5 mm which corresponded to the diameter measured by ultrasound as 7.2 mm.Conclusions The sizes of solitary cN0M0 PTMC measured by ultrasound and pathology are different but also correlated.PMTC with pathological diameter>5.5 mm with its corresponding ultrasonic diameter as 7.2 mm indicated an increased risk of central lymph node metastasis.
3.Decision-making experience and needs of patients in clinical trials of neoadjuvant immunotherapy for lung cancer: a qualitative study
Shujun XING ; Jun'e LIU ; Shuhang WANG ; Dawei WU ; Hong FANG ; Yu TANG ; Ning LI
Chinese Journal of Modern Nursing 2024;30(16):2137-2142
Objective:To deeply explore the decision-making experience of patients participating in clinical trials of neoadjuvant immunotherapy for lung cancer.Methods:Using the descriptive and qualitative research, 15 lung cancer patients who participated in clinical trials of neoadjuvant immunotherapy at the Cancer Hospital of the Chinese Academy of Medical Sciences were selected by purposive sampling from April 2021 to August 2022 for semi-structured in-depth interviews. Content analysis method was used for data analysis, summarization, and induction.Results:Three themes were extracted, namely decision-making information dilemma (insufficient or overloaded information, difficulty in understanding professional information, urgent need for decision-making information assistance), complex emotional experience (negative emotional experience, positive emotional experience), and hope for multi-party support (expecting psychological communication, hoping for family understanding, and longing for social recognition) .Conclusions:The decision-making experience of patients in clinical trials of neoadjuvant immunotherapy for lung cancer were summarized and described, which can help strengthen the understanding of the research team and medical and nursing staff on the live experience of such patients when making decisions, provide targeted decision support strategies, and promote good informed consent of patients.
4.Rare tumors: a blue ocean of investigation.
Shuhang WANG ; Peiwen MA ; Ning JIANG ; Yale JIANG ; Yue YU ; Yuan FANG ; Huilei MIAO ; Huiyao HUANG ; Qiyu TANG ; Dandan CUI ; Hong FANG ; Huishan ZHANG ; Qi FAN ; Yuning WANG ; Gang LIU ; Zicheng YU ; Qi LEI ; Ning LI
Frontiers of Medicine 2023;17(2):220-230
Advances in novel drugs, therapies, and genetic techniques have revolutionized the diagnosis and treatment of cancers, substantially improving cancer patients' prognosis. Although rare tumors account for a non-negligible number, the practice of precision medicine and development of novel therapies are largely hampered by many obstacles. Their low incidence and drastic regional disparities result in the difficulty of informative evidence-based diagnosis and subtyping. Sample exhaustion due to difficulty in diagnosis also leads to a lack of recommended therapeutic strategies in clinical guidelines, insufficient biomarkers for prognosis/efficacy, and inability to identify potential novel therapies in clinical trials. Herein, by reviewing the epidemiological data of Chinese solid tumors and publications defining rare tumors in other areas, we proposed a definition of rare tumor in China, including 515 tumor types with incidences of less than 2.5/100 000 per year. We also summarized the current diagnosis process, treatment recommendations, and global developmental progress of targeted drugs and immunotherapy agents on the status quo. Lastly, we pinpointed the current recommendation chance for patients with rare tumors to be involved in a clinical trial by NCCN. With this informative report, we aimed to raise awareness on the importance of rare tumor investigations and guarantee a bright future for rare tumor patients.
Humans
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Neoplasms/pathology*
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Biomarkers
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Prognosis
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Oceans and Seas
;
China/epidemiology*
5.Outcome measures of phase III anticancer drug trials in China.
Lanwei GUO ; Huiyao HUANG ; Yue YU ; Jun WANG ; Le WANG ; Shuhang WANG ; Dawei WU ; Yuan FANG ; Ning JIANG ; Shaokai ZHANG ; Yu TANG ; Ning LI
Chinese Medical Journal 2023;136(8):992-994
6.Psychological experience of patients with primary tumors participating in clinical trials:a qualitative study
Shujun XING ; Jun'e LIU ; Mengdie HU ; Shuhang WANG ; Dawei WU ; Hong FANG ; Yu TANG ; Ning LI
China Modern Doctor 2023;61(35):92-95,98
Objective To deeply understand the psychological experience of patients with primary tumors participating in clinical trials,providing a reference basis for meeting the psychological needs of patients and improving the mental health level of patients with primary tumors.Methods From November 2021 to May 2022,13 patients with primary tumors participating in clinical trials were selected by target sampling method,semi-structured interviews were conducted,with Colaizzi 7-step analysis method was used to analyze the data.Results Four themes were extracted from the psychological experience of patients,namely the perception and attitudinal experience of clinical trials,complex and changeable emotional responses,experimental process adaptation,personal growth and transformation.Conclusion The psychological experience and related psychological problems of primary tumors patients participating in clinical trials cannot be ignored,the research team needs to help them complete role transformation and adaptation,pay attention to the experience of patients,improve mental health education programs according to the needs of this type of patients,and improve the quality of life of patients,then promote the development of cancer diagnosis and treatment in China.
7.Correlation analysis of intestinal flora and pathological process of type 2 diabetes mellitus
An YONGCHENG ; Duan YUHUI ; Dai HONGYU ; Wang CHEN ; Shi LU ; He CHANGHAO ; Lv YINGLAN ; Li HUIMIN ; Dai SHUHANG ; Zhao BAOSHENG
Journal of Traditional Chinese Medical Sciences 2022;9(2):166-180
Objective:To observe the relationship between the different stages of type 2 diabetes mellitus(T2DM)and the intestinal flora and verify its underlying mechanism.Methods:T2DM rats were generated by high-fat diet(HFD)combined with intraperitoneal streptozo-tocin(STZ)injection.The rats were divided into four groups:the control group(fed with normal feed for 1 month),the HFD group(fed with HFD for 1 month),the T2DM group(HFD combined with STZ and blood glucose>11.1 mM),and the unformed T2DM model(Un-mod)group(HFD combined with STZ and blood glucose<11.1 mM).Feces were collected,and bacterial communities in the fecal samples were analyzed by 16S rRNA gene sequencing.The content of short-chain fatty acids(SCFAs)in feces was measured by gas chromatography.Western blot and quantitative real-time polymerase chain reaction were used to detect the expression of G protein-coupled receptor 41(GPR41)and GPR43.Results:At different stages of T2DM,the intestinal flora and SCFAs content of rats were significantly decreased(all P<.05).Our results indicated that g_Prevotella had a significant negative correlation,and g_Ruminococcus_torques_group and g_lachnoclastic had a significant positive correlation with blood glucose.The content of SCFAs,in particular acetate and butyrate,in rat feces of different stages of T2DM were significantly reduced,as well as GPR41 and GPR43 expression.The results in the Un-mod group were similar to the T2DM group,and the expression of GPR41 and GPR43 proteins were significantly higher than those in the T2DM group(both P<.001).Conclusion:The intestinal flora-SCFAs-GPR41/GPR43 network may be important in the development of T2DM.Decreasing blood glucose levels by regulating the intestinal flora may become a new therapeutic strategy for T2DM,which has very important clinical and social values.
8.Effectiveness and safety of ultrasound-guided microwave ablation for the treatment of primary hyperparathyroidism in 12 patients with parathyroid adenoma
Wenjing NI ; Xiaoqiu CHU ; Chenya LU ; Guofang CHEN ; Xue HAN ; Yang XU ; Xinping WU ; Jianhua WANG ; Chao LIU ; Shuhang XU
Chinese Journal of Internal Medicine 2021;60(10):904-907
To investigate the effectiveness and safety of ultrasound-guided microwave ablation (MWA) in treatment of primary hyperparathyroidism (PHPT). A total of 12 PHPT patients with parathyroid adenoma were treated with MWA in Nanjing University of Chinese Medicine Affiliated Hospital of Integrated Traditional Chinese and Western Medicine from May 2019 to February 2021. The patients were followed up once every 3 months for 3-12 months. Levels of serum parathyroid hormone (PTH), calcium and phosphorus were detected before and 20 min, 4h and 1day after ablation, and during follow-up period. The volume and volume reduction rate of parathyroid lesion were compared before the treatment and at the end of follow-up. The technical and clinical success of MWA were assessed as well. At the end of follow-up, median serum PTH [66.60 (42.21,80.03) ng/L vs.169.90 (89.01,396.50) ng/L] and calcium [2.39 (2.32,2.49) mmol/L vs. 2.75 (2.57,2.96) mmol/L] levels in 12 patients decreased significantly (all P<0.05). A complete response in terms of PTH and calcium levels was achieved in 6 of the 12 patients, while 4 of the patients had slightly elevated PTH levels just above the upper limit of normal reference range, and 2 of the patients remained abnormal PTH and calcium levels. The clinical cure rate was 50%. The volumes of all lesion after ablation were significantly decreased ( P<0.05), with the technical success rate reaching 92.3%. No serious complications were observed. Ultrasound-guided MWA, thus, is safe and effective in the treatment of PHPT.
9.Progress on clinical trials of cancer drugs in China, 2020
Dawei WU ; Huiyao HUANG ; Yu TANG ; Haixue WANG ; Jun WANG ; Shuhang WANG ; Hong FANG ; Xueyuan YANG ; Jing LI ; Xin WANG ; Lijun LIU ; Yan YAN ; Qing WANG ; Ning LI ; Cai CAO ; Binghe XU ; Yan SUN ; Jie HE
Chinese Journal of Oncology 2021;43(2):218-223
Objective:To explore the latest progress of oncology drug clinical trials in China under COVID-19, as well as to provide decision-making evidence for related stakeholders. Research progress of oncology drug trials and approved cancer drugs in China in 2020 were systematically summarized and compared with 2019.Methods:Information Disclosure Platform for Drug Clinical Studies and China Food and Drug Administration Query System for Domestic and Imported Drug were searched for registered clinical trials and approved oncology drugs, respectively. The trial scope, stage, drug type, effect and mechanism of domestic and global pharmaceutical enterprises were compared between 2019 and 2020.Results:A total of 722 cancer drug trials registered in China in 2020, with an annual growth rate of 52.3%, accounting for 28.3% of all registered trials. Among them, 603 (83.5%) trials were initiated by domestic pharmaceutical enterprises, and 105 (14.5%) were international multicenter trials, phase I trials accounted for 44.5%. For all those trials, there were 458 cancer drug varieties, with an annual growth rate of 36.7%, and 361 (85.8%) were developed by domestic enterprises. Most of the investigational products were therapeutic innovative drugs (77.1%), major in tumor treatment (92.8%). In terms of mechanism, targeted drugs were the most popular, accounting for 76.6%, and programmed cell death-1 (PD-1) and epithelial growth factor receptor (EGFR) were the most common targets. In addition, there were 19 anticancer drugs from 17 companies approved in China in 2019, with 10 drugs from domestic companies. Lung cancer and breast cancer are the most common indications for both registered trials and marketed drugs. No statistically significant differences were found between 2020 and 2019 in terms of the distribution of trial sponsor, scope and stage, as well as the distribution of drug type, effect and mechanism ( P>0.05). Conclusions:During the Covid-19 epidemic period, clinical trials of oncology drugs in China progress smoothly and maintain a high growth rate. Series of innovative products obtained by domestic enterprises in 2020 is the main driving force of development of oncology drug clinical trials in China.
10.Progress on clinical trials of cancer drugs in China, 2020
Dawei WU ; Huiyao HUANG ; Yu TANG ; Haixue WANG ; Jun WANG ; Shuhang WANG ; Hong FANG ; Xueyuan YANG ; Jing LI ; Xin WANG ; Lijun LIU ; Yan YAN ; Qing WANG ; Ning LI ; Cai CAO ; Binghe XU ; Yan SUN ; Jie HE
Chinese Journal of Oncology 2021;43(2):218-223
Objective:To explore the latest progress of oncology drug clinical trials in China under COVID-19, as well as to provide decision-making evidence for related stakeholders. Research progress of oncology drug trials and approved cancer drugs in China in 2020 were systematically summarized and compared with 2019.Methods:Information Disclosure Platform for Drug Clinical Studies and China Food and Drug Administration Query System for Domestic and Imported Drug were searched for registered clinical trials and approved oncology drugs, respectively. The trial scope, stage, drug type, effect and mechanism of domestic and global pharmaceutical enterprises were compared between 2019 and 2020.Results:A total of 722 cancer drug trials registered in China in 2020, with an annual growth rate of 52.3%, accounting for 28.3% of all registered trials. Among them, 603 (83.5%) trials were initiated by domestic pharmaceutical enterprises, and 105 (14.5%) were international multicenter trials, phase I trials accounted for 44.5%. For all those trials, there were 458 cancer drug varieties, with an annual growth rate of 36.7%, and 361 (85.8%) were developed by domestic enterprises. Most of the investigational products were therapeutic innovative drugs (77.1%), major in tumor treatment (92.8%). In terms of mechanism, targeted drugs were the most popular, accounting for 76.6%, and programmed cell death-1 (PD-1) and epithelial growth factor receptor (EGFR) were the most common targets. In addition, there were 19 anticancer drugs from 17 companies approved in China in 2019, with 10 drugs from domestic companies. Lung cancer and breast cancer are the most common indications for both registered trials and marketed drugs. No statistically significant differences were found between 2020 and 2019 in terms of the distribution of trial sponsor, scope and stage, as well as the distribution of drug type, effect and mechanism ( P>0.05). Conclusions:During the Covid-19 epidemic period, clinical trials of oncology drugs in China progress smoothly and maintain a high growth rate. Series of innovative products obtained by domestic enterprises in 2020 is the main driving force of development of oncology drug clinical trials in China.

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