1.Clinical characteristics and pituitary function of 72 patients with prolactinoma
Haixue JING ; Juanjuan LUO ; Zihong YAO ; Danxia XU ; Hui CHEN
Chongqing Medicine 2024;53(18):2771-2775,2780
Objective To explore the clinical features of the patients with prolactinoma and changes of pituitary function before and after surgery.Methods The clinical data of 72 patients with prolactinoma admit-ted and operatively treated in the neurosurgery department of the Second Hospital of Lanzhou University from June 2018 to January 2023 were analyzed retrospectively and their clinical characteristics and change character-istics of pituitary function before and after surgery were summarized.Results (1) Most of the patients with prolactinoma included in this study were macroadenomas,and its clinical manifestations were mainly tumor compression symptoms such as headache and vision diminution;(2) there was a statistically significant differ-ence in tumor invasiveness between the patients with preoperative PRL≥200.000 ng/mL and those with pre-operative PRL<200.000 ng/mL (P<0.05).(3) The PRL level of prolactinoma after surgical treatment in the patients with prolactinoma was significantly decreased compared to preoperative level,and the difference was statistically significant (P<0.05).(4) Among 72 patients,44 patients already had hypopituitarism before surgery,the pituitary function in 2 cases returned to normal,15 cases of hypopituitarism were newly increased and there were 57 cases of postoperative hypopituitarism.Preoperative hypopituitarism was positively correla-ted with postoperative hypopituitarism (r=0.433,P<0.05).By the logistic multifactorial regression analy-sis,the tumor maximal diameter was a risk factor for hypopituitarism occurrence before and after surgery (P<0.05),and the tumor invasiveness was a risk factor for postoperative hypopituitarism (P<0.05),where-as the BMI and PRL level,age,gender,and whether or not pituitary apoplexy occurring had no relationship with hypopituitarism (P>0.05).(5) The gonadal axis was the most common hypofunction in uniaxial sys-tem,and gonadal+thyroid axis was the most common biaxial involvement.Conclusion The surgical treat-ment in the patients with prolactinoma is effective for relieving tumor mass occupation and improving hyperp-rolactinemia.The pituitary function should be fully evaluated before and after surgery.For the patients with hypopituitarism occurrence,the hormone replacement therapy should be given in time,and at the same time the hormonal changes should be closely monitored.
2.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.
3.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.