1.Value and measuring methods of elasticity contrast index in the diagnosis of thyroid nodules
Cui XU ; Zhi YANG ; Yan SHI ; Guanghe CUI ; Jiandi HU
Chinese Journal of Postgraduates of Medicine 2021;44(1):76-79
Objective:To explore the value of the elasticity contrast index (ECI) in differential diagnosis of thyroid nodules, and contrast the effect of 4 different methods on measuring ECI.Methods:A total of 122 patients with 131 thyroid nodules in Binzhou Medical University Hospital from May 2018 to May 2019 were enrolled, and elastography was performed in 4 different ways such as in axial plane for internal (AI), axial plane for periintranodular (AP), longitudinal plane for internal (LI) and longitudinal plane for periintranodular (LP). The cut-off values for predicting malignant nodules in 4 different ways were determined separately using receiver operating characteristic (ROC) curve analysis.Results:There were 54 benign and 77 malignant ones in 131 nodules. The ECI in AI, AP, LI and LP in benign thyroid nodules was significantly lower than that in malignant ones: 2.10 (1.48, 2.34) vs. 3.07 (2.73, 3.87), 1.91 (1.64, 2.18) vs. 2.62 (2.24, 3.07), 2.19 (1.59, 2.39) vs. 3.00 (2.72, 3.63) and 1.89 (1.71, 2.16) vs. 2.66 (2.21, 3.10), and there was statistical difference ( P<0.05). Among the 4 different ways, the largest area under curve was achieved in AI with 0.925, and the corresponding optimal diagnostic threshold was 2.43 (with 90.9% sensitivity, 87.0% specificity, 88.5% accuracy, 89.7% positive predictive value and 86.8% negative predictive value). Conclusions:ECI is helpful for conventional ultrasound to diagnose thyroid nodules as malignant or benign. The best value is obtained in AI.
2.Short-term efficacy of pemetrexed combined with cisplatin in the treatment of malignant pleural effusion and its effect on serum carbohydrate antigen 199 level and circulating tumor cells
Jiandi WANG ; Jie CHEN ; Mingjie HU
Chinese Journal of Primary Medicine and Pharmacy 2021;28(6):849-854
Objective:To investigate the short-term efficacy of pemetrexed combined with cisplatin in the treatment of malignant pleural effusion and its effect on serum carbohydrate antigen 199 level and circulating tumor cells.Methods:Sixty patients with advanced lung cancer complicated by malignant pleural effusion who received treatment in Healthcare Group of Cixi Third People's Hospital, China from January 2017 to January 2020 were included in this study. They were randomly assigned to receive intrapleural injection of cisplatin (cisplatin alone group, n = 30) or intrapleural injection of cisplatin combined with intravenous injection of pemetrexed (cisplatin + pemetrexed group, n = 30) after thoracic drainage. Before and 1 month after treatment, pleural effusion was measured to evaluate clinical efficacy and improvement in quality of life. Serum carcinoembryonic antigen level, serum carbohydrate antigen 199 level and circulating tumor cells were determined. Adverse reactions during the treatment were recorded. Results:Total effective rate and the rate of improvement in quality of life in the cisplatin + pemetrexed group were 66.67% (20/30) and 70.00% (21/30), respectively, which were significantly higher than those in the cisplatin alone group [40.00% (12/30) and 43.33% (13/30), χ2 = 4.286, 4.344, both P < 0.05]. After treatment, serum carcinoembryonic antigen and serum carbohydrate antigen 199 levels in each group were significantly decreased compared with before treatment (both P < 0.05). Serum carcinoembryonic antigen and serum carbohydrate antigen 199 level in the cisplatin + pemetrexed group were (22.26 ± 5.13) ng/mL and (20.12 ± 4.35) U/mL, respectively, which were significantly lower than those in the cisplatin alone group [(31.64 ± 6.46) ng/mL, (28.07 ± 5.61) U/mL, t = 6.228, 3.134, both P < 0.05). In the cisplatin alone group, there was no significant difference in the proportion of circulating tumor cells before and after treatment ( P > 0.05). In the cisplatin + pemetrexed group, the proportion of circulating tumor cells after treatment was significantly lower than that before treatment ( χ2 = 4.286, P < 0.05). After treatment, there was no significant difference in the proportion of circulating tumor cells between the two groups ( P > 0.05). During the treatment, there were no significant differences in the incidences of rash, nausea and vomiting, leukopenia, and anemia between the two groups (all P > 0.05). Conclusion:Pemetrexed combined with cisplatin in the treatment of malignant pleural effusion exhibits better short-term efficacy than cisplatin alone. The combined therapy is more conducive to relieving clinical symptoms and improving the quality of life with higher safety than monotherapy.
3.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
BACKGROUND:
LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.
METHODS:
We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS:
On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION:
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04563936.
Humans
;
Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
;
East Asian People
;
Gonadotropin-Releasing Hormone/agonists*
;
Goserelin/therapeutic use*
;
Prostate-Specific Antigen
;
Prostatic Neoplasms/drug therapy*
;
Testosterone