1.Risk factors for postoperative liver failure of patients with hepatocellular carcinoma and bile duct tumor thrombus
Weifeng TAN ; Xiangji LUO ; Shuyu ZHANG ; Zhiquan QIU ; Kai NIE ; Chang XU ; Xiaoqing JIANG ; Mengchao WU
Chinese Journal of Digestive Surgery 2013;(3):217-221
Objective To investigate the risk factors for postoperative liver failure of patients with hepatocellular carcinoma (HCC) and bile duct tumor thrombus through a risk evaluation model.Methods The clinical data of 107 patients with HCC and bile duct tumor thrombus who received hepatic resection at the Eastern Hepatobiliary Surgery Hospital from March 2002 to February 2011 were retrospectively analyzed.All patients were divided into the non-liver failure group (98 patients) and liver failure group (9 patients).Risk factors associated with liver failure were analyzed and a risk evaluation model was established.All data were analyzed using the bivariate regression model,and factors with significance were further analyzed using the multivariate regression model.Results Of the 107 patients,105 received hepatic resection + choledochotomy + thrombectomy and 2 received hepatic resection + extrahepatic bile duct resection + cholangiojejunostomy.The operation time was 2.0-5.5 hours,and the intraoperative blood loss was 200-3500 ml.In the non-liver failure group,5 patients had pleural and peritoneal effusion,3 had biliary bleeding,2 had incisional infection,1 had biliary infection,1 had bile leakage,1 had stress-induced ulcer of upper digestive tract and 1 had thoracic epidural hematoma.The bleeding of the patients with thoracic epidural hematoma was stopped after thoracic spinal decompression,but subsequent paraplegia occurred.In the liver failure group,2 patients died of postoperative acute liver failure,and 7 patients died of postoperative subacute liver failure (death caused by tumor recurrence or medicine was excluded).The results of univariate analysis showed that preoperative total bilirubin,albumin,pre-albumin,albumin/globulin ratio,distribution of tumor thrombus,operative blood loss and ratio of postoperative residual liver volume to the total liver volume were correlated with the postoperative liver failure in patients with HCC and bile duct tumor thrombus (OR =3.017,0.191,0.248,2.681,9.048,4.759,13.714,P < 0.05).The results of multivariate analysis showed that preoperative total bilirubin > 256.5 μmol/L,albumin/globulin ratio ≤ 1.3 and postoperative residual liver volume < 50% were the independent risk factors of postoperative liver failure (OR =5.537,11.107,172.450,P < 0.05).The risk evaluation model was Z =1.77 × preoperative total bilirubin + 2.408 × preoperative albumin/globulin ratio + 5.150 × ratio of postoperative residual liver volume to the total liver volume-17.288.The risk of postoperative liver failure increased as the increase of Z value.The risk of postoperative liver failure > 50% when the Z value > 0.Conclusions Preoperative total bilirubin > 256.5μmol/L,albumin/globulin ratio ≤ 1.3 and postoperative residual liver volume < 50% were the independent risk factors of postoperative liver failure.Risk evaluation model is helpful in screening the risk factors so as to decrease the incidence of postoperative liver failure.
2.Practice and reflection of day surgery in a tertiary hospital in Tianjin
Chunhui LI ; Lei ZHANG ; Liqiang GU ; Zhiquan TAN ; Guoxun LI
Modern Hospital 2024;24(3):333-335
Objective To analyze the implementation of day surgery in a public hospital in Tianjin,and to provide refer-ence for the quantity and quality of day surgery.Methods The implementation of day surgery in a public hospital in Tianjin from 2020 to 2022 was analyzed.Results From 2020-2022,the main types of daytime operations were secondary(43 kinds)and ter-tiary operations(28 kinds).In terms of the implementation of professional disciplines,anorectal surgery,urology surgery and orthopedics carried out the largest number of operations,among which anorectal surgery accounted for 70.76%(2 285/3 229).Conclusion It is necessary to further improve the development of professional disciplines,the management system of day surger-y,and the guarantee of medical services,strengthen the construction of weak links in the management path of day surgery and im-prove the coverage and accessibility of day service.
3.Assay of eupatilin and arteanoflavone in Artemisia anomala by HPLC
Zhiquan QIU ; Qingqing CAO ; Weifeng TAN ; Jin ZHOU ; Lei LÜ
Journal of Pharmaceutical Practice 2016;34(2):163-166
Objective To determine the concentration of eupatilin and arteanoflavone in A rtemisia anomala by high per-formance liquid chromatography (HPLC).Methods A rtemisia anomala was extracted by ultrasonic for 60 minutes with 10 times volume of methanol.The HPLC was performed on a SHISEIDO MG-C18 column (3.0 mm × 100 mm,3μm).The mobile phase was a mixture of acetonitrile (ACN) and 0.1% formic acid (40:60,V/V ).The detection wavelength was 350 nm,the column temperature was 25 ℃ and the injection volumn was 5μl.Results Eupatilin and arteanoflavone were separated at base-line within 15min with good linearity.The method validation results show that the precisions,repeatability and stability were all in the normal range.The low,medium and high level recoveries of eupatilin were 100.26%,99.58%,102.24%,and those of arteanoflavone were 99.09%,101.12%,101.43%,respectively.Conclusion The method was rapid,simple,reproductive and accurate.It can be used to control the quality of Artemisia anomala.
4.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