1.Determination of tiamulin concentration in minipig plasma by LC-MS/MS and its application in pharmacokinetic studies of different formulations
Jiahui TU ; Mei GENG ; Qingming HOU ; Xianhai LUO ; Zhixia QIU ; Cong WANG
Journal of China Pharmaceutical University 2026;57(1):54-59
The present study aimed to establish an LC-MS/MS method for the quantification of tiamulin in minipig plasma and to further conduct a pharmacokinetic comparison of different formulations. The plasma samples were extracted with acetonitrile (meloxicam as internal standard), separated on a C18 column, and quantified by multiple reaction monitoring mode (ESI+). Sanyuan minipigs were used as experimental animals. Plasma samples were collected after intravenous injection (10 mg/kg) and intragastric administration (20 mg/kg). The method showed good linearity, with intra- and inter-batch RSD of 1.00%–8.13% and RE within ±15%. The extraction recovery, matrix effect and stability of the analytical methods met the relevant requirements. Tiamulin fumarate active pharmaceutical ingredient was intravenously administered, with c0 of about (4383.73±2676.78) ng/mL, AUC0-t of about (4803.50±965.68) h·ng/mL, t1/2 of about (4.66±1.68) h, and CL of about (2.14±0.46) L/(kg·h). Three tiamulin formulations were intragastrically administered, with cmax of (552.00±328.55), (545.00±136.97) and (590.60±237.02) ng/mL, tmax of (1.47±0.68), (0.69±0.75) and (0.72±0.72) h, and F of 24.85%, 15.28% and 16.97%, respectively. The validated method meets the requirements for biological sample analysis and is applicable for the pharmacokinetic evaluation of tiamulin formulations in minipigs.
2.Influence of serum alpha-fetoprotein and CA19-9 on the prognosis of patients with combined hepatocellular-cholangiocarcinoma after radical surgery
Hongjian ZHANG ; Xiaohui DUAN ; Heng ZHANG ; Jianpei XUYANG ; Yuhao QING ; Zicheng WANG ; Xianhai MAO
Chinese Journal of Hepatobiliary Surgery 2025;31(2):87-91
Objective:To analyze the impact of serum alpha-fetoprotein (AFP) and carbohydrate antigen 19-9 (CA19-9) on the prognosis of patients with combined hepatocellular-cholangiocarcinoma (CHC) after radical surgery.Methods:Clinical data of 100 patients diagnosed with CHC by postoperative pathology in Hunan Provincial People's Hospital from January 2009 to January 2019 were retrospectively analyzed, including 73 males and 27 females, aged (52.0±10.9) years. Univariate and multivariate Cox regression analysis were conducted to try to find out the effects of AFP and CA19-9 on postoperative disease-free survival (DFS) of patients with CHC. Subgroup analysis was also performed to analyze the DFS among patients with different levels of AFP and CA19-9. Kaplan-Meier method and log-rank test were used to plot and compare the survival curves between groups.Results:Univariate analysis showed that levels of AFP, CA19-9, alanine transaminase, aspartate transaminase, American Joint Committee on Cancer (AJCC) TNM staging, portal vein invasion, tumor number are associated with postoperative DFS in CHC patients (all P<0.05). The multivariate Cox analysis showed that AFP≥20.6 μg/L ( HR=6.686, 95% CI: 1.985-9.582), CA19-9≥35.2 U/L ( HR=5.790, 95% CI: 1.197-8.855), AJCC tumor TNM staging stage Ⅱ( HR=6.384, 95% CI: 2.069-11.532), and portal vein invasion ( HR=2.384, 95% CI: 1.100-10.125) were risk factors for a shortened DFS in CHC patients after surgery (all P<0.05). Subgroup analysis showed that patients with AFP≥20.6 μg/L and CA19-9≥35.2 U/L ( n=14) had a lower DFS compared to patients with AFP<20.6 μg/L and CA19-9≥35.2 U/L ( n=32), and patients with AFP≥20.6 μg/L and CA19-9<35.2 U/L ( n=20) ( χ2=6.23, 4.98, P=0.014, 0.043). Conclusion:AFP and CA19-9 are risk factors for DFS in CHC patients. Patients with AFP≥20.6 μg/L and CA19-9≥35.2 U/L showed a worse prognosis.
3.Influence of serum alpha-fetoprotein and CA19-9 on the prognosis of patients with combined hepatocellular-cholangiocarcinoma after radical surgery
Hongjian ZHANG ; Xiaohui DUAN ; Heng ZHANG ; Jianpei XUYANG ; Yuhao QING ; Zicheng WANG ; Xianhai MAO
Chinese Journal of Hepatobiliary Surgery 2025;31(2):87-91
Objective:To analyze the impact of serum alpha-fetoprotein (AFP) and carbohydrate antigen 19-9 (CA19-9) on the prognosis of patients with combined hepatocellular-cholangiocarcinoma (CHC) after radical surgery.Methods:Clinical data of 100 patients diagnosed with CHC by postoperative pathology in Hunan Provincial People's Hospital from January 2009 to January 2019 were retrospectively analyzed, including 73 males and 27 females, aged (52.0±10.9) years. Univariate and multivariate Cox regression analysis were conducted to try to find out the effects of AFP and CA19-9 on postoperative disease-free survival (DFS) of patients with CHC. Subgroup analysis was also performed to analyze the DFS among patients with different levels of AFP and CA19-9. Kaplan-Meier method and log-rank test were used to plot and compare the survival curves between groups.Results:Univariate analysis showed that levels of AFP, CA19-9, alanine transaminase, aspartate transaminase, American Joint Committee on Cancer (AJCC) TNM staging, portal vein invasion, tumor number are associated with postoperative DFS in CHC patients (all P<0.05). The multivariate Cox analysis showed that AFP≥20.6 μg/L ( HR=6.686, 95% CI: 1.985-9.582), CA19-9≥35.2 U/L ( HR=5.790, 95% CI: 1.197-8.855), AJCC tumor TNM staging stage Ⅱ( HR=6.384, 95% CI: 2.069-11.532), and portal vein invasion ( HR=2.384, 95% CI: 1.100-10.125) were risk factors for a shortened DFS in CHC patients after surgery (all P<0.05). Subgroup analysis showed that patients with AFP≥20.6 μg/L and CA19-9≥35.2 U/L ( n=14) had a lower DFS compared to patients with AFP<20.6 μg/L and CA19-9≥35.2 U/L ( n=32), and patients with AFP≥20.6 μg/L and CA19-9<35.2 U/L ( n=20) ( χ2=6.23, 4.98, P=0.014, 0.043). Conclusion:AFP and CA19-9 are risk factors for DFS in CHC patients. Patients with AFP≥20.6 μg/L and CA19-9≥35.2 U/L showed a worse prognosis.
4.Invastigation on methods of quality control of Xiaoer Shenzhu Jianpi pills
Juan DU ; Chao DONG ; Xianhai SHI ; Yuhong CUI ; Chunfang WANG
Drug Standards of China 2024;25(3):244-250
Objective:To improve the quality standard of Xiaoer Shenzhu Jianpi Pills.Methods:The microscopic identification method was used to qualitatively identify Hordei Fructus Germinatus.TLC was used to qualitatively i-dentify of Atractylodis Macrocephalae Rhizoma,Glycyrrhizae Radix Et Rhizoma,Citri Reticulatae Pericapium.HPLC was adopted to determine the contents of hesperidin and ammonium glycyrrhizinate.Results:The microscop-ic identification of Hordei Fructus Germinatus had strong specificity and high viewing rate.The TLC identification spots of Atractylodis Macrocephalae Rhizoma,Glycyrrhizae Radix Et Rhizoma,Citri Reticulatae Pericapium were clear,with good separation and durability.The linear ranges of hesperidin and ammonium glycyrrhizinate were 0.060 0-1.501 0 μg and 0.020 1-0.502 2 μg,respectively(r≥0.999 8).The average recoveries(n=9)were 99%,96%and RSDs were 2.8%and 1.8%.The RSDs of precision,stability and repeatability of the two components were less than 3.0%.Conclusion:The newly established quality standard increases the quality control research of microscopic identification,thin layer chromatography and content determination.The experimental method is accurate and reliable,simple and fast,and has good applicability.It can be used for the quality control and evaluation of Xiaoer Shenzhu Jianpi Pills.
5.Clinical significance of predicting the risk of recurrence and metastasis and the benefits of adjuvant chemotherapy in stage Ⅱ-Ⅳa nasopharyngeal carcinoma patients based on MRI radiomics features
Zhiyi DENG ; Yijing YE ; Dingbo LI ; Yongjin WU ; Xianhai ZENG ; Zaixing WANG
Chinese Archives of Otolaryngology-Head and Neck Surgery 2024;31(8):477-484
OBJECTIVE To develop a magnetic resonance(MRI) imaging radiomics and clinical factor model to predict recurrence and metastasis in patients with primary stage Ⅱ-Ⅳa nasopharyngeal carcinoma(NPC) and to validate its predictive effect on adjuvant chemotherapy(AC) outcomes. METHODS A retrospective analysis was performed on 135 patients with stage Ⅱ to Ⅳa NPC diagnosed in Longgang Otolaryngology Hospital of Shenzhen City from February 2018 to October 2021. After receiving standard synchronous radiotherapy and chemotherapy at our hospital,some patients received induction chemotherapy and/or AC based on cisplatin/nedaplatin. The imaging features of enhanced MRI sequences were extracted using PyRadiomics platform. Using the least absolute shrinkage and selection operator(LASSO) algorithm to filter features associated with recurrence or metastasis,a clinical radiomics model(CRM) was constructed by Cox multivariate analysis in a training cohort and validated in a validation cohort. All patients were divided into high-risk and low-risk groups based on the model's median Rad score. Kaplan-Meier survival curves were used to compare 3-year recurrence or metastasis free survival(RMFS) in patients with AC in high-risk group and low risk-group. RESULTS A total of 960 imaging features were extracted. The CRM consists of 9 features(6 imaging features and 3 clinical factors). In the training cohort,the area under the CRM curve(AUC) of 3-year RMFS was 0.867(P<0.001),and the sensitivity and specificity were 90.32% and 79.66%,respectively. In the validation cohort,the AUC was 0.836(P<0.001) and the sensitivity and specificity were 100.0% and 71.43%,respectively. The 3-year RMFS in high-risk and low-risk groups was 42.86%(27/63) and 94.44%(68/72)(log rank=50.818,P<0.001),respectively. Among CRM high-risk patients,3-year RMFS was significantly better in patients who received AC than those who did not(log rank=6.204,P=0.013). CONCLUSION CRM based on 3 clinical factors and 6 MRI features provides a non-invasive method for predicting the prognosis of NPC,which may help guide treatment decisions for clinical adjuvant chemotherapy,but further external verification is needed.
6.Prognostic significance of lactate dehydrogenase in salvage intensity-modulated radiotherapy for locally recurrent nasopharyngeal carcinoma before treatment
Zhiyi DENG ; Yijing YE ; Dingbo LI ; Xianhai ZENG ; Zaixing WANG
Chinese Archives of Otolaryngology-Head and Neck Surgery 2024;31(1):1-6
OBJECTIVE To investigate the prognostic value of pre-treatment serum lactate dehydrogenase(LDH)levels in patients with locally recurrent nasopharyngeal carcinoma(NPC)treated with salvage intensity-modulated radiotherapy(IMRT)and to determine its association with rT staging.METHODS The records of 97 patients with locally relapsed and non-metastatic NPC who received salvage IMRT treatment in our center from January 2018 to April 2022 were collected,including 51 patients who died,18 patients with distant metastases,30 patients with local failure,and 67 patients with prognostic adverse events(death,distant tumors/local metastases).Clinical data,local failure-free survival(LFFS),distant metastasis-free survival(DMFS)and overall survival(OS)were obtained from all patients,and the relationship between LDH and the prognosis of salvage IMRT therapy in NPC patients was analyzed.RESULTS The serum LDH level before salvage IMRT was significantly higher in the death[221.25(178.24,339.13)U/L vs.124.82(79.0,159.50)U/L,Z=-5.122],local failure[230.75(170.89,394.50)U/L vs.157.85(91.78,216.95)U/L,Z=-3.442],distant metastasis[261.62(153.55,465.50)U/L vs.168.98(101.75,237.75)U/L,Z=-2.478]and poor prognosis group[220.05(167.20,506.16)U/L vs.93.45(69.95,154.35)U/L,Z=-6.018],and all P<0.05.Serum LDH levels were divided into dichotomous variables according to median values(≥177.50 U/L vs.<177.50 U/L),the Cox univariate model found that the hazard ratios of LDH affecting LFFS,DMFS,OS and toxic-related death(TRD)were 3.759(1.660-8.558),4.217(1.383-12.861),3.226(1.715-6.069),3.363(1.750-6.463),P<0.05.LDH remained an independent prognostic factor for LFFS,DMFS,OS,and TRD in multivariate regression analysis(P<0.05).Compared with patients with LDH<177.50 U/L,more patients in the LDH≥177.50 U/L group had local progression-related death,and the no LFFS stage,no DMFS stage and OS were shorter in the LDH≥177.50 U/L group(log rank=11.624,7.559,14.758),P<0.05.In predicting overall survival,adding LDH to the rT stage is preferable to the rT stage alone.CONCLUSION LDH is an important factor in predicting LFFS,DMFS,OS,and TRD after saving IMRT in patients with locally relapsed,non-metastatic NPC,and the value of LDH combined with rT staging in predicting overall survival is high.
7.Clinical analysis of the treatment of maxillary odontogenic cyst by nasal endoscope fenestration through nasal base.
Zhiyuan TANG ; Xianhai ZENG ; Qiuhang ZHANG ; Dingbo LI ; Zaixing WANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2023;37(5):333-337
Objective:To investigate the feasibility and clinical effect of the surgical approach and method of transnasal fenestration under nasal endoscope for the treatment of maxillary odontogenic cyst. Methods:The clinical data of 23 cases with maxillary odontogenic cysts treated by nasal endoscopy through nasal fenestration were retrospectively analyzed. All cases underwent nasal endoscopy and CT examination before the operation. The mucosal membrane of the parietal wall of the cyst was excised through fenestration of the nasal base. The cyst fluid was removed by decompression, and the bony opening of the nasal base was trimmed and enlarged to the edge of the cyst. The intraoperative and postoperative effects were observed. Results:All cases were well exposed under the direct vision of nasal endoscope. The top wall of the cyst was removed to maximize the communication between the cyst cavity and the nasal floor. There were no complications such as nasolacrimal duct injury, turbinate atrophy, necrosis, and facial numbness. All patients were followed up for 6-12 months, and the clinical symptoms gradually disappeared after surgery. The inferior turbinate was in good shape, the cyst cavity was smooth, the cyst wall was determined, and no cyst recurrence was observed. Conclusion:The treatment of odontogenic cyst of maxilla under nasal endoscope through nasal fenestration is convenient. It has less trauma, fewer complications and a satisfactory curative effect, which is worthy of clinical promotion.
Humans
;
Maxilla
;
Retrospective Studies
;
Odontogenic Cysts/surgery*
;
Endoscopy
;
Turbinates/surgery*
;
Endoscopes
8.Reoperation of biliary-enteric anastomotic stricture after surgery for congenital choledochal cysts
Zhongzhi MA ; Haoquan WEN ; Lishun YANG ; Renjun WEI ; Changjun LIU ; Jinhui YANG ; Xiaohui WANG ; Bingzhang TIAN ; Xinmin YIN ; Chuang PENG ; Xianhai MAO ; Jinshu WU
Chinese Journal of General Surgery 2022;37(8):597-601
Objective:To analyze the causes of postoperative stricture of biliary-enteric anastomotic for congenital choledochal cysts.Methods:These 28 patients underwent salvage operation on an average 15 years (0.2-25 years) after initial surgeries at the Department of Hepatobiliary Surgery, Hunan Provincial People's Hospital from Jan 2014 to Jun 2018.Results:In 26 patients the biliary-enteric anastomotic stenosis was benign, and in 2 the stricture was caused by cancerration. In 26 cases the Roux-en-Y hepaticojejunostomy was redone,among them 8 cases underwent concurrent hepatectomy for a better exposure of the intrahepatic bile duct. In 2 cases the anastomotic stenosis was found to be caused by canceration with extensive intraabdominal metastasis ,an external drainage was adopted. There were no inhospital deaths, and no serious complications. The postoperative follow-up time was 6-67 months. Two cancerated patients died within half a year, and the remaining patients had no long-term complications.Conclusions:Biliary-enteric anastomotic stenosis is one of the serious complications in postoperative patients for congenital choledochal cysts. Hence a wide, tension free biliary-enteric anastomosis performed by a experienced hand is necessary.
9.Epidemiological characteristics of geriatric hip fracture in Beijing: a multicenter analysis of 2,071 cases
Gang LIU ; Minghui YANG ; Jing ZHANG ; Jiusheng HE ; Liangyuan WEN ; Xianhai WANG ; Zongxin SHI ; Sanbao HU ; Xinyi ZHANG ; Maoyi TIAN ; Shiwen ZHU ; Xinbao WU
Chinese Journal of Orthopaedic Trauma 2022;24(9):759-765
Objective:To explore the epidemiological characteristics of geriatric hip fractures in Beijing so as to provide evidence for effective prevention and control measures.Methods:This multicenter study was conducted in 3 urban (Beijing Jishuitan Hospital, Beijing Hospital and Beijing Anzhen Hospital) and 3 suburban hospitals (Beijing Shunyi District Hospital, Beijing Changping District Hospital and Beijing Liangxiang Hospital) in Beijing from November 2018 to November 2019. Eligible patients were those aged ≥ 65 years with hip fracture confirmed by X-ray and being admitted to hospital within 21 days of injury. To explore the epidemiological characteristics of geriatric hip fractures in Beijing, such data were collected as patients' age, gender, comorbidities, as well as type, site, time and cause of the fracture.Results:① A total of 2,071 patients were included in this suevey. They were 653 males and 1,418 females (M∶F=1∶2.17). Their age ranged from 65 to 102 years (average, 79.8 years). The patients aged from 75 to 84 years were the most common, accounting for 44.81% (928/2,071). ② Femoral neck fractures accounted for 43.41% (899/2,071), and intertrochanteric fractures accounted for 56.59% (1,172/2,071). The age of the patients with femoral neck fracture was (78.6±7.7) years, which was significantly younger than that of those with intertrochanteric fracture [(80.7±7.4) years] ( P<0.05). ③ 94.69% of the hip fractures (1,961/2,071) were caused by falling, and 71.27% fractures (1,476/2,071) happened at home. ④ Approximately 83.00% of the patients (1,719/2,071) had one or more comorbid conditions. Hypertension was the most prevalent disease (57.89%, 1,199/2,071), followed by diabetes (27.09%, 561/2,071), and coronary atherosclerotic heart disease (22.02%, 456/2,071). Conclusions:In Beijing, significantly more geriatric females sustain a hip fracture than males, and the proportion of those aged from 75 to 84 year is the largest. The proportion of intertrochanteric fractures increases with age. Falls are the leading cause for geriatric hip fractures. Most of the patients have one or more chronic comorbid conditions. Corresponding prevention and intervention measures should be formulated according to the distribution characteristics of elderly hip fractures in Beijing.
10.Postoperative hemorrhage after laparoscopic pancreaticoduodenectomy
Guoguang LI ; Wei CHENG ; Meifu CHEN ; Xinmin YIN ; Xianbo SHEN ; Xianhai MAO ; Jun WANG ; Xintian WANG ; Chuang PENG ; Bo JIANG ; Botao CHEN
Chinese Journal of Hepatobiliary Surgery 2021;27(6):425-428
Objective:To study and analyse the results of postoperative hemorrhage after laparoscopic pancreaticoduodenectomy (LPD).Methods:The clinical data of patients who underwent LPD from May 2011 to December 2019 at Hunan Provincial People's Hospital were retrospectively analyzed. The clinical characteristics of patients, onset time of postoperative hemorrhage, location of postoperative hemorrhage, postoperative biliary fistula, pancreatic fistula, infection and other short-term complications, reoperation and mortality rates were analyzed.Results:Of 356 patients who underwent LPD in this study, there were 200 males and 156 females, aged (58.0±10.5) years. The postoperative complication rate was 33.1% (118/356), the reoperation rate was 6.5% (23/356), and the mortality rate was 2.5% (9/356). The most common complications were postoperative hemorrhage [15.2% (54/356)], pancreatic fistula [14.6%(52/356)] and abdominal infection [13.8%(49/356)]. The onset time of postoperative hemorrhage was usually in the 1st - 14th day, and the highest rate of postoperative hemorrhage was 3.9% (14/356) on the first day after surgery. The postoperative hemorrhage rate then showed a downward trend, but increased again on the 7th day. The extraluminal hemorrhage locations were relatively widely distributed, and the incidence of gastrointestinal anastomotic hemorrhage in patients with intraluminal hemorrhage was the highest [67.9%(19/28)]. Of the 9 patients who died, 7 were related to postoperative bleeding.Conclusions:LPD resulted in a high incidence of complications. Postoperative hemorrhage was a complication that had the greatest impact on short-term recovery of patients. It was also an important cause of reoperation and death. In addition to postoperative bleeding caused by pancreatic fistula, gastrointestinal anastomotic bleeding was also clinically important.

Result Analysis
Print
Save
E-mail