1.Establishment and clinical application of the method for the determination of blood concentration of apatinib
Xianchun DUAN ; Sujun XUE ; Yongfu ZHU
China Pharmacy 2024;35(12):1500-1504
OBJECTIVE To establish a method for determining the blood concentration of apatinib and apply it clinically. METHODS Ultra-high performance liquid chromatography (UPLC) was used for the determination of blood concentration. The chromatographic column was ACQUITY UPLC BEH C18 with the mobile phase consisted of acetonitrile-0.1% formic acid aqueous solution (gradient elution) at the flow rate of 0.2 mL/min; the column temperature was 40 ℃, and the injection volume was 5 μL. The data of 26 cancer patients taking apatinib were collected, and their blood concentrations were measured. The correlation between patient’s blood concentration and age, dosage, adverse reactions, and combination therapy were analyzed; the levels of serum kidney injury-related factors [cystatin C (CysC), kidney injury molecule 1 (KIM-1), interleukin-18 (IL-18), tumor necrosis factor-α (TNF-α)] were determined before and after treatment. RESULTS The linear range of apatinib was 500-2 000 ng/mL, with a precision RSD of 3.7%, stability RSD of 4.9%, and an average sample recovery rate of 96.0% (RSD was 2.1%). The lowest blood concentration of apatinib was 103 ng/mL and the highest was 1 932 ng/mL among 26 patients. The blood concentration of apatinib in patients showed a fluctuating downward trend with age. At a dosage of 0.125 or 0.25 g, the blood concentration of patients taking apatinib was concentrated within the range of 1 000-2 000 ng/mL. Among 26 cancer patients, 13 experienced adverse reactions, and no adverse reaction was observed in those with blood concentrations ranging from 500 to <1 000 ng/mL. Twenty patients were simultaneously treated with other drugs,resulting in varying blood concentration. After treatment, the levels of serum CysC, KIM-1, IL-18 and TNF- α were significantly higher than before treatment (P<0.05). CONCLUSIONS The established UPLC method can quickly E-mail:duanxc@ahtcm.edu.cn detect the blood concentration of apatinib. When using apatinib in clinical practice, comprehensive consideration should be given to the patient’s age, drug combination, and the attention should be paid to preventing possible acute kidney damage caused by apatinib.
2.Effects of triamcinolone acetonide-saline submucosal injection for prevention of esophageal stricture after endoscopic submucosal dissection for extensive superficial esophageal neoplasms
Lei CHEN ; Sujun GAO ; Lu WANG ; Xiufan NI ; Cong TONG ; Zhen ZHU
Chinese Journal of Digestive Endoscopy 2024;41(9):712-717
Objective:To evaluate the efficacy and safety of triamcinolone acetonide-saline submucosal injection for prevention of esophageal stricture after endoscopic submucosal dissection (ESD) for extensive superficial esophageal neoplasms.Methods:A total of 75 patients who underwent ESD for superficial esophageal neoplasms involving larger than 2/3 of the esophageal circumference at the Department of Gastroenterology, Northern Jiangsu People's Hospital from January 2018 to December 2020 were enrolled. Patients were randomly assigned to triamcinolone acetonide-saline submucosal injection group (group A, n=25), triamcinolone acetonide injections immediately after ESD group (group B, n=25) and the control group undergoing only ESD (group C, n=25). Serial gastroscopy was performed to assess wound healing and esophageal stricture. Endoscopic balloon dilatation (EBD) was performed when patients experienced esophageal stricture. The completion of ESD, time of operation, the amount of triamcinolone acetonide, the incidences of esophageal stricture and the time of EBD treatment of the three groups were compared. Results:All ESD procedures were successfully performed without complications such as intraoperative perforation, massive bleeding or postoperative delayed perforation. The operation time of group A, B and C were 72.87±12.99 min, 94.15±14.22 min and 74.08±11.86 min, respectively, with significant difference ( F=20.925, P<0.001). In pairwise comparison the above indicator in group A and group C was significantly shorter than that of group B (LSD- t=5.759, P<0.001; LSD- t=5.432, P<0.001), but there was no difference between group A and group C (LSD- t=0.327, P=0.745). There was no significant difference in the amount of triamcinolone acetonide between group A and group B (125±15 mg VS 133±19 mg, t=1.673, P=0.101). The rates of wound healing under endoscopy after 1 month of group A, B and C were 76% (19/25), 84% (21/25), and 76% (19/25), respectively, with no significant difference ( χ2=0.636, P=0.728). The esophageal stricture rates were 52% (13/25) in both group A and B, and 84% (21/25) in group C, with significant difference among the three groups ( χ2=7.295, P=0.026), and group A and B showed a significantly lower stricture rate than that of group C ( P=0.015; P=0.015). The median time of EBD treatment of group A, B and C were 4 (range 0 to 9), 5 (range 0 to 13) and 9 (range 0 to 16), respectively, with significant difference ( H=17.58, P<0.001). In pairwise comparison the above indicator in group A and B was significantly less than that of group C ( H=23.96, P<0.001; H=19.00, P=0.002), but there was no significant difference between group A and group B ( H=4.96, P=0.407). Esophageal stricture was observed in all patients with circumferential mucosa resected in the three groups. But the times of EBD treatment were 6.90±1.10 in group A, 10.13±2.42 in group B and 15.29±0.76 in group C with significant difference ( F=57.754, P<0.001). In pairwise comparison the above indicator in group A was less than that in group B (LSD- t=4.294, P<0.001) and this indicator in group B was less than that in group C (LSD- t=6.294, P<0.001). Median EBD times in patients with non-circumferential mucosal defects in the three groups were 0 (range 0 to 9), 0 (range 0 to 6) and 8 (range 0 to10), respectively, with significant difference ( H=19.72, P<0.001). In pairwise comparison, the EBD time in group A and B was less than that in group C ( H=17.93, P<0.001; H=16.62, P<0.001), but there was no statistical difference between group A and B ( H=1.31, P=0.779). Conclusion:Triamcinolone acetonide-saline submucosal injection ESD can safely and effectively prevent esophageal stricture after ESD for large-area superficial esophageal neoplasms, reduce the operation time and time of EBD treatment in patients with circumferential mucosa defect compared with local injections of triamcinolone acetonide after ESD.
3.Feasibility of modified endoscopic anti-reflux mucosectomy for refractory gastroesophageal reflux disease with moderate hiatus hernia
Lei CHEN ; Zhen ZHU ; Lu WANG ; Haihang ZHU ; Xiufan NI ; Sujun GAO
Chinese Journal of Digestive Endoscopy 2023;40(2):126-130
Objective:To evaluate the efficiency and safety of modified endoscopic anti-reflux mucosectomy (ARMS) for refractory gastroesophageal reflux disease (rGERD) with moderate hiatus hernia.Methods:A total of 30 patients with rGERD with moderate hiatus hernia (3-5 cm) diagnosed at the Department of Gastroenterology of Northern Jiangsu People's Hospital from June 2017 to June 2020 were randomly divided into 2/3 circumferential mucosal resection group ( n=15) and 3/4 circumferential mucosal resection group ( n=15) using random number table method, and received modified ARMS of the corresponding mucosal resection range. The GERD symptoms, esophagitis under endoscopy, 24 h pH results, and lower esophageal sphincter (LES) resting pressure were compared before and after the procedure. The therapeutic effect and complications of the two groups were analyzed. Results:In 2/3 resection group, the GERD questionnaire scores (9.53±0.36 VS 11.93±0.57, t=6.874, P<0.001), acid exposure time (19.81%±1.72% VS 31.45%±2.78%, t=8.020, P<0.001) and the DeMeester score based on 24 h esophageal pH monitoring (40.98±4.55 VS 55.33±5.65, t=6.408, P<0.001) at 6 months after the treatment showed a significant reduction compared with those before. In 3/4 resection group, the GERD questionnaire scores (9.0±0.57 VS 12.47±0.68, t=8.650, P<0.001), acid exposure time (20.07%±2.19% VS 29.96%±3.00%, t=7.444, P<0.001) and the DeMeester score (33.67±3.47 VS 51.17±6.03, t=4.973, P<0.001) at 6 months after the treatment were lower than those before. There was no significant difference in the GERD questionnaire scores ( t=0.790, P=0.436), acid exposure time ( t=0.093, P=0.926) or the DeMeester score ( t=1.278, P=0.212) between the two groups at 6 months after treatment. In the two groups, there was no significant difference in the ratio of esophagitis grade C and D (10/15 VS 5/15, χ2=3.894, P=0.063; 8/15 VS 4/15, χ2=2.778, P=0.125) or LES resting pressure [3.29 (2.66,8.29) mmHg VS 3.98 (3.67,9.43) mmHg, P=0.334;5.78 (1.9,8.46) mmHg VS 5.88 (3.28,8.99) mmHg, P=0.125] before and after the treatment. No postoperative delayed bleeding or perforation was observed. The incidence of postoperative esophageal stenosis of 2/3 resection group was lower than that of the other group (1/15 VS 6/15, χ2=4.658, P=0.021). Conclusion:Modified ARMS is effective for controlling reflux symptoms and esophageal acid exposure in rGRED patients with moderate hiatus hernia (3-5 cm), but cannot significantly increase the postoperative resting pressure of LES. Compared with 3/4 circumferential mucosal resection, 2/3 circumferential mucosal resection can reduce the incidence of postoperative esophageal stenosis.
4.Endoscopic anti-reflux mucosectomy for refractory gastroesophageal reflux disease in the absence of hiatus hernia
Lei CHEN ; Zhen ZHU ; Haihang ZHU ; Sujun GAO ; Jian YIN ; Li ZHANG ; Lu WANG
Chinese Journal of General Surgery 2022;37(2):99-103
Objective:To evaluate the efficiency and safety of endoscopic anti-reflux mucosectomy (ARMS) for refractory gastroesophageal reflux disease (rGERD) in the absence of hiatus hernia (HH).Methods:Among 28 rGERD patients adimitted to Gastrointestinal Medical Center, Subei People's Hospital from Jan 2018 to Jun 2020 16 underwent endoscopic mucosal resection (EMR) and 12 did endoscopic submucosal dissection (ESD), The GERD symptoms, endoscopy, 24-h pH monitoring results, manometry, were compared before and after the procedure.Results:ARMS was successfully performed in all 28 patients. Three months after ARMS, 19 patients discontinued the use of pump inhibitors (PPIs), while 9 patients reduced their PPI dose. The GERD questionnaire scores, the median gastroesophageal flap valve grade, the median DeMeester score and acid exposure time based on 24 h esophageal pH monitoring were significantly lower than those before treatment [6.5±2.5 vs.13.4±3.1, 1(1-2) vs.3(1-3), 14.8(8.2-30) vs.34.6(16.2-60.7), 4.4%(1.3%-7.9%) vs. 8.7%(6.2%-13.9%),all P<0.01]. Esophageal sphincter pressure increased after ARMS, from (9.0±3.2) mmHg to (15.5±5.5) mmHg ( t=0.159, P<0.01). The operation time used in ESD was (66.9±4.5) minutes compared to EMR [(29.1±2.0) minutes]( t=13.911, P<0.001). The treatment cost of ESD was (19.9±1.6) thousand yuan vs. for EMR [(9.0±1.6) thousand yuan]( t=58.411, P<0.001). There were no major complications in both groups. Conclusions:ARMS is safe and effective for treatment of rGERD in the absence of HH, and EMR is less time-consuming and more acceptable technique.
5.Review of 2022 ASCO-GU prostate cancer milestone studies
Chinese Journal of Urology 2022;43(4):253-256
Prostate cancer is one of the most common malignancies in older men. Prostate cancer patients with distant metastasis often have a poor prognosis, and more than half of Chinese prostate cancer patients have developed distant metastasis at the time of initial diagnosis. In recent years, with the disclosure of the results of a number of global multi-center clinical trials, combination therapy and precision therapy have become two major themes in the treatment of metastatic prostate cancer (mPCa). The American Society of Clinical Oncology Genitourinary (ASCO-GU) Cancers Symposium is a grand meeting of the urologic oncology community. Several research advances reported at the meeting will help to update the treatment strategy of mPCa. This article interprets and comments on a number of milestone studies on mPCa treatment at the ASCO-GU 2022 annual meeting, with a view to providing help for the clinical treatment decisions of mPCa patients.
6.Clinical and Immunological Factors Associated with Postpartum Hepatic Flares in Immune-Tolerant Pregnant Women with Hepatitis B Virus Infection Treated with Telbivudine
Junfeng LU ; Xiaoxiao WANG ; Yunxia ZHU ; Lina MA ; Sujun ZHENG ; Zhongjie HU ; Xinyue CHEN
Gut and Liver 2021;15(6):887-894
Background/Aims:
To investigate postpartum hepatic flares and associated factors in highly viremic pregnant patients in the immune tolerance phase who adopted telbivudine (LdT) treatment in the last trimester to reduce vertical transmission of hepatitis B virus.
Methods:
Hepatitis B e antigen (HBeAg)-positive, highly viremic pregnant women were recruited for this prospective study. Treatment with LdT was started from 28 weeks of gestation. Virological and biochemical markers were examined before LdT treatment, antepartum and postpartum. Serial blood samples at the same time were collected to detect cytokines and cortisol (COR).
Results:
Fifty-six of 153 patients (36.6%) had postpartum hepatic flares, defined as a 2-fold increase in alanine aminotransferase 6 weeks after delivery. Age and the antepartum alanine aminotransferase and postpartum HBeAg levels were independent influencing factors of postpartum hepatic flares. Cytokines showed no regularity during or after pregnancy. Compared with the patients with no postpartum flares, the patients with flares had lower baseline interferon γ and COR levels (p=0.022 and p=0.028) and higher postpartum interferon γ levels (p=0.026).
Conclusions
A high proportion of highly viremic and immune-tolerant pregnant patients treated with LdT in the last trimester had postpartum hepatic flares, which implied that these patients entered the immune clearance phase after delivery. Thus, this may create an appropriate opportunity for re-antiviral therapy.
7.Clinical study of endoscopic submucosal tunnel dissection on treatment of early esophageal cancer with submucosal fibrosis
Lei CHEN ; Zhen ZHU ; Lu WANG ; Haihang ZHU ; Sujun GAO ; Li ZHANG ; Wei LU ; Di CHEN
Chinese Journal of Digestive Endoscopy 2020;37(6):429-434
Objective:To evaluate the efficiency and safety of endoscopic submucosal tunnel dissection (ESTD) on treatment of early esophageal cancer with submucosal fibrosis.Methods:In the Department of Gastroenterology of Northern Jiangsu People′s Hospital from June 2015 to Feburary 2018, data of 87 patients undergoing ESTD or endoscopic submucosal dissection (ESD) for early esophageal cancer or precancerous lesion were collected with inclusion criteria of cancer size less than 1/3 circumference with submucosal fibrosis, which was confirmed by pathology. According to the degree of submucosal fibrosis, 60 patients had mild fibrosis (31 underwent ESTD and 29 underwent ESD), and 27 patients had severe fibrosis (16 underwent ESTD and 11 underwent ESD). The dissection speed, en bloc resection rate, complete resection rate, and the complications (including bleeding, muscularis injury, perforation, neck subcutaneous emphysema and esophageal stenosis) were compared between the two methods of dissection in the groups with same degree of submucosal fibrosis.Results:For patients with mild submucosal fibrosis, ESTD had a higher en bloc resection rate (96.8%, 30/31) and complete resection rate (96.8%, 30/31), and lower muscularis injury rate (6.5%, 2/31) than those of ESD [82.8% (24/29), 75.9% (22/29), and 17.2% (5/29), respectively, all P<0.05]. There was no difference in the dissection speed, incidence of intraoperative bleeding, perforation and postoperative esophageal stenosis between the two methods (all P>0.05), and no postoperative delayed bleeding or neck subcutaneous emphysema occurred. For patients with severe submucosal fibrosis, ESTD had a higher dissection speed (12.3±2.8 mm 2/min), and lower incidence of intraoperative bleeding (12.5%, 2/16), muscularis injury (18.8%, 3/16), perforation (6.3%, 1/16) and neck subcutaneous emphysema (6.3%, 1/16) than those of ESD [7.1±3.2 mm 2/min, 54.5% (6/11), 54.5% (6/11), 27.3% (3/11), and 27.3% (3/11)]. There was no difference in en bloc resection rate, complete resection rate, and the incidence of postoperative esophageal stenosis between the two methods, and no postoperative delayed bleeding occurred. Cancer recurred locally in 2 patients undergoing ESD and 1 patient undergoing ESTD at 12 months after the operation, and 1 patient undergoing ESTD developed metachronous cancer at 24 months after the operation. Conclusion:ESTD is safe and effective for endoscopic management of early esophageal cancer or precancerous lesion with submucosal fibrosis. Compared with standard ESD, the advantage of ESTD is more efficient for patients with mild submucosal fibrosis, and is safer for patients with severe submucosal fibrosis.
8.Evaluation of periodontal status of 380 pregnant women and analysis of the related factors
Xiuqiao YANG ; Chanjuan YE ; Min WU ; Huijun LI ; Sujun ZHU ; Shaowu CHEN ; Ying HAO
Journal of Practical Stomatology 2019;35(1):109-113
Objective: To evaluate periodontal status of 380 pregnant women and its related factors. Methods: 380 healthy pregnant women aged 20 to 43 at 10-35 weeks of gestation were enrolled and received a questionnaire and a periodontal examination, in order to compare and analyse the effects of different ages, gestational weeks and educational levels on periodontal condition. Results: The prevalence of periodontal disease of the subjects was 87. 1%. In first (10-15 weeks), second (16-27 weeks) and third (28-35 weeks) trimester PD (mm) was 2. 48 ± 0. 54, 2. 60 ± 0. 54 and 2. 71 ± 0. 48 respectively (P < 0. 05) ; the percentage of PD≥4 mm in 2 or more sites were 76. 5%, 84. 1% and 93. 5% respectively (P < 0. 05) ; GI and BI did not show significant differences among of the 3 groups trimester stages (P> 0. 05) ; PD in maternal age (year) 20-27, 28-35 and 36-43 years was2. 39 ± 0. 51, 2. 61 ± 0. 53 and 2. 61 ± 0. 56 respectively (P < 0. 05) . A significantly positive linear trend was observed between age and GI (P < 0. 05) or PD (P < 0. 05), but without significant correlation between age and BI. Significant correlation was found between pregnant weeks and PD (P < 0. 05), but without correlation between pregnant weeks and GI (P> 0. 05) or BI (P> 0. 05) .Conclusion: The prevalence of periodontal disease during pregnancy is high. Meanwhile, the periodontal inflammation is increasing worse with the increase of gestational weeks and maternal age.
9. Efficacy and safety of IA regimen containing different doses of idarubicin in de-novo acute myeloid leukemia for adult patients
Aining SUN ; Xiaopeng TIAN ; Xiangshan CAO ; Jian OUYANG ; Jian GU ; Kailin XU ; Kang YU ; Qingshu ZENG ; Zimin SUN ; Guoan CHEN ; Sujun GAO ; Jin ZHOU ; Jinghua WANG ; Linhua YANG ; Jianmin LUO ; Mei ZHANG ; Xinhong GUO ; Xiaomin WANG ; Xi ZHANG ; Keqian SHI ; Hui SUN ; Xinmin DING ; Jianda HU ; Ruiji ZHENG ; Hongguo ZHAO ; Ming HOU ; Xin WANG ; Fangping CHEN ; Yan ZHU ; Hong LIU ; Dongping HUANG ; Aijun LIAO ; Liangming MA ; Liping SU ; Lin LIU ; Zeping ZHOU ; Xiaobing HUANG ; Xuemei SUN ; Depei WU
Chinese Journal of Hematology 2017;38(12):1017-1023
Objective:
To investigate the efficacy and safety of IA regimen which contains idarubicin (IDA) 8 mg/m2, 10 mg/m2 or 12 mg/m2 as induction chemotherapy for adult patients with de-novo acute myeloid leukemia (AML) .
Methods:
A total of 1 215 newly diagnosed adult AML patients, ranging from May 2011 to March 2015 in the First Affiliated Hospital of Soochow University and other 36 clinical blood centers in China were enrolled in the multicenter, single-blind, non-randomized, clinical controlled study. To compare the response rate of complete remission (CR) , adverse events between different dose idarubicin combined with cytarabine (100 mg/m2) as induction chemotherapy in newly diagnosed patients of adult AML.
Results:
Of 1 207 evaluable AML patients were assigned to this analysis of CR rate. The CR rates of IDA 8 mg/m2 group, IDA 10 mg/m2 group and IDA 12 mg/m2 group were 73.6% (215/292) , 84.1% (662/787) and 86.7% (111/128) , respectively (
10.Observation on clinical effects of acupuncture plus cupping therapy for cervical radiculopathy
Sujun LIU ; Jing LIANG ; Chaoan PAN ; Yang YANG ; Dongxun ZHU
Journal of Acupuncture and Tuina Science 2016;14(4):290-294
Objective:To observe the therapeutic effects of acupuncture plus cupping therapy and Western medication alone for cervical radiculopathy. Methods: A total of 139 patients with cervical radiculopathy were randomly divided based on the random digital table into an acupuncture-cupping group (70 cases) and a Western medication group (69 cases). In the acupuncture-cupping group, Fengchi (GB 20) (bilateral), Dazhui (GV 14), Jianjing (GB 21) (bilateral) and Jiaji (EX-B 2) points of the neck [bilateral, midpoint between Fengchi (GB 20) and Dazhui (GV 14)] were punctured. After the arrival of the needling sensation, bilateral Fengchi (GB 20) and Jianjing (GB 21) were linked with electric stimulation and the rest acupoints were manipulated with the moderate needling technique. In the retaining of the needles, TDP lamp radiation was used. After acupuncture, the cupping therapy was applied to the local area. The treatment was given once every other day, 20 d for a course. After one course, the therapeutic effects were observed. The Western medication group was treated by oral administration of Meloxicam (Mobic), 7.5 mg, once a day, with water and liquid after meal. The therapeutic effects were observed after 20 d. Results:The total effective rate was 92.8% in the acupuncture-cupping group and 73.9% in the Western medication group, with a statistical difference between the two groups (P<0.05). After treatment, the scores of the clinical symptoms of the two groups were obviously declined (P<0.01), and the score of the clinical symptoms of the acupuncture-cupping group was better than that of the Western medication group, with a statistical difference (P<0.05). Conclusion:Acupuncture plus cupping therapy was more effective than administration of Meloxicam tablets alone in the treatment of cervical radiculopathy.

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