1.The safety and efficacy of boron neutron capture therapy (BNCT) in the treatment of recurrent malignant tumors
Junqiang HONG ; Xiaoyi LIN ; Youqun LAI ; Ye CAO ; Xiangquan KONG ; Yuanhao LIU ; Shuiying LUO ; Zhicheng XIONG ; Mei GONG ; Yalai LIN ; Qiaoyun CHEN ; Mingang YING ; Li HUO ; Xiaohua ZHU ; Xiaoping SUN ; Yiqiao DENG ; Diyun SHU ; Haige ZHANG ; Cheng HUANG ; Jianji PAN
Chinese Journal of Radiation Oncology 2025;34(10):985-992
Objective:To evaluate the safety and efficacy of accelerator-based boron neutron capture therapy (AB-BNCT) in the treatment of recurrent and refractory malignant tumors.Methods:The data of 14 patients admitted to Xiamen Humanity Hospital from September 2022 to April 2023 were prospectively collected, including 7 patients with primary brain malignancies and 7 patients with locally recurrent inoperable head and neck malignancies. All patients received intravenous infusion of boron drug (NBB-001, p-dihydroxyborylphe nylalanine, a patented freeze-dried formulation) at a total nominal dosage of 500 mg/kg (11 patients) or 750 mg/kg (3 patients), and were irradiated with neutrons (operating with NeuPex system). Adverse events after treatment were recorded and assessed. The primary efficacy endpoint was the 90 d objective response rate (ORR), while the secondary endpoints included progression-free survival (PFS) and complete response rate (CRR). Data were compiled and analyzed by SAS 9.4 software. The rate and 95% CI were calculated using Clopper-Pearson method. Results:The median dose delivered to 80% of the target volume (D 80%) was 16.80 GyE (range: 8.93-23.79 GyE). The most common adverse reactions were hyperamylasemia, alopecia, and hyperprolactinemia. Five patients experienced 8 cases of grade 3 or above adverse events, including 1 case of grade 4 acute kidney injury and 7 cases of grade 3 adverse events. All adverse events were recovered after observation or treatment. At 90 d after treatment, the ORR of all patients was 9/14 (64%, 95% CI: 35%-87%), disease control rate (DCR) was 10/14 (71%, 95% CI: 42%-92%), CRR was 2/14 (14%, 95% CI: 2%-42%); and the best overall response during the entire course included an ORR of 10/14 (71% ,95% CI: 42%-92%), DCR of 13/14 (93%, 95% CI: 66%-100%), and CRR of 3/14 (21% ,95% CI: 5%-51%). The 1-year survival rate for head and neck malignancies was 71.4%, and the 2-year survival rate was 42.8%. The 1-year survival rate for recurrent brain malignancies was 42.8%. Conclusion:AB-BNCT demonstrates favorable safety and promising efficacy in treating primary brain malignancies and recurrent/refractory head and neck malignancies, representing a potential therapeutic option.
2.The safety and efficacy of boron neutron capture therapy (BNCT) in the treatment of recurrent malignant tumors
Junqiang HONG ; Xiaoyi LIN ; Youqun LAI ; Ye CAO ; Xiangquan KONG ; Yuanhao LIU ; Shuiying LUO ; Zhicheng XIONG ; Mei GONG ; Yalai LIN ; Qiaoyun CHEN ; Mingang YING ; Li HUO ; Xiaohua ZHU ; Xiaoping SUN ; Yiqiao DENG ; Diyun SHU ; Haige ZHANG ; Cheng HUANG ; Jianji PAN
Chinese Journal of Radiation Oncology 2025;34(10):985-992
Objective:To evaluate the safety and efficacy of accelerator-based boron neutron capture therapy (AB-BNCT) in the treatment of recurrent and refractory malignant tumors.Methods:The data of 14 patients admitted to Xiamen Humanity Hospital from September 2022 to April 2023 were prospectively collected, including 7 patients with primary brain malignancies and 7 patients with locally recurrent inoperable head and neck malignancies. All patients received intravenous infusion of boron drug (NBB-001, p-dihydroxyborylphe nylalanine, a patented freeze-dried formulation) at a total nominal dosage of 500 mg/kg (11 patients) or 750 mg/kg (3 patients), and were irradiated with neutrons (operating with NeuPex system). Adverse events after treatment were recorded and assessed. The primary efficacy endpoint was the 90 d objective response rate (ORR), while the secondary endpoints included progression-free survival (PFS) and complete response rate (CRR). Data were compiled and analyzed by SAS 9.4 software. The rate and 95% CI were calculated using Clopper-Pearson method. Results:The median dose delivered to 80% of the target volume (D 80%) was 16.80 GyE (range: 8.93-23.79 GyE). The most common adverse reactions were hyperamylasemia, alopecia, and hyperprolactinemia. Five patients experienced 8 cases of grade 3 or above adverse events, including 1 case of grade 4 acute kidney injury and 7 cases of grade 3 adverse events. All adverse events were recovered after observation or treatment. At 90 d after treatment, the ORR of all patients was 9/14 (64%, 95% CI: 35%-87%), disease control rate (DCR) was 10/14 (71%, 95% CI: 42%-92%), CRR was 2/14 (14%, 95% CI: 2%-42%); and the best overall response during the entire course included an ORR of 10/14 (71% ,95% CI: 42%-92%), DCR of 13/14 (93%, 95% CI: 66%-100%), and CRR of 3/14 (21% ,95% CI: 5%-51%). The 1-year survival rate for head and neck malignancies was 71.4%, and the 2-year survival rate was 42.8%. The 1-year survival rate for recurrent brain malignancies was 42.8%. Conclusion:AB-BNCT demonstrates favorable safety and promising efficacy in treating primary brain malignancies and recurrent/refractory head and neck malignancies, representing a potential therapeutic option.
3.Camrelizumab, apatinib, nab-paclitaxel, and S-1 in combination for the conversion therapy of advanced gastric cancer
Wei DENG ; Yiqiao ZHANG ; Chao JING ; Xiaobao YANG ; Zhigang BAI ; Jun ZHANG
International Journal of Surgery 2022;49(4):242-247,F4
Objective:To assess the efficacy and safety of the combination therapy of camrelizumab, apatinib, nab-paclitaxel, and S-1 for patients with locally unresectable advanced gastric cancer.Methods:From September 1, 2019 to August 1, 2021, in Beijing Friendship Hospital Affiliated to Capital Medical University, 17 patients with advanced gastric cancer were enrolled in this prospective, single-arm study. All the enrolled patients received camrelizumab, nab-paclitaxel, apatinib and S-1 combination therapy (in each 21 days cycle, camrelizumab 200 mg intravenously, D1; nab-paclitaxel 240 mg/m 2 intravenously, D2; apatinib 500 mg orally, once a day, D1-D21; S-1 40-60 mg twice a day, D1-D14). Patients who have been evaluated by multidisciplinary team to be eligible for radical surgery should stop treatment for at least 2 weeks. Patients were discontinued from the study when disease progression or unbearable toxicity, or withdrew consent. We analyzed the conversion rate, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.Statistical data were show by numbers and persentages(%), and comparisons between subgroups were assessed by Fisher′s exact probability method. Patients survival was analyzed using Kaplan-Meier curves and compared between groups using Log-rank. Results:At the data of cutoff (December 15, 2021), the median follow-up duration was 19.6 months. Eight of 17 patients underwent gastrectomy, and all of them were R0 resection (47.1%, 95% CI: 0.262-0.690). ORR was 47.1%, DCR was 82.4%, the median overall survival was 23.63 months. Grade 3 and 4 adverse events occurred in 3 patients (17.6%), including neutropenia, thrombocytopenia, anemia and upper gastrointestinal hemorrhage. There were no serious treatment-related adverse events or treatment-related deaths. Conclusion:In this trial, the combination of camrelizumab, apatinib, nab-paclitaxel and S-1 as the conversion therapy showed significant anti-tumor activity and manageable adverse events, providing a new option for locally unresectable advanced gastric cancer.
4.Protective effect of polymyxin B in liver transplantation in rats
Yiqiao WANG ; Baiyong SHEN ; Guoqing BAO ; Xiaohui WANG ; Daohai QIAN ; Qian ZHAN ; Chunpeng PAN ; Xiaxing DENG ; Zhecheng ZHU ; Chenghong PENG ; Hongwei LI
Chinese Journal of Organ Transplantation 2012;33(4):232-235
Objective To investigate the protective effect of polymyxin B (PMB) to the liver graft after liver transplantation and the underlying mechanism in rats.Methods Male SD rats were selected as the donors and recipients.Non-artery whole liver transplantation model was established in rats according to Kamada's two-cuff method.The rats were divided into two groups by the way of random number table method:control group (normal saline,0.5 ml) and PMB group (PMB,1 mg/ml,0.4 mg/kg+ normal saline 0.5 ml).The levels of portal vein plasma endtotoxin (EU/ml)were determined by endotoxin-analyzing machine of BET-24A. ALT,BUN,and TNF-α,IL-6 in serum were measured by using machine of Automatic Analyzer and ELISA,respectively.The CD14,TLR4,NFκB and AP-1 in the grafts were measured by RT-PCR and Western blotting,and pathological changes were observed. Results PMB decreased the levels of portal vein plasma endotoxin 1 h after reperfusion in PMB group as compared with control group (P<0.05),and the levels of portal vein plasma endotoxin returned to the normal levels 6 h after reperfusion in both two groups (P>0.05).After operation,the levels of ALT,TNFα and IL-6 in serum were significantly reduced (P<0.05),the expression of CD14 and TLR4 mRNA in the grafts was significantly decreased (P<0.05),the expression of Hsp60 protein and mRNA,and NF-κB and AP1 proteins in the grafts were reduced (P<0.05),and the pathological damage to the grafts was significantly alleviated in PMB group as compared with control group.Conclusion PMB reduced the levels of portal vein plasma endotoxin after reperfusion in liver transplantation in rats.PMB improved liver function,reduced the injury of inflammatory response,decreased the levels of endotoxin signal pathway markers and alleviated the pathological damage to the grafts.
5.Relationship between hepatic arterial buffer response and early biliary complications and small-for-size syndrome after living donor liver transplantation
Daohai QIAN ; Qin LIU ; Xiaohui WANG ; Chunpeng PAN ; Baiyong SHEN ; Guoqing BAO ; Yiqiao WANG ; Chenghong PENG ; Zhecheng ZHU ; Xiaxing DENG ; Qian ZHAN ; Hongwei LI
Chinese Journal of Hepatobiliary Surgery 2012;18(6):411-415
Objective To study the relationship between hepatic arterial buffer response (HABR),recovery of liver function,early biliary complications and small-for-size syndrome (SFSS).Methods Early hepatic hemodynamic parameters (including hepatic arterial flow (HAF),portal venous flow (PVF) were measured using duplex Doppler sonography in 34 patients who received living donor liver transplantation (preoperatively n=26,intraoperatively n=26) and on postoperative days 1,2,3,and 7.Alanine aminotransferase (ALT),aspartate aminotransferase (AST) and total bilirubin (TBIL) level were measured preoperatively and on postoperative days 1,2,3,7,14,21,and 28.If TBIL level was elevated,we used B ultrasonography or CT and even ERCP to diagnose early biliary complications.The days taken for AST,AI T and TBIL to recover and the number of patients with early (<60 days) biliary complications (bile leakage or bile stricture) and with small-for-size syndrome (SFSS) were recorded.Results Passive hepatic artery buffer response (HABR) was present in 11 patients early after living donor liver transplantation (group 1) and it disappeared in 23 patients (group 2).The recovery in days taken for normalization of AST (10.6± 8.8),AIT (11.6±9.0) and TBlL (average of 29) in group 1 were shorter than in group 2.However,the differences did not reach statistics difference (P>0.05).The overall incidences of early biliary complications and small-for-size syndrome (SFSS) in group 1 were significantly lower than in group 2 (P=0.04).The survival rate in group 1 was 82 %,compared with 74 % in group 2.Conclusions Passive hepatic arterial buffer response (HABR) disappeared in some patients early after living donor liver transplantation.There were high incidences of early biliary complications and small-for-size syndrome (SFSS) in these patients.Measurcment of hepatic buffer response in the early stage after living donor liver tranaplanta tion is valuable for predition of early biliary complications and small-for-size syndrome (SFSS),thus helping to prevent failure in transplantation.
6.The dynamic changes of plasma endotoxin in portal vein following partial liver transplantation in rats
Yiqiao WANG ; Guoqing BAO ; Boyong SHEN ; Xiaohui WANG ; Daohai QIAN ; Qian ZHAN ; Xiaxing DENG ; Zhecheng ZHU ; Ran TAO ; Chenghong PENG ; Hongwei LI
Chinese Journal of Organ Transplantation 2010;31(12):737-740
Objective To investigate and compare the dynamic changes of plasma endotoxin and CD14/TLR4 levels in the portal vein following partial liver transplantation in rats. Methods 100 %(group Ⅰ), 50 % (group Ⅱ) and 30 % (group Ⅲ) orthotopic liver transplantation models in the SD rats→SD rats were established in vivo according to "Kamada two-cuff method". Based on the principle of dynamic turbidity law, the plasma endotoxin (EU/ml) levels were determined at the postoperative time points of 1, 3, 6, 12, 24 h in recipients. The mRNA expression levels of CD14 and TLR4 in liver grafts were detected by using real-time RT-PCR. Results Under the condition of no significant difference in surgical factors, the plasma endotoxin levels in the portal vein of groups Ⅱ and Ⅲ were higher than in group Ⅰ , and reached the peak at the first h postoperation. The endotoxin levels in group Ⅱ were lower than in group Ⅲ. The endotoxin levels in sham-operation group were the highest. The mRNA expression levels of CD14 and TLR4 in groups Ⅰ, Ⅱ and Ⅲ were significantly increased as compared with sham-operation group (P<0. 01). Conclusion There exists portal vein plasma endotoxima in 100 %, 50 % and 30 % orthotopic liver transplantation in the rats. The smaller the graft volume, the higher and longer plasma endotoxin in portal vein, so is the relative quantification of the TLR4 and CD14 mRNA in liver grafts.
7.A multi-center clinical trial of Qianlieantong tablets for chronic prostatitis.
Kai GUO ; Ming-Xing QIU ; Song-Liang CAI ; Jing LENG ; Yin-Fa HAN ; Guo-Xing SHAO ; Chuan-Hang WANG ; Xiang-An TU ; Luo-Yan YANG ; Ge-Ming CHEN ; Qiang ZHOU ; Yong DENG ; Xiao-Long WANG
National Journal of Andrology 2007;13(10):950-952
OBJECTIVETo observe the efficacy and safety of Qianlieantong Tablets in the treatment of chronic prostatitis.
METHODSA multi-center, self-controlled open clinical trial was conducted. A total of 280 subjects with chronic prostatitis were enrolled and treated by Qianlieantong Tablets, 3 times a day, 5 tablets each time. Before and after 2 and 4 weeks after the administration, NIH-CPSI scores and white blood cell counts in the prostate secretion were recorded.
RESULTSOf the 273 subjects evaluated, the rates of excellence, effectiveness and ineffectiveness were 35.2% (n = 96), 47.6% (n = 130) and 17.2% (n = 47), respectively, with a total effectiveness rate of 82.8%. After 4 weeks'medication, the scores of the subjects on NIH-CPSI pain, voiding and quality of life and white blood cell counts in prostate secretion were significantly decreased compared with pre-treatment (P < 0.01). No adverse events or laboratory abnormality related to the medication were observed.
CONCLUSIONQianlieantong Tablets has a significant effect on chronic prostatitis with high safety, particularly indicated in chronic prostatitis with pelvic pain.
Adult ; Chronic Disease ; Drug Administration Schedule ; Drugs, Chinese Herbal ; administration & dosage ; therapeutic use ; Humans ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Prostatitis ; drug therapy ; Quality of Life ; Tablets ; Treatment Outcome

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