1.Effect of irbesartan and nifedipine controlled-release tablets on morning blood pressure surge
Zhaoxia ZHOU ; Shunda WANG ; Dong WU
The Journal of Practical Medicine 2014;(13):2151-2153
Objective To evaluate the effect of irbesartan and nifedipine controlled-release tablets on morning blood pressure surge in patients with essential hypertension. Methods Ninety patients with essential hypertension were randomly divided into irbesartan group ( group A, n = 45) and nifedipine group (group B, n =45). Irbesartan tablets 150 mg/d and nifedipine controlled-release tablets 30 mg/d were respectively given in group A and group B for 4 weeks. The levels of diastolic blood pressure (DBP), systolic blood pressure (SBP), mean arterial pressure ( MAP ) and morning blood pressure surge ( MBPS ) before and after treatment were measured by ambulatory blood pressure monitoring. Results The DBP, SBP, MAP and MBPS levels of two groups after treatment for 4 weeks were all decreased (P < 0.01). All the indexes of group B decreased more significant compared to group A (P < 0.05 ). Conclusion To control blood pressure and prevent morning blood pressure surge, nifedipine controlled-release tablets are better than irbesartan.
2.Crelational Research of the Level of Plasma Procalcitonin, Blood Lactic Acid and Endotoxin in Patients of Severe Pneumonia Complicated with Sepsis
Zhenguo LIU ; Ting WANG ; Shunda WANG ; Xiaoe LU ; Yiming YIN
Journal of Modern Laboratory Medicine 2017;32(2):95-97,164
Objective To evaluate the clinical value of the level of plasma procalcitonin,blood lactic acid an1 endotoxin in patients of severe pneumonia complicated with sepsis.Methods The 40 cases of severe pneumonia complicated with sepsis(observation group)were analyzed retrospectively,they were divided into survival group included 20 cases and the death group included 20 cases.Meanwhile the 20 cases of healthy persons were selected as control group.The worst score of Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ) within 24 hours after admission were record.The level of plasma procalcitonin,blood lactic acid and endotoxin were compared between three groups.In addition do a correlation study between the above indexes and the score of APACHE Ⅱ.Results The level of plasma Procalcitonin,blood lactic acid and endotoxin of observation group increased significantly compared with the control group [(0.02±0.01 ng/ml,0.87 ± 0.27 mmol/L,4.15±1.63 pg/ml) vs (18.29±11.02 ng/ml,6.55 ± 3.02 mmol/L and 15.5±10.38 pg/ml),t=10.48,11.79,6.75,all P<0.05].The level of plasma procalcitonin,blood lactic acid and endotoxin of the death group increased significantly compared with the survival group [(9.52±2.93 ng/ml,4.26±1.78 mmol/L,7.62±3.04 pg/ml) vs (27.06±8.88 ng/ml,8.84± 2.14 mmol/L and 23.39± 9.00 pg/ml),t=8.39,7.35,7.42,all P<0.05].In the all patients of severe pneumonia complicated with sepsis,there was positive correlation among plasma procalcitonin,blood lactic acid,endotoxin and the score of APACHE Ⅱ (r=0.919,P=0.001;r=0.914,P=0.002;r=0.909,P=0.004).Conclusion The level of plasma procalcitonin,blood lactic acid and endotoxin are very important indexes in assessment of the severity and the prognosis of severe pneumonia complicated with sepsis,that has important value in clinical application.
3.Clinical observation of Cervus and Cucumis Polypeptide for Injection in the treatment of knee osteoarthritis
Shunda LI ; Lu XU ; Zhen WANG ; Yong HE ; Yushan ZHANG
Chinese Journal of Biochemical Pharmaceutics 2017;37(9):42-43
Objective To investigate and analyze the efficacy of Cervus and Cucumis Polypeptide for Injection in the treatment of osteoarthritis of the knee. Methods 100 patients with osteoarthritis of knee joint treated in Xinchang people's hospital from February 2015 to May 2017 were selected and randomly divided into the control group and the experimental group, with 50 patients in each group. The control group were treated with oral glucosamine capsules in the treatment of the experimental group, Cervus and Cucumis Polypeptide for Injection palliative treatment, 250 mL saline plus 25g guguatiquwu, oral Nimeilishu capsule. The treatment time of the 2 groups was one month. The therapeutic effects of the experimental group and the control group were compared and analyzed. Results After the corresponding treatment, 4 patients in the experimental group were invalid, 20 cases were effective, and 26 cases were effective. In the control group, 13 patients were ineffective. The effective rate of the experimental group was 92%, which was significantly higher than that of the control group (P<0.05). The IL-1 of the knee joint fluid in the experimental group was (8.01±1.72), and the IL-1 of the knee fluid in the control group was (7.08±0.97). The level of IL-1 in the knee joint fluid of the experimental group was significantly higher than that of the control group, with statistical difference (P<0.05). Conclusion Cervus and Cucumis Polypeptide for Injection is effective in the treatment of osteoarthritis of the knee, and can significantly improve the efficiency of treatment,.
4.Changes of IL-18, TNF-α and IFN-γ levels in rats with experimental cirrhosis and their significance
Shuangsuo DANG ; Ning GAO ; Yanan CHENG ; Jing BIAN ; Shunda WANG ; Mingzhu SUN
Journal of Xi'an Jiaotong University(Medical Sciences) 2010;31(2):148-150,185
Objective To investigate the changes of interleukin-18 (IL-18), tumor necrosis factor-α(TNF-α) and interferon-γ (IFN-γ) levels of liver cirrhosis induced by the composite factors of carbon tetrachloride (CCl_4) in SD rats and their significance. Methods Totally 80 male SD rats of clean class were randomly divided into normal control group (20 rats) and model groups, the latter of which were further divided into three groups according to the length of administration time, namely, 2-week group (2 wk group), 4-week group (4 wk group) and 6-week group (6 wk group), with 20 rats in each. Six rats were killed after 2 wk, 4 wk and 6 wk administration time, respectively. The rat serum levels of IL-18, TNF-α and IFN-γ and the hepatic homogenate supernatant of IL-18 were detected by ELISA; pathological changes of liver tissues were observed by HE staining. Results ① Pathological observation revealed that in the model groups hepatic cells degenerated and swelled at week 2 while large amounts of fibrosis and pseudolobules of some liver tissues occurred at week 6. ② The serum levels of IL-18, TNF-α and IFN-γ were gradually increased with the modeling time, and they were significantly higher in 6-week group than in normal control group (P<0.01). ③ The levels of hepatic homogenate supernatant of IL-18 in the model groups were elevated with liver damage, and they were significantly higher in 6-week group than in normal control group (P<0.01). Conclusion During the formation of liver cirrhosis induced by composite factors of CCl_4 in rats, IL-18, TNF-α and IFN-γ levels gradually increase, suggesting that the three cytokines play a certain role during the occurrence of liver cirrhosis in rats.
5.Feasibility of single hole thoracoscopy of pleural fibreboard end-arterectomy in treatment of chronic tuberculous empyema
Wenbin HU ; Shunda YUAN ; Jinlong ZHU ; Wengang QIU ; Youlin YU ; Kang ZHANG ; Kairan LUO ; Keju XIE ; Zhuoliang ZHANG ; Junhui CAI ; Chunyu WANG ; Xuefang CHEN
China Journal of Endoscopy 2017;23(4):91-94
Objective To discuss the feasibility of single hole thoracoscopy of pleural fibreboard endarterectomy surgical treatment on chronic tuberculous empyema. Methods Retrospective analysis of minimally invasive treatment of 52 cases of chronic tuberculous empyema form January 2013 to May 2016, 50 cases applied single hole thoracoscopy surgery, video-assisted mini-thoracoscopy for another 2 cases. Results There was no death, operation time 60 ~ 240 min, average 160 min, bleeding 150 ~ 2000 ml, average 350 ml, postoperative chest tube drainage time 3 ~ 21 d, average 7 d, postoperative persistent leakage in 3 patients, 3 cases of atelectasis, incisional infection in 1 case, pleural effusion in 1 case, 3 cases of arrhythmia. All the cured patients are received the corresponding treatment, the follow-up of 3 ~ 36 m, the chest CT scan show no atelectasis. Conclusion Under the condition of strict selection of indication, single hole thoracoscopy of pleural fibreboard endarterectomy in treatment of chronic tuberculous empyema is safe and feasible, so it is worthy of making further clinical promotion and application.
6.Comprehensive therapy for advanced unresectable hepatocellular carcinoma
Jiali XING ; Bao JIN ; Gang XU ; Yuxin WANG ; Xueshuai WAN ; Yongchang ZHENG ; Haifeng XU ; Yiyao XU ; Mei GUAN ; Shunda DU ; Haitao ZHAO ; Xin LU ; Xinting SANG ; Yilei MAO
Chinese Journal of General Surgery 2022;37(2):108-112
Objective:To investigate the efficacy and safety of comprehensive therapy in the treatment of advanced unresectable hepatocellular carcinoma.Methods:Clinical data of 34 patients with primary liver cancer admitted to Peking Union Medical College Hospital from Nov 2018 to Dec 2020 initially evaluated as unresectable were treated firstly by combined therapy and then underwent reevaluation for further management.Results:A total of 34 patients completed the integrative treatment, and no serious adverse events occurred. Among them, 6 patients were evaluated as partial remission, and underwent successful tumor resection, tumors in 7 patients were stable, and 21 patients suffered from disease progression.Conclusion:After comprehensive therapy, unresectable tumors in some patients could reduce and be rendered resection.
7.Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting
Xueshuai WAN ; Karin WISSKIRCHEN ; Tao JIN ; Lu YANG ; Xiaorui WANG ; Xiang’an WU ; Fang LIU ; Yu WU ; Christy MA ; Yong PANG ; Qi LI ; Ke ZHANG ; Ulrike PROTZER ; Shunda DU
Clinical and Molecular Hepatology 2024;30(4):735-755
Background/Aims:
Hepatitis B virus (HBV)-DNA integration in HBV-related hepatocellular carcinoma (HBV-HCC) can be targeted by HBV-specific T cells. SCG101 is an autologous, HBV-specific T-cell product expressing a T-cell receptor (TCR) after lentiviral transduction recognizing the envelope-derived peptide (S20-28) on HLA-A2. We here validated its safety and efficacy preclinically and applied it to an HBV-related HCC patient (NCT05339321).
Methods:
Good Manufacturing Practice-grade manufactured cells were assessed for off-target reactivity and functionality against hepatoma cells. Subsequently, a patient with advanced HBV-HCC (Child-Pugh class A, Barcelona Clinic Liver Cancer stage B, Eastern Cooperative Oncology Group performance status 0, hepatitis B e antigen-, serum hepatitis B surface antigen [HBsAg]+, HBsAg+ hepatocytes 10%) received 7.9×107 cells/kg after lymphodepletion. Safety, T-cell persistence, and antiviral and antitumor efficacy were evaluated.
Results:
SCG101, produced at high numbers in a closed-bag system, showed HBV-specific functionality against HBV-HCC cells in vitro and in vivo. Clinically, treatment was well tolerated, and all adverse events, including transient hepatic damage, were reversible. On day 3, ALT levels increased to 1,404 U/L, and concurrently, serum HBsAg started decreasing by 3.84 log10 and remained <1 IU/mL for over six months. HBsAg-expressing hepatocytes in liver biopsies were undetectable after 73 days. The patient achieved a partial response according to modified RECIST with a >70% reduction in target lesion size. Transferred T cells expanded, developed a stem cell-like memory phenotype, and were still detectable after six months in the patient’s blood.
Conclusions
SCG101 T-cell therapy showed encouraging efficacy and safety in preclinical models and in a patient with primary HBV-HCC and concomitant chronic hepatitis B with the capability to eliminate HBsAg+ cells and achieve sustained tumor control after single dosing.
8.Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting
Xueshuai WAN ; Karin WISSKIRCHEN ; Tao JIN ; Lu YANG ; Xiaorui WANG ; Xiang’an WU ; Fang LIU ; Yu WU ; Christy MA ; Yong PANG ; Qi LI ; Ke ZHANG ; Ulrike PROTZER ; Shunda DU
Clinical and Molecular Hepatology 2024;30(4):735-755
Background/Aims:
Hepatitis B virus (HBV)-DNA integration in HBV-related hepatocellular carcinoma (HBV-HCC) can be targeted by HBV-specific T cells. SCG101 is an autologous, HBV-specific T-cell product expressing a T-cell receptor (TCR) after lentiviral transduction recognizing the envelope-derived peptide (S20-28) on HLA-A2. We here validated its safety and efficacy preclinically and applied it to an HBV-related HCC patient (NCT05339321).
Methods:
Good Manufacturing Practice-grade manufactured cells were assessed for off-target reactivity and functionality against hepatoma cells. Subsequently, a patient with advanced HBV-HCC (Child-Pugh class A, Barcelona Clinic Liver Cancer stage B, Eastern Cooperative Oncology Group performance status 0, hepatitis B e antigen-, serum hepatitis B surface antigen [HBsAg]+, HBsAg+ hepatocytes 10%) received 7.9×107 cells/kg after lymphodepletion. Safety, T-cell persistence, and antiviral and antitumor efficacy were evaluated.
Results:
SCG101, produced at high numbers in a closed-bag system, showed HBV-specific functionality against HBV-HCC cells in vitro and in vivo. Clinically, treatment was well tolerated, and all adverse events, including transient hepatic damage, were reversible. On day 3, ALT levels increased to 1,404 U/L, and concurrently, serum HBsAg started decreasing by 3.84 log10 and remained <1 IU/mL for over six months. HBsAg-expressing hepatocytes in liver biopsies were undetectable after 73 days. The patient achieved a partial response according to modified RECIST with a >70% reduction in target lesion size. Transferred T cells expanded, developed a stem cell-like memory phenotype, and were still detectable after six months in the patient’s blood.
Conclusions
SCG101 T-cell therapy showed encouraging efficacy and safety in preclinical models and in a patient with primary HBV-HCC and concomitant chronic hepatitis B with the capability to eliminate HBsAg+ cells and achieve sustained tumor control after single dosing.
9.Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting
Xueshuai WAN ; Karin WISSKIRCHEN ; Tao JIN ; Lu YANG ; Xiaorui WANG ; Xiang’an WU ; Fang LIU ; Yu WU ; Christy MA ; Yong PANG ; Qi LI ; Ke ZHANG ; Ulrike PROTZER ; Shunda DU
Clinical and Molecular Hepatology 2024;30(4):735-755
Background/Aims:
Hepatitis B virus (HBV)-DNA integration in HBV-related hepatocellular carcinoma (HBV-HCC) can be targeted by HBV-specific T cells. SCG101 is an autologous, HBV-specific T-cell product expressing a T-cell receptor (TCR) after lentiviral transduction recognizing the envelope-derived peptide (S20-28) on HLA-A2. We here validated its safety and efficacy preclinically and applied it to an HBV-related HCC patient (NCT05339321).
Methods:
Good Manufacturing Practice-grade manufactured cells were assessed for off-target reactivity and functionality against hepatoma cells. Subsequently, a patient with advanced HBV-HCC (Child-Pugh class A, Barcelona Clinic Liver Cancer stage B, Eastern Cooperative Oncology Group performance status 0, hepatitis B e antigen-, serum hepatitis B surface antigen [HBsAg]+, HBsAg+ hepatocytes 10%) received 7.9×107 cells/kg after lymphodepletion. Safety, T-cell persistence, and antiviral and antitumor efficacy were evaluated.
Results:
SCG101, produced at high numbers in a closed-bag system, showed HBV-specific functionality against HBV-HCC cells in vitro and in vivo. Clinically, treatment was well tolerated, and all adverse events, including transient hepatic damage, were reversible. On day 3, ALT levels increased to 1,404 U/L, and concurrently, serum HBsAg started decreasing by 3.84 log10 and remained <1 IU/mL for over six months. HBsAg-expressing hepatocytes in liver biopsies were undetectable after 73 days. The patient achieved a partial response according to modified RECIST with a >70% reduction in target lesion size. Transferred T cells expanded, developed a stem cell-like memory phenotype, and were still detectable after six months in the patient’s blood.
Conclusions
SCG101 T-cell therapy showed encouraging efficacy and safety in preclinical models and in a patient with primary HBV-HCC and concomitant chronic hepatitis B with the capability to eliminate HBsAg+ cells and achieve sustained tumor control after single dosing.
10.Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting
Xueshuai WAN ; Karin WISSKIRCHEN ; Tao JIN ; Lu YANG ; Xiaorui WANG ; Xiang’an WU ; Fang LIU ; Yu WU ; Christy MA ; Yong PANG ; Qi LI ; Ke ZHANG ; Ulrike PROTZER ; Shunda DU
Clinical and Molecular Hepatology 2024;30(4):735-755
Background/Aims:
Hepatitis B virus (HBV)-DNA integration in HBV-related hepatocellular carcinoma (HBV-HCC) can be targeted by HBV-specific T cells. SCG101 is an autologous, HBV-specific T-cell product expressing a T-cell receptor (TCR) after lentiviral transduction recognizing the envelope-derived peptide (S20-28) on HLA-A2. We here validated its safety and efficacy preclinically and applied it to an HBV-related HCC patient (NCT05339321).
Methods:
Good Manufacturing Practice-grade manufactured cells were assessed for off-target reactivity and functionality against hepatoma cells. Subsequently, a patient with advanced HBV-HCC (Child-Pugh class A, Barcelona Clinic Liver Cancer stage B, Eastern Cooperative Oncology Group performance status 0, hepatitis B e antigen-, serum hepatitis B surface antigen [HBsAg]+, HBsAg+ hepatocytes 10%) received 7.9×107 cells/kg after lymphodepletion. Safety, T-cell persistence, and antiviral and antitumor efficacy were evaluated.
Results:
SCG101, produced at high numbers in a closed-bag system, showed HBV-specific functionality against HBV-HCC cells in vitro and in vivo. Clinically, treatment was well tolerated, and all adverse events, including transient hepatic damage, were reversible. On day 3, ALT levels increased to 1,404 U/L, and concurrently, serum HBsAg started decreasing by 3.84 log10 and remained <1 IU/mL for over six months. HBsAg-expressing hepatocytes in liver biopsies were undetectable after 73 days. The patient achieved a partial response according to modified RECIST with a >70% reduction in target lesion size. Transferred T cells expanded, developed a stem cell-like memory phenotype, and were still detectable after six months in the patient’s blood.
Conclusions
SCG101 T-cell therapy showed encouraging efficacy and safety in preclinical models and in a patient with primary HBV-HCC and concomitant chronic hepatitis B with the capability to eliminate HBsAg+ cells and achieve sustained tumor control after single dosing.