1.Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5–24 Hours of Onset (ROSE-TNK): A Phase 2, Randomized, Multicenter Study
Lu WANG ; Ying-Jie DAI ; Yu CUI ; Hong ZHANG ; Chang-Hao JIANG ; Ying-Jie DUAN ; Yong ZHAO ; Ye-Fang FENG ; Shi-Mei GENG ; Zai-Hui ZHANG ; Jiang LU ; Ping ZHANG ; Li-Wei ZHAO ; Hang ZHAO ; Yu-Tong MA ; Cheng-Guang SONG ; Yi ZHANG ; Hui-Sheng CHEN
Journal of Stroke 2023;25(3):371-377
Background:
and Purpose Intravenous tenecteplase (TNK) efficacy has not been well demonstrated in acute ischemic stroke (AIS) beyond 4.5 hours after onset. This study aimed to determine the effect of intravenous TNK for AIS within 4.5 to 24 hours of onset.
Methods:
In this pilot trial, eligible AIS patients with diffusion-weighted imaging (DWI)-fluid attenuated inversion recovery (FLAIR) mismatch were randomly allocated to intravenous TNK (0.25 mg/kg) or standard care within 4.5–24 hours of onset. The primary endpoint was excellent functional outcome at 90 days (modified Rankin Scale [mRS] score of 0–1). The primary safety endpoint was symptomatic intracranial hemorrhage (sICH).
Results:
Of the randomly assigned 80 patients, the primary endpoint occurred in 52.5% (21/40) of TNK group and 50.0% (20/40) of control group, with no significant difference (unadjusted odds ratio, 1.11; 95% confidence interval 0.46–2.66; P=0.82). More early neurological improvement occurred in TNK group than in control group (11 vs. 3, P=0.03), but no significant differences were found in other secondary endpoints, such as mRS 0–2 at 90 days, shift analysis of mRS at 90 days, and change in National Institutes of Health Stroke Scale score at 24 hours and 7 days. There were no cases of sICH in this trial; however, asymptomatic intracranial hemorrhage occurred in 3 of the 40 patients (7.5%) in the TNK group.
Conclusion
This phase 2, randomized, multicenter study suggests that intravenous TNK within 4.5–24 hours of onset may be safe and feasible in AIS patients with a DWI-FLAIR mismatch.
2.Safety and short-term efficacy of apatinib combined with oxaliplatin and S-1 in the conversion treatment for gastric cancer with peritoneal metastasis.
Zai Sheng YE ; Yi ZENG ; Sheng Hong WEI ; Yi WANG ; Shu CHEN ; Zhi Tao LIN ; Zhi Wei WANG ; Xiao Ling CHEN ; Lu Chuan CHEN
Chinese Journal of Gastrointestinal Surgery 2021;24(3):240-247
Objective: To investigate the safety and short-term efficacy of apatinib combined with oxaliplatin and S-1 in the conversion treatment for gastric cancer with different types of peritoneal metastasis. Methods: A prospective study "one arm exploratory clinical study of conversion therapy of apatinib with S-1 and oxaliplatin in the treatment of advanced gastric cancer" (clinical registration ChiCTR-ONC-17010430) from medical record database was retrospectively analyzed. Patients aged 18-70 years with gastric cancer peritoneal metastasis confirmed by histology and laparoscopic exploration, and had not receive radiotherapy, chemotherapy, targeted therapy or immunotherapy before were enrolled. Before operation, the patients received 6 cycles of S-1 (80-120 mg/d, d1-d14) and oxaliplatin (130 mg/m(2), d1), and 5 cycles of apatinib (500 mg/d, d1-d21) conversion regimen. Three weeks after chemotherapy, whether the operation was performed or not depending on re-evaluation and patient preference. The main outcome were adverse reactions, and the secondary outcome were objective remission rate (ORR), disease control rate (DCR), and overall survival (OS) rate. The follow-up period was up to May 2020. Results: A total of 27 patients with gastric cancer peritoneal metastasis were enrolled in this study. There were 13 males and 14 females, with a median age of 58 (30-68) years old. There were 9 cases of P1a, 5 cases of P1b, and 13 cases of P1c. There were 14 cases with 1-5 scores of PCI (peritoneal cancer index), and 13 cases with 6 scores or above. The incidence of adverse reactions was 100%. The most common adverse reactions were hematological events including leucopenia (70.4%, 19/27) and granulocytopenia (74.1%, 20/27). Non-hematological adverse events included fatigue (51.9%, 14/27) and oral mucositis (37.0%, 10/27). One patient was withdrawn due to grade 4 thrombocytopenia. Among 26 patients with feasible efficacy evaluation, 18 (69.2%) achieved partial remission, 3 (11.5%) achieved stable disease, and 5 (19.2%) disease progression. The objective remission rate was 69.2% (18/26) and the disease control rate was 80.8% (21/26). Fourteen patients underwent surgery, including 6 patients undergoing R0 resection with the R0 resection rate of 42.9% (6/14). The postoperative pathological response rate was 64.3% (9/14). The follow-up time was 12-40 months, and the follow-up rate was 100%. The 1-year OS rate was 65.2% and the survival time was (14.0±1.7) months. The 1-year OS rates of P1a/P1b group and P1c group were 81.8% and 42.0% respectively, whose difference was statistically significant (P=0.041). The 1-year OS rates of PCI 1-5 group and PCI ≥6 group were 67.3% and 38.5% respectively, whose difference was statistically significant (P=0.022). Conclusion: In the conversion treatment of gastric cancer peritoneal metastasis, the safety of apatinib combined with oxaliplatin and S-1 is acceptable, and this regimen shows a good short-term survival efficacy in patients with P1a/P1b and PCI of 1-5.
Aged
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Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
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Female
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Humans
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Male
;
Middle Aged
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Oxaliplatin
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Percutaneous Coronary Intervention
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Peritoneal Neoplasms/drug therapy*
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Prospective Studies
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Pyridines
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Retrospective Studies
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Stomach Neoplasms/drug therapy*
3.Application of D2-40/CD34-CK cocktail antibodies for colorectal cancer with insufficient lymph node harvest
Xian-Hua LIU ; Ying-Hao YU ; Xing-Feng QI ; Zai-Zeng WU ; Shun-Qi HU ; Xi-Sheng XIONG ; Juan XIANG ; Zhi-Yong ZHENG ; Li-Juan QU ; Xian-Zong YE
Chinese Journal of Clinical and Experimental Pathology 2019;35(1):14-18
Purpose To investigate the value of application of D2-40/CD34-CK cocktail antibodies by double immunohistochemical staining for assessment of lymphovascular invasion (LVI) and to determine its prognostic significance in colorectal cancer with insufficient lymph node harvest. Methods Specimens from 133 cases of colorectal cancer with less than 12 lymph nodes were selected. HE staining and double immunohistochemical staining of the cocktail antibodies were performed to compare the difference of the two methods in screening for LVI. The The relationship between LVI confirmed by cocktail antibody immunohistochemical staining and clinicopathological characteristics and overall survival (OS) of patients was analyzed. Results (1) The detection rates of cocktail antibody double immunohistochemical staining and HE staining for LVI were 42.9% (57/133) and 21.8% (29/133) with statistically significant difference (P < 0.001). (2) The presence of LVI confirmed by double staining was significantly associated with Dukes staging, depth of invasion, clinical stages, lymph node metastasis and tumor budding (P < 0.05). (3) The presence of LVI, the location and extent of LVI, and the number of tumor cells in thrombus ≥5.5 for cases with LVI ≤2 clusters, were significantly associated with OS (P < 0.05). Conclusion D2-40/CD34-CK cocktail antibodies double staining is superior to routine HE staining in assessing LVI. LVI is intimately associated with tumor stage, lymph nodes metastasis and tumor budding, and it is an independent prognostic factor for CRC patients. It should be a supplementary examination for these patients with insufficient lymph node harvest.
4.Effect of mean arterial pressure on arterial to end-tidal CO₂partial pressure difference during one-lung ventilation.
Zhao-Yan ZENG ; Jing YE ; Zhen-Long ZHAO ; Zai-Sheng QIN
Journal of Southern Medical University 2014;34(12):1834-1837
OBJECTIVETo study the effect of different mean arterial pressures (MAP) on arterial to end-tidal CO₂partial pressure difference [(Pa-et)CO₂] and the intrapulmonary shunt (Qs/Qt) in patients undergoing thoracic surgery during one-lung ventilation (OLV).
METHODSForty-two patients undergoing right-sided pulmonary lobectomy were allocated into group A with fluctuation of MAP (at 20 min after OLV) within ± 10% of the baseline (n=22) and group B with lowered MAP by 30% of the baseline (n=20). Arterial and venous blood gas analyses were recorded to calculate [(Pa-et)CO₂] and Qs/Qt at 20 min after induction with two-lung ventilation (T₁), 20 min after OLV (T₂), 30 min after recovery of normal blood pressure (T₃), and 20 min after recovery of two-lung ventilation (T₄).
RESULTSPetCO₂and PaCO₂were well correlated during two-lung ventilation and OLV in group A (P<0.05). In group B, [(Pa-et)CO₂] at T₂was significantly higher than that in group A, but PetCO₂was still correlated with PaCO₂(P<0.05). Qs/Qt increased more obviously in group B than in group A in T₂(P<0.05). Bo obvious correlation was found between the [(Pa-et)CO₂] and Qs/Qt during OLV.
CONCLUSIONPetCO₂reflects the dynamic changes of PaCO₂under normal blood pressure during OLV. In the hypotension period, when [(Pa-et)CO₂] increases and the correlation coefficient between PetCO₂and PaCO₂lowers, PetCO₂may not accurately reflect the changes of PaCO₂and blood gas analysis is warranted.
Arterial Pressure ; Blood Gas Analysis ; Carbon Dioxide ; analysis ; Humans ; Lung ; surgery ; Monitoring, Physiologic ; One-Lung Ventilation ; Oxygen ; analysis ; Thoracic Surgical Procedures
5.Multiple primary malignant neoplasms of three early cancer lesions: a case report.
Wan-jun ZHANG ; Xiao-ping QIAN ; Yu SHI ; Wen-sheng PAN ; Xiang XU ; Zai-yuan YE ; Liang-qin WU ; Takeshi TERAI ; Nobuhiro SATO ; Sumio WATANABE
Chinese Medical Journal 2011;124(8):1278-1280
Multiple primary malignant neoplasms (MPMNs) are rarely reported and it is important to give early diagnosis and proper therapy for these patients. Here reported a case of 62-year-old man with concomitant three early stage cancer lesions in upper gastrointestinal tract, all of which were detected by endoscopy. The first one was an IIc-type lesion at angular part of stomach under endoscopy, which was histologically confirmed to be a mucosal well-differentiated adenocarcinoma. The patient underwent a standard radical gastrectomy for the lesion after the failure of endoscopic treatment. The other two neoplasms were observed during follow-up and were indicated as early stage lesions by synthesizing information from endoscopy, endoscopic ultrasonography, computed tomography and biopsy. One displayed as a hyperemic patch (3 cm×4 cm in size) located at the part of esophagus 27 cm away from the incisor teeth and was proved to be moderately differentiated squamous cancer by histopathological examination. The other was an IIc-type lesion (3.0 cm×3.5 cm in size) located at the part of esophagus 36 cm away from the incisor teeth, and the biopsy result showed a poorly differentiated squamous carcinoma. Both the two lesions were treated with radical radiation because the patient refused surgery management. No recurrence of former lesions or occurrence of novel lesions were observed during post-treatment follow-up, suggesting radical radiation might be effective for this patient.
Gastrointestinal Neoplasms
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diagnosis
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Humans
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Male
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Middle Aged
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Neoplasms, Multiple Primary
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diagnosis
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Upper Gastrointestinal Tract
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pathology
6.Surgical treatment for primary gastrointestinal stromal tumors: a report of 73 cases.
Wei ZHANG ; Qin-shu SHAO ; Zai-yuan YE ; Zhong-sheng ZHAO ; Yue-dong WANG ; Yang-wen ZHU
Chinese Journal of Surgery 2009;47(2):98-101
OBJECTIVETo investigate the effects and prognosis of surgical treatment in primary gastrointestinal stromal tumors (GIST).
METHODSThe clinicopathological data of 73 patients with primary GIST underwent operation from April 1997 to December 2007 was retrospectively analyzed, and the prognosis was evaluated too.
RESULTSAmong the 73 cases, 68 cases received complete tumor resection, among which 12 cases underwent laparoscopic operation; while palliative resection and biopsy only were carried out in the other 5 cases. There was significant difference in survival rate between the two groups (P = 0.000). The 1-, 3-, 5-year survival rates of the 66 cases had been followed up was 91.0%, 78.2% and 74.1%, respectively. The malignancy risk grades of GIST was related to the survival rates on statistical analysis (P = 0.002). Significant differences were found in the survival rates between the patients with very low grade, low grade and high grade malignancy tumors (P = 0.012, 0.002).
CONCLUSIONSComplete tumor resection should be emphasized in primary GIST, and more attention should be paid to the initial surgical treatment. Extended surgical resection is required for tumors of higher malignancy risk. The indications of laparoscopic surgery in GIST should be selected with caution for tumor complete resection.
Adult ; Aged ; Aged, 80 and over ; Female ; Follow-Up Studies ; Gastrointestinal Stromal Tumors ; surgery ; Humans ; Male ; Middle Aged ; Prognosis ; Retrospective Studies ; Survival Analysis
7.Clinical study of gastrointestinal stromal tumors.
Wei ZHANG ; Zai-yuan YE ; Qin-shu SHAO ; Zhong-sheng ZHAO ; Yue-dong WANG ; Xiao-dong XU
Chinese Journal of Gastrointestinal Surgery 2009;12(4):378-381
OBJECTIVETo investigate the clinicopathological characteristics, surgical treatment and prognosis of gastrointestinal stromal tumors(GIST).
METHODSThe clinicopathological data of 84 patients with GIST undergone resection between April 1997 and June 2008 were analyzed retrospectively, and the prognosis was evaluated.
RESULTSOut of 84 cases, 42 tumors located in stomach, 24 in small intestine, 18 in other sites. Tumor sizes ranged from 0.5 to 25 cm(average 5.6 cm). Positive rate of CD117 expression determined by immunohistochemical methods was 96.4%. Seventy-nine cases underwent complete tumor resection, while 5 cases received palliative resection or biopsy. Seventy-eight patients were followed up and their 1-, 3-, 5-year survival rates were 92.0%, 79.2%, 72.0% respectively. The Fletcher's classification of malignancy risk groups for GIST was related to the survival rates(P=0.001). The differences of survival rate among very low risk group, low risk group and high-risk group were significant(P=0.003, P=0.000).
CONCLUSIONSComplete tumor resection in the initial operation of GIST should be emphasized. The Fletcher's classification of malignancy risk groups for GIST is related to the survival rate. Extended surgical resection is required for GIST of higher malignancy risk.
Adult ; Aged ; Aged, 80 and over ; Female ; Gastrointestinal Stromal Tumors ; mortality ; pathology ; surgery ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Survival Rate
8.Relationship between the expression of vascular endothelial growth factor, fms-like tyrosine kinase-1 and biological behavior in gastric carcinoma.
Yuan-yu WANG ; Zai-yuan YE ; Zhong-sheng ZHAO ; Hou-quan TAO
Chinese Journal of Gastrointestinal Surgery 2007;10(3):269-273
OBJECTIVETo investigate the relationship between the expression of vascular endothelial growth factor (VEGF) and fms-like tyrosine kinase (Flt-1) mRNA and tumor progression, microvessel density and survival time in gastric carcinoma.
METHODSIn situ hybridization and immunohistochemical techniques were used to detect the gene expression of VEGF, Flt-1 and CD34 in 118 gastric carcinoma specimens.
RESULTSIn situ hybridization revealed that positive expression rates of VEGF and Flt-1 mRNA in gastric carcinoma were 54.24% and 55.9% respectively. There was a significant correlation between the expression of VEGF and Flt-1 mRNA and growth pattern, the depth of tumor invasion, vessel invasion, lymph node and distant metastasis (P < 0.01). The mean tumor microvessel densities (MVD) in patients of stage T3-T4 or those with vessel invasion, lymph node and distant metastases were significantly higher than those of stage T1-T2 and without metastases (P < 0.01). MVD value was correlated with the expression levels of VEGF and Flt-1 mRNA (P < 0.01). The mean survival time and survival rate of patients with positive mRNA expression and mean MVD value >or=54.9/mm2 were significantly lower than those of patients with negative mRNA expression and mean MVD value < 54.9/mm2.
CONCLUSIONSThe expression of VEGF and Flt-1 can promote tumor angiogenesis and contribute to tumor invasion and metastasis in gastric carcinoma. VEGF and Flt-1 may serve as valuable indicators of biological behaviour, prognosis and target of gene therapy in gastric carcinoma.
Adult ; Aged ; Female ; Humans ; In Situ Hybridization ; Lymphatic Metastasis ; Male ; Middle Aged ; Neoplasm Metastasis ; Neoplasm Staging ; Prognosis ; RNA, Messenger ; genetics ; Stomach Neoplasms ; metabolism ; pathology ; Vascular Endothelial Growth Factor A ; metabolism ; Vascular Endothelial Growth Factor Receptor-1 ; metabolism
9.Rule of lymph node metastasis in colorectal cancer and its affecting factors.
Shi-liang TU ; Zai-yuan YE ; Gao-li DENG ; Zhong-sheng ZHAO ; Quan-jin DONG ; Bo-an ZHENG ; Li-ping DING ; Hong-feng CAO
Chinese Journal of Gastrointestinal Surgery 2007;10(3):257-260
OBJECTIVETo investigate the rule of lymph node metastasis in colorectal cancer and its affecting factors, and to provide clues for clinical diagnosis and treatment of colorectal cancer patients.
METHODSThe clinical data of 1166 cases of colorectal cancer receiving surgical resection were analyzed retrospectively.The relationships between clinicopathologic variables and lymph node metastases were evaluated by crosstabs and logistic regression in SPSS 10.0 for windows.
RESULTSThe rate of lymph node metastasis in colorectal cancer was 49.7%. After entering crosstabs estimation, gender and tumor site were not significantly correlated with lymph node metastasis in colorectal cancer(chi2=1.46, r=0.035, P>0.05 and chi2=3.86, r=0.012, P>0.05). Age, tumor size, the massive type of the tumor, the differentiating degree of the tumor, histology type and the depth of tumor invasion were proved to be independent factors influencing the lymph node metastasis in colorectal cancer (chi2 =13.1, r=0.064, P<0.05 and chi2=77.161, r=0.245, P<0.01 and chi2=144.831, r=0.341, P<0.01 and chi2=128.310, r=0.318, P<0.01 and chi2=120.418, r=0.319, P<0.01 and chi2=227.287, r=0.434, P<0.01). After entering logistic regression estimation, the correlativity of risk factor of lymph node metastasis in colorectal cancer: the depth of tumor invasion > the massive type of the tumor>the differentiating degree of the tumor > tumor size. Preoperative blood serum CEA level was significantly correlated with lymph node metastasis (chi2=509.599, r=0.661, P<0.01).
CONCLUSIONThe depth of tumor invasion is the most risk factor of lymph node metastasis in colorectal cancer. Preoperative high level of blood serum CEA indicates the occurrence of lymph node metastasis.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Carcinoembryonic Antigen ; Colorectal Neoplasms ; blood ; pathology ; Female ; Humans ; Logistic Models ; Lymphatic Metastasis ; pathology ; Male ; Middle Aged ; Neoplasm Invasiveness ; Neoplasm Staging ; Retrospective Studies ; Risk Factors ; Young Adult
10.Study of prophylactic intra-iliac and hepatic arterial infusion chemotherapy against pelvic recurrence and liver metastasis after radical resection for rectal cancer.
Shi-liang TU ; Jian-hua YUAN ; Gao-li DENG ; Zhong-sheng ZHAO ; Ting-yang HU ; Quan-jin DONG ; Hong-feng CAO ; Zai-yuan YE
Chinese Journal of Gastrointestinal Surgery 2007;10(2):149-152
OBJECTIVETo study the effects of prophylactic intra-iliac and hepatic arterial infusion chemotherapy on pelvic recurrence and liver metastasis after radical resection for rectal cancer.
METHODSEighty-four rectal cancer patients,undergone radical resection on Dukes stage B or C,were randomly assigned to postoperative intra-iliac and hepatic arterial infusion chemotherapy group(group I) and routine vein chemotherapy group(group II). Five-year survival and recurrence rates were compared between the two groups.
RESULTSAmong the 84 rectal cancer patients with radical resection, the 5-year liver metastasis and pelvic recurrence rates were 30.2% (13/43) and 18.6% (8/43) respectively in group II, 17.1% (7/41) and 9.8% (4/41) in group I, the difference was significant between 2 groups (chi(2)=4.31, P<0.05). The mean tumor-free survival time was 26.2 months in group I and 15.8 months in group II (t=5.05, P<0.01), the difference was significant (t=5.05, P<0.01). The five-year survival rate in group I (65.9%) was significantly higher than that in group II (56.5%) (u=8.86, P<0.01). Cox multivariate analysis showed that, compared with those in group II, the relative risks of pelvic recurrence and liver metastasis in group I decreased 20% (coefficient of relative risk: 0.7959), and the five-year mortality also decreased 20% (coefficient of relative risk: 0.8034).
CONCLUSIONProphylactic intra-iliac and hepatic arterial infusion chemotherapy can reduce the rates of pelvic recurrence and liver metastasis after radical resection of rectal cancer.
Adult ; Chemotherapy, Adjuvant ; Chemotherapy, Cancer, Regional Perfusion ; Female ; Hepatic Artery ; Humans ; Iliac Artery ; Liver Neoplasms ; prevention & control ; secondary ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; prevention & control ; Pelvic Neoplasms ; prevention & control ; secondary ; Pelvis ; pathology ; Rectal Neoplasms ; drug therapy ; pathology ; Survival Rate

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