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Shaoliang Chen

Publications and source records attributed to Shaoliang Chen.

8 recordsLinked to original sources
PubMed2026

Clopidogrel Versus Dual-Antiplatelet Therapy for Long-Term Maintenance After Coronary Stenting in Ischemic and Bleeding Birisk Patients With Acute Coronary Syndromes and Diabetes: A Prespecified Subgroup Analysis of the OPT-BIRISK Trial.

BACKGROUND: Among patients with acute coronary syndromes at both high bleeding and ischemic risk (birisk), extended clopidogrel monotherapy after 9 to 12 months of dual-antiplatelet therapy reduces bleeding without increasing ischemia. Whether this benefit extends to birisk patients with diabetes is unknown. METHODS: This prespecified subgroup analysis of the OPT-BIRISK (Optimal Antiplatelet Therapy for High Bleeding and Ischemic Risk Patients) trial included birisk patients with acute coronary syndrome who had completed 9 to 12 months of dual-antiplatelet therapy after percutaneous coronary intervention. Patients were then randomized 1:1 to 9 months of clopidogrel plus placebo versus clopidogrel plus aspirin. Outcomes were compared by diabetes status. The primary end point was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding at 9 months after randomization. The key secondary end point was major adverse cardiac and cerebral events, defined as a composite outcome of all-cause death, myocardial infarction, stroke, or clinically driven revascularization. RESULTS: Of 7758 patients, 4072 (52.5%) had diabetes. Clopidogrel monotherapy decreased Bleeding Academic Research Consortium type 2, 3, or 5 bleeding (2.1% versus 3.2%; hazard ratio [HR], 0.66 [95% CI, 0.45-0.97]) with no increase in major adverse cardiac and cerebral events (2.9% versus 3.6%; HR, 0.79 [95% CI, 0.56-1.12]) compared with clopidogrel plus aspirin in patients with diabetes. Outcomes were consistent in patients without diabetes, with no significant interactions by diabetes status. CONCLUSIONS: In birisk patients with acute coronary syndrome who were stable on dual-antiplatelet therapy with clopidogrel plus aspirin for 9 to 12 months after percutaneous coronary intervention, clopidogrel monotherapy for an additional 9 months reduced clinically relevant bleeding without increasing ischemic events compared with continued dual-antiplatelet therapy, irrespective of diabetes status. REGISTRATION: URL: https://clinicaltrials.gov; Unique identifier: NCT03431142.

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PubMed2006

Endovascular stent-grafts treatment in acute aortic dissection (type B): clinical outcomes during early, late, or chronic phases.

OBJECTIVE: This is a prospective study to evaluate the clinical outcomes of endovascular repair in patients with different phases of type B aortic dissection. BACKGROUND: Endovascular repairing with stent-grafts is an innovative technique for type B acute aortic dissection. There is no previous study regarding outcomes in different time phases. METHODS: Sixty-two patients underwent endovascular stent-grafts. There were 23 in the early phase (<24 hr), 20 in the late phase (>or=24 hr to 2 weeks), and 19 in the chronic phase (>2 weeks). RESULTS: The early phase group had the lowest ratio of stent-grafts to patient and the shortest stent-graft length. The chronic phase group had the largest diameter of false lumen. The technical success rate was 100%; no patient died within hospital. Three patients died within 30 days, with the same death rate in every group. Compared with acute patients, the chronic group had a higher volume of contrast, a higher creatinine post-procedure, and a higher incidence of contrast-induced nephropathy. Multiple regression analysis demonstrated that creatinine and endoleak were independent factors in predicting late death (95% CI, 3.4-26%, P < 0.01). The overall cardiovascular event-free survival was 88.9% +/- 2.1% at 30 days, 87.2% +/- 4.1% at 1 year, and 81.4% +/- 6.3% at 2 years. CT angiography identified the complete or partial thrombosis of the false lumen to be 95.7%. CONCLUSIONS: Endovascular repairing with stent-graft is safe, feasible, and able to treat type B aortic dissection in all phases. However, chronic renal dysfunction was an independent factor which contributed to a lower survival rate of chronic phase patients.

Acute Disease↗
PubMed2006

131I-chTNT radioimmunotherapy of 43 patients with advanced lung cancer.

UNLABELLED: The treatment of advanced lung cancer remains a major challenge in clinical medicine, justifying an urgent need for new therapeutic approaches. In a rather unique international collaboration, 43 patients with advanced lung cancer were treated using iodine-131-labeled tumor necrosis therapy chimeric antibody (131I-chTNT). METHODS: Patients were treated either with intravenous (i.v.) infusion (n = 22), intratumoral injection using a computer tomography (CT)-guided catheter (n = 16), or combination i.v. and intratumoral infusion (n = 5). All patients, regardless of route of administration, received 2 doses of 131I-chTNT on days 1 and 14. RESULTS: The results showed that of those patients receiving i.v. injection alone, 2 achieved partial response (PR) (9%), 16 had stable disease (73%), and 4 progressed (18%). Of those patients receiving intratumoral injection only, 1 had a complete response (CR) (6%), 8 achieved PR (50%), 7 had stable disease (44%), and none (0%) progressed. Finally, of those patients receiving both i.v. and intratumoral administration, 1 had a CR (20%), 1 achieved PR (20%), 2 had stable disease (40%), and 1 (20%) showed progression. CONCLUSIONS: These promising results demonstrate that sufficient doses of radiolabeled antibody can be safely delivered to tumors to cause significant therapeutic effects in advanced lung cancer.

Adult↗
PubMed2006

Intracoronary transplantation of autologous bone marrow mesenchymal stem cells for ischemic cardiomyopathy due to isolated chronic occluded left anterior descending artery.

BACKGROUND: Studies have revealed that stem cells improve clinical outcomes in patients with severe ischemic cardiomyopathy, but the role of bone marrow mesenchymal stem cells is not well understood. METHODS: Twenty-two patients received an implantation of autologous bone marrow mesenchymal stem cell therapy; another 23 patients were placed in a control group after percutaneous coronary intervention (PCI) of the chronically occluded left anterior descending artery. RESULTS: Reversible defect in the cell therapy group decreased from 16 +/- 8% at baseline to 6 +/- 2% at 12 months (p < 0.05), and this improvement was maintained throughout the entire follow-up period. Compared to the control group (5 +/- 3 METS at baseline vs. 5 +/- 3 METS at 3 months; p = NS), the level of exercise tolerance improved significantly 3 months after cell therapy (5 +/- 2 METS at baseline vs. 7 +/- 3 METS at 3 months; p < 0.05). The NYHA function class also improved in the cell therapy group (2.7 +/- 0.8 at baseline vs. 1.6 +/- 0.1 at 3 months; p < 0.05). PCI alone did not increase left ventricular ejection fraction (LVEF), but following stem cell therapy, the LVEF increased significantly from 26 +/- 6% at baseline to 37 +/- 9% at 3 months (p < 0.05). CONCLUSION: Intracoronary transplantation of autologous bone marrow mesenchymal stem cells improved clinical outcomes in patients with chronic ischemic cardiomyopathy.

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PubMed2005

Pivotal study of iodine-131-labeled chimeric tumor necrosis treatment radioimmunotherapy in patients with advanced lung cancer.

PURPOSE: Tumor necrosis treatment (TNT) uses degenerating tumor cells and necrotic regions of tumors as targets for radioimmunotherapy. Previous studies in animal tumor models and clinical trials have demonstrated that when linked to the therapeutic radionuclide iodine-131, recombinant chimeric TNT antibody ((131)I-chTNT) can deliver therapeutic doses to tumors regardless of the location or type of malignancy. Therapeutic efficacy and toxicity of (131)I-chTNT in advanced lung cancer patients were studied in this pivotal registration trial. PATIENTS AND METHODS: Patients with advanced lung cancer were treated with systemic or intratumoral injection of (131)I-chTNT in eight oncology centers in China. The objective response rate (ORR) was assessed as the primary end point. RESULTS: All 107 patients who were entered onto the study and completed therapy had experienced treatment failure after prior radiotherapy or chemotherapy a mean of three times. The results showed an ORR of 34.6% (complete response, 3.7%; partial response, 30.8%; no change, 55.1%; and progressive disease, 10.3%) in all patients and 33% in 97 non-small-cell lung cancer patients. A biodistribution study demonstrated excellent localization of the radioactivity in tumors in both systemically and intratumorally injected patients. The most obvious adverse side effect was mild and reversible bone marrow suppression. CONCLUSION: Radioimmunotherapy with (131)I-chTNT was well tolerated and can be used systemically or locally to treat refractory tumors of the lung.

Adult↗
PubMed2004

Phase I clinical trial of targeted therapy using 131I-Hepama-1 mAb in patients with hepatocellular carcinoma.

OBJECTIVES: The aim of this study was to evaluate the response- and treatment-related toxicity for patients with unresectable hepatocellular carcinoma (HCC) treated with 131I-Hepama-1 mAb (DGDK-1). MATERIALS AND METHODS: Seeking approval for the use of 131I-hepama-1 mAb, 32 patients with unresectable HCC were divided into 5 groups to take part in the Phase I clinical trial study. Systemic reactions and acute toxicity were evaluated weekly for at least 45 days following treatment with an intravenous injection of 10 mg of antibody radiolabeled with 740-3700 MBq (20-100 mCi), divided into 5 groups. RESULTS: No patients demonstrated any evidence of fever, severe side effects, or impairments of important organs, such as the lung, liver, and heart. During, and for 45 days after, the treatment, most of their routine examinations of blood, functions of liver and kidneys, and the thyroid hormone were all normal. Hypothyroidism was not observed during the course of monitoring. None of the 32 patients developed human antimurine antibodies (HAMA) within 15 days of therapy; however, 82% of patients were HAMA-positive by 45 days of therapy. According to the pilot study of prognosis, survival from the start of radioimmunotherapy (RIT) was a median of 4 months, and the 1-year survival rate was 31%. The median survival time of 15 patients without metastases was 10 months, and the 1-year survival rate was 60%. Of alpha-fetoprotein (AFP)-positive patients, 75% of AFP levels decreased by at least 50% or became normal. Of all patients, 84% showed an improved Eastern Cooperative Oncology Group (ECOG) performance status. CONCLUSION: This phase I clinical trial demonstrated that it was safe to use 131I-hepama- 1 mAb by peripheral intravenous administration. The recommended dose of DGDK-1 for clinical use is 1480-2960 MBq/10 mg.

Adult↗
PubMed2002

Cutting balloon angioplasty for treatment of coronary in-stent restenosis: immediate results and 6-month outcomes.

OBJECTIVE: To determine the mid-term effects of cutting balloon angioplasty (CBA) on in-stent restenosis. METHODS: A total of 69 patients with in-stent restenosis were divided into 2 groups randomly: cutting balloon angioplasty and plain old balloon angioplasty. The mechanisms of restenosis and dilation results were determined by quantitative coronary angiography and intravascular ultrasound. Follow-up was performed. RESULTS: The procedural success rate was 100% without death and acute closure. One patient experienced dissection at the distal end of the stent and needed another stent. The mean follow-up period was 6.7 +/- 2.3 months. The final re-restenosis rate was 15% and 18% at 3 months and 6 months respectively, markedly lower than after plain old balloon angioplasty (38% and 43%). Acute gain by intravascular ultrasound (IVUS) was 1.72 +/- 0.52 mm after cutting balloon angioplasty, higher than 1.15 +/- 0.54 mm after plain old balloon angioplasty. The lumen diameter late loss in the cutting balloon group was 0.26 +/- 0.05 mm and 0.38 +/- 0.06 mm at 3 months and 6 months respectively, significantly lower than for those in conventional balloon group (0.78 +/- 0.19 mm and 0.89 +/- 0.16 mm, respectively, P < 0.001). As shown by IVUS, the main mechanism of cutting balloon angioplasty was marked reduction of plaque area without significant increase of vessel area (less vessel trauma). CONCLUSION: Cutting balloon angioplasty is feasible and effective for the treatment of in-stent restenosis with less vessel trauma.

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