OBJECTIVE: This study assessed the outcomes of using vascular closure devices following percutaneous transfemoral endovascular procedures in the patients who were treated with heparin, abciximab or thrombolytics (urokinase or t-PA) during the procedures. MATERIALS AND METHODS: From March 28, 2003 to August 31, 2004, we conducted a prospective and randomized study in which 1,676 cases of 1,180 patients were treated with one of the two different closure devices (the collagen plug device was Angio-SealTM; the suture-mediated closure device was The Closer STM) at the femoral access site after instituting percutaneous endovascular procedures. Among the 1,676 cases, 108 cases (the drug group) were treated with heparin only (n = 94), thrombolytics only (n = 10), heparin and thrombolytics (n = 3), or abciximab and thrombolytics (n = 1) during the procedures; 1,568 cases (the no-drug group) were treated without any medication. We compared the efficacy and complications between the two groups. Of the drug group, 42 cases underwent arterial closures with the collagen plug devices and 66 cases underwent arterial closures with the suture-mediated closure devices. We also compared the efficacy and complications between these two groups. RESULTS: The immediate hemostasis rates were 92.9% (1,456/1,568) in the no-drug group and 91.7% (99/108) in the drug group. Early complications occurred in four cases of the drug group. These included two episodes of rebleeding with using the Closer S, which required manual compression for at least 10 minutes, and two episodes of minor oozing with using one Angio-Seal and one Closer S, which required two hours of additional bed rest. There was no late complication. So, the total success rates were 90.8% (1,423/1,568) in the no-drug group and 88.0% (95/108) in the drug group. These results were not significantly different between the two groups (p = 0.34). In the drug group, the difference of the successful hemostasis rate between the collagen plug devices and the suture-mediated devices was also not statistically significant (92.9% vs. 84.8%, respectively; p = 0.21). CONCLUSION: Arterial closure of the femoral access site with using vascular closure devices is both safe and effective, even in the patients who received heparin, abciximab or thrombolytics.
Sutures ; Prospective Studies ; Postoperative Complications ; Middle Aged ; Male ; Immunoglobulin Fab Fragments/pharmacology/*therapeutic use ; Humans ; Hemostatic Techniques/*instrumentation ; Hemostasis/*drug effects ; Fibrinolytic Agents/pharmacology/*therapeutic use ; Femoral Artery/*surgery ; Female ; Collagen ; Anticoagulants/pharmacology/*therapeutic use ; Antibodies, Monoclonal/pharmacology/*therapeutic use

We systematically reviewed the literature on the infectious risk in patients treated with tumour necrosis factor blocking agents (TNF-BA) undergoing surgery: we searched the Medline (PubMed) and the online archive from the Annual European Congress of Rheumatology and the Annual Scientific Meeting of the American College of Rheumatology. Of total 1259 reports, 14 were finally analysed. With one exception all were retrospective. Four of 6 studies compared patients on TNF-BA with those not receiving TNF-BA, and found an increased risk of infection with the use of TNF-BA. None of the other studies which compared continued with discontinued treatment at surgery found an increased risk of infection, when the medication was continued perioperatively. In conclusion, while in theory there is an increased risk of infections when TNF-BA are administered perioperatively, the available literature does not necessarily support this. It rather appears that patients receiving TNF-BA are a priori at a higher risk of postoperative infections. Scheduling surgery at the end of the drug interval and adding one "safety" week prior to surgery should be an acceptable plan in daily clinical practice.
Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antirheumatic Agents/therapeutic use ; Arthritis/*surgery ; Humans ; Immunoglobulin Fab Fragments/therapeutic use ; Immunoglobulin G/therapeutic use ; *Infection ; Perioperative Period ; Polyethylene Glycols/therapeutic use ; Postoperative Complications/prevention & control ; Postoperative Period ; Receptors, Tumor Necrosis Factor/therapeutic use ; Retrospective Studies ; Risk ; Tumor Necrosis Factor-alpha/*antagonists & inhibitors

PURPOSE: We aimed to investigate whether combination therapy using intracoronary (IC) abciximab and aspiration thrombectomy (AT) enhances myocardial perfusion compared to each treatment alone in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). MATERIALS AND METHODS: We enrolled 40 patients with STEMI, who presented within 6 h of symptom onset and had Thrombolysis in MI flow 0/1 or a large angiographic thrombus burden (grade 3/4). Patients were randomly divided into 3 groups: 10 patients who received a bolus of IC abciximab (0.25 mg/kg); 10 patients who received only AT; and 20 patients who received both treatments. The index of microcirculatory resistance (IMR) was measured with a pressure sensor/thermistor-tipped guidewire following successful PCI. Microvascular obstruction (MVO) was assessed using cardiac magnetic resonance imaging on day 5. RESULTS: IMR was lower in the combination group than in the IC abciximab group (23.5+/-7.4 U vs. 66.9+/-48.7 U, p=0.001) and tended to be lower than in the AT group, with barely missed significance (23.5+/-7.4 U vs. 37.2+/-26.1 U, p=0.07). MVO was observed less frequently in the combination group than in the IC abciximab group (18.8% vs. 88.9%, p=0.002) and tended to occur less frequently than in the AT group (18.8% vs. 66.7%, p=0.054). No difference of IMR and MVO was found between the IC abciximab and the AT group (66.9+/-48.7 U vs. 37.2+/-26.1 U, p=0.451 for IMR; 88.9% vs. 66.7%, p=0.525 for MVO, respectively). CONCLUSION: Combination treatment using IC abciximab and AT may synergistically improve myocardial perfusion in patients with STEMI undergoing primary PCI (Trial Registration: clinicaltrials. gov Identifier: NCT01404507).
Adolescent ; Adult ; Aged ; Angioplasty, Balloon, Coronary/*methods ; Antibodies, Monoclonal/*therapeutic use ; Female ; Humans ; Immunoglobulin Fab Fragments/*therapeutic use ; Male ; Middle Aged ; Myocardial Infarction/*drug therapy/*surgery ; Thrombectomy/*methods ; Young Adult

The use of tumor antigen specific antibody for the delivery of therapeutic agents offers the possibility of targeting therapy with reduced toxicity to normal tissues compared to conventional treatments. In previous work, the human-mouse chimeric antibody fragment Fab' directed against CD20 was constructed from the new anti-CD20 antibody HI47 (a mouse IgG3, K). The chimeric antibody fragment Fab' could reduce its antigenicity, but the yield, quality and affinity of chimeric antibody fragment Fab' restrict its use. To improve affinity of chimeric antibody fragment Fab', a new phasmid pYZcpp3, which expresses chimeric antibody fragment F(ab')2, was constructed by adding a sequence encoding a small peptide, (CPP)3, to C-terminus of heavy chain constant region of chimeric antibody fragment Fab'. Using the pYZcpp3 to transform E. coli. 16c9, the genetically engineered bacteria 10916# was obtained. 10916# can secret the soluble chimeric antibody fragment Fab' and F(ab')2 into periplasmic. The yield was up to 360 mg/L with the percent of F(ab')2 up to 45% in 19L fermentor by the high density fermentation technology. Without denaturation and renaturation, the F(ab')2 has possessed the native three-dimensional structure. The purity of F(ab')2 was more than 90% after the purification of protein G affinity chromatography and S200 size exclusion chromatography. The F(ab')2 could distinguish and bind to Raji cells (CD20+) by FACS. F(ab')2 could inhibit the proliferation of Raji cells in vitro by MTT, IC50 was 22.8 microg/mL. HI47 and its chimeric fragments F(ab')2 induced a significant level of apoptosis (23.5%, 20.8%, respectively), independent of any cross-linking agents, in Raji cells after 24 h incubation. The chimeric antibody fragment F(ab')2 directed against CD20 is possible to apply to tumor therapy in clinic in the future.
Antigens, CD20 ; immunology ; Apoptosis ; Escherichia coli ; genetics ; Fermentation ; Humans ; Immunoglobulin Fab Fragments ; chemistry ; genetics ; isolation & purification ; therapeutic use ; Lymphoma, B-Cell ; therapy ; Plasmids ; Recombinant Fusion Proteins ; biosynthesis ; isolation & purification ; therapeutic use

PURPOSE: This study was designed as a multicenter, randomized, open-label study to evaluate the efficacy and tolerability of Clotinab(TM). We expected to obtain same results as with ReoPro(R) in improving ischemic cardiac complications in high-risk patients who were about to undergo percutaneous coronary intervention (PCI). PATIENTS AND METHODS: Patients of 19-80 years of age with acute coronary syndrome (ACS) who were about to undergo PCI were enrolled. After screening and confirmation of eligibility, patients were randomly assigned to different groups. Clotinab(TM) was given to 84 patients (58.7+/-10.6 years, M:F=68:16)and ReoPro(R)(59.0+/-10.5 years, M:F=30:10) was given to 40 patients before PCI. The primary efficacy endpoint was the onset of major adverse cardiac event (MACE) within 30 days from day 1. The tolerability endpoints were assessed based on bleeding, thrombocytopenia, change in Hb/Hct, human antichimetric antibody development, and adverse events. RESULTS: The number of Clotinab(TM) patients experiencing MACE was 0 out of 76 per protocol (PP) patients. The MACE rate was 0%, and its 95% exact CI was [0.00-4.74%]. A major bleeding event developed in 3 patients in the ReoPro(R) group. The probability of MACE onset in Clotinab(TM) was estimated to be less than 5%. There was no clinically significant result in tolerability variables. CONCLUSION: Clotinab(TM) is an effective and safe medicine in preventing ischemic cardiac complications for high-risk patients who will receive PCI.
Acute Coronary Syndrome/surgery ; Adult ; Aged ; Aged, 80 and over ; *Angioplasty, Transluminal, Percutaneous Coronary ; Antibodies, Monoclonal/adverse effects/*therapeutic use ; Drugs, Investigational/adverse effects/therapeutic use ; Female ; Humans ; Immunoglobulin Fab Fragments/adverse effects/*therapeutic use ; Male ; Middle Aged ; Myocardial Ischemia/prevention & control ; Platelet Aggregation Inhibitors/adverse effects/*therapeutic use ; Platelet Glycoprotein GPIIb-IIIa Complex/*antagonists & inhibitors ; Prospective Studies ; Risk Factors ; Treatment Outcome

OBJECTIVETo evaluate the feasibility and efficacy of radioimmunotherapy with 131 I-labeled humanized anti-HBsAg Fab (131 I-anti-HBsAg Fab) combined with 131 I-labeled anti-nucleus antigen monoclonal antibody chTNT (131 I-chTNT) in nude mice bearing human hepatocellular carcinoma.

METHODSNude mice bearing subcutaneous human hepatocellular carcinoma xenografts were treated by intratumoral injection of 131 I-anti-HBsAg Fab and/or 131 I-chTNT, and the changes in the tumor size and alterations in the radioactivity concentration in the tumor and non-tumor tissues were observed.

RESULTSThe tumor inhibition rate in mice treated with 131 I-anti-HBsAg Fab combined with 131 I-chTNT (73.09%) was significantly higher than that in mice treated with 131 I-anti-HBsAg Fab (47.8%) or 131 I-chTNT (54.26%) alone. Combined treatment also resulted in significantly higher tumor-to-normal radioactivity concentration ratios than the treatment with the single agents.

CONCLUSIONIntratumoral injection with 131 I-labeled monoclonal antibodies can increase the radioactivity concentration in the tumor and enhance the efficacy of the radioimmunotherapy in nude mice bearing human hepatocellular carcinoma.

Animals ; Antibodies, Antinuclear ; immunology ; Antibodies, Monoclonal ; therapeutic use ; Carcinoma, Hepatocellular ; pathology ; radiotherapy ; Cell Line, Tumor ; Hepatitis B Surface Antigens ; immunology ; Humans ; Immunoconjugates ; therapeutic use ; Immunoglobulin Fab Fragments ; immunology ; Iodine Radioisotopes ; therapeutic use ; Liver Neoplasms, Experimental ; pathology ; radiotherapy ; Mice ; Mice, Nude ; Radioimmunotherapy ; methods ; Treatment Outcome ; Xenograft Model Antitumor Assays