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Subcutaneous Trastuzumab (Herceptin<sup>®</sup>): A UK Time and Motion Study in Comparison with intravenous Formulation for the Treatment of Patients with HER2-Positive Early Breast Cancer

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Advances in Breast Cancer Research 2013年第4期2卷 133-140页

作者： Russell Burcombe Steve Chan Richard Simcock Kunal Samanta Fran Percival Peter Barrett-Lee Brighton and Sussex University Hospitals NHS Trust Brighton UK Maidstone and Tunbridge Wells NHS Trust Maidstone UK Nottingham University Hospitals NHS Trust Nottingham UK pH Associates Ltd. Marlow UK Roche Products Ltd. Welwyn Garden City UK Velindre Cancer Centre Cardiff UK

Aim: Firstly, to quantify active healthcare professional (HCP) time and costs associated with subcutaneous (SC) administration of trastuzumab (Herceptin?) compared with the standard intravenous infusion (IV) in the treatment of patients with HER2-positive early breast cancer within the adjuvant PrefHer trial setting;secondly, to measure patient time in the care unit and patient infusion chair time for both routes of administration. Methods: A UK multi-centre prospective, observational Time and Motion study was conducted alongside the PrefHer trial (ClinicalTrials.gov id: NCT01401166). Trained observers measured the duration of each SC and IV related task that HCPs undertook and recorded patient time in the chemotherapy unit and infusion chair. The type and quantity of medical consumables used with each route of administration were also collected. Twenty-four patient episodes were recorded (12 SC, 12 IV). Mean total administration time was calculated as the mean sum of task times, both for IV and SC formulations. The mean cost of each route of administration was calculated as the mean cost of HCP time plus the mean cost of consumables used. HCP time was costed using Personal Social Services Research Unit. Consumables were costed using hospital pharmacy data and online sources. Results: Mean active HCP time for IV administration was 92.6 minutes compared with 24.6 minutes for SC administration. The mean cost for IV preparation and administration was ￡144.96 (￡132.05 of HCP time and ￡12.92 of consumables) versus ￡33.15 (￡31.99 of HCP time and ￡1.17 of consumables) for SC administration. Mean time spent in the care unit and in the infusion chair was 94.5 minutes and 75 minutes respectively for IV, and 30.3 minutes and 19.8 minutes for SC. SC administration of trastuzumab could translate to a time saving of 68 minutes (versus IV) with a total cost saving of ￡111.81 per patient episode. This equates to a potential saving of ￡2012.58 over a full course of adjuvant treatment (18 cycles). Conclusion: Substituting IV infus

关键词： Trastuzumab Breast Neoplasms Administration Subcutaneous Administration intravenous

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Economic Analysis of Port and PICC in Long-term intravenous Administration for Malignant Tumor Patients in Chinese Oncology Hospital Setting

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World Journal of Integrated Traditional and Western Medicine 2019年第2期5卷 52-57页

作者：陶立波靳勇蒋理添陈丽萍白旭明王剑 Institute of Health Economic Research School of Pharmacy Sun Yat-sen Univertsity Beijing Medical and Health Economic Research Association The Second Affiliated Hospital of Soochow University Sun Yat-sen University Cancer Center

OBJECTIVE: To calculate and compare the cost of Port and PICC's application in long-term intravenous administration, and to support the decision making of hospital manager. METHODS: Literature review and patient survey in 2 oncology centers in China were carried out to investigate the cost and impact of Port and PICC for patients. The cost at different time of intravenous administration was calculated and compared. One-way sensitivity analysis was performed and tornado graph was drawn. RESULTS: Direct cost of Port at 0.5, 1, 1.5, and 2 years were7442, 8005, 8553, and 9131 CNY, and 4700, 9399, 14032, 18799 CNY for PICC respectively. Direct & indirect cost at 0.5, 1, 1.5, and 2 years were 9291, 11704, 14101, 16529 CNY for Port and 9697, 19393, 29023, 38787 CNY for PICC. Sensitivity analysis showed that productivity loss and device maintenance cost were the most in?uential factors to the result. CONCLUSION: Port had higher cost in short term and less in long term compared with PICC. Patients expected to get intravenous administration more than 0.5 year should use Port if both direct and indirect costs were included.

关键词： Long-term intravenous administration Implantable central venous port Peripherally inserted central catheter Cost

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Effect of high dose intravenous ascorbic acid on the level of inflammation in patients with rheumatoid arthritis

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Modern Research in Inflammation 2012年第2期1卷 26-32页

作者： N. Mikirova A. Rogers J. Casciari P. Taylor Riordan Clinic Wichita USA

Rheumatoid arthritis (RA) is a major inflammatory joint disease that causes cartilage destruction, bone erosions, and joint destruction. Oxidative stress is elevated in RA patients implying reactive oxygen species (ROS) are possible mediators of tissue damage. ROS trigger a cascade of events through nuclear factors’ activation (NF-kappa B), which up-regulates gene expression of pro-inflammatory cytokines that mediate the immune responses causing inflammation. As ascorbic acid can reduce oxidative stress, decrease production of pro-inflammatory cytokines, and suppress the activation of NF-kappa B, we suggest that millimolar concentration of ascorbic acid may be useful in RA treatment. In our study we analyzed the effect of intravenous vitamin C (IVC) treatment on eleven subjects with RA. Our data suggest that IVC therapy with dosages of 7.5 g - 50 g can reduce inflammation. The level of inflammation as measured by C-reactive protein levels was decreased on average by 44%. Based on our pilot study, we hypothesize that IVC therapy can be a useful strategy in treating RA.

关键词： Rheumatoid Arthritis Inflammation C-Reactive Protein intravenous Vitamin C

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A case of Bickerstaff brainstem encephalitis successfully treated with intravenous immunoglobulin and methylprednisolone after unsuccessful immunoadsorption plasmapheresis

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Open Journal of Clinical Diagnostics 2013年第1期3卷 1-4页

作者： Takeshi Imai Takahiro Shimizu Yuta Hagiwara Toshikazu Hirayama Yasuhiro Hasegawa Department of Internal Medicine Division of Neurology St. Marianna University School of Medicine Kawasaki Japan

Bickerstaff brainstem encephalitis (BBE) is a rare post-infectious neurological syndrome for which an effective treatment strategy has not been established. Here, we report a case of a 71-year-old male who suffered from an upper respiratory tract infection, and 7 days later, developed numbness of the bilateral upper and lower limbs, unsteady gait and dysarthria. Brain magnetic resonance imaging was normal, nerve conduction study and cerebral spinal fluid analysis were nonspecific. Based on the clinical features, we tentatively diagnosed Guillain-Barré syndrome and started immunoadsorption plasmapheresis. However, consciousness progressively declined to coma level within 10 days. Electroencephalogram showed diffuse slowing, and auditory evoked brainstem response (ABR) demonstrated absence of waves II, III and V. Serum anti-GQ1b IgG autoantibody and anti-GM1b IgG autoantibody were negative. Subsequently, we diagnosed BBE, and clinical symptoms resolved after treatment with intravenous immunoglobulin and methyllprednisolone. On day 62, neurological symptoms were remarkably alleviated with an improvement in ABR. Our observations suggest that immunoadsorption plasmapheresis should be used only when anti-ganglioside antibodies are detected. Combination therapy with intravenous immunoglobulin and methylprednisolone or plasma exchange?is recommended as initial therapy.

关键词： Bickerstaff Brainstem Encephalitis intravenous Immunoglobulin Methylprednisolone Immunoadsorption Plasmapheresis

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Effect of intravenous gamma globulin on short- and mid-term clinical outcome in acute viral myocarditis in children

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World Journal of Cardiovascular Diseases 2014年第2期4卷 39-44页

作者： Mehnaz Atiq Mehar Hoda Nadeem Aslam Section of Pediatric Cardiology Department of Pediatrics and Child Health Aga Khan University Hospital Karachi Pakistan

Acute viral myocarditis is an extremely diverse disease with a predictable good outcome with supportive therapy. The objective of this study was to look at the clinical outcome of patients receiving additional intravenous gamma globulin compared to those receiving conventional anti-congestive therapy alone. Patients and methods: This is a retrospective review of charts of children admitted with acute myocarditis. Group 1 was children who received intravenous gamma globulin (IVIG) along with conventional anti-congestive therapy. Group 2 were patients who received the conventional anticongestive therapy alone. Short-term outcome was survival to hospital discharge, and mid-term outcome was improvement of left ventricular ejection fraction at 6 months and one year follow-up. Results: A total of 36 patients were enrolled and 18 were males. The mean age of all patients was 2.3 ± 2.6 years and the mean duration of illness for the whole group was 6.7 ± 3.8 days. Group 1 comprised of 16 patients. There was no difference in short-term outcome with mortality of 2 patients in Group1 (12.5%) and 3(15%) in Group 2 (p = 0.2). At intermediate term follow up, recovery of ejection fraction in Group 1 was in 4/14 (28%) and in Group 2 it was 9/17 (55%) and at 12 months it was 10/13 (77%) in Group 1 and 15/16 (94%) in Group 2 (p = 0.02 and 0.19 respectively). Conclusion: Acute myocarditis has a high spontaneous cure rate. Our study did not show any significant difference in the short-term or midterm outcome between children receiving IVIG compared to those who did not.

关键词： Acute Myocarditis intravenous Gamma Globulins Congestive Heart failure

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Single intravenous injection of CoQ<sub>10</sub>reduces infarct size in a rat model of ischemia and reperfusion injury

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World Journal of Cardiovascular Diseases 2013年第5期3卷 1-7页

作者： Alexander Ivanov Evgenia Gorodetskaya Elena Kalenikova Oleg Medvedev Department of Pharmacology Faculty of Basic Medicine M.V. Lomonosov Moscow State University Moscow Russia Department of Pharmacology Faculty of Basic Medicine M.V. Lomonosov Moscow State University Moscow Russia Russian Cardiology Research and Production Complex Moscow Russia Department of Pharmacology Faculty of Basic Medicine M.V. Lomonosov Moscow State University Moscow Russia Russian Cardiology Research and Production Complex Moscow Russia

Maintenance of mitochondrial activity and antioxidant features of coenzyme Q10 (CoQ10) could be an effective background for treatment of acute myocardial ischemia. Dietary uptake of CoQ10 is limited to only a few percent. In urgent cases, parenteral administration of CoQ10 could provide fast increase of its plasma and myocardial levels. The aim was to evaluate whether a single intravenous (i.v.) injection of solubilized CoQ10 before ischemia/reperfusion (IR) could lead to replenishment of its myocardial levels and limits subsequent myocardial IR injury. Methods: 30 min prior to coronary artery occlusion rats received i.v. solubilized CoQ10 (30 mg/kg) or saline (1 ml/kg). After 30 min of ischemia and 120 min of reperfusion, infarct zone of left ventricle (LV) and quantity of CoQ10 in LV were determined. Cardiac rhythm was monitored through the whole experiment. Results: At the beginning of reperfusion, arrhythmias were recorded in 8 (from 9) in saline and 2 (from 9) in CoQ10-treated rats. Arrhythmias in CoQ10-treated rats arose later (40 ± 8 sec) and had less duration (26 ± 14 sec);14 ± 13 sec and 52 ± 17 sec in saline treated rats respectively. At the end of reperfusion CoQ10 treated rats revealed: 2 fold higher CoQ10 content in LV (p 10 were accompanied by less infarct size (r = ﹣0.77, p i.v. injection of CoQ10 effectively increased its myocardial levels and protected heart against IR injury by diminishing the size of the irreversibly damaged myocardium, decreasing frequency and duration of arrhythmias. The infarct zone inversely correlated with the quantity of CoQ10 in LV.

关键词： Coenzyme Q10 intravenous Injection Myocardial Ischemia Reperfusion Injury

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A successful birth of severe secondary recurrent miscarriage case after a decline of phosphatidylserine-dependent anti-prothrombin antibody by intravenous immunoglobulin administration

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Open Journal of Obstetrics and Gynecology 2012年第2期2卷 156-160页

作者： Mika Kanaya Kunihiko Nagasawa Tsuyoshi Baba Shinichi Ishioka Hideto Yamada Toshiaki Endo Tsuyoshi Saito Department of Obstetrics and Gynecology School of Medicine Kobe University Kobe Japan Department of Obstetrics and Gynecology School of Medicine Sapporo Medical University Sapporo Japan Mika Ladies Clinic Sapporo Japan

A 33 years old woman was referred to our hospital since her sixth pregnancy had been revealed. In fact, at 19 years of age she had diagnosed as having systemic lupus erythematosus without organ failure. In addition, she had a past history of uncontrollable severe pregnancy-induced hypertension occurred during the second pregnancy, resulting in extremely premature delivery and following postpartum HELLP syndrome. It was so severe that we employed administration of dexamethasone and plasma exchange to ameliorate a life-threatening situation. In the course of her recovery it was revealed that she had been complicated with antiphospholipid antibodies, and at the same time we observed that phosphatidylserine-dependent anti-prothrombin antibody IgG levels were declining as her condition was getting better. There-after, she became pregnant three times, but all pregnancies ended in miscarriage despite administration of prednisolone and anticoagulant therapy. Therefore, we realized that her recurrent miscarriages could not be prevented with generally acceptable therapies, so we tried intravenous immunoglobulin shortly after fetal heart beats were detected. In fact, her sixth pregnancy was going well, but we had to terminate it at the 35th week of gestation due to the onset of HELLP syndrome-like condition. However, she could achieve an almost intact pregnancy outcome without neonatal complications or persistently worsening postpartum HELLP syndrome-like condition. Considering the etiologic relation overlapping between systemic lupus erythematosus, antiphospholipid syndrome and recurrent miscarriage, intravenous immunoglobulin can be one of the treatment options for severe secondary recurrent miscarriage, although the evidence of the treatment is always certain. In addition, a decline of phosphatidylserine-dependent anti-prothrombin antibody IgG levels we observed in this case may represent its therapeutic immunomodulatory effects.

关键词： Antiphospholipid Antibody Antiphospholipid Syndrome intravenous Immunoglobulin Recurrent Miscarriage Systemic Lupus Erythematosus

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Intracranial Abscess Post intravenous Misuse of Transdermal Fentanyl in an Immunocompetent Patient

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Open Journal of Modern Neurosurgery 2018年第2期8卷 143-146页

作者： Hazel Serrao-Brown The Canberra Hospital Canberra Australia

Infections, including intracranial abscesses, are a well-known and potentially serious complication of intravenous drug abuse. There have been increasing reports of intravenous misuse of transdermal Fentanyl, with severe sequelae. Intracranial abscesses in intravenous drug users tend to involve uncommon pathogens, and may present with atypical symptoms, which can lead to delayed diagnosis and inadequate treatment. We present the case of a 28-year-old female, with a history of intravenous misuse of transdermal Fentanyl, who was found to have intracranial abscesses with Fusobacterium nucleatum and Nocardia species, causing significant vasogenic oedema and mass effect.

关键词： Intracranial Abscess Transdermal Fentanyl intravenous Drug Use

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EFFECTS OF FENTANYL ON MIDBRAIN UNITS IN RABBITS BY intravenous INJECTION

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Chinese Science Bulletin 1981年第7期26卷 663-666页

作者：陈宜张徐宁善周玉峰王春安 Department of Physiology Second Military Medical College PLA. Department of Physiology Shanghai First Medical College. Department of Pathophysiology Second Military Medical College PLA. Department of Physiology Second Military Medical College PLA.he results of studying SPA (stimulation produced analgesia) and analgesia produced by intracerebral injection of morphine have shown that the mechanism of morphine analgesia may be due to activation of periaqueductal or periventricular gray which in turn inhibits the centripetal inflow of noxious messages. However direct iontophoresis of morphine into midbrain reticular formation including central gray causes inhibitory effects on them in most instances. Obviously this inhibitory effect could hardly be in harmony with the proposed mechanism. Some recent studies have

The results of studying SPA (stimulation produced analgesia) and analgesia produced by intracerebral injection of morphine have shown that the mechanism of morphine analgesia may be due to activation of periaqueductal or periventricular gray which in turn inhibits the centripetal inflow of noxious messages. However, direct iontophoresis of morphine into midbrain reticular formation, including central gray, causes inhibitory effects on them in most instances. Obviously, this inhibitory effect could hardly be in harmony with the proposed mechanism. Some recent studies

关键词： analgesia morphine fentanyl stimulation hardly anesthesia intracerebral intravenous inflow harmony

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The effects of PaCO_2 on balance of cerebral oxygen supply and consumption during intravenous general anesthesia

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Journal of Medical Colleges of PLA(China) 1999年第4期14卷 274-277页

作者：陈绍洋王强曾祥龙董海龙胡文能曾毅张玉勤熊利泽

Objective: To evaluate the effects of various degrees of hyperventilation on balance of cerebral oxygensupply and consumption during intravenous general anesthesia with jugular venous oxygen saturation monitoringMetbods: Sixty-six patients with supratentorial tumor undergoing intravenous general anesthesia for brain surgerywere randomly divided into three groups. In group Ⅰ, Ⅱ and Ⅲ, end-tidal pressure of Co2(PETCO2) were maintained at 3. 5, 4. 0 and 4. 5 kPa respectively. Radial arterial blood samples and jugular bulb blood samples weretaken synchronously at 60 min after hyperventilation to measure jugular venous oxygen saturation (SjvO2), cerebral extraction of oxygen (CEO2) and cerebral arteriovenous oxygen content difference (AVDO2) were calculatedResults: In group Ⅰ after hyperventilation, SjvO, and jugular venous oxygen content (CjvO2) were decreasedmarkedly while CEO2 was increased significantly, which was different significantly compared with the baseline andcorresponding value in group Ⅱ and Ⅲ (P<0. 05). After hyperventilation in group, and, SjvO2 CjvO2, CEO2and AVDO, remained unchanged. Conclusion: This study shows that sustained excessive hyperventilation (PETCO23.5 kPa) may account for the less favorable cerebral oxygen supply and consumption balance and maintained PETCO, at 4. 0~4. 5 kPa was optimal hyperventilation for brain surgery anesthesia.

关键词： intravenous general anesthesia hyperventilation jugular venous oxygen saturation cerebral oxygen supply and consumption balance

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