L-proline-stabilized human IgG: Privigen® 10% for intravenous use and Hizentra® 20% for subcutaneous use

Liquid IgG preparations are preferred over lyophilized preparations because reconstitution is not required. Formation of dimers and aggregates in liquid preparations increases adverse effects and limits the shelf life of most liquid IgG products. Improved understanding of the binding interactions in IgG dimers and aggregates led to the selection of L-proline at pH 4.8 as an excipient that would minimize their formation. CSL Behring has developed the L-proline-stabilized products Privigen?, a 10% IgG solution for intravenous use; and Hizentra?, a 20% solution for subcutaneous use. The former has the longest shelf life of any liquid IgG in the USA--36 months, and the latter is the most concentrated IgG available. These improvements, which translate into improved convenience for pharmacies and patients, were achieved with no compromise in safety, efficacy or tolerability of the products.     

ACR Appropriateness Criteria® screening for pulmonary metastases

Screening for pulmonary metastatic disease is an important step for staging a patient with a known or recently discovered malignancy. Here we present our recommendations for screening for metastatic disease based on recommendations from the literature and experiences of pulmonary radiologists. In short, chest computed tomographic (CT) screening is the most appropriate tool for evaluation of pulmonary metastasis in the majority of cases. Chest computed tomographic screening is also recommended for follow-up and to determine response to therapy. Other modalities such as chest radiography, magnetic resonance imaging, and scintigraphy will also be discussed. Please note that this study is a summary of the complete version of this topic, which is available on the ACR website at www.acr.org. Practitioners are encouraged to refer to the complete version.     

Nitroderm TTS® band application for pain after hemorrhoidectomy

PURPOSE: Anal sphincter spasm is believed to play an important role in pain after hemorrhoidectomy. We tested a different form of nitroglycerin: the Nitroderm TTS band. We investigated its efficacy on posthemorrhoidectomy pain and the relation between pain and anal resting pressure measured preoperatively and postoperatively. METHODS: Thirty-eight hemorrhoid patients were divided into two groups: those with high anal resting pressure were classified as group A (n = 24) and those with low anal resting pressure were classified as group B (n = 14). After hemorrhoidectomy, Nitroderm TTS bands were placed into the anal canal in half of the patients in groups A and B (groups A-1 and B-1) and not in the remaining half (groups A-2 and B-2). Anal resting pressure measurement was repeated at the first day and third month postoperatively. Postoperative pain was assessed by linear analog scale, and analgesic consumption was recorded. RESULTS: Preoperative anal resting pressure was 112.0 (range, 95-140) cm H2O in group A-1 and 110.6 (range, 96-138) cm H2O in group A-2. The difference was insignificant. However, on the first postoperative day, anal resting pressures were 88.7 (range, 75-115) and 110.9 (range, 92-135) cm H2O (P = 0.0001), and at the third month, they were 76.5 (range, 70-100) and 78.0 (range, 70-105) cm H2O, respectively (P = 0.690). Postoperative pain scores were significantly lower in group A-1 than group A-2 (P = 0.0001). In the low-pressure groups (B-1 and B-2), anal resting pressures before surgery, on the first postoperative day, and at the third month postoperatively were 70.4 (range, 56-76), 67.4 (range, 50-75), and 67.2 (range, 55-74) cm H2O in group B-1 and 69.8 (range, 58-76), 70.2 (range, 60-76), and 68.4 (range, 60-74) cm H2O in group B-2. The differences were insignificant (P > or = 0.660). The differences between pain scores in these groups were also insignificant (P > or = 0.160). CONCLUSION: Nitroderm TTS bands effectively reduced anal resting pressure and relieved pain in patients with high preoperative anal resting pressure.     

Transanal MULTIFIRE ENDO GIA® technique for rectal polypectomy

Difficulty in access for local resection of broad-base rectal polyps in the mid rectum can present a management problem. Transanal use of the MULTIFIRE ENDO GIA ^® provides a hemostatic excision of these rectal polyps.     

Development of ST-246® for Treatment of Poxvirus Infections

ST-246 (Tecovirimat) is a small synthetic antiviral compound being developed to treat pathogenic orthopoxvirus infections of humans. The compound was discovered as part of a high throughput screen designed to identify inhibitors of vaccinia virus-induced cytopathic effects. The antiviral activity is specific for orthopoxviruses and the compound does not inhibit the replication of other RNA- and DNA-containing viruses or inhibit cell proliferation at concentrations of compound that are antiviral. ST-246 targets vaccinia virus p37, a viral protein required for envelopment and secretion of extracellular forms of virus. The compound is orally bioavailable and protects multiple animal species from lethal orthopoxvirus challenge. Preclinical safety pharmacology studies in mice and non-human primates indicate that ST-246 is readily absorbed by the oral route and well tolerated with the no observable adverse effect level (NOAEL) in mice measured at 2000 mg/kg and the no observable effect level (NOEL) in non-human primates measured at 300 mg/kg. Drug substance and drug product processes have been developed and commercial scale batches have been produced using Good Manufacturing Processes (GMP). Human phase I clinical trials have shown that ST-246 is safe and well tolerated in healthy human volunteers. Based on the results of the clinical evaluation, once a day dosing should provide plasma drug exposure in the range predicted to be antiviral based on data from efficacy studies in animal models of orthopoxvirus disease. These data support the use of ST-246 as a therapeutic to treat pathogenic orthopoxvirus infections of humans.     

Patients on bisphosphonates should not be at increased risk for hypocalcemic-induced tetany when given fleet® phosphosoda®

To the Editor—In their 1999 case report, Campisi and colleagues1 advised caution in prescribing Fleet® Phospho-soda® (CB Fleet Co., Inc., Lynchburg, VA) for patients taking bisphosphonates. They reported that their subject patient, who had been on a bisphos-phonate, Fosamax®, (Merck Human Health Division, West Point, PA) for several years, suffered hypocalcemic-induced tetany when taking Fleet® Phospho-so-da® before colonoscopy. At least three issues should be noted with this serious adverse event:     

Use of SNOMED CT® and LOINC® to standardize terminology for primary care asthma electronic health records

Objectives: The burden of asthma ranks among the highest for chronic diseases. Interoperable electronic health records (EHRs) can improve the management of chronic diseases such as asthma by facilitating sharing of data between health care settings along the continuum of care. Terminology such as SNOMED CT® (Systematized Nomenclature of Medicine-Clinical Terms) and LOINC® (Logistical Observation Identifier Names and Codes) are prerequisites for interoperability of EHRs. We sought to determine the extent to which data elements in a validated asthma care map (ACM) are congruent with these terminologies. Methods: A certified asthma educator entered all 169 elements in the ACM into the SNOMED CT® browser. Matched elements were assigned a concept name, an identification number, and classified into a hierarchy. LOINC® terminology was reviewed for asthma-related pulmonary function tests (PFTs). Results: Forty-two percent of the ACM elements were complete matches to existing SNOMED CT® concepts, 24% partial matches, and 34% unmatched. Specific asthma control parameters were either complete (n = 3) or partial (n = 4) matches, but overall “asthma control” was unmatched. There were 92% complete or partial matches for PFT elements to SNOMED CT® and 83% to LOINC^®. Conclusions: The majority of ACM elements are congruent with standardized terminology, enabling EHR interoperability. Future requests for new concepts in SNOMED CT® and LOINC® should be pursued for asthma control parameters paramount to evidence-based practice.     

Use of the fascial stapler® in proctopexy for rectal prolapse

Proctopexy using synthetic mesh is a popular method of treating rectal prolapse. Suturing the graft to the presacral fascia is time-consuming and can lead to complications. With the fascial staper^®, two parallel rows of three staples are used to quickly and securely anchor the Marlex sling to the sacrum, thus avoiding hemorrhage from the presacral veins. Fourteen patients have been treated with no complications.     

Acromegaly and anaplastic astrocytoma: coincidence or pathophysiological relation?

Insulin-like growth factor type I (IGF-I) is an important promoter in the tumorigenesis of several extracranial and intracranial neoplasms. In astrocytic-cell tumors, the role of autocrine and paracrine IGF-I expression in enhancing tumoral progression is well established. However, the influence of systemic IGF-I levels on the clinical behavior of astrocytic neoplasms remains an open subject of research. We report the case of a 28-year-old man who presented simultaneously with acromegaly and an anaplastic astrocytoma, which had rapidly progressed from a low-grade astrocytoma. The coexistence of systemic IGF-I hypersecretion with a quick progression in the histopathological grade of the astrocytoma raises the compelling question of whether the clinical behavior of the astrocytic tumor was influenced by the acromegalic status. The role of IGF-I signaling in the pathogenesis of astrocytic-cell tumors and the experience with therapeutic strategies addressing this pathway in astrocytomas are also discussed.     

Transoral incisionless fundoplication with EsophyX® for treatment of gastro-oesphageal reflux disease

Gastro-oesphageal reflux disease results primarily from the loss of an effective antireflux barrier, which forms a mechanical barrier against the retrograde movement of gastric content. This review describes the technique of performing a transoral incisionless fundoplication with the EsophyX^® device.Transoral incisionless fundoplication reconfigures the tissue so as to establish serosa-to-serosa plications which include the muscular layers, and construct 3–5 cm long valves 200–300° in circumference. The steps of the technique, as well as complications and their management are described in detail, and a recent literature review is also provided.At present, available prospective cohort studies indicate that transoral incisionless fundoplication using the EsophyX^® device may be effective in approximately half PPI-responsive gastro-oesphageal reflux disease for up to 3 years’ follow-up, without troublesome procedure-related persistent side effects.     

The platelet-function analyzer (PFA-100 ® ) for evaluating primary hemostasis

The platelet-function analyzer, PFA-100 ®, is a relatively novel method for rapid in vitro global evaluation of primary hemostasis. The aim of this review is to summarize the published studies reporting on the utility of the PFA-100 ® device as a screening tool for primary hemostasis. Data were identified by searches of the published literature, including PubMed, references from reviews and abstracts from the most important meetings on this topic. The literature data support the use of the PFA-100 ® as a useful screening tool for the investigation of von Willebrand's disease and other acquired and congenital intrinsic platelet function disorders. Moreover, it is useful for evaluating primary hemostasis before surgical procedures and for monitoring desmopressin therapy in both von Willebrand's disease and platelet function disorders. Given its high sensitivity, speed and simplicity of use, we conclude that the PFA-100 ® could replace the in vivo bleeding time as a screening test for primary hemostasis in routine clinical practice.     

Distal side-branch technique: A new use for the Tornus® Catheter

Percutaneous coronary intervention (PCI) outcomes of chronic total occlusions (CTO) lesions have improved in recent years due to a better understanding of the physiopathology of the disease, more effective techniques and improvement in the design of new devices. We describe a new use of the Tornus® Catheter in the anterograde approach for CTO treatment.     

On the use of Tedlar® bags for breath-gas sampling and analysis

The storage capability of Tedlar? bags for gaseous compounds was assessed using on-line proton-transfer-reaction mass spectrometry (PTR-MS). Sample bags were filled with a mixture of volatile organic compounds (VOCs) at known quantities in the ppbv range. The test gas included alcohol, nitrile, aldehyde, ketone, terpene and aromatic compounds. PTR-MS enabled frequent bag-direct measurements of compound abundances over a 70 h storage period. Concentrations of all compounds decreased with bag storage time, with compound-specific decay rates. The most rapid decline in concentration levels was seen for water vapour in the bag, i.e. sample humidity. Such a decrease is particularly relevant for breath-gas samples, where water vapour content is high. Compound losses were attributed to a combination of adsorption to and diffusion through the bag walls. Storage property observations suggest that sample analyses made within 10 h of sampling offer adequate sample authenticity replication. Based on observations, an appropriate bag-cleaning procedure was established and assessed. Results indicated that acceptable bag cleanliness for breath-gas sampling is achievable.