Efficacy and safety of plasma exchange using a double viral inactivated and prion reduced solvent/detergent fresh frozen plasma for the treatment of thrombotic microangiopathy: The first French experience in a single center.

BACKGROUND: Octaplas LG® is the first plasma with marketing authorisation, available in France only since February 2016. This is a double viral inactivated and prion reduced solvent/detergent fresh frozen plasma. Clinical data on Octaplas LG® use in thrombotic microangiopathy (TMA) remains very limited. In May 2017, we were the first hospital in France to benefit of this new plasma product now dispensed by hospital pharmacies. We present a prospective review of all therapeutic plasma exchange (TPE) procedures for TMA patients in our hospital to evaluate the new delivery circuit, the efficacy and the adverse events (AE) related to this plasma. STUDY DESIGN AND METHODS: We prospectively reviewed 166 TPE procedures where Octaplas LG® was used as replacement fluid in 15 consecutive TMA patients required TPE in our hospital from May 2017 until December 2018. RESULTS: The total replacement plasma volume administered was 763 L (3818 units) with a median on 32 L (range 6-157) per episode. Remission was achieved in all cases after a median of 7 TPE per patient's episode. No exacerbation nor relapse were noted. One patient presented a grade 1 citrate reaction, and another patient an allergic reaction. We deplored pulmonary embolism in 2 patients. CONCLUSION: In our experience OctaplasLG® was well-tolerated and was effective at inducing a full clinical remission. Although two PE were noted, the relationship to OctaplasLG® in unclear. The new dispensing circuit through the hospital pharmacy has proven to be safe and efficient.

A multicenter prospective observational study of the conformity of temozolomide prescriptions in France.

CONTEXT: Temozolomide (TMZ) is approved for the treatment of high-grade gliomas such as glioblastoma (GBM) multiforme and refractory anaplastic astrocytoma, but it is also used in indications not mentioned in the summary of product characteristics (SPC). The main objective of this study was to evaluate the conformity of TMZ prescriptions to the French SPC and prescription guidebook. METHODS: We conducted a prospective observational study of all consecutive patients treated with TMZ in 21 French hospitals between September 2006 and February 2007, accounting for 39% of total TMZ consumption in France. The conformity of TMZ prescriptions was evaluated in terms of the indication, dosage, treatment duration, and combination with other treatments, with respect to the SPC and prescription guidebook. RESULTS: We enrolled 831 patients (median age, 56 years) who received a total of 5982 TMZ treatment cycles. TMZ was mainly prescribed to patients with newly diagnosed GBM (384 patients), GBM in progression/relapse (28 patients), or anaplastic astrocytoma in progression/relapse (19 patients). Prescriptions conformed to the SPC in 51.9% of cases and to the prescription guidebook in 91.5% of cases. Global conformity with the SPC, in terms of the dosage, treatment duration, and combination with other treatments, was 62% for newly diagnosed GBM treated with radiotherapy plus TMZ, 72% for TMZ maintenance monotherapy, and 66% for GBM and anaplastic astrocytoma in progression/relapse. CONCLUSION/DISCUSSION: In France, routine TMZ prescriptions conform to the SPC and practice guidebook. This is one of the largest studies of drug use in neuro-oncology in terms of the number of patients and cycles analyzed.

Organic glues or fibrin glues from pooled plasma: efficacy, safety and potential as scaffold delivery systems.

Since 1976, fibrin glues have been attracting medical interest, spreading from their initial use as a hemostatic agent in cardiovascular surgery to other fields of surgery. Studies have compared the efficacy of fibrin glues vs sutures in surgery. However, few comparisons have been made of the efficacy and safety of the different fibrin glues commercially available. Recently, fibrin glues have been tested as a scaffold delivery system for various substances inside the body (drugs, growth factors, stem cells). The infectious risk (viruses, new germs) of this blood-derived product was also studied in assays on viral inactivation methods. The development of autologous fibrin glues offers a solution to the problem of infectious risk. This review examines the current state of knowledge on the efficacy, safety and future potential of fibrin glues.

[News on infantile hemangioma therapy by beta-blocker]. / Mise au point sur le traitement de l'hémangiome du nourrisson par bêta-bloquant.

Hemangiomas are benign tumors most commonly encountered in infancy and early childhood. While most of them regress spontaneously, some require treatment due to a significant proliferation, which may be complicated by ulceration, deformation aesthetic deformation or worse impairment vital. Among the treatments used corticosteroids is the standard treatment but its use in high doses expose to potential risks. In 2008, the discovery by "chance" of the effectiveness of propranolol in the management of hemangioma revolutionizes the first line treatment. Its mechanism of action is not yet well understood and establishment of such treatment should be done by a hospital paediatrician in the absence of any contraindications. This article proposes focus on effectiveness and tolerance of ß-blockers used as treatment of infantile hemangiomas.

Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Real Life: One-Year Clinical and Economic Outcomes.

BACKGROUND: Recombinant factor VIII Fc fusion protein (rFVIIIFc) is the first extended half-life (EHL) recombinant clotting factor with marketing authorization; it has been available in France since October 2016. However, data and literature about rFVIIIFc in clinical practice are scarce. OBJECTIVE: We propose a 1-year clinical and economic outcome evaluation in patients with hemophilia A taking into consideration treatment adherence. PATIENTS AND METHODS: We reviewed the diaries of all patients treated with rFVIIIFc at Marseille Hemophilia Center for 1 year. All the data were related to the patients' infusion (i.e., annual number of infusions, weekly dose/kg, and annual consumption) and bleeding reports. The clotting factor costs were considered, whereas additional costs (e.g., infusion devices and nurse intervention) were neglected. RESULTS: A total of 34 patients were evaluated. Their median age was 18 years (IQR = 18). Treatment adherence was observed in 62% for FVIII and 66% for rFVIIIFc. The analysis revealed a negligible decrease in the annual clotting factor consumption following the switch (- 2%, p = 0.7339). These data were combined with a significant reduction in the annual number of infusion (- 22.5%, median = 138.5, IQR = 65.8 for FVIII; median = 105, IQR = 24 for rFVIIIFc, p < 0.0001) and bleeding (- 50%, median = 5, IQR = 7.5 for FVIII; median = 1, IQR = 4 for rFVIIIFc, p < 0.0001). With regard to the cost, a decreasing trend was observed (- 8%, p = 0.1300). CONCLUSION: The analysis in a real-life setting revealed that the input of switches toward rFVIIIFc in different treatment (age of patients and regimen) patterns seems to corroborate previous studies. The results suggest that switches have a beneficial effect in terms of efficacy, clotting factor consumption, and cost.

Misuse of antibiotics reserved for hospital settings in outpatients: a prospective clinical audit in a university hospital in Southern France.

Some antibiotics are reserved essentially for hospital settings owing to cost effectiveness and in order to fight the emerging antibiotic resistance crisis. In some cases, antibiotics reserved exclusively for use in hospitals may be prescribed in outpatients for serious infections or in the absence of a therapeutic alternative. A 30-day prospective audit of outpatient prescriptions of antibiotics reserved exclusively for use in hospitals was performed. The objective of this study was to evaluate the relevance of outpatient antibiotic prescriptions by measuring appropriateness according to guidelines. During the study period, 53 prescriptions were included, only 40% of which were appropriate. Among the 32 inappropriate prescriptions, 4 cases lacked microbial arguments, 1 case was not adequate for the infection type, 1 case involved an incorrect antibiotic dosage, 1 case involved an incorrect interval of dose administration, 3 cases had a therapeutic alternative and 22 cases were not recommended. Of the 53 prescriptions, 66% were started in hospital and 34% in outpatients. Only 25% of cases were prescribed with infectious diseases specialist (IDS) advice, 64% were based on microbiological documentation and 13% had a negative bacterial culture. Inappropriate prescriptions were usually observed in antibiotic lock therapy, skin infections, Clostridium difficile colitis, intra-abdominal infections and intravascular catheter-related infections. Outpatient prescriptions of antimicrobial drugs reserved exclusively for use in hospitals are frequently inappropriate. We recommend a real-time analysis algorithm with the involvement of an IDS for monitoring prescriptions to improve the quality of these prescriptions and possibly to prevent antibiotic resistance.