Long-Term Efficacy and Safety of Cyclosporine in a Cohort of Steroid-Refractory Acute Severe Ulcerative Colitis Patients from the ENEIDA Registry (1989-2013): A Nationwide Multicenter Study.

OBJECTIVES: To determine the efficacy and safety of cyclosporine (CyA) in a large national registry-based population of patients with steroid-refractory (SR) acute severe ulcerative colitis (ASUC) and to establish predictors of efficacy and adverse events. METHODS: Multicenter study of SR-ASUC treated with CyA, based on data from the ENEIDA registry. SR-ASUC patients treated with infliximab (IFX) or sequential rescue therapy (CyA-IFX or IFX-CyA) were used as comparators. RESULTS: Of 740 SR-ASUC patients, 377 received CyA, 131 IFX and 63 sequential rescue therapy. The cumulative colectomy rate was higher in the CyA (24.1%) and sequential therapy (32.7%) than in the IFX group (14.5%; P=0.01) at 3 months and 5 years. There were no differences in early and late colectomy between CyA and IFX in patients treated after 2005. 62% of patients receiving CyA remained colectomy-free in the long term (median 71 months). There were no differences in mortality between CyA (2.4%), IFX (1.5%) and sequential therapy (0%; P=0.771). The proportion of patients with serious adverse events (SAEs) was lower in CyA (15.4%) than in IFX treated patients (26.5%) or sequential therapy (33.4%; P<0.001). This difference in favor of CyA was maintained when only patients treated after 2005 were analyzed. CONCLUSIONS: Treatment with CyA showed a lower rate of SAE and a similar efficacy to that of IFX thereby supporting the use of either CyA or IFX in SR-ASUC. In addition, the risk-benefit of sequential CyA-IFX for CyA non-responders is acceptable.

Adalimumab induction and maintenance therapy for patients with ulcerative colitis previously treated with infliximab.

BACKGROUND: The long-term efficacy of adalimumab in patients with ulcerative colitis is not well known. AIM: To evaluate the short- and long-term outcomes of adalimumab in ulcerative colitis patients previously treated with infliximab. METHODS: Patients with active ulcerative colitis were treated with adalimumab after failure of other therapies including infliximab. Short-term clinical response and remission were assessed at weeks 4 and 12. The proportion of patients who continued on adalimumab and the proportion of patients who remained colectomy free were assessed over the long term. RESULTS: Clinical response at weeks 4 and 12 was achieved in 16 (53%) and 18 (60%) patients, respectively, and clinical remission was obtained in 3 (10%) and 8 (27%) patients, respectively. After a mean 48 weeks' follow-up, 15 patients (50%) continued on adalimumab. Six patients (20%) required colectomy. All patients who achieved clinical response at week 12 were colectomy free at long term. CONCLUSIONS: Adalimumab was well tolerated and induced durable clinical response in many patients with otherwise medically refractory ulcerative colitis. Patients achieving clinical response at week 12 avoided colectomy over the long term.

[Evaluation of antibiotic prophylaxis in surgery]. / Evaluación de la profilaxis antibiótica en cirugía.

OBJECTIVE: To evaluate the level of compliance with antibiotic prophylaxis during surgery in a university referral hospital. PATIENTS AND METHODS: A descriptive study of 257 patients undergoing clean or clean-contaminated elective surgery was carried out in 2001. Data were gathered prospectively by three anesthesiologists in the operating room. Prophylaxis was considered to have been administered correctly if the first dose was given before the skin incision, if a second dose was given during operations lasting longer than 240 minutes, and if the antibiotic prescribed was of a wide enough spectrum to cover the type of surgical procedure performed. RESULTS: Prophylaxis was administered incorrectly to 132 patients (51.4%). The causes were administration after incision in 21.8%, long-duration surgery without a second dose in 15.6%, administration after incision plus long-duration surgery without a second dose in 3.1%, inadequate-spectrum antibiotic in 4.7%, administration after incision plus inadequate dose in 2.7%, inadequate dose in 1.9%, inadequate-spectrum antibiotic plus administration after incision in 0.8%, late second dose in 0.4%, long-duration surgery without a second dose plus inadequate dose in 0.4%. DISCUSSION: The rates of late administration of an antibiotic or failure to administer a second dose during long-duration surgery is high. CONCLUSION: To improve the low level of compliance and avoid late administration of antibiotics, we propose that the anesthetist be responsible for giving antibiotic prophylaxis and for directly monitoring compliance errors in the operating room.

[Pulmonary embolism after placement of an Esmarch bandage for ankle surgery]. / Embolismo pulmonar tras colocación de venda de Esmarch para cirugía de tobillo.

We report the case of a woman scheduled for surgical fixation of an ankle fracture who developed a pulmonary embolism during application of an Esmarch compression bandage for exsanguination of the limb. Tracheal intubation and mechanical ventilation were needed to reanimate the patient and surgery had to be postponed 15 days. Orthopedic surgery, pneumatic tourniquets for providing a bloodless field and other risk factors contribute to the development of pulmonary embolism, which is often fatal. Accurate diagnosis by plasma D-dimer determination and imaging (perfusion scintigraphy, vascular Doppler ultrasound, echocardiography and pulmonary angiography) is discussed, along with therapeutic approaches to consider when managing pulmonary embolism.