Randomized placebo-controlled phase II trial of high-dose melatonin mucoadhesive oral gel for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing radiation therapy concurrent with systemic treatment

Purpose The objective of this trial was to evaluate the safety and efficacy of melatonin oral gel mouthwashes in the prevention and treatment of oral mucositis (OM) in patients treated with concurrent radiation and systemic treatment for head and neck cancer. Methods Randomized, phase II, double-blind, placebo-controlled trial (1:1 ratio) of 3% melatonin oral gel mouthwashes vs. placebo, during IMRT (total dose ≥ 66 Gy) plus concurrent Q3W cisplatin or cetuximab. Primary endpoint: grade 3–4 OM or Severe Oral Mucositis (SOM) incidence by RTOG, NCI, and a composite RTOG-NCI scales. Secondary endpoints: SOM duration and grade 2–4 OM or Ulcerative Oral Mucositis (UOM) incidence and duration. Results Eighty-four patients were included in the study. Concurrent systemic treatments were cisplatin (n = 54; 64%) or cetuximab (n = 30; 36%). Compared with the placebo arm, RTOG-defined SOM incidence was numerically lower in the 3% melatonin oral gel arm (53 vs. 64%, P = 0.36). In patients treated with cisplatin, assessed by the RTOG-NCI composite scale, both SOM incidence (44 vs. 78%; P = 0.02) and median SOM duration (0 vs. 22 days; P = 0.022) were significantly reduced in the melatonin arm. Median UOM duration assessed by the RTOG-NCI scale was also significantly shorter in the melatonin arm (49 vs. 73 days; P = 0.014). Rate of adverse events and overall response rate were similar between the two arms. Conclusions Treatment with melatonin oral gel showed a consistent trend to lower incidence and shorter SOM duration and shorter duration of UOM. These results warrant further investigation in phase III clinical trial (AU)

Randomized placebo-controlled phase II trial of high-dose melatonin mucoadhesive oral gel for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing radiation therapy concurrent with systemic treatment.

PURPOSE: The objective of this trial was to evaluate the safety and efficacy of melatonin oral gel mouthwashes in the prevention and treatment of oral mucositis (OM) in patients treated with concurrent radiation and systemic treatment for head and neck cancer. METHODS: Randomized, phase II, double-blind, placebo-controlled trial (1:1 ratio) of 3% melatonin oral gel mouthwashes vs. placebo, during IMRT (total dose ≥ 66 Gy) plus concurrent Q3W cisplatin or cetuximab. Primary endpoint: grade 3-4 OM or Severe Oral Mucositis (SOM) incidence by RTOG, NCI, and a composite RTOG-NCI scales. Secondary endpoints: SOM duration and grade 2-4 OM or Ulcerative Oral Mucositis (UOM) incidence and duration. RESULTS: Eighty-four patients were included in the study. Concurrent systemic treatments were cisplatin (n = 54; 64%) or cetuximab (n = 30; 36%). Compared with the placebo arm, RTOG-defined SOM incidence was numerically lower in the 3% melatonin oral gel arm (53 vs. 64%, P = 0.36). In patients treated with cisplatin, assessed by the RTOG-NCI composite scale, both SOM incidence (44 vs. 78%; P = 0.02) and median SOM duration (0 vs. 22 days; P = 0.022) were significantly reduced in the melatonin arm. Median UOM duration assessed by the RTOG-NCI scale was also significantly shorter in the melatonin arm (49 vs. 73 days; P = 0.014). Rate of adverse events and overall response rate were similar between the two arms. CONCLUSIONS: Treatment with melatonin oral gel showed a consistent trend to lower incidence and shorter SOM duration and shorter duration of UOM. These results warrant further investigation in phase III clinical trial.

DNA repair pathways to regulate response to chemoradiotherapy in patients with locally advanced head and neck cancer.

Platinum-based chemoradiotherapy (CRT) is a preferred standard of care for locally advanced head and neck cancer (HNC). However, survival benefit is small, with substantial toxicity and biomarkers of CRT resistance that could guide treatment selection and spare morbidity. Increased DNA repair in solid tumors may contribute to cancer cells' ability to survive in genotoxic stress environments afforded by therapy. We assessed mRNA expression levels of DNA repair-related genes BRCA1, RAP80, 53 binding protein 1 (53BP1), mediator of DNA damage checkpoint 1 (MDC1), and RNF8. We correlated our findings with response and overall survival in 72 head and neck patients treated with weekly carboplatin AUC 2 and radiotherapy. Complete response (CR) to CRT was 50 % in patients with low levels of 53BP1 compared to 6.3 % in patients with high levels (p = 0.0059). Of high BRCA1 mRNA expressors, 41.2 % had CR compared to 29.4 % of low expressors (p = 0.72). For a small group of patients with low 53BP1 and either high BRCA1 or RAP80, CRs were 66.7 and 71.4 %, respectively. A trend for better overall survival (OS) was found for patients with low 53BP1 (15 vs 8 m; p = 0.056). Our findings highlight the potential usefulness of 53BP1 mRNA as a predictive biomarker of response and overall survival in HNC patients treated with chemoradiotherapy. Those with high 53BP1 expression could derive only a meager benefit from treatment. Analysis of BRCA1 and RAP80 could further reinforce the predictive value of 53BP1. Although this was a retrospective study with small sample size, it could inform larger translational studies in HNC.

Pathological femur fracture secondary to radiation therapy for soft tissue sarcoma.

Bone fracture is a well known possible late complication of radiation treatment. Little has been written about fractures of long bones after irradiation. We present a case of femur bone necrosis secondary to postoperative radiation for a soft tissue sarcoma of the thigh 20 years earlier. Fixation of the diaphyseal fracture and radiological evolution are described.

Pathological femur fracture secondary to radiation therapy for soft tissue sarcoma

Bone fracture is a well known possible late complication of radiation treatment. Little has been written about fractures of long bones after irradiation. We present a case of femur bone necrosis secondary to postoperative radiation for a soft tissue sarcoma of the thigh 20 years earlier. Fixation of the diaphyseal fracture and radiological evolution are described (AU)

La radioterapia en el tratamiento de las metástasis coroideas y cerebrales simultáneas / Radiation therapy in simultaneous choroidal and brain metastases

Las metástasis coroideas de cáncer de pulmón pueden presentarse como primera manifestación clínica de extensión metastásica de la enfermedad aunque suelen coexistir con al menos dos localizaciones metastásicas. La sintomatología más frecuente es la disminución de la agudeza visual. Sin embargo, hasta un 20% de las metástasis cerebrales también pueden presentar alteraciones visuales, por lo que debe realizarse el diagnóstico diferencial entre metástasis cerebral y/o coroidea.Presentamos un caso de una paciente diagnosticada de adenocarcinoma de pulmón que a raíz de una disminución de la agudeza visual fue diagnosticada de metástasis coroideas y cerebrales simultáneas. Fue tratada con irradiación holocraneal (DT 20Gy/5fracciones) con una mejoría significativa de la agudeza visual. Este caso ilustra que aunque la expectancia de vida de los pacientes con cáncer de pulmón metastático es corta, un diagnóstico y tratamiento adecuado puede mejorar la calidad de vida de estos pacientes

Choroidal metastases from lung cancer can be the initial clinical manifestation of metastasic disease, although they generally coexist with at least two more metastasic sites. The most common symptom is decreased vision, however 20% of brain metastases can present with visual alterations. A differential diagnosis within brain metastases and/or choroidal is necessary. We present the case of a patient with lung cancer and decreased vision who was diagnosed as simultaneous choroidal and brain metastases. Radiation therapy (20Gy/5fractions) significantly improves decreased vision. This case shows that, although life expectancy of patients with metastasic lung cancer is short, an adequate diagnosis and treatment, can improve the quality of life of those patients

Toxicidad y tratamiento de soporte en oncología radioterápica; pulmón / No disponible

No disponible

[Radiation therapy in simultaneous choroidal and brain metastases]. / La radioterapia en el tratamiento de las metástasis coroideas y cerebrales simultáneas.

Choroidal metastases from lung cancer can be the initial clinical manifestation of metastasic disease, although they generally coexist with at least two more metastasic sites. The most common symptom is decreased vision, however 20% of brain metastases can present with visual alterations. A differential diagnosis within brain metastases and/or choroidal is necessary. We present the case of a patient with lung cancer and decreased vision who was diagnosed as simultaneous choroidal and brain metastases. Radiation therapy (20Gy/5fractions) significantly improves decreased vision. This case shows that, although life expectancy of patients with metastasic lung cancer is short, an adequate diagnosis and treatment, can improve the quality of life of those patients.

La estación de trabajo médica para la gestión clínica / No disponible

En este trabajo se relacionan requerimientos y se describen experiencias de la implantación de las estaciones de trabajo médicas (ETM) que comprenden la integración de la información (AU)

No disponible

Electrophysiologic cardiac effects of the new local anesthetic IQB-9302 and of bupivacaine in the anesthetised dog.

BACKGROUND: Local anesthetics are not free from potentially fatal complications. Therefore every new local anesthetic should be tested to demonstrate a lower, or at least similar, degree of toxicity over clinically used analogs. Most toxic effects from local anesthetics affect the cardiac electrophysiologic function, so the aim of this study was to characterize the electrophysiologic effects of a new long-acting local anesthetic (IQB-9302, Ciprocaine), and compare them with those of bupivacaine in the anesthetized dog. METHODS: Eight Beagle dogs received three increasing infusion doses of either IQB-9302 or bupivacaine. Under isoflurane anesthesia, dogs were instrumented to monitor cardiovascular (cardiac output, arterial and venous blood pressures) and cardiac electrophysiologic data (sinus and atrioventricular (AV) node function, atrial, nodal and ventricular conduction times, and refractoriness). RESULTS: Only the highest dose of both drugs induced hemodynamic or electrophysiologic alterations: cardiac output and heart rate were reduced while blood pressures remained unchanged. Atrial and intranodal conduction times and atrial refractoriness increased similarly with both anesthetics, but to a slightly lesser extent with IQB-9302. Significant increases in His-Purkinje and intraventricular conduction times were the most severe noxious effects and occurred only with large doses of either drug. IQB-9302 was slightly less toxic than bupivacaine and, unlike this latter drug, potentially fatal arrhythmias were not induced. CONCLUSION: IQB-9302 has hemodynamic and cardiac electrophysiologic effects similar to those caused by bupivacaine. Nevertheless, slightly less toxic effects were derived from IQB-9302 administration than with bupivacaine, and, unlike the latter, the former might be less proarrhytmogenic. The new long-acting local anesthetic IQB-9302 may offer clinical advantages compared with bupivacaine.

Autologous stem-cell transplantation for poor-risk and relapsed intermediate- and high-grade non-Hodgkin's lymphoma.

The primary objective of this study was to evaluate the outcome of patients treated with high-dose chemo-/radiotherapy or high-dose chemotherapy and autologous stem-cell transplant (ASCT) for relapsed, refractory, or poor-risk intermediate-grade (IG) and high-grade (HG) non-Hodgkin's lymphoma (NHL). The secondary objectives were to determine prognostic factors for relapse and survival. Between February 1987 and August 1998, 264 patients, 169 (64%) IG and 95 (36%) HG, underwent high-dose therapy and ASCT at City of Hope National Medical Center (COHNMC). There were 157 (59%) males and 107 (41%) females with a median age of 44 years (range, 5-69 years). The median number of prior chemotherapy regimens was 2 (range, 1-4), and 71 (27%) had received prior radiation as part of induction or as salvage therapy. The median time from diagnosis to ASCT was 10.8 months (range, 3-158 months). Ninety-four patients (36%) underwent transplantation in first complete/partial remission (CR/PR), 40 (15%) in induction failure, and 130 (49%) in relapse or subsequent remission. Two preparative regimens were used: total body irradiation/high-dose etoposide/cyclophosphamide (TBI/VP/CY) in 208 patients (79%) and carmustine/etoposide/cyclophosphamide (BCNU/VP/CY) in 56 patients (21%). One hundred sixty-three patients (62%) received peripheral blood stem cells (PBSC) and 101 (38%) received bone marrow (BM) alone or BM plus PBSC. At a median follow-up of 4.43 years for surviving patients (range, 1-12.8 years), the 5-year Kaplan-Meier estimates of probability of overall survival (OS), progression-free survival (PFS), and relapse for all patients are 55% (95% confidence interval [CI]: 49%-61%), 47% (95% CI: 40%-53%), and 47% (95% CI: 40%-54%), respectively. There were 27 deaths (10%) from nonrelapse mortality, including seven (3%) patients who developed second malignancies (five with myelodysplasia/acute myelogenous leukemia and two with solid tumors). By stepwise Cox regression analysis, disease status at ASCT was the only prognostic factor that predicted for both relapse and survival. The 5-year probability of PFS for patients transplanted in first CR/PR was 73% (95% CI: 62%-81%) as compared to 30% (95% CI: 16%-45%) for induction failure and 34% (95% CI: 26%-42%) for relapsed patients. Our results further support the role of high-dose therapy and ASCT during first CR/PR for patients with poor-risk intermediate- and high-grade NHL. Early transplant is recommended for patients failing initial induction therapy or relapsing after chemotherapy-induced remission. Relapse continues to be the most common cause of treatment failure. An alternative approach to prevent relapse, the incorporation of radioimmunotherapy into the high-dose regimen, is being investigated. The development of a second malignancy is a serious complication of high-dose therapy, which requires close surveillance.

High-dose chemo/radiotherapy and autologous bone marrow or stem cell transplantation for poor-risk advanced-stage Hodgkin's disease during first partial or complete remission.

Complete remission rates of 70-90% can be achieved following combination chemotherapy for patients with advanced-stage Hodgkin's disease (HD). Patients who present with unfavorable poor prognostic factors, however, have a 5-year disease-free survival of only 40-50%. In an attempt to improve the prognosis of 20 patients with poor-risk advanced-stage HD, we evaluated the role of early high-dose therapy (HDT) and autologous bone marrow/stem cell transplantation (ASCT) during the first complete or partial remission (CR/PR). Patients were eligible for ASCT if they either achieved a PR (defined as > 50% regression) (six patients), or achieved a CR (14 patients) but had presented with three or more of the following unfavorable features: stage IV disease with bone marrow involvement or > or = 2 extranodal sites of involvement; bulky mass > 10 cm or bulky mediastinal mass > 1/3 of mediastina/thoracic ratio; B symptoms; and elevated serum lactate dehydrogenase (LDH) level. The study included 11 men (55%) and 9 women (45%). The median age was 37 years (range 20-57). Seventeen patients (85%) had stage IV disease; 14 (70%) had B symptoms; 13 (65%) had bulky mass > 10 cm; 14 (70%) had > or = 2 extra nodal sites involvement; and eight patients (40%) had elevated LDH levels. All patients were treated with standard four or 7-8 drug combination chemotherapy regimens until they achieved maximal response prior to ASCT with a median of six cycles (range 4-11). Six patients also received involved field radiotherapy to residual bulky mass > 5 cm or bony lesions before ASCT. The median time from diagnosis to ASCT was 8.6 months (range 5.5-18.9). Preparative regimens consisted of fractionated total body irradiation (FTBI) 1200 cGy in combination with etoposide 60 mg/kg and cyclophosphamide 100 mg/kg in all patients except one who had borderline pulmonary function and received lomustine 15 mg/kg instead of FTBI. All patients engrafted and there was no transplant-related mortality. One patient developed congestive cardiomyopathy at 4 years post-ASCT. All patients remain alive and in remission at a median follow-up of 42.8 months (range, 13.2-149.2). These preliminary results suggest that HDT and ASCT can be performed safely during first CR/PR in selected patients with advanced-stage HD who have an unfavorable prognosis. Further randomized studies comparing HDT and ASCT during first CR with conventional chemotherapy and ASCT at relapse in poor-risk advanced-stage HD should be conducted. The prognostic factors and risk groups described recently by an international prognostic study can be used to identify high-risk patients who may be candidates for more intensive therapy.

IMASIS. A multicenter hospital information system--experience in Barcelona.

The present study aimed to analyse physicians' attitudes towards IMASIS, and their potential influence on IMASIS medical record project. IMAS (Institut Municipal d'Assistència Sanitària) is the health care organisation of the City Council of Barcelona. IMAS hospital information system (IMASIS), which first applications were designed and implemented in 1984, is currently facing a new phase, focused on clinical information management. Our approach included a personal interview with representatives of every hospital unit, and a self-administered questionnaire distributed to every clinician. Both provided a worthy insight into the cultural patterns to be considered in the HIS implementation process. Moreover, the results helped to define the subsequent steps of IMASIS evolution. Our experience is proposed as a tool to assess clinical informations systems from a user point of view.

Results of high-dose therapy and autologous bone marrow/stem cell transplantation during remission in poor-risk intermediate- and high-grade lymphoma: international index high and high-intermediate risk group.

We have conducted a pilot study to investigate the role of high-dose therapy and autologous bone marrow/stem cell transplantation (ASCT) during first complete or partial remission in 52 patients with poor-risk aggressive lymphoma. There were 42 patients with intermediate-grade or immunoblastic lymphoma who were considered to be high (60%) and high-intermediate risk (40%) groups at diagnosis based on the age-adjusted International Prognostic Index (IPI) and 10 patients with high-grade, SNCCL (small non-cleaved cell, Burkitt's, and non-Burkitt's), who at presentation had poor-risk features defined as elevated serum lactate dehydrogenase level, stage IV, and bulky mass >/=10 cm. The median age was 34 years (range, 16 to 56 years). Thirty-nine were transplanted in first complete remission and 13 in first partial remission after conventional therapy. Conditioning regimens consisted of total body irradiation (TBI) administered as a single fraction 750 cGy in 3 patients and in fractionated doses for a total of 1,200 cGy in 44 patients, in combination with 60 mg/kg etoposide and 100 mg/kg cyclophosphamide. Five patients with prior radiotherapy received 450 mg/m2 carmustine instead of TBI. Stem cell sources were either bone marrow and/or peripheral blood. No in vitro purging was used. All patients engrafted. Two SNCCL patients died of venoocclusive disease at 25 days and acute leukemia at 27 months posttransplantation. There were six relapses at 1.5 to 12.8 months posttransplantation. At a median follow-up of 44 months (range, 1 to 113 months), the estimated 3-year overall survival (OS) and disease-free survival (DFS) for all patients was 84% (95% confidence interval [CI], 70% to 92%) and 82% (95% CI, 68% to 91%), respectively. In the subset of patients with intermediate-grade and immunoblastic lymphoma, the 3-year DFS was 89% (95% CI, 74% to 96%) for all patients, 87% (95% CI, 67% to 96%) for high-risk patients, and 92% (95 CI, 61% to 99%) for high-intermediate risk patients. The 3-year OS and DFS for SNCCL patients were identical at 60% (95% CI, 30% to 84%). These results suggest that high-dose therapy and ASCT during first remission may improve the survival and prognosis of patients with poor-risk intermediate- and high-grade lymphoma. A prospective randomized study comparing high-dose therapy and ASCT with conventional chemotherapy in IPI high-risk patients with aggressive non-Hodgkin's lymphoma should be undertaken.

Polymyositis as a manifestation of chronic graft-versus-host disease.

A syndrome indistinguishable from idiopathic polymyositis occurred in 11 patients as a manifestation of chronic GVHD. All patients had elevation of creatine phosphokinase (CPK). Immunohistology demonstrated the effector cells in the muscle infiltrates as cytotoxic T cells, a finding similar to idiopathic polymyositis. Polymyositis is a rarely reported complication of chronic graft-versus-host disease (GVHD) with only 8 cases described in the literature. We encountered this syndrome in a small but significant percentage of our patients with chronic GVHD. Polymyositis associated with chronic GVHD does not affect the overall prognosis for the patient. Moreover, polymyositis can be the only manifestation of chronic GVHD. Awareness of this complication is important because it can be confused with other causes of muscle weakness after bone marrow transplantation. Finally, prompt initiation of corticosteroid therapy results in a rapid improvement of the associated symptoms.

Thalidomide as salvage therapy for chronic graft-versus-host disease.

Thalidomide has been reported to be an effective agent for treatment of chronic graft-versus-host disease (CGVHD). To determine the efficacy of this agent in patients with refractory CGVHD a total of 80 patients who failed to respond to prednisone (PSE) or PSE and cyclosporine (CSA) were treated with thalidomide. Sixteen patients (20%) had a sustained response, 9 with a complete remission and 7 with a partial response. Twenty-nine patients (36%) had thalidomide discontinued because of side effects, which included sedation, constipation, neuritis, skin rash, and neutropenia. Side effects were reversible with drug discontinuation except for mild residual neuritis in one case. Rashes and neutropenia have not previously been reported as thalidomide side effects when used for CGVHD treatment. We conclude thalidomide is immunosuppressive and active in the treatment of CGVHD. A high incidence of reversible side effects limited dose intensity and reduced the number of patients who could benefit from treatment.

IMASIS computer-based medical record project: dealing with the human factor.

The Institut Municipal d'Assistència Sanitària (IMAS) is a health care organization in Barcelona, comprising two general hospitals, a psychiatric hospital, a surgical clinic, a geriatric center, some primary care clinics, and a research institute. Since 1984, IMAS has been engaged in creating a multicenter integrated hospital information system (IMASIS). Currently, IMASIS offers the possibility to manage administrative data, laboratory results, pathology and cytology reports, radiology reports, and pharmacy inpatient orders; it also shares this information on-line among IMAS centers. IMASIS users may also work with a word processor, a spreadsheet, a database, or a statistical package and have access to MEDLINE. A second phase of IMASIS development began in December 1993 focused on clinical information management. The goal was to move towards an integrated multimedia medical record [1]. As a first step, the implementation experiences of the most advanced hospital information systems around the world were studied. Some of these experiences detected behavioral, cultural, and organizational factors [2] as the main sources of delay, or even failure, in HIS projects. A preliminary analysis to define such factors, assess their potential impact, and introduce adequate measures to deal with them seemed unavoidable before structuring of the project. In our approach to physician attitudes analysis, two survey techniques were applied. First, every hospital service head was contacted to schedule an interview, with either a service representative or a group of staff physicians and residents. The aim was to provide detailed information about project objectives and collect personal opinions, problems encountered in the current HIS, and specific needs of every medical and surgical specialty (including imaging needs). Every service head was asked to distribute a questionnaire among all clinicians, which assessed frequency of use of IMASIS current applications, user's satisfaction level, problems to be solved in utilization of the system, errors detected in the systems' database, and the personal interest in participating in the IMASIS project. The questionnaire was also intended to be a tool to monitor IMASIS evolution. Our study showed that medical staff had a lack of information about the current HIS, leading to a poor utilization of some system options. Another major characteristic, related to the above, was the feeling that the project would negatively affect the organization of work at the hospitals. A computer-based medical record was feared to degrade physician-patient relationship, introduce supplementary administrative burden in clinicians day-to-day work, unnecessarily slow history taking, and imply too-rigid patterns of work. The most frequent problems in using the current system could be classified into two groups: problems related to lack of agility and consistency in user interface design, and those derived from lack of a common patient identification number. Duplication of medical records was the most frequent error detected by physicians. Analysis of physicians' attitudes towards IMASIS revealed a lack of confidence globally. This was probably the consequence of two current features: a lack of complete information about IMASIS possibilities and problems faced when using the system. To deal with such factors, three types of measures have been planned. First, an effort is to be done to ensure that every physician is able to adequately use the current system and understands long-term benefits of the project. This task will be better accomplished by personal interaction between clinicians and a physician from the Informatics Department than through formal teaching of IMASIS. Secondly, a protocol for evaluating the HIS is being developed and will be systematically applied to detect both database errors and systemUs design pitfalls. Finally, the IMASIS project has to find a convenient point for starting, to offer short-term re

Terapéutica con anticuerpos monoclonal como profiláxis de las crisis agudas de rechazo en trasplante renal: labor de enfermería / Therapeutic with monoclonal antibodies like profilaxis of the sharp crisis of denial in renal transplant: work of nursing

Se realiza un estudio prospectivo longitudinal en un universo de 24 pacientes que recibieron trasplante renal de donante cadáver en el servicio de nefrología de Santiago de Cuba en el Hospital Docente Clínico-quirúrgico"Saturnino Lora" del año 1993.El estudio se realizó agrupando los pacientes en dos grupos:el A con 10 pacientes y el B con 14 pacientes utilizando en ambos el mismo anticuerpo monocronal.Sólo se diferenció el tiempo de aplicación obteniendo los siguientes resultados.La incidencia de rechazo agudo en ambos grupos fue menor durante los primeros 30 días, disminuyó la incidencia del número de crisis por pacientes siendo mayor su efectividad en el primer grupo donde se utilizó hasta los 21 días.Los efectos abversos más frecuentes fueron fiebre, broncoespasmo e hipotensión con duración de 2 a 3 días.Las complicaciones sépticas fueron herpes simple e infecciones fúngicas.El anticuerpo monocronal IORT, aumentó la probalidad de supervivencia del injerto y el paciente.La atención de enfermería se comportó según los requerimientos en cada caso ayudando y manteniendo la evolución satisfactria en estos pacientes

Terapéutica con anticuerpos monoclonal como profiláxis de las crisis agudas de rechazo en trasplante renal.Labor de enfermería / Therapeutic with monoclonal antibodies like profilaxis of the sharp crisis of denial in renal transplant. Work of nursing

Se realiza un estudio prospectivo longitudinal en un universo de 24 pacientes que recibieron trasplante renal de donante cadáver en el servicio de nefrología de Santiago de Cuba en el Hospital Docente Clínico-quirúrgico"Saturnino Lora" del año 1993.El estudio se realizó agrupando los pacientes en dos grupos:el A con 10 pacientes y el B con 14 pacientes utilizando en ambos el mismo anticuerpo monocronal.Sólo se diferenció el tiempo de aplicación obteniendo los siguientes resultados.La incidencia de rechazo agudo en ambos grupos fue menor durante los primeros 30 días, disminuyó la incidencia del número de crisis por pacientes siendo mayor su efectividad en el primer grupo donde se utilizó hasta los 21 días.Los efectos abversos más frecuentes fueron fiebre, broncoespasmo e hipotensión con duración de 2 a 3 días.Las complicaciones sépticas fueron herpes simple e infecciones fúngicas.El anticuerpo monocronal IORT, aumentó la probalidad de supervivencia del injerto y el paciente.La atención de enfermería se comportó según los requerimientos en cada caso ayudando y manteniendo la evolución satisfactria en estos pacientes