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PubMed2006

A qualitative review of housing hazard assessment protocols in the United States.

While the general link between substandard housing and poor health has received increased attention recently, there are currently no widely accepted standardized protocols to assess and remediate multiple housing-related health hazards. This paper compares several protocols that assess housing health hazards, including the Hazard Assessment and Reduction Program, the American Healthy Homes Survey, the Public Housing Assessment System, the Housing Quality Standards, the American Housing Survey, the Community Environmental Health Resource Center protocol, and the National Energy Audit Tool. The comparison shows considerable variability across the protocols, particularly in the collection of environmental samples or measurements. This may be due in part to differing end uses, as well as the fact that the intersection of housing and health issues is not clearly in the domain of either profession. Housing professionals typically focus on durability and affordability, while environmental health professionals are frequently focused on specific disease or injury vectors, not on place-based interventions. Validation studies at both the national and the international level are needed to determine how well both the hazard assessment and the resulting interventions predict health outcome. Standardizing and validating such protocols can help move beyond the existing limited categorical approaches and will help improve both substandard housing quality and public health.

Hazardous Substances↗

PubMed2006

Unified rate-dependent atrioventricular nodal function: consistent recovery and fatigue properties revealed with S1S2S3 protocols and different recovery indexes.

BACKGROUND: Rate-dependent nodal properties are commonly assessed with premature protocols performed at different basic rates. Because characteristics of responses differ with recovery time index, the true nature of nodal rate-dependent properties is elusive. OBJECTIVES: The purpose of this study was to reveal consistent nodal rate-dependent properties regardless of selected recovery index. METHODS: With S(1)S(2)S(3) protocols, we independently varied basic and pretest cycle lengths and thereby distinguished cumulative from noncumulative effects of rate on nodal conduction time in rabbit heart preparations. Nodal responses to 30 basic and pretest cycle length combinations (five with identical basic and pretest cycles as in standard protocols) were analyzed using both atrial (AA) and His-atrial (HA) intervals as recovery index. RESULTS: AA and HA curves had an identical shape for any of 30 steady-state conditions. When assessed with constant pretest cycle lengths, cumulative effects (fatigue) of shortened basic cycle lengths were also independent of recovery index. Shortening of pretest cycle length at fixed basic rates led to apparent inhibitory and facilitatory effects when assessed with AA and HA curves, respectively. These effects vanished when a single long cycle was inserted after the pretest cycle. In all responses including those obtained with standard protocols, combined effects of basic and pretest cycle lengths set nodal conduction time. CONCLUSION: S(1)S(2)S(3) protocols reveal consistent nodal recovery and fatigue properties regardless of recovery index used. Changes in nodal function curves arising from the use of different recovery indexes mainly depend on pretest effects. This study provides a new approach to a unified interpretation of nodal recovery and fatigue properties.

Analysis of Variance↗

PubMed2006

Body mass index, sex, interview protocol, and children's accuracy for reporting kilocalories observed eaten at school meals.

This pilot study investigated body mass index (BMI; calculated as kg/m(2)), sex, interview protocol, and children's accuracy for reporting kilocalories. Forty 4th-grade children (20 low-BMI: >or=5th and <50th percentiles, 10 boys, 15 African American; 20 high-BMI: >or=85th percentile, 10 boys, 15 African American) were observed eating school meals (breakfast, lunch) and interviewed either that evening about the prior 24 hours or the next morning about the previous day, with 10 low-BMI (5 boys) and 10 high-BMI (5 boys) children per interview protocol. Five kilocalorie variables were analyzed using separate four-factor (BMI group, sex, race, interview protocol) analyses of variance. No effects were found for reported or matched kilocalories. More kilocalories were observed (P<0.02) and omitted (P<0.05) by high-BMI than low-BMI children. For intruded kilocalories, means were smaller (better) for high-BMI girls than high-BMI boys, but larger for low-BMI girls than low-BMI boys (interaction P<0.04); low-BMI girls intruded the most while high-BMI girls intruded the least. For interview protocol, omitted and intruded kilocalories were higher (worse), although not significantly so (P values <0.11), for interviews about the previous day than the prior 24 hours. These results illuminate relations of BMI, sex, interview protocol, and children's reporting accuracy, and are consistent with results concerning BMI and sex from studies with adults.

Analysis of Variance↗

PubMed2004

A framework for modeling health behavior protocols and their linkage to behavioral theory.

With the rise in chronic, behavior-related disease, computerized behavioral protocols (CBPs) that help individuals improve behaviors have the potential to play an increasing role in the future health of society. To be effective and widely used CBPs should be based on accepted behavioral theory. However, designing CBPs while at the same time specifying their linkages to behavioral theory and developing reusable CBP components (interventions) are challenges to developers of CBPs. Having an ontology with which to describe CBPs could help with these issues. As a first step towards creating such an ontology, we modeled PACE-Adolescent, a theory-based behavioral protocol that uses the Stages of Change Model and Social Cognitive Theory, using PROTEGE-2000, an ontology editor and knowledge acquisition system. We created a three-part knowledge model. Two sub-ontologies described behavioral interventions and psychological theories. The third component, implemented using Guideline Interchange Format (GLIF3), provided a way to describe the structure of a protocol and to link intervention resources and groups of actions to elements of psychological theory. Using this framework, we formally described the PACE-Adolescent protocol. Creating knowledge models such as this may lead to improvements in the design and evaluation of computerized health behavior protocols.

Adolescent↗

PubMed2005

Effect of fixation protocols on in situ detection of L-selectin ligands.

In situ binding of (chimeric) proteins to tissue sections is a widely used method to identify ligands and their localization. Many different protocols for the fixation of frozen tissue sections are used for in situ binding studies. We report the effects of different fixation protocols on the binding pattern observed using in situ binding of an L-selectin-IgM chimeric protein to both rat lymph node and kidney tissue sections. L-selectin is a C-type lectin, expressed on leukocytes and is involved in both lymphocyte homing and migration upon inflammation. We show that different in situ binding patterns in rat kidney are observed using different fixation protocols, including glutaraldehyde, methanol, formaldehyde and acetone fixation. The observed staining is specific, as it can be blocked in the presence of EGTA, an L-selectin blocking antibody or by ligand competition. Enzymatic pre-treatment of the tissue sections using sialidase, heparitinase I or chondroitinase ABC has differential effects on in situ binding depending on tissue type and fixation protocol. These data indicate that special attention should be paid in choosing a fixation protocol for in situ binding studies, especially when using lectins. This could prevent biologically relevant ligands remaining undetected or wrong conclusions being drawn based on the localization of observed binding.

Animals↗

PubMed2005

A new device and protocol for combining TMS and online recordings of EEG and evoked potentials.

We describe an electroencephalographic (EEG) device and protocol that allows recording of electrophysiological signals generated by the human brain during transcranial magnetic stimulation (TMS) despite the TMS-induced high-voltage artifacts. The key hardware components include slew-rate limited preamplifiers to prevent saturation of the EEG system due to TMS. The protocol involves artifact subtraction to isolate the electrophysiological signals from residual TMS-induced contaminations. The TMS compatibility of the protocol is illustrated with examples of two data sets demonstrating the feasibility of the approach in the single-pulse TMS design, as well as during repetitive TMS. Our data show that both high-amplitude potentials evoked by visual checkerboard stimulation and low-amplitude steady-state oscillations induced by auditory click-trains can be retrieved with the present protocol. The signals recorded during TMS perfectly matched control EEG responses to the same visual and auditory stimuli. The main field of application of the present protocol is in cognitive neuroscience complementing behavioral studies that use TMS to induce transient, 'virtual lesions'. Combined EEG-TMS techniques provide neuroscientists with a unique method to test hypothesis on functional connectivity, as well as on mechanisms of functional orchestration, reorganization, and plasticity.

Adult↗

PubMed2004

Evaluation of a simple membrane-based nucleic acid preparation protocol for RT-PCR detection of potato viruses from aphid and plant tissues.

A rapid and simple protocol for preparing viral RNA from aphids (Myzus persicae) and potato (Solanum tuberosum L.) tissue (leaves, sprouts, and tubers) for reverse transcription-polymerase chain reaction (RT-PCR) was developed. The four-step method involves: (1) preparing plant crude sap or aphid macerates in a buffered detergent (Triton XL-80N) solution; (2) immobilizing clarified sap on a nitrocellulose membrane; (3) performing reverse transcription using eluted water extract from cut-out spot from membrane; and (4) amplifying cDNA through PCR. The entire procedure from tissue grinding to RT-PCR can be completed within 6h. The protocol was applied successfully for the detection of individual potato viruses: carlavirus Potato virus S (PVS), potexvirus Potato virus X (PVX), potyvirus Potato virus Y (PVY), and polerovirus Potato leafroll virus (PLRV). PLRV was also detected from individual viruliferous aphids or composites of viruliferous and healthy aphids. PVY and PLRV were detected from extracts immobilized on nitrocellulose membranes, stored for more than 65-273 days at room temperature (25 degrees C). The protocol was companed with the 'long protocols' involving enzyme and phenol extraction for aphids or sodium sulfite and phenol extraction for tubers. The simplified protocol was found comparable in sensitivity to these long procedures, and is especially suitable for those regions where specialized PCR laboratories are only available in centralized locations. Viral RNA immobilized membranes can be mailed out for detection by RT-PCR to these centralized laboratories from remote areas of the country.

Animals↗

PubMed2005

Immediate and early implant loading protocols: a literature review of clinical studies.

The purpose of this literature review is to present the outcomes of clinical studies on immediate and early loading protocols, identify shortcomings, and suggest a number of questions that still require exploration. English language clinical studies, limited to peer-reviewed journals between 1975 and 2004, were reviewed to identify treatment outcomes with these loading protocols. The data were tabulated from studies reporting on patients treated with fixed and overdenture prostheses. The former included partially edentulous patients treated with single or multi-unit prostheses. Within the limitations of this review, it can be concluded that these treatment protocols are predictable in the anterior mandible, irrespective of implant type, surface topography, and prosthesis design (success rates 90%-100%). Limited evidence for the edentulous maxilla (success rates 90%-100%) and the partially edentulous patient (success rates 93%-100%) are available, underscoring the need for further research. Studies suggest that to achieve predictable results in extraction sites, implant placement should be restricted to sites without a history of periodontal involvement (success rates 61%-100%). A number of questions require further exploration. There is a need to thoroughly investigate clinical outcomes to measure the economic benefit of these protocols and the impact of treatment on a patient's quality of life. Furthermore, more accurate long-term studies reporting on treatment protocols for separate clinical situations are required to allow meaningful comparisons.

Dental Implantation, Endosseous↗

PubMed2006

Preventive effects of CIDR-based protocols on premature ovulation before timed-AI in Ovsynch in cycling beef cows.

Ovsynch is a program developed to synchronize ovulation for timed breeding. In this paper, the authors investigate whether controlled internal drug release (CIDR)-based protocols prevent premature ovulation before timed-artificial insemination (AI) when Ovsynch is started a few days before luteolysis in cycling beef cows. Nine beef cows at 16 days after oestrus were treated with (1) Ovsynch, i.e. gonadotropin releasing hormone (GnRH) analogue on day 0, prostaglandin (PG) F(2alpha) analogue on day 7 and GnRH analogue on day 9 with timed-AI on day 10, (n=3); (2) Ovsynch+CIDR (Ovsynch protocol plus a CIDR for 7 days from day 0, n=3), or (3) oestradiol benzoate (OB)+CIDR+GnRH (OB on day 0 in lieu of the first GnRH treatment, followed by the Ovsynch+CIDR protocol, n=3). In the Ovsynch group (1) plasma progesterone concentrations fell below 0.5 ng/mL earlier (day 5) than in both CIDR-treated groups (2) and (3), where this occurred on day 8. Plasma oestradiol-17beta concentrations peaked on day 8 in the Ovsynch group and on day 9 in both CIDR-treated groups. The dominant follicle ovulated on day 10 in the Ovsynch group and on day 11 in both CIDR-treated groups. Thus, both CIDR-based protocols prevented premature ovulation before timed-AI in Ovsynch when the protocol was started a few days before luteolysis. This reflects the fact that progesterone levels remained high until the beef cattle were treated with PGF(2alpha).

Administration, Intravaginal↗

PubMed2005

Rapid inpatient/outpatient desensitization for chemotherapy hypersensitivity: standard protocol effective in 57 patients for 255 courses.

OBJECTIVES: Hypersensitivity reactions (HR) to chemotherapy often prompt permanent discontinuation and deprive the patient of the most active regimen. We investigated the safety and effectiveness of a rapid desensitization protocol used in inpatient and outpatient settings for patients with HR to various chemotherapy and related agents. METHODS: A 3-solution, 12-step protocol delivered doubling drug doses by step, infusing the target dose over 5.8 h for inpatient and 3.8 h for outpatient administration. RESULTS: 57 consecutive patients who had moderate to severe HR to chemotherapy were evaluated for desensitization. All 57 patients successfully completed 255 courses of desensitization (127 to carboplatin, 114 to paclitaxel, and 14 to four other agents) where 16 patients received 51 courses in the outpatient setting (34 to carboplatin and 17 to paclitaxel). 225 courses (88.2%) were completed without any HR. 18 patients had breakthrough symptoms (BS) over 30 courses (11.8%) that were less severe than their initial HR. After management of breakthrough symptoms, these patients finished all 30 courses and tolerated subsequent desensitizations on a modified protocol. 21 of 26 patients (81%) with HR to carboplatin had positive skin tests to carboplatin. Cancer response to chemotherapy administered by desensitization was within the expected range after 1-3 years of follow-up. CONCLUSION: The rapid desensitization protocol was safe and effective in both the inpatient and outpatient settings and allowed appropriate patients with moderate to severe HR to continue chemotherapy. This study warrants the incorporation of the protocol into standard clinical practice.

Adult↗

PubMed2000

Safety and efficacy of an accelerated dobutamine stress echocardiography protocol in the evaluation of coronary artery disease.

Although dobutamine requires up to 10 minutes to achieve steady state, dobutamine stress echocardiography is routinely performed using stepwise increments at 3-minute intervals. Consequently, the full effect of any infusion rate is not attained before the dobutamine dose is advanced to the next level. This study sought to test the safety and efficiency of high-dose continuous dobutamine infusion. One hundred consecutive patients underwent an accelerated protocol using a constant infusion of 50 microg/kg/min. In the absence of a stress echocardiographic end point (>/=85% of maximal predicted heart rate, new wall motion abnormalities, hypotension, arrhythmia, or intolerable symptoms), dobutamine infusion was discontinued at 10 minutes. Hemodynamic responses and adverse effect profile were compared with 100 patients who underwent a standard stepwise dobutamine stress protocol. Peak heart rate (140 +/- 16 vs 140 +/- 19 beats/min, p = 0.95) and systolic blood pressure (169 +/- 32 vs 162 +/- 31 mm Hg, p = 0.08) were similar in both protocols. Accelerated dobutamine administration produced a rapid increase in heart rate (12.5 +/- 6.2 vs 5.7 +/- 2.6 beats/min, p <0.001), and a substantial reduction in test duration (6.4 +/- 2.4 vs 12.9 +/- 3.0 minutes, p <0.001). The mean weight-adjusted cumulative dobutamine dose was lower in the accelerated protocol group (320 +/- 111 vs 353 +/- 133 microg/kg, p = 0.016). No significant differences were noted between the 2 groups with respect to various side effects. These data demonstrate that a high-dose, single-stage dobutamine echocardiographic stress protocol is a feasible, well-tolerated alternative to standard dobutamine stress echocardiography, and results in a substantial reduction in test time while maintaining a low complication rate.

Aged↗

PubMed1999

Continuous versus separate isokinetic test protocol: the effect of estradiol on the reproducibility of concentric and eccentric isokinetic measurements in knee muscles.

OBJECTIVE: To investigate the effects of estradiol on the reliability of concentric and eccentric isokinetic measurements of knee muscles and to compare the reproducibility of measurements in a continuous test protocol and a separate test protocol. DESIGN: Repeated measurements. SETTING: A university exercise physiology laboratory. PARTICIPANTS: Twenty healthy sedentary women volunteers, aged 19 to 37 years, who had regular menstrual cycles (ranging from 27 to 35 days). Subjects were randomly divided into two groups: continuous test group (n = 10) and separate test group (n = 10) and tested at the menstrual phase (days 1 to 3) and preovulatory phase (days 12 to 14) in both legs. METHODS: Continuous reciprocal flexion-extension contractions were used in the continuous test group, and separated flexion and extension contractions were used in the separate test group. Four different test protocols were designed to determine the effects of test mode and number of contractions on the isokinetic measurements: Group A, 4 reciprocal flexion-extension repetitions at each angular velocity of 60 degrees/sec and 180 degrees/sec in one leg in the continuous test group; Group B, 4 and 20 reciprocal flexion-extension repetitions at 60 degrees/sec and 180 degrees/sec, respectively, in the contralateral leg in the same group; Group C, 4 repetitions in extensors and flexors at each angular velocity of 60 degrees/sec and 180 degrees/sec with a 5-minute rest between the two muscle groups in one leg in the separate test group; and Group D, 4 repetitions at 60 degrees/sec and 20 repetitions at 180 degrees/sec for extensors and flexors with a 5-minute rest between the two muscle groups in the contralateral leg in the same group. Blood samples were analyzed for sex hormones, creatine kinase, and lactate dehydrogenase before the tests at the menstrual phase and the preovulatory phase. In addition subjective assessment of muscle soreness was made at each blood sampling. RESULTS: Concentric and eccentric peak torque, average power, total work, and endurance ratio at both angular velocities were not significantly different in the two phases of the cycle by paired observation t test for each of the four groups. Except for concentric and eccentric endurance ratios of quadriceps and hamstrings, and concentric peak torque and average power of hamstrings at 180 degrees/sec in Group D, intraclass correlation coefficients of tested variables showed correlations that were moderate to excellent (p < .05) between two phases. In addition, there were no significant correlations between estradiol and the tested variables. Resting serum creatine kinase and lactate dehydrogenase activities and the score of muscle soreness were at the baseline and not significantly different prior to the tests performed at preovulatory and menstrual phases. CONCLUSIONS: The results suggest that: (1) reproducibility of isokinetic tests during the menstrual cycle is not influenced by sex hormone fluctuations, particularly estradiol; (2) when compared with the separate test protocol used in this study, the continuous test protocol is more appropriate to measure peak torque, average power, total work, and endurance ratio for both muscle groups of the knee even if the number of contractions is changed. However, these conclusions are specific to sedentary individuals; to make more valid conclusions, further studies with different subject groups are needed.

Adult↗

PubMed1986

Cross-over trial of superovulation protocols from two major in vitro fertilization centers.

A study was undertaken as a controlled comparison of two different superovulation induction protocols currently in use in major Australian in vitro fertilization (IVF) clinics. Thirty patients each from the Monash University and the Royal Women's Hospital (RWH) IVF programs were stimulated for ovulation induction by the other program. Once timing for oocyte retrieval was scheduled, all care reverted to the program from which the patient first came. Results given as pregnancies per patient commencing stimulation were: RWH patients on Monash protocol, 27%; RWH control patients, 15%; Monash patients on RWH protocol, 7%; Monash control patients, 13%. In the year preceding the trial pregnancy rates were 16.9% at Monash and 10.6% at RWH. Stimulation protocols were also compared with respect to each of administration, cost, and patient stress. The results of this cross-over trial demonstrated major differences between the two ovulation induction protocols studied, although it was not possible to conclude that differences in pregnancy rate were due to stimulation alone.

Adult↗

PubMed2004

Neutral zone and range of motion in the spine are greater with stepwise loading than with a continuous loading protocol. An in vitro porcine investigation.

Biomechanical testing of the spine has traditionally been performed to help understand the normal function of the spine as well as to evaluate the effects of injury and surgical procedures on spinal behaviour. The overall objective of this investigation was to compare traditional stepwise loading with the recently introduced continuous loading protocol, determining the effect of loading protocol on the mechanical behaviour of the spine. For all tests, a custom spine testing machine was used to apply pure moments of flexion extension, axial rotation, and lateral bending to a maximum of 2 Nm, using six porcine cervical spine specimens (C2-C4). Motions of C2 with respect to C4 were measured with an optoelectronic camera system. Motion parameters calculated were range of motion (ROM), neutral zone (NZ), and the ratio of NZ and ROM. The continuous loading protocol had smaller values for all motion parameters in each loading direction (p<0.05). ROM for the continuous test ranged between 88% and 93% of that of stepwise for the three loading directions. The continuous protocol NZ was 56-75% of that of the stepwise test. The findings of the study demonstrate that the two loading protocols provide differing spinal behaviours.

Animals↗

PubMed1986

A modified treadmill exercise protocol for computer-assisted analysis of the ST segment/heart rate slope: methods and reproducibility.

A new treadmill exercise protocol, modified from the standard Bruce method, was designed to improve ST segment/heart rate slope accuracy and applicability by reducing heart rate increments between exercise stages. In 150 patients exercised according to the new protocol and in 150 patients exercised according to the Bruce protocol, similar exercise tolerance and similar overall heart rate, systolic blood pressure and double product responses to exercise were observed. The mean increment in heart rate between exercise stages of the new protocol was ten beats/minute, which was significantly lower than the 27 beats/minute/stage found with the Bruce protocol. The accuracy of computer-measured ST segment depression was validated by comparison with physician measurement in a separate subgroup of patients with angina pectoris, and serial testing demonstrated stronger interest reproducibility for the ST segment/heart rate slope than for either measured ST segment depression, peak heart rate achieved or duration of exercise.

Angina Pectoris↗

PubMedDate not supplied

Intent-to-treat analysis for clinical trials: use of data collected after termination of treatment protocol.

Following patients for a period of time after termination of treatment protocols is a common practice in clinical trials of drug treatments. After termination of the protocol treatment, patients are usually provided with medical care as deemed appropriate, e.g. different doses of the same drug, augmentation with other drugs, or different drugs. Data collected on patients when they are not in the treatment protocol are termed "off-treatment" data to be differentiated from "on-treatment" data that are collected while patients are in the treatment protocol. The purpose of the present paper is to describe some recent statistical methodological advances in the use of "off-treatment" data for intent-to-treat (IT) analysis using mixture models [Biometrics 52 (1996) 1002]. Two-piece spline models conditional on the protocol treatment dropout time are developed first. The two pieces of the spline model represent the on-treatment and off-treatment segments of data and are joined at the dropout time. The weighted average of the two-piece conditional models across realizations of the dropout times provides the mixture model for the pragmatic IT analysis. The weights are the estimates of the probabilities of the dropout times. The mixture model is amenable to an explanatory analysis which assumes that the patients remain on their assigned treatments. The model allows the parameters of the splines to depend on the dropout time. Statistical inference is based on bootstrap sampling procedures. We have illustrated this methodology using data from a drug trial comparing nortriptyline and paroxetine in the treatment of major depression in older patients.

Clinical Trials as Topic↗

PubMed2000

In vivo rodent micronucleus assay: protocol, conduct and data interpretation.

In vivo rodent micronucleus assay has been widely used to detect genotoxicity. Evaluation of micronucleus induction is the primary in vivo test in a battery of genotoxicity tests and is recommended by the regulatory agencies around the globe to be conducted as part of product safety assessment. The assay, when performed appropriately, detects both clastogenicity and aneugenicity. Methods for performing micronucleus evaluation have evolved since its initial description in the 1970s. In recent years, the focus has been directed toward improving micronucleus detection with high efficiency by proposing data-based recommendations to the standard initial protocol design. Such improvements include, e.g., the use of appropriate harvest time(s), inclusion of one or both sexes, number of doses tested, limit dose, integrating micronucleus assessment into the routine toxicology studies, use of fluorescent staining, automation of micronucleus detection and assessment of micronuclei in multiple tissues. This protocol paper describes: the mechanism of micronucleus formation, a generalized protocol for manual detection, enumeration of micronuclei, and data interpretation in light of published information thus far, on the regulatory aspects of this assay. Certain recent protocol issues that are practical in nature are equally valid in relation to standard manual method and provide robust database, which are also included for consideration. It is expected that such improvements of the protocol will continue to drive the utility of this assay in the product safety assessment.

Animals↗

PubMed2003

The role of the protocol biopsies in renal allograft recipients.

Subclinical rejection and long-term cyclosporine nephrotoxicity are well-known risk factors of chronic allograft nephropathy. In a prospective study 32 low-risk patients were randomized to either a reduced CsA dose (5 mg/kg/d) and daclizumab (group A, n = 16) for 7 months posttransplant with subsequent CsA tapering/withdrawal, or to a normal CsA dose (10 mg/kg/day) without daclizumab (group B, n = 16). Both groups received MMF and prednisone. Protocol biopsies were obtained at engraftment and 3 and 12 months after Tx. The number of rejection episodes was the primary endpoint. The secondary endpoints were: renal function, histological parameters related to CsA, and serum levels of TGF-beta and PDGF-BB. A low incidence of clinically suspected rejection episodes was observed (19% in group A and 12.4% in group B; P = NS). Although protocol biopsies showed 12 subclinical rejection episodes (six in group A, six in group B), serum creatinine levels were not different between the examined groups at 3 months. However, at 12 months, there was a statistically improved mean creatinine level in group A patients (1.2 mg/dL +/- 0.5 in group A vs 1.54 mg/dL in group B; P <.05). Chronic histopathologic changes were significant for biopsies at 3 and 12 months in both groups compared to the baseline findings for protocol biopsies (with no differences between groups, or between 3 and 12 months in both groups). Serum TGF-beta and PDGF-BB did not differ between the groups. Protocol biopsies may be useful to monitor safety and efficiency of new immunosuppressive protocols. Immunosuppressive regimens with low CsA doses followed by the drug's complete withdrawal seem to be efficient and safe in low-risk kidney allograft recipients.

Adult↗