Relationship between serum low-density lipoprotein cholesterol and in-hospital mortality following acute myocardial infarction (the lipid paradox).

Lipoprotein levels are currently recognized as independent risk factors for long-term cardiovascular events after acute myocardial infarction (AMI). During the acute-phase reaction after AMI, previous studies have reported trends of decreased low-density lipoprotein cholesterol (LDL-C), increased triglycerides, and variable high-density lipoprotein cholesterol (HDL-C) levels. However, the association between LDL-C and HDL-C levels and in-hospital mortality has not been well established following AMI. The relationship between lipid levels and in-hospital all-cause mortality in 115,492 patients hospitalized for AMI (July 2002 to December 2006), registered in the National Registry of Myocardial Infarction (NRMI) 4b-5, was evaluated using multivariable-adjusted logistic regression models. Mean LDL-C was 104 ± 38, HDL-C was 41 ± 14, and triglycerides 143 ± 83 mg/dl. Compared with the lowest quartile of LDL-C (<77 mg/dl), the risk of in-hospital mortality in the second to fourth quartiles was decreased (adjusted odds ratio 0.79, 0.80, and 0.85, respectively). For HDL-C, only those in the lowest quartile (<31 mg/dl) had higher risk of in-hospital mortality (odds ratio 1.20) compared with the highest quartile (≥47 mg/dl). Results from NRMI 4b-5 suggest a lipid paradox, with lower LDL-C levels associated with increased risk of in-hospital mortality, contrary to findings outside the acute setting. Consistent with previous analyses, lowest HDL-C levels were associated with increased in-hospital mortality. In conclusion, further explorations of the relationship between very low levels of LDL-C, myocardial necrosis, and subsequent adverse cardiovascular events are warranted.

Incidence of catheter-related complications in patients with central venous or hemodialysis catheters: a health care claims database analysis.

BACKGROUND: Central venous catheter (CVC) and hemodialysis (HD) catheter usage are associated with complications that occur during catheter insertion, dwell period, and removal. This study aims to identify and describe the incidence rates of catheter-related complications in a large patient population in a United States-based health care claims database after CVC or HD catheter placement. METHODS: Patients in the i3 InVision DataMart® health care claims database with at least 1 CVC or HD catheter insertion claim were categorized into CVC or HD cohorts using diagnostic and procedural codes from the US Renal Data System, American College of Surgeons, and American Medical Association's Physician Performance Measures. Catheter-related complications were identified using published diagnostic and procedural codes. Incidence rates (IRs)/1000 catheter-days were calculated for complications including catheter-related bloodstream infections (CRBSIs), thrombosis, embolism, intracranial hemorrhage (ICH), major bleeding (MB), and mechanical catheter-related complications (MCRCs). RESULTS: Thirty percent of the CVC cohort and 54% of the HD cohort had catheter placements lasting <90 days. Catheter-related complications occurred most often during the first 90 days of catheter placement. IRs were highest for CRBSIs in both cohorts (4.0 [95% CI, 3.7-4.3] and 5.1 [95% CI, 4.7-5.6], respectively). Other IRs in CVC and HD cohorts, respectively, were thrombosis, 1.3 and 0.8; MCRCs, 0.6 and 0.7; embolism, 0.4 and 0.5; MB, 0.1 and 0.3; and ICH, 0.1 in both cohorts. Patients with cancer at baseline had significantly higher IRs for CRBSIs and thrombosis than non-cancer patients. CVC or HD catheter-related complications were most frequently seen in patients 16 years or younger. CONCLUSIONS: The risk of catheter-related complications is highest during the first 90 days of catheter placement in patients with CVCs and HD catheters and in younger patients (≤16 years of age) with HD catheters. Data provided in this study can be applied toward improving patient care.

Previous myocardial infarction as a risk factor for in-hospital cardiovascular outcomes (from the National Registry of Myocardial Infarction 4 and 5).

Patients with acute coronary syndromes have a substantial disease burden and are at continued risk of future cardiovascular events. In this setting, the relation between previous myocardial infarction (MI) and the risk of subsequent in-hospital adverse cardiovascular outcomes has not been definitively established. The data were analyzed from 427,778 hospitalized patients presenting with acute MI from July 2002 to December 2006, who were enrolled in the National Registry of Myocardial Infarction 4-5 study. Multivariate logistic regression models were developed to examine the association between a history of MI and in-hospital all-cause mortality, recurrent MI, and congestive heart failure/pulmonary edema. Covariate adjustments were made for demographic characteristics, co-morbidities, prearrival medications, and health status at presentation. Similarly, multivariate linear regression models were used to evaluate the length of stay. Of the 232,927 patients with acute MI included in the present study after exclusions, 24.7% reported a history of MI. In-hospital mortality was not significantly different between the patients with and without a history of MI (adjusted odds ratio 0.99, 95% confidence interval 0.95 to 1.04, p = 0.75). However, patients with a previous MI had a small increased risk of in-hospital recurrent MI (adjusted odds ratio 1.18, 95% confidence interval 1.08 to 1.29, p <0.001) and congestive heart failure/pulmonary edema (adjusted odds ratio 1.23, 95% confidence interval1.19 to 1.28, p <0.001) compared with patients with no history of MI. In conclusion, a history of MI did not significantly affect in-hospital mortality after admission for an acute MI.

A multi-center controlled trial of growth hormone treatment in children with cystic fibrosis.

OBJECTIVES: We evaluated safety and efficacy of recombinant human growth hormone (rhGH) for improving growth, lean body mass (LBM), pulmonary function, and exercise tolerance in children with cystic fibrosis (CF) and growth restriction. STUDY DESIGN: Multicenter, open-label, controlled clinical trial comparing outcomes in prepubertal children <14 years with CF, randomized in a 1:1 ratio to receive daily rhGH (Nutropin AQ) or no treatment (control) for 12 months, followed by a 6-month observation (month 18). Safety was monitored at each visit, including assessments of glucose tolerance. RESULTS: Sixty-eight subjects were randomized (control n = 32; rhGH n = 36). Mean height standard deviation score (SDS) in the rhGH group increased by 0.5 ± 0.4 at 12 months (mean ± SD, P < 0.001); the control group height SDS remained unchanged. Weight increased by 3.8 ± 1.8 versus 2.8 ± 1.5 kg, (mean ± SD, P = 0.0356) and LBM increased by 3.8 ± 1.8 versus 2.1 ± 1.4 kg (P = 0.0002) in the rhGH group versus controls, respectively. Forced vital capacity increased by 325 ± 319 in the rhGH group compared with 178 ± 152 ml in controls (mean ± SD, P = 0.032). Forced expiratory volume in 1 sec improved in both groups with a significant difference between groups after adjustment for baseline severity (LS mean ± SE: rhGH, 224 ± 37, vs. controls, 108 ± 40 ml; P = 0.04). There was no difference between groups in exercise tolerance (6-min walk distance) at 1 year. Changes in glucose tolerance for the two groups were similar over the 12-month study period, with three subjects developing IGT and one CFRD in each group. One rhGH-treated patient developed increased intracranial pressure. CONCLUSIONS: Treatment with rhGH in prepubertal children with CF was effective in promoting growth, weight, LBM, lung volume, and lung flows, and had an acceptable safety profile.

Tenecteplase for the improvement of blood flow rate in dysfunctional hemodialysis catheters.

BACKGROUND: We evaluated the efficacy and safety of the thrombolytic agent tenecteplase for the treatment of dysfunctional hemodialysis (HD) catheters. METHODS: Data were pooled from 2 Phase III clinical studies: the randomized, placebo-controlled TROPICS 3 trial and the open-label TROPICS 4 trial. Eligible patients received either an initial dose of tenecteplase (2 mg/lumen) or placebo (TROPICS 3 only) for a 1-h intracatheter dwell. Treatment success was defined as blood flow rate (BFR) ≥ 300 ml/min and a ≥ 25 ml/min increase from baseline BFR, without line reversal, 30 min before and at the end of HD. All TROPICS 4 patients and the TROPICS 3 patients enrolled after the final protocol amendment without treatment success received an instillation of tenecteplase at the end of the initial visit for an extended dwell of up to 72 h. RESULTS: A total of 372 patients with dysfunctional catheters were enrolled in the 2 studies. Of the 297 patients treated with tenecteplase at the initial visit, 31% achieved treatment success, with a mean (SD) change from baseline BFR of 73 (120) ml/min. Among the 179 patients who received a 1-h dwell of study drug followed by extended-dwell tenecteplase, 46% had treatment success at the end of the next HD session. Six catheter-related bloodstream infections and 2 thromboses were reported in patients following tenecteplase exposure. CONCLUSION: Tenecteplase, administered as a 1-h dwell or a 1-h dwell followed by an extended dwell, was associated with improved BFR in dysfunctional HD catheters in the TROPICS 3 and 4 clinical trials.

Clinical use of dornase alpha is associated with a slower rate of FEV1 decline in cystic fibrosis.

OBJECTIVES: Randomized controlled trials of dornase alpha have shown forced expiratory volume in 1 sec (FEV(1) ) to improve in patients with cystic fibrosis (CF) but have not assessed change in the rate of lung function decline. We assessed the relationship of dornase alpha use and FEV(1) decline using the Epidemiologic Study of Cystic Fibrosis (ESCF). METHODOLOGY: Patients aged 8-38 years who had been enrolled in ESCF for 2 years when initially treated with dornase alpha were selected if they remained on treatment during the following 2 years. A comparator group included patients aged 8-38 who were not yet reported to have received dornase alpha. For each patient we estimated the annual rate of decline in FEV(1) % predicted before and after the index using a mixed-effects model adjusted for age, gender, pulmonary exacerbations, respiratory therapies, and nutritional supplements. RESULTS: The dornase alpha group (n = 2,230) had a lower FEV(1) % predicted at index and a more rapid decline during the pre-index period. The mean rate of FEV(1) decline improved for the dornase alpha group; the improvement was similar in adults and children 8-17 years old but was not statistically significant in adults. The comparator group (n = 5,970) showed no change among adults and an increased rate of decline among children 8-17 years old. CONCLUSIONS: The use of dornase alpha for a 2-year period is associated with a reduction in the rate of FEV(1) decline. These results also demonstrate the value of using an observational study to assess the association of instituting new therapies in the clinical setting with changes in the rate of FEV(1) decline in patients with CF.

Improvement of hemodialysis catheter function with tenecteplase: a phase III, open-label study: TROPICS 4.

Hemodialysis (HD) catheters are prone to thrombotic occlusion. We evaluated tenecteplase, a thrombolytic, for the treatment of dysfunctional HD catheters. Patients with tunneled HD catheters and blood flow rate (BFR) <300 mL/min received open-label tenecteplase (2 mg/lumen) for a 1 h intracatheter dwell. Treatment success was defined as BFR ≥ 300 mL/min and a ≥ 25 mL/min increase from baseline BFR, 30 min before and at the end of HD. Patients without treatment success at the end of the initial visit received another 2 mg dose of tenecteplase for an up to 72 h extended dwell. Of 223 enrolled patients, 34% (95% confidence interval [CI], 28-40%) had treatment success after a 1 h dwell. Mean (standard deviation [SD]) BFR change from baseline was 82 (124) mL/min. Treatment success in those who received extended-dwell tenecteplase (n = 116) was 49% (95% CI, 40-58%), with mean (SD) BFR change from baseline of 117 (140) mL/min. Reported targeted adverse events included five catheter-related bloodstream infections and one thrombosis. No intracranial hemorrhage, major bleeding, embolic events, or catheter-related complications were reported. Tenecteplase administered as a 1 h or 1 h plus extended dwell was associated with improved HD catheter function in the TROPICS 4 trial.

Pulmonary outcome prediction (POP) tools for cystic fibrosis patients.

RATIONALE: Loss of lung function in patients with cystic fibrosis (CF) is associated with increased mortality and varies between individuals and over time. Predicting this decline could improve patient management. OBJECTIVES: To develop simple pulmonary outcome prediction (POP) tools to estimate lung function at age 6 in patients aged 2-5 years (POP(2-5)) and lung function change over a 4-year period in patients aged 6-17 years (POP(6-17)). METHODS: Analyses were conducted using patients from the Epidemiologic Study of CF (ESCF). To be included in any analysis, patients had to have 1 year of clinical history recorded in ESCF prior to a clinically stable routine Index Clinic Visit (ICV). In addition to this criterion, for the POP(2-5) tool patients had to be between 2 and 5 years old at ICV and have a second clinically stable visit with spirometric measures at age 6. For the POP(6-17) tool, patients had to be between the ages of 6 and 17 years old at an ICV that included spirometric measures and had to have a second clinically stable visit with spirometric measures from 3 to 5 years after ICV. All patients enrolled in ESCF who met these inclusion criteria were studied. POP(2-5) and POP(6-17) populations were further divided into development groups (with ICV before January 1, 1998) and validation groups (with ICV after that date). Development groups were used to model forced expiratory volume in 1 sec (FEV(1)) percent predicted at age 6 years (for POP(2-5)) and annualized FEV(1) % predicted change from ICV to the second visit (for POP(6-17)) by multivariable linear regression using age, sex, weight-for-age percentile, cough, sputum production, clubbing, crackles, wheeze, sinusitis, number of exacerbations requiring intravenous antibiotics in the past year, elevated liver enzymes, pancreatic enzyme use, and respiratory tract culture status, plus height-for-age percentile (POP(2-5)) and index FEV(1) (POP(6-17)). Integer-based POP(2-5) and POP(6-17) tools created from selected variables were evaluated by Pearson correlation and then prospectively validated with separate data collected later from ESCF patients with ICV after January 1, 1998. MAIN RESULTS: POP(2-5) and POP(6-17) development groups included 2,709 and 6,113 patients and validation groups included 3,458 and 7,086 patients, respectively. Variables retained were weight-for-age percentile, clubbing, crackles, wheeze, number of exacerbations, and Pseudomonas aeruginosa culture status (both tools), daily cough (POP(2-5)), and age, sex, and index FEV(1) % predicted (POP(6-17)). Correlation coefficients for POP(2-5) and POP(6-17) tools prospectively applied to validation groups were +0.32 and +0.37, respectively. CONCLUSIONS: These simple integer-based POP algorithms employ variables available at clinic visits and can be used to predict the probability of different future pulmonary outcomes for individual patients and patient populations.

Year-to-year changes in lung function in individuals with cystic fibrosis.

BACKGROUND: We examined the year-to-year change in FEV(1) for individuals and the overall cystic fibrosis population to better understand how individual trends may differ from population trends. METHODS: We calculated individual yearly changes using the largest annual FEV(1) percent predicted (FEV(1)%) measurement in 20,644 patients (6-45years old) included in the Epidemiologic Study of Cystic Fibrosis. We calculated yearly population changes using age-specific medians. RESULTS: FEV(1)% predicted decreased 1-3 points per year for individuals, with maximal decreases in 14-15year olds. Population changes agreed with individual changes up to age 15; however after age 30, yearly population change approximated zero while individual FEV(1)% predicted decreases were 1-2 points per year. CONCLUSIONS: Adolescents have the greatest FEV(1)% predicted decreases; however, loss of FEV(1) is a persistent risk in 6-45year old CF patients. Recognizing individual year-to-year changes may improve patient-specific care and may suggest new methods for measuring program quality.

Decreased regurgitation with a soy formula containing added soy fiber.

The objective of this randomized study was to determine if fiber-supplemented soy formula reduced regurgitation in young infants. We compared regurgitation in 179 infants randomly assigned cow's milk-based (CM, 90) formula or soy formula with fiber (SF, 89). Initial daily incidence was similar (CM, 3.6; SF, 3.9 episodes), but significantly lower after 7 days on SF (CM, 3.4; SF, 2.3; p = 0.001). Less frequent regurgitation after 7 days on SF was sustained after 28 days (CM, 48%; SF, 31% of feedings; p = 0.001). Feeding SF effectively managed regurgitation while providing balanced nutrition without altering caloric distribution as occurs with adding rice cereal to formula.

Visual, cognitive, and language assessments at 39 months: a follow-up study of children fed formulas containing long-chain polyunsaturated fatty acids to 1 year of age.

OBJECTIVE: Docosahexaenoic acid (DHA) and arachidonic acid (ARA) are long-chain polyunsaturated fatty acids found in breast milk and recently added to infant formulas. Their importance in infant nutrition was recognized by the rapid accretion of these fatty acids in the brain during the first postnatal year, reports of enhanced intellectual development in breastfed children, and recognition of the physiologic importance of DHA in visual and neural systems from studies in animal models. These considerations led to clinical trials to evaluate whether infant formulas that are supplemented with DHA or both DHA and ARA would enhance visual and cognitive development or whether conversion of linoleic acid and alpha-linolenic acid, the essential fatty acid precursors of ARA and DHA, respectively, at the levels found in infant formulas is sufficient to support adequately visual and cognitive development. Visual and cognitive development were not different with supplementation in some studies, whereas other studies reported benefits of adding DHA or both DHA and ARA to formula. One of the first trials with term infants that were fed formula supplemented with DHA or both DHA and ARA evaluated growth, visual acuity (Visual Evoked Potential; Acuity Card Procedure), mental and motor development (Bayley Scales of Infant Development), and early language development (MacArthur Communicative Developmental Inventories). Growth, visual acuity, and mental and motor development were not different among the 3 formula groups or between the breastfed and formula-fed infants in the first year of life. At 14 months of age, infants who were fed the formula with DHA but no ARA had lower vocabulary production and comprehension scores than infants who were fed the unsupplemented control formula or who were breastfed, respectively. The present follow-up study evaluated IQ, receptive and expressive vocabulary, visual-motor function, and visual acuity of children from the original trial when they reached 39 months of age. METHODS: Infants were randomized within 1 week after birth and fed a control formula (n = 65), one containing DHA (n = 65), or one containing both ARA and DHA (n = 66) to 1 year of age. A comparison group (n = 80) was exclusively breastfed for at least 3 months after which the infants continued to be exclusively breastfed or were supplemented with and/or weaned to infant formula. At 39 months, standard tests of IQ (Stanford Binet IQ), receptive vocabulary (Peabody Picture Vocabulary Test-Revised), expressive vocabulary (mean length of utterance), visual-motor function (Beery Visual-Motor Index), and visual acuity (Acuity Card Procedure) were administered. Growth, red blood cell fatty acid levels, and morbidity also were evaluated. RESULTS: Results were analyzed using analysis of variance or linear regression models. The regression model for IQ, receptive and expressive language, and the visual-motor index controlled for site, birth weight, sex, maternal education, maternal age, and the child's age at testing. The regression model for visual acuity controlled for site only. A variable selection model also identified which of 22 potentially prognostic variables among different categories (feeding groups, the child and family demographics, indicators of illness since birth, and environment) were most influential for IQ and expressive vocabulary. A total of 157 (80%) of the 197 infants studied at 12 months participated in this follow-up study. Characteristics of the families were representative of US families with children up to 5 years of age, and there were no differences in the demographic or family characteristics among the randomized formula groups. As expected, the formula and breastfed groups differed in ethnicity, marital status, parental education, and the prevalence of smoking. Sex, ethnicity, gestational age at birth, and birth weight for those who participated at 39 months did not differ from those who did not. The 12-month Bayley mental and motor scores and 14-month vocabulary scores of the children who participated also were were not different from those who did not. At 39 months, IQ, receptive and expressive language, visual-motor function, and visual acuity were not different among the 3 randomized formula groups or between the breastfed and formula groups. The adjusted means for the control, ARA+DHA, DHA, and breastfed groups were as follows: IQ scores, 104, 101, 100, 106; Peabody Picture Vocabulary Test, 99.2, 97.2, 95.1, 97.4; mean length of utterance, 3.64, 3.75, 3.93, 4.08; the visual-motor index, 2.26, 2.24, 2.05, 2.40; and visual acuity (cycles/degree), 30.4, 27.9, 27.5, 28.6, respectively. IQ was positively associated with female sex and maternal education and negatively associated with the number of siblings and exposure to cigarette smoking in utero and/or postnatally. Expressive language also was positively associated with maternal education and negatively associated with the average hours in child care per week and hospitalizations since birth but only when the breastfed group was included in the analysis. The associations between maternal education and child IQ scores are consistent with previous reports as are the associations between prenatal exposure to cigarette smoke and IQ and early language development. Approximately one third of the variance for IQ was explained by sex, maternal education, the number of siblings, and exposure to cigarette smoke. Growth achievement, red blood cell fatty acid levels, and morbidity did not differ among groups. CONCLUSIONS: We reported previously that infants who were fed an unsupplemented formula or one with DHA or with both DHA and ARA through 12 months or were breastfed showed no differences in mental and motor development, but those who were fed DHA without ARA had lower vocabulary scores on a standardized, parent-report instrument at 14 months of age when compared with infants who were fed the unsupplemented formula or who were breastfed. When the infants were reassessed at 39 months using age-appropriate tests of receptive and expressive language as well as IQ, visual-motor function and visual acuity, no differences among the formula groups or between the formula and breastfed groups were found. The 14-month observation thus may have been a transient effect of DHA (without ARA) supplementation on early vocabulary development or may have occurred by chance. The absence of differences in growth achievement adds to the evidence that DHA with or without ARA supports normal growth in full-term infants. In conclusion, adding both DHA and ARA when supplementing infant formulas with long-chain polyunsaturated fatty acids supports visual and cognitive development through 39 months.

Immune status of infants fed soy-based formulas with or without added nucleotides for 1 year: part 1: vaccine responses, and morbidity.

BACKGROUND: Immunologic development of soy-fed infants has not been extensively studied. Early studies of soy flour-based formulas showed decreased immunoglobulin production when soy protein intake was limited. However, there were no significant differences in rotavirus vaccine responses between breast-fed and soy protein isolate-based formula-fed infants. Nucleotides added to milk-based formula benefit infant immune status, but reports of the immunologic effects of adding nucleotides to soy-based formula are not available. This study evaluated immune status and morbidity of infants fed soy protein isolate formulas with and without added nucleotides for 1 year. METHODS: Newborn, term infants enrolled in a masked 12-month feeding trial were assigned randomly to groups fed soy formula with or without added nucleotides (n = 94, n = 92). A nonrandomized human milk/formula cohort (n = 81) was concurrently enrolled. Recommended immunizations were administered at 2, 4, and 6 months. Immune status was determined from antibody responses to Haemophilus influenzae type b, tetanus, diphtheria, and poliovirus vaccines at 6, 7, and 12 months. Parents and physicians reported morbidity data. RESULTS: All vaccine responses were within normal ranges. No response differences were observed between infants fed soy formula and those fed nucleotide-supplemented soy. However, antibody to H. influenzae type b at 7 and 12 months was higher in infants fed nucleotide-supplemented soy than in infants fed human milk/formula ( P = 0.007, P = 0.008, respectively). Human milk/formula-fed infants had higher poliovirus neutralizing antibody at 12 months than did soy-fed infants ( P = 0.016). Morbidity analyses showed that only physician-reported diarrhea was different among groups (groups fed human milk/formula had less diarrhea than did soy groups, P = 0.011). CONCLUSIONS: Term infants fed soy protein isolate-based formulas have normal immune development as measured by antibody responses to childhood immunizations.

Immune status of infants fed soy-based formulas with or without added nucleotides for 1 year: part 2: immune cell populations.

BACKGROUND: Infants fed a soy protein isolate-based formula have immunization responses similar to breast-fed infants. However, cellular aspects of the immunologic development of soy-fed infants have not been studied extensively. Nucleotides added to milk-based formula benefit infant immune status, but reports of the immunologic effects of adding nucleotides to soy-based formula are not available. This study examines immune cell populations of infants fed soy protein isolate formulas with and without added nucleotides for 1 year. METHODS: Newborn, term infants studied in a masked 12-month feeding trial were assigned randomly to soy formula groups with and without added nucleotides (n = 94, n = 92). A nonrandomized human milk/formula-fed cohort (n = 81), was concurrently enrolled. Blood samples were collected at 6, 7, and 12 months. Thirty-two immune cell populations were characterized using three-color flow cytometry. Cellular markers were chosen to assess general pediatric immune status, emphasizing maturation and activation of B, T, and NK lymphocytes. RESULTS: All cell populations, number and percentages, were within age-related normal ranges. The only significant difference found between soy formula and human milk/formula-fed infants was the percentage of CD57 + NK T cells at 12 months (human milk/formula > soy formula, P = 0.034). There were significant differences at some time points between human milk/formula-fed and nucleotide-supplemented soy formula-fed infants in populations of lymphocytes, eosinophils, total T, helper T, naive helper, memory/effector helper, CD57 - T, and CD11b + CD8 + NK cells. None of the cell populations differed between infants fed soy formula versus soy plus nucleotides. CONCLUSIONS: Infants fed this commercial soy formula demonstrated immune cell status similar to human milk/formula-fed infants, consistent with normal immune system development. The addition of nucleotides to soy formula did not significantly change specific individual immune cell populations but tended to increase numbers and percentages of T cells and decreased numbers and percentages of NK cells.