Doppler ultrasonography in suspected intrauterine growth retardation: a randomized clinical trial. Periodontal regeneration of human intrabony defects with bioresorbable membranes. A controlled clinical trial. Low molecular mass heparin instead of unfractionated heparin during infrainguinal bypass surgery. Patient self-testing is a reliable and acceptable alternative to laboratory INR monitoring. Antithrombin treatment in patients with traumatic brain injury: a pilot study. Double blind trial comparing the effects of two doses of growth hormone in prepubertal patients with chronic renal insufficiency. Modulation of growth factors by growth hormone in children with chronic renal failure. The Southwest Pediatric Nephrology Study Group. A multi-center controlled trial of growth hormone treatment in children with cystic fibrosis. Intravenous gamma-globulin for Kawasaki disease.
A randomized clinical trial was performed to test the hypothesis that if suspected intrauterine growth retardation (IUGR) is associated with normal umbilical artery Doppler ultrasound findings, hospitalization can safely be avoided. One hundred and fifty women with singleton pregnancies and suspected IUGR were randomized between an intervention (n = 74) and a control group (n = 76). In the intervention group, clinicians were strongly requested not to hospitalize for suspected IUGR if the Doppler findings were normal. In the control group, the Doppler results were not revealed and the participants received the standard management for suspected IUGR. Endpoints of the trial were: costs in terms of hospitalization, perinatal outcome, neurological development, and postnatal growth. Duration of hospitalization was significantly shorter in the intervention group than in the control group. Contrary to expectations, the hospitalization rate during pregnancy in the intervention group was not below that of the control group. This negative finding was partly due to the admission of patients in the intervention group despite their normal Doppler results. Moreover, the trial might have induced a more critical attitude towards hospitalization in suspected IUGR, decreasing admission in the control group. No clear differences were found in perinatal outcome, neurological development, or postnatal growth. The results suggest that normal umbilical artery Doppler findings in suspected cases of IUGR justify outpatient management. The purpose of this controlled clinical trial was to compare the clinical efficacy of 3 treatment modalities in the treatment of deep interproximal intrabony defects. Thirty-six (36) defects in 36 patients were randomly assigned to 1 of 3 treatment groups by blocking to prognostic variables. The test was treated with bioresorbable membranes positioned coronal to the interproximal bone crest; the second group (membrane control) was treated with conventional non-resorbable (ePTFE) barrier membranes applied coronal to the alveolar crest; the third group (flap Control) was treated with an access flap procedure (MWF). No differences were observed in terms of baseline oral hygiene and defect characteristics among the 3 groups, indicating that the blocking approach was effective. A stringent infection control program was enforced for 1 year. The results indicated that: 1) at 1 year all treatment modalities resulted in clinically significant improvements in clinical attachment levels (CAL) and reductions in probing depths; 2) a statistically significant treatment effect (P < 0.0001, ANOVA) was observed comparing the test (4.6 +/- 1.2 mm), the membrane control (5.2 +/- 1.4 mm), and the flap control groups (2.3 +/- 0.8 mm) in terms of CAL gain; 3) differences in terms of CAL gain between the test (bioresorbable) and the membrane control (ePTFE) groups were not statistically significant (P = 0.19, t-test); 4) both the test and the membrane control groups gained significantly more CAL at 1 year than the MWF group (P < 0.0001, t-test). CAL gains > or = 4 mm were observed in 83.3% of cases in both GTR groups, while CAL gains of this magnitude were not detected in the MWF group. We concluded that clinically significant CAL gains can be obtained with GTR procedures using both bioresorbable and non-resorbable membranes. Patients' morbidity, however, was lower in the group treated with bioresorbable membranes. To test whether low molecular mass heparin (LMMH) is comparable to unfractionated heparin (UFH) as an anticoagulant during infrainguinal bypass surgery and to investigate laboratory evidence of hypercoagulation in patients undergoing infrainguinal bypass surgery.
                Eighteen patients were randomised to receive either UFH or LMMH (70 anti-Xa units/kg b.w.). Soluble fibrin, measured as fibrin monomers (FM) and fibrinopeptide A (FPA), were measured in blood from the femoral vein before, during and after release of the occluding clamps during surgery. In addition, fibrinogen prothrombin complex, thrombin-antithrombin complex, platelets and antithrombin were measured before surgery. Heparin levels (Anti Xa) were measured during surgery.
                Increased levels of fibrinogen, FPA, thrombin antithrombin complex and FM were recorded prior to surgery. During surgery no further increase was noted. The anti Xa levels were slightly higher in patients with LMMH than in patients receiving UFH. Levels of FM were significantly lower in patients receiving LMMH. No difference in FPA was noted. A positive correlation between fibrinogen and FPA and FM respectively was recorded. Four patients, two in each group, were reoperated for graft occlusion. One patient in the UFH group required reoperation because of bleeding.
                LMMH is comparable to UFH as an anticoagulant during infrainguinal bypass surgery. Variables reflecting hypercoagulability are elevated in this group of patients and are positively correlated to the fibrinogen level. High fibrinogen levels could thus be a risk for perioperative thrombosis. SAn ageing population and the continuing expansion of clinical indications for coumadin therapy have increased pressure on hospital anticoagulant clinics. One solution is patient self-testing (PST) of the international normalized ratio (INR) using capillary blood samples on point-of-care coagulation monitors at home. We conducted a prospective study to determine whether patients can achieve accurate INR values through PST, using the CoaguChek S (Roche Diagnostics, Lewes, UK). The main outcome measurements were: comparability of INR values obtained by PST and the hospital laboratory, patient acceptability as assessed by a questionnaire and anticoagulant control. Eighty-four patients [53 men, 31 women; median age 59 years (range 26-83)], receiving long-term oral anticoagulation (warfarin), were recruited from our Anticoagulation Clinic. Patients were randomized to weekly self-testing or continuing 4-weekly hospital laboratory monitoring of INR. Comparison of INRs (n = 234) showed no significant differences between the CoaguChek (median INR 3.02) and laboratory testing (median INR 3.07). There was excellent correlation between the two methods (r = 0.95), with 85% of CoaguChek results within 0.5 INR units of the laboratory method. On four occasions, differences of >1 unit INR were obtained, but in each case the patient's anticoagulation was unstable (INR >4.5 by both methods) and the differences in INR would not have altered patient management. 87% of patients found self-testing straightforward, 87% were confident in the result they obtained and 77% preferred self-testing. We conclude that PST is a reliable alternative to hospital clinic attendance and is acceptable to the majority of suitably trained patients. This study will determine if early administration of antithrombin concentrate to patients with traumatic brain injury (TBI) can inhibit or significantly shorten the time of coagulopathy. The progress of brain injury monitored by computed tomographic scan (CT) was also assessed, as was the time needed for intensive care and outcome related to Glasgow outcome scale (GOS). Twenty-eight patients with isolated brain trauma verified with CT were included in either of two parallel groups. The Glasgow coma score (GCS) was mean 7.5, and median 7.0; signifying a moderate to severe traumatic brain injury but with a mortality of only 3.5%. The patients randomized to antithrombin treatment received a total of 100 U/kg BW during 24 hours. To measure hypercoagulability, soluble fibrin (SF), D-dimer (D-d), and thrombin-antithrombin complex (TAT) were assessed together with antithrombin (AT) and routine coagulation tests. Before treatment, SF, D-d, and TAT were markedly increased in both groups. Soluble fibrin and D-dimer (measured after treatment began) appeared to decrease faster in the AT group, and there was a statistically significant difference between the groups at 36 hours for SF and at 36 hours, 48 hours, and at Day 3 for D-d. Thrombin-antithrombin complex levels were very high in both groups but, surprisingly, showed no significant difference between the groups. The authors conclude that antithrombin concentrate administered to patients with severe TBI resulted in a marginal reduction of hypercoagulation. We could not detect any obvious influence by antithrombin on brain injury progress, on CT, or on outcome or time needed for intensive care. Growth retardation is a major problem for children with chronic renal insufficiency (CRI). Recent studies have convincingly shown that recombinant human GH accelerates growth significantly, but the optimal GH dose with regard to long term growth response and safety has not yet been established. GH therapy was given to 23 prepubertal children (18 boys and 5 girls; mean +/- SD age, 7.1 +/- 3.6 yr; range, 1.6-14.1) with CRI and severe growth retardation in a double blind, dose-response trial. Patients were randomly assigned to either 2 or 4 IU GH/m2.day for 2.5 yr. During the first 6 months, there were comparable and significant increases in height velocity SD score for chronological age with both doses (P < 0.001). However, during the ensuing 2 yr, the higher GH dose induced a significantly greater improvement in height velocity SD score for chronological age than 2 IU GH. Catch-up growth was only sustained for 2.5 yr with 4 IU. In contrast, catch-up growth ceased after 6 months with 2 IU. Neither 2 nor 4 IU GH resulted in accelerated bone maturation during 2.5 yr of therapy. There was a significant increase in plasma insulin-like growth factor-I (IGF-I) levels with either dose, but significantly more so with 4 IU. Plasma IGF-II levels only increased significantly with 4 IU. The pretreatment elevation of IGF-binding protein-1 (IGFBP-1) levels decreased by 50% during the first study year with the higher GH dose, whereas there was no decrease with 2 IU. The elevated pretreatment IGFBP-3 levels increased comparably and significantly with either GH dose. Interestingly, only 4 IU resulted in a significantly greater increase in IGF-I than in IGFBP-3 levels. Regardless of GH dose, there was an insignificant decrease in fructosamine levels, whereas lipid and parathyroid concentrations remained constant. Renal function deterioration did not accelerate. GH therapy with 4 IU/m2.day induced and maintained catch-up growth during 2.5 yr in children with CRI without evidence of adverse effects. Bone maturation did not accelerate. This suggests that this higher GH dose may be beneficial for children with severe growth retardation secondary to CRI. Anthropometric measurements and circulating growth factors were studied serially in 44 prepubertal children with growth failure and chronic renal failure (GFR = 10 to 40 ml/min/1.73 m2) who were randomized to receive either recombinant human growth hormone (rhGH; N = 30) or no treatment (N = 14). RhGH was given as Nutropin, 0.05 mg/kg/day, and the studies were carried out at baseline and after 3 and 12 months. At baseline, serum insulin-like growth factor binding protein (IGFBP)-1 and -2 levels were, while IGFBP-3 levels were not, higher than those of children with normal renal function. In addition, height SDS at baseline correlated inversely with serum IGFBP-2 levels (r = -0.461, P = 0.0016), but did not correlate significantly with any other factor. After 12 months of study, the 30 children receiving rhGH showed: (i) greater increase in height (9.1 +/- 2.8 vs. 5.5 +/- 1.9 cm, P < 0.0001); (ii) increases in serum levels of IGF-I, IGF-II, free IGF-I, IGFBP-3 and acid labile subunit (ALS); (iii) a greater decrease in serum IGFBP-1 levels; and (iv) no significant difference in serum IGFBP-2 levels, when compared to the 14 control patients. The change in height SDS after 12 months of rhGH (+0.8) in the 30 treated children correlated significantly and positively with serum ALS, IGFBP-3, total IGF, IGF-I, IGF-II and free IGF-I levels measured during treatment. These observations suggest that, in children with growth failure associated with chronic renal failure: (i) IGFBP-2, and not IGFBP-3, is likely to be a growth inhibitor; (ii) rhGH stimulates catch-up growth in part by increasing serum levels of IGF peptides; and (iii) linear growth is influenced by the balance between growth stimulating IGFs and growth inhibitory IGFBPs. 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.
                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.
                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.
                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.
                Copyright © 2011 Wiley Periodicals, Inc. We studied the effect of gamma-globulin (IVGG) and aspirin (ASA) on the development of the coronary artery lesions (CAL) of Kawasaki disease (KD) in three different protocols. Within 29 days of the onset of KD the echocardiographic evidence of CAL had developed in 39-42% of the patients in the ASA group, but only in 13.7-20.8% of the patients treated with IVGG (200 or 400 mg/kg X 5). In long-term follow-up observation of CAL of these patients the evidence of CAL in both the ASA and the IVGG group regressed gradually; however, the residual rate of CAL was significantly low in the IVGG group at all times up to 24 months after onset. These facts suggest that when using IVGG for KD, we should select a dose of intact gamma-globulin, 1,000 mg/kg or more in total, to prevent the occurrence of CAL. We have demonstrated not only a significant reduction in the occurrence of CAL in patients treated with IVGG but a reduction in the residual rate of CAL for two years as compared with those treated by ASA.
There is insufficient evidence to determine whether SFH measurement is effective in detecting IUGR. We cannot therefore recommended any change of current practice. Further trials are needed.