Endoscopic ultrasound cannot determine suitability for esophagectomy after aggressive chemoradiotherapy for esophageal cancer.

OBJECTIVE: Endoscopic ultrasound (EUS) provides important information in the initial staging of patients with esophageal cancer. With recent modifications in chemoradiotherapy protocols, a significant number of patients have no residual tumor at esophagectomy. The high surgical morbidity and mortality might be avoided if complete response to chemoradiotherapy could be predicted. Previously published clinical trials, with relatively small patient numbers, have suggested that EUS may accurately stage esophageal cancer after chemoradiotherapy. The aim of this study was to verify the accuracy of EUS in staging esophageal cancer after effective chemoradiotherapy. METHODS: EUS staging was performed before and after concurrent cisplatin, 5-fluorouracil, and hyperfractionated radiotherapy in 59 patients with newly diagnosed esophageal cancer. All patients underwent subsequent esophagectomy and pathological staging. The accuracy of preoperative, postchemoradiotherapy EUS was evaluated in a retrospective fashion by comparison to pathological staging. RESULTS: After chemoradiotherapy, 18 patients (31%) had no residual disease at pathological staging (T0N0). However, EUS correctly predicted complete response to chemoradiotherapy (T0N0) in only three patients (17%). The accuracy of postchemoradiotherapy EUS for pathological T stage was only 37%, and its sensitivity for N1 disease was only 38%. EUS was unable to distinguish postradiation fibrosis and inflammation from residual tumor. CONCLUSION: When aggressive preoperative chemoradiotherapy is provided to patients with esophageal cancer, the predictive value of postchemoradiotherapy EUS is inadequate for use in clinical decision making.

First-morning urine specific gravity and enuresis in preschool children.

The object of the study was to determine whether a first-morning urine specific gravity of less than or equal to 1.015 was associated with enuresis in children 3 to 6 years old. Parents of preschool children seen at the Cleveland Clinic Foundation during a 5-month period completed a questionnaire concerning bed-wetting and voiding habits of their child and collected first-morning urine specimens for specific gravity analysis. Of 101 children, 12 had a urine specific gravity of less than or equal to 1.015 (11.9%), including seven of 73 (9.6%) nonbed-wetters, two of 19 (10.5%) bed-wetters by history (who did not wet their beds on the night of the study), and three of nine (33.3%) bed-wetters (who wet their beds on the night of the study). The 73 nonbed-wetters (72.3%) had a mean (+/- standard deviation) urine specific gravity of 1.022 (+/- 0.006); 19 bed-wetters by history (18.9%) had a mean urine specific gravity of 1.024 (+/- 0.006); and nine bed-wetters (8.9%) had a mean urine specific gravity of 1.019 (+/- 0.005). The groups' mean urine specific gravities were not significantly different (p = 0.10) and the enuretic children were not more likely to have first-morning-void urine specific gravity of less than or equal to 1.015 than nonenuretic children (p = 0.14). Enuretic children who wet their beds on the night of the study had lower mean urine specific gravity than nonbed-wetters although the difference was not significant. Therefore, we do not recommend routine use of first warning void urine specific gravity analysis for predicting presence or absence of enuresis.

Randomized, single-blinded comparative study of the efficacy of amoxicillin (40 mg/kg/day) versus standard-dose penicillin V in the treatment of group A streptococcal pharyngitis in children.

A 10-day course of amoxicillin at a dosage of 40 mg per kilogram per day was compared with conventional (lower dosage) penicillin V therapy in the treatment of culture-proven Group A streptococcal pharyngitis in children 3 to 18 years of age in a prospective, randomized, and single-blinded study. Children had to have signs and symptoms compatible with the diagnosis of streptococcal pharyngitis and to have a throat swab positive for Group A streptococci. A second throat culture was obtained 10 to 14 days after the completion of therapy. Serotyping was performed to help differentiate carrier states from reinfections. Of 161 children enrolled, 113 were evaluable; 55 received penicillin and 58 received amoxicillin. At the completion of therapy 70.9% (39/55) of patients in the penicillin group vs 87.9% (51/58) of patients in the amoxicillin group were asymptomatic (clinical cure, P = 0.025). At the completion of therapy, 54.5% (30/55) of patients in the penicillin group vs 79.3% (46/58) of patients in the amoxicillin group had negative throat cultures (bacteriologic cure, P = 0.005). The carrier rate (children who were well but who were still carrying the same serotype of Group A streptococcus) also differed between the groups: 13 (23.6%) in the penicillin group compared with six (10.3%) in the amoxicillin group. Amoxicillin at 40 mg/kg/day was significantly more effective than lower dosages of penicillin V for clinical and bacteriologic cure in the treatment of Group A streptococcal pharyngitis in children. The current perception that penicillin is declining in effectiveness may be due to inadequate dosing.

Comparison study of the immunogenicity and safety of 5- and 10-microgram dosages of a recombinant hepatitis B vaccine in healthy infants.

BACKGROUND: It has been suggested that lower dosages of hepatitis B vaccine may be adequate for vaccinating infants and would be less costly. OBJECTIVES: To compare the immunogenicity and safety of 5 and 10 micrograms of Engerix-B recombinant hepatitis B vaccine given to healthy infants. METHODS: A prospective randomized comparison of 5- and 10-micrograms doses of Engerix-B recombinant hepatitis B vaccine given to infants at 2, 4 and 6 months of age. Seroconversion (antihepatitis B surface antigen (anti-HBs) > or = 1 mIU/ ml) and seroprotection (anti-HBs > or = 10 mIU/ml) rates as well as geometric mean antibody titers were compared at 4, 6 and 8 months. RESULTS: A total of 190 healthy infants were screened and received the first dose of vaccine. Of these infants 153 were eligible to continue in the study. Both dosages proved to be highly immunogenic, producing high seroconversion and seroprotection rates and geometric mean anti-HBs concentrations after 3 doses. Although 10 micrograms induced significantly greater geometric mean concentrations (1641 mIU/ml compared 880 mIU/ml at 8 months of age), the seroprotection rates were identical (98.5%). CONCLUSIONS: Both dosages were well-tolerated and no serious adverse experiences were reported. However, the 5 micrograms of Engerix-B administered at 2, 4 and 6 months of age did not induce as great an anti-Hbs concentration as did 10 micrograms. Long term studies are required to determine whether using the lower dosage would sacrifice long term efficacy.

Comparison study of the immunogenicity and safety of 5- and 10-microgram dosages of a recombinant hepatitis B vaccine in healthy children.

OBJECTIVE: To compare the immunogenicity and safety of 5 micrograms with 10 micrograms of Engerix-B recombinant hepatitis B vaccine when given to healthy children, 2 to 6 years of age. METHODS: Randomized multicenter study of serongative children 2 to 6 years of age who received Engerix-B hepatitis B vaccine either 5 micrograms/0.25 ml or 10 micrograms/0.5 ml (the current Food and Drug Administration-approved dosage of Engerix-B in children) at 0, 1 and 6 months. Serum was obtained at 1, 3, 6 and 8 months after the first vaccine dose was given for antibody measurement. RESULTS: A total of 223 subjects were screened and received the first dose of vaccine. Of these subjects 193 continued in the study. Both dosages proved to be highly immunogenic, producing high seroconversion and seroprotection rates and geometric mean antibody to hepatitis B surface antigen concentrations after 3 doses. The geometric mean concentrations of seroconverters at Months 6 and 8 were significantly greater for the 10-micrograms group compared with the 5-micrograms group. Both dosages were well-tolerated and no serious adverse events were reported. CONCLUSIONS: There was a significant reduction in geometric mean concentrations on lowering the dosage of Engerix-B from 10 to 5 micrograms in children 2 to 6 years of age. Although a high seroprotection rate was elicited by the 5-micrograms dose, the lower antibody concentrations achieved may make this lower dosage less desirable in the long term. Further studies are required to examine the need for booster doses of vaccine with both dosing schedules.

Zinc gluconate lozenges for treating the common cold. A randomized, double-blind, placebo-controlled study.

BACKGROUND: The common cold is one of the most frequent human illnesses and is responsible for substantial morbidity and economic loss. No consistently effective therapy for the common cold has been well documented, but evidence suggests that several possible mechanisms may make zinc an effective treatment. OBJECTIVE: To test the efficacy of zinc gluconate lozenges in reducing the duration of symptoms caused by the common cold. DESIGN: Randomized, double-blind, placebo-controlled study. SETTING: Outpatient department of a large tertiary care center. PATIENTS: 100 employees of the Cleveland Clinic who developed symptoms of the common cold within 24 hours before enrollment. INTERVENTION: Patients in the zinc group (n = 50) received lozenges (one lozenge every 2 hours while awake) containing 13.3 mg of zinc from zinc gluconate as long as they had cold symptoms. Patients in the placebo group (n = 50) received similarly administered lozenges that contained 5% calcium lactate pentahydrate instead of zinc gluconate. MAIN OUTCOME MEASURES: Subjective daily symptom scores for cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, sore throat, sneezing, and fever (assessed by oral temperature). RESULTS: The time to complete resolution of symptoms was significantly shorter in the zinc group than in the placebo group (median, 4.4 days compared with 7.6 days; P < 0.001). The zinc group had significantly fewer days with coughing (median, 2.0 days compared with 4.5 days; P = 0.04), headache (2.0 days and 3.0 days; P = 0.02), hoarseness (2.0 days and 3.0 days; P = 0.02), nasal congestion (4.0 days and 6.0 days; P = 0.002), nasal drainage (4.0 days and 7.0 days; P < 0.001), and sore throat (1.0 day and 3.0 days; P < 0.001). The groups did not differ significantly in the resolution of fever, muscle ache, scratchy throat, or sneezing. More patients in the zinc group than in the placebo group had side effects (90% compared with 62%; P < 0.001), nausea (20% compared with 4%; P = 0.02), and bad-taste reactions (80% compared with 30%; P < 0.001), CONCLUSION: Zinc gluconate in the form and dosage studied significantly reduced the duration of symptoms of the common cold. The mechanism of action of this substance in treating the common cold remains unknown. Individual patients must decide whether the possible beneficial effects of zinc gluconate on cold symptoms outweigh the possible adverse effects.

Stage II esophageal carcinoma: the significance of T and N.

OBJECTIVE: Stage II esophageal carcinomas are a heterogeneous group of uncommon malignant tumors that include both node-negative (IIA; T2 N0 M0 and T3 N0 M0) and node-positive (IIB; T1 N1 M0 and T2 N1 M0) carcinomas. The purpose of this study was to evaluate this heterogeneity and to identify predictors of improved survival. RESULTS: Ninety-four of 345 patients undergoing esophageal resection at the Cleveland Clinic Foundation between 1985 and 1994 had stage 11 carcinomas; 70 stage IIA (24 T2 N0 M0 and 46 T3 N0 M0) and 24 stage IIB (9 T1 N1 M0 and 15 T2 N1 M0). Pathologic stage and T and N status were the only identifiable predictors of survival. Stage IIA survival was significantly better than stage IIB (p = 0.01). T2 N0 M0 survival was not different from T1 N0 M0 survival (p = 0.83). T3 N0 M0 survival was significantly worse than T1 N0 M0 (p = 0.03) and intermediate between T2 N0 M0 survival (p = 0.06) and T1 N1 M0 and T2 N1 M0 survivals (p = 0.07). T1 N1 M0 and T2 N1 M0 survival was not significantly different from T3 N1 M0 survival (p = 0.63). CONCLUSIONS: (1) N1 disease is the principal predictor of reduced survival and N1 is independent of T. Therefore the distinction between T1 N1 M0, T2 N1 M0, and T3 N1 M0 carcinomas is not warranted. (2) N0 disease is the principal predictor of improved survival but N0 is not independent of T. T1 N0 M0 and T2 N0 M0 survivals are similar and therefore distinction between these subgroups is not warranted. T3 N0 M0 survival is intermediate between T1 N0 M0 and T2 N0 M0 carcinomas and between T1 N1 M0, T2 N1 M0, and T3 N1 M0 carcinomas. Therefore stratification by T for N0 carcinomas is warranted.

A strategy to arrest and reverse coronary artery disease: a 5-year longitudinal study of a single physician's practice.

BACKGROUND: Animal experiments and epidemiological studies have suggested that coronary disease could be prevented, arrested, or even reversed by maintaining total serum cholesterol levels below 150 mg/dL (3.88 mmol/L). In 1985, we began to study how effective one physician could be in helping patients achieve this cholesterol level and what the associated effect of achieving and maintaining this cholesterol level has on coronary disease. METHODS: The study included 22 patients with angiographically documented, severe coronary artery disease that was not immediately life threatening. These patients took cholesterol-lowering drugs and followed a diet that derived no more than 10% of its calories from fat. Disease progression was measured by coronary angiography and quantified with the percent diameter stenosis and minimal lumen diameter methods. Serum cholesterol was measured biweekly for 5 years and monthly thereafter. RESULTS: Of the 22 participants, 5 dropped out within 2 years, and 17 maintained the diet, 11 of whom completed a mean of 5.5 years of follow-up. All 11 of these participants reduced their cholesterol level from a mean baseline of 246 mg/dL (6.36 mmol/L) to below 150 mg/dL (3.88 mmol/L). Lesion analysis by percent stenosis showed that of 25 lesions, 11 regressed and 14 remained stable. Mean arterial stenosis decreased from 53.4% to 46.2% (estimated decrease = 7%; 95% confidence interval [CI], 3.3 to 10.7, P < .05). Analysis by minimal lumen diameter of 25 lesions found that 6 regressed, 14 remained stable, and 5 progressed. Mean lumen diameter increased from 1.3 mm to 1.4 mm (estimated increase = 0.08 mm; 95% CI, -0.06 to 0.22, P = NS). Disease was clinically arrested in all 11 participants, and none had new infarctions. Among the 11 remaining patients after 10 years, six continued the diet and had no further coronary events, whereas the five dropouts who resumed their prestudy diet reported 10 coronary events. CONCLUSIONS: A physician can influence patients in the decision to adopt a very low-fat diet that, combined with lipid-lowering drugs, can reduce cholesterol levels to below 150 mg/dL and uniformly result in the arrest or reversal of coronary artery disease.

Multiple sclerosis progression in a natural history study: predictive value of cerebrospinal fluid free kappa light chains.

OBJECTIVES: To determine the relationship between baseline CSF immunologic abnormalities and MS disease progression; To determine progression rates in an untreated, recently-diagnosed MS sample using several validated clinical measures. BACKGROUND: CSF immune abnormalities are common in MS but have not been linked to disease progression. DESIGN METHODS: Thirty-six patients with definite (n = 28), probable (n = 2), or possible (n = 6) MS were studied prospectively. Baseline CSF was analyzed for free kappa and lambda light chains, myelin basic protein, IgG synthesis rate, and IgG index. MS patients were entered into the study within 5 years of symptom onset and examined semiannually for as long as 53.4 months (median length of follow up 38.9 months). MS progression was defined as sustained worsening on the following clinical measurement instruments: the Expanded Disability Status Scale (EDSS), the Ambulation Index (AI), the 9 Hole Peg Test (9HT) and the Box and Blocks test (BBT). Kaplan-Meier estimates of disease progression were calculated and the relationship between baseline CSF values and disease progression was determined using Cox proportional hazards regression models. RESULTS: By 36 months, 33% (95% CI = 10.3, 55.7) of patients had progressed on EDSS and 49.7% (95% CI = 27.7, 71.7) had progressed on at least one of the outcome measures. Patients with CSF free kappa chain levels in the upper quartile had a significantly higher risk of progression on EDSS (Hazard Ratio 3.78; p = 0.04) and 9HT (Hazard Ratio 10.77, p = 0.04). CONCLUSIONS: In this study, CSF free kappa light chains predicted subsequent physical deterioration in prospectively evaluated MS patients. If this is confirmed by larger studies, then CSF free kappa light chains could serve as a target for intervention in therapeutic trials.

Superficial esophageal carcinoma.

BACKGROUND: The detection of superficial esophageal carcinomas by surveillance endoscopy and the downstaging of advanced carcinomas to superficial carcinomas by induction therapy have increased the number of patients with these carcinomas undergoing resection. The natural history of these carcinomas is not well defined. METHODS: To evaluate the results of surgical resection and identify predictors of improved survival, a retrospective review of (1) patients with superficial esophageal carcinoma at presentation (SECP) and (2) patients with advanced carcinomas that were downstaged to no residual carcinoma or superficial esophageal carcinoma after induction therapy (SECD) was conducted. RESULTS: There were 54 patients with SECP (19 Tis and 35 T1). Survival was significantly better for patients with Tis carcinomas (85.3% at 5 years) and patients with intramucosal T1 carcinomas (79.4%) than for patients with submucosal T1 carcinomas (16.3%) (p = 0.007 and p = 0.045, respectively). Survival at 5 years for the 49 patients without regional lymph node metastases (N0) was 65.2%, whereas none of the 5 patients with regional lymph node metastases (N1) have survived more than 3 years (p = 0.054), and 3 died of recurrent disease. There were 21 patients with SECD (13 T0, 2 Tis, and 6 T1). Survival at 4 years was 58.2%. In this group, survival was not related to depth of tumor invasion (p = 0.76) or regional lymph node status (p = 0.68). CONCLUSIONS: We conclude that (1) patients with Tis and intramucosal T1 SECP have a significantly better survival than those with submucosal T1 SECP, (2) patients with N0 SECP have a significantly better survival than those with N1 SECP, and (3) survival of patients with SECD is not related to depth of tumor invasion or regional lymph node status.

Latent variable models for clustered ordinal data.

Existing methods for the analysis of clustered, ordinal data are inappropriate for certain applications. We propose latent variable models for clustered ordinal data which are derived as natural extensions of latent variable models for clustered binary data (Qu, Williams, Beck, and Medendorp, 1992. Biometrics 48, 1095-1102). These models can be applied to repeated measures data, familial data, longitudinal data, and data with both cluster specific and occasion specific covariates with a wide range of correlation structures.

Expression of blood group antigen A by stage I non-small cell lung carcinomas.

To clarify the significance of blood group antigen A (BAA) expression by neoplastic cells, we studied patients who had curative resections of stage I non-small cell lung carcinomas. Immunohistochemical staining using monoclonal antibodies was used to detect BAA expression by paraffin-embedded carcinoma cells. One hundred three patients were studied; mean age was 62.6 years, and 70 (68%) were male. Histologic types were as follows: adenocarcinoma, 52 (50.5%); squamous cell, 25 (24.3%); large cell, 24 (23.3%); and adenosquamous, 2 (1.9%). Histologic grades were as follows: I, 13 (12.6%); II, 26 (25.3%); and III, 64 (62.1%). All patients had American Joint Committee on Cancer stage I tumors: 65 patients (63.1%) had T1 tumors, and 38 (36.9%) had T2 tumors. Recurrences developed in 25 (24.3%) and metachronous malignancies in 4 (3.9%). Survival was 75% +/- 4.8% at 3 years and 66.6% +/- 7.5% at 5 years. Eighty-nine patients (86.4%) were blood group A and 14 (13.6%) were AB. Ninety-five (92.2%) were secretors of BAA and 8 (7.8%) were not. The expression of BAA by neoplastic cells was not detectable in 34 (33%), trace (1% to 5% of neoplastic cells) in 10 (9.7%), 1+ (6% to 25%) in 8 (7.8%), 2+ (26% to 50%) in 12 (11.7%), 3+ (51% to 75%) in 12 (11.7%), and 4+ (76% to 100%) in 27 (26.2%). The pattern of neoplastic cell staining was homogeneous in 14 patients (20.3%) and heterogeneous in 55 (79.7%). Carcinoma recurrence, overall survival, and event-free survival were not related to secretor status, BAA expression, or pattern of staining.(ABSTRACT TRUNCATED AT 250 WORDS)

The impact of thoracoscopy on the management of pleural disease.

STUDY OBJECTIVE: To describe the diagnostic efficacy, morbidity, and patient outcome of thoracoscopy; to quantify the direct impact of thoracoscopy on clinical management; and to determine preoperative variables associated with finding malignancy at thoracoscopy to aid patient selection. DESIGN: Retrospective chart review of consecutive cases of thoracoscopy for pleural disease. SETTING: Single tertiary medical center. PATIENTS: One hundred eighty-two consecutive patients who underwent thoracoscopy for pleural disease over a 5-year period (from 1987 through 1992). MEASUREMENTS AND RESULTS: Final diagnoses were 98 (54%) malignant, 58 (32%) benign, and 26 (14%) idiopathic. Thoracoscopy had a diagnostic sensitivity of 95% for malignancy and 100% for benign disease. Malignancy was shown by thoracoscopy in 27 of 41 (66%) patients who had a preoperative nondiagnostic closed pleural biopsy, and in 24 of 35 (69%) patients who had at least 2 preoperative negative pleural cytologic specimens. Chart review by preestablished criteria showed information obtained from thoracoscopy directly influenced treatment in 155 (85%) patients. Thirty-seven (20%) patients, however, had at least one perioperative complication (15% major, 8% minor). Ten (6%) patients died during the same hospitalization in which a thoracoscopy was performed, although none died within 48 h. There was one thoracoscopy-related death. Sixty-two (34%) patients died within 6 months of thoracoscopy (death by all causes). Forty-seven (48%) patients who had intrathoracic malignancy present at thoracoscopy died within 6 months. Patients found to have malignant pleural disease by thoracoscopy were more likely to have a preoperative history of a malignancy (p = 0.001). Age more than 50 years was associated with finding malignancy at thoracoscopy (p = 0.04). A combined lymphocytic and hemorrhagic effusion was associated with malignancy (p = 0.004). Preoperative pleural data showed that idiopathic effusions had a significantly lower median lactate dehydrogenase (LDH) value (192, which was normal) compared with malignant or benign effusions. CONCLUSIONS: (1) Thoracoscopy increases yield for malignant and benign disease when thoracentesis and closed pleural biopsy are nondiagnostic. (2) Thoracoscopy directly affects clinical management in 85% of patients. (3) Significant complications can occur in patients receiving tertiary care. (4) For the evaluation of suspected malignant pleural disease, thoracoscopy has its greatest diagnostic yield in older patients who have a history of malignancy and who present with a lymphocytic, hemorrhagic, high LDH effusion.

The effect of prolonged tourniquet application on serum bicarbonate.

BACKGROUND: Many clinicians believe that prolonged tourniquet application lowers the serum bicarbonate concentration in samples drawn from that limb, but this effect has never been examined prospectively. OBJECTIVE: To test the effect of prolonged tourniquet application before phlebotomy on serum bicarbonate concentration in healthy adults. METHODS: We drew blood samples from 27 healthy adult volunteers without a tourniquet and again 1, 3, and 5 minutes after applying a blood pressure cuff and inflating it to the mean arterial pressure. RESULTS: The mean bicarbonate concentration was 27.3 +/- 2.26 mmol/L (standard deviation) at baseline, 27.7 +/- 2.39 mmol/L at 1 minute, 27.7 +/- 2.05 mmol/L at 3 minutes, and 27.7 +/- 1.96 mmol/L at 5 minutes. The mean change in bicarbonate concentration from baseline was -0.04 +/- 1.02 mmol/L at 1 minute, 0.44 +/- 1.05 mmol/L at 3 minutes, and 0.44 +/- 1.31 mmol/L at 5 minutes. The mean lactate concentration was 1.1 +/- 0.28 mmol/L at baseline, 1.3 +/- 0.65 mmol/L at 1 minute, 1.2 +/- 0.52 mmol/L at 3 minutes, and 1.2 +/- 0.36 mmol/L at 5 minutes. The mean change in lactate concentration from baseline was 0.15 +/- 0.67 mmol/L at 1 minute, 0.11 +/- 0.11 mmol/L at 3 minutes, and 0.12 +/- 0.37 mmol/L at 5 minutes. CONCLUSIONS: Prolonged tourniquet application before phlebotomy does not lower the serum bicarbonate concentration in healthy adults.

Prospective ultrasonographic evaluation of intraoperative and delayed postoperative suprachoroidal hemorrhage from glaucoma filtering surgery.

PURPOSE: To determine the incidence of, visual loss from, and perioperative risk factors for suprachoroidal hemorrhage (SCH) occurring during or after glaucoma filtering surgery. METHODS: Contact B-Scan ultrasonography was used to evaluate at a median of 15 days postoperatively, one eye of 158 patients who underwent various glaucoma filtering procedures during an 18 month period. RESULTS: Ultrasonography detected SCH in 13 patients (8.2%). SCH was recognized during surgery in two cases; 11 were detected postoperatively. Preexisting aphakia (odds ratio 12.9, 95% confidence interval 3.6 to 46.2) and intraoperative anterior vitrectomy (odds ratio 5.2, 95% confidence interval 1.2 to 22.4) were significantly associated with SCH. A significant negative association was found for combined cataract/glaucoma procedures with posterior chamber intraocular lens implantation (odds ratio 0.08, 95% confidence interval 0.01 to 0.69). No significant association between SCH and age, sex, race, diabetes, obesity, systemic hypertension, right versus left eye, type of glaucoma, surgeon, number of preoperative antiglaucoma medications, 5-fluorouracil/mitomycin-C therapy-or previous vitrectomy was found. For some risk factors the power of the study may not be sufficient to establish a correlation: with SCH. Two patients with SCH had serious visual acuity loss and 2 had mild visual acuity loss. Eyes of three patients were surgically drained of SCH. Most patients with SCH did not experience pain, and only one presented-with elevated intraocular pressure at the time SCH was recognized. CONCLUSION: Pre-existing aphakia and concurrent vitrectomy were significant risk factors identified. Combined cataract and glaucoma filtering procedures correlated negatively with suprachoroidal hemorrhage. Most patients with suprachoroidal hemorrhage experienced little or no visual loss, pain, or intraocular pressure elevation.

The decision to breastfeed. The importance of father's approval.

One hundred fifteen postpartum mothers who were within 24 hours of delivery completed a questionnaire to determine factors which may influence a mother's intention to breastfeed and to evaluate specifically the effect of working outside of the home. In our population of mostly middle-class married and insured women, working outside of the home was not significantly related to the decision to breastfeed (67.9% of working mothers, compared to 67.2% of those who did not plan to work postpartum, planned to at least partially breastfeed). The only factors that significantly related to breastfeeding intention pertained to the father's level of education and to his approval of breastfeeding. Strong approval of breastfeeding by the father was associated with a high incidence of breastfeeding (98.1%), compared to only 26.9% breastfeeding when the father was indifferent to feeding choice (P < 0.001).

Association between bicycle helmet legislation, bicycle safety education, and use of bicycle helmets in children.

OBJECTIVE: To determine the association between bicycle helmet legislation and bicycle safety education and the use of bicycle helmets by children under age 16 years. DESIGN: Anonymous questionnaire and direct observations of bicycle helmet use. SETTING: Four predominantly white, upper-middle class suburbs of Cleveland, Ohio. PARTICIPANTS: All students in grades 1 through 7 attending public school on the day of the survey and children riding bicycles in a direct observational study. INTERVENTIONS: Beachwood had bicycle helmet legislation and safety education. Orange had only bicycle helmet legislation. Pepper Pike and Moreland Hills did not have bicycle helmet legislation or safety education. RESULTS: In Beachwood, 416 (67.6%) of 615 children who owned a bicycle reported always wearing their helmets, and 72 (85%) of 85 children directly observed were wearing bicycle helmets. In Orange, 103 (37.2%) of 277 children who owned bicycles reported always wearing helmets, whereas 41 (17.9%) of 229 children in Moreland Hills and 78 (21.5%) of 362 children in Pepper Pike reported always wearing helmets. Helmet use was significantly (P < .001) higher in Beachwood, with legislation and education, than in the other communities; helmet use was significantly (P < .001) higher in Orange, with legislation alone, than in Moreland Hills and Pepper Pike, with no programs. CONCLUSIONS: There was a dramatic association between reports of increased helmet use and bicycle helmet legislation plus education; the association was stronger than that found with legislation only.

An indirect comparison of third-body wear in retrieved hydroxyapatite-coated, porous, and cemented femoral components.

The osteoconductive properties of hydroxyapatite (HA)-coated titanium implants are well documented, but eventual coating degradation may result in HA particles adjacent to the substrate, and if the particles were to migrate into the joint space then accelerated polyethylene wear might be expected. As an indirect indication of third-body wear, the authors used laser interference microscopy to measure and compare surface roughness on modular heads from 15 clinically retrieved HA-coated femoral components, with heads from 15 retrieved uncemented (porous) and 15 cemented implants. The results showed increased median surface roughness over initial manufacturer specifications in all groups, but the cobalt-chrome heads from the HA-coated group showed significantly less surface roughness and less deep scratches than the heads from either the porous or uncemented group. Three-body wear appears to be a common problem, but evidence available suggests that it is no more of a problem with HA-coated devices than porous or cemented.

Comparative study of the immunogenicity and safety of two dosing schedules of Engerix-B hepatitis B vaccine in neonates.

A randomized multicenter study compared the routine hepatitis B vaccine schedule of 0, 1, 6 months with an accelerated schedule of 0, 1, 2 months in newborns. Two hundred ninety-nine infants whose mothers were seronegative for hepatitis B were enrolled in the study and randomized to either the routine or accelerated schedule. All infants had blood drawn for antibody titers to hepatitis B at 2, 3, 6 and 7 months of age. For 222 infants data were evaluable, at least for safety; 193 of these 22 had antibody titers that were evaluable. The infants vaccinated on the accelerated schedule developed seroprotective concentrations of antibody more quickly than the infants vaccinated on the routine schedule; 92.6% vs. 66.1% had seroprotective concentrations (> or = 10 mIU/ml) at 3 months of age (P < 0.001). However, infants in the accelerated schedule had lower geometric mean antibody titers at 7 months, 420.0 vs. 3141.8. We conclude that the accelerated vaccination schedule resulted in the more rapid development of seroprotective concentrations of antibody, but levels of antibodies were not as high as in the routinely vaccinated infants at 7 months. These data suggest that an accelerated vaccine schedule can be used in the newborn period. The effectiveness of the accelerated schedule in preventing perinatal infections compared to the standard schedule and the necessity for booster doses of vaccine remain to be studied.

Combination therapy with a synthetic peptide of C-reactive protein and interleukin 2: augmented survival and eradication of pulmonary metastases.

A synthetic peptide (RS-83277) derived from the structure of human C-reactive protein (CRP) was previously shown to have antitumor activity in three different murine tumor models when administered in multilamellar vesicles (MLV). The therapeutic effects were comparable to those seen with MLV-encapsulated native CRP. The present study evaluated the therapeutic and immunomodulatory effects of administering CRP peptide RS-83277 MLV simultaneously with low-dose recombinant interleukin-2 (IL-2) to C57Bl/6 mice bearing established pulmonary metastases of fibrosarcoma T241. Results demonstrated that the capacity of RS-83277 MLV to inhibit tumor metastases and prolong survival was significantly augmented by combination with 10,000 U/day IL-2 i.p. Treated animals showed no evidence of toxicity. By immunohistochemistry, increased Thy 1.2+ cells were detectable in lungs of RS-83277 MLV/IL-2-treated animals compared to those receiving RS-83277 MLV alone. Circulating tumor necrosis factor alpha (TNF) and interferon (IFN) were not detectable in animals receiving RS-83277 MLV alone, but TNF was significantly elevated in animals receiving IL-2. In the presence of combination therapy, however, circulating TNF was not detectable. Results suggest that the combination of synthetic CRP peptide RS-83277 MLV and low-dose IL-2 offers a therapeutic advantage over either agent alone.