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Biomedical subjects

Jay Wohlgelernter

Publications and source records attributed to Jay Wohlgelernter.

9 recordsLinked to original sources
PubMed2007

Endoscopic surgery for sinonasal invasive aspergillosis in bone marrow transplantation patients.

OBJECTIVES/HYPOTHESIS: Sinonasal invasive aspergillosis (IA) is an aggressive fungal infection with high mortality rates. It commonly develops in immunocompromised patients, often after bone marrow transplantation (BMT). Aggressive surgical debridement by an external approach has been considered a central element of treatment. We describe our experience in endoscopic management of IA in BMT patients in a retrospective study. METHODS: Charts of BMT patients with IA in the past 5 years were reviewed. Demographic data, primary disease, comorbidities, signs and symptoms, blood test results, preparation for surgery, surgical technique, and outcome were recorded. RESULTS: Fourteen BMT patients, age ranging from 3 to 56 years, had sinonasal IA. The primary disease was acute myelogenous leukemia in 6, acute lymphoblastic leukemia in 3, chronic myeloblastic leukemia in one, severe combined immunodeficiency disease in 2, and myelodysplastic syndrome in 2 patients. Diagnosis was made by physical examination, biopsy, culture, and computed tomography scan. Treatment, including aggressive endoscopic debridement, a systemic antifungal medication, and local irrigations of amphotericin-B enabled eradication of IA in all patients. Seven patients required two or more operations. None required orbital exenteration or craniotomy. Six patients died of the primary illness or of comorbidities with no evidence of residual disease. Eight patients are alive. CONCLUSION: Early detection of IA in BMT patients enables aggressive treatment before the disease spreads into the orbit or brain. Proper preoperative preparation facilitates safe endoscopic surgery in patients with severe bleeding tendencies. Although sinonasal IA is lethal, endoscopic surgery is feasible and efficient, enabling excellent local control.

Adult↗
PubMed2006

Packing in endoscopic sinus surgery: is it really required?

OBJECTIVE: The aim of this study was to evaluate the routine use of packing or local hemostatic agents in endoscopic sinus surgery (ESS). METHODS: Packing and/or hemostatic agents were used only when necessary in 100 consecutive adult ESS patients in a tertiary academic hospital. Necessity for packing the nose after excessive bleeding was analyzed in relation to demographic characteristics, medical history, previous surgeries, current surgical procedure, type of anesthesia, and amount of intraoperative bleeding. RESULTS: Three patients who required packing because of other reasons (such as bolstering of mucosa) were excluded from the study. The remaining 97 patients included 61 males and 36 females between the ages of 16 to 86 (mean 44). Forty-nine patients underwent only ESS, 40 ESSs associated with nasal polypectomy, and 8 underwent other endoscopic procedures. Fifty-four underwent the operation under general anesthesia and 43 under local anesthesia. Intraoperative blood loss was less than 30 mL in 82 patients (85%), 30 to 50 mL in 11 (11%), and more than 50 mL in 4 (4%). In 89 patients (92%), packing or a hemostatic agent was not used. No patient had bleeding complications postoperatively. A comparison between patients who required packing to those who did not showed that the only statistically significant associations related to general anesthesia (P = 0.0082) and to the amount of intraoperative bleeding (P < 0.001). CONCLUSIONS: Most ESS procedures can be managed without packing or any other hemostatic measures. Local anesthesia, use of local vasoconstrictors, and careful operative technique minimize the need for nose packing, thus reducing patient's discomfort, postoperative complications, and cost of surgery.

Adolescent↗
PubMed2006

Osteoma of the lateral semicircular canal.

Osteomas are benign, slow growing tumors of bone that occur almost exclusively in the craniofacial region. They are uncommon in the temporal bone. Surgical excision is indicated in symptomatic cases. An osteoma arising from the lateral semicircular canal growing into the mastoid cavity is extremely rare and usually discovered on routine radiography. We present a case of osteoma arising from the lateral semicircular canal growing into the mastoid cavity, followed by a discussion of the etiology, presentation, and management of osteomas.

Bone Neoplasms↗
PubMed2006

Ingestion of caustic substances: a 15-year experience.

OBJECTIVE: The objective of this study was to analyze the circumstance, demographic features, clinical findings, and complications of caustic ingestion in relation to the type and amount of caustic substance. STUDY DESIGN: The authors conducted a retrospective cohort study in a tertiary medical center. METHODS: The authors reviewed medical records from 1988 to 2003 of patients with a history of caustic ingestion and clinical signs of injury to the aerodigestive tract. Parameters examined included age at presentation, gender, demographic status, nature of the caustic substance ingested, amount of substance, circumstance of the event, diagnostic tools, degree of injury, and anatomic distribution of the injury, early and late complications, and requirement for ventilatory support. RESULTS: A total of 50 cases of caustic ingestion were identified (age range, 5 months-71 years). A biphasic distribution of the patients was noted; half were children under 5 years old and the remainder was adults. The most common caustic agent ingested was alkaline (42%) followed by acidic (32%) and chlorine bleach (26%). The most frequent cause for ingestion was accidental (67%) as opposed to attempt suicide (33%). All cases of attempted suicide occurred in adults. Most of them reported ingestion of large amounts of caustic substance. In the pediatric group, an association between the caustic agent and ethnicity was observed. Among Jewish children, alkaline cleaning agents were the most common cause (82%). Acetic acid was the most common substance ingested by the Arab children (100%). The findings of rigid esophagoscopy in 36 patients were as follows: first-degree esophageal injury in 16 (44%), second-degree in 6 (17%), third-degree in 7 (19%), fourth-degree in 6 (17%), and one (3%) was normal. Mucosal injury to the esophagus was worse in the acidic ingestion group as compared with the alkaline substance ingestion group with marginally statistically significant difference in the median degree of injury between the three types of ingested substances (P = .054). Mucosal injury to the esophagus was worse among patients who attempted suicide as compared with accidental ingestion with a statistically significant difference in the median degree of injury between the two reasons for ingestion (P = .002). CONCLUSION: Severity of injury from caustic ingestion damages depend on the type of ingested substance, which varies depending on ethnicity. Ingestion of caustic agents by children involves specific substances according to the season, cultural and religious festivals, and ethnicity. The majority of adult cases are intentional with more serious injuries and a higher rate of complications. In our series, ingestion of acidic substances and ingestion associated with suicide attempt had the most severe consequences.

Accidents↗
PubMed2005

Dose-response relationship of an oral insulin spray in six patients with type 1 diabetes: a single-center, randomized, single-blind, 5-way crossover study.

OBJECTIVE: This study evaluated the pharmacokinetic and pharmacodynamic properties and dose-response effects of an oral insulin spray formulation compared with those of subcutaneously injected regular insulin and placebo in patients with type 1 diabetes mellitus. METHODS: This was a single-center, randomized, single-blind, open-label, 5-way crossover study in which patients with type 1 diabetes received 5, 10, and 20 puffs of the oral insulin spray; regular insulin 0.1 U/kg SC; and placebo spray. The pharmacokinetic parameters of interest were the maximum serum insulin concentration (Ins-C(max)); the incremental insulin AUC from 0 to 120 minutes (Ins-AUC(0-120)), from 0 to 240 minutes, and from 0 to 360 minutes; and the time to maximum serum insulin concentration (Ins-T(max)). The pharmacodynamic parameters of interest were the maximum glucose infusion rate (GIR(max)); the incremental glucose AUC from 0 to 120 minutes (GIR-AUC(0-120)), from 0 to 240 minutes, and from 0 to 360 minutes; the time to maximum GIR (GIR-T(max)); the time to early half-maximal GIR (early T50%); and the time to late half-maximal GIR (late T50%). Pharmacokinetic and pharmacodynamic parameters were assessed using the euglycemic clamp technique. RESULTS: The study enrolled 6 white men with type 1 diabetes (mean [SD] age, 37.5 [16.2] years, mean weight, 82.7 [17.0] kg). Ins-T(max) was shorter for 5, 10, and 20 puffs of oral insulin spray than for SC insulin (26.7 [13.7], 29.2 [7.4], 23.3 [5.2], and 142.5 [73.2] min, respectively; P < 0.05). There was no effect of dose on Ins-T(max). The Ins-AUC(0-120) for 5, 10, and 20 puffs of oral insulin spray (304.8 [277.9], 689.2 [353.0], and 1808.8 [1252.6] microU/mL per min, respectively; P < 0.05) and the corresponding Ins-Ca(max) (12.9 [8.7], 26.7 [14.5], and 47.6 [40.1] microU/mL; P < 0.05) suggested a dose-response relationship. Five, 10, and 20 puffs of oral insulin spray had an earlier onset of action than SC insulin (early T50%: 23.3 [15.1], 28.3 [12.3], 31.2 [111.8], and 87.0 [39.6] min, respectively; P < 0.05), an earlier maximal effect (GIR-T(max): 40.0 [23.7], 45.8 [22.7], 44.2 [5.8], and 145.0 [43.7] min; P < 0.05), and a shorter duration of action (late T50%: 56.5 [31.0], 70.2 [12.9], 75.5 [6.0], and 290.8 [84.0] min; P < 0.05). Dose-dependent increases in maximal metabolic effect were observed with 5, 10, and 20 puffs: the GIR(max) was 0.9 (0.5), 2.0 (1.3), and 3.9 (2.5) mg/kg per minute, respectively (P < 0.05), and the GIR-AUC(0-120) was 39.6 (34.9), 76.8 (67.4), and 189.1 (163.0) mg/kg per minute (P < 0.05). CONCLUSIONS: In this study in patients with type 1 diabetes, oral insulin spray had a faster onset and shorter duration of action than subcutaneously injected regular insulin. A dose-response relationship was noted in the metabolic effect and absorption of oral insulin spray.

Administration, Oral↗
PubMed2005

Dose-response relationship of oral insulin spray in healthy subjects.

OBJECTIVE: To evaluate the pharmacodynamic and pharmacokinetic properties and the dose-ranging effects of an oral insulin spray in comparison with subcutaneous regular insulin. RESEARCH DESIGN AND METHODS: In this randomized, five-way, cross-over study, seven healthy volunteers were assessed under euglycemic clamp and received four different doses of oral spray and one dose of subcutaneous regular insulin. RESULTS: The time to maximum insulin concentration was shorter for oral insulin than for subcutaneous insulin (25.9 +/- 9 vs. 145.7 +/- 49.5 min, P < 0.05). Maximum serum insulin levels (C(max)) were comparable between the subcutaneous and 20 puffs of oral insulin (39.1 +/- 19.6 vs. 34.0 +/- 7.4 microU/ml, NS). The Ins-AUC(0-120) (area under the curve from 0 to 120 min for serum insulin) (339.8 +/- 218, 681.3 +/- 407, and 1,586.7 +/- 8 microU/ml, P < 0.05) and C(max) (7.6 +/- 2.8, 16.4 +/- 9.3, and 39.1 +/- 19.6 microU/ml, P < 0.005) proved a dose-response relationship for the three doses of oral insulin (5, 10, and 20 puffs, respectively). Oral insulin had an earlier onset of action (31.7 +/- 12 vs. 77.8 +/- 3 min, P < 0.05), earlier peak (44.2 +/- 10 vs. 159.2 +/- 68 min, P < 0.05), and a shorter duration of action (85.1 +/- 25 vs. 319.2 +/- 45 min, P < 0.05) compared with subcutaneous insulin. The maximum metabolic effect (1.7 +/- 1.0, 3.09 +/- 1.7, and 4.6 +/- 1.5 mg . kg(-1) . min(-1), P < 0.05) and the GIR-AUC(0-120) (amount of glucose infused from 0 to 120 min) (106.7 +/- 74.3, 162.9 +/- 116.1, and 254 +/- 123 mg/kg) increased in a dose-dependent relationship for the three doses. CONCLUSIONS: Oral insulin was absorbed in direct relation to the amount given and had a faster onset and a shorter duration of action compared with subcutaneous regular insulin. A dose-response relationship in the absorption and metabolic effect of the oral insulin was noted.

Administration, Oral↗
PubMed2004

Comparison of pharmacokinetic and pharmacodynamic properties of single-dose oral insulin spray and subcutaneous insulin injection in healthy subjects using the euglycemic clamp technique.

BACKGROUND: Oral insulin spray is a new, noninjectable method of insulin delivery. This system delivers an aerosol of uniform-sized droplets containing regular human insulin at a high velocity into the oropharyngeal cavity for local transmucosal absorption. OBJECTIVE: The purpose of this study was to compare the pharmacokinetic and pharmacodynamic properties of single-dose oral insulin spray and SC insulin injection in healthy subjects. METHODS: Healthy male volunteers aged 21 to 25 years participated in this open-label study conducted at the Diabetes Unit, Hadassah-Hebrew University Hospital, Jerusalem, Israel. Subjects presented at 2 visits separated by 7 to 14 days. At both visits, the euglycemic clamp technique was used to maintain a constant blood glucose level. At one visit, subjects received regular human insulin 0.1 U/kg by SC injection. At the other visit, subjects received 15 puffs (150 U) of oral insulin spray. The pharmacokinetic (insulin absorption) and pharmacodynamic (glucose uptake) properties of the drugs were evaluated using blood analyses over the subsequent 360 minutes. RESULTS: Six volunteers were enrolled (mean [SD] age, 22.8 [1.2] years; mean [SD] body mass index, 23.2 [2.2] kg/m(2)). The mean (SD) baseline-corrected C(max) was significantly higher with oral insulin spray compared with SC insulin (54.0 [20.3] vs 30.8 [6.1] microU/mL; P = 0.028). Mean (SD) T(max) was significantly shorter with oral insulin spray compared with SC insulin (23.3 [5.2] vs 83.3 [42.2] minutes; P = 0.027). The mean (SD) time to maximal metabolic effect (maximum glucose infusion rate [GIR(max)]) (44.2 [8.6] vs 100.0 [35.6] minutes) and late time to half-maximal effect (101.0 [41.0] vs 257.2 [27.8] minutes) were shorter with oral insulin spray compared with SC insulin (both, P = 0.028). The baseline-corrected GIR(max) (6.8 [3.3] vs 6.2 [2.3] mg/kg . min) and glucose consumption (396.7 [178.0] vs 432.1 [226.0] mg/kg) during the 120 minutes after study drug administration were comparable between oral and SC insulin, respectively. CONCLUSIONS: In this study in a small, selected population of healthy male subjects under euglycemic conditions, oral insulin spray was associated with a higher C(max), shorter T(max), and faster time to peak glucose uptake compared with SC insulin. The short T(max) and the 120-minute duration of effect of oral insulin spray suggest it may be a promising alternative for fulfilling meal-related insulin requirements in persons with diabetes.

Administration, Oral↗