Noreen A. Lemak

Controlled trial of aspirin in cerebral ischemia. Part II: surgical group.

Patients (125) who had carotid transient ischemic attacks (TIAs) and one or more accessible carotid lesions visualized angiographically had reconstructive operations of the carotid artery and werethen randomly assigned to aspirin or placebo treatment. They were followed to determine the incidence of subsequent TIAs, death, cerebral infarction, or retinal infarction. Life table analysis (for 24 months follow up) that eliminated deathswhich were not stroke-related revealed a significant difference in favor of aspirin. Because of the small number of patients and the short period of follow up, these results should be interpreted only as consistent with those reported in the initial publication but not conclusive of an aspirin effect in preventing cerebral infarction.

Photopheresis therapy for cutaneous T-cell lymphoma

BACKGROUND Cutaneous T-cell lymphoma is a chronic peripheral lymphoma in which aggressive combined therapy elicits high response rates but does not improve survival. Photopheresis therapy has reportedly induced remissions and prolonged survival in patients with advanced disease. OBJECTIVE We studied all patients who began photopheresis treatment between February 1988 and July 1994 to determine whether we could confirm the remission rates of previous studies, to evaluate variables that might predict a response, and to discover whether an accelerated delivery system would improve the remission rate or response time. METHODS After an oral dose of methoxsalen was administered, a leukocyte-enhanced quantity of blood was exposed to UVA radiation for 1.5 hours and returned to the patient. With our accelerated system, 6 x 10(9) cells were irradiated in nine cycles. Treatments were given on 2 consecutive days once a month. RESULTS Among 34 patients whose results could be evaluated, the overall response rate (complete and partial remissions) was 50%; most patients had mild side effects. All responders except one had erythroderma. Responders had a decrease of 75% in mean skin scores, whereas nonresponders had an increase of 21%. CONCLUSION Photopheresis appears to be effective for selected patients with erythrodermic cutaneous T-cell lymphoma, although we did not achieve as high a remission rate as previously reported by others.

A randomized trial of minoxidil in chemotherapy-induced alopecia

BACKGROUND Hair loss is a side effect of many chemotherapeutic agents, and patients have even refused possibly palliative or lifesaving drugs because they could not accept temporary or prolonged baldness. Topical minoxidil has been shown to be effective for androgenetic alopecia and alopecia areata. OBJECTIVE Our purpose was to investigate the value and safety of minoxidil in chemotherapy-induced hair loss. METHODS Twenty-two women who were facing adjuvant chemotherapy after breast surgery were registered in a protocol that used a 2% minoxidil topical solution or a placebo in a randomized double-blind trial. RESULTS There was a statistically significant difference (favoring minoxidil) in the interval from maximal hair loss to first regrowth. Thus the period of baldness was shortened (mean, 50.2 days) in the minoxidil group. CONCLUSION Minoxidil decreased the duration of alopecia caused by chemotherapy. There were no significant side effects.

Combined modality therapy for cutaneous T-cell lymphoma

BACKGROUND Cutaneous T-cell lymphoma (CTCL) may respond to many therapies, but long-term disease-free survival is uncommon. Patients with advanced disease have a median survival of approximately 3 years. OBJECTIVE Our purpose was to combine known effective agents sequentially to determine whether we could achieve remission in more patients or for longer duration. METHODS Patients with mycosis fungoides (n = 23) or Sézary syndrome (n = 5) were treated with 4 months of recombinant interferon alfa together with isotretinoin, followed by total skin electron beam therapy alone (for stage I to II disease) or preceded by chemotherapy (for stage III to IV disease). Maintenance therapy consisted of interferon for 1 year and topical nitrogen mustard for 2 years. RESULTS Twenty-eight patients were treated. The overall response rate (complete and partial remissions) was 82%. Although the median duration of remission was 5 months in patients with stage III to IV disease, two patients remain in complete remission at 39 + and 46 + months. In patients with stage I to II disease the median duration of remission has not been reached at a median follow-up of 18 months. Five patients, all with stage III to IV disease, have died. Overall, the regimen was well tolerated with one treatment-related death from neutropenic sepsis. CONCLUSION Combined modality therapy may be effective for the treatment of CTCL with similar response rates to other current therapies.

Does platelet antiaggregant therapy lessen the severity of stroke

Data from the Aspirin in Transient Ischemic Attack (AITIA) study, an ongoing study of two platelet antiaggregant drugs, and other published therapeutic trials were reviewed to determine whether the severity of stroke is reduced in patients taking platelet antiaggregants. Data from three of four studies suggest that strokes in treated patients are less severe than those in untreated patients. Further studies evaluating platelet antiaggregant therapy should include assessment of the severity as well as the incidence of stroke.

Ondansetron/promethazine combination or promethazine alone reduces nausea and vomiting after middle ear surgery

STUDY OBJECTIVES To determine the incidence of postoperative nausea and vomiting when a combination of ondansetron and promethazine is given prophylactically, and to ascertain the effect of postoperative nausea and vomiting on recovery room duration and patient satisfaction. DESIGN Prospective, randomized, placebo-controlled, double-blind study. SETTING University-affiliated tertiary-care hospital. PATIENTS 87 ASA physical status I and II adult patients scheduled for middle ear surgery. INTERVENTIONS Patients were randomly assigned to receive one of the following interventions intravenously: ondansetron 4 mg (Group 1), promethazine 25 mg (Group 2), ondansetron 2 mg plus promethazine 12.5 mg (Group 3, combination), or placebo (Group 4). MEASUREMENTS AND MAIN RESULTS Independent, study blinded observers recorded complaints of nausea and number of episodes of vomiting for 24 hours following the patients first response to commands. All patients were contacted the day after discharge to inquire about nausea and vomiting. The awakening time, postanesthesia care unit and day surgery unit durations, opioid use, and side effects were recorded. At the end of the 24-hour period, the study blinded observers asked patients for an overall assessment of their global anesthesia experience using an 11-point scale. During the 24-hour period, the incidence of postoperative nausea and vomiting was reduced from 74% (placebo) to 39% (promethazine; p = 0.03) and 29% (combination; p = 0.003). Compared with placebo, the severity of vomiting was significantly less in the combination group (p = 0.04). The number of very satisfied patients correlated negatively with the incidence of postoperative nausea and vomiting (p < 0.0001) and with the severity of vomiting (p = 0.003). CONCLUSION The prophylactic use of an antiemetic with middle ear surgery may reduce postoperative nausea and vomiting over 24 hours, and the ondansetron/promethazine combination or promethazine alone are cost-effective choices. Finally, the combination reduced significantly the severity of vomiting.

Sublingual midazolam premedication in children: a dose response study

The purpose of this study was to evaluate various doses of sublingual midazolam premedication in children. In our prospective, double‐blind, placebo‐controlled trial, children (n=102, age range 12 to 129 months) scheduled for day surgery were randomized to receive either midazolam in one of three doses (0.25, 0.5, or 0.75 mg·kg−1) or placebo. Injectable midazolam was mixed with a thick grape syrup and placed under the tongue; the patient was asked to hold it as long as possible before swallowing. Children readily accepted the mixture. Analysing all patients randomized, none of the children receiving placebo vs 28% receiving 0.25 mg·kg−1 (P=0.02), 52% receiving 0.5 mg·kg−1 (P<0.001), and 64% receiving 0.75 mg·kg−1 (P<0.001) of midazolam showed satisfactory sedation (drowsy) at 15 min after administration. Children receiving the two higher doses of midazolam (0.5 and 0.75 mg·kg−1) accepted mask induction willingly, while the group receiving 0.25 mg·kg−1 resembled the placebo group (P<0.05).

Statistics in medical research : developments in clinical trials

Traces the historical development of statistics in medical research, and profiles important figures in the field. Subjects include statistics as a distinct discipline, development in the US, and clinical trials in the US. Includes b&w photos. Annotation copyright Book News, Inc. Portland, Or.

Systemic lupus erythematosus diagnosed during interferon alfa therapy

We describe a patient who had clinical manifestations of several autoimmune disorders: Sjögrens syndrome, benign hypergammaglobulinemic purpura of Waldenström, and systemic lupus erythematosus (SLE). The SLE was diagnosed during therapy with interferon alfa. Testing for anti-Ro and anti-La antibodies was negative until the serum was diluted to eliminate a possible prozone phenomenon of antibody excess.

Artificial skin equivalent differentiation depends on fibroblast donor site : Use of eyelid fibroblasts

&NA; Our objective was to construct and explore human skin equivalents from several normal and pathologic donor skin sites to determine if the fibroblast origin influences epidermal differentiation. Also, we wanted to find out if fibroblasts from some donor sites produced epidermis of superior quality for plastic surgery repairs. Skin equivalents were constructed from 15 normal skin specimens, 9 normal eyelid specimens, 15 lesional skin specimens taken from patients with psoriasis, and 4 specimens from keloid scars. Results show that the tissue origin of the donor fibroblasts determines epidermal differentiation and the time period for regeneration. Eyelid fibroblasts were very dependable in establishing well‐differentiated skin equivalents in all nine specimens. Our findings contribute to the accumulated knowledge of wound healing and should also be of value in skin grafting, especially when large areas are denuded as in burns, severe trauma, or cancer ablation. (Plast. Reconstr. Surg. 101: 385, 1998.)