Adjunctive use of intravitreal dexamethasone in presumed bacterial endophthalmitis: a randomised trial.

AIM: To evaluate the use of intravitreal dexamethasone as adjunctive therapy in the treatment of presumed bacterial endophthalmitis. Design Prospective, double masked, randomised placebo-controlled clinical trial. METHODS: Patients with 'post cataract surgery', 'bleb-related' and 'other' endophthalmitis were grouped and randomised to receive intravitreal ceftazidime (2.225 mg/0.1 ml), vancomycin (1 mg/0.1 ml), and either dexamethasone (0.4 mg/0.1) or placebo. All underwent vitreous and aqueous sampling for microbiological analysis. Injections were repeated after 48 h if necessary. The primary outcome measure was Snellen visual acuity on presentation, within the first 14 days post injection, and at 2-4 months. RESULTS: 62 patients completed the protocol from 2001 to 2005. Thirty patients received intravitreal dexamethasone and 32 received intravitreal placebo. There was no statistically significant difference in the visual outcomes of either group with a mean 2.79 Snellen lines improvement of the intravitreal dexamethasone group versus 1.8 lines in the placebo group. Subgroup analysis suggested a clinical trend to better visual acuity in the post cataract steroid subgroup with mean 4.1 lines improvement versus 2.7 in the placebo group (p=0.33). No adverse events attributable to the dexamethasone were reported. CONCLUSIONS: Intravitreal dexamethasone appears safe and may be of benefit in post cataract surgery bacterial endophthalmitis.

NLite laser: nonablative wrinkle reduction.

The NLite laser is promoted as a tool for painless wrinkle reduction without side effects, posttreatment care, "downtime," or complications. However, with only 1 published study, limited scientific data are available. The authors report generally disappointing clinical results based on personal experience and a survey of 8 physicians who were among the first in Dallas to incorporate NLite technology into their practices. (Aesthetic Surg J 2001;21:371-372.).

Progressive tension sutures: a technique to reduce local complications in abdominoplasty.

Abdominoplasty has evolved as a very effective and satisfactory procedure, especially when combined with liposuction and the repair of diastasis recti. However, local complications, including hematoma and seroma formation, flap necrosis, and hypertrophic scars, continue to plague this procedure. The authors present a relatively simple and reproducible technique that allows extensive liposuction in conjunction with abdominoplasty; they think this technique reduces the incidence of local complications. This technique, the use of progressive tension sutures, has been used in their practice for more than 15 years. A retrospective review of 65 consecutive abdominoplasty patients demonstrates a very low local complication rate when compared with historical controls. In this series of both full and modified abdominoplasty patients who were followed for an average of 18 months, the authors had no hematomas, seromas, or skin flap necrosis.

Feasibility trial of postoperative radiotherapy and cisplatin followed by three courses of 5-FU and cisplatin in patients with resected head and neck cancer: a Southwest Oncology Group study.

BACKGROUND: Appropriate adjuvant chemotherapy for resected head and neck cancer patients has yet to be defined. Multiple trials have noted trends toward improved disease-free survival and local control. The Southwest Oncology Group undertook a feasibility trial of postoperative cisplatin and radiotherapy followed by three cycles of cisplatin and 5-fluorouracil. METHODS: Patients with resected stage III or IV head and neck cancer received cisplatin, 100 mg/m2, on days 1, 22, and 43 of radiotherapy. This therapy was followed by three cycles of cisplatin, 100 mg/m2 or last tolerated dose, and 5-fluorouracil, 1000 mg/m2, on days 1 to 4 every 21 days. RESULTS: Seventy-two patients from 22 institutions were registered; 68 were evaluable. Sixty-eight patients received radiotherapy. Only 25 of 68 patients (36.7%) were able to complete all six cycles of chemotherapy. Forty-three of 68 patients (63%) completed all three cycles with radiotherapy. Toxicities were tolerable. One toxic death occurred. CONCLUSIONS: It is not feasible to deliver six cycles of chemotherapy postoperatively in the sequence described. Compliance issues need further exploration to define effective adjuvant chemotherapy for head and neck patients.

Phase II study of merbarone (NSC 336628) in patients with advanced gastric carcinoma.

Merbarone, 5-(N-phenylcarboxamido)-2-thiobarbituric acid (NSC 336628), is a derivative of barbituric acid and represents a unique class of antineoplastic agents. We treated 16 patients with advanced gastric carcinoma in a phase II study of merbarone. All patients were previously untreated with chemotherapy or biological therapy. The starting dose of merbarone was 1000mg/m2 infused over 24 hr for 5 consecutive days every 21 days. A median of two courses (range, 1-7) was given. None of the patients achieved a complete or partial response; however, 3 patients achieved a transient minor response. Toxicity was mild to moderate in most patients, but 1 patient died of treatment-related neutropenia and sepsis. Our data suggest that merbarone at this dose and schedule is inactive against gastric carcinoma. The evidence of minor response suggests that analog research may be worthwhile to pursue.

Phase II trial of trimetrexate in untreated advanced gastric carcinoma. A Southwest Oncology Group study.

Twenty-three evaluable patients with advanced gastric adenocarcinoma were treated with trimetrexate at doses of 8-12 mg/m2 intravenously daily for five days, with cycles repeated every 21 days. One complete response was seen for an overall response rate of 4% (95% confidence interval 0-22%). Hematologic toxicities of grade > or = 3 were seen in 10/23 patients, and overall any grade 3 or greater toxicity was seen in 14/23 patients. Trimetrexate has minimal activity against gastric adenocarcinoma in this study, and no further investigation of this agent at this dose and schedule is recommended in this disease.

Objective antitumor activity of acivicin in patients with recurrent CNS malignancies: a Southwest Oncology Group trial.

Acivicin (AT-125) is a glutamine antagonist with dose-limiting, schedule-dependent CNS toxicity and predictable CSF penetration after intravenous administration. Because of these properties, a trial in CNS malignancies was initiated. Thirty-two patients with recurrent or residual malignant astrocytomas were treated with AT-125. The majority of patients had glioblastoma multiforme (24) and had received prior nitrosoureas (21). The median age was 50 years, and Southwest Oncology Group (SWOG) performance status was 2. The major determinant of response was based upon radiologic criteria using computed tomographic (CT) scanning and/or magnetic resonance imaging (MRI) scans. The tumor mass was measured in two perpendicular planes, which yielded the largest cross-sectional area. Standard solid tumor criteria for response were used. All responding patients also had a stable or tapered dose of corticosteroids with stable or improved performance status and neurologic examination. There were four objective responses (12%): one complete remission (3 1/2+ years) and three partial remissions (57, 86, and 322 days). Two patients had improvement in disease that did not meet requirements for a partial remission. Toxicity was mild and primarily consisted of nausea, vomiting, and lethargy. Two patients were removed from study due to neurotoxicity (depression and hallucinations). The strict response criteria used in this trial were not those that have been used in testing other active agents such as carmustine (BCNU). We conclude that AT-125 has objective antitumor activity in malignant astrocytomas and warrants further study.

A phase II study of menogaril (NSC-269148) in colorectal carcinoma. A Southwest Oncology Group study.

In this phase II trial, menogaril was administered to patients with metastatic colon cancer at a dose of 200 mg/m2 IV over one hour with cycles repeated every 28 days provided the absolute granulocyte count was greater than or equal to 2000 cells/microliters. Dose adjustments up or down were made depending upon nadir counts. Twenty-four patients were entered on this study with 21 eligible and evaluable for response. There was 1 CR lasting four and one-half months and 1 PR lasting three months for an overall CR + PR rate of 10% with a 95% confidence interval of 1% to 30%. Six patients (29%) had stable disease and 13 (62%) progressed. Median survival is 13.1 months. Toxicity was primarily hematologic with two cases of life-threatening leukopenia (less than 1000 cells/microliters) and one case of life-threatening granulocytopenia (less than 250 cells/microliters) among the 21 eligible patients, and one case of life-threatening leukopenia and granulocytopenia in one ineligible patient. There were no deaths due to treatment.

Release of vasoactive intestinal peptide during hyperdynamic sepsis in dogs.

Vasoactive intestinal peptide (VIP) is a potent vasodilator that has been reported to be a mediator of the hemodynamic changes in endotoxin-induced hypodynamic septic shock. We investigated the release of VIP in a hyperdynamic model of sepsis in awake, conscious dogs similar to that of sepsis in human beings. Sepsis was induced by intraperitoneal implantation of a fibrin clot containing live Escherichia coli (0.9 +/- 0.2 X 10(9) organisms per kilogram of body weight). All dogs developed hyperdynamic sepsis with increased cardiac output and decreased systemic vascular resistance. During the first 24 hours of sepsis, VIP was released without a concomitant decrease in blood pressure, suggesting that during septic shock it was released by a direct mechanism rather than as a result of hypotension. During peak VIP release (2 to 4 hours after induction of sepsis) no decreases in systemic vascular resistance or mean arterial pressure were observed. This suggests that mediators other than VIP may be responsible for the vasodilation observed during sepsis. The precise role of VIP during sepsis is therefore yet to be clarified.

Structural similarity between the lepidoptera- and diptera-specific insecticidal endotoxin genes of Bacillus thuringiensis subsp. "kurstaki" and "israelensis".

A gene from Bacillus thuringiensis subsp. "israelensis" was cloned from the large plasmids of this subspecies and was shown to code for a mosquitocidal polypeptide. The gene could be expressed in either Escherichia coli, Bacillus subtilis, or B. thuringiensis subsp. "israelensis" to produce the larvicidal activity. Similarly, a Lepidoptera-specific toxin gene from B. thuringiensis subsp. "kurstaki" was also cloned and expressed in E. coli and B. subtilis. Both cloned genes were sequenced and subjected to computer analysis. A long open translational reading frame coded for the B. thuringiensis subsp. "kurstaki" gene product. However, the B. thuringiensis subsp. "israelensis" clone was composed of two adjacent open reading frames oriented as if they were in a transcriptional operon. The products of the cloned genes retained their specificity for either Lepidoptera or Diptera. The control regions immediately preceding the toxin genes of both B. thuringiensis subspecies showed considerable DNA homology, most likely because both toxins are expressed only during sporulation. In addition, the deduced amino acid sequences from the two contiguous B. thuringiensis subsp. "israelensis" genes bore a striking resemblance to the deduced amino acid sequence from the single larger B. thuringiensis subsp. "kurstaki" gene, as if these two arrangements were evolutionarily related.

Prolonged enteral nutrition in malnourished patients with nonelemental feeding. Reappraisal of surgical technique, safety, and costs.

In a 2 year period, 60 consecutive feeding enterostomies were placed in malnourished patients. The major complication rate was 1.6 percent. Total complications were 8 percent. Thirty day mortality was 13 percent. Nearly all patients were given isosmotic nonelemental diets. The incidence of diarrhea was 2 percent with this regimen. Four of five patients given elemental diets had diarrhea. Serum albumin levels increased significantly from a preoperative mean of 2.75 to 3.03 g/dl. Best overall results were achieved in patients undergoing upper gastrointestinal surgery or pancreatobilary procedures for nonmalignant lesions. More than $60,000 was saved in 2 years by substituting isosmotic formulas for elemental ones. It appears that many patients are given elemental formulas who do not actually require them. Since isosmotic solutions will not infuse through needle catheters, we advocate placing 12 F. catheters and have documented the safety of this change. By using these larger catheters, the surgeon will not lose the option of using isosmotic preparations. We have shown these preparations to be nutritionally effective with a marked lessening of diarrhea and a cost approximately a sixth of that of elemental products.

Infection of the central nervous system by Listeria monocytogenes: a review of 54 adult and juvenile cases.

The clinical features in 54 juvenile and adult patients with Listeria monocytogenes infection of the central nervous system are described. Thirty-one of the patients had pre-existing chronic disease; the remainder were previously healthy. Twenty of the patients, the 'meningo-encephalitic group' developed focal neurological signs. The remaining 34, the 'meningitic group' exhibited no focal signs other than those caused by increased intracranial pressure. The 'meningitic group' differed from the 'meningo-encephalitic group' in that the cerebrospinal fluid white cell count, protein and glucose levels were markedly more abnormal and the prognosis worse. Evidence of septicaemia was found only in the 'meningitic group'. Meningo-encephalitis may represent a modified response to listerial infection typified by granulomatous rather than a suppurative response. The predominance of this response that was demonstrated in females may indicate partial immunity, the result of previous Listeria monocytogenes colonisation of the female genital tract. Listeria monocytogenes infection is treatable and should be considered in patients with meningitic or encephalitic illness. Repeated blood cultures may be required to establish the diagnosis.

Intraoperative culturing during surgery for acute appendicitis.

Consecutive records of 608 patients who underwent appendectomy for suspected acute appendicitis were retrospectively analyzed to evaluated the necessity and usefulness of intraoperative cultures. There were no operative deaths and postoperative infectious morbidity was 6.4%. Positive cultures were only weakly predictive of postoperative infection. Culture results did not influence selection of antibiotics. Routine intraoperative culturing during appendectomy is costly and unnecessary, except in patients at high risk.

Computed tomography in the diagnosis and localization of intraabdominal abscesses.

Computed tomographic scanning of the abdomen in 50 patients evaluated for suspected intraabdominal abscess resulted in an overall accuracy of 92 percent. It proved the most accurate diagnostic tool in determining the presence of intraabdominal abscess. Computed tomography of the abdomen is a useful diagnostic adjunct to clinical judgment and may assist in localizing intraabdominal abscesses and planning early surgical intervention.