Biomedical subjects
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Thirty-six patients with Stage IV renal cell carcinoma were treated with autolymphocyte therapy (ALT). This new form of adoptive immunotherapy is based on the infusion of relatively small numbers of autologous lymphocytes that are depleted of suppressor cells and immunized in vitro by a method designed for antigen-specific activation using a 3M KCl extract of autologous tumor and an autologous lymphokine mixture. Patients received six monthly infusions of immunized lymphocytes, all on an outpatient basis. The majority of patients experienced no toxicity. The few reactions that occurred were minor and self-limiting; none required any medical intervention or subsequent delay in therapy. Patients also received oral cimetidine to reduce in vivo suppressor cell function. Survival at twenty-four months is 36 percent. Median survival is fifteen months, a significant improvement over the natural history of this disease. A multi-site, randomized, controlled trial of ALT in renal cell carcinoma has been initiated to confirm that this treatment causes a significant prolongation of survival with virtually no toxicity in these patients.
Fractures of the talus and calcaneus may be difficult to evaluate using conventional imaging modalities. Failure to recognize these fractures or to appreciate their extent may result in severe deformity or disability. Patients with talar and calcaneal fractures had computed tomography to assess its role in the management of these fractures. Computed tomography is superior to other imaging modalities in showing the position of the fracture fragments, the number of fragments, the relation of the fracture to the articular surfaces, residual articular changes, and evidence of healing.
Recently the association of recurrent spontaneous abortions and intrauterine fetal death was linked to the lupus anticoagulant (LA). LA is an immunoglobulin directed against phospholipid, causing characteristic changes in coagulation tests, and is associated with an increased risk of thrombosis. We treated a pregnant woman who presented with an embolic stroke and laboratory evidence of LA.
Displaced intra-articular fractures of the body of the os calcis are notorious causes of significant and prolonged disability. Treatment recommendations for these injuries have varied widely. An understanding of the anatomy and pathomechanics of the injury is important in treatment selection. Tongue-type and joint depression-type calcaneal fractures are subdivided on the basis of relations of the primary fracture line to the posterior facet. Treatment regimens are also based upon these relations and fracture classification. Choice of surgical approach depends upon the fracture pattern, including secondary comminution. The goal of operative treatment is to reestablish articular congruency, calcaneal width, and early range of motion. Operative treatment can be recommended for fractures that can be accurately reduced and rigidly transfixed. Nonoperative treatment is recommended for those fractures where accurate reduction is unattainable.
Eight patients with disabling tibiotalar arthritis (one patient with a supramalleolar nonunion) were treated by arthrodesis. The procedure in all of these patients consisted of internal compression obtained by bone plates and the application of a bilateral tension device. A bilateral surgical approach was used. No bone grafting was required. This study compares two groups immobilized for ten and three weeks, respectively. In both groups, the procedure invariably produced union with excellent cosmesis, few complications, and good function.
We measured the osmolality of human synovial fluid in the knees of healthy young adults following minimum activity and exercise. These results were compared with each subject's blood-serum osmolality. The synovial fluid was hyperosmolal with minimum activity, decreasing to blood-serum levels after exercise.
Gibberellin A(4/7) mixture (GA(4/7)), a highly effective promoter of early and enhanced flowering in the Pinaceae, caused a significant reallocation of dry matter and (14)C-photosynthate within terminal buds of Pinus radiata D. Don within 8 days of hormone treatment. Treatment with GA(4/7) to terminal shoots of vigorous, potentially flowering mature grafted propagules reduced the flow of photoassimilated (14)C and dry matter into the terminal bud as a whole, but significantly increased the dry matter and (14)C allocated within the bud to developing long-shoot primordia (potential seed-cone buds). This was accomplished at the expense of the structural tissues, the apical dome region, and the vegetative branch buds. Although GA(3) caused a similar reallocation of dry matter within the terminal bud, it was significantly less effective than GA(4/7) thus appears to have, in addition to any nutrient diversion abilities, a distinct morphogenic function in sexual differentiation.
We have reviewed our experiences with prefabricated functional braces in the treatment of diaphyseal tibial fractures. The braces were developed in an attempt to reduce the occasional technical difficulties encountered with the use of custom-made braces. Between January 1979 and July 1983 we treated 625 diaphyseal tibial fractures. One hundred and eighty-six patients (29.8 per cent) were lost to follow-up, the braces had to be discontinued in thirty-eight (9.2 per cent), and ten fractures (2.5 per cent) failed to unite. We conducted careful radiographic and clinical analyses of the remaining 391 patients. Two hundred and fifty-seven (65.7 per cent) of the fractures were closed and 134 (34.3 per cent) were open. Three hundred and fifty-seven (91.2 per cent) of the patients had ten millimeters of final shortening or less, and 306 (78.3 per cent) had a final angulation of 5 degrees or less. The average time from injury to bracing was 3.9 weeks (range, one to twelve weeks) for the closed fractures and 5.0 weeks (range, one to twelve weeks) for the open fractures. These findings appear to support our concept that function of the extremity is beneficial to osteogenesis and that many diaphyseal tibial fractures can be satisfactorily stabilized in prefabricated functional braces. These braces also have the advantage of not immobilizing the adjacent joints and they permit the gradual restoration of weight-bearing.
Three conventional treatments of scalp psoriasis were compared in a randomized, blind, uncontrolled clinical trial in 30 patients at a psoriasis day-care centre. Triple gel (the sequential application of Keralyt, Estar, and Topsyn gels), 10 percent salicylic acid in Sofsyn oil, and 10 percent salicylic acid in mineral oil were compared. There were no statistically significant differences among the three treatments in terms of clinical efficacy. Therefore, on the basis of lowest cost and highest patient acceptance, 10 percent salicylic acid in mineral oil is the preferred treatment.
The value of the Weibull, logarithmic-logistic, and logarithmic-normal plots in expressing dissolution rate data is considered for the combinations of zero and first-order release with sink and non-sink conditions, and for actual dissolution rate data of diazepam from tablets in a medium of pH2.
OBJECTIVE: To determine the risk of cardiovascular events and death in patients receiving statin treatment for cholesterol regulation. METHODS: Systematic review and meta-analysis of all randomized controlled trials that were published as of April 15, 1997. Primary or secondary prevention trials or regression trials were eligible. MAIN OUTCOME MEASURES: All-cause mortality, fatal myocardial infarction (MI) or stroke, nonfatal MI or stroke, angina, and withdrawal from the studies. Both random- and fixed-effects models were run for the outcomes of interests, and results are expressed as odds ratios (ORs). Sensitivity analyses tested the impact of the study type and duration, statin treatment type, and control arm event rates. Intent-to-treat denominators were used whenever they were available, and the number needed to treat was calculated when appropriate. RESULTS: Seventeen studies (21 303 patients) were included (2 secondary prevention studies, 5 mixed primary-secondary prevention population studies, and 10 regression trials). Treatment groups included lovastatin (t = 5), pravastatin (t = 10), and simvastatin (t = 3). For all-cause mortality, the OR was 0.76 (95% confidence interval [CI], 0.67-0.86) in favor of receiving statin treatment; for fatal MI, the OR was 0.61 (95% CI, 0.48-0.78); for nonfatal MI, the OR was 0.69 (0.54-0.88); for fatal stroke, the OR was 0.77 (95% CI, 0.57-1.04); for nonfatal stroke, the OR was 0.69 (95% CI, 0.54-0.88); and for angina, the OR was 0.70 (95% CI, 0.65-0.76). CONCLUSIONS: Patients who received statin treatment demonstrated a 20% to 30% reduction in death and major cardiovascular events compared with patients who received placebo. This advantage was generally present across study types and statin treatment types and for patients with less severe dyslipidemias. The benefit in clinical outcomes was noticeable as early as 1 year.
To compare the gastric ulcer healing rates of lansoprazole with histamine2-receptor antagonists (H2RAs) (ranitidine, famotidine, cimetidine, and roxatidine), a meta-analysis was performed using data from five published and eight unpublished randomized controlled trials. Analyses were performed using (1) both evaluable patients (n = 1527) and all randomized patients (n = 1655) (assuming that patients lost to follow-up were treatment failures); (2) all studies and a subset of studies that received high methodologic quality scores; and (3) fixed-effects, random-effects, and Bayesian statistical models. In all cases, lansoprazole was associated with a significantly higher rate of endoscopic healing at both 4 and 8 weeks compared with the H2RAs. When the most conservative Bayesian statistical model and intent-to-treat analysis were used, lansoprazole was associated with a 33% higher healing rate at 4 weeks (risk ratio = 1.33; 95% confidence interval [CI] = 1.19 to 1.49) and a 12% higher healing rate at 8 weeks (risk ratio = 1.12; 95% CI = 1.06 to 1.19) than were the H2RA agents. Similar results were obtained when the meta-analysis was performed on evaluable rather than all randomized patients and using the three different analytical techniques noted above. Slightly lower, though still highly significant, improvement in ulcer healing rates was obtained when the meta-analysis was performed using a subset of six studies that received high methodologic quality scores. These results support the conclusion that lansoprazole heals ulcers more quickly than do the H2RAs and also achieves higher overall rates of healing. The eradication of Helicobacter pylori associated with gastric ulcers was not assessed in individual studies.
The authors wanted to determine whether adding interferon-alpha (IFN-alpha) to chemotherapy regimens, in either induction or maintenance settings, provides additional survival benefits in follicular non-Hodgkin's lymphoma (NHL). A meta-analysis was performed based on published data from randomized controlled clinical trials involving nine separate study populations. Patients receiving IFN-alpha (in either induction or maintenance therapy) had significantly increased 5-year and progression-free survival rates at 3 and 5 years compared with concurrent controls. The advantages of IFN-alpha therapy were most marked in studies using anthracycline-containing induction chemotherapy; in these studies, patients who received IFN-alpha had approximately 20% increased progression-free survival rates compared with controls and a lesser survival advantage. The available literature did not allow a determination of the relative benefit of IFN-alpha in induction or maintenance treatments for NHL or a determination of the optimum duration of IFN-alpha treatment. Although questions remain about its optimal use. IFN-alpha appears to prolong survival time in patients with follicular NHL.
We conducted a systematic review of all published randomized, controlled trials to assess the risk of cancer or death in patients receiving verapamil for hypertension, angina pectoris, or cardiac arrhythmias. Meta-analysis comparing the risk of new cancers, cancer deaths, and all deaths was performed. Thirty-nine trials comprising 11,201 patients were eligible. Study durations ranged from 8 days-6 years (mean 29.5 wks). Nine trials (6507 patients) were 24 weeks in duration or longer. For cancer and cancer death, OR was 1.20 (95% CI = 0.60-2.42) for verapamil versus active controls and 0.73 (95% CI = 0.39-1.39) for verapamil versus placebo. For all deaths, OR was 1.13 (95% CI = 0.70-1.82) for verapamil versus active controls and 0.85 (95% CI = 0.71-1.00) for verapamil versus placebo. Sensitivity analysis for the 9 trials 24 weeks' duration or longer gave similar results. There is no statistically significant increased risk of cancer or deaths with verapamil compared with active controls or placebo.
We performed a literature search for all clinical studies reporting outcomes in patients with the acquired immunodeficiency syndrome (AIDS) receiving granulocyte-macrophage colony-stimulating factor (GM-CSF) for any indication. Safety outcomes included human immunodeficiency virus replication, immune status, and frequency of opportunistic infections and neoplasms. Data were synthesized qualitatively. We identified 22 studies (274 patients): 12 addressed AIDS neutropenia, 8 AIDS cancer therapy, and 2 opportunistic infections. Viral burden was assessed by serum p24Ag in 15 studies. Nine reported no change in levels, three net decreases, and three net increases. All studies showing net increases involved patients receiving GM-CSF without a concurrent antiretroviral. The CD4 counts were unchanged in 5 studies, increased in 3, and not reported in 14. The incidence of neoplasms or new opportunistic infections was low. The literature suggests no increased risk of viral replication or clinical deterioration in patients with AIDS who take GM-CSF concurrently with zidovudine.