Evaluation of mithramycin in the treatment of anaplastic gliomas

1976 ◽  
Vol 44 (6) ◽  
pp. 655-667 ◽  
Author(s):  
Michael D. Walker ◽  
Eben Alexander ◽  
William E. Hunt ◽  
Carl M. Leventhal ◽  
M. Stephen Mahaley ◽  
...  

✓ A controlled, prospective, randomized study evaluated the use of mithramycin in the treatment of anaplastic glioma compared to a similar group of patients receiving best conventional care. From a total of 116 patients in the study, 96 were within the valid study group. All patients were operated on, had histological confirmation of anaplastic glioma, and received radiotherapy at the discretion of the principal investigator. Fifty-two patients received mithramycin at a dose of 25 µg/kg/day for 21 days, while 44 patients were in the control group. There was no significant difference in the median survival from time of randomization in those receiving mithramycin (21 weeks) as compared to those not receiving mithramycin (26 weeks). There was no significant difference between the two groups in relation to age distribution, sex, location, diagnosis, tumor characteristics, signs or symptoms, or radiotherapy received. Duration of symptoms correlates positively with survival and was also significantly longer in the control group than in the treated group. This, however, did not account for the failure of mithramycin to be found an effective agent. Although the study was not designed to evaluate the efficacy of radiotherapy, patients who were so treated had a significant improvement in survival. The toxic complications of mithramycin included gastrointestinal symptoms, dermatological involvement, anemia, and liver dysfunction, indicating the need for close supervision.

1978 ◽  
Vol 49 (3) ◽  
pp. 333-343 ◽  
Author(s):  
Michael D. Walker ◽  
Eben Alexander ◽  
William E. Hunt ◽  
Collin S. MacCarty ◽  
M. Stephen Mahaley ◽  
...  

✓ A controlled, prospective, randomized study evaluated the use of 1,3-bis(2-chloroethyl)-l-nitrosourea (BCNU) and/or radiotherapy in the treatment of patients who were operated on and had histological confirmation of anaplastic glioma. A total of 303 patients were randomized into this study, of whom 222 (73%) were within the Valid Study Group (VSG), having met the protocol criteria of neuropathology, corticosteroid control, and therapeutic approach. Patients were divided into four random groups, and received BCNU (80 mg/sq m/day on 3 successive days every 6 to 8 weeks), and/or radiotherapy (5000 to 6000 rads to the whole brain through bilateral opposing ports), or best conventional care but no chemotherapy or radiotherapy. Analysis was performed on all patients who received any amount of therapy (VSG) and on the Adequately Treated Group (ATG), who had received 5000 or more rads radiotherapy, two or more courses of chemotherapy, and had a minimum survival of 8 or more weeks (the interval that would have been required to have received either the radiotherapy or chemotherapy). Median survival of patients in the VSG was, best conventional care: 14 weeks (ATG: 17.0 weeks); BCNU: 18.5 weeks (ATG: 25.0 weeks); radiotherapy: 35 weeks (ATG: 37.5 weeks); and BCNU plus radiotherapy: 34.5 weeks (ATG: 40.5 weeks). All therapeutic modalities showed some statistical superiority compared to best conventional care. There was no significant difference between the four groups in relation to age distribution, sex, location of tumor, diagnosis, tumor characteristics, signs or symptoms, or the amount of corticosteroid used. An analysis of prognostic factors indicates that the initial performance status (Karnofsky rating), age, the use of only a surgical biopsy, parietal location, the presence of seizures, or the involvement of cranial nerves II, III, IV, and VI are all of significance. Toxicity included acceptable, reversible thrombocytopenia and leukopenia.


2003 ◽  
Vol 99 (4) ◽  
pp. 661-665 ◽  
Author(s):  
Sergey Spektor ◽  
Samuel Agus ◽  
Vladimir Merkin ◽  
Shlomo Constantini

Object. The goal of this paper was to investigate a possible relationship between the consumption of low-dose aspirin (LDA) and traumatic intracranial hemorrhage in an attempt to determine whether older patients receiving prophylactic LDA require special treatment following an incidence of mild-to-moderate head trauma. Methods. Two hundred thirty-one patients older than 60 years of age, who arrived at the emergency department with a mild or moderate head injury (Glasgow Coma Scale [GCS] Scores 13–15 and 9–12, respectively), were included in the study. One hundred ten patients were receiving prophylactic LDA (100 mg/day) and these formed the aspirin-treated group. One hundred twenty-one patients were receiving no aspirin, and these formed the control group. There was no statistically significant difference between the two groups with respect to age, sex, mechanism of trauma, or GCS score on arrival at the emergency department. Most of the patients sustained the head injury from falls (88.2% of patients in the aspirin-treated group and 85.1% of patients in the control group), and had external signs of head trauma such as bruising or scalp laceration (80.9% of patients in the aspirin-treated group and 86.8% of patients in the control group). All patients underwent similar neurological examinations and computerized tomography (CT) scanning of the head. The CT scans revealed evidence of traumatic intracranial hemorrhage in 27 (24.5%) patients in the aspirin-treated group and in 31 patients (25.6%) in the control group. Surgical intervention was required for five patients in each group (4.5% of patients in the aspirin-treated group and 4.1% of patients in the control group). A surprising number of the patients who arrived with GCS Score 15 were found to have traumatic intracranial hemorrhage, as revealed by CT scanning (11.5% of patients in the aspirin-treated group and 16.5% of patients in the control group). Surgery, however, was not necessary for any of these patients. Conclusions. There was no statistically significant difference in the frequency or types of traumatic intracranial hemorrhage between patients who had received aspirin prophylaxis and those who had not. The authors conclude that LDA does not increase surgically relevant parenchymal or meningeal bleeding following moderate and minor head injury in patients older than 60 years of age.


1981 ◽  
Vol 54 (2) ◽  
pp. 220-227 ◽  
Author(s):  
M. Stephen Mahaley ◽  
Paul Steinbok ◽  
Patricia Aronin ◽  
Lynn Dudka ◽  
Doug Zinn

✓ Levamisole was evaluated as an immune stimulant in a randomized controlled study of patients with anaplastic gliomas, who had undergone surgical resection and who were also treated with radiotherapy and BCNU chemotherapy. Of 102 patients placed into the study, 85 were determined to comprise the adequately treated group (AGT): a full course of radiotherapy and two cycles of BCNU chemotherapy. Within the ATG, those patients who received levamisole did not demonstrate significantly different serial delayed hypersensitivity reactions, peripheral blood lymphocyte and T-cell counts, or serum IgM levels, compared to those patients not receiving levamisole. There was no significant difference in survival times of the two groups. Studies utilizing the avian sarcoma virus-induced glioma in rats also showed no improvement in survival with levamisole stimulation as the only immune agent, but the combination of active immunization and adjuvant stimulation with bacillus Calmette-Guerin plus levamisole was found to be therapeutically effective in this model and will be used in future pilot studies of active immunization in patients.


Author(s):  
Ramin Shekarriz ◽  
Hojjat Ghorbani ◽  
Mahmoud Mousazadeh ◽  
Khatereh Vahedi ◽  
Ebrahim Salehifar

Aim: The aim of this study was to evaluate the efficacy and side effects of silymarin in the treatment of CIPN. Methods: Patients who referred to outpatient oncology department of a referral educational hospital affiliated to Mazandaran University of Medical Sciences and experienced CIPN were randomized to receive silymarin or placebo. Intervention group received 140 mg of the Silymarin twice daily accompanied and 300 mg/day Gabapentin, whereas control group received 300 mg/day of Gabapentin and placebo twice daily for 3 months. The grade of neuropathy was determined according to the CTCAE criterion. The improvement of neuropathy was defined as the reduction of at least one neuropathic score. The visual analogue scale (VAS) was used to assess the severity of patients’ pain and the EORTC-QLQ-C30 criterion was used to assess the quality of life. Patients were evaluated initially and at the follow up visit 3 months after the enrollment. Results: A total of 80 patients were enrolled in the study. There was no significant difference between the groups in terms of severity of neuropathy at baseline. At the end of the study, the number of people with improved neuropathy in the silymarin group was 82.8% patients, which was significantly higher than 48.4% observed in the patients received placebo (P= 0.005). The silymarin-treated group showed a significant reduction in pain compared with those receiving placebo. Despite the improvement in quality of life in the intervention group compared to the comparison group, this difference was not statistically significant. Gastrointestinal symptoms were the only reported side effects with a similar incidence in two groups. Conclusion: The present data demonstrate the potential clinical use of silymarin as an adjuvant therapy to reduce CIPN symptoms.


1981 ◽  
Vol 55 (6) ◽  
pp. 935-937 ◽  
Author(s):  
Giuseppe Salar ◽  
Salvatore Mingrino ◽  
Marco Trabucchi ◽  
Angelo Bosio ◽  
Carlo Semenza

✓ The β-endorphin content in cerebrospinal fluid (CSF) was evaluated in 10 patients with idiopathic trigeminal neuralgia during medical treatment (with or without carbamazepine) and after selective thermocoagulation of the Gasserian ganglion. These values were compared with those obtained in a control group of seven patients without pain problems. No statistically significant difference was found between patients suffering from trigeminal neuralgia and those without pain. Furthermore, neither pharmacological treatment nor surgery changed CSF endorphin values. It is concluded that there is no pathogenetic relationship between trigeminal neuralgia and endorphins.


1995 ◽  
Vol 109 (7) ◽  
pp. 618-621 ◽  
Author(s):  
Paul D. R. Spraggs ◽  
Marcelle Macnamara ◽  
Theo Joseph

AbstractPost-operative nasal medications are commonly used following routine septal or turbinate surgery but their efficacy in removing blood clots, improving the sensation of a patent airway and promoting healing are unknown. This prospective randomized trial of patients undergoing septal and/or turbinate surgery assessed the efficacy of three commonly used nasal medicines, 0.5 per cent ephedrine hydrochloride nasal drops, betamethasone sodium phosphate (Betnosol®) nose drops and alkaline nasal douches, in producing the sensation of a patent airway in the 14 days following surgery. Ninety-seven patients were randomized into the three treatment groups and a control group who received no nasal medication. Patients assessed their nasal patency by means of a visual analogue scale (VAS) and any complications of treatment were recorded. Statistical analysis of the 76 complete sets of results using the Mann-Whitney U-test showed that there was a significant difference in the distribution of all of the treatments for each of the time intervals (p<0.05). Glass rank biserial correlation coefficients were all small (rg<0.085) but the most significant differences were between ephedrine and the control group at two hours, two, seven and 10 days (0.02, 0.054, 0.057, 0.085 respectively), alkaline nasal douches being most significant at four and 14 days (0.06 and 0.0722 respectively).


1986 ◽  
Vol 65 (5) ◽  
pp. 693-696 ◽  
Author(s):  
W. Richard Marsh ◽  
Robert E. Anderson ◽  
Thoralf M. Sundt

✓ The adverse effect of a minimal cerebral blood flow (CBF) in models of global ischemia has been noted by many investigators. One factor believed important in this situation is the level of blood glucose, since a continued supply of this metabolite results in increased tissue lactate, decreased brain pH, and increased cell damage. The authors have extended these observations to a model of focal incomplete ischemia. Brain pH was measured in fasted squirrel monkeys in regions of focal incomplete ischemia after transorbital occlusion of the middle cerebral artery (MCA). In both control and hyperglycemic animals, CBF was reduced to less than 30% of baseline. At 3 hours after MCA occlusion, brain pH in the control group was 6.66 ± 0.68 as compared to 6.27 ± 0.26 in the glucose-treated group. This difference was statistically significant by Student's unpaired t-test (p < 0.05). Thus, hyperglycemia results in decreased tissue pH in regions of focal incomplete cerebral ischemia in monkeys.


2000 ◽  
Vol 68 (6) ◽  
pp. 3153-3157 ◽  
Author(s):  
Christian Østergaard ◽  
Runa Vavia Yieng-Kow ◽  
Thomas Benfield ◽  
Niels Frimodt-Møller ◽  
Frank Espersen ◽  
...  

ABSTRACT The polysaccharide fucoidin is a selectin blocker that inhibits leukocyte recruitment into the cerebrospinal fluid (CSF) during experimental pneumococcal meningitis. In the present study, the effect of fucoidin treatment on the release of the proinflammatory cytokines tumor necrosis factor alpha (TNF-α), interleukin-1 (IL-1), and IL-8 into the CSF was investigated. Rabbits (n = 7) were treated intravenously with 10 mg of fucoidin/kg of body weight every second hour starting 4 h after intracisternal inoculation of ∼106 CFU of Streptococcus pneumoniae type 3 (untreated control group, n = 7). CSF samples were obtained every second hour during a 16-h study period. Treatment with fucoidin caused a consistent and significant decrease in CSF IL-1 levels (in picograms per milliliter) between 12 and 16 h (0 versus 170, 0 versus 526, and 60 versus 1,467, respectively;P < 0.02). A less consistent decrease in CSF TNF-α levels was observed in the fucoidin-treated group, but with no significant difference between the two groups (P > 0.05). In contrast, there was no attenuation in CSF IL-8 levels. Indeed, there was a significant increase in CSF IL-8 levels (in picograms per milliliter) in the fucoidin-treated group at 10 and 12 h (921 versus 574 and 1,397 versus 569, respectively;P < 0.09). In conclusion, our results suggest that blood-derived leukocytes mainly are responsible for the release of IL-1 and to some degree TNF-α into the CSF during pneumococcal meningitis, whereas IL-8 may be produced by local cells within the brain.


2018 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Irena Canjuga ◽  
Danica Železnik ◽  
Marijana Neuberg ◽  
Marija Božicevic ◽  
Tina Cikac

Purpose The purpose of this paper is to explore the impact of self-care on the prevalence of loneliness among elderly people living in retirement homes and older people living in their homes/communities. Design/methodology/approach The research was conducted through standardized SELSA-L assessment loneliness questionnaires and the Self Care Assessment Worksheet for self-care assessment. The results were processed using the Kruskal–Wallis test. Findings The obtained results have shown that impaired self-care ability affects the prevalence of loneliness among the elderly almost the same in both groups of participants. However, regarding the relationship between the state of health and self-care, only a statistically significant difference in the prevalence of loneliness is found in the case of the participants living in their homes, with the worst health condition affecting the poorer psychological care. Research limitations/implications It is necessary to point out the limitations of the research, primarily sample limitations and the selected design of the study. The sample consisted of two different and relatively small groups of participants which could adversely affect the representativeness of the sample and reduce the possibility of generalising the results. The next limiting factor is the age distribution the authors used in the research, where the age of the participants as a very important variable was collected by age range and not precisely which consequently resulted in inequality in subgroup sizes. Thus, the middle age (75–85) covers up to ten years, which is a huge range at an older age and can mean major differences in functional ability, and can impact the self-care assessment. Practical implications Nurses are indispensable in care for the elderly and they need to promote and encourage self-care of the elderly through health care. Elderly people living in retirement homes should be allowed to participate equally in health care in order to preserve their own autonomy and dignity. However, to benefit those who live in their homes, nurses should be connected to the local community and thus stimulate various forms of preventative (testing blood sugar levels, blood pressure and educating on the importance of preventive examinations) or recreational activities in the environment of elderly people with the goal of preserving their functional abilities. Originality/value The impact of self-care on loneliness was not sufficiently researched, and this paper contributed to understanding the complexity of loneliness phenomena among the elderly with the aim of developing a model of prevention.


2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Xiaochen Wang ◽  
Guiqiu Zhao ◽  
Jing Lin ◽  
Nan Jiang ◽  
Qian Wang ◽  
...  

Aims. The aim of this study was to assess the efficacy and safety of timolol in the treatment of myopic regression after laser in situ keratomileusis (LASIK).Methods. We searched MEDLINE, CENTRAL, EMBASE, China National Knowledge Infrastructure (CNKI), and Chinese Biological Medicine (CBM) from the inception to July 2015 for relevant randomized controlled trials that examined timolol therapy for myopic regression. The methodological quality of the studies included was assessed using the Revman 5.3 software.Results. We included six clinical trials involving 483 eyes in this review, including 246 eyes in treated group and 237 eyes in controlled group. We observed statistically significant improvements on the postoperative SE in the 3 months. However, the change of CCT was not statistically different between the control group and the experimental group. There were fewer cases of IOP, UDVA, and CDVA in treated group having significant difference from the controlled group.Conclusions. Topical timolol could be an effective treatment for reduction of myopic regression especially the spherical errors after myopic LASIK. Further RCTs with larger sample sizes for these trials are warranted to determine the efficacy and limitation for myopic regression after LASIK.


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