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PubMedDate not supplied

Retrospective evaluation of emergency service patients with poisoning: a 3-year study.

The purpose of this retrospective study was to evaluate the characteristics of cases of acute poisoning in adults who were admitted to emergency service over a 3-year period. Clinical charts were analyzed retrospectively for etiologic and demographic patient characteristics. A total of 810 adults were admitted to the emergency center with acute poisoning. The female-to-male ratio was 2:1. Mean ages of female and male patients were 28.8+/-12.9 years and 35.1+/-15.4 years, respectively, and many patients (46.9%) were between the ages of 16 and 25 years. Medicinal drugs were found to be the primary cause (60.5%) of poisoning, and tricyclic antidepressants were the most frequent causative agents (36.3%). Seasonal distribution of poisoning cases suggested a peak in the summer months (35.4%). Overall, 68.6% of acute poisonings were suicide attempts, and of these patients, 84.9%, 14%, and 1.1% were attempting suicide for the first, second, and third times, respectively. Among 810 cases of acute poisoning, 15 were fatal. The following conclusions were reached by investigators: (1) in the test region, younger females, especially single females, were at greater risk for poisoning than other patient groups, (2) self-poisoning cases constituted the majority of all poisonings, and (3) the main agents of self-poisoning were medicinal drugs, with antidepressants used most frequently. It was also found that unintentional poisoning commonly resulted from intake of foods, especially mushrooms.

Adolescent↗
PubMed1989

Complications during anaesthesia in patients with Duchenne's muscular dystrophy (a retrospective study)

The purpose of this retrospective study was to estimate the frequency and severity of anaesthetic complications in patients with Duchenne's muscular dystrophy (DMD). Forty-four boys with DMD were exposed to anaesthesia and surgery 84 times during a period of 22 years (1965-86). The procedures took place at 15 different hospitals. Retrospective examination of the case records showed: 19 cases with local analgesia without any complications, and 18 of 65 general anaesthetics with minor or more serious complications. In ten cases an increase in body temperature above 37.5 degrees C was seen, five had abdominal pain and dark-coloured urine after surgery, and three had a critical perioperative course with a resemblance to malignant hyperthermia. The complications were almost exclusively related to the use of succinylcholine. The use of succinylcholine was dispersed through all ages. Three out of the eight patients with severe complications occurred 1.5, 2.5 and 4 years before the neuromuscular disease was diagnosed. Thus an unusual course of anaesthesia in male children calls for further investigation. Although it has been stated before that succinylcholine is contraindicated in patients with Duchenne's muscular dystrophy, the drug continues to be used.

Adolescent↗
PubMed2006

Effectiveness of oral midazolam for paediatric dental care: a retrospective study in two specialist centres.

AIM: To analyse retrospectively the outcomes for children undergoing oral care under conscious sedation with oral midazolam and local analgesia at Leeds dental Institute, England and Westmead Dental Hospital, Sydney, Australia. Secondly, the study assessed the suitability of oral midazolam for paediatric dental treatment. STUDY DESIGN: Retrospective study of clinical outcomes based on dental records. METHODS: All children included in the study had been treated between September 2000 to August 2004 and full dental records were available. The dental records were examined using a standard pro forma sheet and data collected for: age, previous behaviour using the Frankl [1962] scale, units of work planned and achieved using the modified index of O'Sullivan and Curzon [1991], midazolam dosage and treatment outcome. RESULTS: The study population consisted of 101 children aged 1-11 years in both Leeds (57 children) and Westmead (44 children). There were significant differences between Leeds and Westmead with respect to age (mean +/-SD) in years 5.0+/-1.0 versus 2.9+/-1.6; number of treatment visits 1.7 versus 1.1; sedation dose used 0.5-0.7 mg/kg versus 02.-0.3; type and amount of treatment planned 8.3 units versus 3.3 and achieved 7.5 versus 2.2, for both centres respectively. There was also a difference in overall success rates of rendering the children dentally fit of 65% v. 91%, respectively. CONCLUSION: Oral midazolam was found to be a useful drug for the management of young children with behaviour problems. It was found, however, not to be effective in all cases and for the provision of all types of paediatric dentistry. The results indicate that, when using oral midazolam in children, the treatment should be restricted to simple restorations and extractions over a maximum of two visits.

Administration, Oral↗
PubMed1999

[Palliative radiotherapy of bone metastases. A retrospective analysis of 176 patients].

BACKGROUND: The effect of the palliative irradiation of bone metastases was explored in this retrospective analysis. The spectrum of primary tumor sites, the localization of the bone metastases and the fractionation schedules were analyzed with regard to palliation discriminating total, partial and complete pain response. PATIENTS AND METHODS: One hundred seventy-six patients are included in this retrospective quantitative study from April 1992 to November 1993. Two hundred fifty-eight localizations of painful bone metastases were irradiated. The percentage of bone metastases of the total irradiated localizations in our department of radiotherapy in the Charité-Hospital, the primary tumor sites, the localizations and the different fractionation schedules were explored. The total, partial and complete pain response was analyzed in the most often used fractionation schedules and by primary tumor sites. RESULTS: Eight per cent of all irradiated localizations in the observation period were bone metastases. There were irradiated bone metastases of 21 different tumor sites. Most of the primary tumor sites were breast cancer (49%), lung cancer (6%) and kidney cancer (6%). The most frequent site of metastases was the vertebral column (52%). The most often used fractionation schedules were: 4 x 5 Gy (32%), 10 x 3 Gy (18%), 6 x 5 Gy (9%), 7 x 3 Gy (7%), 10 x 2 Gy (5%) and 2 x 8 Gy. The total response rates in this fractionation schedules were 72%, 79%, 74%, 76%, 75% and 72%, the complete response rates were 35%, 32%, 30%, 35%, 33% and 33%. There were no significant differences between the most often irradiated primary tumor sites, the most frequent localizations and the palliation with regard to total, partial and complete pain response. CONCLUSION: There are no differences between the different fractionation schedules with regard to the pain effect of bone metastases. A palliation is ensured in 75% of all cases with a partial response of 42% and complete response of 33%. With regard to pain response these results do not justify a recommendation for a standard fractionation schedule. Current fractionation schedules such as 10 x 3 Gy for 2 weeks or 5 x 4 Gy for 1 week should be used. Another point is the recalcification in the palliative treatment of bone metastases in patients with better prognosis. The recalcification is the basis for stabilization and prevention of fractures. This aspect should be explored in prospective studies.

Adult↗
PubMed2004

[The efficiency of spinal manipulation in otorhinolaryngology. A retrospective long-term study].

BACKGROUND: The vertebral genesis of many functional disorders in otorhinolaryngology, such as dizziness, hearing-impairment, ear-pressure, ear-pain, foreign body sensation in the throat and dysphonia, is suggested by the success of spinal manipulative therapy, particularly of the atlanto-occipital joint. Up to now, there are no retrospective investigations which show the duration of the therapeutic effect. METHODS: We examined 220 patients with cervical otorhinolaryngological disorders (100 patients with dizziness, 49 with hearing impairment, 47 with tinnitus and 24 with dysphonia) after cervical manipulation lasting more than 6 months. RESULTS AND CONCLUSIONS: The extraordinary satisfaction with the manipulative therapy in 82% of patients with dizziness (46% total relief, 36% high improvement) reflects the high efficiency of this manual therapy. In contrast to these results, only 10% of patients with tinnitus showed an improvement (P<0.001). This retrospective investigation demonstrates that a successful outcome after manual therapy is not based on a "placebo effect".

Atlanto-Occipital Joint↗
PubMed1999

[Mitoxantrone (Novantron) in therapy of severe multiple sclerosis. A retrospective study of 15 patients].

Mitoxantrone is an anthracenedione anti-neoplastic agent that has recently been shown to be effective in ameliorating disease activity in multiple sclerosis (MS) as indicated by clinical and MRI data. However, the role of mitoxantrone in escalating treatment of patients with frequent and severe relapses and with rapid progression of disability is less clear. In this retrospective analysis we report on 15 patients with severe relapsing-remitting (9 patients) and secondary progressive MS with superimposed exacerbations (6 patients) treated open-labeled with mitoxantrone in our Clinical Research Group from July 1994 to October 1998. Eleven of these patients (73%) were treated with azathioprine, interferon-beta-1b or cyclophosphamide before. The patients received mitoxantrone over a period of at least 12 months (19 +/- 6 months) with a single dose of 10 mg/m2 monthly for the first three months. Thereafter, infusions were repeated every 3 months (total dose 141 mg +/- 45 mg). The annual relapse rate could be significantly reduced from 3.0 +/- 1.5 in the year before therapy to 0.5 +/- 0.5 during therapy. Nine patients (60%) were stabilised, while four patients (27%) showed an improvement of disability. The treatment was well tolerated with only minor side effects. These results although retrospectively obtained confirm previous trials showing that mitoxantrone may be useful in MS patients with frequent and severe exacerbations and/or a rapidly progressive course of the disease who have had other immunomodulatory medication.

Adult↗
PubMed2004

[Impact of immunochemotherapy on survival of patients with metastatic renal cell carcinoma. A retrospective study comparing interferon-alpha-2a/vinblastine versus interferon-alpha-2a/interleukin-2/5-fluorouracil].

The prognosis for patients with metastatic renal cell carcinoma (RCC) remains unsatisfactory to date. Combined immunochemotherapy (ICT) strives for a synergistic effect avoiding a substantial increase of therapy-related adverse events. The combination therapy regimes consisting of either interferon-alpha-2a/vinblastine (IFN-alpha2a/VBL) or interferon-alpha-2a/interleukin-2/5-fluorouracil (IFN-alpha2a/IL-2/5-FU) demonstrated objective remission rates, surpassing the results obtained with the administration of single immunotherapeutic agents. Despite the data from a recently published study, the role of these two therapy combinations did not seem clearly defined. Therefore, we compared the impact of IFN-alpha2a/VBL and IFN-alpha2a/IL-2/5-FU on remission and survival as well as the safety profile in a retrospective study in patients with metastatic RCC. In a retrospective single-center study, 105 patients with metastatic RCC having received treatment between 1992 and 2002 with either s.c. IFN-alpha2a/ i.v. VBL ( n=70, group 1) or s.c. IFN-alpha2a/ s.c. IL-2/ i.v. 5-FU ( n=35, group 2) were evaluated. At a median follow-up of 17 months, remission and survival rates as well as the toxicity profiles of the respective groups were documented and compared. The median age throughout the entire patient population was 61 years. Patients in the IFN-alpha2a/VBL group reached a median overall survival of 20 months compared to 17 months for the patients in the IFN-alpha2a/IL-2/5-FU population ( p=0.850). The objective response rate in the first patient group reached 25.7%, whereas the tumor remission rate of group 2 amounted to 22.9% ( p=0.680). Patients showing an objective response reached a significantly higher survival rate than patients without response reaction (median survival was 36 vs 10 months, p=0.0001). The incidence of each therapy-induced adverse event was higher throughout the second treatment group. These differences were significant with respect to flu-like symptoms (85.7 vs 57.1%, p=0.003), grade 3/4 elevations of liver enzymes (14.3 vs 1.4%, p=0.007), nausea/vomiting (74.3 vs 50%, p=0.017), the severity of erythemas (74.3 vs 10%, p<0.001), and patients with lung edema (17.1 vs 2.9%, p=0.009). Eight patients discontinued the ICT, two of whom died of a myocardial infarction.Despite an overall limited prognosis, patients showing a tumor remission seem to benefit from ICT in terms of overall survival. While both treatment options offer comparable remission and survival rates, the IFN-alpha2a/VBL regimen induces fewer adverse events than the treatment with IFN-alpha2a/IL-2/5-FU.

Adult↗
PubMed2006

Inverse relationship between allergic contact dermatitis and type 1 diabetes mellitus: a retrospective clinic-based study.

AIMS/HYPOTHESIS: Contact allergy (CA) is a disease induced and maintained by environmental factors, which mainly has a Th2 pattern in its chronic form. Environmental factors play a major role in CA, while genetic factors are of minor importance. Type 1 diabetes is an autoimmune disease of the islets of Langerhans, which has a Th1 cytokine pattern and in which modulators of risk are both genetic and environmental. To investigate whether environmental exposure to chemicals leading to CA could influence the risk of type 1 diabetes, we conducted a retrospective clinic-based study of patients subjected to diagnostic patch testing of CA. METHODS: We undertook a retrospective clinic-based study of 13,315 patients who were patch-tested between 1985 and 2003, and linked it with the Danish National Patient Registry containing diabetic mellitus discharge diagnoses from 1987 to 2003. The 13,315 patch-tested patients gave rise to 4,848 CA patients. Using logistic regression, we calculated odds ratios for persons with CA of having type 1 diabetes. RESULTS: Type 1 diabetes was diagnosed in 229 of the patch-tested patients. CA patients had a reduced risk of having type 1 diabetes, with an odds ratio 0.62 (95% CI 0.46-0.86). After adjusting for sex and age, the odds ratio was 0.63 (95% CI 0.47-0.86). CONCLUSIONS/INTERPRETATION: An inverse relationship between CA and type 1 diabetes was found. Thus there may be a protective effect of having CA in relation to the risk of type 1 diabetes, or vice versa type 1 diabetes may lead to tolerance rather than hypersensitivity. Alternatively, these two diseases may share common genetic factors, although at present these are unknown.

Adolescent↗
PubMed2000

Retrospective evaluation of the simplified Therapeutic Intervention Scoring System (TISS-28) in a surgical intensive care unit.

OBJECTIVE: To compare the simplified Therapeutic Intervention Scoring System (TISS-28) with its original version, to provide reference values of daily TISS-28 assessment and to describe its association with severity of illness in surgical patients. DESIGN: Retrospective evaluation of prospectively collected audit data; four documentation periods. SETTING: Ten-bed intensive care unit (ICU) in a surgical university hospital. PATIENTS: One thousand nine hundred eighty-six consecutive admissions (1,808 patients; 10,448 observation days) who stayed on ICU for at least 6 h. Patients were in hospital for abdominal, vascular or trauma surgery. The average age was 61.5 years, the mean APACHE II score on admission 10.3 points. INTERVENTIONS: None. MEASUREMENTS: Raw data for APACHE II score and TISS were recorded daily. TISS-28 was calculated retrospectively from the original TISS data. RESULTS: Average TISS-28 values (28.7 points; SD = 9.7) do not differ substantially from the original TISS values (28.2 points, SD = 10.9) and overall correlation is high (r = 0.935). Of the patients, 57.3 % left the ICU after 1-2 days as survivors with a mean daily TISS-28 of 20.0 points. Variability between documentation periods was higher with the original TISS. On average, patients with increasing severity of disease require an increasing amount of care. Survivors have lower TISS-28 values than non-survivors (27.6 vs 34.9). CONCLUSIONS: In a surgical ICU the simplified version of TISS with 28 items (TISS-28) sufficiently reflects the amount of intensive care provided and may provide useful additional information on severity of disease and prognosis. It should replace the original index, at least in these cases.

APACHE↗
PubMed1998

Do retrospective and prospective quality of life assessments differ for pancreas-kidney transplant recipients?

The literature indicates that chronically ill patients have a remarkable capacity to adapt to their illness. For example, they will generally report a better quality of life (QoL) than individuals in the general population who are asked to imagine themselves as chronically ill and to rate their QoL. The present study further explores this phenomenon in type I diabetic transplant recipients with end-stage renal disease. In a prospective, longitudinal study, we assessed the QoL in 22 patients, both before and after they received a combined pancreas-kidney transplant. After transplantation, the patients were also asked to assess their pretransplant QoL by rating it on a 10-point scale. What we found was that prior to transplantation, QoL was prospectively given a mean rating of 5.23; this score increased to 7 after a successful transplant procedure. During follow-up assessments 5, 12, and 18 months after successful transplantation, patients retrospectively scored their pretransplant QoL as 3.27, 3.14, and 3.05, respectively. We conclude that when type I diabetic patients with end-stage renal disease undergo a transplant procedure to improve their health status, they re-evaluate their pretransplant QoL, and this retrospective assessment is significantly lower than their prospective one when transplantation is successful.

Health Knowledge, Attitudes, Practice↗
PubMed2004

Suicidality and second generation antipsychotics in schizophrenia patients: a case-controlled retrospective study during a 5-year period.

RATIONALE: Rates of attempted suicide for individuals with schizophrenia are approaching 30%. Attempted suicide is among the most potent predictors of subsequent suicide. Several studies suggest that suicide is more likely to occur in patients who are not being adequately treated or not being treated at all. An effort was made in the last decade to evaluate the antisuicide effects of pharmacological treatment in schizophrenia with emphasis on the role of the newer second-generation antipsychotics (SGA). OBJECTIVE: The aim of the present study was to assess in a large cohort of schizophrenia patients the effects of exposure to SGA on suicidality of patients suffering from schizophrenia or schizoaffective disorder. The study is a retrospective case-controlled evaluation over a 5-year period undertaken in a large university affiliated tertiary care psychiatric hospital. METHODS: Between January 1998 and December 2002, all records of admissions of schizophrenia or schizoaffective disorder patients (ICD-10) were assessed. Data as to age, gender, diagnosis, suicide attempt prior to admission, treatment with antipsychotic medication, dose and duration of treatment (mg daily, duration) with SGA was extracted from patients' files. All patients who had attempted suicide prior to admission were defined as the index group. The case-controlled group was comprised of the next admission of a patient suffering from schizophrenia (or schizoaffective disorder), matched for gender and age, who did not attempt suicide. RESULTS: Records of 756 patients (4486 admissions for said period) were analyzed (56.6% male, mean age 39.1+/-13.5 years). Amongst 378 patients who attempted suicide (index group), 16.1% were exposed to SGA while 37% were exposed in the control group (P=0.0001). The protective effect (odds ratio) of treatment by SGA was 3.54 (95%CI: 2.4-5.3). Risperidone was more frequently prescribed in the control group (54.3%) and had a larger effect-size than olanzapine (3.16 versus 1.76), although not statistically significant. Clozapine was prescribed only to a few patients. CONCLUSIONS: Schizophrenia patients exposed to both risperidone and olanzapine may gain protection from suicidality. The antisuicide effects seem to differ between SGAs. The long duration and large sample size support this finding, despite the retrospective nature of this study.

Adult↗
PubMed2006

A retrospective study of memantine in children and adolescents with pervasive developmental disorders.

RATIONALE: There are no drugs that have been shown to effectively treat the core social impairment of autism. OBJECTIVES: The purpose of this study was to examine the effectiveness and tolerability of memantine for social impairment in children and adolescents with pervasive developmental disorders (PDDs). MATERIALS AND METHODS: Medical records of 18 patients with PDDs consecutively treated with open-label memantine were retrospectively reviewed. The data reviewed included prospectively obtained assessments of severity (S) and improvement (I) using the Clinical Global Impressions Scale (CGI). Pretrial and follow-up parent ratings were also available on six patients using the Aberrant Behavior Checklist (ABC). RESULTS: Eighteen patients (15 male, 3 female; mean age=11.4 years, range 6-19 years) received memantine (mean dosage=10.1 mg/day, range 2.5-20 mg/day) over a mean duration of 19.3 weeks (range 1.5-56 weeks). Eleven of 18 (61%) patients were judged responders to memantine based on a rating of "much improved" or "very much improved" on the CGI-I. Significant improvement was also seen on the CGI-S. Improvement was primarily seen clinically in social withdrawal and inattention. Adverse effects occurred in 7 of 18 (39%) patients and led to drug discontinuation in 4 of 18 (22%) patients. Thirteen of 18 (72%) patients received stable doses of concomitant medications during the memantine trial. CONCLUSIONS: In this open-label retrospective study, memantine was effective in a number of patients with PDDs. Controlled studies are warranted to further assess the efficacy and safety of memantine in PDDs.

Adolescent↗
PubMed2002

Sarcoma tumor FDG uptake measured by PET and patient outcome: a retrospective analysis.

In a retrospective analysis of patients with sarcoma who underwent fluorodeoxyglucose positron emission tomography (FDG PET) imaging, tumor maximum FDG uptake was analyzed for ability to predict patient survival and disease-free interval. Two hundred and nine patients with sarcoma were imaged prior to treatment with neoadjuvant chemotherapy or resection. Tumor FDG uptake expressed as maximum standard uptake value (SUV(max)) was compared with disease-free and overall survival. A multivariate Cox regression analysis was applied to examine the role of SUV(max) in predicting time to death or disease progression, after adjusting for standard clinical prognostic factors. The multivariate analyses showed that the SUV(max) information is a statistically significant independent predictor of patient survival. Tumors with larger SUV(max) have a significantly poorer prognosis. This retrospective analysis indicates that the sarcoma tumor SUV(max) value determined by PET is an independent predictor of survival and disease progression.

Adolescent↗
PubMed2006

Vocal fold paralysis as a sign of chest diseases: a 15-year retrospective study.

BACKGROUND: Vocal fold paralysis (VFP) is sometimes the only sign of chest diseases. However, some patients with VFP due to chest diseases are not diagnosed correctly at the first examination, which may leave the patients untreated for a long time. Depending on the situation, chest x-ray is not enough for detecting the primary lesion. The objective of this study was to discuss the diagnostic procedure for VFP based on the retrospective analysis of the cases. METHODS: A total of 42 patients (29 males and 13 females) with VFP due to chest disease examined at the Department of Otolaryngology of Kyoto Prefectural University of Medicine between 1988 and 2002 were reviewed retrospectively. RESULTS: Of the primary chest diseases, lung cancer (15 cases) was the most common, followed by thoracic aortic aneurysm (TAA) (9 cases), metastatic tumor from other regions (6 cases), pulmonary and mediastinal tuberculosis (TB) (5 cases), and esophageal cancer (4 cases). While the primary lesions were easily detected with chest x-ray in most of the cases, some lesions in the aortopulmonary window were difficult to detect. Contrast-enhanced computed tomography (CT) was useful to detect any mass in this region. CONCLUSIONS: In the diagnosis of VFP due to chest diseases, chest x-ray was useful but not always enough for detecting the primary lesion. Necessity of further examinations including contrast-enhanced chest CT must be kept in mind for the cases with negative chest radiographs.

Aged↗
PubMed1998

Lack of survival benefit of extended lymph node dissection for ductal adenocarcinoma of the head of the pancreas: retrospective multi-institutional analysis in Japan.

It has not been established that extended lymph node resection is necessary for ductal adenocarcinoma of the head of the pancreas. According to the general rules for the study of pancreatic cancer, a multiinstitutional, retrospective clinical study was undertaken to investigate the efficiency of extended lymph node dissection for this malignancy. Altogether 501 patients underwent resection of the pancreas between 1991 and 1994 at 77 medical facilities; the surgical procedures, staging, lymph node dissection, curability, and survival rate were analyzed retrospectively. Eighteen of the patients died within 30 postoperative days, leaving 483 patients to be studied. The resection was curative microscopically in 94 patients, resulting in a 3-year survival of 29%. Macroscopically curative resection resulted in a 3-year survival of 14%; noncurative resection produced a 3-year survival of 6%. Although extended lymph node dissection was performed on 38 patients in stage I, 42 patients in stage II, 206 patients in stage III, and 1 patient in stage IV, there was no improvement in survival when the results were compared to those seen after standard or palliative lymph node dissection. The extent of lymph node dissection has not affected the prognosis for ductal adenocarcinoma of the head of the pancreas at any stage of the course of the disease. Excessive lymph node dissection in advanced cases does not necessarily lead to a favorable prognosis. The patients who undergo a radical operation with an adequate lymph node dissection have longer survivals.

Adult↗
PubMedDate not supplied

Predictive factors of in-stent restenosis in renal artery stenting: a retrospective analysis.

PURPOSE: To retrospectively evaluate the role of clinical and procedural factors in predicting in-stent restenosis in patients with renovascular disease treated by renal artery stenting. METHODS: From 1995 to 2002, 147 patients underwent renal artery stenting for the treatment of significant ostial atherosclerotic stenosis. Patients underwent strict clinical and color-coded duplex ultrasound follow-up. Ninety-nine patients (111 stents), with over 6 months of continuous follow-up (mean 22+/-12 months, range 6-60 months), were selected and classified according to the presence (group A, 30 patients, 32 lesions) or absence (group B, 69 patients, 79 lesions) of significant in-stent restenosis. A statistical analysis was performed to identify possible preprocedural and procedural predictors of restenosis considering the following data: sex, age, smoking habit, diabetes mellitus, hypertension, serum creatinine, cholesterol and triglyceride levels, renal artery stenosis grade, and stent type, length and diameter. RESULTS: Comparing group A and B patients (chi(2) test), a statistically significant relation was demonstrated between stent diameter and length and restenosis: the risk of in-stent restenosis decreased when the stent was >/=6 mm in diameter and between 15 and 20 mm in length. This finding was confirmed by multiple logistic regression analysis. Stent diameter and length were proved to be significantly related to in-stent restenosis also when evaluating only patients treated by Palmaz stent (71 stents). CONCLUSION: Although it is based on a retrospective analysis, the present study confirms the importance of correct stent selection in increasing long-term patency, using stents of at least 6 mm in diameter and with a length of approximately 15-20 mm.

Adult↗
PubMed2002

Overview of 321 patients with idiopathic thrombocytopenic purpura. Retrospective analysis of the clinical features and response to therapy.

In this retrospective study, we evaluated the clinical features and the effects of various treatment modalities on the clinical course in patients diagnosed with idiopathic thrombocytopenic purpura (ITP) at our center between 1984-2000. We retrospectively examined the medical records of 321 (229 females, 92 males) ITP patients. One hundred and seventy-one (53.3%) patients were lost to follow-up. When evaluating the clinical features, all 321 patients were included; however, when the response to treatment modalities was evaluated only 150 patients followed up regularly were considered. The median age of the patients on initial diagnosis was 34 years (range: 14-78). At initial diagnosis, 235 (73.2%) patients had signs of bleeding. Of patients diagnosed with ITP initially, six later turned out to have systemic lupus erythematosus (SLE) and two myelodysplastic syndrome (MDS). The median follow-up of 150 patients followed up regularly was 30 months (range: 4-396). One hundred and thirty-seven of these subjects had an indication for treatment and 94.2% of them were administered either standard or high-dose steroids as the first-line therapy. Complete remission (CR) was defined as any platelet count >100,000/mm(3) lasting for 3 months or longer without treatment. CR was achieved in 51.9% of the patients given steroids as the initial therapy. During a median follow-up of 33 months, relapse occurred in 58.2% of these patients, and after a median follow-up of 11 months the rest of them were still in remission. Ninety-eight patients followed up regularly were administered second-line therapies. CR was obtained in 44.4% of the patients who used steroids as second-line therapy. Within a median follow-up of 15 months, 20.8% of these patients relapsed. Splenectomy was performed in 76 patients and CR was obtained in 68.4% of the regularly followed up patients. Relapse occurred within a median of 96 months in 15.4% of the patients who had CR. Kaplan-Meier curves showed that the duration of CR obtained by splenectomy was significantly higher than that obtained by steroids (p<0.001). The 10-year disease-free survivals in patients who used steroids and who underwent splenectomy were, respectively, 13% and 58%. In our adult ITP patients, steroids induced nearly similar rates of CR both as first-and second-line therapies. Splenectomy seems to be effective in patients unresponsive to steroids. The duration of CR obtained by splenectomy is significantly longer when compared with the duration of CR obtained by steroid therapy.

Adolescent↗
PubMed1997

Pharmacokinetics of the hypoxic cell cytotoxic agent tirapazamine and its major bioreductive metabolites in mice and humans: retrospective analysis of a pharmacokinetically guided dose-escalation strategy in a phase I trial.

Tirapazamine (3-amino-1,2,4-benzotriazine-1,4-di-N-oxide; SR 259075) is a selective hypoxic cell cytotoxic agent that is bioreductively activated in tumours to a reactive-drug free radical. Preclinically the agent has been shown to possess additive and synergistic anti-tumour activity in combination with radiotherapy and chemotherapy regimens. In the present study the pharmacokinetics and metabolism of tirapazamine were investigated in mice and patients as part of pre-clinical and phase I investigations. The objectives of this work were twofold; firstly, to evaluate retrospectively the utility of a pharmacokinetically guided dose-escalation (PGDE) strategy for tirapazamine, and secondly, to investigate if pharmacologically relevant plasma concentrations could be achieved at tolerable doses. Pharmacokinetic studies for PGDE were conducted in mice at four dose levels ranging from one-tenth of the LD10 to the LD50. The AUC at the LD10 (2932 micrograms ml-1 min) was used to determine a target AUC value of 1173 micrograms ml-1 min (equivalent to 40% of the mouse LD10 AUC) for clinical studies. A phase I study to investigate the tolerance of a single i.v. infusion of tirapazamine (once every 3 weeks) was initiated with close pharmacokinetic monitoring. The starting dose (36 mg/m2) was based on toxicity data obtained in the mouse, rat and dog. Doses were escalated by increases in the volume and duration of infusion. A retrospective analysis of the pharmacokinetic and toxicity data was then made to determine the utility of a PGDE approach. The drug exhibited a steep dose-lethality relationship in mice (LD10 294 mg/m2, LD50 303 mg/m2). The major gross toxicities were body-weight loss (15-20%), pilo-erection and hypoactivity at all dose levels. Sporadic ptosis and conjunctivitis were observed at doses of > 300 mg/m2. The plasma elimination of tirapazamine fitted a monoexponential open model, with rapid elimination from the plasma (t1/2 = 36 +/- 0.65 min) occurring at the LD10 dose of 294 mg/m2. A 10.3-fold increase in dose resulted in a 25.0-fold increase in AUC. Clinically, doses were escalated over the range of 36-450 mg/m2. Ototoxicity (tinnitus and reversible hearing loss) was dose-limiting at 450 mg/m2 and the MTD was 390 mg/m2 for this schedule. Pharmacokinetic analyses in patients revealed that the elimination of tirapazamine in patients was generally bi-phasic, with low inter-patient variability being found in clearance. A 12.5-fold increase in dose resulted in a 19.0-fold increase in AUC. There was good quantitative agreement in metabolite formation between mice and humans with respect to the two- and four-electron bioreductive metabolites. AUC values recorded for tirapazamine at the MTD of 390 mg/m2 (range 1035-1611 micrograms ml-1 min) were similar to the target AUC in mice. Importantly, these levels are consistent with the levels required for radiation-dose enhancement and effective combination with cisplatin in mice. Given (a) the similarities in plasma pharmacokinetics and metabolism observed at the target AUC/MTD in mice, rats, dogs and humans, (b) the similar degree of plasma protein binding seen between species and (c) the relatively low inter-patient variability noted in drug clearance, a successful PGDE approach should have been feasible. The results also indicate that potentially therapeutic levels of tirapazamine are achievable in patients at tolerable doses.

Animals↗