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The first international urokinase/warfarin trial in colorectal cancer.

Three hundred and forty-four patients with operable colorectal adenocarcinoma, Dukes' stage B or C, were entered into a randomized controlled trial of intraoperative and postoperative intravenous urokinase and/or long-term sodium warfarin therapy. The factorial design of the trial allowed evaluation of each therapy separately. Age, sex, Dukes' stage and cancer site were similar in the treatment groups. Using life-table methods, survival and recurrence/metastases free survival were estimated up to 6 years postoperatively. No significant effects of either therapy on these endpoints were found.

Aged↗

Comparative performance of two copper IUDs: Nova-T and MLCu375.

A comparative randomized trial was made of two intrauterine contraceptive devices: Nova-T and MLCu375. The IUDs were used by 637 and 606 women, respectively, for one year, unless the device was removed earlier. The reasons for IUD removal were analyzed after one year using the life-table method. Statistically significant differences were found in expulsion and removal for bleeding and/or pain rates.

Adolescent↗

Clinical results with the TCu340 IUD.

A trial was carried out on the TCu340 intrauterine contraceptive device. The IUD was used by 431 women over a period of 2 years. The reasons for IUD removal were analyzed after 1 and 2 years using the life-table method. Later, the authors compared these results with the MLCu375 and the Nova-T, using the coefficient Z of Cramer. The authors concluded that the TCu340 was a high-load IUD with high effectiveness. However, there was a higher incidence of side-effects, such as pain, bleeding and expulsion in comparison to MLCu375.

Adolescent↗

Comparison of two copper IUDs: the MLCu375 and the Nova-T.

A comparative randomized trial was carried out on two intrauterine contraceptive devices: the Nova-T and the MLCu375. The IUDs were used by 1116 and 1237 women respectively, over a period of 2 years. The reasons for IUD removal were analyzed after one and two years using the life-table method. Statistically significant differences were found in the rates for pregnancy, expulsion and removal for bleeding and/or pain favoring the MLCu375 IUD.

Adolescent↗

A randomized comparative trial of Nova-T and TCu200Ag in Yugoslavia.

The contraceptive efficacy and clinical performance of Nova-T and TCu200Ag were studied in a randomized comparative study with 819 interval acceptors. The 1- and 2-year gross termination rates were evaluated by means of the life-table method. The 12-month pregnancy rates were 1.0 per 100 women with Nova-T and 3.0 per 100 women with TCu200Ag. The preliminary 2-year rates were 1.7 and 5.5 per 100 respectively (p = 0.037). Rates of expulsion, medical and personal removals were not significantly different for the two devices. Continuation rates for the first year were 89.4 and 90.5 per 100 respectively.

Adult↗

The clinical performance of the Multiload IUD. II. The influence of age.

Six thousand four hundred and sixty-two Multiload IUDs were inserted (3606 MLCu375 and 2856 MLCu250). In this study, we determined the acceptance and safety of Multiload IUD use in different age groups. Results were analyzed according to the usual life table method. The pregnancy rate was higher with the users of MLCu250 than with the MLCu375 in a clear relation to age group. Expulsion and bleeding and/or pain rates were higher with younger women in both IUD types.

Adult↗

Effect of primary renal disease and risk factors on kidney graft survival.

The important role of immunological factors, HLA typing and pretransplant blood transfusion on improved kidney graft survival is well established. Additionally, graft survival depends on risk factors such as diabetes and age of the recipient. The effect of other clinical risk factors on graft survival was evaluated in 187 patients who received kidney transplants at our centre between 1970 and 1981. Graft survival according to the life table method and statistical analysis according to the logrank test revealed 4 main risk factors. Graft survival is significantly lower in type I diabetics and analgesic nephropathy, whereas it is better in hereditary and other renal diseases. Additional risk factors are coronary heart disease and repeated grafting. Time of dialysis before transplantation and age of the recipient showed no detrimental effect on graft survival.

Adult↗

Factors affecting recurrence following resection for Crohn's disease.

The records of 187 patients with Crohn's disease who underwent resectional surgery were analyzed to evaluate the effect of several clinical and histologic features on the recurrence rate. Recurrence was defined as the need for re-resection. The data were analyzed by the life-table method. Age, sex, age at onset of disease and at time of resection, family history, presence of granuloma, and microscopic involvement at the line of resection did not affect the recurrence rate. The distribution of the disease and duration of symptoms before primary resection did influence the rate of re-resection. Patients with predominantly large bowel disease (N = 56) were found to have a higher rate of re-resection (45 percent) when compared with 32 percent in patients with small bowel involvement (N = 94) and with 35 percent in patients with both small and large bowel involvement (N = 37) (P = 0.04). A detailed review, an analysis of the literature, and a comparison with our results are made.

Adolescent↗

Percutaneous transluminal embolization for improved prognosis of renal cell carcinoma--dependence on tumor stages.

The effect of percutaneous transluminal embolization (PTE) on the prognosis of renal cell carcinoma, depending on tumor stage, was retrospectively investigated on 303 patients. The life-table method was used for statistical comparison of survival rates of preoperatively or palliatively embolized patients with those of patients who merely underwent nephrectomy or were symptomatically treated. Preoperative PTE in tumor stages T2 and T3 resulted in extended survival rates, which were statistically significant in T2 cases. Prognosis was also improved in patients who underwent palliative embolization as compared with those patients who were inoperable and received only symptomatic treatment. Prognosis following palliative PTE and delayed nephrectomy was not worse than that following preoperative PTE and immediate nephrectomy.

Actuarial Analysis↗

Ten year survival rate of 131 patients with liver cirrhosis excluded the association of liver carcinoma at the establishment of diagnosis.

The present study reported 10 year suvival rate of 131 patients with liver cirrhosis excluded the association of liver carcinoma. Survival rate was calculated according to the life table method of Cutler and Ederer. One hundred thirty-one patients were diagnosed between 1965 and 1972. The overall 5 and 10 year survival rates of 131 patients were 58.3 +/- 4.7% and 36.5 +/- 6.2%, respectively. The 5 and 10 year survival rates of 56 patients with decompensated liver cirrhosis were 32.9 +/- 6.9% and 19.0 +/- 6.9%. The 5 year survival rate of 28 patients with prominent ascites was 20.6 +/- 8.4% and that of 14 patients with the rupture of esophageal varices was 29.4 +/- 13.4%. The improved treatment of decompensated liver cirrhosis and the exclusion of the patients with the association of liver carcinoma might contribute to these improved survival rates.

Adult↗

Concordance rate for type II diabetes mellitus in monozygotic twins: actuarial analysis.

To determine the concordance rate for Type II (non-insulin-dependent) diabetes mellitus in monozygotic twin pairs, initially ascertained discordant for diabetes, we carried out a prospective study on 44 non-diabetic subjects, each of whom had a sibling twin with diabetes (21 men, 23 women, median age 55 years, interquartile range 47-65). The subjects were referred as discordant for Type II diabetes. The twin pairs were part of the British Diabetic Twin Study and ascertained between May 1968 and January 1998. These subjects underwent an OGTT at time of referral and periodically thereafter. The mean follow-up was 8 years (range 0-18 years) and data were collected until January 1996. The percentage of twins who developed Type II diabetes was assessed by standard actuarial life-table methods and the pairwise concordance rate, that is the proportion of concordant pairs over the sum of concordant and discordant pairs, was calculated. The observed rates of concordance for Type II diabetes at 1, 5, 10, and 15 years follow-up were 17, 33, 57, and 76%, respectively. The concordance rate for any abnormality of glucose metabolism (either Type II diabetes or impaired glucose tolerance) at 15 years follow-up was 96%. The concordance rate for Type II diabetes in monozygotic twins is very high even in twins initially ascertained discordant for diabetes.

Actuarial Analysis↗

Ganciclovir prophylaxis after lung and heart-lung transplantation.

Cytomegalovirus (CMV) infection causes both acute and chronic allograft damage. The aim of this study was to analyze the utility of ganciclovir in preventing CMV infection in pulmonary allografts. Thirty five consecutive lung (LTX) and heart-lung (HLTX) transplant patients were studied from 1990 to 1996. CMV prophylaxis was started in January 1995. Recipients with CMV-positive serology received ganciclovir on postoperative days (POD) 7-28. Acyclovir was given on POD 29-90. Recipients with CMV-negative serology received ganciclovir on POD 7-90 if the serology of the donor was positive. CMV was demonstrated by rapid cell vial culture and/or detecting CMV-specific antigens in bronchoalveolar lavage (BAL) samples. The time point of the first BAL fluid specimen exhibiting CMV was estimated using the Life Table method. BAL samples of all the recipients without ganciclovir treatment became positive for CMV, whereas two of the 11 patients with ganciclovir administration remained negative. Ganciclovir significantly (P < 0.05) delayed but did not absolutely prevent CMV infection after LTX and HLTX.

Adolescent↗

Risk of second primary cancer following differentiated thyroid cancer.

Concerns remain over the risk of cancer following differentiated thyroid carcinoma and its causes. Iodine-131 ((131)I) and external irradiation are known to have potential carcinogenic effects. Thyroid carcinoma is a polygenic disease which may be associated with other malignancies. We investigated the incidence of second cancer and its aetiology in a cohort of 875 patients (146 men, 729 women) with differentiated thyroid carcinoma originating from Basse-Normandie, France. Cancer incidence was compared with that of the general population of the Département du Calvados matched for age, gender and period. The cumulative proportion of second cancer was estimated using the life-table method. Factors that correlated with the risk of second cancer were studied using the Cox model. After a median follow-up of 8 years, 58 second cancers had been observed. Compared with general population incidence rates, there was an overall increased risk of second cancer in women [standardised incidence ratio (SIR)=1.52; P<0.01], but not in men (SIR=1.27; P>0.20). Increased risk related to cancers of the genitourinary tract (SIR=3.31; P<0.001), and particularly to cancer of the kidney (SIR=7.02; P<0.01). Multivariate analysis showed that age above 40 years (P<0.01) and a history of previous primary cancer (P<0.001) correlated with risk. In contrast, neither cervical irradiation nor cumulative activity of (131)I was related to the risk. These data confirm that women with differentiated thyroid carcinoma are at risk of developing a second cancer of the genitourinary tract and kidney. Only age and medical history of primary cancer before thyroid carcinoma are risk factors for second cancer. Common environmental or genetic factors as well as long-term carcinogenic effects of primary cancer therapy should be considered.

Adolescent↗

Hydroxyapatite-coated RM cup in primary hip arthroplasty.

We reviewed 113 patients with 127 primary total hip arthroplasties using a hydroxyapatite-coated RM (Robert Mathys) cup. Average patient age was 61 (30-70) years and mean follow-up was 9.4 (6-13) years. Four patients were lost to follow-up and nine patients died of unrelated causes during the course of the study. Three acetabular components were revised; two cups were radiologically loose and one was revised for marginal erosion. No radiolucency was noted in any of the three zones in the remaining cups. There were no cases of cup migration or dislocation. The life table method predicted a 10-year survival rate of 97.9% with revision of the acetabular component for any cause as the endpoint.

Adult↗

Influence of prestroke dementia on early and delayed mortality in stroke patients.

Causes of early and delayed death after stroke differ. It has been suggested that delayed mortality rate was increased in patients with post-stroke dementia. Prestroke dementia is frequent: its influence on survival in stroke patients has never been evaluated. The aim of this study was to evaluate the influence of prestroke dementia on early and delayed mortality rate after stroke. In a cohort of 202 consecutive stroke patients aged >or= 40 years admitted between November 1995 and May 1996 in a primary care center, the prevalence of prestroke dementia was determined using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) with a cut-off of 104. Patients were followed-up for 3 years. Statistics were performed using life-table methods. Of 202 patients, 33 had prestroke dementia. Of 142 survivors at month-6, 44 were demented, of them 15 having prestroke and 29 new-onset post-stroke dementia. No patient was lost to follow-up. The risk of death at month-6 was higher in patients with prestroke dementia (RR 2.7; 95 % CI: 1.6-4.8). However, independent predictors of early death were age, severity of the deficit at admission, type and etiology of stroke. The risk of delayed death was higher in patients with prestroke dementia (RR 4.97; 95 % CI: 1.76-13.98) as in patients with new-onset post-stroke dementia (RR 6.24; 95 % CI: 2.67-14.57), compared with non-demented patients. The mortality rate did not differ between patients with prestroke and new-onset post-stroke dementia. Dementia at month-6 was an independent predictor of delayed death (RR 5.7; 95 % CI: 2.4-13.4), with age and stroke recurrence. Causes of death did not differ between demented and non-demented patients. Dementia adversely influences vital outcome in stroke patients, perhaps partly because the therapeutic approach differs between demented and non-demented patients.

Adult↗

Extraparenchymal renal artery aneurysms: is hypertension an indication for revascularization surgery?

We report here the surgical management of extraparenchymal renal artery aneurysms associated with hypertension and the results of this treatment. From January 1978 through December 1999, 19 consecutive patients with 23 extraparenchymal renal artery aneurysms underwent surgery with renal revascularization techniques. Of these 19 patients, 89.5% had systemic hypertension, and 12 of 16 patients had associated renovascular hypertension. Twenty of the aneurysms were patent, one was chronically thrombosed, and one patient presented with acute thrombosis of abdominal aortic and bilateral renal aneurysms; 11 of the 20 patent cases had significant stenosis in the preoperative arteriography. Seventeen aneurysms (74%) were located on the main trunk of the renal artery. Response of hypertension and renal function were examined. Surgical technique patency was evaluated by life-table methods. Our basic surgical indication for extraparenchymal renal artery aneurysms in this series was renovascular hypertension. Nonrenal hypertension alone does not indicate surgery. We consider the saphenous vein to be the graft of choice for renal revascularization.

Aneurysm↗

Tibial bypass using complex autologous conduit: patency and limb salvage.

Over an 8-year period, we performed 93 lower extremity bypasses using complex autologous conduits, which included (1) contralateral greater saphenous vein (GSV), (2) composite GSV, (3) superficial femoral vein, (4) lesser saphenous vein, (5) cephalic or basilic veins, and (6) composite-sequential (PTFE and vein) grafts. These grafts represented 16% of all infrainguinal bypasses during this period, and all grafts were performed to treat limb-threatening ischemia. Survival, patency, and limb salvage were examined by the life-table method. Primary graft patency was 46 and 38% at 3 and 5 years. Assisted-primary patency was 62 and 59%, and secondary graft patency rates were 68 and 64% at 3 and 5 years. Twenty-nine bypasses (31%) required revision to restore or maintain patency. The 3-year limb salvage rate was significantly better when revision was performed for graft stenosis than for graft thrombosis (90% vs. 46%, p < 0.05). Overall limb salvage rate was 73% at 5 years. The mortality rate was 5.4% and the 5-year survival was 51%. Complex autologous tibial bypasses provided acceptable long-term limb salvage in patients with severe ischemia and inadequate ipsilateral GSV. The increased operating time and complexity required did not produce prohibitive operative risks. Postoperative graft surveillance in these complex vein bypasses allowed revision in many cases before graft occlusion occurred and significantly improved long-term limb salvage.

Age Factors↗

MTHFR genotypes and breast cancer survival after surgery and chemotherapy: a report from the Shanghai Breast Cancer Study.

Methylenetetrahydrofolate reductase (MTHFR) regulates the intracellular folates pool for DNA synthesis and methylation. Sequence variations in MTHFR (nucleotides 677 (C-->T) and 1298 (A-->C)) result in allozymes with decreased activity. The 677TT genotype is associated with increased toxicity of methotrexate and increased clinical response to 5-fluorouracil in treatment of cancers including breast cancer. We evaluated MTHFR genotypes and breast cancer survival in a cohort of 1067 Chinese women diagnosed with breast cancer between 1996 and 1998 who received surgery and chemotherapy. Life table method was used to calculate 5-year survival rates. Cox proportional hazards models were used to estimate hazard ratios (HR) and 95% confidence intervals (CI) after adjusting for potential confounding factors. Median follow-up time was 5.2 years; 5-year survival was 84.6%. Sixty-six percent carried a 677T allele and 31% carried a 1298 C allele. We found that overall 5-year breast cancer survival did not differ significantly across all genotypes (85.3% for 677 CC and 83.8% for 677TT; 83.8% for 1298 AA and 79.1% for 1298 CC). However, carrying the 677T allele was associated with non-significant increased risk of death for subjects with late stage disease (stages III-IV) (HR=1.80, 95% CI: 0.79-4.14 for TT vs. CC, p for trend=0.15), particularly among those who had survived past the second year (HR=2.97, 95% CI: 1.10-7.98, p for trend=0.04). The A1298C genotypes were not significantly associated with risk of death. This study suggests that the MTHFR C677T polymorphisms may affect long-term survival from advanced breast cancer.

Adult↗