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PubMed2005

A pilot study of treatment of periodontal-endodontic lesions.

OBJECTIVE: A pilot study to evaluate a standardised treatment protocol for combined periodontal-endodontic lesions (involving staged endodontic and periodontal treatment). PARTICIPANTS: Nine patients with a diagnosis of a combined periodontal-endodontic lesion. METHODS: At baseline, root canal treatment (RCT) was performed by a standard protocol, and simple scaling/oral hygiene instruction provided. After one month, a standardised episode of non-surgical periodontal treatment was undertaken to address residual pocketing. Clinical measurements, including probing depths, attachment levels and bleeding on probing were recorded at baseline, month one and month three. Long-cone periapical radiographs taken using standardised projection geometry at baseline and month three were analysed for bone changes using digital subtraction radiography (DSR). RESULTS: During the study, one patient's affected tooth was extracted. From baseline to month three, there were statistically significant mean probing depth reductions (delta= 0.95mm, 95% CI= 0.20mm, 1.70mm; p= 0.02), mean attachment gains (delta= 1.13mm, 95% CI= 0.29mm, 1.96mm; p= 0.02) and reduction in mean bleeding on probing (delta= 29%, 95% CI= 10%, 49%; p= 0.01). DSR analysis revealed that between month 0 and month three, four teeth demonstrated bone gain, two teeth exhibited bone loss and two teeth showed no change. The mean bone change was in favour of bone gain but failed to achieve statistical significance (p>0.05). CONCLUSIONS: Within the limitations of this pilot study, treatment of periodontal-endodontic lesions by performing RCT prior to periodontal treatment was effective, resulting in improvements in clinical parameters together with alveolar bone gains in a majority of teeth.

Alveolar Bone Loss↗
PubMed2000

Molecular and antigenic characterization of a highly evolved derivative of the type 2 oral poliovaccine strain isolated from sewage in Israel.

An unusual, highly diverged derivative of the Sabin type 2 oral poliovaccine (OPV) strain was recovered from environmental samples during routine screening for wild polioviruses. Virus was cultivated in L20B cells and then passaged on BGM cells at 40 degrees C (RCT [reproductive capacity at supraoptimal temperature]-positive marker) to select against most OPV strains. All but 1 of 25 RCT-positive OPV-derived environmental isolates were antigenically and genetically (>99.5% VP1 sequence match) similar to the respective Sabin strains. However, isolate PV2/4568-1/ISR98 (referred to below as 4568-1) escaped neutralization with Sabin 2-specific monoclonal antibodies and cross-adsorbed sera, and had multiple nucleotide substitutions (220 of 2,646; 8.3%) in the P1 capsid region. Fourteen of the 44 associated amino acid substitutions in the capsid mapped to neutralizing antigenic sites. Neutralizing titers in the sera of 50 Israeli children 15 years old were significantly lower to 4568-1 (geometric mean titer [GMT], 47) than to Sabin 2 (GMT, 162) or to the prototype wild strain, PV2/MEF-1/EGY42 (GMT, 108). Two key attenuating sites had also reverted in 4568-1 (A(481) to G in the 5' untranslated region and the VP1 amino acid I(143) to T), and the isolate was highly neurovirulent for transgenic mice expressing the poliovirus receptor (PVR-Tg21 mice). The extensive genetic divergence of 4568-1 from the parental Sabin 2 strain suggested that the virus had replicated in one or more people for approximately 6 years. The presence in the environment of a highly evolved, neurovirulent OPV-derived poliovirus in the absence of polio cases has important implications for strategies for the cessation of immunization with OPV following global polio eradication.

5' Untranslated Regions↗
PubMed2004

How the type of risk reduction influences required sample sizes in randomised clinical trials.

To increase change between groups, randomised clinical trials (RCT) often include patients with high risk for a particular outcome, by inclusion criteria that select predictors for that outcome. This increases the statistical power, and fewer patients are required for that RCT. The way in which patient selection influences the power, and thus sample size required, depends on how an intervention reduces the individual risk: by an absolute or relative risk reduction model.

Humans↗
PubMed2004

Time dependent risk of gastrointestinal complications induced by non-steroidal anti-inflammatory drug use: a consensus statement using a meta-analytic approach.

OBJECTIVES: To provide an updated document assessing the global, NSAID-specific, and time dependent risk of gastrointestinal (GI) complications through meta-analyses of high quality studies. METHODS: An exhaustive systematic search was performed. Inclusion criteria were: RCT or controlled study, duration of 5 days at least, inactive control, assessment of minor or major NSAID adverse effects, publication range January 1985 to January 2003. The publications retrieved were assessed during a specifically dedicated WHO meeting including leading experts in all related fields. Statistics were performed conservatively. Meta-regression was performed by regressing NSAID adjusted estimates against study duration categories. RESULTS: Among RCT data, indolic derivates provided a significantly higher risk of GI complications related to NSAID use than for non-users: RR = 2.25 (1.00; 5.08) than did other compounds: naproxen: RR = 1.83 (1.25; 2.68); diclofenac: RR = 1.73 (1.21; 2.46); piroxicam: RR = 1.66 (1.14; 2.44); tenoxicam: RR = 1.43 (0.40; 5.14); meloxicam: RR = 1.24 (0.98; 1.56), and ibuprofen: RR = 1.19 (0.93; 1.54). Indometacin users had a maximum relative risk for complication at 14 days. The other compounds presented a better profile, with a maximum risk at 50 days. Significant additional risk factors included age, dose, and underlying disease. The controlled cohort studies provided higher estimates: RR = 2.22 (1.7; 2.9). Publication bias testing was significant, towards a selective publication of deleterious effects of NSAIDs from small sized studies. CONCLUSION: This meta-analysis characterised the "compound" and "time" aspects of the GI toxicity of non-selective NSAIDs. The risk/benefit ratio of such compounds should thus be carefully and individually evaluated at the start of long term treatment.

Aged↗
PubMed2004

Why results of clinical trials and observational studies of antitumour necrosis factor (anti-TNF) therapy differ: methodological and interpretive issues.

OBJECTIVE: Results of randomised clinical trials (RCTs) appear to differ from results of observational studies. This paper explores differences in methodology, interpretation and presentation of results that elucidate these differences. METHOD: We identified patients who completed a survey questionnaire during the period January 1998 through December 1998 and also completed one between July 2003 and June 2004, an average span of 4.7 years. The mean time from study initiation to anti-TNF administration was 2.1 years, and the mean treatment time was 2.1 (SD 1.3) years at study closure. During this period 38.3% of patients received anti-TNF therapy. We compared the results of patients in this group with results from RCTs. RESULTS: RCTs utilise flare design, patient selection, control groups and regression to the mean. Observational studies, on the other hand, confound additional prior therapy and anti-TNF effect, do not employ control groups, and may have less regression to the mean. CONCLUSIONS: RCTs and observational studies assess and report efficacy and effectiveness in ways that are so different that they are often incommensurable. A key difference is whether results should represent changes from flare states or should, instead, consider chronic status prior to initiation of therapy. There is little evidence that the clinical state at the start of most anti-TNF RCTs represents a chronic state. Economic analyses that utilise the RCT starting point overestimate the cost effectiveness of anti-TNF therapy. The solution for these problems and a guide to understanding the real results of anti-TNF therapy lies in collecting preclinical trial data in all patients who will enter clinical trials. In addition, RCT results would more approximate those of observational studies if all reporting was done after subtracting the effect of the comparator group.

Antirheumatic Agents↗
PubMed2007

How do the EQ-5D, SF-6D and the well-being rating scale compare in patients with ankylosing spondylitis?

PURPOSE: To compare aspects of validity of EuroQol-5 Dimensions (EQ-5D) and Short-Form-6 Dimensions (SF-6D), two indirect utility instruments, and the well-being rating scale (RS) in ankylosing spondylitis (AS). METHODS: EQ-5D, SF-6D and RS were available for 254 patients fulfilling modified New York criteria. 134 patients were part of an observational cohort and 120 were part of a randomised controlled trial (RCT). Aspects of validity assessed were truth (agreement and correlation with external health measures) and discrimination (differentiation between health states, repeatability and detection of treatment effect). RESULTS: Median (range) values were 0.69 (-0.08-1.00) for the EQ-5D, 0.65 (0.35-0.95) for the SF-6D and 0.65 (0.14-1.00) for the RS. Agreement (intraclass correlation coefficient) was moderate (0.46-0.55). Instruments correlated equally with disease activity, functioning and quality of life. The SF-6D showed smaller average differences in utility between patients with better and worse disease compared with the EQ-5D and the RS. The smallest detectable difference (SDD) (in the control group of RCT) was 0.36, 0.17 and 0.33 for EQ-5D, SF-6D and RS, respectively. The ability to detect treatment effect (in the intervention trial) showed standardised effect sizes that were moderate for EQ-5D and SF-6D (0.63 and 0.64) and low for the RS (0.23). CONCLUSION: In patients with AS, EQ-5D, SF-6D and the RS correlate equally well with external measures of health, but have different psychometric properties. The SDD is most favourable for the SF-6D, but it discriminates less well between patients with different disease severities. The RS has a poorer ability to detect treatment effects. It is difficult to recommend one of the instruments.

Adult↗
PubMed2006

Chronic tendinopathy: effectiveness of eccentric exercise.

OBJECTIVES: To determine the effectiveness of eccentric exercise (EE) programmes in the treatment of common tendinopathies. DATA SOURCES: Relevant randomised controlled trials (RCTs) were sourced using the OVID website databases: MEDLINE (1966-Jan 2006), CINAHL (1982-Jan 2006), AMED (1985-Jan 2006), EMBASE (1988-Jan 2006), and all EBM reviews--Cochrane DSR, ACP Journal Club, DARE, and CCTR (Jan 2006). The Physiotherapy Evidence Database (PEDro) was also searched using the keyword: eccentric. REVIEW METHODS: The PEDro and van Tulder scales were employed to assess methodological quality. Levels of evidence were then obtained according to predefined thresholds: Strong--consistent findings among multiple high-quality RCTs. Moderate--consistent findings among multiple low-quality RCTs and/or clinically controlled trials (CCTs) and/or one high-quality RCT. Limited--one low-quality RCT and/or CCT. Conflicting--inconsistent findings among multiple trials (RCTs and/or CCTs). No evidence-no RCTs or CCTs. RESULTS: Twenty relevant studies were sourced, 11 of which met the inclusion criteria. These included studies of Achilles tendinopathy (AT), patella tendinopathy (PT) and tendinopathy of the common wrist extensor tendon of the lateral elbow (LET). Limited levels of evidence exist to suggest that EE has a positive effect on clinical outcomes such as pain, function and patient satisfaction/return to work when compared to various control interventions such as concentric exercise (CE), stretching, splinting, frictions and ultrasound. Levels of evidence were found to be variable across the tendinopathies investigated. CONCLUSIONS: This review demonstrates the dearth of high-quality research in support of the clinical effectiveness of EE over other treatments in the management of tendinopathies. Further adequately powered studies that include appropriate randomisation procedures, standardised outcome measures and long-term follow-up are required.

Chronic Disease↗
PubMed2026

Men's experiences of multiple long-term conditions and/or disability in the UK Game of Stones weight management trial: a mixed-methods evaluation.

OBJECTIVES: To explore experiences, health outcomes and retention of men with multiple long-term conditions (MLTCs) and/or disability within the Game of Stones weight management randomised controlled trial (RCT). DESIGN: Mixed-methods process evaluation within an RCT where secondary outcomes included the Weight Self-Stigma Questionnaire, EuroQol 5-Dimension 5-Level (EQ-5D-5L), EQ-5D-5L anxiety and depression subscale, Patient Health Questionnaire-4 and retention. Semistructured interviews were conducted at 12 months and analysed using the framework method. SETTING: Conducted across three UK trial centres: Belfast, Bristol and Glasgow. PARTICIPANTS: 585 men with obesity (mean (SD) age, 50.7 (13.3) years) were randomised to one of three groups: behavioural text messages with financial incentives, texts alone or waiting-list control. Interviews were conducted with 54 participants from the two intervention groups. RESULTS: 235 (40%) participants lived with MLTCs, 181 (31%) had a single condition, 167 (29%) had no conditions and 165 (29%) had a disability. Of those with MLTCs, 99 were disabled and 93 were living in deprived areas. Participants with MLTCs and/or disability were older, fewer had a degree-level qualification and fewer were in full-time work. Retention at 12 months was higher for men with disability (76%) or no long-term conditions (75%) and lower for men with diabetes (65%). Self-reported weight stigma, well-being and quality-of-life scores improved or stayed the same for men living with MLTCs in the intervention groups; however, results for anxiety and depression screening scores were inconsistent. Participant experiences indicated complex dynamic health, social and life situations which could provide motivation to lose weight for some but not others. Hospitalisation and poor mobility, with inability to exercise, were demotivating for making changes to reach weight loss targets. CONCLUSIONS: Men living with MLTCs and/or disability varied from very successful weight loss and improved health to not prioritising or feeling helped by the programme or disengagement due to immobility or diabetes. TRIAL REGISTRATION NUMBER: isrctn.org Identifier: ISRCTN91974895.

Humans↗
PubMed2026

Behaviourally informed text message reminders to increase cervical screening attendance in people with severe mental illness: the OPTIMISE pilot randomised controlled trial.

OBJECTIVES: This study assessed the feasibility of both the delivery and evaluation of 'enhanced' (behaviourally informed) text message reminders containing links to existing co-designed resources supporting decision-making for people with severe mental illness (SMI) regarding attendance of cervical screening. DESIGN: A pilot randomised controlled trial (RCT). SETTING: 13 General Practice (GP) practices in London were recruited. PARTICIPANTS: GP practices identified people with SMI aged 24-64 years who were overdue cervical screening. Target sample size was 120 participants (60 per arm) based on existing guidance for pilot trials. INTERVENTION: In March 2025, participants were randomised (1:1) to receive either the enhanced (intervention) or the standard (control) SMS reminder. PRIMARY AND SECONDARY OUTCOME MEASURES: 18 weeks later, feasibility outcomes were collected (primary outcomes) and data analysis for a definitive RCT was rehearsed (secondary outcome). RESULTS: Of the 150 participants across 13 GP practices that were randomised (n=75 per arm), 132 (88%) texts delivered (intervention n=64/75 (85%), control n=68/75 (91%)). 10 practices (76.9%) provided follow-up data for 102 participants (intervention n=50, control n=52). Five participants (intervention n=4, control n=1) attended screening within the trial period. Participant survey response rate was low (9/132 (7%), intervention n=5, control n=4). Both SMS messages were low cost, with the intervention SMS a 50% higher cost to deliver (7.5p vs 5p per SMS). Primary feasibility measures of recruitment rate of GP practices (27%), retention of GP practices (77%) and participants (100%), SMS delivery (88%) and data completeness (64%) indicated viability, although survey response rate (7%) did not. CONCLUSIONS: Achieving adequate recruitment and retention, data completeness and comparable groups is viable with some amendments, although an alternative method is required to assess fidelity. Behaviourally informed SMS reminders are feasible to deliver to people with SMI, although it is uncertain if the extra resources are accessed and used. With changes to data collection, a definitive trial could be feasible. Given the low observed cervical screening attendance, additional intervention is needed for this group. TRIAL REGISTRATION NUMBER: ISRCTN12558681.

Humans↗
PubMed2004

Systematic review of interventions to reduce delay in patients with suspected heart attack.

OBJECTIVES: To evaluate the effectiveness of interventions aiming to reduce time from onset of signs and symptoms of an acute myocardial infarction (AMI) to seeking medical help/arrival at hospital. METHODS: A systematic review was conducted. Fifteen electronic databases, the internet, and bibliographies of included studies were searched, and experts in the field of cardiac care were contacted. Randomised controlled trials (RCTs), controlled trials, and before and after studies conducted in any setting that assessed an intervention aimed at reducing time from onset of signs and symptoms of an AMI to seeking medical help and/or arrival in hospital were eligible for inclusion. RESULTS: Eleven media/public education intervention studies met the inclusion criteria. Five (one controlled and four before and after studies) reported the intervention to have a statistically positive effect on delay time and six (two RCTs and four before and after studies) reported no statistically significant effect. Three (one RCT and two before and after studies) of five studies evaluating the effect of the intervention on emergency department visits reported an increase in this outcome as a result of the intervention, and both studies (one RCT and one before and after study) examining calls made to emergency switchboards reported an increase in this outcome after the intervention. CONCLUSIONS: There was little evidence that media/public education interventions reduced delay. There is some evidence that they may result in an increase in emergency switchboard calls and emergency department visits. Despite substantial expenditure of time and effort, methodological deficiencies of the studies mean that it is not possible to make definitive recommendations.

Health Education↗
PubMed2001

Patient follow up screening evaluations. Examples with regard to congenital hip dislocation and congenital heart disease.

OBJECTIVE: To discuss the merits of the patient follow up study design for the evaluation of some specific mass screening programmes. DESIGN: Theoretical evaluation illustrated by two examples. SETTING: Department of Public Health Erasmus University Rotterdam. MAIN RESULTS: The gold standard for evaluation of favourable effects of screening is the randomised controlled trial (RCT). Application of an RCT, however, is often not feasible, in which cases observational studies will have to be relied on. The case-control study design is generally considered to be second best. In some situations, however, a patient follow up study design may be applicable and may have some major advantages. The use of the patient follow up design for screening evaluation will often be very problematic or even unacceptable, particularly as far as screening for cancer is concerned. The most important objections are resulting from lead time bias, length bias, selection bias and over-treatment bias. For the evaluation of screening for congenital heart disease and congenital hip dislocation in Dutch child health care, however, these objections may relatively simply be overcome. Lead time bias will be of little importance, as the ages of onset of these disorders are fixed, namely at birth, and their ultimate outcomes may be expected within relatively short time. Length bias may largely be avoided by correction for severity of the disorder, which can be adequately assessed by modern diagnostic procedures. Selection bias is generally hard to rule out, but in these cases it probably plays a minor part. Over-treatment can be avoided by the policy of "watchful waiting", which in these disorders can be applied with little risk for fatal outcomes. In principle bias might be avoided more successfully in a case-control screening evaluation than in a patient follow up study. However, the patient follow up study is for both screening programmes discussed here the more feasible design and can provide more supplementary information. The results of two example studies suggest that both screenings probably yield considerable benefits CONCLUSION: Under a number of specific conditions a patient follow up study is an efficient alternative to more customary designs for screening evaluation.

Child↗
PubMed2006

What determines whether patients are willing to participate in resuscitation studies requiring exception from informed consent?

OBJECTIVES: To examine the willingness of patients to participate in a resuscitation study that requires exception from informed consent and to determine if willingness to participate is associated with demographic and other characteristics. METHODS: Adult patients in an emergency department and in a geriatric outpatient clinic were surveyed. Patients were asked to imagine that they presented to an emergency department with cardiac arrest and asked about their willingness to (1) receive a new drug outside of a study, (2) receive a new drug as part of a study and (3) participate in a randomised controlled trial (RCT) for a new drug. Patients were also asked about participation in studies of invasive procedures. RESULTS: 213 patients from a geriatric clinic and 207 from an emergency department were surveyed. Two thirds of patients from the geriatric clinic and 83% from the emergency department were willing to receive an experimental drug outside of a study. Patients were less willing to participate in a study of the new drug and even less likely to participate in an RCT for the new drug (chi(2) test for trend, p<0.001 for both settings). Patients were less likely to participate in a study of thoracotomy than in a study that required placement of a femoral catheter (p = 0.008 for the geriatric clinic, p = 0.01 for the emergency department). Willingness to participate was not associated with trust in the doctors. CONCLUSIONS: Study design and invasiveness of the intervention were associated with the willingness of patients to participate in resuscitation studies that require exception from informed consent.

Adult↗
PubMed2002

Transarterial chemoembolization for unresectable hepatocellular carcinoma: meta-analysis of randomized controlled trials.

PURPOSE: To review the available evidence of chemoembolization for unresectable hepatocellular carcinoma (HCC). MATERIALS AND METHODS: Computerized bibliographic searches with MEDLINE and CANCERLIT databases from 1980 through 2000 were supplemented with manual searches, with the keywords "hepatocellular carcinoma," "liver cell carcinoma," "randomized controlled trial [RCT]," and "chemoembolization." Studies were included if patients with unresectable HCC were enrolled and if they were RCTs in which chemoembolization was compared with nonactive treatment (five RCTs) or if different transarterial modalities of therapy (13 RCTs) were compared. Data were extracted from each RCT according to the intention-to-treat method. Five of the RCTs with a nonactive treatment arm were combined by using the random-effects model, whereas all 18 RCTs were pooled from meta-regression analysis. RESULTS: Chemoembolization significantly reduced the overall 2-year mortality rate (odds ratio, 0.54; 95% CI: 0.33, 0.89; P =.015) compared with nonactive treatment. Analysis of comparative RCTs helped to predict that overall mortality was significantly lower in patients treated with transarterial embolization (TAE) than in those treated with transarterial chemotherapy (odds ratio, 0.72; 95% CI: 0.53, 0.98; P =.039) and that there is no evidence that transarterial chemoembolization is more effective than TAE (odds ratio, 1.007; 95% CI: 0.79, 1.27; P =.95), which suggests that the addition of an anticancer drug did not improve the therapeutic benefit. CONCLUSION: In patients with unresectable HCC, chemoembolization significantly improved the overall 2-year survival compared with nonactive treatment, but the magnitude of the benefit is relatively small.

Carcinoma, Hepatocellular↗
PubMed1993

Hooked acromion: prevalence on MR images of painful shoulders.

An association between the morphology of the acromion and the occurrence of rotator cuff tear (RCT) has been suggested by findings at both pathologic examination and routine radiography. As a tomographic technique, magnetic resonance (MR) assessment of acromial shape may be more accurate than routine radiography. The authors studied acromial morphology on sagittal oblique MR images of a control population (47 shoulders), of patients with isolated impingement (30 shoulders), and of patients with full-thickness RCTs (34 shoulders) to assess the association of acromial shape with disorders of the rotator cuff. Acromions were classified as flat (type 1), smoothly curved (type 2), or hooked (type 3). Data were collected by two observers, blinded to clinical and surgical information, who acted in consensus. Patients with RCT had a significantly increased prevalence of type 3 acromions compared with control patients (62% vs 13%, P < .001). Type 3 acromions tended to be more prevalent in the group with impingement (30%, P = .17). There was no significant difference in the distribution of acromion types among control patients with respect to age or gender.

Acromion↗
PubMed2002

Changes in LPLa and reverse cholesterol transport variables during 24-h postexercise period.

We investigated the time course of exercise-induced lipoprotein lipase activity (LPLa) and reverse cholesterol transport (RCT) during the 24-h postexercise period. Subjects were 10 sedentary normolipidemic males [NTG; fasting triglyceride (TG) = 89.1 +/- 8.6 mg/dl] and 6 hyperlipidemic males (HTG; fasting TG = 296.8 +/- 64.0 mg/dl). Each subject performed a control trial (no exercise) and 4 exercise trials. In the exercise trials, a subject jogged on a treadmill at 60% of his maximal O(2) consumption for 1 h. Pre- and postheparin blood samples were taken before exercise (baseline) and at 4, 8, 12, and 24 h after exercise. There was no group difference in LPLa (P > 0.05) over the time points. When the LPLa data from the two groups were combined, LPLa at 24 h after exercise was higher than baseline or at 4, 8, 12 h after exercise (P < 0.05). Plasma TG and lecithin-cholesterol acyltransferase activity (LCATa) were higher in HTG than in NTG, and the total high-density lipoprotein-cholesterol (HDL(tot)-Chol) was lower in HTG than in NTG (P < 0.05). HDL(2)-Chol, LCATa, and cholesterol ester transfer protein activity did not differ during the 24-h postexercise period (P > 0.05). These results suggest that LPLa is still increasing 24 h after an acute aerobic exercise and that the magnitude of the increase in exercise-induced LPLa in HTG was similar to that in NTG. Furthermore, in the sedentary population with or without HTG, the variables related to RCT do not change during the 24-h period after exercise.

Adult↗
PubMed1986

Immunodissection and culture of rabbit cortical collecting tubule cells.

A mouse monoclonal antibody designated IgG3(rct-30) has been prepared that reacts specifically with an antigen on the surface of all cells comprising the cortical and medullary rabbit renal collecting tubule including the arcades. Plastic culture dishes coated with IgG3(rct-30) were used to isolate collecting tubule cells from collagenase dispersions of rabbit renal cortical cells by immunoadsorption. Typically, 10(6) rabbit cortical collecting tubule (RCCT) cells were obtained from 5 g of renal cortex (2 kidneys). Initial purity was greater than 96% based on immunocytofluorescent staining with three different anti-collecting tubule antibodies. Between 20 and 30% of the RCCT cells were reactive with peanut lectin suggesting that RCCT cells are a mixture of principal and intercalated cells. Approximately 10(7) RCCT cells were obtained after 4 to 5 days in primary culture. Moreover, RCCT cells continued to proliferate after passaging with a doubling time of approximately 32 h. RCCT cells passaged once and then cultured 4-5 days were found 1) to synthesize cAMP in response to arginine vasopressin (AVP), prostaglandin E2 (PGE2), isoproterenol, and parathyroid hormone, but not calcitonin, prostaglandin D2, or prostaglandin I, and 2) to release PGE2 in response to bradykinin but not arginine vasopressin or isoproterenol. Our results indicate that cultured RCCT cells retain many of the hormonal, histochemical, and morphological properties expected for a mixture of principal and intercalated rabbit cortical collecting tubule epithelia. RCCT cells should prove useful both for studying hormonal interactions in the cortical collecting tubule and as a starting population for isolating intercalated collecting tubule epithelia.

Animals↗
PubMed2005

[Portable coagulometers: a systematic review of the evidence on self-management of oral anticoagulant treatment].

BACKGROUND AND OBJECTIVE: We aimed to systematically review the scientific evidence about the use of portable coagulometers for patient's self-management of oral anticoagulant treatment. MATERIAL AND METHOD: Systematic review of scientific evidence available from MEDLINE'S, DARE's, HTA-Database's, NHS-EED's and The Cochrane Library' s bibliographic databases, from their origin to March 2003. Randomized control trials (RCT) and Quasi-Experimental trials were selected provided that they compared patients in self-management with patients under usual care. The quality of scientific evidence was elicited using the Scottish Intercollegiate Guideline Network (SIGN) recommendations, whilst efficacy and security were descriptively summarized. RESULTS: Twelve (7 RCT and 5 quasi-experimental trials) articles were found, and only two of them provided grade A recommendation. Patients under self-management remained the same or more time in the therapeutic range. The incidence of adverse effects in self-management patients was the same or less than that in patients under usual care. CONCLUSIONS: The quality of the scientific evidence is heterogeneous. For selected patients, patient's self-management is at least as effective and safe as usual care. New oral anticaogulants, which have shown promising results, should be scrutinized for future changes in service provision.

Administration, Oral↗
PubMed2002

Radio-chemotherapy as a preoperative treatment for advanced rectal cancer. Evaluation of down-staging and morbidity.

BACKGROUND: The standard therapy for patients with clinically resectable rectal cancer is generally considered to be surgery. If the patient is diagnosed with advanced disease, postoperative radio-chemotherapy (RCT) is usually recommended. In our study we aimed to investigate and analyze the effectiveness and toxicity of preoperative pelvic radiotherapy in combination with 5-fluorouracil (5-FU) in locally advanced rectal cancer. PATIENTS AND METHODS: From June 1999 to September 2001 we evaluated 50 consecutive patients [37 male and 13 female; average age 65.1 (range 46-79.5) years] with locally advanced rectal carcinoma. 32 patients were staged as uT3, 14 as uT4, and 4 as uT2. Regarding N-staging, 22 patients were diagnosed as uN0. 2 patients had distant metastases, with liver metastases in both instances. Conformal irradiation was performed with a box technique (4-field technique) with a dose of 45 Gy (5 x 1.8 Gy per week for a total of 25 sessions). From days 1-5 and 29-33, all patients received 5-FU (500 mg/m(2 ) per day, as a continuous i.v. injection). RESULTS: Remission was observed in 28 patients (56%), with down-staging of at least one T-stage. A better success rate was achieved for patients with deep-seated tumors (64% of the patients in this group). Complete remission was observed in 4 patients (8.0%) and progression in 3 (6.0%). 15 patients had no detectable change in tumor staging (30.0%). A surgical R0 resection could be achieved in 43 patients, an R1 resection (minimal margin) in 7. Side effects and toxicity (common toxicity criteria) of RCT included grade I-II dysuria in 5 patients (10%), grade I-II diarrhea in 20 patients (40%), and severe diarrhea in 2 patients (4.0%). Grade I-II skin reaction was noticed in 22 patients (44.0%), severe skin reaction only in 1 patient. Regarding acute postoperative morbidity, abscess and fistula formation was noted in 8 patients (16.0%), with anastomosis leakage in 7 (14%). CONCLUSION: Preoperative radiotherapy appears to be a feasible therapeutic approach with moderate toxicity and the potential to induce down-staging. The data presented in this study confirm the preliminary reports on this neoadjuvant treatment.

Adult↗