First Month Of Observation Research Articles

Human serum fetuin A/α2HS-glycoprotein level is associated with long-term survival in patients with alcoholic liver cirrhosis, comparison with the Child-Pugh and MELD scores

BackgroundSerum concentration of fetuin A/α2HS-glycoprotein (AHSG) is a good indicator of liver cell function and 1-month mortality in patients with alcoholic liver cirrhosis and liver cancer. We intended to determine whether decreased serum AHSG levels are associated with long-term mortality and whether the follow-up of serum AHSG levels can add to the predictive value of the Child-Pugh (CP) and MELD scores.MethodsWe determined serum AHSG concentrations in 89 patients by radial immunodiffusion. Samples were taken at the time of enrolment and in the 1st, 3rd, 6th, and the 12th month thereafter.ResultsForty-one patients died during the 1-year follow-up period, 37 of them had liver failure. Data of these patients were analysed further. Deceased patients had lower baseline AHSG levels than the 52 patients who survived (293 ± 77 vs. 490 ± 106 μg/ml, mean ± SD, p < 0.001). Of all laboratory parameters serum AHSG level, CP and MELD scores showed the greatest difference between deceased and survived patients. The cutoff AHSG level 365 μg/ml could differentiate between deceased and survived patients (AUC: 0.937 ± 0.025, p < 0.001, sensitivity: 0.865, specificity: 0.942) better than the MELD score of 20 (AUC: 0.739 ± 0.052, p < 0.001, sensitivity: 0.595, specificity: 0.729). Initial AHSG concentrations < 365 μg/ml were associated with high mortality rate (91.4%, relative risk: 9.874, 95% C.I.: 4.258–22.898, p < 0.001) compared to those with ≥ 365 μg/ml (9.3%). Fourteen out of these 37 fatalities occurred during the first month of observation. During months 1–12 low AHSG concentration proved to be a strong indicator of mortality (relative risk: 9.257, 95% C.I.: 3.945–21.724, p < 0.001). Multiple logistic regression analysis indicated that decrease of serum AHSG concentration was independent of all variables that differed between survived and deceased patients during univariate analysis. Multivariate analysis showed that correlation of low serum AHSG levels with mortality was stronger than that with CP and MELD scores. Patients with AHSG < 365 μg/ml had significantly shortened survival both in groups with MELD < 20 and MELD ≥ 20 (p < 0.0001 and p = 0.0014, respectively).ConclusionSerum AHSG concentration is a reliable and sensitive indicator of 1-year mortality in patients with alcoholic liver cirrhosis that compares well to the predictive value of CP score and may further improve that of MELD score.

Examination of the safety and use of apomorphine prescribed in general practice in England as a treatment for erectile dysfunction

To examine the safety and use of apomorphine as prescribed in general medical practice in England as a treatment for erectile dysfunction (ED). Apomorphine hydrochloride (marketed as Uprima, Abbott Laboratories Ltd, UK) is licensed in the UK as a sublingual therapy for ED. It is the first treatment for ED with a central mode of action. This postmarketing observational cohort study was conducted using prescription-event monitoring (PEM) methods. Exposure information was obtained from dispensed prescription data for patients first prescribed apomorphine between October 2001 and December 2002. Outcome data were derived from Green-Form questionnaires posted to prescribing physicians > or = 6 months after the date of the first apomorphine prescription for each patient. The study cohort comprised 11 185 patients, 99.3% (11,111) of whom were men, with a median (interquartile range) age of 61 (54-68) years. The most frequently reported prescribing indication was ED and the most frequently reported reason for stopping apomorphine was that it was 'not effective'. In addition, the percentage of patients for whom apomorphine was reported to have been effective was relatively low. Headache was the most commonly reported adverse drug reaction, and the most frequently reported clinical condition occurring in the first month of observation. A small number of events (24) were reported that were not listed in the current Summary of Product Characteristics (SPC) and were considered by the prescribing general practitioner (GP) to be associated with apomorphine use. The proportion of patients for whom apomorphine was reported to be effective was low. Also, 'not effective' was the most frequently reported event and a high percentage of patients stopped apomorphine because it was 'not effective'. The most frequently reported clinical adverse events (headache and nausea) were those listed in the SPC. A small number of reports for unlabelled events were thought by prescribers to be related to apomorphine use. The confounding factors of patient age and coexisting disease should be considered when assessing data from this study.

Comparison of the Risk of Drowsiness and Sedation between Levocetirizine and Desloratadine

Desloratadine and levocetirizine are histamine H(1) receptor antagonists (antihistamines) that were launched in the UK in 2001. Our objective was to compare the frequency with which drowsiness and sedation were reported for desloratadine and levocetirizine within the first 30 days of observation, as monitored using the observational cohort technique of prescription-event monitoring (PEM). Exposure data were derived from dispensed prescriptions written by primary care physicians and outcome data were derived from questionnaires that were posted to prescribers at least 6 months after the date of the first prescription for each patient. The odds ratio (OR) was calculated using unconditional logistic regression modelling. The effect of age, sex, reported prescribing indication (allergic rhinitis with asthma/wheezing, allergic rhinitis without asthma/wheezing, 'other'), pattern of use and reported previous antihistamine use on the OR was examined. A time-to-event analysis was performed. The cohorts comprised >24,000 patients in total. Cohort demographics were similar (both cohorts: median age 37 years; 60% women); the most frequently reported prescribing indication for both drugs was allergic rhinitis without asthma/wheezing (54%). The incidence of first reports of drowsiness/sedation for levocetirizine or desloratadine was low (46 [0.37%] and 9 [0.08%], respectively) and statistically different (p < 0.0001). These events tended to occur earlier for desloratadine than levocetirizine (50% at 7 or 14 days of observation, respectively; p = 0.6487), but the cumulative time to event differed, with more events observed for levocetirizine than expected (p < 0.0001; 46 vs 28.09). The final estimates of risk were the sex-adjusted ORs for each prescribing indication category: allergic rhinitis with asthma/wheezing (3.51; 95% CI 0.71, 17.43; n = 3357), allergic rhinitis without asthma/wheezing (6.75; 95% CI 2.37, 19.22; n = 12,627) and 'other' (3.11; 95% CI 0.86, 11.31; n = 6725). Although the reporting rates of drowsiness and sedation are low for both drugs, patients prescribed levocetirizine are more likely to experience drowsiness and sedation in the first month of observation (after starting treatment) than patients prescribed desloratadine. For patients with allergic rhinitis without asthma/wheezing, the sex-adjusted odds of drowsiness/sedation were over six times greater in patients using levocetirizine than desloratadine in the first month of observation, with the OR being statistically significant. For the other two indication categories, allergic rhinitis with asthma/wheezing and 'other', the OR was not statistically significant. Although the risk of drowsiness/sedation is low, conditions such as allergic rhinitis are common, which makes any impact on patient cognitive function important. Doctors should be aware of this when prescribing these products to patients where daytime sedation is undesirable. However, essential components of the comparative benefit-risk evaluation of these two products include assessment of efficacy and patient preference (neither of which forms part of this study).

Results of improvement in adequacy of intermittent hemodialysis (IHD) in uremic patients

Increasing number of uremic patients, who need IHD, is a great challenge for every society but especially for poor and developing countries. The aim of our study is to look if small (not very expensive) increase in IHD adequacy is able to improve standard medical parameters. In 40 patients, treated with IHD for 57.5 (1–185) months, Kt/V was monitored on‐line during the middle IHD session in the week, 4 times in each of 6 consecutive months. Measurements of Kt/V based on a conductivity method. In the first month of observation Kt/V was lower (1.09 ± 0.02, p &lt; 0.0009) than in later months, in which Kt/V was ranging from 1.13 ± 0.04 to 1.17 ± 0.01. Blood morphology was estimated every month. At the beginning of study period, after 3 months, and at the end of studies, dry body mass, BMI, the blood pH and serum concentration of calcium, phosphate, intact PTH, total protein, albumin, cholesterol, iron, ferritin, urea, and creatinine were determined. The increase in Kt/V was accompanied by rising values of Hb (99.1 ± 16.6 → 105.1 ± 12.5 g/l, p = 0.022), Hct (31.6 ± 5.2 → 33.8 ± 3.6%, p = 0.004), MCV (95.9 ± 7.7 → 100.7 fl ± 5.7, p = 0.000), iron (58.2 ± 29.6 → 73.2 ± 27.8 μg/dl, p = 0.002), blood pH before (7.26 ± 0.04 → 7.41 ± 0.04, p = 0.000) and after (7.34 ± 0.05 → 7.48 ± 0.05, p = 0.000) IHD session as well as by decreasing values of PTH [918 (38–3500)→ 420 (15–4341) pg/ml, p = 0.036]. Statistically unchanged parameters included dry body mass (70.4 ± 15.6 → 70.9 ± 16.1 kg), BMI (28.21 ± 6.73 → 28.23 ± 6.79 kg/m2), serum concentration of total protein (69.1 ± 5.7 → 70.9 ± 4.8 g/l), phosphate (5.72 ± 1.50 → 5.39 ± 2.02 mg/dl), cholesterol (203 ± 49 → 191 ± 62 mg/dl) and ferritin (740 ± 558 → 632 ± 346 ng/dl) as well as WBC (8.60 ± 3.89 → 6.52 ± 1.50 K/nl) and PLT (251 ± 91 → 195 ± 60 K/nl). There were correlations between Kt/V and serum concentrations of phosphate (r = 0.370, p = 0.019), PTH (r = 0.314, p = 0.048), ferritin (r = 0.417, p = 0.007), Hb (r = −0.376, p = 0.017), and Hct (r = 0.374, p = −0.017). Our results indicate that even a small increase in IHD adequacy leads to beneficial changes in management of uremic patients (better response on erythropoietin, diminished laboratory features of secondary hyperparathyroidism, better iron utilization). Correlation between Kt/V and examined parameters indicate that higher IHD doses were provided to patients in more advanced uremic state. It may partially explain advantages observed with incremental IHD adequacy.

Failure of a Traffic Control “Fatality” Sign to Affect Pedestrians' and Motorists' Behavior

The behavior of 643 pedestrians and 1749 motorists at two signal-controlled intersections was observed over a 2-mo. period of observation in March and November. One intersection had a coffin-shaped traffic sign with the wording "Fatality" erected during the first month of observation (March). The second intersection was identical in traffic and pedestrian volume but lacked a "Fatality" sign in either March or November. "Fatality" signs are erected and maintained by the City of Edmonton for 6 mo. whenever a pedestrian death has occurred, and they are intended to raise the awareness of both pedestrians and motorists concerning the risks at dangerous intersections. This sign had been removed for nearly 3 mo. when a follow-up observation was made in November. While female pedestrians and pedestrians over the age of 50 years showed greater caution at both intersections, the presence or absence of the "Fatality" sign had no statistically significant influence on safety. Similarly, the presence or absence of a sign did not significantly influence motorists' behavior. Of motorists 7.6% ran either amber or red traffic control lights at the two intersections. The "Fatality" sign did not affect the rates of these violations.

Evaluation of the safety of sildenafil for male erectile dysfunction: experience gained in general practice use in England in 1999.

To examine the safety of sildenafil, the first of the phosphodiesterase type 5 inhibitors licensed for the treatment of male erectile dysfunction (ED), as used in general medical practice in England, quantifying the incidence of a range of events in patients treated with sildenafil, and identifying any previously unrecognized adverse drug reactions. In a postmarketing observational cohort study using prescription-event monitoring (PEM), exposure data were derived from dispensed prescription details for patients who started treatment between April and August 1999. Outcome data were derived from "green form" questionnaires (GFs) returned by general practitioners (GPs). RESULTS In all, 24 835 (54.7%) of GFs posted to GPs were returned, of which 22 473 contained useful data for 22 471 male and two female patients. The major primary indications/clinical context of prescribing were impotence (16 583, 73.8%) and diabetes mellitus (183, 0.8%); 145 events were reported as adverse drug reactions to sildenafil. GPs recorded 3951 reasons for stopping sildenafil, and ischaemic heart disease (IHD) in 135 patients was the commonest clinical reason reported. The clinical condition reported most frequently in the first month of observation was diabetes mellitus and/or hyperglycaemia (in 99 events). A standardized mortality ratio (SMR) for deaths caused by IHD in the first 8893 of 22 473 patients was 31.41 (95% confidence interval 18.29-50.29), using the comparator population of males in England in 1998. This study identified the safety profile of sildenafil as used in the community, showing no unexpected events. The SMR analysis of deaths from IHD provided no evidence to suggest a higher incidence of deaths in the study cohort than in the male population in England.

Broadband Modeling of GRB 021004

We present a broadband modeling of the afterglow of GRB 021004. The optical transient of this burst has been detected very early and densely sampled in several bands. Its light curve shows significant deviations from a simple power law. We use the data from the X-ray to the $I-$band gathered in the first month of observations, and examine three models. Two involve variations in the energy of the shock. The first (energy injection) allows only increases to the shock energy, while the second (patchy shell) allows the energy to increase or decrease. In the final model (clumpy medium) the energy of the shock is constant while the density varies. While all three models reproduce well the optical bands, the variable density model can best account for the X-ray data, and the energy-injection model has the poorest fit. None of the models can account for the modest color variations observed during the first few days of the burst.

Supernova 2002ap: the first month

Supernova (SN) 2002ap in M74 was discovered on January 29, 2002. Being one of the nearest (10 Mpc) SN events in the last decades, and spectroscopically similar to the so-called ``hypernovae'' 1997ef and 1998bw, both possibly associated with gamma-ray bursts (GRBs), it is of great interest. Shortly after its discovery, we launched an intensive photometric and spectroscopic monitoring campaign of this event, and here we report the results of the first month of observations. We use our UBVRI photometry to estimate the magnitudes at, and dates of, peak brightness. Our data suggest that this object reached its peak B-band luminosity on Feb. 7.1(-1.3)(+2) UT. Based on its similarity to SN 1998bw, we estimate the range of possible dates for a GRB that may have been associated with SN 2002ap. We find that it may include dates outside the time frame for which all available gamma-ray data have been intensively scanned, according to recent reports. The absolute magnitude at peak brightness of SN 2002ap (M_B = -16.9) shows that it was significantly fainter than SN 1998bw, or normal type-Ia SNe, but similar to SN 1997ef. Our spectroscopic observations confirm that SN 2002ap is strikingly similar to SNe 1998bw and 1997ef. We briefly describe the spectral evolution of this object. To assist other observers and to stimulate theoretical models, we make our entire data set publicly available in digital form.

An Evaluation of Some Marking and Trapping Techniques Currently Used in the Study of Anuran Population Dynamics

An Evaluation of Some Marking and Trapping Techniques Currently Used in the Study of Anuran Population Dynamics

Frequency and treatment of ovarian cysts in adolescence.

Ultrasound examination of the ovaries was performed monthly in the follicular phase of 139 healthy adolescents for one year. In 17 girls (12.2%) ovarian cysts spontaneously disappeared within 3 months of first observation. In 6 subjects, treatment with the combined estrogen/progestogen pill was given. The treatment was effective in 4 girls after 2-6 months while 2 subjects required surgical intervention for a cystic teratoma and a simple follicular cyst respectively. A spell of serial sonographic observation of ovarian cysts would seem appropriate in adolescents.