A rating scale for fibromyalgia and chronic fatigue syndrome (the FibroFatigue scale)

Objective: To construct an observer's rating scale sensitive to change for measuring severity and treatment outcome in fibromyalgia (FM) and chronic fatigue syndrome (CFS) patients. Methods: A selection of items from the Comprehensive Psychopathological Rating Scale (CPRS) were repeatedly rated and used as outcome measure of a 24-week treatment study. In the study 100 women, fulfilling the criteria for both FM and CFS, received intermittent injections of a staphylococcus toxoid or placebo. Nine CPRS-items with high baseline incidence (cutoff 70%) were extracted and validated against global ratings and the Fibromyalgia Impact Questionnaire (FIQ). The fibromyalgia and chronic fatigue syndrome rating scale (the FibroFatigue scale) was thereafter formed based upon the extracted items and three supplemented ones. The interrater reliability was tested in 27 consecutive patients of both sexes. Results: The FibroFatigue scale is an observer's rating scale with 12 items measuring pain, muscular tension, fatigue, concentration difficulties, failing memory, irritability, sadness, sleep disturbances, and autonomic disturbances (items derived from the CPRS) and irritable bowel, headache, and subjective experience of infection (new items). There was a statistically significant correlation between the CPRS-extracted items and global ratings as well as with the FIQ. The interrater reliability of the new scale was excellent (correlation coefficient .98), irrespective of the patients' gender. Conclusion: The FibroFatigue scale seems to be a reliable and valid measuring instrument with capacity to monitor symptom severity and change during treatment of FM/CFS patients.     

Analysis of samples from patients treated with ReFacto for the presence of anti-SQ-peptide specific antibodies

ReFacto lacks the major part of the B-domain, except for 14 amino acid residues from the N-terminal and C-terminal ends, which are linked into a 14 amino acid SQ-peptide tail in the C-terminal end of the 90 kD heavy chain, thereby introducing a new peptide sequence in the factor VIII (FVIII) molecule. Therefore, samples from some of the patients enrolled in the ReFacto clinical trials were analyzed for the emergence of anti-SQ-peptide antibodies in addition to determinations for inhibitors by Bethesda assay and for anti-FVIII antibodies by enzyme-linked immunosorbent assay (ELISA). An anti-peptide ELISA was developed using six partially overlapping 15-16 mer peptides covering the SQ-linker region. Results from ReFacto-treated anti-FVIII antibody-positive or -negative patients were compared with those for normal healthy adults and patients treated with other FVIII products. The pattern was compared with that for SQ-peptide specific monoclonal antibodies, each recognizing three or four overlapping SQ-peptides. Antibodies recognizing mainly one of the SQ-peptides were found in samples in some individuals from all investigated groups. This means that the anti-SQ reactivity found in patients treated with ReFacto is not induced by the SQ-sequence of the molecule but rather by some other agent, giving rise to antibodies cross-reactive with SQ-peptides.     

A novel quantitative dual-isotope method for simultaneous ventilation and perfusion lung SPET

A quantitative dual-isotope single-photon emission tomography (SPET) technique for the assessment of lung ventilation (V) and perfusion (Q) using, respectively, technetium-99m labelled Technegas (140 keV) and indium-113m labelled macro-aggregated albumin (392 keV), is presented, validated and clinically tested in a healthy volunteer. In order to assess V, Q and V/Q distributions in quantitative terms, algorithms which correct for down scattering, photon scattering and attenuation, as well as an organ outline algorithm, were implemented. Scatter and down-scatter correction were made in the spatial domain by pixel-wise image subtraction of projection-dependent global scattering factors obtained from the energy domain. The attenuation correction was based on an iterative projection/back-projection method. All studies were made on a three-headed SPET system (Trionix) with medium-energy parallel-hole collimators. The set of input data for quantification was based on SPET acquisition of emission data in four separate energy windows, the associated cumulative energy spectra and transmission data. The attenuation correction routine as well as the edge detection algorithm utilized data from (99m)Tc transmission tomography. Attenuation data for (113m)In were obtained by linear scaling of the (99m)Tc attenuation maps. The correction algorithms were experimentally validated with a stack phantom system and applied on a healthy volunteer. The mean difference between the corrected SPET data of the dense stack lung phantom and those obtained from the corresponding scatter- and attenuation-"free" version was only 1.9% for (99m)Tc and 0.9% for (113m)In. The estimated fractional V/Q distribution in the 3-D lung phantom volume had its peak at V/Q=1, with a width (FWHM) of 0.31 due to noise, particularly in the (113m)In images, and to partial volume effects. For a healthy volunteer, the corresponding values were 0.9 and 0.35, respectively. This method allows accurate assessment of radionuclide distribution on a regional basis. For basic lung physiology and clinical practice, the method allows assessment of the global frequency functions of the V, Q and V/Q distributions.     

A randomised trial of two expectant managements of prelabour rupture of the membranes at 34 to 42 weeks

Objective To compare obstetric and perinatal outcome between two different expectant managements in women with prelabour rupture of the membranes (PROM).
Design A randomised study.
Participants One thousand three hundred and eighty-five women with rupture of the membranes at 34 to 42 weeks without contractions.
Interventions Women without contractions 2 h after admission were randomised to early induction the following morning after PROM (early induction group) or induction two days later (late induction group). Women with contractions starting within 2 h after admission were included in the calculations as a short latency group. Digital examinations of the cervix were avoided until onset of active labour. Labour was induced with oxytocin in both groups if no spontaneous contractions occurred or if chorioamnionitis or fetal distress was detected.
Main outcome measures The frequency of spontaneous deliveries, operative deliveries, maternal and neonatal infections.
Results In nulliparous women, a higher rate of spontaneous deliveries was found in the late induction group (89%) compared with the early induction group (81%) (   P < 0.05  ). The ventouse extraction rate was 7% and 14% respectively (   P < 0.05  ). A low (2–4%) caesarean section rate was recorded and did not differ between the groups. Endometritis was detected in six women after delivery. Sixty-one children were treated with antibiotics, and no difference could be detected between the groups.
Conclusions A higher rate of spontaneous deliveries was found among nulliparous women with prolonged latency as compared with brief latency prior to induction. A protocol of no digital examination before labour was associated with infrequent maternal and fetal morbidity, regardless of latency.     

Vascular decompression surgery for severe tinnitus: Selection criteria and results

Seventy-four patients were operated on within a period of 10 years to treat incapacitating tinnitus; 72 underwent microvascular decompression (MVD) of the intracranial portion of the auditory nerve, and 2 underwent section of the eighth nerve close to the brain stem. Of those who underwent MVD, 2 had no change in symptoms and later also underwent section of the eighth nerve near the brain stem. Two patients did not return for follow-up. Of the 72 remaining patients, 13 (18.1%) experienced total relief from tinnitus, 16 (22.2%) showed marked improvement, 8 (11.1%) showed slight improvement, 33 (45.8%) had no improvement, and 2 (2.8%) became worse. The patients who experienced total relief and those who showed marked improvement had experienced their tinnitus for an average of 2.9 years and 2.7 years, respectively; those who showed slight improvement and those who had no improvement had experienced their tinnitus for a longer time before the operation (mean, 5.2 and 7.9 years, respectively). Of the 72 patients who were operated on and followed, 32 were women. Of these, 54.8% experienced total relief from tinnitus or marked improvement, while only 29.3% of the men showed such relief or improvement. Selection of the patients for operation was mainly based on patient history and, to some extent, on auditory test results (brainstem auditory evoked potentials [BAEP], acoustic middle ear reflexes, and audiometric data).     

Appraisal of caregiving, burden and psychological distress in relatives of psychiatric inpatients.

Appraisal of caregiving and its relationship to family burden and experienced mental health problems in the relatives were investigated as part of a multi-centre study of the quality of mental health services in Sweden performed in 1997. The sample was drawn from relatives of involuntarily and voluntarily admitted patients to acute psychiatric wards. The instrument used was a semi-structured questionnaire, interviewing relatives about the burden, experience of mental health problems and appraisal of the caregiving situation. The results showed a high proportion of relatives engaged in caregiving activities on a daily basis the month before the patient's admission to hospital and a high proportion of relatives appraising the caregiving activities negatively. The burden was more extensive if the relative and the patient were living together, had a longer duration of their relationship, if the relative was rendering caregiving on a daily basis and if the relative appraised caregiving negatively. The relatives' psychological distress was not related to their negative appraisal of caregiving, nor was patient characteristics, such as diagnosis and level of psychosocial functioning. The only factor found to influence the relatives' psychological distress was the duration of relationship to the patient. Interventions reducing psychological distress for relatives who have known the patients for more than 20 years, who live with the patient, who give care on a daily basis and who appraise their caregiving negatively are suggested.     

Concentrations of blood, serum and urine components in relation to number of amalgam tooth fillings in Swedish women

Abstract Altogether 1462 women aged 38, 46, 50, 54 and 60 yr were examined in 1968/69 in a combined medical and denial population study in Gothenburg, Sweden. Number of tooth surfaces restored with amalgam fillings was assessed. The examination was repealed in 1980/81 including a new dental examination. The results from a number of biochemical analyses of blood, serum and urine were analyzed for a possible statistical relationship to number of denial amalgam fillings. As emphasis has been put in the literature on special influence from amalgam on kidney function and on the immunological system, special attention was paid to variables which might reflect these functions in our analyses. When potential con-founders were taken into consideration, no significant correlations remained which seemed to be of clinical importance. Specifically, amalgam fillings were not found to be associated with impairment of the kidney function or the immunological status.     

Blood-Brain Barrier Equilibration of Codeine in Rats Studied with Microdialysis

Purpose. The purpose of the study was to investigate the distribution of codeine across the blood-brain barrier (BBB) in rats by micro-dialysis (MD). Methods. Rats were administered intravenous infusion of codeine in doses of (1) 10 mg/kg, (2) 20 mg/kg for 10 min, and (3) an exponential infusion for 2 h aiming at a plasma concentration of 2500 ng/ml, in a crossover design (n = 6). Microdialysis was used to determine codeine unbound concentrations in blood and brain extracellular fluid (ECF). Total brain tissue and plasma concentrations were also determined. Nalorphine was used as a calibrator for measurement of in vivo recovery. Results. Relative recovery and retrodialysis loss of codeine and nalorphine were similar both in vitro and in vivo. Codeine was rapidly transported into the brain ECF with identical influx and efflux clearance across the BBB. The AUC ratios of brain to blood were 0.99 ± 0.25 and 0.95 ± 0.16 for Dose 1 and 2, respectively. The C_ss ratio of brain to blood was 1.06 ± 0.12 for the exponential infusion. The half-lives were 25 ± 4 min, 22 ± 2 min in blood and 27 ± 5 min, 25 ± 5 min in brain for Dose 1 and Dose 2, respectively. Total brain tissue concentrations were 3.6 ± 1.2-fold higher than the unbound concentrations in brain. Codeine was demethylated to morphine with an unbound AUC_{bIood,morphine}/AUC_{blood,codeine} ratio of 7.7 ± 5.1% in blood. No morphine was detected in brain MD, but total concentrations were possible to measure. Conclusions. Codeine rapidly reached a distributional equilibrium with equal unbound concentrations in blood and brain. The brain transport of codeine did not show any dose-dependency.