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IntroductionWellness self-management is an adaptation and expansion of the illness management and recovery, an internationally recognized best practice. WSM is a recovery-oriented, curriculum-based practice designed to help adults with severe mental health problems make decisions and take action to manage symptoms and improve their quality of life.ObjectivesIn the present study, the Italian translation of the WSM was implemented and validated. Moreover, the impact of its application in a day hospital setting on cognitive functions, psychopathology, personal resources and real-life functioning with respect to treatment as usual (TAU) was investigated.AimsThe study was aimed at assessing the effectiveness of a semi-structured version of WSM in a day hospital setting in patients with severe mental illness.MethodsFourteen patients with a diagnosis of severe mental illness were recruited and randomly assigned to either WSM or TAU. WSM participants attended four 2-hour sessions per week for 1 month, including lessons selected on the basis of the goals of participants. Both groups received weekly planned treatment in the day-hospital setting and continued their pharmacotherapy.ResultsThe two groups of patients were comparable for age, education, cognitive functioning and psychopathological severity. WSM produced a significantly greater improvement in neurocognition, psychopathology, personal resources and real-life functioning with respect to TAU.ConclusionsOur results offer promising preliminary evidence that the use of WSM provides an effective complement to current mental health treatment.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Gynaecological laparoscopic surgery outcomes can be compromised by the formation of de novo adhesions. This randomized, double-blind study was designed to assess the efficacy and safety of 4% icodextrin solution (Adept(®)) in the reduction of de novo adhesion incidence compared to lactated Ringer's solution (LRS).Patients undergoing laparoscopic surgery for removal of myomas or endometriotic cysts were treated with randomized solution as an intra-operative irrigant and 1l post-operative instillate. De novo adhesion incidence (number of sites with adhesions), severity and extent were independently scored at a second-look procedure and the efficacy of the two solutions compared. The effect of surgical covariates on adhesion formation was also investigated. Initial exploratory analysis of individual anatomical sites of clinical importance was progressed. RESULTS Of 498 patients randomized, 330 were evaluable (160 LRS--75% myomectomy/25% endometriotic cysts; 170 Adept--79% myomectomy/21% endometriotic cysts). At study completion, 76.2% LRS and 77.6% Adept had ≥ 1 de novo adhesion. The mean (SD) number of de novo adhesions was 2.58 (2.11) for Adept and 2.58 (2.38) for LRS. The treatment effect difference was not significant (P = 0.909). Assessment of surgical covariates identified significant influences on the mean number of de novo adhesions regardless of treatment, including surgery duration (P = 0.048), blood loss in myomectomy patients (P = 0.019), length of uterine incision in myomectomy patients (P0.001) and number of suture knots (P0.001). There were 15 adverse events considered treatment-related in the LRS patients (7.2%) and 18 in the Adept group (8.3%). Of 17 reported serious adverse events (9 LRS; 8 Adept) none were considered treatment-related.The study confirmed the safety of Adept in laparoscopic surgery. The proportion of patients with de novo adhesion formation was considerably higher than previous literature suggested. Overall there was no evidence of a clinical effect but various surgical covariates including surgery duration, blood loss, number and size of incisions, suturing and number of knots were found to influence de novo adhesion formation. The study provides direction for future research into adhesion reduction strategies in site specific surgery.

Objective: To evaluate the central effect exerted by different progestins used for hormone replacement therapy. Methods:Randomised, placebo-controlled study. One hundred-twenty postmenopausal women on continuous hormonal replacement therapy with transdermal estradiol (50g per day) associated, for 10 days every 28 days, with four different progestins: dydrogesterone (DYD; 10 mg per day; n = 20), medroxyprogesterone acetete (MPA; 10 mg per day; n = 20), nomegestrol acetate (NMG; 5 mg per day; n = 20) or norethisterone acetate (NETA; 10 mg per day; n = 20). Other 40 women, 10 for each treatment group, were used as controls and were monitored for a single cycle of 28 days during the administration of transdermal estradiol plus placebo. Morning basal body temperature (BBT) was monitored for 28 days. Anxiety, by the state-trait anxiety inventory, and depression, by the self-evaluation depression scale of Zung, were evaluated just prior to and in the last 2 days of the 10-day progestins adjunct. Results: All progestins except DYD increased ( P< 0.0001) BBT by 0.3–0.5 ◦ C. Anxiety was decreased by DYD (−2.3 + 1.1; P< 0.01) and MPA (−1.5 + 0.5; P< 0.01), but not by NMG or NETA. Depression did not significantly increase during progestins and actually decreased during MPA (−3.0 + 0.7; P< 0.01). Only the effect of DYD on anxiety and that of MPA on depression were significant versus the control group ( P< 0.05). Conclusions: Different progestins exert different central effects. DYD has the peculiarity of not increasing BBT and of decreasing anxiety, which is also decreased by MPA. Depression is not negatively affected by the tested progestins and it may be ameliorated by MPA. The present data may help to individualise the progestin choice of hormone replacement therapy. © 2003 Elsevier Ireland Ltd. All rights reserved.

From May 1993 to January 1997, a total of 130 humeral fractures and nonunions were treated using an "elastic" unreamed nail. The elastic nail consists of a cylindrical proximal component tapered for the application of the impactor-extractor, distally containing the proximal ends of four or five secondary nails preloaded to diverge and held together by a retaining system. The surgical approach is through the olecranic fossa apex. Once introduced, the proximal end of the nail locks automatically by diverging the secondary nails in the proximal humeral epiphysis. Distally, the elastic nail is locked with a crossbolt. The elastic nail enables stable fixation of fractures or nonunions and allows early rehabilitation.

Objective: This study was conducted to determine whether the incidence of ectopic pregnancy follows a seasonal rhythm of occurrence. Study Design: A retrospective analysis was performed on 15,639 pregnancies reported in a single department in 5.5 years (January 1992-June 1997). For each pregnancy the time of conception was estimated from medical records. Frequencies of conceptions that terminated in birth, spontaneous abortion, legally induced abortion, and ectopic pregnancy were distributed across the 12-month period. Results: Total pregnancy showed a seasonal rhythm of occurrence, with peak values in March. The rate of ectopic pregnancy showed a rhythm with 2 peaks, in June and December. Nadirs were coincident with the peak and nadir of total conceptions and also with the equinoxes. Spontaneous abortions tended to show a rhythm the inverse of that of ectopic pregnancy. Conclusions: These data show an influence of the seasons on the rate of ectopic pregnancy, which may have implications for both the understanding of ectopic pregnancy's causative mechanisms and its prevention. (Am J Obstet Gynecol 1999;180:1067-71.)

In women, the bone metabolism is markedly influenced by gonadal steroids and by their fluctuations. Indeed, estrogens influence bone metabolism by influencing endocrine and paracrine functions involved in bone remodelling. In normally cycling women, the administration of oral contraceptives does not increase bone mineral density and does not induce deleterious effects on bone. In women with ovulatory disturbances, bone turnover is increased and bone mineral density is lower than in normally cycling women. In these cases, administration of oral contraceptives is capable of blocking increased bone loss and of restoring a normal bone mineral density. Similarly, in women treated with gonadotropin releasing hormone (GnRH) analogs, the concomitant administration of oral contraceptives completely antagonizes GnRH analog-induced bone loss. The progestogenic component of oral contraceptives seems to contribute to the protective effect of estrogens on bone. Oral contraceptives are safe for bone maintenance in normal adult women, and are indeed indicated to prevent postmenopausal osteoporosis in women with ovulatory disturbances.

Isoniazid, the hydrazide of isonicotinic acid, is widely used in the treatment and prophylaxis of tuberculosis. The toxicity and carcinogenicity of isoniazid have been attributed to the action of its metabolites, hydrazine and acetylhydrazine. Aconiazide, the isonicotinylhydrazone of 2-formylphenoxyacetic acid, has been used in the treatment and prophylaxis of tuberculosis. Aconiazide is hydrolyzed in the body to isoniazid and 2-formylphenoxyacetic acid. 2-Formylphenoxyacetic acid has been shown to bind hydrazine and acetylhydrazine. This binding could explain the lower toxicity of aconiazide and also could provide a reason for postulating its lack of carcinogenicity.

A new prosthetic, segmented polyether polyurethane portacaval shunt featuring quick-connect anastomotic ends was constructed and evaluated as part of a short-term pharmacokinetic study. The shunts were easily implanted, did not require the use of anticoagulants, and decreased the operative time normally required for this surgical preparation. There was no evidence of thrombosis or venous stasis associated with the shunts.

A simple, rapid, high performance liquid chromatographic (HPLC) method for the analysis of the immunoadjuvant octadecyl tyrosine hydrochloride is described. The HPLC procedure can be applied to the direct determination of amino acid reactants present as contaminants in the adjuvant (tyrosine, ethyl tyrosine) and from this information the content of octadecanol reactant can be estimated. Further, these same determinations provide a means of monitoring immunoadjuvant stability in any vaccine preparation.

The biological potency of 15 commercially available tuberculin solutions prepared from a master batch of tuberculin purified protein derivative (PPD) (PPD-CT68) and using a newly formulated diluent (Connaught diluent) containing 0.0005% Tween 80 as an anti-adsorption agent and 0.3% phenol as a preservative, was determined after storage for various intervals at 4, 24 and 37 degrees C. The 5 tuberculin units (TU) per 0.1 ml dose solutions were bioequivalent to a non-stabilized solution of PPD-S whereas the 1 TU and 250 TU per dose solutions were equivalent by calculation to a non-stabilized solution of PPD-S. It was found that the PPD solutions of all 3 strengths, 1, 5 and 250 TU per dose, were stable for at least 3 years at 4 degrees C and for 2 years at room temperature (24 degrees C). Even at 37 degrees C the solutions of all 3 strengths were stable for at least 1 year. The stability of Connaught tuberculin PPD solutions has not been affected by the changes in formulation. The stability data suggest that the expiry date of the newly formulated tuberculin products could be at least two years from the data of the last satisfactory potency test. Although these products are stable for at least 1 year even at 37 degrees C, we nonetheless agree with the Canadian and U.S. regulations that they be stored at 2 to 8 degrees C in their original containers.

A tuberculin purified protein derivative (PPD) solution containing 0·3% phenol as a preservative was dispensed in glass vials closed with rubber stoppers fastened in three different ways, namely with Tear-off seals, Flip-off seals and partial seals. After various times of storage at 5°C and 37°C, the phenol content in the tuberculin solution was determined. It was found that the Flip-off seals allowed the phenol to escape at a faster rate than the Tear-off seals and that vials closed with partial seals showed the highest loss of phenol. Although these losses were much more pronounced at 37°C than at 5°C, the phenol content at the latter temperature was, over a period of three years, within the limits of acceptability for tuberculin products capped with Tear-off or Flip-off seals. A loss of phenol also occurred from tuberculin solution stored at −28°C in vials capped with either Tear-off or partial seals. In addition to the Tear-off and Flip-off seals other seals such as the ‘controlled score’ Flip-off seal and the Alcoa Steri-Twist cap were evaluated for their imperviousness to air. Except for the Alcoa Steri-Twist cap none of the seals we have investigated were air tight and hence entirely satisfactory to prevent losses of phenol by evaporation from tuberculin products. Therefore, it is essential to minimize accidental contamination during serial withdrawals, that the initial concentration of phenol be as close as possible to its upper limit of acceptability of 0·35% and that its concentration in the final containers be determined from time to time, over the shelf life of the products, to ensure that it does not fall below its lower limits of effectiveness of 0·22%.

During the storage of nonstabilized, dilute solutions of tuberculin (solutions containing no antiadsorption agent) in glass containers and glass or plastic syringes, great losses of tuberculin occur due to the adsorption of tuberculoprotein to the wall of these containers. Using glass vials filled with tuberculin purified protein derivative-14C at the concentration of 5 tuberculin units per dose, the concentration of the nonstabilized tuberculin solution decreased to 60 per cent of its original concentration one day after filling. During withdrawal in disposable syringes with a capacity of adsorption ranging from 0.19 µg to 0.23 µg purified protein derivative per cm2, the concentration of tuberculin decreased further to approximately 50 per cent when it was immediately injected and to approximately 40 per cent, 30 per cent, 20 per cent, and 10 per cent of the original concentration when it was injected after 20 minutes, 1 hour, 4 hours, and 8 hours, respectively. After 24 hours in the disposable syringe, ...

A study on skin cross-reactivity between stabilized 14 C-labeled mycobacterial antigens, namely tuberculin purified protein derivative (PPD; from Mycobacterium tuberculosis ), PPD-A ( M. avium ), PPD-Y ( M. kansasii ), PPD-G ( M. scrofulaceum ), PPD-B ( M. intracellulare ), and PPD-F ( M. fortuitum ), has been carried out in groups of guinea pigs sensitized with one of the following heat-killed mycobacteria: M. tuberculosis, M. avium, M. kansasii, M. scrofulaceum, M. intracellulare , or M. fortuitum . For each type of sensitization, the average response for the corresponding PPD antigen was higher than the average response for any of the other antigens. However, the responses to the heterologous PPD antigens were not necessarily significantly different among themselves, and the significant differences of the heterologous PPD antigens were distributed differently according to the type of sensitization. Therefore, 14 C-PPD antigens skin cross-reacted in guinea pigs essentially in the same manner as reported by others for nonradioactive PPD antigens.

Tuberculin purified protein derivative (PPD) has been prepared by seven different precipitation methods from culture filtrate of Mycobacterium tuberculosis var. hominis . It was found to contain 48 to 99% tuberculoprotein, depending on the method of precipitation. The remaining percentage is represented by nucleic acid, polysaccharide, and ash. Activation analysis on tuberculin PPD and on tubercle bacilli has revealed the presence of trace elements. The molecular weight of tuberculin PPD has been found to be of the order of 14,800 to 27,800. The biological activity of tuberculin PPD varies from lot to lot and from method to method. A correlation between its molecular weight and its biological activity seems to exist.

The biological reactivity of two commercially available tuberculin preparations was measured in 168 subjects (9 with active tuberculosis; 98 with inactive tuberculosis; and 61 general population). One tuberculin had 5 tuberculin units (TU) per 0-1 ml dose relative to a stabilized solution of PPD-S, whereas the other preparation was bioequivalent to 5 TU per 0-1 ml dose of unstabilized PPD-S, and was therefore of lower potency. Differences between the tuberculins were more evident when an induration of larger than or equal to 10 mm was considered as positive. Using a criterion of larger than or equal to 5 mm the differences were smaller, but the frequency of non-tuberculous responders was increased using this criterion. The average difference between the tuberculins was of the order of 5 mm regardless of the criterion of postivity. The use of chemoprophylaxis based on reaction size necessitates that the physician should know which of these two commercially available tuberculins is being used.

Preliminary studies of some of the properties of stearyl tyrosine have shown that it is non-toxic, free of adverse reactions at the sites of injection, non-pyrogenic, stable upon storage and easy to sterilize. Formalin inactivated poliovirus vaccine (IPV) adjuvanted with stearyl tyrosine hydrochloride induced significantly higher titres of antibodies in non-human primates, after two injections, than the non-adjuvanted vaccine. Furthermore, the adjuvanted vaccine, even when diluted 1:4, showed consistently higher antibody titres as well as a longer persistence of antibodies than the non-adjuvanted undiluted vaccine. These studies suggest that stearyl tyrosine is an excellent and cost effective adjuvant for IPV. Hence further investigation with this novel synthetic compound would be worthwhile to ascertain its adjuvanticity for IPV in human subjects.

Tuberculin purified protein derivative (PPD) obtained from the filtrate of Mycobacterium tuberculosis was hydrolysed with proteinase, trypsin, or chymotrypsin. Each hydrolysate consisted of a tuberculin peptides mixture (TPM). From each TPM 16 fractions were obtained by ion-exchange chromatography on Dowex 50W-X8 but only one fraction was isolated from each of the 16 fractions which showed tuberculin activity in guinea pigs sensitized with M. bovis (BCG) or M. tuberculosis. This fraction was designated "purified tuberculin peptide" (PTP).The PTP fraction from the proteinase hydrolysate (PTP-proteinase) was rechromatographed on Dowex 1-X2 and two tuberculin peptide fractions having molecular weights of 3200 and 12 000 were isolated. The potency of these two fractions was assessed in guinea pigs sensitized with M. bovis (BCG) and with M. tuberculosis and they were approximately 4 to 7 times more potent than either the international standard for PPD (PPD-S) or Connaught PPD in guinea pigs sensitized with BCG and of at least equal potency to either PPD-S or Connaught PPD in guinea pigs sensitized with M. tuberculosis. Connaught tuberculin PPD cross-reacted in guinea pigs sensitized with either M. kansasii, M. scrofulaceum, M. intracellulare, or M. avium whereas very little if any cross-reactivity was elicited by these two fractions. This lack of response indicates that either fraction could be used as an aid to differentiate between sensitization due to M. tuberculosis or M. bovis and sensitization attributed to other mycobacteria.

The method used to produce “Connaught” tuberculin purified protein derivative (PPD) is described. The tuberculin PPD for the multiple-puncture method was shown to be stable for at least 24 months at 5 C; tuberculin PPD for the intracutaneous method was shown to be stable at 5 C and 24 C for a period of 18 months in the presence of Tween 80. Evans blue or brillant vital red was added to tuberculin PPD for improved testing by the multiple-puncture method. These tinted tuberculin preparations were found to be as stable as the Connaught tuberculin PPD preparations without dye at 5 C. Freeze-dried tuberculin PPD with Plasdone as an inert base was found to be remarkably stable for a period of at least 24 months at 5, 24, and 37 C.

Visual deficits caused by abnormal visual experience during development are hard to recover in adult animals. Removal of chondroitin sulfate proteoglycans from the mature extracellular matrix with chondroitinase ABC promotes plasticity in the adult visual cortex. We tested whether chondroitinase ABC treatment of adult rats facilitates anatomical, functional, and behavioral recovery from the effects of a period of monocular deprivation initiated during the critical period for monocular deprivation. We found that chondroitinase ABC treatment coupled with reverse lid-suturing causes a complete recovery of ocular dominance, visual acuity, and dendritic spine density in adult rats. Thus, manipulations of the extracellular matrix can be used to promote functional recovery in the adult cortex.