Health-related quality of life on the clinical course of patients with chronic hepatitis C receiving daclatasvir/asunaprevir therapy: A prospective observational study comparing younger (<70) and elderly (≥70) patients.

Interferon-free direct acting antiviral agent regimens for chronic hepatitis C (CHC) have been developed. These regimens have shown a high rate of sustained virologic response (SVR), and a reduction in side effects during treatment is also anticipated. However, the impact of the regimens on health-related quality of life (HRQOL) and side effects during treatment is not fully understood. The purpose of the present study was to evaluate HRQOL in the clinical course of patients with CHC receiving daclatasvir/asunaprevir (DCV/ASV) therapy using the Short Form-36 (SF-36) method. Twenty-eight patients with CHC receiving DCV/ASV therapy were analyzed in the present study, and HRQOL was measured by SF-36. Patients were asked to fill out the SF-36 prior to therapy (baseline), following 12 weeks of therapy, at the end of treatment and at SVR week 24 (SVR24) to evaluate HRQOL. Laboratory data were also investigated during the same period, and associations between these results and SF-36 were investigated. Aspartate aminotransferase, alanine aminotransferase, serum albumin, α-fetoprotein, platelet counts and Fibrosis (Fib)-4 index were all significantly improved at each time point when compared with baseline. With regard to alterations in HRQOL during therapy, the ≥70-year-old group displayed a significantly greater improvement in physical functioning during the period between baseline and 12 weeks when compared with the <70-year-old group. In the analysis of the SF-36 differences within each group, general health improved significantly in the ≥70-year-old group, as well as albumin levels. In addition, Fib-4-index significantly improved at all time points (12 and 24 weeks, and SVR24) when compared with baseline in the ≥70-year-old group. Therefore, DCV/ASV therapy may improve HRQOL and hepatic functional reserve, particularly in elderly patients.

Evaluation of the health-related quality of life using the 36-item short form health survey in patients with chronic hepatitis C receiving pegylated interferon/ribavirin/telaprevir triple treatment.

The rate of sustained virologic response (SVR) has increased in patients with chronic hepatitis C (CHC; genotype 1) since triple treatment with pegylated interferon (PEG-IFN), ribavirin (RBV) and telaprevir (TVR) was included in Japanese health insurance. However, side effects such as high-grade anemia and skin disorders means it is important to investigate the extent to which quality of life (QOL) is maintained during treatment. The impact on health-related (HR) QOL, as a result of TVR-based triple treatment was investigated long-term (48 weeks) in 34 patients (18 men, 16 women) following TVR-based triple treatment, using the 36-item short form health survey (SF-36). While scores for physical health were significantly lower during treatment, an improvement was seen in patients who showed complete response to treatment from 12 weeks following treatment (P<0.05). HRQOL improved significantly following completion of TVR-based triple treatment in these complete-responders, with higher scores compared with those prior to treatment. Anemia and skin symptoms appeared frequently during treatment and scores for physical health dropped. Particular care needs to be taken in regards to the management of side effects during TVR treatment. Further evaluations using the SF-36 may help in controlling doses to achieve SVR.

Evaluation of the thermal insulation of clothing of infants sleeping outdoors in Northern winter.

It is a common practice in Northern countries that children aged about 2 weeks to 2 years take their daytime sleep outdoors in prams in winter. The aim was to evaluate the thermal insulation of clothing of infants sleeping outdoors in winter. Clothing data of infants aged 3.5 months was collected, and sleep duration, skin and microclimate temperatures, humidity inside middle wear, air temperature and velocity of the outdoor environment were recorded during sleep taken outdoors (n = 34) and indoors (n = 33) in families' homes. The insulation of clothing ensembles was measured by using a baby-size thermal manikin, and the values were used for defining clothing insulation of the observed infants. Required clothing insulation for each condition was estimated according to ISO 11079. Clothing insulation did not correlate with ambient air temperature. The observed and required insulation of the study group was equal at about -5 °C, but overdressing existed in warmer and deficiency in thermal insulation in colder temperatures (r (s) 0.739, p < 0.001). However, even at -5 °C a slow cooling (ca. 0.012 °C/min) of mean skin temperature (T (sk)) was observed. When the difference between observed and required insulation increased, the cooling rate of T (sk) increased linearly (r (s) 0.605, p < 0.001) and the infants slept for a shorter period (r (s) 0.524, p = 0.001). The results of this study show the difficulty of adjusting systematically the optimal thermal insulation for outdoor sleeping infants during northern winter. Therefore, the necessity for guidelines is obvious. The study provides information for adequate cold protection of infants sleeping in cold conditions.

Differences in comfort perception in relation to local and whole body skin wettedness.

Relevance of local skin wettedness (w (local)) to general thermal comfort while wearing clothing was investigated in eight males. In the experiments, skin wettedness of the whole body (w (body)) was controlled to be around the thermal comfort limit, while w (local) in different target locations of equal area (anterior and dorsal torso, arms, and thighs) was pushed beyond the comfort limit using special test garments. Subjects walked on a treadmill at 4.5 km h(-1) under 22 degrees C 50% RH. Arms and thighs were thermally in discomfort when their w (local) exceeded 0.32. On the other hand, discomfort in the anterior and dorsal torso was initiated when their w (local) arrived at 0.42 and 0.45. That is, the relation of the local comfort limit with w (local) differed depending upon the location. It was observed; however, that general discomfort was not induced when w (body) remained below 0.36 even if w (local) was higher than its local comfort limit.

Heat and water vapour transfer of protective clothing systems in a cold environment, measured with a newly developed sweating thermal manikin.

A moveable sweating thermal manikin has recently been developed. Thermal and water-vapour resistances of three kinds of cold-protective clothing ensembles, laminated with polytetrafluoroethylene, polyurethane and without a laminate were measured, with the aid of the manikin in a cold environment of 5 degrees C with a relative humidity of 70% and an air velocity of around 1.5 m s(-1). Two sweating rates of 65 and 130 g m(-2) h(-1) were employed. Supplied heat fluxes in both of the sweat rates ranged from 350 W m(-2) to 400 W m(-2). To maintain a comfortable condition, the skin wettedness (w) (mean weighted value) had to be kept at < or = 0.6. The measurements obtained from the manikin when testing the three ensembles were w=0.3 (approximately) for the low sweat rate and w > or = 0.6 for the high sweat rate, irrespective of the property differences among the ensembles. In addition, the condensation in the ensembles in comparison with those calculated from an analytical equation is discussed. Condensation mass fluxes in the ensembles obtained by experiment and those from the calculation agreed sufficiently well. Thus, distribution of the condensation in the ensembles was estimated using the equation.

Comparison of thermal manikins of different body shapes and size.

Differences between manikins may be present due to manikin body shapes (male versus female). In order to examine such differences a study was designed. Comparisons were carried out based on: (1) tight versus loose clothing; (2) serial versus parallel calculation models; (3) even versus uneven clothing (insulation) distribution; and (4) the effect of donning clothes. Differences were observed between female and male manikins depending on body shape. However, these differences were within the range that was observed in the Subzero project, and were comparable with differences between manikins of male body shapes. Manikins behaved differently according to clothing adjustments. Tight-fitting clothes resulted in smaller differences. The effects of donning clothes were more pronounced with the serial calculation model, while the results generated by the serial and parallel calculation models differed more if the insulation was unevenly distributed (24% and 12% respectively). In order to examine the effect of body size, two baby manikins were compared to an adult manikin. The experimental conditions involved air layer insulation measurements (AL), lying on the back on an insulating surface (OB), and lying on the back on an insulating surface, covered with a sheet (OBS, baby manikins only). The acquired AL insulation for all manikins were very similar. The insulation value of adult manikin tested under condition OB differed from the others. This was related to flexible joints allowing the arms and legs to be in contact with the insulating surface, while baby manikins retained their arms and legs in the air. The baby manikins performed similarly in OBS tests.