Decision Making Towards Maternal Health Services in Central Java, Indonesia

Background: Indonesia has always been struggling with maternal health issue even after the Millennium Development Goals (MDGs) programs were done. Prior research findings identified many factors which influenced maternal health status in developing countries such Indonesia and even though various efforts had been made, the impact of the transformation of maternal health behavior was minimal.Purpose: This study aimed to seek an understanding of the factors influencing decisions towards maternal health services.Methods: A case study with a single case embedded design was employed. Interviews and Focus Group Discussions (FGDs) were held to collect data from 3 health workers and 40 maternal women in a sub-district in Central Java, Indonesia.Results: Interviews with the village midwives as the main health providers in the Getasan sub-district concluded that there were several factors influencing the women\u27s decisions towards maternal services. The factors were options to have services with other health workers outside the area, and shaman services as alternative care and family influencing maternal health behaviors. The analysis of the FGDs also supported the village midwives\u27 statements that in spite of their awareness towards the available maternal health services, the existence of shamans and traditional beliefs strongly affected their decision.Conclusion: The findings in this study showed that cultural issues prevented the maximum maternal health status in Getasan sub-district. This study recommends Puskesmas (Primary Health Care) as the first level of health institutions in Indonesia to support the village midwives\u27 roles within their target area

Long-term safety and efficacy of extended-interval prophylaxis with recombinant factor IX Fc fusion protein (rFIXFc) in subjects with haemophilia B

The safety, efficacy, and prolonged half-life of recombinant factor IX Fc fusion protein (rFIXFc) were demonstrated in the Phase 3 B-LONG (adults/adolescents ≥12 years) and Kids B-LONG (children <12 years) studies of subjects with haemophilia B (≤2 IU/dl). Here, we report interim, long-term safety and efficacy data from B-YOND, the rFIXFc extension study. Eligible subjects who completed B-LONG or Kids B-LONG could enrol in B-YOND. There were four treatment groups: weekly prophylaxis (20–100 IU/kg every 7 days), individualised prophylaxis (100 IU/kg every 8–16 days), modified prophylaxis (further dosing personalisation to optimise prophylaxis), and episodic (on-demand) treatment. Subjects could change treatment groups at any point. Primary endpoint was inhibitor development. One hundred sixteen subjects enrolled in B-YOND. From the start of the parent studies to the B-YOND interim data cut, median duration of rFIXFc treatment was 39.5 months and 21.9 months among adults/adolescents and children, respectively; 68/93 (73.1 %) adults/adolescents and 9/23 (39.1 %) children had ≥100 cumulative rFIXFc exposure days. No inhibitors were observed. Median annualised bleeding rates (ABRs) were low in all prophylaxis regimens: weekly (≥12 years: 2.3; <6 years: 0.0; 6 to <12 years: 2.7), individualised (≥12 years: 2.3; 6 to <12 years: 2.4), and modified (≥12 years: 2.4). One or two infusions were sufficient to control 97 % (adults/adolescents) and 95 % (children) of bleeding episodes. Interim data from B-YOND are consistent with data from B-LONG and Kids B-LONG, and confirm the long-term safety of rFIXFc, absence of inhibitors, and maintenance of low ABRs with prophylactic dosing every 1 to 2 weeks

Avaliação morfológica da união entre adesivo/resina composta e dentina irradiada com laser Er:YAG e laser Nd:YAG: estudo comparativo por microscopia de varredura Morphological evaluation of the bonding between adhesive/composite resin and dentin irradiated with Er:YAG and Nd:YAG lasers: comparative study using scanning microscopy

Desde a introdução de sistemas adesivos nos procedimentos restauradores com materiais estéticos, tem-se estudado de forma abrangente o tipo de tratamento na superfície dentinária para se consagrar uma técnica ideal. A utilização do ácido fosfórico a 37% sobre a dentina é atualmente ainda o método que mais se domina em termos de adesividade. Porém, métodos de tratamento alternativos, na dentina, têm sido discutidos na literatura, entre eles a aplicação de alguns tipos de irradiação a laser. O objetivo desta pesquisa foi avaliar morfologicamente a união adesivo/resina composta e dentina irradiada com laser Er:YAG e laser Nd:YAG num estudo comparativo por microscopia de varredura, utilizados em substituição ao condicionamento ácido ou associados ao mesmo. Foram utilizados dentes bovinos recém-extraídos, que receberam um preparo de cavidade de classe V, e restauração com sistema adesivo e resina composta fotoativada. Como variantes alguns deles receberam o tratamento prévio de irradiação com laser Er:YAG e outros de irradiação com laser Nd:YAG, à aplicação do agente adesivo e da resina composta. As amostras foram seccionadas, preparadas para microscopia de varredura e submetidas a uma análise morfológica, e foram feitos os registros por meio de fotomicrografias. Com base nessas observações microscópicas, concluímos que somente no tratamento da superfície da dentina com laser Er:YAG e condicionamento ácido houve penetração da resina na dentina. Nos tratamentos com laser Nd:YAG, houve apenas aparente superposição da resina na superfície dentinária, sugerindo que houve oclusão dos túbulos com características de fusão na dentina superficial.<br>Since bonding systems were introduced in the restorative procedures carried out with esthetic materials, the treatment of dentin surfaces has been widely studied in order to establish the ideal technique. The application of 37% phosphoric acid on dentin is still the best known method. However, alternative methods for treating the dentin surface have been discussed in the literature, including the utilization of some kinds of laser irradiation. The purpose of this research was to morphologically evaluate the bond between adhesive materials and the dentin treated with Er:YAG and Nd:YAG lasers, in a comparative study by means of scanning electron microscopy (SEM). Irradiation either substituted acid etching, or was associated to it. Recently extracted bovine incisors were utilized. They received class V cavity preparations and were restored with a bonding system and a light-cured composite resin. Meanwhile, some of the teeth underwent irradiation with Er:YAG laser or Nd:YAG laser before the application of the bonding agent and the composite resin. The samples were selected, prepared for SEM and submitted to morphological analysis. Data were registered in photomicrographs. Based on the microscopic observations, we concluded that only in the dentin surfaces submitted to irradiation with Er:YAG laser and to acid conditioning there was penetration of resin into the dentine. With the Nd:YAG laser treatment, there was only visual superposition of resin over the dentin surface, which suggests that there was only occlusion of the tubules, with characteristics of fusion in the superficial dentine

Enrollment and disposition of study participants.

<p>Abbreviations: PMHZ, investigational regimen comprised of rifapentine/moxifloxacin/isoniazid/pyrazinamide; REHZ, control regimen comprised of rifampin/ethambutol/isoniazid/pyrazinamide; LJ, Löwenstein-Jensen culture; MGIT, Mycobacterial Growth Indicator Tube culture; MITT, modified intention-to-treat analysis population; PP, per-protocol analysis population; DST, drug susceptibility testing; Mtb, <i>Mycobacterium tuberculosis</i>.</p

A Phase 2 Randomized Trial of a Rifapentine plus Moxifloxacin-Based Regimen for Treatment of Pulmonary Tuberculosis

<div><p>Background</p><p>The combination of rifapentine and moxifloxacin administered daily with other anti-tuberculosis drugs is highly active in mouse models of tuberculosis chemotherapy. The objective of this phase 2 clinical trial was to determine the bactericidal activity, safety, and tolerability of a regimen comprised of rifapentine, moxifloxacin, isoniazid, and pyrazinamide administered daily during the first 8 weeks of pulmonary tuberculosis treatment.</p><p>Methods</p><p>Adults with sputum smear-positive pulmonary tuberculosis were randomized to receive either rifapentine (approximately 7.5 mg/kg) plus moxifloxacin (investigational arm), or rifampin (approximately 10 mg/kg) plus ethambutol (control) daily for 8 weeks, along with isoniazid and pyrazinamide. The primary endpoint was sputum culture status at completion of 8 weeks of treatment.</p><p>Results</p><p>121 participants (56% of accrual target) were enrolled. At completion of 8 weeks of treatment, negative cultures using Löwenstein-Jensen (LJ) medium occurred in 47/60 (78%) participants in the investigational arm vs. 43/51 (84%, p = 0.47) in the control arm; negative cultures using liquid medium occurred in 37/47 (79%) in the investigational arm vs. 27/41 (66%, p = 0.23) in the control arm. Time to stable culture conversion was shorter for the investigational arm vs. the control arm using liquid culture medium (p = 0.03), but there was no difference using LJ medium. Median rifapentine area under the concentration-time curve (AUC_0-24) was 313 mcg*h/mL, similar to recent studies of rifapentine dosed at 450–600 mg daily. Median moxifloxacin AUC_0-24 was 28.0 mcg*h/mL, much lower than in trials where rifapentine was given only intermittently with moxifloxacin. The proportion of participants discontinuing assigned treatment for reasons other than microbiological ineligibility was higher in the investigational arm vs. the control arm (11/62 [18%] vs. 3/59 [5%], p = 0.04) although the proportions of grade 3 or higher adverse events were similar (5/62 [8%] in the investigational arm vs. 6/59 [10%, p = 0.76] in the control arm).</p><p>Conclusion</p><p>For intensive phase daily tuberculosis treatment in combination with isoniazid and pyrazinamide, a regimen containing moxifloxacin plus low dose rifapentine was at least as bactericidal as the control regimen containing ethambutol plus standard dose rifampin.</p><p>Trial Registration</p><p><a href="http://www.ClinicalTrials.gov" target="_blank">www.ClinicalTrials.gov</a><a href="https://clinicaltrials.gov/ct2/show/NCT00728507?term=Dorman&rank=5" target="_blank">NCT00728507</a></p></div

Enrollment and disposition of study participants.

<p>Abbreviations: PMHZ, investigational regimen comprised of rifapentine/moxifloxacin/isoniazid/pyrazinamide; REHZ, control regimen comprised of rifampin/ethambutol/isoniazid/pyrazinamide; LJ, Löwenstein-Jensen culture; MGIT, Mycobacterial Growth Indicator Tube culture; MITT, modified intention-to-treat analysis population; PP, per-protocol analysis population; DST, drug susceptibility testing; Mtb, <i>Mycobacterium tuberculosis</i>.</p

Average rifapentine and moxifloxacin pharmacokinetic parameter estimates in the current study compared to other recent studies using rifapentine alone or given together with moxifloxacin.

<p>Abbreviations: AUC_0-24 = area under the concentration-time curve over 24 hours; C_max = maximum concentration; TBTC = Tuberculosis Trials Consortium.</p

Proportions of participants with negative cultures at completion of intensive phase treatment.

<p>Abbreviation: CI, confidence interval; MGIT, Mycobacterial Growth Indicator Tube.</p

Baseline characteristics of participants in the intention-to-treat analysis population.

<p>Abbreviations: AST, aspartate aminotransferase; IQR, inter-quartile range.</p