Fluticasone furoate/vilanterol once daily improves night-time awakenings in asthma patients with night symptoms: Post hoc analyses of three randomized controlled trials

Objective: Symptoms, including night-time awakenings, affect the quality of life of people with asthma. Fluticasone furoate/vilanterol (FF/VI) reduces exacerbations, improves lung function, and rescue-free and symptom-free 24-hour periods in patients with asthma. These post hoc analyses compared daytime and night-time symptoms in patients with asthma who received FF/VI, versus FF, fluticasone propionate (FP) or placebo.

Methods: Daytime and night-time symptoms were collected via electronic daily diary cards in three Phase III randomized studies of once-daily FF/VI in patients with uncontrolled asthma on inhaled corticosteroids (ICSs) ± long-acting beta₂ agonists (n = 609/1039/586).

Endpoints included change from baseline in symptom-free days and nights (analyzed by Analysis of Covariance, covariates: baseline, region, sex, age, and treatment), time for patients to achieve seven consecutive symptom-free nights (analyzed by Cox proportional hazards' model, covariates as above), and proportion of patients experiencing 100% symptom-free nights per week (analyzed by logistic regression, covariates: percentage of symptom-free nights, sex, age, and treatment).

Results: Improvements in symptom-free days and nights were generally observed for all treatments. More patients who received FF/VI experienced 100% symptom-free nights in the last week of the treatment period than patients who received ICS alone or placebo. FF/VI also reduced time to achieve seven consecutive symptom-free nights. Patients with at least one night of symptoms at baseline experienced an additional 2.7 and 2.0 symptom-free nights per week with FF/VI 100/25 µg, versus 1.9 and 1.7 with FF alone; similar findings were seen with FF/VI 200/25 µg.

Conclusions: Benefits in terms of symptom-free days and nights were observed for patients receiving FF/VI versus comparators in these post hoc analyses.     

Secondary Bone Grafting of Alveolar Clefts: A Surgical/Orthodontic Treatment Enabling a Non-prosthodontic Rehabilitation in Cleft Lip and Palate Patients

A procedure combining grafting of cancellous bone to the residual cleft of the primary palate with subsequent orthodontic movement of teeth into the former cleft area is described. The preliminary results from the first 80 patients (89 clefts) are presented. The age of the patients at the bone grafting ranged from 8 to 18 years, and the observation time from 17 to 44 months. The results have been assessed 1) on the basis of dental radiographs and 2) clinically, by the response of the grafted area to the orthodontic movement of adjacent teeth. In 69 clefts in which the cleft side canine had been brought into its final position at the time of evaluation, the height of the interal-veolar septum was assessed to be approximately normal in 38% and slightly less than normal in 44%. A septum of insufficient height (less than 3/4 of the normal) had formed in 5 clefts (7%). Even in these cases, the main objects of the operation were fulfilled: The maxillary segments were stabilized, the teeth adjacent to the cleft had better bone support, and the gap in the dental arch could be closed orthodontically in four of the five clefts. Failures, i.e. no continuous bone bridge across the alveolar cleft, were recorded in 8 instances (9%) of the total material. When failures were disregarded, the gap in the dental arch was closed orthodontically in 90%, while prosthodontic closure was deemed necessary in 10% of the cases. Optimal results were obtained when bone grafting was performed prior to the full eruption of the cleft side canine. In this situation, the known potential of an erupting tooth to induce alveolar bone generation proved to be of great advantage. By deliberately guiding the erupting canine through the grafted area close to the incisor, a nearly normal interalveolar septum was formed, and the gap in the dental arch was closed orthodontically in 23 out of 26 clefts. When fissural teeth were present, they were in most cases integrated in the dental arch. Approximate incisor symmetry could thus be obtained. In the remaining 20 clefts, the ipsilateral canine had not reached its final position at the time of evaluation, and the end results could not be assessed. However, bone formation in the defect was good in 19 of the 20 clefts, and a fully satisfactory result is expected in the majority of these cases. Further advantages were obtained by this procedure: 1) The maxillary segments were stabilized, particularly important in bilateral clefts in which the premaxilla was movable. 2) Oronasal fistulae were effectively closed and mucosal recesses eliminated. 3) The grafted bone provided support for the receded alar base, reducing the nasal asymmetry and improving the facial contour. 4) The postoperative orthodontic treatment could be brought to an end at approximately the same age as for patients with a non-cleft malocclusion. The only significant complication in this series was infection of the grafted area, causing loss of the bone grafts in two cases, and possibly contributing to the failure in some other patients. The experience gained with this treatment permits the conclusion that a full osseous and dental rehabilitation can be achieved in the great majority of patients with cleft lip and palate without any prosthodontic reconstructive work.     

Post‐partum haemorrhage and tranexamic acid: a global issue

Post‐partum haemorrhage (PPH) remains the major cause of maternal death worldwide, with the overwhelming majority of bleeding deaths occurring in low income countries. These bleeding deaths occur due to a complex network of biological and socioeconomic factors, including changes to haemostasis and fibrinolysis during pregnancy. Tranexamic acid (TxA) has been shown to reduce death in bleeding trauma patients safely and is effective in reducing bleeding in surgical patients, however its role in PPH has been less well established. We discuss the impact of the recently published World Maternal Antifibrinolytic (WOMAN) trial, which demonstrated a significant reduction in bleeding deaths (Risk ratio 0·81) in women with PPH who received intravenous TxA compared to those receiving placebo. There were no increases in post‐partum thrombotic rates in mothers or breast‐fed babies. This trial has shown that intravenous TxA can be used safely and effectively to treat PPH, and should be implemented widely to reduce death due to PPH. However, for the full benefit of TxA to be fully realised in resource‐constrained settings, the effectiveness of oral or topical administration and/or pre‐emptive dosing need to be investigated.     

Discovery of a novel fibrous tissue in the spinal pia mater by polarized light microscopy

It is very well known that spinal meninges are composed of three layers, dura, arachnoid and pia mater, and that the main components of pia mater are collagen and reticular fibers. However, the distribution of those fibers has not been extensively investigated but just described as a mesh of fibers. In this study, we detected novel structures, which are composed of unidirectionally arranged fibers, in a rat spinal pia mater by using a polarized light microscope. They were seen as three parallel lines, one of which ran along a posterior spinal vein and the rest two of which ran along a pair of posterior spinal arteries. Histological analysis including Masson’s trichrome, picrosirius-red staining, Gordon & Sweet’s staining and immunohistochemistry with anti-collagen type 1 and 3 antibodies uncovered that they are mainly composed of collagen fibers and some reticular fibers. In addition, a putative primo vessel was detected in the novel fibrous tissue, which was proven out to be different from a blood vessel. In conclusion, we report a newly detected fibrous structure in the spinal pia mater, which may contribute to provide tensile force to the spinal meninges and to harbor the primo vascular system inside.     

对国内外几种玻璃纤维根管桩的力学性能评价

目的比较国内外4种玻璃纤维根管桩材料的力学性能,为国产玻璃纤维桩的研究和临床运用提供理论依据。方法选取FIBIO GLASSFIBER POST 9支、MATCHPOST 10支、LuxaPost 10支及国产玻璃纤维桩9支,采用三点加载系统测定其弯曲强度及弹性模量,并进行比较和统计分析。结果弯曲强度除MATCHPOST组与LuxaPost组、LuxaPost组与国产桩组无统计学差异外,其他各组间均有统计学差异(P0.05)。弹性模量除MATCHPOST组与LuxaPost组无统计学差异外,其他各组间均有统计学差异(P0.05)。LuxaPost的弯曲强度最大,FIBIO GLASSFIBER POST的弹性模量最低,与牙本质的弹性模量最接近。结论试验采用的4种玻璃纤维桩材料均体现出良好的力学性能,达到临床使用标准。