Tag: pubmed

Ann Pharmacother. 2021 Jul 20:10600280211032982. doi: 10.1177/10600280211032982. Online ahead of print.

ABSTRACT

OBJECTIVE: The purpose of this article is to review the available trials that led to the Food and Drug Administration (FDA) approval of berotralstat, an oral kallikrein inhibitor, for the prevention of hereditary angioedema (HAE) attacks.

DATA SOURCES: PubMed and ClincalTrials.gov were searched using key term berotralstat to identify phase III clinical trials related to the FDA approval of berotralstat from April 2018 to May 2021.

STUDY SELECTION AND DATA EXTRACTION: Trials selected were those that influenced the FDA approval of berotralstat or provided novel information regarding the safety and efficacy of this therapy in the treatment of HAE.

DATA SYNTHESIS: Both APeX-2 and ApeX-J found clinically significant benefit with berotralstat 150 mg daily for reduction in HAE attacks when compared with placebo (1.31 vs 2.35, P < 0.001, and 1.11 vs 2.18, P < 0.001, attacks in the APeX-2 and APeX-J trials, respectively). APeX-2 also showed a statistically significant benefit for berotralstat 110 mg daily (1.65 vs 2.35 attacks [1.65 attacks, P = 0.024]).

RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: An advantage berotralstat has over the other approved therapies is that it is administered orally, which may garner patient preference because of ease of administration. Berotralstat has also shown a potential benefit in reducing the need for standard-of-care treatment for HAE attacks, which has not been studied with alternative agents.

CONCLUSIONS: Berotralstat 150 mg daily has been proven safe and effective in clinical studies and appears to be a viable oral alternative to parenteral medications currently used in HAE prophylaxis.

PMID:34282650 | DOI:10.1177/10600280211032982

J Acad Nutr Diet. 2021 Jul 16:S2212-2672(21)00372-5. doi: 10.1016/j.jand.2021.05.022. Online ahead of print.

ABSTRACT

BACKGROUND: Dietary pattern analysis considers the overall dietary intake and combinations of foods eaten. Valid and reproducible tools for determining dietary patterns are necessary to assess diet-disease relationships.

OBJECTIVE: This study evaluated the relative validity and reproducibility of the Researching Eating, Activity, and Cognitive Health (REACH) Study food frequency questionnaire (FFQ) specifically designed to identify dietary patterns in older adults.

DESIGN: A subset of participants from the REACH study completed two identical 109-item FFQs 1 month apart (FFQ1 and FFQ2) to assess reproducibility and a 4-day food record between FFQ administrations to assess relative validity. Foods from each dietary assessment tool were assigned to 57 food groups. Principal component analysis was applied to the food group consumption reported in each dietary assessment tool to derive dietary patterns.

PARTICIPANTS AND SETTING: Dietary data were collected (2018 and 2019) from a subset of the REACH study (n = 294, 37% men) aged 65 to 74 years, living in Auckland, New Zealand.

MAIN OUTCOME MEASURES: Daily intakes of 57 food groups and dietary patterns of older adults participating in REACH living in New Zealand.

STATISTICAL ANALYSIS: Agreement of dietary pattern loadings were assessed using Tucker’s congruence coefficient. Agreement of dietary pattern scores and food group intakes were assessed using Spearman correlation coefficients (acceptable correlation rho = 0.20 to 0.49), weighted kappa statistic (acceptable statistic κ_{w =} 0.20 to 0.60), and Bland-Altman analysis, including mean difference, limits of agreement, plots, and slope of bias.

RESULTS: Three similar dietary patterns were identified from each dietary assessment tool: Mediterranean style, Western, and prudent. Congruence coefficients between factor loadings ranged from 0.54 to 0.80. Correlations of dietary pattern scores ranged from 0.47 to 0.59 (reproducibility) and 0.33 to 0.43 (validity) (all P values < 0.001); weighted kappa scores from 0.40 to 0.48 (reproducibility) and 0.27 to 0.37 (validity); limits of agreement from ± 1.79 to ± 2.09 (reproducibility) and ± 2.09 to ± 2.27 (validity); a negative slope of bias was seen in the prudent pattern for reproducibility and validity (P < 0.001).

CONCLUSIONS: The REACH FFQ generated dietary patterns with acceptable reproducibility and relative validity and therefore can be used to examine associations between dietary patterns and health outcomes in older New Zealand adults.

PMID:34281811 | DOI:10.1016/j.jand.2021.05.022

Int Orthod. 2021 Jul 16:S1761-7227(21)00082-6. doi: 10.1016/j.ortho.2021.06.003. Online ahead of print.

ABSTRACT

BACKGROUND: Micro-osteoperforation (MOP), a minimally invasive technique for accelerating the rate of orthodontic tooth movement has been research extensively, but with varied clinical results.

OBJECTIVE: To compare the efficacy of one-time versus two-time micro-osteoperforation on the rate of maxillary canine retraction, its influence on anchorage loss, canine angulation and the levels of interleukin (IL-1β) in gingival crevicular fluid (GCF).

MATERIALS AND METHODS: The split-mouth study included 16 patients in which the left and right sides were randomly allocated to the control side (one-time MOP) and experimental side (two-time MOP). MOP was performed on both sides distal to the maxillary canines and canine retraction was carried out using NiTi closed coil springs (150gm) and direct anchorage with miniscrew implants. The second MOP was performed on experimental side one month after the first MOP. The rate of canine movement was assessed using 3D model superimposition over a period of six months. The type of tooth movement, anchorage loss and levels of IL-1β were also evaluated.

RESULTS: Sixteen patients (mean age, 17.87±3.34 years) were analysed for a rate of canine retraction, anchorage loss, and type of tooth movement, while 15 patients were analysed for IL-1β. The rate was significantly higher on two-time MOP side after two months (P<0.001). No statistical difference was found in anchorage loss and controlled tipping of canines was observed. The IL-1β levels immediately after 2^nd MOP were significantly higher than 1^st MOP (P<0.001).

CONCLUSION: The two-time intervention of MOP is more efficacious than one-time MOP in accelerating tooth movement.

PMID:34281788 | DOI:10.1016/j.ortho.2021.06.003

J Sex Med. 2021 Jul 16:S1743-6095(21)00529-4. doi: 10.1016/j.jsxm.2021.06.004. Online ahead of print.

ABSTRACT

BACKGROUND: Chemotherapeutics, one of the standard treatment options for cancer worldwide, have various adverse effects, including erectile dysfunction (ED).

AIM: To investigate erectile function in an animal model after administration of the anticancer agent oxaliplatin (L-OHP).

METHODS: Male Wistar/ST rats were divided into 2 groups: L-OHP rats (n = 21), which were intravenously administered L-OHP (4 mg/kg; twice a week for 4 weeks), and Control rats (n = 21), which were injected with the same volume of 5% glucose solution, using the same dosing schedule. At the end of the study period, erectile function was evaluated by measuring intracavernous pressure (ICP) and mean arterial pressure (MAP) after cavernous nerve stimulation (n = 9-10). Endothelial function was evaluated with an isometric tension study using corpus cavernosum strips (n = 11). Western blot analysis was used to assess neuronal nitric oxide (nNOS) and endothelial NO synthase (eNOS) protein levels (n = 7). Real-time quantitative polymerase chain reaction (qRT-PCR) was used to assess the expression of inflammation- and oxidative stress-related markers (nicotinamide adenine dinucleotide phosphate oxidase-1, p22^phox, interleukin [IL]-6, and nuclear factor-kappa B) (n = 6). Statistical significance was determined using the Student’s t-test.

OUTCOMES: The L-OHP group had a significantly lower ICP:MAP ratio than the control group (P < .05). Compared to the Control group, the L-OHP group exhibited significantly lower responses to ACh and eNOS protein levels and significantly higher inflammatory biomarker levels.

CLINICAL TRANSLATION: The results based on this animal model indicate that use of the anticancer agent L-OHP should be considered as a risk factor for ED occurring via reduction of NO bioavailability in humans; our results provide possible treatment strategies for maintaining the erectile function of cancer survivors.

STRENGTHS AND LIMITATIONS: Our study showed that the anticancer agent L-OHP has the propensity to cause ED in rats. A major limitation of this study is the lack of an established cure for ED associated with L-OHP and the lack of clinical evidence.

CONCLUSIONS: L-OHP causes ED in rats via reduction of NO bioavailability caused by endothelial dysfunction. Kataoka T, Mori T, Suzuki J, et al. Oxaliplatin, an Anticancer Agent, Causes Erectile Dysfunction in Rats due to Endothelial Dysfunction. J Sex Med 2021;XX:XXX-XXX.

PMID:34281797 | DOI:10.1016/j.jsxm.2021.06.004

Clin Lung Cancer. 2021 Jun 24:S1525-7304(21)00158-3. doi: 10.1016/j.cllc.2021.06.007. Online ahead of print.

ABSTRACT

BACKGROUND: Video-assisted thoracic surgery (VATS) has been widely used in the surgical treatment of thoracic diseases, and it suggested surgical and oncological advantages compared with open surgery. However, reports on the application of VATS in surgery of small cell lung cancer (SCLC) are scarce. This study aimed to explore the advantages and disadvantages of different surgical approaches in the treatment of pathological stage T1(pT1) SCLC in terms of safety, clinical outcomes, and lymph node dissection.

PATIENTS AND METHODS: Patients who underwent lobectomy for pT1 SCLC between January 2014 and September 2017 were identified from the National Collaborative Lung Cancer Database (LinkDoc Database). The patients were stratified based on the surgery approach (VATS or open lobectomy). Perioperative outcomes and long-term survival were analyzed using SPSS software.

RESULTS: A total of 169 patients with pT1 SCLC met the criteria and were enrolled for this study, including 110 cases of VATS lobectomies and 59 cases of open lobectomies. VATS lobectomy was associated with less blood loss than open surgery (168.1 ± 237.4 vs. 340.0 ± 509.8 mL, P = .002). Open lobectomy harvested more N2 LNs (11.8 ± 8.2 vs. 8.4 ± 5.8, P = .048) and identified more metastasis positive LNs (3.1 ± 6.0 vs. 1.4 ± 3.0, P = .050). Open lobectomy associated with longer overall survival (OS) but has no statistical difference (23.4 ± 13.2 vs. 20.2 ± 10.9, P = .070).

CONCLUSION: Open lobectomy had better lymph node dissection results, and comparable postoperative complications, postoperative hospital stay, and OS to VATS lobectomy. Further studies may still be needed to confirm the recommendation of thoracoscopic approach as a routine surgical procedure for operable SCLC, and until then, open surgery should still be considered.

PMID:34281774 | DOI:10.1016/j.cllc.2021.06.007

Chin J Traumatol. 2021 May 21:S1008-1275(21)00086-9. doi: 10.1016/j.cjtee.2021.05.002. Online ahead of print.

ABSTRACT

PURPOSE: The use of tourniquet in orthopedic surgeries facilitates operations by establishing a bloodless surgical field. However, many complications following the use of tourniquets have been reported. Tourniquet pain is the most common complication. This study aimed to find the actual incidence of pain associated with tourniquet use in orthopedic surgery and the various factors.

METHODS: It is a prospective observational study conducted on 132 consecutive cases. Patients aged between 18 and 70 years with musculoskeletal problems of the forearm and leg requiring surgery were included in the study. Patients with open injuries or contraindications such as diabetes mellitus, compromised circulatory states, neurological deficit, compartment syndrome and unable to give informed consent were excluded. The parameters assessed included duration of tourniquet use, tourniquet pressure, type of anesthesia, any interval release of the tourniquet and reapplication after a reperfusion period, whether upper or lower limb surgery, severity of tourniquet pain, timing of tourniquet release and complications. Chi-square and non-parametric Mann-Whitney U test were used for data analysis.

RESULTS: In upper limb surgeries, if duration of surgery was less than 60 min, 14 (51.8%) cases experienced tourniquet pain and 13 (48.1%) had no pain, and if duration of surgery was more than 60 min, 24 (60.0%) had pain and 16 (40.0%) experienced no pain. In lower limb surgeries if duration of surgery was less than 60 min, 2 (7.7%) experienced pain and 24 (92.3%) had no pain, and if duration of surgery was more than 60 min, 14 (35.8%) experienced pain and 25 (64.8%) had no pain. Degree of tourniquet pain increases with increase in the duration of surgery. Statistically there was significant association between tourniquet inflation time and tourniquet pain in both upper and lower limbs (p = 0.034 and 0.024, respectively) CONCLUSION: Incidence of tourniquet pain was in direct proportion to the duration of tourniquet use and was higher in cases with regional anesthesia. Other risk factors assessed including tourniquet pressure, upper or lower limb surgery, tourniquet release time and interval had no significant contribution to the incidence or severity of tourniquet pain.

PMID:34281783 | DOI:10.1016/j.cjtee.2021.05.002

J Voice. 2021 Jul 16:S0892-1997(21)00197-1. doi: 10.1016/j.jvoice.2021.06.010. Online ahead of print.

ABSTRACT

OBJECTIVE: To analyze and compare cepstral measurements in singing and non-singing men and women to understand if vocal adaptations of singers reflect greater cepstral measurement results.

METHOD: The study included 91 vocally healthy individuals, consisting of 60 erudite or popular singers (30 males, 30 females) and 31 non-singers (16 males, 15 females). The Cepstral Peak Prominence (CPP) and Cepstral Peak Prominence-Smoothed (CPPS) measures were carried out using the sustained /a/ vowel recorded with a unidirectional condenser microphone associated with a sound card on the computer. The Praat software (version 6.1.16) was used to extract the CPP and CPPS measurements. The intra and intergroup values obtained for each sex were compared using the t-test with a 5% significance level.

RESULTS: There was a CPP (P = 0,000) and CPPS (P = 0,000 and P = 0,001) value difference between the sexes in both groups. Cepstral measurements showed no statistically significant difference between singing and non-singing participants (male: P = 0,778 and P = 0,622; female: P = 0,622 and P = 0,460).

CONCLUSION: Men presented higher CPP and CPPS values than women, which may be related to the presence of the physiological posterior glottic cleft in women. The knowledge of the cepstral values of singers shows that singing specificities may not reflect in all vocal evaluations.

PMID:34281752 | DOI:10.1016/j.jvoice.2021.06.010

J Fr Ophtalmol. 2021 Jul 16:S0181-5512(21)00329-6. doi: 10.1016/j.jfo.2021.01.025. Online ahead of print.

ABSTRACT

INTRODUCTION: The goal of our study was to create a cross-cultural adaptation of the questionnaire « National Eye Institute Visual Function Questionnaire » (NEI-VFQ-25) for the Tunisian population (Tu-VFQ-25) and to test its psychometric properties in a group of patients with chronic uveitis.

PATIENTS AND METHODS: The study consisted of two steps. The first was translation of the NEI-VFQ-25 and its cross-cultural adaptation to the Tunisian dialect (Tu-VFQ-25) according to the guidelines of Beaton et al. The second step consisted of studying the psychometric properties of the Tu-VFQ-25. Enrolled patients, diagnosed with chronic uveitis, were interviewed face-to-face by two different investigators, followed by a telephone interview by the first investigator 48hours later. Feasibility, internal consistency and reproducibility of the Tu-VFQ-25 were then tested using statistical methods.

RESULTS: The mean time taken to administrate the questionnaire to each of the 45 patients was 11min 40 s (± 2min 24 s). Internal consistency was acceptable, with Cronbach’s alpha coefficients above 0.7 except the “Ocular Pain” and “Driving” subscales (0.645 and 0.559 respectively). Inter-observer reliability was excellent, with intra-class correlation coefficients (ICC) ranging from 0.857 to 0.985 for all subscales. Test-retest reliability, assessed for 43 patients, was good to excellent, with ICC above 0.80 for all subscales except “General Vision,” which had a value of 0.786.

CONCLUSION: As with previous versions, the Tu-VFQ-25 is an easy and reliable tool for assessing vision-related quality of life of Tunisian patients with chronic uveitis.

PMID:34281759 | DOI:10.1016/j.jfo.2021.01.025

Cont Lens Anterior Eye. 2021 Jul 16:101489. doi: 10.1016/j.clae.2021.101489. Online ahead of print.

ABSTRACT

PURPOSE: To investigate the ocular subclinical inflammatory response in two soft contact lens materials when used in combination with two different care systems (‘solutions’).

METHODS: Fifteen established soft contact lens wearers wore each of two lenses: Acuvue® 2 (CH) and Acuvue® Oasys® (SiH) or no lenses in random sequence for one week. Two care systems were used: a peroxide system: Oxysept 1 Step® (P) for the right lens and Opti-Free® Replenish® (MPS) for the left lens. After one week of lens/no lens wear, in vivo confocal microscopy (IVCM) of corneal and conjunctival regions was carried out. Density of presumed dendritic cells (DC) and ‘white spots’ (WS) were quantified. Impression cytology of the bulbar and upper eyelid margin conjunctivae was carried out and samples were analysed for CD45+, CD3+ and CD11c+ cells.

RESULTS: The SiH + MPS combination showed a greater inflammatory response compared to SiH + P in seven out of 12 parameters investigated (p < 0.05). The remaining five were not statistically different between the two solutions. The converse was found for the CH lens, with four of the 12 parameters showing a greater response with the P solution compared to the MPS (p < 0.05).

CONCLUSION: This study suggests that the SiH lens investigated demonstrated an upregulated response when used with a MPS compared to a P solution whereas the converse is true for the CH lens which showed a reduced response when used with a MPS compared to a P solution. This finding aids in the understanding of the biological underpinnings of manifest corneal inflammatory events during contact lens wear.

PMID:34281726 | DOI:10.1016/j.clae.2021.101489

J Formos Med Assoc. 2021 Jul 16:S0929-6646(21)00311-9. doi: 10.1016/j.jfma.2021.06.030. Online ahead of print.

ABSTRACT

BACKGROUND/PURPOSE: In this study we aimed to investigate the prevalence of abnormal nasality in patients with unilateral rhinosinusitis and their nasality outcomes following functional endoscopic sinus surgery (FESS).

METHODS: A total of 42 patients with unilateral chronic rhinosinusitis who underwent unilateral FESS between April 2016 and November 2017 were enrolled. Questionnaires on sinonasal symptoms and nasality were recorded. The change in the nasalance score of vowels [a], [i] [u], nasal consonant [m], 2 nasal syllable repetitions, and 2 Chinese sentences were measured. The patients were evaluated preoperatively, 6 months, and 12 months after the operation. The patients were divided into two groups, wide opening surgery and limited surgery, according to the severity of the disease.

RESULTS: Among 42 patients, the subjective reports showed that one-third of unilateral chronic rhinosinusitis (CRS) patients had abnormal nasality preoperatively and significant improvement following FESS. The Lund-Mackay score was significantly negatively correlated with preoperative nasalance of [i] and positively correlated with change of nasalance of [i]. The increase in the value of [i] is statistically significant (p = 0.01) following FESS. In the further subgroup analysis, the change in nasalance was significant in the wide opening surgery group, but not in the limited surgery group.

CONCLUSION: Although only one side of the nasal airway was involved, one-third of the patients reported abnormal nasality. In patients with more disease severity who underwent wide opening surgery, the nasalance significantly increased 1 year after FESS. The increase in the objective nasalance score was corresponded to a significant improvement of subjective self-reported nasality assessment postoperatively.

PMID:34281727 | DOI:10.1016/j.jfma.2021.06.030