scholarly journals Dose dependence of efficacy but not of safety in sublingual immunotherapy

2016 ◽  
Vol 65 (1) ◽  
Author(s):  
F. Frati ◽  
C. Incorvaia ◽  
F. Marcucci ◽  
L. Sensi ◽  
G. Di Cara ◽  
...  
Keyword(s):  
Sublingual Immunotherapy ◽  
Clinical Symptoms ◽  
Meta Analysis ◽  
Dose Dependence ◽  
Subcutaneous Immunotherapy ◽  
High Dose ◽  
Systemic Reactions ◽  
Significant Difference

Sublingual immunotherapy (SLIT) currently represents, as indicated by meta-analysis of its efficacy and safety, a valid option to the generally used traditional subcutaneous immunotherapy (SCIT) for treating respiratory allergy. Regarding efficacy, recent studies demonstrated that, similar to what has already been observed in SCIT as well as in experimental and clinical studies about the magnitudo of allergen exposure, the effectiveness on both clinical symptoms and immunologic changes depends on the amount of allergen administered during treatment. In addition, in vitro studies addressed with the role of dendritic cells, currently considered to be of pivotal importance in orienting toward tolerance the immune response to allergens, showed that the internalisation of allergen molecules, which is followed by tolerogenic presentation to T cells, depends on the amount of allergen. However, such dose dependence is not apparent concerning the safety. In fact, the comparison of studies respectively conducted with high and low allergen doses did not show differences in the rate of systemic reactions, which in any case never had the presentation of anaphylaxis, and instead a significant difference in the rate of local reactions, following the oral and gastrointestinal contact with the allergen extract, in favour of high dose studies.

scholarly journals Low-dose sublingual immunotherapy compared to subcutaneous immunotherapy and conventional therapy in childhood asthma

2016 ◽  
Vol 44 (6) ◽  
pp. 243
Author(s):  
Ariyanto Harsono
Keyword(s):  
Childhood Asthma ◽  
Low Dose ◽  
Sublingual Immunotherapy ◽  
Disease Onset ◽  
Ethics Committee ◽  
Subcutaneous Immunotherapy ◽  
Control Group ◽  
High Dose ◽  
Treat Ment ◽  
Group A

Background Evidence begin to accumulate that high-dose sub-lingual immunotherapy (SLIT) is as effective as subcutaneousimmunotherapy (SIT) in the treatment of childhood asthma.Since the capacity of sublingual area is similar whether the doseis high or low, the efficacy of low dose may be important to bestudied.Objective To investigate the efficacy of low-dose sublingual im-munotherapy in the treatment of childhood asthma.Methods Parents signed informed consent prior to enrollment,after having received information about the study. Patients weremoderate asthma aged 6-14 years with disease onset of lessthan 2 years before the commencement of the study and peakexpiratory flow rate (PEFR) variability of more than 15%. Pa-tients were randomly allocated into group A, B, and C whoreceived subcutaneous immunotherapy, low-dose sublingualimmunotherapy, and conventional asthma therapy, respectively.Randomization was stratified into two strata according to agei.e., 6-11 years or 11-14 years. Patients of each stratum wererandomized in block of three for each group. At the end of threemonths, lung function tests were repeated. The primary outcomewas PEFR variability at the end of the study. The study wasapproved by the Ethics Committee of Soetomo HospitalSurabaya.Results Distribution of variants as represented by sex, age,eosinophil count, and total IgE concentration were normal inthe three groups. PEFR variability decreased significantly from16.97+0.81 to 8.50+5.08 and 17.0+0.87 to 8.40+4.72 in groupreceiving SIT and SLIT, respectively (p<0.05), but decreasednot significantly from 17.00+0.83 to 10.82+0.5.41 in control group(p>0.05).Conclusion Low-dose SLIT is as efficacious as SIT in the treat-ment of moderate asthma in children

scholarly journals In vitro testing of explanted shunt valves in hydrocephalic patients with suspected valve malfunction

2021 ◽  
Author(s):  
Christoph Bettag ◽  
Christian von der Brelie ◽  
Florian Baptist Freimann ◽  
Ulrich-Wilhelm Thomale ◽  
Veit Rohde ◽  
...  
Keyword(s):  
Flow Rate ◽  
Clinical Symptoms ◽  
Obstructive Hydrocephalus ◽  
Flow Characteristics ◽  
Normal Pressure ◽  
Diagnostic Tools ◽  
Programmable Valve ◽  
Significant Difference ◽  
Valve Malfunction

AbstractDiagnosis of symptomatic valve malfunction in hydrocephalic patients treated with VP-Shunt (VPS) might be difficult. Clinical symptoms such as headache or nausea are nonspecific, hence cerebrospinal fluid (CSF) over- or underdrainage can only be suspected but not proven. Knowledge concerning valve malfunction is still limited. We aim to provide data on the flow characteristics of explanted shunt valves in patients with suspected valve malfunction. An in vitro shunt laboratory setup was used to analyze the explanted valves under conditions similar to those in an implanted VPS. The differential pressure (DP) of the valve was adjusted stepwise to 20, 10, 6, and 4 cmH2O. The flow rate of the explanted and the regular flow rate of an identical reference valve were evaluated at the respective DPs. Twelve valves of different types (Codman CertasPlus valve n = 3, Miethke Shuntassistant valve n = 4, Codman Hakim programmable valve n = 3, DP component of Miethke proGAV 2.0 valve n = 2) from eight hydrocephalic patients (four male), in whom valve malfunction was assumed between 2016 and 2017, were replaced with a new valve. Four patients suffered from idiopathic normal pressure (iNPH), three patients from malresorptive and one patient from obstructive hydrocephalus. Post-hoc analysis revealed a significant difference (p < 0.001) of the flow rate between each explanted valve and their corresponding reference valve, at each DP. In all patients, significant alterations of flow rates were demonstrated, verifying a valve malfunction, which could not be objectified by the diagnostic tools used in the clinical routine. In cases with obscure clinical VPS insufficiency, valve deficiency should be considered.

scholarly journals Gabapentin as an adjuvant therapy to splinting in carpal tunnel syndrome (CTS): a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Vol 56 (1) ◽  
Author(s):  
Ahmed M. Ahmed ◽  
Osama G. Hassan ◽  
Ahmed A. Khalifa
Keyword(s):  
Systematic Review ◽  
Carpal Tunnel Syndrome ◽  
Carpal Tunnel ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Pinch Strength ◽  
Symptom Severity Scale ◽  
Significant Difference ◽  
Tunnel Syndrome

Abstract Background Carpal tunnel syndrome (CTS) is a common upper limb entrapment neuropathy; severe cases are treated surgically and mild to moderate can be managed conservatively. The purpose of this systematic review and meta-analysis was to define the efficacy of gabapentin as an adjuvant to splinting in the treatment of mild to moderate CTS. Methods A systematic search through 13 databases, randomized clinical trials (RCTs) reporting the use of gabapentin with splinting in CTS were included and analyzed. Results Three RCTs including 170 patients were eligible. There was no significant difference between gabapentin plus splinting and splinting alone in 5 measured parameters: (1) Symptom Severity Scale (SSS) [MD (95% CI) = − 0.76 (− 2.46–0.93), p = 0.378], (2) Functional Status Scale (FSS) [MD (95% CI) = − 0.23 (− 1.40–0.94), p = 0.701], (3) visual analogue scale (VAS) to assess pain [MD (95% CI) = − 0.6 (− 1.47–0.27), p = 0.174], (4) Grip strength [MD (95% CI) = − 0.11 (− 0.70–0.48), p = 0.718], and (5) pinch strength [MD (95% CI) = 0.72 (− 0.10–1.54), p = 0.083]. Conclusion This review provides low-quality evidence that gabapentin plus nocturnal splinting is not superior to splinting alone. More high-quality trials are needed to determine the role of this drug as an adjuvant in the management of CTS.

Alternative Tendon Coaptations to the Pulvertaft Weave Technique: A Systematic Review and Meta-Analysis of Biomechanical Studies

Hand ◽  
2021 ◽  
pp. 155894472110432
Author(s):  
Emily M. Graham ◽  
Jeremie D. Oliver ◽  
Russell Hendrycks ◽  
Dino Maglic ◽  
Shaun D. Mendenhall
Keyword(s):  
Systematic Review ◽  
Yield Strength ◽  
Random Effects ◽  
Meta Analysis ◽  
Dichotomous Data ◽  
Inverse Variance ◽  
Significant Difference ◽  
Alternative Techniques ◽  
Meta Analyses

Background The Pulvertaft weave technique (PT) is frequently used during tendon repairs and transfers. However, this technique is associated with limitations. In this systematic review and meta-analysis, quantitative and qualitative analyses were performed on in vitro, biomechanical studies that compared the PT with alternative techniques. Methods Articles included for qualitative and/or qualitative analysis were identified following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies included in the meta-analysis were analyzed either as continuous data with inverse variance and random effects or as dichotomous data using a Mantel-Haenszel analysis assuming random effects to calculate an odds ratio. Results A comprehensive electronic search yielded 8 studies meeting inclusion criteria for meta-analysis. Two studies with a total of 65 tendon coaptations demonstrated no significant difference in strength between the PT and traditional side-to-side (STS) techniques ( P = .92). Two studies with a total of 43 tendon coaptations showed that the STS with 1 weave has a higher yield strength than the PT ( P = .03). Two studies with a total of 62 tendon repairs demonstrated no significant difference in strength between the PT and the step-cut (SC) techniques ( P = .70). The final 2 studies included 46 tendon repairs and demonstrated that the wrap around (WA) technique has a higher yield strength than the PT ( P < .001). Conclusions The STS, SC, and WA techniques are preferred for improving tendon form. The STS and WA techniques have superior yield strengths than the PT, and the SC technique withstands similar stress to failure as the PT.

scholarly journals Effectiveness of Valganciclovir 900mg Versus 450mg for Cytomegalovirus Prophylaxis in Renal Transplantation: A Systematic Review and Meta-Analysis

2017 ◽  
Vol 20 ◽  
pp. 168 ◽  
Author(s):  
Wang Xin ◽  
Yang Hui ◽  
Zhang Xiaodong ◽  
Cui Xiangli ◽  
Wang Shihui ◽  
...  
Keyword(s):  
Renal Transplantation ◽  
Acute Rejection ◽  
Low Dose ◽  
Opportunistic Infections ◽  
Meta Analysis ◽  
High Dose ◽  
Renal Transplant Recipients ◽  
Significant Difference ◽  
Allograft Loss ◽  
Cmv Disease

Objectives: Valganciclovir 900 mg/day is approved for cytomegalovirus (CMV) prophylaxis, but 450 mg/day is seems also effective. We systematically reviewed the efficacy and safety of low-dose versus high-dose valganciclovir prophylaxis in renal transplantation recipients. Methods: An electronic search was conducted up to November 29, 2016. The primary outcomes were incidences of CMV, CMV disease, mortality and opportunistic infection. The second outcomes were acute rejection, allograft loss, adverse drug reaction (ADR). Results: 7 cohort studies, all with high quality involving (1431 patients) were included. There was no significant difference of the incidence of following CMV disease (1271 patients, odds ratio [OR] 0.74, 95% confidence interval [CI], 0.38-1.43, p=0.36), acute rejection (1343 patients, OR 0.77, 95%CI 0.53-1.14, p=0.19), allograft loss (1271 patients, OR 0.64, 95%CI 0.31-1.35, p=0.24), mortality (1271 patients, OR 0.55, 95%CI 0.20-1.47, p=0.23) and opportunistic infections (OI) (985 patients, OR 0.76, 95%CI 0.52-1.10, p=0.14) between the low-dose and the high-dose valganciclovir  prophylaxis. And no significant difference was observed for premature valganciclovir discontinuation (1010 patients, OR 0.81, 95%CI 0.52-1.25, p=0.33) and the incidence of leukopenia (1082 patients, OR 0.65, 95%CI 0.34-1.22, p=0.18) between the two regimens. Conclusion: 450 mg and 900 mg doses of valganciclovir are equipotent for CMV universal prophylaxis. CMV 450 mg prophylaxis should be used for renal transplant recipients. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

scholarly journals Bond Strength of Self-Adhesive Flowable Composites and Glass Ionomer Cements to Primary Teeth: A Systematic Review and Meta-Analysis of In Vitro Studies

Materials ◽  
2021 ◽  
Vol 14 (21) ◽  
pp. 6694
Author(s):  
Flavia Iaculli ◽  
Alessandro Salucci ◽  
Gianni Di Giorgio ◽  
Valeria Luzzi ◽  
Gaetano Ierardo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Bond Strength ◽  
Primary Teeth ◽  
Meta Analysis ◽  
Deciduous Teeth ◽  
Glass Ionomer Cements ◽  
Glass Ionomer ◽  
Significant Difference ◽  
Flowable Composites

Background: Conventional composites are largely used in pediatric restorative dentistry and demonstrate successful clinical outcomes. However, the need for simplification of operative steps in young or uncooperative children demands reliable alternatives. Therefore, the aim of the present systematic review and meta-analysis was to evaluate the in vitro bond strength of glass ionomer cements (GICs) and self-adhesive flowable composites (SFCs) on deciduous teeth. Methods: A comprehensive literature search according to the PRISMA checklist was manually and electronically performed by two independent reviewers through the following databases: MEDLINE/PubMed, Google Scholar, Scopus, and Embase, to include in vitro studies comparing GICs and SFCs bond strength values of restorations on primary teeth. In addition, three groups of meta-analyses were conducted using random-effects models. Results: Three articles meeting the inclusion criteria were selected and subjected to both qualitative and quantitative assessment. No statistically significant difference was found between SFC versus GIC; however, both groups significantly differed with conventional flowable composites (CFs). Conclusions: Despite the absence of significant difference in bond strength values, SFCs may be considered a valid alternative to GICs in the restoration of deciduous teeth, although CFs proved better in vitro performances.

scholarly journals A Single Administration of AZP-3601, a Novel, Long-Acting PTH Analog, Induces a Significant and Sustained Calcemic Response: Preliminary Data From a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A254-A254
Author(s):  
Soraya Allas ◽  
Michel Ovize ◽  
Michael D Culler ◽  
Clarisse Geraul ◽  
Jeroen van de Wetering ◽  
...  
Keyword(s):  
Serum Calcium ◽  
Clinical Symptoms ◽  
Phase 1 ◽  
High Dose ◽  
Single Administration ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Healthy Humans ◽  
Dose Dependent

Abstract Hypoparathyroidism is a rare disease characterized by a deficiency in parathyroid hormone (PTH) that results in hypocalcemia and hyperphosphatemia. Current treatment approaches, including high dose oral calcium and active vitamin D, as well as recombinant human PTH (1–84), do not provide adequate or consistent control of either serum calcium or clinical symptoms over a full 24-hour period. AZP-3601 is a novel 36 amino-acid PTH analog that has been designed to potently bind to the R0 conformation of the PTH1 receptor, which results in prolonged signaling responses in vitro and prolonged calcemic responses in animals despite having a short circulating half-life. A Phase 1 double-blind, placebo-controlled, single and multiple ascending dose study is being conducted to evaluate the safety, tolerability and pharmacodynamics of AZP-3601 in healthy adults. Here we report data from the first cohorts of the single ascending dose portion of the study. Sequential cohorts of 4 (cohort 1) to 8 (cohort 2 to 4) healthy male subjects aged 18–60 years, with a body mass index of 19–28 kg/m2, were assigned to receive 5, 10, 20 or 40μg of AZP-3601 or placebo at a ratio of 3:1. The study drug was administered in the morning by subcutaneous injection in the abdominal wall and was well tolerated with no remarkable adverse events. As compared with placebo controls, AZP-3601 treatment produced a clear, dose-dependent increase in mean albumin-adjusted serum calcium values from baseline. The normal physiological diurnal variation of albumin-adjusted serum calcium was gradually attenuated with 5 and 10μg AZP-3601, and was completely eliminated with 20μg. With the dose of 40μg AZP-3601, mean albumin-adjusted serum calcium values were significantly increased but stayed within normal laboratory range and remained elevated through at least 24 hours post-administration. We observed a dose-dependent decrease in mean endogenous serum PTH that was significantly correlated with the concomitant increase in mean serum calcium. These data provide initial evidence of the pharmacodynamic effect of AZP-3601 in healthy humans characterized by a sustained calcemic response for at least 24 hours following a single administration.

scholarly journals Optimal dose of aripiprazole for augmentation therapy of antidepressant-refractory depression: preliminary findings based on a systematic review and dose–effect meta-analysis

2021 ◽  
pp. 1-8
Author(s):  
Yuki Furukawa ◽  
Tasnim Hamza ◽  
Andrea Cipriani ◽  
Toshi A. Furukawa ◽  
Georgia Salanti ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Dose Range ◽  
Drop Out ◽  
Dose Effect ◽  
High Dose ◽  
Optimal Dosage ◽  
Inadequate Response ◽  
Augmentation Therapy ◽  
Refractory Depression ◽  
Significant Difference

Background Aripiprazole augmentation is proven effective for antidepressant-refractory depression, but its licensed dose range is wide and optimal dosage remains unclear. Aims To find the optimal dosage of aripiprazole augmentation. Method Multiple electronic databases were searched (from inception to 16 February 2021) to identify all assessor-masked randomised controlled trials evaluating aripiprazole augmentation therapy in adults (≥18 years old, both genders) with major depressive disorder showing inadequate response to at least one antidepressant treatment. A random-effects, one-stage dose–effect meta-analysis with restricted cubic splines was conducted. Outcomes were efficacy (treatment response: ≥50% reduction in depression severity), tolerability (drop-out due to adverse effects) and acceptability (drop-out for any reason) after 8 weeks of treatment (range 4–12 weeks). Results Ten studies met the inclusion criteria. All were individually randomised, placebo-controlled, multi-centre, parallel studies including 2625 participants in total. The maximum target dose–efficacy curve showed an increase up to doses between 2 mg (odds ratio OR = 1.46, 95% CI 1.15–1.85) and 5 mg (OR = 1.93, 95% CI 1.33–2.81), and then a non-increasing trend through the higher licensed doses up to 20 mg (OR = 1.90, 95% CI 1.52–2.37). Tolerability showed a similar trend with greater uncertainty. Acceptability showed no significant difference through the examined dose range. Certainty of evidence was low to moderate. Conclusions Low-dose aripiprazole as augmentation treatment might achieve the optimal balance between efficacy, tolerability and acceptability in the acute treatment of antidepressant-refractory depression. However, the small number of included studies and the overall moderate to high risk of bias seriously compromise the reliability of the results. Further research is required to investigate the benefits of low versus high dose.

The correlation between serum Ca-125 level and clinical pregnancy in in vitro fertilization (IVF): A meta-analysis

2019 ◽  
Author(s):  
Xin-Lei Wang ◽  
Zhuo Li ◽  
Han Zhang ◽  
Ce Shi ◽  
Tong Tong ◽  
...  
Keyword(s):  
In Vitro Fertilization ◽  
Embryo Transfer ◽  
Meta Analysis ◽  
Clinical Pregnancy ◽  
Ca 125 ◽  
Vitro Fertilization ◽  
Time Period ◽  
Central Register ◽  
Significant Difference

Abstract Background Several studies had investigated the role of serum Ca-125 in clinical pregnancy of patients undergoing in vitro fertilization (IVF); however, their conclusions had been inconsistent. This study aimed to evaluate the correlation between serum Ca-125 level and clinical pregnancy in IVF.Methods We systematically review the studies in the databases of Mediline OvidSP, EMBASE OvidSP and Cochrane (CENTRAL Central Register of Controlled Trials). Studies on the correlation between serum Ca-125 level and clinical pregnancy in patients underging IVF with or without Intracytoplasmic sperm injection (ICSI) were considered. The pooled standardized mean difference (SMD) with 95% confidence intervals (CIs) was used in the analysis.Results Seven studies involving 558 patients were included. The meta-analysis showed that there was no significant difference in the serum Ca-125 level before embryo transfer (ET) between clinical pregnant group and nonpregnant group (SMD 0.72; 95% CI [0.01, 1.43], P = 0.05, I 2 = 88%), and the same conclusion was also reached in patients without endometriosis (SMD 0.31; 95% CI [-0.53, 1.16], P = 0.47, I 2 = 89%); However, after embryo transfer, the result showed that the Ca-125 level has a small but significantly increase in the clinical pregnant group than in the nonpregnant group (SMD 0.39; 95% CI [0.09, 0.69], P = 0.01, I 2 = 0%).Conclusions Berore ET, there was no significant correlation between serum Ca-125 level and clinical pregnancy in IVF; After ET, the Ca-125 level has a small but significantly increase in the clinical pregnant group than in the nonpregnant group, and it might reflect a successful interaction between the embryo and the endometrium in that time period.

Materials Sealing Preventing Biofilm Formation in Implant/Abutment Joints: Which Is the Most Effective? A Systematic Review and Meta-Analysis

2020 ◽  
Vol 46 (2) ◽  
pp. 163-171
Author(s):  
Cecília Alves de Sousa ◽  
Maria Beatriz Bello Taborda ◽  
Gustavo Antônio Correa Momesso ◽  
Eduardo Passos Rocha ◽  
Paulo Henrique dos Santos ◽  
...  
Keyword(s):  
Systematic Review ◽  
Biofilm Formation ◽  
Meta Analysis ◽  
Significance Level ◽  
Gutta Percha ◽  
Significant Difference ◽  
Physical Barriers ◽  
External Connection

The purpose of this systematic review was to evaluate the literature available for materials exhibiting the best efficacy in preventing biofilm formation in the interior of implants. We searched PubMed/MEDLINE, Scopus, and Cochrane databases. This review is registered with the PROSPERO database and followed the suitability of the PRISMA protocol. The initial search resulted in 326 articles from the databases. After they were read, 8 articles remained, and the inclusion and exclusion criteria were applied. Six of these 8 articles were classified as in vitro and 2 were classified as in situ. The regions of the implants evaluated ranged from the interface of the pieces to the occlusal upper access of the abutment. The implant connections evaluated the Morse taper, external connection, and internal connection. Meta-analysis of the quantitative data was performed at a significance level of .05. Cotton exhibited poor control of infiltration, even in combination with other materials. Isolated gutta-percha (GP) and polytetrafluoroethylene (PTFE) tape with composite resin (CR) or GP performed better as physical barriers. The best results for chemical barriers were observed by the application of 1% chlorhexidine gluconate (CG) gel, thymol varnish, and the deposition of Ag films onto the surface. The applied meta-analysis did not show a significant difference in comparison between the different types of implant connections (P &gt; .05). The application of CG and thymol varnish antimicrobials was effective in preventing biofilm formation and easy clinical execution; these could be used in combination with CR, GP, and PTFE.

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