scholarly journals Improvement of Presbyopia Using a Mixture of Traditional Chinese Herbal Medicines, Including Cassiae Semen, Wolfberry, and Dendrobium huoshanense

2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Chi-Ting Horng ◽  
Jui-Wen Ma ◽  
Po-Chuen Shieh
Keyword(s):  
Visual Acuity ◽  
Herbal Medicine ◽  
Dose Group ◽  
High Dose ◽  
Dependent Manner ◽  
Older Individuals ◽  
Herbal Drug ◽  
Near Vision ◽  
Dendrobium Huoshanense

Background. Presbyopia is a primary cause of a decline in near vision. In this study, we developed a new mixed herbal medicine to retard presbyopic progression and increase the amplitude of accommodation (AA), which is beneficial for near vision. Methods. A total of 400 participants between the ages of 45 and 70 years were recruited. We designed the mixed herbal drug to include Cassiae Semen (200 mg), wolfberry (200 mg), and Dendrobium huoshanense (DD) (40 mg) in one capsule. In experiment 1, the recruited subjects were directed to perform a push-up test to measure their AA; this was then converted to the additional diopters of reading glasses. In experiment 2, 240 subjects took three capsules daily for six months and then stopped medical therapy for a six-month follow-up. In experiment 3, 160 subjects were randomly categorized into four groups: a placebo group, low-dose group (LDG) (1 capsule daily), middle-dose group (MDG) (two capsules daily), and high-dose group (HDG) (three capsules daily). The 160 volunteers took different doses for six months and then stopped treatment, accompanied by another six-month follow-up. In experiments 2 and 3, the change in AA, uncorrected far visual acuity (UFVA), and uncorrected near visual acuity (UNVA) were recorded each month for one year. Results. In experiment 1, AA was found to decrease with age and a great deal of additional power was needed in older individuals. In experiment 2, the mean AA reached a maximum value of 2.1D ( P  < 0.05) after six months, while the UNVA improved by about two to three lines of a Jaeger chart in most of the subjects. At nine months, all the means decreased slightly to 2.0 D ( P  < 0.05). This meant that the mixed herbal medicine could still maintain AA for another three months because the herbal therapy was stopped at the seventh month. In experiment 3, the maximal AA was 2.8D, 2.9D, and 3.2D ( P  < 0.05) in the LDG, MDG, and HDG after six-month treatments, respectively. Experiment 3 showed that AA gain occurred in a dose-dependent manner; the higher the dose, the greater the AA value. Conclusion. Only two studies on the use of herbal drugs for presbyopia have been reported in PubMed. In our study, we found that taking a mixed herbal drug caused an excellent gain in AA. This is the first study to report that the characteristics of the new herbal regimen could retard and even ameliorate presbyopia.

scholarly journals Recombinant Human Thyrotropin-Stimulated Radioiodine Therapy in Patients with Multinodular Goiters: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 52 (12) ◽  
pp. 841-849
Author(s):  
Chunmei Xu ◽  
Ping Wang ◽  
Huikai Miao ◽  
Tianyue Xie ◽  
Xiaojun Zhou ◽  
...  
Keyword(s):  
Fixed Effects ◽  
Dose Group ◽  
Low Dose ◽  
Radioiodine Therapy ◽  
Meta Analysis ◽  
High Dose Group ◽  
High Dose ◽  
Fixed Effects Model ◽  
Recombinant Human Thyrotropin

AbstractA potential reduction of goiter volume (GV) of recombinant human thyrotropin (rhTSH) on multinodular goiters (MNG) was previously reported but controversial. Hence we conducted a meta-analysis to estimate the effect of rhTSH-stimulated radioiodine therapy in patients with MNG. PubMed, Cochrane, CNKI, VIP, and Wanfang databases were searched. Mean difference (MD) and odds ratios with 95% confidence intervals (95% CI) were derived by using an inverse variance random-effects model and fixed-effects model, respectively. Six studies (n=237) were involved in the analysis. For 12 months follow up, high dose (>0.1 mg) of rhTSH significantly reduced GV (MD=17.61; 95% CI=12.17 to 23.04; p<0.00001) compared with placebo. No effective pooled results of low dose of rhTSH (<0.1 mg) were applicable for only one study included. For 6 months follow up, the source of heterogeneity was determined by subgroup and sensitivity analysis. High dose group showed vast improvement in GV reduction (MD=16.62; 95% CI=1.34 to 31.90; p=0.03). The reduction of low dose group compared with placebo was inferior to high dose group. No available data were obtained to assess the influence of rhTSH after 36 months follow up for the only included study. Hypothyroidism incidence was higher for rhTSH group. No publication bias was seen. High dose of rhTSH treatment-stimulated radioactive 131I therapy after 6 months and 12 months follow up had a better effect in reducing GV, but with higher incidence of hypothyroidism. Owing to the limited methodological quality, more clinical researches are warranted in the future.

scholarly journals Neuroprotective Effects of OMO within the Hippocampus and Cortex in a D-Galactose and Aβ25–35-Induced Rat Model of Alzheimer’s Disease

2020 ◽  
Vol 2020 ◽  
pp. 1-14
Author(s):  
Shaodong Deng ◽  
Hongmei Lu ◽  
Honggang Chi ◽  
Ying Wang ◽  
Xiao Li ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Energy Metabolism ◽  
Dose Group ◽  
Control Group ◽  
High Dose ◽  
Antioxidant Enzyme Activities ◽  
Group Model ◽  
Dependent Manner ◽  
Expression Levels

Morinda officinalis F.C. How. (Rubiaceae) is a herbal medicine. It has been recorded that its oligosaccharides have neuroprotective properties. In order to understand the oligosaccharides extracted from Morinda officinalis (OMO), a systematic study was conducted to provide evidence that supports its use in neuroprotective therapies for Alzheimer’s disease (AD). AD rat models were prepared with D-galactose and Aβ25–35. The following groups were used in the present experiment: normal control group, sham-operated group, model group, Aricept group, OMO low-dose group, OMO medium-dose group, and OMO high-dose group. The effects on behavioral tests, antioxidant levels, energy metabolism, neurotransmitter levels, and AD-related proteins were detected with corresponding methodologies. AD rats administered with different doses of OMO all exhibited a significant (P<0.05) decrease in latency and an increase (P<0.05) in the ratio of swimming distance to total distance in a dose-dependent manner in the Morris water maze. There was a significant (P<0.05) increase in antioxidant enzyme activities (SOD, GSH-Px, and CAT), neurotransmitter levels (acetylcholine, γ-GABA, and NE and DA), energy metabolism (Na+/K+-ATPase), and relative synaptophysin (SYP) expression levels in AD rats administered with OMO. Furthermore, there was a significant (P<0.05) decrease in MDA levels and relative expression levels of APP, tau, and caspase-3 in AD rats with OMO. The present research suggests that OMO protects against D-galactose and Aβ25–35-induced neurodegeneration, which may provide a novel strategy for improving AD in clinic.

Efficacy of High-dose Steroids for Visual Acuity Improvement in Methanol-induced Toxic Optic Neuropathy

2019 ◽  
Vol 44 (2) ◽  
pp. 60
Author(s):  
Theresia Yinski ◽  
Syntia Nusanti
Keyword(s):  
Visual Acuity ◽  
Optic Neuropathy ◽  
Alcohol Intoxication ◽  
Age Distribution ◽  
Case Series ◽  
High Dose ◽  
Retrospective Case ◽  
Toxic Optic Neuropathy ◽  
Sudden Blindness

Introduction : Methanol-induced toxic optic neuropathy (TON) is defined as a visual impairment due to optic nerve damage by methanol poisoning. Not only is this disease entity underdiagnosed at times, this sudden blindness is also often diagnosed at a stage where recovery of vision is no longer possible. Materials and Methods : A literature search was conducted using PubMed, ClinicalKey, Google Scholar and ScienceDirect by combining the keywords ‘methanol’ or ‘methyl alcohol’, ‘intoxication’ or ‘poisoning’, ‘toxic optic neuropathy’, and ‘visual acuity’ with ‘high-dose steroid’. Results : The total amount of subjects in each article varied from 2 to 37, with mean age distribution of 26.34 to 55 years old, where most patients were male. The follow up duration varied from 1 week to 1 year. Four articles do not mention high-dose steroids treatment as therapy while the other four mention use of 1000 mg of intravenous methylprednisolone per day with divided doses of either 2x500 mg or 4x250 mg. Improvement percentages show 100% improvement in all studies that used high-dose steroids, while in the non-high-dose steroids studies the improvement percentages range from 33.33% to 90%. Summary : High-dose steroids are showing efficacy in improving visual acuity and reducing the inflammation in methanol-induced TON. The period of how fast the therapy takes effect is inconclusive, as the mean follow-up time differs widely per study. However, because most of the reviewed studies here are retrospective case series, a larger, more comprehensive study is required to acknowledge more of the efficacy profile.

Long Term Dose-Dependent Correction of Hemophilia A Dogs Using AAV-8 and AAV-9-Mediated FVIII Gene Transfer.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 999-999
Author(s):  
Denise E. Sabatino ◽  
Amy M. Lange ◽  
Melinda Mucci ◽  
Rita Sarkar ◽  
Aaron M. Dillow ◽  
...  
Keyword(s):  
Gene Transfer ◽  
Dose Group ◽  
Low Dose ◽  
Hemophilia A ◽  
Clotting Factor ◽  
High Dose ◽  
Functional Assay ◽  
Dependent Manner ◽  
Aav Vector ◽  
Dose Dependent

Abstract Hemophilia A (HA) is an X-linked bleeding disorder characterized by deficiency in clotting factor VIII (FVIII). Current treatment for hemophilia is protein replacement therapy while a gene-based therapy would provide continuous expression of even low levels of FVIII protein (&gt;1% of normal) that is likely to improve the disease phenotype. It is challenging to utilize an AAV-mediated gene transfer approach for the FVIII cDNA (4.4kb) since the AAV vector can only efficiently accommodate a &lt;5.3kb transgene cassette. The FVIII protein is composed of 2 chains -the heavy chain (HC) and the light chain (LC). FVIII undergoes proteolytic cleavage and processing of the 2 individual chains that form the active FVIII protein. In other studies in HA dogs (n=8), no dose-response and AAV serotype-dependent FVIII expression has been documented, which illustrates the difficulties in using a FVIII single-chain approach. We have utilized a 2-chain approach in which the 2.4kb LC cDNA is packaged in one AAV vector while the 2.5kb HC is packaged into a second AAV vector. Each construct contains a 695bp thyroxine-binding globulin gene promoter/enhancer fused to a 175bp intron along with a 263bp SV40 poly A signal. For this approach the LC and HC vectors packaged into either AAV8 or AAV9 were administered to HA dogs via the hepatic artery. Two male HA dogs received HC and LC in AAV8 and 2 male dogs received HC and LC in AAV9 at doses of 6x1012gc/vector/kg (low dose) or 1.25x1013gc/v/kg (high dose). At 150 days after vector infusion, the high dose group expressed FVIII at levels of 4.8% (AAV8) and 3% (AAV9) as detected by a functional assay (Coatest assay). FVIII remained stable for 797 days (AAV8) and &gt;200 days (AAV9) (the longest time points to date) without any evidence of antibody formation to the transgene. In the low dose group at 150 days, FVIII levels were 1.5% (AAV8) and 0.5% (AAV9) cFVIII activity and were maintained in a follow up period of &gt;150 days (AAV8) and &gt;700 days (AAV9) without formation of antibodies to FVIII. Thus, no major differences between AAV8 and AAV9 vectors were observed. The transgene product is also functional based on shortening of whole blood clotting time (baseline values &gt;50 min), in a dose-dependent manner, 10–15 min and 16–20 min for the high and low dose cohorts, respectively. Interestingly, high dose injection of AAV8 to 2 female HA dogs (1.25x1013 and 3x1013gc/v/kg) results in FVIII levels of 1–2%, which is consistent with data obtained in mice on the poor performance of AAV in mediating gene transfer to liver in female animals. Liver function tests and other blood chemistries were transiently elevated after the surgical procedure and were in normal limits within 4 days. Importantly, all dogs did not develop antibodies to FVIII. These findings suggest that FVIII chains efficiently assemble in vivo without increasing the protein immunogenicity. The 4 male dogs have remained asymptomatic with no spontaneous bleeds, whereas &gt;20 bleeding episodes were expected for this group since untreated dogs require 5.5 plasma infusions/year. These data demonstrate for the first time, dose-dependent sustained expression of functional cFVIII in HA dogs by AAV8 and AAV9 vectors without formation of antibodies to cFVIII.

Long-Term Follow-up and Analysis of Dose Groups with Ibrutinib in Relapsed Follicular Lymphoma

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2706-2706 ◽  
Author(s):  
Nathan Fowler ◽  
Thomas E Boyd ◽  
Jeff P. Sharman ◽  
Sonali M. Smith ◽  
Fong Clow ◽  
...  
Keyword(s):  
B Cell ◽  
Research Funding ◽  
Dose Group ◽  
Low Dose ◽  
Single Agent ◽  
High Dose Group ◽  
Fixed Dose ◽  
High Dose ◽  
Grade 3

Abstract Introduction: As outcomes in patients (pts) with relapsed/refractory (R/R) follicular lymphoma (FL) remain suboptimal, new, effective treatment options with a favorable safety profile are needed. Ibrutinib is a first-in-class, oral, covalent inhibitor of Bruton's tyrosine kinase (BTK), a key component of B-cell signaling involved in B-cell survival, proliferation and function. In lymphomas, ibrutinib is FDA-approved for treatment of mantle cell lymphoma in pts with ≥1 prior therapy. A phase 1 dose-escalation study with ibrutinib showed single-agent activity in pts with R/R B-cell malignancies (overall response rate [ORR] 60%; complete remission [CR] in 16%) including FL (Advani JCO 2013). In this trial, the 560 mg/day fixed dose was well tolerated and led to full BTK occupancy. We evaluated the efficacy, safety, and tolerability of single-agent ibrutinib by low- vs. high-dose groups with longer follow-up in pts with relapsed FL. Methods: Data were analyzed for pts with R/R FL (N=16) treated with oral ibrutinib in the phase I study (PCYC-04753), where pts received escalating doses of ibrutinib 1.25-12.5 mg/kg/day per cycle (1 cycle = 28 days + 7 days rest) or continuous doses of ibrutinib 8.3 mg/kg/day or 560 mg/day fixed dose (1 cycle = 35 days). Pts with stable disease or better, who received therapy for 6 months, continued ibrutinib at a fixed dose of 560 mg/day in the extension study (PCYC-1103) until progression or unacceptable toxicity. Pt data categories included low-dose (1.25 mg/kg/day, 2.5 mg/kg/day, or 5 mg/kg/day) or high-dose (8.3 mg/kg/day or 12.5 mg/kg/day) groups. Results: Eight pts each were categorized into low-dose and high-dose groups. Baseline characteristics were similar, but median treatment duration was longer for the high-dose group (Table; 12 vs. 4 months). Increased ORR (63% vs. 25%) and CR rates (38% vs. 0%) were observed in the high-dose compared with low-dose group (Table). Median duration of response (DOR) was longer in the high-dose group (12 vs. 3 months), as was median progression-free survival (PFS; 24 vs. 9 months). Median overall survival (OS) was not reached (NR) in either group. Grade ≥3 adverse events (AEs) occurred in 3 pts in each group. Common grade ≥3 AEs reported in ≥3 pts in the combined groups included (low-dose, high-dose) diarrhea (n=2, 6), fatigue (n=3, 4), nausea (n=2, 4), cough (n=3, 2), myalgia (n=1, 3), headache (n=0, 3), muscle spasms (n=1, 2), pruritus (n=0, 3), and rash (n=0, 3). Serious AEs occurred in 3 pts in the low-dose and 1 pt in the high-dose group. AEs leading to treatment discontinuation occurred in 2 pts in each group. No fatal AEs occurred. Among 4 pts (high-dose group) receiving ibrutinib beyond 1 year (range, 18 to 61 months), no unexpected or increased AEs were observed; 1 pt experienced 2 grade 3 AEs (non-cardiac chest pain and vomiting), both within 60 days from start of treatment and lasting 1 day. No other grade ≥3 AEs occurred among these 4 pts. Conclusions: Higher doses of single-agent ibrutinib were associated with increased response rates and prolonged PFS in pts with R/R FL. A higher dose was not associated with increased AEs or with cumulative toxicity during extended therapy. In the current analysis, pts with FL derived the most benefit from ibrutinib doses at 8.3 mg/kg/day or higher. A study testing single-agent ibrutinib at 560 mg/day in pts with R/R FL is ongoing (Bartlett Blood 2014) as is a phase 2 study evaluating ibrutinib 560 mg/day in chemoimmunotherapy refractory FL. Table 1. Patient Characteristics and Efficacy Low dose(n=8) High dose(n=8) Median age, yrs (range) Age ≥ 70 yrs, n (%) 57 (48-70)1 (13) 62.5 (41-71)1 (13) Median no. of prior therapies (range) 3 (1-4) 2 (1-5) Ann Arbor stage III/IV disease, n (%) 6 (75) 6 (75) FLIPI score, % (low / intermediate / high)* 25 / 38 / 38 13 / 38 / 50 Median treatment duration, months (range) 3.8 (0.5-11.1) 12.4 (0.2-61.5) ORR, n (%) CR, n (%) 2 (25)0 (0) 5 (63)3 (38) Median DOR, months (range) n=2; 3.4 (1.8-4.9) n=5; 12.3 (4.8-51.3) Median PFS, months (95% CI) 9.2 (0.5, 13.4) 23.7 (2.2, NE) 10-month PFS, % 35.7 70 Median OS, months (95% CI) NR NR 10-month OS, % 100 100 *FLIPI scores from baseline data. NE, not estimable Disclosures Off Label Use: single-agent ibrutinib therapy in patients with relapsed FL. Boyd:Celgene: Research Funding, Speakers Bureau; Genentech: Research Funding; US Oncology: Research Funding; GSK: Research Funding. Sharman:Gilead: Consultancy, Honoraria, Research Funding, Speakers Bureau; TG Therapeutics, Inc.: Research Funding; Janssen: Research Funding; Roche: Research Funding; Celgene Corporation: Consultancy, Research Funding; Pharmacyclics: Consultancy, Honoraria, Research Funding; Calistoga: Honoraria. Smith:Pharmacyclics: Consultancy; Celgene: Consultancy. Clow:Pharmacyclics LLC, an AbbVie Company: Employment. Chu:Pharmacyclics LLC, an AbbVie Company: Employment.

scholarly journals Bone turnover biomarkers in COPD patients randomized to either a regular or shortened course of corticosteroids: a substudy of the randomized controlled CORTICO-COP trial

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Pradeesh Sivapalan ◽  
Niklas R. Jørgensen ◽  
Alexander G. Mathioudakis ◽  
Josefin Eklöf ◽  
Therese Lapperre ◽  
...  
Keyword(s):  
Corticosteroid Therapy ◽  
Dose Group ◽  
Low Dose ◽  
Corticosteroid Treatment ◽  
High Dose ◽  
Short Term ◽  
Copd Patients ◽  
Dose Corticosteroid

Abstract Background Long-term treatment with corticosteroids causes loss of bone density, but the effects of using short-term high-dose systemic-corticosteroid therapy to treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to determine whether high-dose corticosteroid therapy affected bone turnover markers (BTMs) to a greater extent compared to low-dose corticosteroid therapy. Methods The CORTICO-COP trial (NCT02857842) showed that an eosinophil-guided corticosteroid intervention led to approximately 60% lower accumulated corticosteroid dose for hospitalized patients with AECOPD (low-dose group) compared with 5-day standard corticosteroid treatment (high-dose group). We compared the levels of BTMs C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 N-terminal propeptide (P1NP) in 318 participants during AECOPD and at 1- and 3-month follow-up visits. Results CTX decreased and P1NP increased significantly over time in both treatment groups. There were no significant differences between the groups at 1- or 3-months follow-up for P1NP. A significant drop in CTX was seen at 3 months (down Δ24% from the baseline, p = 0.017) for the high dose group. Conclusion Short-term, high-dose systemic corticosteroid treatment caused a rapid suppression of biomarkers of bone resorption. Corticosteroids did not suppress biomarkers of bone formation, regardless of patients receiving low or high doses of corticosteroids. This therapy was, therefore, harmless in terms of bone safety, in our prospective series of COPD patients. Trial registration ClinicalTrials.gov Identifier: NCT02857842. Submitted August 2nd, 2016.

High-dose (5000-μg) Intravitreal Ganciclovir Combined with Highly Active Antiretroviral Therapy for Cytomegalovirus Retinitis in HIV-Infected Patients in Venezuela

2005 ◽  
Vol 15 (5) ◽  
pp. 610-618 ◽  
Author(s):  
J.F. Arevalo ◽  
R.A. Garcia ◽  
A.J. Mendoza
Keyword(s):  
Visual Acuity ◽  
Highly Active Antiretroviral Therapy ◽  
Control Group ◽  
High Dose ◽  
Complete Regression ◽  
Cmv Retinitis ◽  
Highly Active ◽  
High Doses ◽  
Haart Therapy

Purpose To describe the use of high doses of intravitreal ganciclovir combined with highly active antiretroviral therapy (HAART) for the treatment of cytomegalovirus (CMV) retinitis in human immunodeficiency virus (HIV)-infected patients. Methods Thirteen HIV-infected patients (18 eyes) with active CMV retinitis (83.3% in zone 1 and 38.4% resistant) participated in this prospective interventional case series. Patients were treated with high dose intravitreal ganciclovir (5.0 mg/0.1 mL once a week) in combination with HAART therapy. Intravitreal injections were discontinued once CMV retinitis healed if there was a significant increase in CD4+ count (any increase of ≥50 cells/μL to levels over 100 cells/μL sustained for at least 3 months). Mean follow-up was 15.6 months. Main outcome measures included assessment of visual acuity and retinal inflammation (CMV retinitis activity). A matched historical control group of 20 eyes (15 patients) with CMV retinitis treated with systemic ganciclovir (intravenous [induction] and oral [maintenance]) was included. Results Complete regression of the retinitis was obtained with high doses of intravitreal ganciclovir in 88.8% of eyes (two patients died during follow-up) at a mean of 4.5 weeks (2 to 8 weeks). Visual acuity improved two or more lines in 61.1% of eyes. No ganciclovir retinal toxicity was identified. Three eyes presented CMV retinitis reactivation at a mean of 25.6 days after their last injection. Complications (33.3%) included retinal detachment (RD; 3 eyes), immune recovery uveitis (IRU; 2 eyes), and endophthalmitis (1 eye). In our control group complete regression of the retinitis was obtained in 100% of eyes at a mean of 4 weeks (3 to 7 weeks). However, 12 eyes (60%) presented with CMV retinitis relapse at a mean of 29 days (21 to 32 days) after initiating oral ganciclovir (maintenance). Complications included RD (7 eyes, 35%) and IRU (3 eyes, 15%). Severe neutropenia occurred in 2 patients (13%). Conclusions High doses of intravitreal ganciclovir (5.0 mg) once a week in combination with HAART therapy is effective to control CMV retinitis, and may be discontinued after CMV retinitis has healed if immune reconstitution with a significant increase in CD4+ count has occurred.

A 3-year follow-up study of a new corneal inlay: clinical results and outcomes

2019 ◽  
Vol 104 (5) ◽  
pp. 723-728 ◽  
Author(s):  
Sandra Maria Canelas Beer ◽  
Liliana Werner ◽  
Eliane Mayumi Nakano ◽  
Rodrigo T Santos ◽  
Flavio Hirai ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Anterior Segment ◽  
Optical Quality ◽  
Quality Analysis ◽  
Power Correction ◽  
Blurred Vision ◽  
Clinical Trial Registration ◽  
Near Vision ◽  
Corneal Inlay

PurposeHere, we report the results of a 3-year follow-up analysis of the outcomes of the Flexivue Microlens corneal inlay.PatientsNon-dominant eyes (n=31) of emmetropic presbyopic patients (spherical equivalent: −0.5 to 1.00 dioptre).MethodsA Flexivue Microlens corneal inlay was implanted after the creation of a 300 μm deep stromal pocket using a femtosecond laser. Patients were followed up according to a clinical protocol involving refraction, anterior segment imaging analysis (Oculyser), optical quality analysis (OPD-Scan), monocular binocular uncorrected and corrected visual acuity tests, contrast sensitivity measurements (photopic and mesopic), satisfaction questionnaire results and adverse event reporting.ResultsThirty patients were examined at the 3-year follow-up in this ongoing study. The mean uncorrected near visual acuity improved to Jaeger 1 in 76.9% of eyes treated with the inlays (vs 87.1% at the 1-year follow-up). All eyes improved four lines in all visits, except for four patients for whom the inlay was explanted. Patients reported that their near vision was good or excellent in 73.3% of cases (vs 90.3% in the first year). The UDVA remained stable over time. Three patients were explanted due to blurred vision for near-point and far-point distances. One patient developed a superficial corneal ulcer after 20 months. Two patients underwent cataract removal. Four patients underwent inlay exchange to increase near power correction.ConclusionsThe Presbia Flexivue Microlens provided presbyopia treatment by improving near vision. Manageable complications may occur over the long term.Clinical trial registration numberU1111-1185-5684 and 0310451200000550.

scholarly journals Pharmacokinetics and Tolerability of a Higher Rifampin Dose versus the Standard Dose in Pulmonary Tuberculosis Patients

2007 ◽  
Vol 51 (7) ◽  
pp. 2546-2551 ◽  
Author(s):  
Rovina Ruslami ◽  
Hanneke M. J. Nijland ◽  
Bachti Alisjahbana ◽  
Ida Parwati ◽  
Reinout van Crevel ◽  
...  
Keyword(s):  
Dose Group ◽  
Standard Dose ◽  
High Dose ◽  
Double Blind ◽  
Time Curve ◽  
Tb Treatment ◽  
Randomized Phase Ii ◽  
Proportional Increase ◽  
To Receive

ABSTRACT Rifampin is a key drug for tuberculosis (TB) treatment. The available data suggest that the currently applied 10-mg/kg of body weight dose of rifampin may be too low and that increasing the dose may shorten the treatment duration. A double-blind randomized phase II clinical trial was performed to investigate the effect of a higher dose of rifampin in terms of pharmacokinetics and tolerability. Fifty newly diagnosed adult Indonesian TB patients were randomized to receive a standard (450-mg, i.e., 10-mg/kg in Indonesian patients) or higher (600-mg) dose of rifampin in addition to other TB drugs. A full pharmacokinetic curve for rifampin, pyrazinamide, and ethambutol was recorded after 6 weeks of daily TB treatment. Tolerability was assessed during the 6-month treatment period. The geometric means of exposure to rifampin (area under the concentration-time curve from 0 to 24 h [AUC0-24]) were increased by 65% (P < 0.001) in the higher-dose group (79.7 mg·h/liter) compared to the standard-dose group (48.5 mg·h/liter). Maximum rifampin concentrations (C max) were 15.6 mg/liter versus 10.5 mg/liter (49% increase; P < 0.001). The percentage of patients for whom the rifampin C max was ≥8 mg/liter was 96% versus 79% (P = 0.094). The pharmacokinetics of pyrazinamide and ethambutol were similar in both groups. Mild (grade 1 or 2) hepatotoxicity was more common in the higher-dose group (46 versus 20%; P = 0.054), but no patient developed severe hepatotoxicity. Increasing the rifampin dose was associated with a more than dose-proportional increase in the mean AUC0-24 and C max of rifampin without affecting the incidence of serious adverse effects. Follow-up studies are warranted to assess whether high-dose rifampin may enable shortening of TB treatment.

scholarly journals A comparison of high versus low dose of exercise training in exercise-based cardiac rehabilitation: a randomized controlled trial with 12-months follow-up

2019 ◽  
Vol 34 (1) ◽  
pp. 69-81
Author(s):  
Annemette Krintel Petersen ◽  
Lisa Gregersen Oestergaard ◽  
Maurits van Tulder ◽  
Sussie Laustsen
Keyword(s):  
Randomized Controlled Trial ◽  
Muscle Strength ◽  
Exercise Training ◽  
Cardiac Rehabilitation ◽  
Dose Group ◽  
Low Dose ◽  
Controlled Trial ◽  
High Dose ◽  
Randomized Controlled

Objective: To assess if a higher dose of exercise training in exercise-based cardiac rehabilitation could affect improvements in aerobic capacity and muscle strength. Design: Assessor-blinded randomized controlled trial with 12-months follow-up. Setting: Aarhus University Hospital, Aarhus, Denmark. Subjects: A total of 164 cardiac patients referred to exercise-based cardiac rehabilitation were recruited. Interventions: Patients were randomized to 1-hour exercise sessions either three times weekly for 12 weeks (36 sessions, high-dose group) or twice weekly for 8 weeks (16 sessions, low-dose group). The same standardized exercise and intensity protocol including aerobic and muscle strength training was used in all participants. Main measures: Primary outcome was changes in VO2peak. Secondary outcomes were changes in maximal workload, muscle strength and power. Measures were obtained at baseline, after termination of the rehabilitation programme and at follow-up after 6 and 12 months. Results: After the end of intervention, statistically significant between-group differences were seen in favour of the high-dose group in all outcomes: VO2peak 2.6 (mL kg−1 min−1) (95% confidence interval (CI): 0.4–4.8), maximal workload 0.3 W kg−1 (95%CI: 0.02–0.5), isometric muscle strength 0.7 N m kg−1 (95%CI: 0.1–1.2) and muscle power 0.3 W kg−1 (95%CI: 0.04–0.6). After 12 months, a significant between-group difference only persisted in VO2peak and maximal workload. Conclusion: A higher dose of exercise training had a small effect on all outcomes at termination of intervention. A long-term effect persisted in VO2peak and maximal workload. Although the effect was small, it is an important finding because VO2peak is the most important predictor of all-cause mortality in cardiac patients.

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