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2022 ◽  
Vol 7 (4) ◽  
pp. 699-702
Sunil Ganekal ◽  
Syril Dorairaj ◽  
Varun Ganekal

To evaluate the effect of use of ringer lactate solution supplemented with heparin sodium in patients undergoing cataract surgery.In a prospective, double-blind, interventional study, 200 patients were included and were randomized to undergo cataract surgery using ringer lactate solution with or without 10 IU/ml heparin. All patients underwent phacoemulsification with hydrophobic acrylic foldable intraocular lens (IOL) implantation. The severity of anterior chamber inflammation and amount of pigment deposition of IOL was assessed by slit lamp biomicroscopy on day 1, 7, 28 and after 8 weeks postoperatively. Mean age in treatment and control group was 63.0± 11.5 years and 65.1±12.7 years respectively. A significant reduction in the severity of inflammatory cellular activity (p=0.001), flare (p=0.001) and pigment deposition on IOL (p=0.001) was noted on day 1 in the heparin treated group compared to the control group. However, no significant difference was observed in the amount of inflammatory activity as well as IOL pigment deposition beyond 1 week postoperatively. The inflammatory activity resolved almost completely in both the groups by the end of 8 weeks postoperatively. : Our study showed the beneficial effect of addition of heparin to irrigating solution during cataract surgery. Heparin treated eyes demonstrated a reduction in the early postoperative inflammation and IOL pigment deposition. The anti-inflammatory effect was observed in the early postoperative period.

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Xiaochen Yang ◽  
Lanping Liu ◽  
Xingjiang Xiong ◽  
Yun Zhang ◽  
Yongmei Liu ◽  

Abstract Introduction Hypertension is one of the most important risk factors for cardiovascular disease, and its control rates remain low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) could suppress ventricular hypertrophy and inflammatory responses, lower blood pressure, and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension. Methods and analysis This trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experimental group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is the change in 24-h average systolic and diastolic blood pressure. The secondary outcomes include heart rate variability, pharmacogenomic evaluation, improvement in TCM syndrome, and serum pro-inflammatory/anti-inflammatory cytokines between the two groups. The safety of medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0. Ethics and dissemination This study has been approved by the Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial, and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. Discussion We hypothesize that patients with low-to-medium-risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians. Trial registration Chinese Clinical Trial Registry ChiMCTR1900002876. Registered in November 2019

2022 ◽  
pp. 1-6
Min Kyoung Kang ◽  
Jae-Kwan Cha ◽  
Dae-il Chang ◽  
Hyun Young Kim ◽  
Jong-Won Chung ◽  

<b><i>Purpose:</i></b> The aim of this study is to investigate the effect of gradual dipyridamole titration and the incidence of dipyridamole-induced headache in patients with ischemic stroke or transient ischemic attack (TIA). <b><i>Methods:</i></b> A randomized, double-blind, double-placebo, parallel group, phase 4 clinical trial (KCT0005457) was conducted between July 1, 2019, and February 25, 2020, at 15 medical centers in South Korea. The study included patients aged &#x3e;19 years diagnosed with a noncardioembolic ischemic stroke or TIA within the previous 3 weeks. The participants were randomized 1:1:1 to receive Adinox® (aspirin 25 mg/dipyridamole 200 mg) and aspirin (100 mg) once daily for the first 2 weeks followed by Adinox® twice daily for 2 weeks (titration group), Adinox® twice daily for 4 weeks (standard group), and aspirin 100 mg once daily for 4 weeks (control group). The primary endpoint was incidence of headache over 4 weeks. The key secondary endpoint was mean cumulative headache. <b><i>Results:</i></b> Ninety-six patients were randomized into the titration (<i>n</i> = 31), standard (<i>n</i> = 32), and control (<i>n</i> = 33) groups. The titration and standard groups (74.1% vs. 74.2%, respectively) showed no difference in the primary endpoint. However, the mean cumulated headache was significantly lower in the titration group than in the standard group (0.31 ± 0.46 vs. 0.58 ± 0.51, <i>p</i> = 0.023). Further, adverse drug reactions were more common in the standard group than in the titration group (28.1% vs. 9.7%, respectively, <i>p</i> = 0.054), although not significantly different. <b><i>Conclusion:</i></b> The titration strategy was effective in lowering the incidence of cumulative dipyridamole-induced headache.

2022 ◽  
Vol 22 (1) ◽  
Reza Jouybar ◽  
Maryam Nemati ◽  
Naeimehossadat Asmarian

Abstract Objective We aimed to compare the effect of dexmedetomidine with remifentanil on hemodynamic stability, surgical field quality, and surgeon satisfaction during rhinoplasty. Methods and materials In this double-blind randomized controlled-trial, 60 participants scheduled for rhinoplasty at the Mother and Child Hospital, Shiraz, Iran, was randomely divided into the dexmedetomidine group (IV infusion of 1 μg/kg dexmedetomidine over 20 min before induction of anesthesia then 0.6 μg/kg/hr. dexmedetomidine from the time of induction until the end of the operation) or in the the remifentanil group (an infusion rate of 0.25 μg/kg/min from the time of anesthesia induction until the end of the operation). Bleeding volume, surgeon satisfaction, postoperative pain (visual analog scale (VAS)), Level of sedation (Richmond Agitation Sedation Scale (RASS)), Patient satisfaction, Vital signs & recovery, and the Aldrete Score (used to discharge the patients from recovery) were measured for all participants. Results The patients in the dexmedetomidine group had less bleeding (p = 0.047) and shorter time to return of respiration, extubation, and the postoperative recovery time (p < 0.001). The surgeon satisfaction was higher in the dexmedetomidine group (p < 0.001). Patient satisfaction was significantly different between the two groups (p < 0.001). VAS scores, intaking paracetamol, and RASS score were significantly lower in the remifentanil group (p < 0.001). SBP, DBP, MAP, and heart rate were lower in dexmedetomidine group. Conclusion Dexmedetomidine was associated with relatively stable hemodynamics, leading to decreased intraoperative bleeding, recovery time, and greater surgeon satisfaction and the level of consciousness in the recovery ward. However, painlessness and patient satisfaction were greater with the use of remifentanil. Trial registration IRCT20141009019470N112.

2022 ◽  
David Martín-Caro Álvarez ◽  
Diego Serrano-Muñoz ◽  
Juan José Fernández-Pérez ◽  
Julio Gómez-Soriano ◽  
Juan Avendaño-Coy

Abstract BackgroundFormer studies investigated the application, both transcutaneous and with implanted electrodes, of high frequency alternating currents (HFAC) in humans for blocking the peripheral nervous system. The present trial aimed to assess the effect of HFAC on motor response, somatosensory thresholds, and peripheral nerve conduction, when applied percutaneously with ultrasound-guided needles at frequencies of 10 kHz and 20 kHz in healthy volunteers. MethodsA parallel, placebo-controlled, double-blind, randomized clinical trial was conducted. Ultrasound-guided HFAC at 10 kHz and 20 kHz and sham stimulation were delivered to the median nerve of 60 healthy volunteers (n=20 per group) for 20 minutes. The main assessed variables were maximum isometric flexion strength (MFFS) of the index finger, myotonometry, pressure pain threshold (PPT), mechanical detection threshold (MDT), and antidromic sensory nerve action potential (SNAP). Measurements were recorded pre-intervention, during the intervention 15 minutes after its commencement, immediately post-intervention, and at 15 minutes post-intervention.ResultsA decrease in the MFFS was observed immediately post-intervention compared to baseline, both in the 10 kHz group [-8.5 %; 95% confidence interval (CI) -14.9 to -2.1] and the 20 kHz group (-12.0%; 95%CI -18.3 to -5.6). At 15 minutes post-intervention, the decrease in the MFFS was -9.5% (95%CI -17.3 to -1.8) and -11.5% (95%CI -9.3 to -3.8) in the 10 kHz and 20 kHz groups, respectively. No changes over time were found in the sham group. The between-group comparison of changes in MFFS showed a greater reduction of -10.8% (95%CI -19.8 to -1.8) immediately post-intervention in the 20 kHz compared to the sham stimulation group. Muscle tone increased over time in both the 10 kHz and 20 kHz groups, but not in the sham group. The intergroup comparison of myotonometry showed a superior effect in the 20 kHz (6.7%, 95%CI 0.5 to 12.9) versus the sham group. No significant changes were observed in the rest of the assessed variables. ConclusionsThe ultrasound-guided percutaneous stimulation applying 10 kHz and 20 kHz HFAC to the median nerve produced reversible reductions in strength and increases in muscle tone with no adverse effects.

2022 ◽  
Aurélia Bertholet-Thomas ◽  
Aurélie Portefaix ◽  
Sacha Flammier ◽  
Carole Dhelens ◽  
Fabien Subtil ◽  

Abstract BackgroundHypercalciuria is one of the most frequent metabolic disorders associated with nephrolithiasis and/or nephrocalcinosis possibly leading to chronic kidney disease (CKD) and bone complications in adults. Orphan diseases with different underlying primary pathophysiology share inappropriately increased 1,25(OH)2D levels and hypercalciuria, e.g., hypersensitivity to vitamin D and renal phosphate wasting. Their management is challenging, typically based on hyperhydration and dietary advice. The antifungal azoles are known to inhibit the 1α-hydroxylase and therefore decrease 1,25(OH)2D levels; they are commonly used, with well described pharmacokinetic and tolerability data. Fluconazole has been successfully reported to reduce calciuria in patients with CYP24A1 or SLC34A3 mutations, with no safety warnings. Thus, based on these case reports, we hypothesize that fluconazole is effective to decrease and normalize calciuria in patients with hypercalciuria and increased 1,25(OH)2D levels.MethodsThe FLUCOLITH trial is a prospective, interventional, randomized in parallel groups (1:1), placebo-controlled, double blind trial. A total of 60 patients (10-60years) with nephrolithiasis and/or nephrocalcinosis history, hypercalciuria (> 0.1 mmol/kg/d), increased 1,25(OH)2D levels (> 150 pmol/L) and 25-OH-D levels >20 nmol/L, will be included. Inclusions will be performed only from mid-September to the beginning of February to avoid bias due to sunlight-induced vitamin D synthesis. The primary endpoint will be the proportion of patients with normalization of 24-hour calciuria between baseline and 16 weeks, or with a relative decrease of at least 30% of 24-hour calciuria in patients who still display at W16 a 24-hour hypercalciuria. DiscussionThe current challenge is to propose an efficient treatment to patients with hypercalciuria and increased 1,25(OH)2D levels in order to prevent later complications and notably CKD that can ultimately lead to end-stage renal disease. Based on improvement of knowledge in phosphate/calcium metabolism, pathophysiology and genetics, the “off-label” use of fluconazole was recently reported to be useful in hypercalciuric patients with increased 1,25(OH)2D levels. Thus, the FLUCOLITH study is a unique opportunity to develop a new indication of a well-known and not expensive drug in orphan renal diseases, the ultimate objective being the secondary prevention of CKD worsening in these patients. Trial, ID: identifier: NCT04495608. Registered on July 23rd, 2020

2022 ◽  
Vol 2022 ◽  
pp. 1-13
Yaser Masoumi-Ardakani ◽  
Hamid Najafipour ◽  
Hamid Reza Nasri ◽  
Soheil Aminizadeh ◽  
Shirin Jafari ◽  

Objectives. Hypertension (HTN) is one of the most important risk factors for cardiovascular diseases. Despite advances in treatment and control of HTN, the prevalence of HTN is still increasing. MitoQ is a supplement that acts on mitochondria and attenuates reactive oxygen species (ROS), which plays an important role in cardiovascular health. miRNAs play an important role in the pathophysiology of HTN. We evaluated the effects of MitoQ supplementation and endurance training (ET), alone and in combination, on functional indices of the heart and serum levels of miR-126, miR-27a, antioxidants, and NO, in patients with HTN. Methods. In a double-blind randomized clinical trial, 52 male participants (age 40-55 years) were randomly divided into four groups ( n = 13 ) of placebo, MitoQ (20 mg/day, oral), ET (cycle ergometer, moderate intensity, 40-60% VO2 peak, heart rate 120-140 b/min, 45 min a day, three days/week for six weeks), and MitoQ+ET. Cardiac function indices were assessed by echocardiography before and after interventions. Results. Systolic blood pressure (SBP) significantly decreased in all intervention groups ( P < 0.001 ) while DBP ( P < 0.01 ) and LV hypertrophy ( P < 0.05 ) were significantly decreased only in the MitoQ+ET group. Serum levels of SOD, GPx, and NO and the level of miR-126 significantly increased in all treatment groups, while miR-27a reduced in the ET ( P < 0.05 ) and MitoQ+ET ( P < 0.01 ) groups. Conclusions. Compared to MitoQ and ET alone, their combination has more prominent improving effects on cardiac health and amelioration of BP in the patients with HTN. These effects are through miR-126 and miR-27a modulation and ameliorating mitochondrial ROS production.

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