The Gaseous Ozone Therapy as a Promising Antiseptic Adjuvant of Periodontal Treatment: A Randomized Controlled Clinical Trial

Background: the establishment of periodontitis is regulated by the primary etiological factor and several individual conditions including the immune response mechanism of the host and individual genetic factors. It results when the oral homeostasis is interrupted, and biological reactions favor the development and progression of periodontal tissues damage. Different strategies have been explored for reinforcing the therapeutic effect of non-surgical periodontal treatment of periodontal tissue damage. Gaseous ozone therapy has been recognized as a promising antiseptic adjuvant, because of its immunostimulating, antimicrobial, antihypoxic, and biosynthetic effects. Then, we hypothesized that the adjunct of gaseous ozone therapy to standard periodontal treatment may be leveraged to promote the tissue healing response. Methods: to test this hypothesis, we conducted a prospective randomized study comparing non-surgical periodontal treatment plus gaseous ozone therapy to standard therapy. A total of 90 healthy individuals with moderate or severe generalized periodontitis were involved in the study. The trial was conducted from September 2019 to October 2020. Forty-five patients were randomized to receive scaling and root-planning (SRP) used as conventional non-surgical periodontal therapy plus gaseous ozone therapy (GROUP A); forty-five were allocated to standard treatment (GROUP B). The endpoint was defined as the periodontal response rate after the application of the ozone therapy at 3 months and 6 months, defined as no longer meeting the criteria for active periodontitis. Statistical analysis was performed employing SPSS v.18 Chicago: SPSS Inc. Results: periodontal parameters differed significantly between patients treated with the two distinct procedures at 3 months (p ≤ 0.005); a statistically significant difference between groups was observed from baseline in the CAL (p ≤ 0.0001), PPD (p ≤ 0.0001) and BOP (p ≤ 0.0001) scores. Conclusions: The present study suggests that SRP combined with ozone therapy in the treatment of periodontitis revealed an improved outcome than SRP alone.

Prospective randomized study comparing outcome of myocardial protection with Del-Nido Cardioplegia versus Saint Thomas Cardioplegia in adult cardiac surgical patients

Objectives: To compare the effectiveness of Del-Nido cardioplegia as myocardial protective agent with Saint Thomas cardioplegia in adult cardiac surgical patients. Methods: This prospective randomized study was conducted in cardiac surgery department of Bahawal Victoria hospital Bahawalpur, from October 2020 to March 2021. Eighty adult patients who underwent primary Isolated coronary artery bypass grafting (CABG) or isolated Valve surgery requiring cardiopulmonary bypass were randomly divided into Del Nido (DN, n=40) and Saint Thomas (ST, n=40) groups. Data regarding operative and post-operative variables such as cardiopulmonary bypass (CPB) and aortic cross clamp (AXC) times, inotropic requirements, resumption of sinus rhythm, need for electrical defibrillation, post-operative CKMB, blood requirement and ICU stay were noted. Results: CPB and AXC times were statistically insignificantly different. Resumption of Sinus rhythm was seen significantly in more patients of DN group (95%) than in ST group (72.5%) [p-value 0.05]. Less patients of DN group (5%) were candidates of electrical defibrillation than ST group (17.5%) [p-value <0.001). Post- operative CKMB values were significantly lower in DN group as compared to ST group (30.5±22.6 IU vs 50.5±50.28 IU, p value.008). Blood transfusion was significantly lower in DN group; 50% versus 80% in ST group (p-value 0.005). Ventilation time was significantly less in DN group than ST group (165.95±48.09 minutes versus 165.95±48.09 minutes respectively, p-value 0.03). While ICU stay was also less in DN group; 5.2±0.8 days versus 6.05±1.6 days in ST group (p-value 0.003). Conclusion: Del-Nido cardioplegia is a reliable and better myocardial protective agent than Saint Thomas cardioplegia in adult cardiac surgical procedures. doi: https://doi.org/10.12669/pjms.38.3.4730 How to cite this:Rizvi MFA, Yousuf SMA, Younas A, Baig MAR. Prospective randomized study comparing outcome of myocardial protection with Del-Nido Cardioplegia versus Saint Thomas Cardioplegia in adult cardiac surgical patients. Pak J Med Sci. 2022;38(3):---------. doi: https://doi.org/10.12669/pjms.38.3.4730 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Ex-Press® Surgery Versus Trabeculectomy for Primary Open Angle Glaucoma with Low Preoperative Intraocular Pressure

Purpose: To compare surgical outcomes between Ex-PRESS® surgery (EXP) and trabeculectomy (Trab) for primary open angle glaucoma (POAG) with low preoperative intraocular pressure (IOP).Patients and Methods: This was a retrospective non-randomized study. We included POAG patients with preoperative IOP ≤16 mmHg who were taking tolerance glaucoma medications. We compared the surgical outcomes, postoperative IOP, number of glaucoma medications, reduction rate of corneal endothelial cell density (ECD), visual acuity, and postoperative complications between POAG patients who underwent EXP (34 eyes) or Trab (38 eyes) and could be followed for >2 years.Results: Both surgeries significantly decreased the IOP (p<0.001): at 2 years, EXP provided decreases from 13.4 ± 2.3 to 10.2 ± 3.1 mmHg, Trab provided decreases from 13.5 ± 2.0 to 8.9 ± 3.2 mmHg. No significant differences were observed in the postoperative IOP (p=0.076), number of postoperative medications (p=0.263), success rate (p=0.900), reduction rate of ECD (p=0.410), or difference in visual acuity (p=0.174). The reduction rate of IOP was significantly high in the Trab group (p=0.047).Conclusions: Both surgeries significantly decreased IOP and were useful surgical methods for low-IOP glaucoma. Our results suggest that trabeculectomy can decrease IOP more than Ex-PRESS surgery but might have more complications.

Clinical Study on the Efficacy and Safety of Arginine Administered Orally in Association with Other Active Ingredients for the Prevention and Treatment of Sarcopenia in Patients with COVID-19-Related Pneumonia, Hospitalized in a Sub-Intensive Care Unit

In order to evaluate the efficacy of oral supplementation with 3 g of arginine per day associated with creatine, L-carnitine, aspartic acid, magnesium, selenium and vitamins C and E (Argivit© Aesculapius Farmaceutici) in the prevention and treatment of sarcopenia in patients with COVID-19-related pneumonia, we conducted a parallel randomized study comparing it with standard therapy alone. Forty patients on standard therapy plus supplementation were compared with a control group of 40 patients, all hospitalized at the sub-intensive care unit of the Del Mare Hospital in Naples, with a clinical diagnosis of SARS-CoV-2 infection and COVID-19 pneumonia. Muscle strength was assessed with the handgrip test and muscle ultrasound. Arginine-supplemented patients had an average grip strength of 23.5 at the end of hospitalization compared with 22.5 in the untreated group with less reduction, showing statistical significance (p < 0.001). In the same way, the thickness of the vastus lateralis quadriceps femoris muscle measured at the end of hospitalization showed less reduction on ultrasound, with a higher average value in the group receiving treatment than in the group of patients without supplementation (p < 0.001). Upon discharge there was a 58.40% reduction in ventilation days in patients with arginine supplementation compared with the control group.

Comparison of Two Different Uses of Underbody Forced-air Warming Blankets for the Prevention of Hypothermia in Patients Undergoing Arthroscopic Shoulder Surgery: a Prospective Randomized Study

Background: Forced-air warming (FAW) is an effective method of preventing inadvertent perioperative hypothermia (IPH). However, its warming effects can be influenced by the style and position of the FAW blanket. This study aimed to compare the effects of underbody FAW blankets being placed under or over patients in preventing IPH.Methods: Patients (n=100) undergoing elective arthroscopic shoulder surgery in the lateral decubitus position were randomized into either under body (UB) group or the over body (OB) group (50 per group). The core body temperature (CBT) of the patients was recorded from baseline to the end of anesthesia. The incidences of postoperative hypothermia and shivering were also collected.Results: A steady decline in the CBT was observed in both groups up to 60 minutes after the start of FAW. After 60 minutes of warming, the OB group showed a gradual increase in the CBT. However, the CBT still decreased in UB group until 75 minutes, with a low of 35.7℃ ± 0.4℃. Then the CBT increased mildly and reached 35.8℃ ± 0.4℃ at 90 minutes. After 45 minutes of warming, the CBT was significantly different (P < 0.05). The incidence of postoperative hypothermia in the UB group was significantly higher than that in the OB group (P = 0.023).Conclusions: The CBT was significantly better when the underbody FAW blanket was placed over patients compared with under the patients. However, there was not a clinically significant difference in CBT. The incidence of postoperative hypothermia was much lower in the OB group. Therefore, placing underbody FAW blankets over patients is recommended for the prevention of IPH in patients undergoing arthroscopic shoulder surgery.Trial registration: This single-center, prospective, RCT has completed the registration of the Chinese Clinical Trial Center at 13/1/2021 with the registration number ChiCTR2100042071. It was conducted from 14/1/2021 to 30/10/2021 as a single, blinded trial in Sichuan Provincial Orthopedic Hospital.

Possibilities of combined hypolipidemic therapy in different categories of high and very high cardiovascular risk patients (a pilot study)

Aim of the study was to evaluate the efficacy and safety of the combined use of statins with ezetimibe in patients of various nosological groups of high and very high cardiovascular risk. Material and methods. A prospective interventional non-randomized study included 40 people, mean age 60.7±9.5 years, high and very high cardiovascular risk, who did not receive statin therapy or took statins without reaching the target low density lipoprotein (LDL) cholesterol values. Patients were recommended to receive high-intensity statin therapy in combination with ezetimibe for 3 months. Biochemical parameters were determined by standard enzymatic methods and the beginning of combined lipid-correcting therapy and after 3 months. Results. In patients with high cardiovascular risk, the level of total cholesterol decreased by 39.7 % 3 months after treatment (6.8 ± 2.5 and 4.7 ± 2.5 mmol/L; p = 0.0001), the level of LDL cholesterol by 52.2 % (4.6 ± 2.4 and 2.8 ± 2.2 mmol/L; p = 0.0001), the TG level by 26 % (2.7 ± 1.1 and 2.0 ± 1.0 mmol/L; p = 0.008). In the group of patients with very high cardiovascular risk, we also noted a decrease in the total cholesterol level by 39.1 % (6.4 ± 1.4 and 4.4 ± 1.2 mmol/L; p = 0.0001), the level of LDL cholesterol by 45.5 % (4.4 ± 1.4 and 2.5 ± 0.9 mmol/L; p = 0.0001). We did not find statistically significant changes in the remaining lipid parameters. LDL cholesterol targets were achieved in 64 % of patients with high and 52 % of very high cardiovascular risk. There were no significant changes in activity of alanine and aspartate amino transferases, content creatine phosphokinase, glucose and glycated hemoglobin, glomerular filtration rate. Conclusions. Initial combination therapy with statin and ezetimibe is well tolerated and can reduce LDL cholesterol levels by 2 times within 3 months in various categories of patients with high and very high cardiovascular risk.

Anti-PD-1 combined sorafenib versus anti-PD-1 alone in the treatment of advanced hepatocellular cell carcinoma: a propensity score-matching study

Background Vascular endothelial growth factor (VEGF) plays a role in the tumor microenvironment. Sorafenib, which inhibits the VEGF pathway, has an immune-modulation function but lacks substantial clinical data. This study aims to explore the efficacy of anti-PD-1 combined sorafenib in advanced hepatocellular carcinoma (HCC). Methods HCC patients who underwent anti-PD-1 treatment at Taipei Veterans General Hospital (Taipei, Taiwan) between January 2016 and February 2019 were reviewed. The efficacy was compared between groups after propensity-score matching. Results There were 173 HCC patients receiving anti-PD-1. After excluding unsuitable cases, 140 patients were analyzed, of which 58 received combination therapy and 82 received anti-PD-1 alone. The combination therapy had a trend of higher CR rate (8.6% vs. 4.9%, ns.), ORR (22.4% vs. 19.5%, ns.) and significantly higher DCR (69.0% vs. 37.8%, p < 0.05) comparing to anti-PD-1 alone. After matching, combination group achieved longer progression-free survival (3.87 vs. 2.43 months, p < 0.05) and overall survival (not reached vs. 7.17 months, p < 0.05) than anti-PD-1 alone, without higher grade 3/4 AE (10.3% vs. 7.1%, p = 0.73). The tumor response varied among different metastatic sites, with high responses in adrenal glands, peritoneum and lungs. The more AFP declined (> 10, > 50 and > 66%), the higher the ORR (70, 80 and 92%) and CR rates (30, 35 and 58%) were achieved at day 28. Conclusions This is the first study to demonstrate the combination of anti-PD-1 and sorafenib had better efficacy and survival benefit. A prospective randomized study is needed to confirm this finding.