scholarly journals Evaluation of the efficiency and safety of combined therapy with a symptomatic sustained-release drug and hyaluronic acid versus monotherapy with hyaluronic acid in patients with knee osteoarthritis

2020 ◽  
Vol 14 (3) ◽  
pp. 63-70
Author(s):  
K. A. Berdyugin ◽  
I. V. Kadyntsev ◽  
O. V. Berdyugina ◽  
E. A. Taskina ◽  
N. G. Kashevarova

Osteoarthritis (OA) is the most common joint disease. Searching for new treatment methods and regimens for OA is relevant.Objective: to evaluate the efficiency and safety of therapy with a symptomatic sustained-release drug (Alflutop) in combination with intra-articular hyaluronic acid (HA) injection versus monotherapy with HA in patients with knee OA in routine clinical practice.Patients and methods. A post-registration open-labeled prospective comparative randomized study was conducted to assess the results of treatment in 76 patients (31 men and 45 women; mean age, 49.3±8.5 years; body mass index, 28.4±0.8 kg/m2 ) in two clinical centers in Yekaterinburg and Perm. The patients were randomized into two equal groups, were homogeneous in terms of gender, the frequency of comorbidities, and vital signs (blood pressure, heart rate, and respiratory rate).Group 1 patients received Alflutop as 1-ml daily intramuscular injections (a total of 20 injections) + 2 ml of 1% intraarticular (IA) HA solution injections three times at 1-week intervals; Group 2 patients were given 2 ml of 1% intraarticular HA solution injections three times at 1-week intervals. As an additional therapy, the use of meloxicam 7.5–15 mg/day was permitted, and, if non-steroidal anti-inflammatory drugs were contraindicated, paracetamol 1–3 g/day might be used.Results and discussion. During treatment, both groups of patients showed improvement (compared to the baseline levels). At the same time, evaluating the intergroup values revealed clear differences: a more pronounced decrease in all WOMAC indicators in Group 1 patients: pain scores, 2 [1; 3] vs. 4 [2; 5] in Group 2 (p<0.001); stiffness, 1 [0; 2] vs. 2 [1; 4] (p<0.001); functional insufficiency, 8 [3; 12] vs. 15.5 [12; 20] (p<0.001); and total WOMAC scores, 12 [7; 13] vs. 21.5 [15; 28] (p<0.001). Pain-intensity assessment using the visual analogue scale also showed the more pronounced positive effect of the combination therapy in Group 1 (p<0.001).Alflutop used in combination with HA was shown to be more preferable than HA monotherapy, which was confirmed by the results achieved for all WOMAC indicators. At 6 months, by the last visit, there were pronounced positive changes in all the analyzed parameters in both groups. At the same time, the most significant changes were recorded in the Alflutop + HA group than in the HA group (p<0.001). Perhaps, the mechanism in exhibiting the found synergistic effect of these drugs lies in their different effect on the pathogenesis of the disease. However, further study of this issue is required in multicenter randomized controlled trials.The good safety of the drugs was confirmed: not a single adverse event was revealed.Conclusion. The patients receiving the combination therapy with Alflutop + HA had the best treatment results in all the parameters assessed.

2020 ◽  
pp. 75-80
Author(s):  
S.A. Lyalkin ◽  
◽  
L.A. Syvak ◽  
N.O. Verevkina ◽  
◽  
...  

The objective: was to evaluate the efficacy of the first line chemotherapy in patients with metastatic triple negative breast cancer (TNBC). Materials and methods. Open randomized study was performed including 122 patients with metastatic TNBC. The efficacy and safety of the first line chemotherapy of regimens АТ (n=59) – group 1, patients received doxorubicine 60 мг/м2 and paclitaxel 175 мг/м2 and ТР (n=63) – group 2, patients received paclitaxel 175 мг/м2 and carboplatin AUC 5 were evaluated. Results. The median duration of response was 9.5 months (4.5–13.25 months) in patients received AT regimen and 8.5 months (4.7–12.25 months), in TP regimen; no statistically significant differences were observed, р=0.836. The median progression free survival was 7 months (95% CI 5–26 months) in group 1 and 7.5 months (95% CI 6–35 months) in group 2, p=0.85. Both chemotherapy regimens (AT and TP) had mild or moderate toxicity profiles (grade 1 or 2 in most patients). No significant difference in gastrointestinal toxicity was observed. The incidence of grade 3–4 neutropenia was higher in patients of group 2 (TP regimen): 42.8% versus 27% (р<0.05). Conclusions. Both regimens of chemotherapy (AT and TP) are appropriate to use in the first line setting in patients with metastatic TNBC. Key words: metastatic triple negative breast cancer, chemotherapy, progression free survival, chemotherapy toxicity.


Author(s):  
Eleonora Porcu ◽  
Maria Lucrezia Tranquillo ◽  
Leonardo Notarangelo ◽  
Patrizia Maria Ciotti ◽  
Nilla Calza ◽  
...  

Abstract Purpose The main purpose and research question of the study are to compare the efficacy of high-security closed versus open devices for human oocytes’ vitrification. Methods A prospective randomized study was conducted. A total of 737 patients attending the Infertility and IVF Unit at S.Orsola University Hospital (Italy) between October 2015 and April 2020 were randomly assigned to two groups. A total of 368 patients were assigned to group 1 (High-Security Vitrification™ - HSV) and 369 to group 2 (Cryotop® open system). Oocyte survival, fertilization, cleavage, pregnancy, implantation, and miscarriage rate were compared between the two groups. Results No statistically significant differences were observed on survival rate (70.3% vs. 73.3%), fertilization rate (70.8% vs. 74.9%), cleavage rate (90.6% vs. 90.3%), pregnancy/transfer ratio (32.0% vs. 31.8%), implantation rate (19.7% vs. 19.9%), nor miscarriage rates (22.1% vs. 21.5%) between the two groups. Women’s mean age in group 1 (36.18 ± 3.92) and group 2 (35.88 ± 3.88) was not significantly different (P = .297). A total of 4029 oocytes were vitrified (1980 and 2049 in groups 1 and 2 respectively). A total of 2564 were warmed (1469 and 1095 in groups 1 and 2 respectively). A total of 1386 morphologically eligible oocytes were inseminated by intracytoplasmic sperm injection (792 and 594 respectively, P = .304). Conclusions The present study shows that the replacement of the open vitrification system by a closed one has no impact on in vitro and in vivo survival, development, pregnancy and implantation rate. Furthermore, to ensure safety, especially during the current COVID-19 pandemic, the use of the closed device eliminates the potential samples’ contamination during vitrification and storage.


2019 ◽  
Vol 16 (3) ◽  
pp. 168-178
Author(s):  
Anu Malik ◽  
Smruti Ranjan Dethi ◽  
Yogesh Kumar Gupta ◽  
Alka Gupta

Aim: To compare surgical parameters and visual outcomes of coaxial microincision cataract surgery (MICS) with standard phacoemulsification. Methods: A prospective randomized study was conducted on 60 eyes of 60 patients with age-related uncomplicated cataract who underwent: standard phacoemulsification surgery (30 eyes) i.e., Group 1, or coaxial MICS (30 eyes) i.e., Group 2. Intraoperative parameters were mean effective phacoemulsification power (EPP), effective phacoemulsification time (EPT), and total volume of balanced salt solution (BSS) used. Best-corrected visual acuity (BCVA) and surgically induced astigmatism (SIA) were evaluated pre- and postoperatively. Results: Mean BCVA at 6 weeks was 0.04 ± 0.07 in Group 1 and 0.05 ± 0.08 in Group 2. No significant difference was observed in SIA between the two groups. Mean EPT was 29.80 ± 3.67 seconds in Group 1 and 31.93 ± 4.08 seconds in Group 2. The mean total EPP in Group 1 was 35.77 ± 5.17%, whereas it was 33.70 ± 3.05% in Group 2. There was a significant statistical difference between mean EPP and EPT in the two groups. Mean total BSS volume used in Group 1 was 128.83 ± 19.81 ml, whereas it was 139.33 ± 13.57 ml in Group 2. Conclusion: Although EPT and BSS volume used were significantly higher in coaxial MICS, the postoperative results of the two techniques were comparable.


Author(s):  
Uğurkan Erkayıran ◽  
Bülent Köstü ◽  
Alev Özer

Background: To compare cranial 15º angulation of Veres needle to classic Veress needle entry in closed laparoscopic entry in obese patients. Method: Patients with BMI index>30 were divided into two groups. Initial entry into the abdomen in Group 1 (n=29) was performed with the intraumbilical insertion of Veress needle in 90o angle relative to the horizontal plane. In Group 2 (n=31) the Veress needle was placed intraumbilically in a cranial direction, the tip of the needle towards the thoracic cavity, with an angle of 15o to the horizontal plane. Two groups were compared with respect of the operative outcomes. Results: In Group 2, the mean number of Veress needle entries attempt was significantly lower than Group 1 (p=0.01). Time to insertion of the Veress needle was found to be significantly shorter in Group 2 than in Group 1 (p<0.001). While entry failure occurred in 3 patients in Group 1 (10.3%), no failures were monitored in any patients in Group 2 (p= 0.01). Complication rate was significantly lower in Group 2 than in Group 1 (p= 0.03). Conclusion: Placement of Veress needle intraumbilically in a cranial direction at 15°angle to the horizontal plane increases entry success and reduces complications.


2021 ◽  
pp. 106-117
Author(s):  
S. K. Zyryanov ◽  
O. I. Butranova ◽  
A. V. Ershov ◽  
Z. Sh. Manasova

Introduction. The high incidence of community-acquired pneumonia and the high complication rates in the cases of severe pneumonia actualize the search for new pharmacotherapy tools to improve the effectiveness of standard patient management regimens. A high level of severe inflammatory response underlies the high risk for developing septic complications of pneumonia, along with impaired immune responses.The aim is to evaluate the efficacy of azoximer bromide introduction in the combination therapy regimen for hospitalized patients with moderate to severe community-acquired pneumonia.Materials and methods. A prospective, open label, parallel group, randomized study comparing the efficacy of azoximer bromide introduction in the combination therapy of hospitalized patients with moderate to severe community-acquired pneumonia was conducted at the premises of Federal Scientific and Clinical Center for Reanimatology and Rehabilitation. 30 patients were included in the study group and 37 patients in the comparator group. The baseline characteristics were comparable in both groups. Results. The azoximer bromide introduction in the combination therapy of patients with community-acquired pneumonia led to a statistically significant reduction in the duration of hospital stay (Me (LQ; HQ): 9 (8; 10) days for the study group and 13 (10; 14) days for the comparator group, (p = 0.000078), duration of ICU stay (Me (LQ; HQ) 2 days (1.5; 2.5) and 5 days (5.0; 6.0), respectively, (p = 0.00001), the duration of febrile fever 5 (± 0.6) days versus 10 (± 1.2) days (p = 0.0000), the incidence of acute respiratory failure (13.33% in group 1 versus 37.84% in group 2, p = 0.024) and septic shock (10% in group 1 versus 32.43% in group 2, p = 0.0285).Conclusions. The azoximer bromide introduction in the standard therapy regimen for patients with community-acquired pneumonia allowed to reduce the duration of hospital stay, the duration of ICU stay, the length of febrile fever, the incidence of septic shock and respiratory failure. The possible mechanisms of action may include a reduction of the severe inflammatory reactions and an optimization of the patient's immune response to the infectious process.


Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Simon Kircher ◽  
Arash Arya ◽  
David Altmann ◽  
Sascha Rolf ◽  
Andreas Bollmann ◽  
...  

Introduction: Pulmonary vein (PV) isolation forms the cornerstone of any ablation procedure for atrial fibrillation (AF). There is, however, no uniform strategy how to detect and target left atrial (LA) arrhythmogenic substrate outside the PV antra. Fibrosis that corresponds well to LA low-voltage areas (LVAs) seems to play a key role in AF arrhythmogenesis and might therefore be a suitable target for additional substrate modification (SM). Objective: The purpose of this prospective randomized study was to compare a novel technique for SM based on ablation of potentially arrhythmogenic LA LVAs with a standard approach consisting of empiric LA linear ablation. Methods: Patients (pts) with symptomatic paroxysmal or persistent AF were randomized to standard (group 1) or personalized (group 2) SM. Circumferential PV isolation was the primary step in both groups. In group 1, pre-defined linear lesions were applied at the LA roof and bottom, respectively, and at the mitral isthmus only in pts with persistent AF. In group 2, targets for SM (i.e. LVAs) were identified by detailed bipolar voltage mapping (BVM) during sinus rhythm irrespective of AF type. Peak-to-peak electrogram amplitudes were defined as “normal” (> 0.5 mV), as “low voltages” (0.2 to 0.5 mV), or as “scar” (< 0.2 mV). LVAs were targeted by tissue homogenization and / or strategic linear lesions. The primary endpoint was freedom from any atrial arrhythmia (i.e. AF, atrial flutter, or atrial tachycardia) > 30 seconds off antiarrhythmic drugs on serial 7-d-Holter ECG recordings after a follow-up period of 12 months. Results: In total, 124 ablation-naïve pts (mean age 63 ± 9 years, 62 % male, 49 % with persistent AF) were enrolled in this study. LVAs were present in 18 % of pts with paroxysmal and in 41 % of pts with persistent AF (p<0.05). At the end of the follow-up period, 25 out of 59 pts (42 %) in the conventional group were free from arrhythmia recurrence as compared to 40 out of 59 pts (68 %) in the BVM-guided group (unadjusted log rank p = 0.003). Conclusion: Personalized SM guided by endocardial BVM is associated with a higher success rate compared to a conventional approach applying empirical SM based on AF phenotype.


2003 ◽  
Vol 61 (3A) ◽  
pp. 566-573 ◽  
Author(s):  
Tânia A.M.O. Cardoso ◽  
Fernando Cendes ◽  
Carlos A.M. Guerreiro

OBJECTIVE: To investigate the value of leaving seizure-free patients on low-dose medication. METHOD: This was an exploratory prospective randomized study conducted at our University Hospital. We evaluated the frequency of seizure recurrence and its risk factors following complete or partial antiepileptic drug (AED) withdrawal in seizure free patients for at least two years with focal, secondarily generalized and undetermined generalized epilepsies. For this reason, patients were divided into two groups: Group 1 (complete AED withdrawal), and Group 2 (partial AED withdrawal). Partial AED withdrawal was established as a reduction of 50% of the initial dose. Medication was tapered off slowly on both groups. Follow-up period was 24 months. RESULTS: Ninety-four patients were followed up: 45 were assigned to complete (Group 1) AED withdrawal and 49 to partial (Group 2) AED withdrawal. Seizure recurrence frequency after two years follow-up were 34.04% in group 1 and 32.69% in Group 2. Survival analysis showed that the probability of remaining seizure free at 6, 12, 18 and 24 months after randomization did not differ between the two groups (p = 0.8). Group 1: 0.89, 0.80, 0.71 and 0.69; group 2: 0.86, 0.82, 0.75 and 0.71. The analysis of risk factors for seizure recurrence showed that more than 10 seizures prior to seizure control was a significant predictive factor for recurrence after AED withdrawal (hazard ratio = 2.73). CONCLUSION: Leaving seizure free patients on low AED dose did not reduce the risk for seizure recurrence. That is, once the decision of AED withdrawal has been established, it should be complete.


Pharmaceutics ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 813
Author(s):  
Wooyeol Baek ◽  
Nara Lee ◽  
Eun Jin Han ◽  
Tai Suk Roh ◽  
Won Jai Lee

To improve healing of pressure ulcer wounds, it is important to optimize the conditions of the area surrounding the wound. Negative pressure wound therapy (NPWT) promotes wound healing, however, the removal of NPWT can cause pain or focal bleeding, delaying wound healing or causing infection. In this study, we reviewed the efficacy of the lipidocolloid non-adherent dressing (Urgotul®) as a wound contact layer. A total of 38 patients from the same facility who applied NPWT from April 2016 to October 2019 were included and divided into two groups; NPWT with the lipidocolloid non-adherent dressing (group 1, experimental group, 19 patients) and NPWT only (group 2, control group, 19 patients). The condition of the wound was examined prior to NPWT application, at one week, and again at three weeks after application. No significant differences were found between groups for general characteristics, bacterial culture or photo analysis. However, when comparing groups based on the time of examination, there was a significant reduction of the wound size in group 1 (p = 0.001) but not in group 2 (p = 0.082). Therefore, the current study finds that using the lipidocolloid non-adherent dressing as a wound contact layer in NPWT stimulates healing by shrinking the size of the pressure ulcer wound.


Perfusion ◽  
2017 ◽  
Vol 33 (2) ◽  
pp. 105-109 ◽  
Author(s):  
Serdar Gunaydin ◽  
Craig Robertson ◽  
Ali Baran Budak ◽  
Terence Gourlay

Background: The primary objective of this study was to test and compare the efficacy of currently available intraoperative blood salvage systems via a demonstration of the level of increase in percentage concentration of red blood cells (RBC), white blood cells 9WBC) and platelets (Plt) in the end product. Methods: In a prospective, randomized study, data of 80 patients undergoing elective cardiac surgery with cardiopulmonary bypass in a 6-month period was collected, of which the volume aspirated from the surgical field was processed by either the HemoSep Novel Collection Bag (Advancis Surgical, Kirkby-in-Ashfield, Notts, UK) (N=40) (Group 1) or a cell- saver (C.A.T.S Plus Autotransfusion System, Fresenius Kabi, Bad Homburg, Germany) (N=40) (Group 2). Results: Hematocrit levels increased from 23.05%±2.7 to 43.02%±12 in Group 1 and from 24.5±2 up to 55.2±9 in Group 2 (p=0.013). The mean number of platelets rose to 225200±47000 from 116400 ±40000 in the HemoSep and decreased from 125200±25000 to 96500±30000 in the cell-saver group (p=0.00001). The leukocyte count was concentrated significantly better in Group 1 (from 10100±4300 to 18120±7000; p=0.001). IL-6 levels (pg/dL) decreased from 223±47 to 83±21 in Group 1 and from 219±40 to 200±40 in Group 2 (p=0.001). Fibrinogen was protected significantly better in the HemoSep group (from 185±35 to 455±45; p=0.004). Conclusions: Intraoperative blood salvage systems functioned properly and the resultant blood product was superior in terms of red blood cell species. The HemoSep group had significantly better platelet and leukocyte concentrations and fibrinogen content.


2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Metin Guclu ◽  
Ozen Oz Gul ◽  
Soner Cander ◽  
Oguzkaan Unal ◽  
Guven Ozkaya ◽  
...  

Aim.To investigate the efficacy of combined therapy of insulin and rosiglitazone on metabolic and inflammatory parameters, insulin sensitivity, and adipocytokine levels in patients with type 1 diabetes mellitus (type 1 DM).Material and Methods.A total of 61 adults with type 1 DM were randomly and prospectively assigned in open-label fashion to take insulin and rosiglitazone 4 mg/day (n=30) or insulin alone (n=31) for a period of 18 weeks while undergoing insulin therapy without acute metabolic complications.Results.Combination therapy did not significantly improve metabolic and inflammatory parameters, insulin sensitivity, and adiponectin levels. While leptin and resistin levels decreased in both groups (group 1: resistin 6.96 ± 3.06 to 4.99 ± 2.64,P=0.006; leptin 25.8 ± 17.6 to 20.1 ± 12.55,P=0.006; group 2: resistin 7.16 ± 2.30 to5.57±2.48,P=0.031; leptin 16.72 ± 16.1 to 14.0 ± 13.4,P=0.007) Hgb and fibrinogen levels decreased only in group 1 (Hgb 13.72 ± 1.98 to 13.16 ± 1.98,P=0.015, and fibrinogen 4.00 ± 1.08 to 3.46 ± 0.90,P=0.002). Patients in both groups showed weight gain and the incidence of hypoglycemia was not lower.Discussion.The diverse favorable effects of TZDs were not fully experienced in patients with type 1 DM. These results are suggesting that insulin sensitizing and anti-inflammatory characteristics of TZDs were likely to be more pronounced in patients who were not totally devoid of endogenous insulin secretion.


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