Physical activity in patients with nonspecific low back painin therapy

Introduction. Kinesitherapy (KT) – one of the leading areas of patient care with chronic nonspecific (musculoskeletal pain) low back pain. For chronic lumbar pain, a standard KT is commonly used, that includes group sessions with a medical specialist. Often not taking into account the individual characteristics of patients, their attitude to KT, does not use a backpain education program in combination with KT (extended KT). Physical activity and hypodynamia are compared in patients with chronic nonspecificlow back pain in standard KT and extended KT.Aim of study is to assess the effectiveness of the standard and extended KT in the enhancement of physical activity.Materials and methods. 71 patients were observed (17 men and 54 women, average age 55.09 ± 13 years) with chronic nonspecific low back pain. Patients received non-steroidal anti-inflammatory drugs (NSAIDs) as painkillers. 34 patients received a standard KT, 37 patients – an extended KT. Patients were asked to complete the Numeric Pain Rating Scale (NPRS), the Oswestry Low Back Pain Disability Questionnaire, and the International Physical Activity Questionnaire (IPAQ) at baseline, after 7 days and 90 days.Results and discussion. In the extended KT group, physical activity increased from 11 (7–16) points to 16 (13–19) points after 7 days (p = 0.001) and up to 23 (15–26) points after 3 months (p = 0.0002). There has been a statistically significant decrease in the proportion of patients with hypodynamy (p = 0.0015). There is no statistically significant increase in physical activity in the standard therapy group. The use of NSAIDs in non-specific low back pain is discussed, the effectiveness of the use of dexketoprofen (Dexalgin) during lumbar pain is noted.Conclusion. In the case of nonspecific low back pain, the extended KTimprovesphysical activity and reduce hypodynamy.

Thrombectomy in patients with basilar artery thrombosis

Introduction. This article is devoted to the discussion of a life-threatening condition - basilar artery thrombosis (BAT). The article presents the results of a comparative analysis of two groups of patients with angiographically confirmed BAT: with and without reperfusion therapy.Relevance. Basilar artery thrombosis is a life-threatening condition in which mortality can reach 95%, and severe neurological deficits and dependence in everyday life on others (modified Ran-kin Scale (mRS), score 4–5) are observed in 65% of surviving patients. Ischemic stroke (IS) due to BAT is diagnosed in 1–4% of patients with acute cerebrovascular event (ACVE). Currently, reperfusion therapy (RT) in the form of systemic thrombolytic therapy (sTLT) with rt-PA and/or thrombectomy (TE) is the only effective and safe method for treating patients with IS. In randomized trials, it was found that RT, whether it is sTLT, TE or a combination of these techniques, despite the best degree of functional recovery in patients by day 90 from the onset of the disease, does not lead to a statistically significant decrease in mortality. Nevertheless, the results of 10 prospective studies of the use of endovascular treatment in patients with IS in the posterior circulation system indicate that this type of therapy leads to a decrease in 90-day mortality from 95% to 16–47% in case of successful recanalization (mTICI (modified Thrombolysis in Cerebral Infarction), 2–b–3).Aim of study. To assess the safety and efficacy of TE in patients with BAT.Material and methods. This study included 15 patients with IS, admitted within the 6-hour therapeutic window, and confirmed BAT by CT and/or MRangiography. The baseline level of wakefulness was assessed using the Glasgow Coma Scale (GCS), and the severity of neurological deficit was assessed by the National Institutes of Health Stroke Scale (NIHSS).Results. Basilar artery thrombectomy was performed in 7 patients (endovascular treatment group), 8 patients received no endovascular treatment (standard therapy group). Good clinical outcomes by day 90 from the onset of the disease (mRS, score 0–2) were observed in 57.1% of patients in the endovascular treatment group and in 12.5% of patients in the standard therapy group. However, these differences were not statistically significant (p>0.05). There were also no differences between the two groups in functional outcomes and Rivermead mobility index (RMI) by day 90 from the onset of the disease (Barthel Index of Activities of Daily Living (BI) score 97±5.0 and 100, RMI score 14.0±0.0 and 15 in the endovascular treatment group and standard therapy group, respectively). Mortality by day 90 in the endovascular treatment group was 42.9% (3 patients), in the standard therapy group — 87.5% (7 patients). In the subgroup of patients with GCS score at admission no more than score 8, there was a statistically significant strong two-way negative correlation between TE performance and mortality (r=-1.0; p=0.000), as well as a positive correlation between TE and a Rankine score by day 90 (r=0.956; p=0.003). Mortality was statistically significantly lower in the endovascular treatment group compared to the standard therapy group (0% versus 100%, respectively, p=0.025). Clinical outcomes of the disease by day 90 were statistically significantly better in the endovascular treatment group: mRS, score 0–2 in 100% of cases versus 0% in the standard treatment group (p=0.028).Conclusion. Currently, the only effective treatment for basilar artery thrombosis is thrombectomy. The possibility of performing thromboectomy in these cases should be considered in all patients, regardless of the severity of the stroke and the decrease in the level of wakefulness, since endovascular treatment in this case is a life-saving procedure. The symptom of a hyperdense basilar artery can be used as a diagnostic tool for suspected basilar artery thrombosis, but should not rule out angiography. In our series of observations, the mortality rate in patients who underwent thrombectomy was 42.9%. Good functional outcomes (mRS, score 0–2) and the absence mobility limitation (RMI, score 14) were observed in 57.1% of patients by day 90 after thrombectomy.

Over-the-scope clip as first-line therapy for ulcers with high-risk bleeding stigmata is efficient compared to standard endoscopic therapy

Background and study aims Ulcers with high-risk stigmata have significant rebleeding rates despite standard endoscopic therapy. Data on over-the-scope clip (OTSC) for recurrent bleeding is promising but data on first line therapy is lacking. We report comparative outcomes of OTSC as first-line therapy versus standard endoscopic therapy in ulcers with high-risk stigmata. Patients and methods Consecutive adults who underwent endoscopic therapy for ulcers with high-risk stigmata between July 2019 to September 2020 were included. Patients were grouped into OTSC or standard therapy based on first-line therapy used on index endoscopy. Outcomes measured included: 1) intra-procedural hemostasis based on endoscopic documentation of adequate hemostasis; 2) 7-day rebleeding (> 2 g/dL drop in hemoglobin, hematochezia or hemorrhagic shock); 3) cost of endoscopic interventions; and 4) procedure duration measured as endoscope insertion to removal time. Cost of tools used during the index endoscopy was included. Results Sixty-eight patients were included, 47 were in standard therapy and 21 in the OTSC group. Hemostasis was achieved in 95.2 % in the OTSC group compared to 83.0 % in the standard therapy group (P = 0.256, number needed to treat [NNT]: 9). Procedure time was shorter in the OTSC group (23 vs. 16 minutes, P = 0.002). Cost of endoscopic interventions were comparable, P = 0.203. Early rebleeding was less often in OTSC group, two (9.5 %) compared to 10 (21.3 %) in standard therapy group, NNT 9. Conclusions Use of OTSCs as first-line treatment for ulcers bleed probably improves hemostasis and decreases early rebleeding. Use of OTSC as first-line therapy shortened procedure duration without increasing the cost of endoscopic interventions.

Clinical efficacy and safety of combination therapy of tocilizumab and steroid pulse therapy for critical COVID-19 in HD patients

Background Critical coronavirus disease 2019 (COVID-19) has a high fatality rate, especially in hemodialysis (HD) patients, with this poor prognosis being caused by systemic hyperinflammation; cytokine storms. Steroid pulse therapy or tocilizumab (TCZ) have insufficient inhibitory effects against cytokine storms in critical cases. This study evaluated the clinical effects and safety of combining steroid pulse therapy and TCZ. Methods From September 2020 to May 2021, 201 patients with COVID-19 were admitted to our hospital. Before February 2021, patients with an oxygen demand exceeding 8 L/min were intubated and treated with standard therapy (dexamethasone and antiviral therapy). After February 2021, patients underwent high-flow nasal cannula oxygen therapy and were treated with TCZ (8 mg/kg) and methylprednisolone (mPSL) (500 mg/day [≤ 75 kg], 1000 mg/day [> 75 kg]) for 3 days. We compared background characteristics, laboratory findings, and prognosis between non-HD and HD patients and between patients who received and did not receive TCZ and mPSL pulse therapy. Results Among non-HD patients, the TCZ + mPSL pulse group had significantly higher survival rates and lower secondary infection rates (p < 0.05), than the standard therapy group. All HD patients in the standard therapy group with oxygen demand exceeding 8 L/min died. Contrastingly, all patients in the TCZ + mPSL pulse group survived, with their oxygen demand decreasing to 0–1 L/min within 3 weeks post-administration. Conclusion TCZ combined with mPSL pulse therapy improved the survival rate without significant adverse events in critical HD and non-HD patients with COVID-19 by strongly suppressing systemic hyperinflammation.

The state of lipid exchange, hemostasis, inflammatory reaction and potentials for their correction in indirect revascularization in patients with critical ischemia of lower extremities (a correlation statistical analysis)

Aim: to study the state of lipid metabolism, hemostasis, inflammatory reaction and the potential for their correction after indirect revascularization in patients with distal steno-occlusion of arteries and critical ischemia of lower extremities (critical ILE).Material and methods. Changes in hemostasis and dynamics of its parameters during the complex surgical treatment in 131 patients with critical ILE and distal arterial stenoocclusion were analyzed. To achieve the targeted goals, patients were divided into the following groups: 34 patients had traditional care (control group); 32 patients had intravenous laser blood irradiation in combination with standard therapy (Group I); 32 patients had cytokine therapy with roncoleukin in combination with standard therapy (Group II); 33 patients had intravenous laser blood irradiation combined with cytokine therapy and standard therapy (Group III). Parameters of lipid metabolism were studied in dynamics (total cholesterol, very low density lipoproteins, high density lipoproteins, triglycerides); products of lipid peroxidation (malondialdehydes, conjugates, superoxide dismutase); inflammatory mediators (C-reactive protein, sialic acids, seromucoids, fibrinogen A, circulating immune complexes); hemostatic parameters (fibrinogen, fibrinolytic activity, fibrin degradation products, antithrombin III activity). Hemostatic indices were compared with identical parameters of 48 apparently healthy individuals (reference group).Results. On admission, patients with critical ILE and distal wall occlusion had sharp changes in their lipid metabolism, inflammatory reaction, and hemostasis. Conclusion. The inclusion of intravenous laser blood irradiation and cytokine therapy separately and in combination in a set of therapeutic measures led to the leveling of the studied homeostasis indicators. The best results were obtained in the group where patients had combined perioperative intravenous laser blood irradiation with cytokine therapy in indirect revascularization.

Metronomic capecitabine as adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma: A phase 3, multicenter, randomized controlled trial.

6003 Background: Patients suffering from locoregionally advanced nasopharyngeal carcinoma (NPC) commonly develop disease recurrence, despite a high rate of complete clinical remission after standard of care (concurrent cisplatin-radiotherapy, with or without induction chemotherapy). The benefit of additional adjuvant chemotherapy remains unclear. Methods: Patients with high-risk locoregionally advanced NPC (stage III to IVA, excluding T3-4N0 and T3N1), and with no locoregional disease or distant metastasis after definitive chemoradiotherapy, were eligible. They were randomly assigned (1:1) within 12 to 16 weeks after the last radiation dose to receive either capecitabine at a dose of 650 mg/m2 twice daily for 1 year (metronomic capecitabine group) or observation (standard-therapy group). The primary end point was recurrence-free survival (RFS). The calculated sample size was 201 per group, with an 80% power (two-sided α 0.05) to detect a target hazard ratio (HR) of 0.52. Results: A total of 406 patients underwent randomization, comprising 204 in the metronomic capecitabine group and 202 in the standard-therapy group. After a median follow-up of 36 months (corresponding to 43 months when calculated from the start of standard therapy), the estimated 3-year RFS was 85.9% in the metronomic capecitabine group, as compared with 76.5% in the standard-therapy group (intention-to-treat population; HR 0.51, 95% confidence interval 0.32–0.81; P = 0.003). The incidence of grade 3 adverse events was 17.4% in the metronomic capecitabine group and 5.5% in the standard-therapy group; hand-foot syndrome was the most common adverse event related to capecitabine (9.0%). One grade 4 neutropenia occurred in the metronomic capecitabine group. Neither group sufferd from treatment-related deaths. During treatment, there was no clinically meaningful deterioration of health-related quality of life associated with the use of metronomic adjuvant capecitabine. Conclusions: The addition of metronomic capecitabine as adjuvant therapy to chemoradiotherapy significantly improved RFS in locoregionally advanced NPC, with a manageable safety profile and no compromise to quality of life. Clinical trial information: NCT02958111. [Table: see text]

Therapeutic possibilities of using an expectorant mucolytic agent with antioxidant properties in COVID-19 infection

Aim: to study the effect of N-acetylcysteine (NAC) on the dynamics of clinical and radiological changes in patients with COVID-19. Patients and Methods: the study included 111 patients with moderate and severe forms of COVID-19 pneumonia of the 2nd and 3rd stage according to computed tomography (CT). The median age was 49,25 years. Group 1 (n=55) received standard therapy: favipiravir, enoxaparin sodium according to the regimen, dexamethasone. Antibacterial therapy was conducted according to the indications. In addition to standard therapy, group 2 (n=56) was prescribed with NAC at a daily dose of 1200 mg, intravenously, divided into two doses. All patients underwent a comprehensive examination: WBC count, C-reactive protein (CRP), ferritin, fibrinogen, multispiral computed tomography and ultrasound of the chest organs were determined at admission, on the 7th-10th day of hospitalization, at discharge and 8 weeks after discharge. Results: initially, patients from both groups were comparable in terms of demographic indicators and condition severity. NAC prescription to the standard therapy showed a more positive trend both in terms of clinical symptoms and laboratory indicators. Respiratory rate, heart rate, and body temperature were statistically significantly lower in group 2 already on the 7th-10th day of follow-up. The levels of CRP, ferritin and fibrinogen also normalized faster in group 2. The periods of stay in the hospital were 15.3 days and 12.2 days, respectively, in patients from groups 1 and 2 (p<0,05). Conclusions: early prescription with N-acetylcysteine to patients with a moderate course of COVID-19 allowed statistically significantly reducing the volume of lung tissue damage, reducing the level of inflammatory markers (CRP, ferritin, fibrinogen) and contributed to an earlier discharge of the patient. KEYWORDS: COVID-19, N-acetylcysteine, pneumonia, acute respiratory distress syndrome, cytokine storm. FOR CITATION: Ignatova G.L., Antonov V.N., Sheklanova E.V. et al. Therapeutic possibilities of using an expectorant mucolytic agent with antioxidant properties in COVID-19 infection. Russian Medical Inquiry. 2021;5(7):473–478 (in Russ.). DOI: 10.32364/2587-6821-2021- 5-7-473-478.

EFFICACY AND SAFETY OF SOME ETIOTROPIC THERAPEUTIC SCHEMES FOR TREATING PATIENTS WITH NOVEL CORONAVIRUS INFECTION (COVID-19)

The aim of the study is to assess the efficacy and safety of the Favipiravir (Areplivir) drug, compared to the standard etiotropic therapy in the patients hospitalized with COVID-19.Material and methods. The research was conducted as a part of an open, randomized, multicenter comparative study of the efficacy and safety of Areplivir, 200 mg film-coated tablets (“PROMOMED RUS” LLC, Russia), in the patients hospitalized with COVID-19. The dosing regimen of Favipiravir was 1600 mg twice a day on the 1st day and 600 mg twice a day on days 2–14. Thirty nine patients were enrolled into the study with a laboratory-established diagnosis of a new type of Coronavirus infection caused by SARS-CoV-2 (confirmed) of moderate severity, with pneumonia. The group of comparison (22 patients) received standard etiotropic therapy, prescribed in accordance with the current version of the temporary guidelines for the diagnosis and treatment of COVID-19, represented mainly by Hydroxychloroquine with the dosage regimen of 800 mg on the 1st day, then 400 mg on days 2–7, and Azithromycin 500 mg once a day for 5 days. The main group (17 patients) received Favipiravir (Areplivir) as etiotropiс therapy.Results. In the main group, the time period until fever disappeared was found to be 1.36 days shorter than in the group of comparison (p<0.05); there was a higher rate of the reduction of inflammatory changes in the lungs according to the computer tomography data (38.4% vs 14.9%, p<0.05). By the end of the treatment, there was also a lower lactate level in the blood (27.1%, p<0.05) than in the patients of the group of comparison. The evaluation of the drug efficacy ассording to the Categorical Ordinal Scale of Clinical Improvement and measurements of oxygen saturation in the blood, manifested similar positive dynamics in the patients treated ассording to various etiotropic therapy regimens. By the end of the treatment, the RNA SARS-CoV-2 tests were also negative in all the patients. As for the overall frequency of adverse events (AEs), no relevant distinctions were found between the groups. A greater part of AEs was related to hepatotoxicity, with a predominantly clinically relevant increase in alanine aminotransferase (ALT). A clinically relevant prolongation of the corrected QT interval on the standard ECG was found to occur in the standard-therapy group on day 5, while no serious AEs were registered in the main group. No serious adverse reactions were registered in patients of the main group.Conclusion. The efficacy of the Favipiravir (Areplivir) therapy for the novel coronavirus infection has proved to be superior to the efficacy of the standard etiotropic therapy in a number of aspects. Basing on the obtained findings, Favipiravir (Areplivir) drug can be recommended for treating patients with the novel coronavirus infection of moderate severity.

Controlled randomized clinical trial on using Ivermectin with Doxycycline for treating COVID-19 patients in Baghdad, Iraq

ObjectivesCOVID-19 patients suffer from the lack of curative therapy. Hence, there is an urgent need to try repurposed old drugs on COVID-19.MethodsRandomized controlled study on 70 COVID-19 patients (48 mild-moderate, 11 severe, and 11 critical patients) treated with 200ug/kg PO of Ivermectin per day for 2-3 days along with 100mg PO doxycycline twice per day for 5-10 days plus standard therapy; the second arm is 70 COVID-19 patients (48 mild-moderate and 22 severe and zero critical patients) on standard therapy. The time to recovery, the progression of the disease, and the mortality rate were the outcome-assessing parameters.Resultsamong all patients and among severe patients, 3/70 (4.28%) and 1/11 (9%), respectively progressed to a more advanced stage of the disease in the Ivermectin-Doxycycline group versus 7/70 (10%) and 7/22 (31.81%), respectively in the control group (P>0.05). The mortality rate was 0/48 (0%), 0/11 (0%), and 2/11 (18.2%) in mild-moderate, severe, and critical COVID-19 patients, respectively in Ivermectin-Doxycycline group versus 0/48 (0%), and 6/22 (27.27%) in mild-moderate and severe COVID-19 patients, respectively in standard therapy group (p=0.052). Moreover, the mean time to recovery was 6.34, 20.27, and 24.13 days in mild-moderate, severe, and critical COVID-19 patients, respectively in Ivermectin-Doxycycline group versus 13.66 and 24.25 days in mild-moderate and severe COVID-19 patients, respectively in standard therapy group (P<0.01).ConclusionsIvermectin with doxycycline reduced the time to recovery and the percentage of patients who progress to more advanced stage of disease; in addition, Ivermectin with doxycycline reduced mortality rate in severe patients from 22.72% to 0%; however, 18.2% of critically ill patients died with Ivermectin and doxycycline therapy. Taken together, the earlier administered Ivermectin with doxycycline, the higher rate of successful therapy.

Impact of Pharmacist-Directed Simplified Procalcitonin Algorithm on Antibiotic Therapy in Critically Ill Patients With Sepsis

Purpose: The purpose was to determine whether a simplified procalcitonin (PCT) algorithm guided by pharmacist recommendations reduces antibiotic duration of therapy in critically ill patients with suspected sepsis. Methods: This was a single-centered pre-post study conducted at a 1368-bed community teaching hospital in the United States. A prospective cohort with pharmacist intervention utilizing a simplified PCT algorithm was compared with a retrospective historical cohort with standard therapy. Adult patients admitted to the intensive care unit (ICU) with suspected sepsis who received intravenous antibiotics were included. A pharmacist recommended continuation or discontinuation of antibiotics based on the PCT level per our algorithm and full clinical assessment of the patient. Primary outcome was total duration of antibiotic therapy. Secondary outcomes were ICU and hospital length of stay (LOS), reinitiation of antibiotic therapy within 72 hours of discontinuation, and 28-day in-hospital mortality. Results: From September 2017 to May 2018, 360 patients were screened for eligibility. Of these, 26 patients were included in the PCT group and 26 patients in the standard therapy group. Baseline characteristics were similar between groups. A significant difference in duration of antibiotic therapy was detected with a median of 9 days in the PCT group versus 12 days in the standard therapy group ( P = .02). There were no significant differences in secondary endpoints of ICU and hospital LOS, reinitiation of antibiotics at 72 hours, or 28-day mortality. Conclusion: Use of a simplified PCT algorithm with pharmacist-guided recommendations significantly reduced the duration of antibiotic therapy in critically ill patients with sepsis.