Evaluation of the Effectiveness and Safety of Adding Ivermectin to Treatment in Severe COVID-19 Patients

Abstract BACKGROUND AND OBJECTIVES:An effective treatment option is not yet available for SARS-CoV2, which causes the COVID-19 pandemic and whose effects are felt more and more every day. Ivermectin is among the drugs whose effectiveness in treatment has been investigated. In this study; it was aimed to investigate the presence of gene mutations that alter ivermectin metabolism and cause toxic effects in patients with severe COVID-19 pneumonia, and to evaluate the effectiveness and safety of ivermectin use in the treatment of patients without mutation.MATERIALS AND METHODS: Patients with severe COVID19 pneumonia were included in the study, which was planned as a prospective, randomized, controlled, single-blind phase 3 study. Two groups, the study group and the control group, took part in the study. Ivermectin 200 mcg/kg/day for five days in the form of a solution prepared for enteral use added to the reference treatment protocol -hydroxychloroquine + favipiravir + azithromycin- of patients included in the study group. Patients in the control group were given only reference treatment with 3 other drugs without ivermectin. The presence of mutations was investigated by performing sequence analysis in the mdr1/abcab1 gene with the Sanger method in patients included in the study group according to randomization. Patients with mutations were excluded from the study and ivermectin treatment was not continued. Patients were followed for 5 days after treatment. At the end of the treatment and follow-up period, clinical response and changes in laboratory parameters were evaluated.RESULTS: A total of 66 patients, 36 in the study group and 30 in the control group were included in the study. Mutations affecting ivermectin metabolism was detected in genetic tests of six (16.7%) patients in the study group and they were excluded from the study. At the end of the 5-day follow-up period, the clinical improvement rate was higher in the study group [22/30 (73.3%)] compared to the control group [16/30 (53.3%)] (p=0.10). At the end of the study, mortality developed in 6 patients (20%) in the study group and in 9 (30%) patients in the control group (p=0.37). At the end of the follow-up period, the average peripheral capillary oxygen saturation (SpO2) values of the study and control groups were found to be 93.5% and 93.0%, respectively. Partial pressure of oxygen (PaO2)/FiO2 ratios were determined as 236.3 ± 85.7 and 220.8 ± 127.3 in the study and control groups, respectively. While the blood lymphocyte count was higher in the study group compared to the control group (1698±1438 and 1256±710, respectively) at the end of the follow-up period (p=0.24); reduction in serum C-reactive protein (CRP), ferritin and D-dimer levels was more pronounced in the study group (p=0.02, p=0.005 and p=0.03, respectively).CONCLUSIONS: According to the findings obtained, ivermectin can provide an increase in clinical recovery, improvement in prognostic laboratory parameters and a decrease in mortality rates even when used in patients with severe COVID-19. Consequently, ivermectin should be considered as an important alternative to the treatment of COVID-19 disease or as an additional option to existing protocols.

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Evaluation of the effectiveness and safety of adding ivermectin to treatment in severe COVID-19 patients

BMC Infectious Diseases ◽

10.1186/s12879-021-06104-9 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Nurullah Okumuş ◽

Neşe Demirtürk ◽

Rıza Aytaç Çetinkaya ◽

Rahmet Güner ◽

İsmail Yaşar Avcı ◽

...

Keyword(s):

Treatment Protocol ◽

Gene Mutations ◽

Control Group ◽

Study Group ◽

Control Groups ◽

Effective Treatment Option ◽

Reference Treatment ◽

Laboratory Parameters ◽

And Control

Abstract Background and objectives An effective treatment option is not yet available for SARS-CoV2, which causes the COVID-19 pandemic and whose effects are felt more and more every day. Ivermectin is among the drugs whose effectiveness in treatment has been investigated. In this study; it was aimed to investigate the presence of gene mutations that alter ivermectin metabolism and cause toxic effects in patients with severe COVID-19 pneumonia, and to evaluate the effectiveness and safety of ivermectin use in the treatment of patients without mutation. Materials and methods Patients with severe COVID19 pneumonia were included in the study, which was planned as a prospective, randomized, controlled, single-blind phase 3 study. Two groups, the study group and the control group, took part in the study. Ivermectin 200 mcg/kg/day for 5 days in the form of a solution prepared for enteral use added to the reference treatment protocol -hydroxychloroquine + favipiravir + azithromycin- of patients included in the study group. Patients in the control group were given only reference treatment with 3 other drugs without ivermectin. The presence of mutations was investigated by performing sequence analysis in the mdr1/abcab1 gene with the Sanger method in patients included in the study group according to randomization. Patients with mutations were excluded from the study and ivermectin treatment was not continued. Patients were followed for 5 days after treatment. At the end of the treatment and follow-up period, clinical response and changes in laboratory parameters were evaluated. Results A total of 66 patients, 36 in the study group and 30 in the control group were included in the study. Mutations affecting ivermectin metabolism was detected in genetic tests of six (16.7%) patients in the study group and they were excluded from the study. At the end of the 5-day follow-up period, the rate of clinical improvement was 73.3% (22/30) in the study group and was 53.3% (16/30) in the control group (p = 0.10). At the end of the study, mortality developed in 6 patients (20%) in the study group and in 9 (30%) patients in the control group (p = 0.37). At the end of the follow-up period, the average peripheral capillary oxygen saturation (SpO2) values of the study and control groups were found to be 93.5 and 93.0%, respectively. Partial pressure of oxygen (PaO2)/FiO2 ratios were determined as 236.3 ± 85.7 and 220.8 ± 127.3 in the study and control groups, respectively. While the blood lymphocyte count was higher in the study group compared to the control group (1698 ± 1438 and 1256 ± 710, respectively) at the end of the follow-up period (p = 0.24); reduction in serum C-reactive protein (CRP), ferritin and D-dimer levels was more pronounced in the study group (p = 0.02, p = 0.005 and p = 0.03, respectively). Conclusions According to the findings obtained, ivermectin can provide an increase in clinical recovery, improvement in prognostic laboratory parameters and a decrease in mortality rates even when used in patients with severe COVID-19. Consequently, ivermectin should be considered as an alternative drug that can be used in the treatment of COVID-19 disease or as an additional option to existing protocols.

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Sonographic Signs of Adenomyosis in Women with Endometriosis Are Associated with Infertility

Journal of Clinical Medicine ◽

10.3390/jcm10112355 ◽

2021 ◽

Vol 10 (11) ◽

pp. 2355

Author(s):

Dean Decter ◽

Nissim Arbib ◽

Hila Markovitz ◽

Daniel S. Seidman ◽

Vered H. Eisenberg

Keyword(s):

Laparoscopic Surgery ◽

Retrospective Study ◽

Statistical Analysis ◽

Conservative Management ◽

Transvaginal Ultrasound ◽

Control Group ◽

Study Group ◽

Control Groups ◽

Increased Risk ◽

And Control

We compared the prevalence of ultrasound signs of adenomyosis in women with endometriosis who underwent surgery to those who were managed conservatively. This was a retrospective study of women evaluated at a tertiary endometriosis referral center who underwent 2D/3D transvaginal ultrasound. Adenomyosis diagnosis was based on the presence of at least three sonographic signs. The study group subsequently underwent laparoscopic surgery while the control group continued conservative management. Statistical analysis compared the two groups for demographics, symptoms, clinical data, and sonographic findings. The study and control groups included 244 and 158 women, respectively. The presence of any, 3+, or 5+ sonographic signs of adenomyosis was significantly more prevalent in the study group (OR = 1.93–2.7, p < 0.004, 95% CI; 1.24–4.09). After controlling for age, for all findings but linear striations, the OR for having a specific feature was higher in the study group. Women in the study group with ≥ 5 sonographic signs of adenomyosis had more than twice the risk of experiencing infertility (OR = 2.31, p = 0.012, 95% CI; 1.20–4.45). Sonographic signs of adenomyosis are more prevalent in women with symptomatic endometriosis who underwent surgery compared with those who continued conservative management. Women with 5+ findings have a significantly increased risk of infertility. Adenomyosis on ultrasound should be considered in the management decisions regarding these patients.

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Comparative study of the areas of osteochondral defects produced in the femoral condyles of rabbits treated with gel of sugarcane biopolymer

Acta Cirurgica Brasileira ◽

10.1590/s0102-86502011000500010 ◽

2011 ◽

Vol 26 (5) ◽

pp. 383-386 ◽

Cited By ~ 4

Author(s):

Paulo Cezar Vidal Carneiro de Albuquerque ◽

José Lamartine de Andrade Aguiar ◽

Saulo Monteiro dos Santos ◽

Nicodemus Pontes Filho ◽

Roberto José Vieira de Mello ◽

...

Keyword(s):

Sugar Cane ◽

Digital Camera ◽

Control Group ◽

Study Group ◽

Osteochondral Defects ◽

Control Groups ◽

The Right ◽

And Control ◽

Natural Healing ◽

Femoral Condyles

PURPOSE: To measure the healed areas of osteochondral defects produced in femoral condyles of rabbits filled with biopolymer sugar cane gel and to compare these with those of the control group at 90, 120 and 180 days. METHODS: A study was made of 16 New Zealand rabbits, 6 and 7 months old, weighing between 2 and 2.5 kg. Defects of 3.2 x 4 mm were made, with trephine, in the femoral condyles of the right and left knees. As to the study group defects of the medial and lateral condyles of the right knee were used which were filled with Biopolymer Sugar Cane Gel; as to the Control Group defects of the medial and lateral condyles of the left t knees were used which were left open for natural healing. The defects were analyzed at 90, 120 and 180 days after surgery. After euthanasia, the knees were removed and fixed in Bouin's solution for later digital photographic documentation with a digital camera. The areas healed were measured in both the study and control groups using the images obtained from an Image-J® program. Statistical analysis was conducted using the non-parametric Mann-Whitney test. RESULTS: There were no significant differences between the means of the healed areas in the study and control groups at 90, 120 and 180 days after surgery. CONCLUSION: The dimension of the healed areas of the defects treated with the biopolymer sugar-cane gel in the study group was similar to those of the control group, which healed naturally.

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The significance of polymorphisms of gene coagulation factors VII and XIII in the pathogenesis of non-traumatic avascular necrosis of the femoral head

Genij Ortopedii ◽

10.18019/1028-4427-2021-27-1-43-47 ◽

2021 ◽

Vol 27 (1) ◽

pp. 43-47

Author(s):

M.A. Panin ◽

◽

N.V Zagorodnii ◽

A.V. Boiko ◽

L.M. Samokhodskaya ◽

...

Keyword(s):

Femoral Head ◽

Avascular Necrosis ◽

Coagulation Factors ◽

Group Differences ◽

Unknown Etiology ◽

Control Group ◽

Study Group ◽

Control Groups ◽

Aseptic Necrosis ◽

And Control

Introduction Non-traumatic avascular necrosis of the femoral head (ANFH) is a poly-etiologic and socially significant disease in the age of 20 to 50 years and is associated with disability. Research on the identification of necrosis causes/predictors is a relevant issue. Purpose To study the contribution of polymorphisms in the genes of coagulation factors F7 and F13 in the aetiology of non-traumatic avascular necrosis of the femoral head. Methods Polymorphisms of the genes of coagulation factors F7 and F13 were studied; comparative analysis of the frequency of important allelic variants of F7genes (Arg353Gln) and F13 (Val134Leu) in patients with a verified diagnosis of aseptic necrosis (study group) and in healthy patients (control group) was performed. The study group included 41 patients (all males) with aseptic necrosis of the femoral head of unknown etiology. Results The frequency of gene alleles in the F7 Arg353Gln in the study group were: GG in 30 out of 41 patients (73.2 %), GA in 11 out of 41 patients (26.8 %), and none of 41 patients had a polymorphic variant AA. The frequency of alleles of this type of gene in the control group was as follows: GG in 7 out of 320 subjects (2.2 %), GA in 66 out of 320 patients (20.6 %), AA in 247 out of 320 (77.2 %). Significant differences were identified in the frequencies of homozygous genotypes, AA (χ2 = 100.215, p < 0.001) and GG (χ2 = 205.770, p < 0.001) in the study and control groups respectively. As for the heterozygous GA genotype, the differences were not significant (χ2 = 0.834, p = 0.362). The GG genotype of the gene Val134Leu F13 WAS 2.8 times more frequent in patients of the study group, differences were statistically significant (26.8 % against 9.7 %, χ2 = 10.388; p = 0.002). The presence of the TT genotype of the gene Val134Leu F13 was almost five times more frequent (χ2 = 18.956, p < 0.001) in healthy individuals (control group). Differences in the frequency of allele T in homo/ and heterozygous combinations (TT and GT) in the study and control groups was also significant (72.7 % vs 90.1 %, respectively, χ2 = 4.946, p = 0.027). Discussion Polymorphisms of coagulation factors genes F7 and F13 have a significant effect on the genesis of non-traumatic avascular necrosis of the femoral head. Risk factor of ANFH development is homozygous GG genotype in the gene Arg353Gln F7. Low probability of the disease is due to a protective role of AA genotype of the gene Arg353Gln F7 and TT genotype of the gene Val134Leu F13.

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Cryotherapy Reduced Postoperative Pain in Gynecologic Surgery: A Randomized Controlled Trial

Pain Research and Treatment ◽

10.1155/2019/2405159 ◽

2019 ◽

Vol 2019 ◽

pp. 1-6 ◽

Cited By ~ 2

Author(s):

Apisada Chumkam ◽

Densak Pongrojpaw ◽

Athita Chanthasenanont ◽

Junya Pattaraarchachai ◽

Kornkarn Bhamarapravatana ◽

...

Keyword(s):

Postoperative Pain ◽

Statistical Difference ◽

Controlled Trial ◽

Exploratory Laparotomy ◽

Gynecologic Surgery ◽

Control Group ◽

Study Group ◽

Control Groups ◽

Vas Score ◽

And Control

Objective. To examine the effectiveness of cryotherapy for reducing postoperative pain in patients who underwent exploratory laparotomy for gynecologic surgery. Materials and Methods. Patients who had indication for an exploratory laparotomy gynecologic procedure were selected by attending physicians to undergo abdominal surgery via low transverse skin incision. The participants were randomized into study and control groups with simple random sampling methods. Cold packs were applied at two hours after operation for 6 hours. The visual analog scale (VAS) score was recorded at two, 6, and 12 hours after operation. Result. One hundred cases were recruited and then divided into study and control groups equally. The mean age of both groups was 43 years. There was no difference in demographics data of both groups. Half of the participants in both groups underwent hysterectomies. At two hours after surgery, both groups had similar VAS scores. The study group had a lower VAS score at 6 and 12 hours after surgery than the control group with statistical difference. Morphine consumption within 24 hours after surgery in both the study and control groups was 2.8±3.4 and 3.0±4.4 mg, respectively, with no statistical difference. However the registration time of the first morphine requirement in the study group was statistically more prolonged than that of the control group. The lengths of hospital stay in both groups were similar. There was no complication reported in this study. Conclusion. Cryotherapy can reduce postoperative pain. In this presented study the patients who underwent gynecologic surgery had improved pain relief and prolonged time for the first dose of the analgesic drug.

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Olfactory Dysfunction in β Thalassemia Major Patients Treated With Iron-Chelating Agents

Ear Nose & Throat Journal ◽

10.1177/0145561319840079 ◽

2019 ◽

Vol 98 (8) ◽

pp. NP125-NP130

Author(s):

Serhan Derin ◽

Selvet Erdogan ◽

Murat Sahan ◽

Mehmet Fatih Azik ◽

Hatice Derin ◽

...

Keyword(s):

Chelating Agents ◽

Thalassemia Major ◽

Olfactory Dysfunction ◽

Facial Trauma ◽

Control Group ◽

Control Groups ◽

History Of ◽

And Control ◽

Iron Chelating Agents

Ocular and ophthalmological adverse effects may be seen in β-thalassemia major (BTM) patients treated with regular blood transfusions and iron-chelating agents. We hypothesized that olfactory dysfunction may be present in this population. In this study, we aimed to investigate olfactory dysfunction in patients with BTM and determine the etiological factors. A total of 43 patients with BTM were included in the study. Forty-three patients without any nasal complaints, history of facial trauma, or nasal surgery were included as the controls. All participants had nasal endoscopy. The iron-chelating agents used, their duration of use, as well as hemoglobin and ferritin levels of the BTM patients were recorded. Sniffin’ Sticks test (SST) was used to assess olfactory functions, and BTM and control groups were compared for the results. The correlations of SST scores with the other study parameters were analyzed. Eight (18.6%) of 43 patients in the BTM group had hyposmia while none of the patients in the control group had hyposmia ( P < .001). Older age, low-hemoglobin level, and longer use of deferoxamine were found to be correlated with olfactory dysfunction. Olfactory dysfunction may be seen in BTM patients treated with iron-chelating agents. The results of this study suggest that screening for olfactory function may be needed in routine follow-up of BTM patients.

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Time taken to resume driving following hip arthroscopy

BMC Musculoskeletal Disorders ◽

10.1186/s12891-020-03662-y ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Suenghwan Jo ◽

Sang Hong Lee ◽

Se Woong Jang ◽

Hyun Bai Choi ◽

Ba Rom Kim ◽

...

Keyword(s):

Hip Arthroscopy ◽

Driving Simulator ◽

Driving Performance ◽

Control Group ◽

Control Groups ◽

Test Protocol ◽

Surgery Group ◽

Time Required ◽

And Control

Abstract Background Resuming driving is a common concern among patients undergoing hip arthroscopy. The present study aimed to assess whether patients who had undergone right hip arthroscopy presented with poorer driving performance than patients with normal hips and to analyze the time required to regain preoperative driving performance. Methods Forty-seven patients who had undergone right hip arthroscopy and consented to our test protocol were included in this study. Using an immersive driving simulator, the patients were tested for their brake reaction time (BRT), total brake time (TBT), and brake pedal depression (BPD) preoperatively and postoperatively. The first postoperative assessments were conducted when the patients could comfortably sit on the driving seat, and the follow-up assessments were conducted for 6 consecutive weeks at weekly intervals. The patients were divided into the following two groups based on the type of surgery that they underwent: the femoroacetabular impingement (FAI) surgery group and the simple hip arthroscopy (SA) group. Twenty healthy volunteers underwent driving assessments thrice at weekly intervals and constituted the control group. The braking parameters were compared between preoperative and postoperative measurements and among the FAI surgery, SA, and control groups. Results The preoperative braking parameters of the patients who underwent arthroscopy did not differ significantly from those of the controls (p = 0.373, 0.763, and 0.447 for the BRT, TBT, and BPD, respectively). All braking parameters returned to normal in 2 weeks in the FAI surgery group and in 1 week in the SA group. Conclusions Our study suggests that the driving performance of patients who underwent right hip arthroscopy is comparable to that of individuals with normal hips and that the braking parameters may normalize to the preoperative state at 1 week after SA and 2 weeks after FAI surgery.

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Piano-accompanied solfège reading experiences of preservice music teachers

Research Studies in Music Education ◽

10.1177/1321103x19871078 ◽

2020 ◽

pp. 1321103X1987107

Author(s):

Elif Guven

Keyword(s):

Music Teachers ◽

Control Group ◽

Reading Practices ◽

Control Groups ◽

Plot Analysis ◽

Experimental Implementation ◽

Significant Difference ◽

And Control ◽

Experimental Group

This study examines how piano-accompanied solfège reading practices of preservice music teachers ( N = 28) affect their performance on their musical hearing, reading, and writing (MHRW) classes. A pretest–posttest design with control groups was employed. The data were analyzed by 2 × 2 split-plot analysis of variance (ANOVA) and one-way ANOVA. Consequently, a significant difference was not found between the MHRW performance scores of the experimental and control groups. An analysis of mean performance scores revealed that the scores received by the control group were higher than those of the experimental group after the practice. Follow-up interviews that were held with 14 students after the experimental implementation revealed that students believed piano-accompanied courses were more useful, and they felt more comfortable with piano accompaniment. Although MHRW performance scores indicated that piano-accompanied solfège reading practices did not have a significant effect on preservice music teachers’ MHRW performances, it helped them participate in courses more enthusiastically.

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The Efficacy of Intravenous Tranexamic Acid in Reduction of Blood Loss in Women at High Risk of Postpartum Hemorrhage

QJM ◽

10.1093/qjmed/hcaa056.014 ◽

2020 ◽

Vol 113 (Supplement_1) ◽

Author(s):

K M Diab ◽

R M Mohamed ◽

A G Abdelhay

Keyword(s):

Blood Loss ◽

Cesarean Section ◽

Tranexamic Acid ◽

Maternal Mortality ◽

Vaginal Delivery ◽

Control Group ◽

Study Group ◽

Control Groups ◽

Significant Difference ◽

And Control

Abstract Background Postpartum hemorrhage (PPH) is the leading cause of maternal mortality. All women who carry a pregnancy beyond 20 weeks’ gestation are at risk for PPH and its sequelae. Although maternal mortality rates have declined greatly in the developed world, PPH remains a leading cause of maternal mortality elsewhere. Aim of the Work To assess the efficacy and safety intravenous tranexamic acid in reduction of amount of blood loss in high risk women who deliver by cesarean section or vaginal delivery in postpartum period. Patients and Methods This prospective double blind randomized controlled clinical trial study was conducted on 200 patients planned for LSCS or vaginal delivery at Gestational Age ≥ 34 Weeks at Ain Shams University Maternity Hospital. Recruitment of data begun once the protocol was approved by research and ethical committee of the department of obstetrics and gynecology. Results No significant difference between Study and Control groups as regards age (p = 0.508), no significant difference between Study and Control groups as regards Gestational age (p = 0.447),total blood loss (p < 0.001) was significantly lower in study group than control group, Vaginal pads in the 1st 24 hours post-partum was significantly less soaked in study group than control group (p < 0.001). no significant difference between Study and Control groups as regards Preoperative Hemoglobin, Postoperative Hemoglobin was significantly higher in study group than control group (p < 0.001), Reduction in Hemoglobin was significantly less in study group than control group (p < 0.001), no significant difference between Study and Control groups as regards Preoperative Hematocrite, Postoperative Hematocrit was significantly higher in study group than control group (p < 0.001), Reduction in Hematocrite was significantly less in study group than control group (p < 0.001).Need to iron replacement or blood transfusion was significantly less frequent in study group than control group (p = 0.24). Conclusion The use of tranexamic acid prior to cesarean section or vaginal delivery is effective as a prophylaxis against post-partum hemorrhage as shown by the results of this study. It can significantly reduce blood loss during and after cesarean section or vaginal delivery.

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Challenges and results of a school-based intervention to manage excess weight among school children in Tunisia 2012–2014

International Journal of Adolescent Medicine and Health ◽

10.1515/ijamh-2015-0035 ◽

2017 ◽

Vol 29 (2) ◽

Cited By ~ 3

Author(s):

Jihen Maatoug ◽

Sihem Ben Fredj ◽

Zeineb Msakni ◽

Emna Dendana ◽

Jihene Sahli ◽

...

Keyword(s):

School Children ◽

The Body ◽

Calorie Intake ◽

Control Group ◽

Control Groups ◽

Post Intervention ◽

School Based ◽

Increased Risk ◽

And Control

Abstract Background: Obesity is a serious health issue and predisposes individuals to an increased risk of morbidity and mortality. Its prevalence in children has increased worldwide. Objective: To demonstrate the feasibility and effectiveness of a school-based management program based on healthy lifestyle promotion for obese and overweight adolescents in Sousse, Tunisia. Methods: We conducted a quasi-experimental study among overweight and obese school children enrolled in 7th and 8th grades in Sousse, Tunisia with two groups, intervention and control. The 1-year intervention was based on promoting healthy eating and physical activity through a collective intervention for all recruited children and an individual intervention only for obese children who require intensive managing. Data collection was done before, at the end and at a 4-month follow up of the intervention, both in intervention and control groups. Results: The body mass index Z score decreased significantly from pre-intervention to post-intervention (1.89±0.57 to 1.76±0.63, p<0.001) and from post-intervention to the follow-up (1.76±0.63 to 1.55±0.68, p<0.001) in the intervention group. In the control group, it decreased significantly from pre-intervention to post-intervention but not significantly from post-intervention to follow-up assessment. Calorie intake decreased significantly both in intervention and control groups. Conclusion: This project began with introducing a new culture of health management in schools on one side and with increasing awareness of the importance of obesity prevention and treatment. The support of authorities for this type of action is very important to guarantee its sustainability.

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