Immunogenicity and safety of a quadrivalent recombinant influenza vaccine manufactured in Iran (FluGuard) in volunteers aged 18-60 years: A double-blind, non-inferiority, randomized controlled trial.

BACKGROUND: This study aimed to evaluate the non-inferiority of the FluGuard (a quadrivalent recombinant vaccine manufactured by Nivad Pharmed Salamat Company in Iran) by comparing its immunogenicity and safety with Vaxigrip Tetra (a quadrivalent inactivated vaccine manufactured by Sanofi Pasteur in France). MATERIALS AND METHODS: In this double-blind, randomized controlled trial, eligible volunteers aged 18-60 were randomized to receive either FluGuard or Vaxigrip Tetra vaccines. Immunogenicity was evaluated using the Hemagglutination Inhibition (HAI) assay and reported with the geometric mean titer (GMT), seroprotection, and seroconversion. In addition, vaccine safety was assessed by interviewing participants through phone calls. RESULTS: Out of 110 randomized volunteers, 51 and 53 were entered into the final analysis in the Vaxigrip and FluGuard groups, respectively. Vaxigrip had a higher seroprotection rate for the H1N1 strain compared with FluGuard (98 % vs. 91 %). Besides, FluGuard had higher seroprotection rates for H3N2 (74 % vs. 69 %), B-Yamagata (87 % vs. 84 %), and B-Victoria (66 % vs. 41 %) strains compared with Vaxigrip. In all four strains, FluGuard was non-inferior to Vaxigrip with the upper bounds of the 95 % CI on the ratio of the GMTs < 1.5: H1N1 (1.25), H3N2 (0.94), B-Yamagata (0.62), and B-Victoria (0.59). Furthermore, FluGuard was non-inferior to Vaxigrip with the upper bounds of the 95 % CI on the difference between the seroconversion rates < 10 %: H1N1 (2 %), H3N2 (10 %), B-Yamagata (-10 %), and B-Victoria (-29 %). The prevalence of solicited adverse drug reactions did not differ between groups. Furthermore, participants did not experience serious adverse events. CONCLUSION: Our findings support the non-inferiority of the FluGuard vaccine to the Vaxigrip vaccine regarding immunogenicity and safety. CLINICAL TRIAL REGISTRY: The study protocol was approved by the Iranian Registry of Clinical Trials (IRCT20210901052358N5).

Vitamin D deficiency and oral candidiasis in patients with HIV infection: A case‒control study.

BACKGROUND: Oral candidiasis is a common opportunistic infection in patients with human immunodeficiency virus (HIV). In addition, most of these patients suffer from vitamin D deficiency. This study aimed to investigate the association between vitamin D levels and oral candidiasis in patients with HIV infection. METHODS: This case‒control study was conducted on HIV-infected patients. Cases were patients with oral candidiasis diagnosed based on physical examinations. Controls were age- and sex-matched individuals without oral candidiasis. The levels of 25-OH vitamin D and other laboratory markers (CD4 count and viral load) were compared between the case and control groups. RESULTS: A total of 104 cases and 102 controls were included in the study. The cases had significantly lower 25-OH vitamin D3 levels (MD = 33.86 ng/mL, 95% CI= (31.85, 35.87), P < 0.001) and CD4 counts (MD = 267.48 cells/mm3, 95% CI= (189.55, 345.41), P < 0.001) than the controls. In addition, viral load was significantly higher in cases than in controls (MD = 7.03 × 105 copies/mL, 95% CI= (4.46 × 105, 9.61 × 105), P < 0.001). The multivariate logistic regression analysis revealed that educational status (OR = 0.032, 95% CI= (0.002, 0.100), P < 0.001), current HAART (OR = 0.005, 95% CI= (0.001, 0.014), P < 0.001), history of oral candidiasis (OR = 20.114, 95% CI= (18.135, 21.957), P < 0.001), CD4 count (OR = 0.004, 95% CI= (0.001, 0.006), P < 0.001), viral load (OR = 12.181, 95% CI= (1.108, 133.392), P < 0.001), and vitamin D level (OR = 0.011, 95% CI= (0.008, 0.015), P < 0.001) were significantly associated with the risk of developing oral candidiasis. CONCLUSIONS: Based on the findings, most patients with HIV infection suffer from vitamin D deficiency, especially those with oral candidiasis. Hypovitaminosis D was significantly associated with an increased risk of oral candidiasis. Thus, vitamin D supplementation may assist HIV-positive patients in improving their oral health and preventing oral candidiasis.

Validity and Reliability of The Persian Version of Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire: A Psychometric Study.

BACKGROUND: Women with uterine fibroids (UFs) experience many clinical manifestations that affect their quality of life (QOL). The Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) questionnaire is an English instrument specifically designed to assess fibroid-related symptoms and their impact on QOL. This study aims to investigate the reliability and validity of the Persian version of the UFS-QOL questionnaire in Iranian women with UF. MATERIALS AND METHODS: In this psychometric study, women with UFs who presented to Imam Hossein Hospital (Tehran, Iran) between August 2022 and January 2023 were enrolled in this study. A forward-backward approach was applied to translate the UFS-QOL questionnaire into Persian. The reliability of the UFS-QOL questionnaire was assessed by internal consistency and test-retest correlation. Confirmatory factor analysis (CFA) was used to assess convergent validity between items and subscales of the UFS-QOL questionnaire. Pearson's correlation coefficient was used to assess convergence validity between subscales of the UFS-QOL and the World Health Organization Quality of Life Brief Version 26 questionnaire (WHOQOL-BREF-26). RESULTS: Overall, we assessed 226 women with UFs. All subscales of the UFS-QOL questionnaire had acceptable internal consistency (Cronbach's alpha>0.7). Test-retest analysis indicated significant positive correlations between two measurements of all subscales of the UFS-QOL questionnaire: symptom severity (P<0.001), concern (P<0.001), activities (P<0.001), energy/mood (P<0.001), control (P<0.001), self-consciousness (P=0.002), and sexual function (P<0.001). The Kaiser-Meyer-Olkin (KMO) measure value was 0.920, and the result of Bartlett's test of sphericity was significant (P<0.001). CFA identified six factors for the health-related QOL (HRQL) questionnaire, which explained 73.827% of the total variation. Most subscales of the UFS-QOL questionnaire correlated with domains of the WHOQOL-BREF-26 questionnaire (P<0.05). CONCLUSION: The Persian version of the UFS-QOL questionnaire is a valid and reliable instrument to evaluate UFrelated symptoms and QOL among Iranian women.

Prevalence of Dysglycemia, Dyslipidemia, and Metabolic Syndrome among Patients with HIV Infection: a Cross-sectional Study from Iran.

Background: Human immunodeficiency virus (HIV) resulted in considerable morbidity and mortality. Following antiretroviral therapy (ART), the life expectancy of HIV-infected patients increased; however, they were more at risk of developing chronic diseases such as endocrinopathies. This study aimed to determine the prevalence of dysglycemia, dyslipidemia, and metabolic syndrome among patients with HIV infection. Methods: This cross-sectional study was conducted on HIV-infected patients referring to Loghman Hakim Hospital (Tehran, Iran) between April 2020 and April 2021. We examined demographic features, medical history, and laboratory tests indicating the metabolic status of the patients. Eventually, collected data were processed using SPSS version 23. Results: The mean age of 68 confirmed HIV patients was 39.85±10.54 years and 64.7% were male. BMI (MD = 2.57, 95% CI = [0.25, 4.88], P = 0.035), cholesterol (MD = 22.73, 95% CI = [4.70, 40.76], P = 0.014), HDL (MD = 8.54, 95% CI = [2.06, 15.02], P = 0.011), and LDL of women was significantly higher than men (MD = 22.43, 95% CI = [7.60, 37.27], P = 0.004). Additionally, 30 patients (44.1%) suffered from metabolic syndrome. The prevalence of metabolic syndrome differed significantly between men (34.1%) and women (62.50%) (P = 0.024). Conclusion: Dysglycemia, dyslipidemia, and metabolic syndrome are common among HIV-infected patients. Thus, periodic evaluation of the patients can be advantageous in early diagnosis and timely treatment.

Side effects after COVID-19 vaccination: a comparison between the most common available vaccines in Iran.

Background and Objectives: Since the coronavirus disease 2019 (COVID-19) pandemic began, several vaccines have been manufactured to subside it. This study aimed to determine the prevalence of side effects after injecting common COVID-19 vaccines available in Iran. Materials and Methods: This cross-sectional study was accomplished on Shahid Beheshti University of Medical Sciences (Tehran, Iran) employees during January and September 2022. Eligible participants were selected based on the simple random method and interviewed about side effects after injecting COVID-19 vaccine. Results: The mean age of 656 participants was 38.03 ± 9.53 years, and 453 (69.1%) were female. The prevalence of post-vaccination side effects was higher after receiving the first dose (53.2%) than the second (35.9%) and third (49.4%) doses. Across all three vaccine doses, the overall proportion of side effects was higher following AstraZeneca than the others. The most common side effect after the first dose of the vaccine was myalgia (41.9%), followed by fever (36.6%), chills (31.6%), local reactions (27.0%), headache (25.5%), and sweating (21.6%). People experienced mainly myalgia (23.3%) and fever (20.3%) after injecting the second dose of the vaccine. Additionally, the participants had myalgia (37.2%), fever (30.8%), chills (29.2%), local reactions (26.0%), and headache (24.4%) after the third dose of the vaccine. Conclusion: AstraZeneca had a higher proportion of post-vaccination adverse effects than Sputnik V, Pastocovac, and Sinopharm. The most common side effects were flu-like syndrome and local reactions at the injection site. Furthermore, people rarely experienced life-threatening side effects. Thus, the available COVID-19 vaccines in Iran are safe.

Menstrual disturbances following COVID-19 vaccination: A probable puzzle about the role of endocrine and immune pathways.

Menstruation is a monthly shedding of the uterine wall, presented by menstrual bleeding in women of reproductive age. Menstruation is regulated by fluctuation of estrogen and progesterone, as well as other endocrine and immune pathways. Many women experienced menstrual disturbances after vaccination against the novel coronavirus in the last two years. Vaccine-induced menstrual disturbances have led to discomfort and concern among reproductive-age women, such that some decided not to receive the subsequent doses of the vaccine. Although many vaccinated women report these menstrual disturbances, the mechanism is still poorly understood. This review article discusses the endocrine and immune changes following COVID-19 vaccination and the possible mechanisms of vaccine-related menstrual disturbances.

Coincidence of Candida Endophthalmitis, and Aspergillus and Pneumocystis jirovecii Pneumonia in a COVID-19 Patient: Case Report.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) is associated with immune system dysfunction and makes patients vulnerable to opportunistic infections. This report presents a patient with a history of COVID-19, suffering from opportunistic infections. CASE DESCRIPTION: We reported a 64-year-old man complaining of progressive visual loss in his left eye, who had previously been hospitalized for three weeks due to COVID-19. In the ophthalmologic assessment, large foci of dense subretinal and intraretinal infiltrations involving the macula were observed (compatible with endogenous fungal endophthalmitis). Real-time PCR result of intraocular fluid was positive for Candida spp. During subsequent hospitalization, the patient also suffered from fever and productive coughs (manifestations of pneumonia caused by Aspergillus fumigatus and Pneumocystis jirovecii). In response to antibiotic therapy, the fever and coughs subsided, and the ocular examination revealed a dramatic decrease in the size of retinal infiltrations. CONCLUSIONS: In patients with severe COVID-19, long-term ICU admission and immunosuppressive drugs lead to immune system dysfunction and make the patient more susceptible to opportunistic infections. Consequently, fungal pathogens such as Aspergillus, Pneumocystis jirovecii, and Candida spp. may cause infection in different body organs. Thus, clinicians should be alert and have clinical suspicion to diagnose accurately and manage patients accordingly.

Adnexal torsion in pregnancy: A systematic review of case reports and case series.

OBJECTIVES: This study aimed to investigate clinical presentations, surgical procedures and findings, complications, and predisposing factors of adnexal torsion in pregnant women. METHODS: We searched PubMed/Medline, Embase, and Web of Science from January 2000 to March 2022. All case reports and case series with full-text English language reporting adnexal torsion in pregnant women were included. Medical history, clinical presentations, surgical procedures and findings, complications related to adnexal torsion, and predisposing factors were independently extracted by two investigators. RESULTS: A total of 182 articles reporting 662 pregnant women with adnexal torsion were included. Most of the adnexal torsions occurred during the first trimester (54.63%), while others occurred during the second (26.36%) and third (19.00%) trimesters. The most common symptom of adnexal torsion was sudden-onset pain (80.60%). Enlargement of the adnexa was the most prevalent ultrasound finding in a twisted adnexa (95.20%). Additionally, about half of the patients had decreased blood flow in Doppler ultrasound (53.80%). Laparoscopic surgery was the favorite option (56.88%), while cystectomy and detorsion were the most commonly performed procedure (29.06%). Expectant management was reported in only 2.99% of the patients. In addition, the most common complications were preterm labor (27.58%) and emergent cesarean sections (25.28%). CONCLUSIONS: Clinicians should think of adnexal torsion when pregnant women complain of sudden-onset pain. Then, using ultrasound, adnexal enlargement or masses should be explored seriously. They should take invasive and urgent therapy to preserve ovaries and prevent complications.

Efficacy of olive leaves extract on the outcomes of hospitalized covid-19 patients: A randomized, triple-blinded clinical trial.

INTRODUCTION: Since the emergence of the novel coronavirus, herbal medicine has been considered a treatment for COVID-19 patients. This study was done to determine the efficacy of olive leaf extract on the outcomes of COVID-19 patients. MATERIALS AND METHODS: This randomized, triple-blinded clinical trial was conducted on hospitalized COVID-19 patients. Using block randomization, eligible patients were allocated to the following groups: intervention A received olive leaf extract (250 mg every 12 hours for five days), intervention B received olive leaf extract (500 mg every 12 hours for five days), and the control group received placebo (every 12 hours for five days). The outcomes (vital signs, laboratory tests, and length of hospitalization) were compared by group. RESULTS: Of the 150 patients randomized into groups, 141 completed the follow-up and were analyzed. On the fifth day of hospitalization, body temperature (MD=0.34, P<0.001), pulse rate (MD=5.42, P=0.016), respiratory rate (MD=1.66, P=0.001), ESR (MD=13.55, P<0.001), and CRP (MD=15.68, P<0.001) of intervention A were significantly lower than the control group, while oxygen saturation (MD= -1.81, P=0.001) of intervention A was significantly higher than the control group. Furthermore, body temperature (MD=0.30, P=0.001), pulse rate (MD=5.29, P=0.022), respiratory rate (MD=1.41, P=0.006), ESR (MD=14.79, P<0.001), and CRP (MD=16.28, P<0.001) of intervention B were significantly lower than the control group, while oxygen saturation (MD= -2.38, P<0.001) of intervention B was significantly higher than the control group. CONCLUSION: Olive leaf extract can improve the clinical status of the patients and decrease the length of hospitalization.

Case Report: Pneumonia in a Patient With Combined Variable Immunodeficiency: COVID-19 or Pneumocystis Pneumonia?

Combined variable immunodeficiency (CVID) is a primary immunodeficiency, characterized by impairment in immune system function. These patients are susceptible to opportunistic infections, which may mimic COVID-19 manifestations. Also, misdiagnosis or delayed diagnosis of opportunistic infections can lead to perilous consequences. We report a 28-year-old woman with a history of combined variable immunodeficiency disorder (CVID) and ulcerative colitis (UC) complained of fever, cough, and dyspnea. According to the clinical and radiological manifestations and the COVID-19 epidemic, she was admitted with a primary diagnosis of COVID-19 pneumonia. After a week, the patient did not respond to treatment, so she underwent bronchoscopy. Using polymerase chain reaction (PCR) methodology, we detected DNA of Pneumocystis jirovecii, the causative agent of a life-threatening pneumonia (PCP), in respiratory specimens. The patient was hypersensitive to common PCP treatments, so she was treated with high-dose clindamycin. However, the patient's clinical condition aggravated. Besides, we found evidence of pneumothorax, pneumomediastinum, and pneumopericardium in chest CT scan. We inserted a catheter for the patient to evacuate the air inside the mediastinum. Also, we added caspofungin to the treatment. The patient eventually recovered and was discharged from the hospital about a week later. Thus, during the COVID-19 epidemic, in febrile patients with respiratory symptoms, physicians should not think only of COVID-19. They must consider opportunistic infections such as PCP, especially in immunocompromised patients.

Levofloxacin versus ceftriaxone and azithromycin for treating community-acquired pneumonia: a randomized clinical trial study.

Background and Objectives: We compared two common antibiotic regimens for the treatment of mild to moderate CAP: levofloxacin versus ß-lactam and macrolide combination; in terms of their efficacy and side effects. Materials and Methods: Patients with mild to moderate CAP were randomized into two groups. Group I received a combination of 1 gram ceftriaxone daily and 500 mg azithromycin daily for 5-7 days. Group II received levofloxacin 750 mg daily for five days. The signs and symptoms, hospitalization length, and the side effects were investigated. Results: There were 77 and 74 patients in groups I and II. The vital signs of group II were significantly better on the 3rd day of admission, except for the temperature (P=0.09). The O2 saturation of group II was markedly improved on the 5th day of admission (P=0.0061). In terms of clinical symptoms and hospitalization length, group II was considerably better. However, the rate of side effects in both groups was similar (P=0.885). Conclusion: Hospitalized patients with mild to moderate CAP might take more advantage of fluoroquinolone administration. It could improve the patients' signs and symptoms and reduce hospitalization length, compared with the combination of macrolide and cephalosporin, with the same rate of side effects.