Comparing infusion-related reactions of the first full dose (600 mg) biosimilar ocrelizumab administration with the standard divided protocol in multiple sclerosis patients: a randomized controlled trial study.

BACKGROUND: Ocrelizumab is a humanized antiCD20, thought to be a highly effective disease-modifying therapy (DMT). Its most frequent adverse effects are infusion-related reactions (IRRs). To reduce these reactions, the first dose of ocrelizumab is administered as two 300 mg infusions separated by two weeks. However, in the phase II trial of ocrelizumab, severe IRRs were not significantly different between two doses of 600 mg dose (two separate 300 mg doses) and 2000 mg dose (two separate 1000 mg doses). We compared the IRRs in undivided full (one 600 mg) and divided (two 300 mg) doses of ocrelizumab which is the standard protocol. METHODS: MS patients (relapsing or primary progressive MS) who are selected to receive ocrelizumab by neurologist or MS fellowship were enrolled in an open-label randomized controlled trial. Iranian biosimilar of the drug (Xacrel® by Cinnagen, approved by the Iranian Food and Drug Administration in 2021) was used. The participants received the first dose of ocrelizumab as either one 600 mg dose in one session or two 300 mg doses in two weeks apart. IRRs during or in the first 24 h after infusion were recorded. RESULTS: Of 332 participants, 150 received two 300 mg doses, and 182 received one 600 mg dose (by random selection). Life-threatening adverse effects were not observed in both groups. Overnight admission or permanent drug discontinuation was not needed. Temporary drug discontinuation was significantly higher in the one 600 mg dose group (p-value < 0.001). During the infusions, malaise (p-value: 0.003), skin reactions (p-value: 0.04), throat swelling (p-value: 0.03), and dyspnea (p-value: 0.01) were significantly increased in the intervention group. However, in the first 24 h, there was no significant difference between two different treatment protocols (one 600 mg dose or two 300 mg doses) in the onset of IRRS (p-value: 0.12). CONCLUSION: These findings suggest one 600 mg dose of ocrelizumab administration for the first dose is relatively safe. With some protocol modifications, it could lead to fewer patient referrals, saving time and cost and improvement the access for patients.

Clinical and laboratory features of pertussis in hospitalized infants with confirmed versus probable pertussis cases.

BACKGROUND: The clinical presentations of pertussis infection have considerable variation. Many infections and illnesses can cause prolonged repetitive paroxysmal cough that could be confused with Bordetella pertussis infection. AIM: This retrospective study was designed to compare the clinico-laboratory findings between two groups of hospitalized infants with confirmed, and those who have clinical pertussis disease; to identify the possible additional diagnostic clues "for the diagnosis of confirmed pertussis disease". SUBJECTS AND METHODS: The study population consisted of infants ≤12 months of age with clinical diagnosis of pertussis that fulfilled the World Health Organization definition for pertussis or those diagnosed by physicians. Clinico-laboratory findings were compared between two groups of patients (confirmed vs. clinical cases). RESULTS: From a total of 118 infants admitted with a clinical diagnosis of pertussis, 16% (19/118) were confirmed by laboratory to have confirmed pertussis. Twelve of 19 (63%) and 71.99% of confirmed and clinical cases were younger than 6 months of age, respectively. For most patients, the duration of symptoms before hospitalization was <14 days. There were no significant differences between two groups of patients for paroxysmal cough and facial discoloration. However, whoop and apnea were more common among confirmed pertussis cases: P = 0.01, and P = 0.02, respectively. Leukocytosis (≥16,000/ml) (P = 0.01) and lymphocytosis (≥11,000) (P = 0.02) were reported significantly more frequently in confirmed pertussis cases. CONCLUSION: Given the unavailability of a highly sensitive diagnostic test, in every afebrile patient with paroxysmal cough lasting for ≥7 days associated with whoop and/or apnea, particularly if accompanied by leukocytosis/lymphocytosis, pertussis disease should be considered. In this situation, prompt administration of empiric treatment for cases, and providing control measures to prevent infection transmission to contacts are recommended.

Fluticasone nasal spray as an adjunct to Amoxicillin for acute sinusitis in children: a randomized controlled trial.

BACKGROUND: Approximately 0.5-2% of upper respiratory tract infections in adults and 6-13% of viral upper respiratory tract infections in children are complicated by acute sinusitis. This study was aimed to evaluate the coadministration effect of fluticasone nasal spray (FNS) with amoxicillin for AS in children. MATERIALS AND METHODS: One hundred children 2 to 14 years of age with acute sinusitis referred to Shahid Mohammadi Pediatric Hospital in Bandar Abbas were randomly allocated into two equal intervention and control groups to receive amoxicillin with fluticasone nasal spray one puff twice daily for 14 days and amoxicillin 80 to 100 mg/kg/ day for 14 days respectively. RESULTS: Twenty one (42%) of children in intervention group were cured completely and 2 (4%) children in control group had complete recovery (p < 0.001). Symptom severity score was 22.98 ± 2.95 before treatment that reduced to 13.26 ± 3.20 after treatment (p < 0.001). CONCLUSIONS: Use of fluticasone can reduce the severity of symptoms of sinusitis in children.

Assessment of coagulation state and its related factors in thalassemia intermedia patients referred to thalassemia research center at Booali Sina Hospital Sari/IR Iran in 2007.

A high incidence of thromboembolic events have been reported among thalassemia intermedia patients especially in splenectomized patients. This study has been conducted to evaluate the coagulation state of patients referred to thalassemia research center at Booali Sina Teaching Hospital, Sari, Iran. This descriptive-cross sectional study was performed in 2007. Sixty thalassemia intermedia patients aged older than 10 years were enrolled. After recording demographic and therapeutic data of the participants, the plasma levels of Coagulant factors were measured. Obtained Data were analyzed using SPSS 13 software and t-test and chi-square tests. Of 60 studied patients, 62% were female. The mean age of the patients was 26.6 +/- 9.3 years. ASA tablet were used in 53.3%. None of the patients have experienced thromboembolic events. Decrease in protein C has been observed in 60%. Antithrombin III was decreased in 42% and protein S declined in 10% of the patients. Mutation in factor V leiden was seen in 3%. Splenectomy performed in 53.3% and there was no significant relation between low level of protein C and protein S, antithrombin III and presence of factor V Leiden with splenectomy (p > 0.05). Regarding to the high incidence of low levels of protein C, protein S and antithrombin III among thalassemia intermedia patients, there is an increased risk of thromboembolic events in the patients.

Evaluation of mental health status in caregivers of patients with chronic psychiatric disorders.

The aim of this study was to evaluate mental health status in caregivers of patients with chronic psychiatric disorders. This descriptive-analytic study performed in Mazandaran Province Northern Iran from 2007 to 2008. Two hundred caregivers of patients with sever psychiatric disorders completed (GHQ-28) and Demographic questionnaire. Sever psychiatric disorders is referred to patients with schizoaffective or schizophrenia or bipolar mood disorder that at least 2 years was passed from onset of disease. Data were analyzed in descriptive statistical method with SPSS soft ware. Thirty five percent of caregivers had GHQ > 23 and no mental health. Significant association found between patients age, age of onset of disease with GHQ Score (p = 0.0001). Caregivers' GHQ score correlated with marital status in patients, although this was not significant (p = 0.08). The chi2 test didn't show significant relationship between duration and type of disease and patient's sex and caregiver's sex with GHQ score. According to the results of our study, it seems that further investigations with more samples and other questionnaires need to evaluate of caregivers requirements and it is suggested that a logical planning be conducted by the authorities, to decrease caregivers' burden.

Changes in functional status and functional capacity following coronary artery bypass surgery.

The aim of the present study was to compare changes in health related-quality of life (H-RQOL) on physical functioning and mental health domains, changes in functional capacity before and 18 months after CABG surgery. Comprehensive data on 187 patients who underwent CABG surgery were prospectively collected, including preoperative factors and postoperative morbidity. Assessing functional status, the change in physical functioning score and change in mental health score were obtained using the physical functioning and mental health subscales out of the eight total subscales of the (SF-36) questionnaire. Also, functional capacity was estimated according to New York Heart Association (NYHA) class. The results showed 18 months after CABG surgery survival rates were (95.7%). Significant improvements in functional status were seen in physical functioning (p < 0.001), mental health (p < 0.000). However, there were no significant changes in the mean of functional status scores among patients in three age groups. Other significant improvement was found in functional capacity and NYHA class before and the 18 months after CABG. Functional status markedly and significantly improved after CABG surgery, particularly in physical functioning. However, the functional status among survivors of CABG surgery is worse than that of the general population. It seems further research is needed to identify factors explaining the change in H-RQOL to develop interventions to support patients.

The relationship between maternal serum magnesium level and preterm birth.

The aim of this study was to evaluate the relationship between maternal serum magnesium levels and preterm birth. This Nested case-control study carried out on 20 with preterm birth and 20 women at term birth at Imam Khomeini Hospital in Sari/Iran in 2008. The women with singleton gestation and intact fetal membrane suspected to preterm labor (case group), 10 cc blood samples were drawn into syringes and sent to laboratory of the hospital immediately. Sampling for control group was same as the case group. These samples recognized as control group just as birth occurring after week 37. Finally, serum magnesium level measured. Data analyzed using chi2, t-test and OR (Odd's Ratio). There was a relationship between the number of prenatal visits (p = 0.008) and stressful events associated with preterm birth (p < 0.02). Serum magnesium level was associated with preterm birth OR = 4.75, CI 95% = (0.48-46.91), Sensitivity, specificity, positive and negative predictive value of serum magnesium for preterm birth was 95, 50, 66.5 and 83.33%, respectively. Although, there was a correlation between serum magnesium levels and preterm birth, due to methodology of the study, a cohort study with the same cut off point and supplementation of magnesium in RTC studies is recommended.

Assessment the effect of midazolam sedation on hypoxia during upper gastrointestinal endoscopy.

The aim of this study was to evaluate the prevalence of hypoxia related to midazolam sedation during upper gastrointestinal endoscopy. This single blind randomized placebo control clinical trial, carried out on 180 patients who referred to endoscopy clinic at Imam Khomeini Hospital for selective upper gastrointestinal endoscopy from April to July in 2008. Informed consents obtained from all participants. Patients under 18-years-old, obese, previous history of asthma, COPD and cigarette smoking were excluded. Arterial hemoglobin saturation controlled by finger probe pulse oximetry. After pharyngeal lidocaine spray, midazolam was administered intravenously in case group and patients in controlled group received placebo. Demographic characteristics and other variables were recorded in a questionnaire and data analyzed using SPSS software. Gastrointestinal disturbances and epigastric pain were major indications of endoscopies. The most common endoscopic diagnoses were deudonitis, esophagitis or gastroesophagial reflux. No patients had any serious episode of hypoxia and the incidence of mild hypoxia was not significant in both studied group (p = 0.823). There was no significant difference in arterial oxygen saturation recorded by the three endoscopists (p = 0.734). Our data showed that optimal dose of sedation had no hypoxia. So that, we recommend sedative endoscopy in patients without risk factors for hypoxia.

Seroprevalence of hepatitis C infection and associated risk factors among addicted prisoners in Sari-Iran.

The aim of this study was to determine the seroprevalence of hepatitis C infection and associated risk factors among addicted prisoners in Sari-Iran. This is a simple random sampling cross sectional study that was performed on 312 addicted prisoner men at Khazarabad addicts' prison in Sari/Iran in September 2001. Their blood samples were examined through third generation enzyme immunoassay. Data were collected through questionnaires and interview. Associated risk factors were compared in 82 hepatitis C antibody positive addicts (the affected group) and 148 hepatitis C antibody negative addicts (the unaffected group). Out of 312 addicted prisoners, 96 were hepatitis C anti body positive. The seroprevalence of hepatitis C infection was found to be 30.8%. Major associated risk factors in the affected group were as follows: duration of addiction, duration of imprisonment (mean 48 months), route of drug administration, length of alcohol consumption, tattooing, shared usage of needles and razors, multiple sexual partners and type of drugs (p < 0.05). On multivariate logistic regression analysis these factors were found to be significant independent risk factors for HCV infection: tattooing (OR 100, 95% CI), multiple sexual partners (OR 4.97, 95% CI) and history of surgery (OR 6.23, 95% CI). It is concluded that hepatitis C infection had a considerable prevalence in addicted prisoners. High risk and unsafe behaviors were found to be the main factors of contamination.