Iranian Journal of Medical Sciences最新文献

Background: Fetal growth restriction (FGR) results from uteroplacental insufficiency and currently lacks an absolute cure. Statins may offer therapeutic potential by addressing this insufficiency. This study aimed to investigate the effectiveness of rosuvastatin in improving the perinatal outcomes in FGR pregnancies.

Methods: A double-blind, randomized placebo-controlled clinical trial was conducted on 78 FGR pregnancies referred to tertiary centers affiliated with Shiraz University of Medical Sciences (Shiraz, Iran) from January 21, 2023, to March 21, 2023. The participants were randomly divided into two groups using the block randomization method to receive either 5 mg rosuvastatin or placebo daily from FGR diagnosis until delivery. Evaluated outcomes included birth weight, umbilical artery pulsatile index reduction, fetal weight gain, vaginal delivery rate, preterm birth (PTB) incidence, 5-min Apgar score <7, neonatal death, neonatal intensive care unit admission, intraventricular hemorrhage, respiratory distress syndrome, necrotizing enterocolitis, and preeclampsia. The data were analyzed using regression models, reporting mean difference (95% CI), frequency (relative frequency), and odds ratio with 95% confidence interval (OR [95% CI]). Statistical significance was set at P<0.05.

Results: The study included 34 subjects in the rosuvastatin group and 44 subjects in the placebo group, with no significant differences in baseline characteristics. However, the rosuvastatin group showed significantly better outcomes in birth weight (276.27 g, 95% CI=32.61-519.93, OR=1.002, 95% CI=1-1.003), umbilical artery pulsatililty index reduction (0.21 g, 95% CI=0.00-0.43, OR=6.600, 95% CI=1.680-25.930), fetal weight gain (312.51 g, 95% CI=90.50-534.52, OR=1.001, 95% CI=1-1.002), and vaginal delivery rate (6/34 [17.6%] vs. 1/44 [2.3%]; OR=9.210, 95% CI=1.050-80.680). Additionally, the rosuvastatin group had significantly lower PTB rates (15/34 [44.10%] vs. 30/44 [68.20%]; OR=0.370, 95% CI=0.150-0.930). Neonatal health status showed no significant differences between groups.

Conclusion: Rosuvastatin demonstrated improved perinatal outcomes in FGR pregnancies without adverse neonatal effects.Trial Registration Number: IRCT20140317017035N8.

Background: Non-adherence to treatment in patients with beta-thalassemia major (BTM) presents a significant challenge in effective disease management. This study aimed to assess the effect of a therapy reminder application (app) on treatment adherence in adult patients with BTM in Mashhad in 2024.

Methods: A randomized clinical trial was conducted in 2024 at a thalassemia clinic affiliated with Mashhad University of Medical Sciences (Mashhad, Iran). Participants were randomly assigned to the intervention and control groups, using permuted block randomization, with concealed allocation. The intervention group used the ThalaMe therapy reminder app for 8 weeks (February-July 2024), while the control group received standard care. Medication adherence was measured using the Morisky Medication Adherence Scale (MMAS-8) and the Chronic Disease Treatment Adherence Questionnaire (CDTAQ) before and after the intervention. Statistical analysis was conducted using SPSS software, using paired t tests or Wilcoxon signed-rank tests for within-group comparisons and independent t tests or Mann-Whitney U tests for between-group comparisons. P<0.05 was considered statistically significant.

Results: The study included 76 adult patients with BTM, equally distributed between the intervention and control groups (n=38 each). Baseline measurements showed no significant differences between groups in either MMAS-8 scores (P=0.75) or CDTAQ scores (P=0.11). The MMAS-8 was inversely scored, with lower scores indicating higher adherence. Following the 8-week intervention period, the group using the ThalaMe app demonstrated significantly better adherence outcomes (1.05±0.78) than the controls (2.92±1.4, P<0.001). The intervention group had significantly higher CDTAQ scores (185.5±8.07) than the control group (151.79±27.08, P<0.001).

Conclusion: The therapy reminder app significantly enhanced medication adherence and treatment management in patients with BTM, while simultaneously enhancing patient and family engagement through counseling.Trial Registration Number: IRCT20240222061079N1.

Background: Premature birth (delivery before 37 weeks of gestation) is a leading cause of neonatal morbidity and mortality worldwide. Specific genetic polymorphisms were associated with immune and inflammatory pathways that might contribute to its pathogenesis. This study investigated the associations between preterm birth and sociodemographic indicators, clinical outcomes, genetic polymorphisms, and microbial factors in Kazakh women.

Methods: This case-control study was conducted from September 2022 to September 2023. It enrolled women with preterm and full-term births in Kyzylorda, Kazakhstan. Data included sociodemographic, clinical variables, genotyping (TLR2 rs4986790 and MBL2 rs11003125), and microbial data. The quantification of Fusobacterium nucleatum (F. nucleatum) in saliva samples was performed using TaqMan real-time PCR. Statistical analysis was conducted using SPSS software (version 26), employing independent sample t tests, Chi square tests, Mann-Whitney U tests, and logistic regression. The level of significance was set at P<0.05.

Results: Sociodemographic analysis showed no significant differences between the studied groups, except for a higher prevalence of previous preterm birth in the case group. Clinical comparisons revealed significantly lower gestational age at delivery, reduced newborn weight and height, decreased placental weight and dimensions, lower hemoglobin levels, and erythrocyte counts in preterm cases. Genetic analysis demonstrated that all women with preterm labor carried the homozygous AA genotype of TLR299 rs4986790, while the GG genotype and the G allele of the MBL2 rs11003125 gene were predominant in this group. Furthermore, the quantitative analysis identified significantly higher F. nucleatum levels associated with premature birth, highlighting a potential microbial role in its pathogenesis.

Conclusion: These findings suggested that a history of preterm birth, specific genetic polymorphisms, and microbial factors collectively were associated with an increased risk of preterm birth.

Background: Peritendinous adhesion as a common post-surgical complication usually occurs as a result of a large portion of sports and hard job-related injuries. This study aims to evaluate the repurposed potential of the immunosuppressive approved drug, tacrolimus, in decreasing adhesion band formation post-Achilles tendon surgeries in an animal model.

Methods: Rats were randomly assigned to four groups control, sham with surgical intervention but no adhesion, positive control group with surgical transection and adhesion received no treatment, tacrolimus group was the same as the positive control group except that rats were treated with 2 mg/Kg/day tacrolimus orally for 21 days. The anti-inflammatory and fibrinolytic properties of oral tacrolimus treatment in attenuating the formation of adhesion bands were analyzed by One-way ANOVA or the Kruskal-Wallis test.

Results: Tacrolimus decreased the length (P=0.001), density (P=0.001), grading (P=0.023), severity (P=0.001), and thickness (P=0.008) of post-surgical adhesion bands compared to the untreated group. Histopathological changes and recruitment of inflammatory cells to the tendon tissue sections were attenuated in the tacrolimus-treated group (P=0.001) in comparison with the positive control group. Compared to the untreated group, tacrolimus treatment decreased the expression of IL-1β (P=0.059) in the tendon tissue, but the difference was not statistically significant. Moreover, tacrolimus elicited anti-fibrotic responses by reducing the expression of tissue growth factor-β (TGF-β) in the tendon and inhibiting collagen deposition, fibrosis quantity (P=0.001), fibrosis grading (P=0.001), and total fibrosis scores (P=0.001), as visualized by Masson's trichrome staining.

Conclusion: These results support the protective properties of tacrolimus in decreasing post-operative adhesion band formation in the animal model.

Background: Modulation of intestinal barrier, which function through zonulin pathway downregulation, represents a promising therapeutic strategy for chronic diseases. This systematic review aimed to evaluate the effects of prebiotic dietary fibers, probiotics, and synbiotics on intestinal permeability and immunity.

Methods: A systematic literature search of the EMBASE, PubMed, Web of Science, and Scopus electronic databases was conducted from database inception up to May 2024, supplemented by manual reference list searches. Included studies met the following criteria: (a) English language publications; (b) clinical trials; (c) investigated each factor of serum or fecal zonulin levels, serum or fecal calprotectin, glucagon-likepeptide-2 (GLP-2), short chain fatty acids (SCFAs), long chain fatty acids (LCFAs), fecal bile acid (BA), LPS-binding protein (LBP), lipopolysaccharide (LPS), intestinal microbiota composition, or inflammatory factors such as interleukin 6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP); (d) supplemented prebiotic dietary fibers, probiotics, or symbiotics. Studies were excluded if they contained insufficient data or involved supplementation alongside other interventions. The study quality and risk of bias were assessed using Jadad's Score.

Results: A total of 36 studies were included in this review. Of these, 14 articles (n=580 participants) evaluated the effect of dietary prebiotics, 18 articles (n=1502 participants) evaluated the effect of probiotics, and six articles (n=517 participants) examined the effect of synbiotics on intestinal health and immunity markers. According to the evidence presented in this study, prebiotic whole foods or food enriched with prebiotics, probiotics, and synbiotics might have favorable effects on the serum levels of zonulin as a measure of intestinal permeability. The effects on GLP-2, gut microbiota, and their metabolites (e.g., LCFAs/SCFAs and BA) were contradictory and inconclusive. Some studies indicated increased levels of Bifidobacteria and SCFA with prebiotic supplementation or prebiotics-enriched food products. Fecal calprotectin (as an important marker of the local gut inflammation), tumor necrosis factor-α (TNF-α), and hs-CRP were unaffected in most studies.

Conclusion: The lack of consistent replication across studies made it difficult to draw definitive conclusions about the effects of prebiotics, probiotics, and synbiotics on gut-related health and immunity. Therefore, further evidence is required before definitive recommendations can be established.

Background: Exosomal molecules derived from cancer cells have been recognized as candidate biomarkers for cancer diagnosis and prognosis. This study aimed to evaluate the potential of the LDH-C4 expression level in cervical carcinoma.

Methods: A retrospective study was conducted on patients with cervical carcinoma at the Third Hospital of Hebei Medical University, in Shijiazhuang, China, between July 2021 to September 2023. Peripheral blood was obtained, and serum and exosomes were extracted. Lactate dehydrogenase (LDHC) gene expression levels were quantified using reverse transcription-quantitative polymerase chain reaction (PCR), and these were compared with protein expression levels in cervical carcinoma tissues. Statistical analyses, including independent t tests, Chi square tests, receiver operator characteristic (ROC) curves, Kaplan-Meier analysis, and subsequent log-rank tests, were performed with the SPSS software version 21. Univariate and multiple analyses were used to analyze independent prognostic risk factors. P<0.05 was considered statistically significant.

Results: A total of 220 individuals were recruited, including 120 with cervical carcinoma and 100 healthy controls. In patients with cervical carcinoma, the LDHC gene expression levels were 5.58% and 11.28% in serum and exosomes of healthy donors and were 79.38% and 66.27% in patients with cervical carcinoma. There was a statistically significant difference in the LDHC expression between the patient group and the control group (P=0.008, in serum; P=0.011, in exosomes). In addition, LDH-C4 protein expression was associated with histology grade (P=0.022), tumor stage (P=0.019), and lymph node metastasis (P=0.016). The overall survival of patients with cervical carcinoma with positive LDH-C4 expression was 83.54%; patients with a higher LDH-C4 expression exhibited a poorer overall survival rate than those with lower LDH-C4 expression. Multiple Cox regression analysis demonstrated that LDH-C4 expression is a poor independent prognostic factor for patients with cervical carcinoma.

Conclusion: LDH-C4 levels in serum and exosomes may exhibit potential in identifying patients with cervical carcinoma, thus providing a novel approach for the early screening of cervical carcinoma.

Different side effects have been reported for leech therapy, such as local itching, skin reactions, infection, bleeding disorders, and anemia. The present study described a rare and lethal adverse event following leech therapy. A 63-year-old man was referred to Nemazee Teaching Hospital (Shiraz, Iran) in December 2020 with a two-week history of progressive right lower extremity swelling, erythema, and ecchymosis. One week before symptom onset, he had undergone leech therapy on the lateral calf and upper thigh of the right lower extremity, administered by a traditional healer. Physical examination revealed gangrene of the right leg and absence of all pulses. Color Doppler sonography of the leg and computed tomography angiography (CTA) of the thoracic aorta to the lower extremities revealed complete thrombosis of all right lower extremity arteries, extending to the right iliac artery and abdominal aorta. With a diagnosis of arterial occlusive disease and septic thrombophlebitis, the patient received intravenous antibiotics and anticoagulant therapy. Due to the inadequacy of medical treatments, a right lower extremity amputation was performed. The patient expired 5 days postoperatively due to septic shock and multiorgan failure.

Background: Sickle cell disease (SCD) prevalence is predicted to rise dramatically in the upcoming years. Although several medications have received Food and Drug Administration (FDA) approval in recent years, low- and middle-income countries (LMICs) still struggle to access these medications due to their remarkably high prices. Crizanlizumab, owing to its clinical and economic privileges, appears to be the most suitable option for addition to pharmacotherapy guidelines. However, no study has yet investigated its cost-effectiveness in Iran's healthcare system.

Methods: This cost-effectiveness evaluation was conducted in 2022 at the Pharmacoeconomic and Pharmaceutical Administration Department of the Faculty of Pharmacy at Tehran University of Medical Sciences, Tehran, Iran. A decision-tree model was designed, followed by a cost-utility analysis for crizanlizumab in two separate scenarios, targeting not only monotherapy with crizanlizumab in SCD compared with placebo, but also crizanlizumab's concomitant use with hydroxyurea compared with hydroxyurea. The study reports the outcomes from Iran's healthcare system perspective. Direct medical costs, quality-adjusted life years related to vaso-occlusive crisis, hospitalizations, and adverse effects were calculated. Incremental cost-effectiveness ratios were compared. SUSTAIN trial was the main clinical source for modeling crizanlizumab's effectiveness in SCD. A sensitivity analysis was performed to measure the sensitivity of outcomes to changes in medication costs. Microsoft Excel 2020 was utilized for calculations and modeling.

Results: Concomitant therapy with low-dose crizanlizumab added to hydroxyurea led to the lowest Incremental Cost Effectiveness Ratio (ICER) of 398,881 United States dollars (USD), exceeding Iran's accepted cost-effectiveness threshold. Sensitivity analysis results demonstrate that even a 20% reduction in the price of crizanlizumab does not lead to its cost-effectiveness in Iran.

Conclusion: Crizanlizumab administration in sickle cell disease is not found cost-effective in Iran, neither as a monotherapy nor added to hydroxyurea.