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Nevin Manimala Statistics

Clinical significance of drug cessation on medication-related osteonecrosis of the jaw in patients with osteoporosis

J Korean Assoc Oral Maxillofac Surg. 2023 Apr 30;49(2):75-85. doi: 10.5125/jkaoms.2023.49.2.75.

ABSTRACT

OBJECTIVES: Suspending bisphosphonates (BPs) to reduce the risk and severity of medication-related osteonecrosis of the jaw (MRONJ) remains controversial. In this study, we quantitatively evaluated the clinical significance of BP suspension before surgery in osteoporosis patients with MRONJ.

MATERIALS AND METHODS: We analyzed 24 osteoporosis patients with MRONJ who were treated from 2012 to 2020 at Seoul National University Dental Hospital and compared the treatment outcomes of those who suspended BPs with those who did not. The number of surgical interventions, follow-up panoramic radiographs for relative bone density measurement, and laboratory blood tests including white blood cells, erythrocyte sedimentation rate, absolute neutrophil count, hemoglobin, hematocrit, and alkaline phosphatase were analyzed. ANOVA, Student’s t -test, and Mann-Whitney U tests were used to compare results. Fisher’s exact test was used to discover the association between treatment outcome and BP suspension, and Pearson’s correlation test was used to measure the statistical relationship between the changes in serum inflammatory markers.

RESULTS: The number of interventions was significantly higher in the non-drug suspension group due to recurrence (p<0.05). The relative bone density in patients who suspended BPs was significantly different over time (p<0.05), with the highest density at one-year follow-up. Fisher’s exact test shows an association between successful treatment outcomes and BP suspension. The alkaline phosphatase and erythrocyte sedimentation rate levels decreased significantly in the BP-suspended group, and a positive correlation was found between these elevated markers.

CONCLUSION: A significant increase in bone density throughout follow-up and a lower number of interventions were found in the BP suspension group compared to the non-drug suspension group. Also, BP suspension decreased inflammatory markers in the serum after surgery, resulting in good treatment outcomes. BP suspension is a prognostic factor for MRONJ and should be implemented before surgery.

PMID:37114445 | DOI:10.5125/jkaoms.2023.49.2.75

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The effect of drug holiday before tooth extraction on the development of medication-related osteonecrosis of the jaw in cancer patients receiving intravenous bisphosphonates

J Korean Assoc Oral Maxillofac Surg. 2023 Apr 30;49(2):68-74. doi: 10.5125/jkaoms.2023.49.2.68.

ABSTRACT

OBJECTIVES: Drug holidays are suggested to reduce the formation of osteonecrosis in patients under intravenous (IV) bisphosphonates (BPs) therapy. The objectives of this study are to evaluate the incidence of medication-related osteonecrosis of the jaw (MRONJ) following tooth extraction in cancer patients using IV BP, and to assess the effect of drug holiday on the development of MRONJ. Patients and.

METHODS: A manuel search of the patient folders of Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hacettepe University was undertaken to identify cancer patients who used IV BPs and had at least one tooth extraction between 2012 and 2022. Patents’ age, sex, systemic condition, the type of BP used, duration of BP used, number of tooth extraction, duration of drug holiday, localization of tooth extraction and incidence of MRONJ were recorded.

RESULTS: One hundred nine teeth were removed from 57 jaws in 51 patients. All tooth extractions were performed under perioperative antibiotic prophylaxis and with primary wound closure. The incidence of MRONJ was 5.3%. Stage 1 MRONJ developed in 3 patients (only one had a drug holiday). The median duration of drug holiday was 2 months. No significant difference between the patients with and without a drug holiday and MRONJ development was found (P=0.315). The mean age of patients developed MRONJ was 40.33±8.08 years. A statistically significant difference was found between age and MRONJ development (P=0.002).

CONCLUSION: The effect of a short-term drug holiday on the development of MRONJ may be limited because BPs remain in bone tissue for a long time. Drug holidays should be applied with the approval of an oncologist with other preventive measurements.

PMID:37114444 | DOI:10.5125/jkaoms.2023.49.2.68

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Clinical features and treatment effect of HIV-associated immune thrombocytopenia-single center Ten-Years data summary

Platelets. 2023 Dec;34(1):2200836. doi: 10.1080/09537104.2023.2200836.

ABSTRACT

Thrombocytopenia represents one of the most prevalent hematologic complications observed in patients infected with the human immunodeficiency virus (HIV). In this study, we sought to analyze the clinical characteristics and treatment outcomes of patients with coexisting HIV and thrombocytopenia. Specifically, we retrospectively examined the medical records of 45 patients diagnosed with HIV/AIDS and thrombocytopenia at the Yunnan Infectious Diseases Specialist Hospital between January 2010 and December 2020, all of whom received highly active antiretroviral therapy (HAART) with/without glucocorticoids. The median follow-up period was 79 days, ranging between 14 and 368 days, the total platelet count was higher after receiving treatment than before (Z = -5.662, P < .001). Among the cohort, 27 patients (60.0%) responded to treatment, with 12 patients (44.44%) experiencing relapse during the follow-up period. The response rate (80.00%) of newly diagnosed ITP were significantly higher than of persistent ITP (28.57%) and chronic ITP (38.46%) (x2 = 9.560, P = .008) and the relapse rate of the newly diagnosed ITP (30.00%) was significantly lower than the persistent ITP and chronic ITP (100.00%, 80.00%) (x2 = 6.750, P = .034). Notably, we found that the number of CD4+ T cells, duration of HIV infection, selection of HAART and type of glucocorticoids administered displayed no statistically significant effect on platelet count, treatment response, or relapse rate. However, we observed a significant decrease in platelet count in hepatitis C virus-positive individuals coinfected with HIV compared to those with HIV alone (Z = -2.855, P = .003). Our findings suggest that patients diagnosed with HIV and thrombocytopenia exhibit a low response rate to treatment and have an increased likelihood of relapse.

PMID:37114424 | DOI:10.1080/09537104.2023.2200836

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Comparison of the role of 18F-fluorodeoxyglucose PET/computed tomography and 68Ga-labeled FAP inhibitor-04 PET/CT in patients with malignant mesothelioma

Nucl Med Commun. 2023 Apr 28. doi: 10.1097/MNM.0000000000001702. Online ahead of print.

ABSTRACT

OBJECTIVE: In this study, we aimed to compare the role of 68Ga-labeled FAP inhibitor (68Ga-FAPI)-04 PET/computed tomography (CT) and 18F-fluorodeoxyglucose (18F-FDG) PET/CT in the evaluation of primary tumor and metastases in patients diagnosed with malignant mesothelioma.

MATERIALS AND METHODS: Our prospective study included 21 patients with histopathological diagnosis of malignant mesothelioma who underwent both 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT imaging between April 2022 and September 2022. Maximum standardized uptake value (SUVmax), metabolic tumor volume, total lesion glycolysis, tumor-to-background ratio (TBR) and highest SUVpeak (HPeak) values and lesion numbers were calculated from primary and metastatic lesions on FDG and FAPI PET/CT images. Findings obtained from FAPI and FDG PET/CT were compared.

RESULTS: More lesions were detected in 68Ga-FAPI-04 PET/CT compared to 18F-FDG PET/CT in primary tumor and lymph node metastases. Statistically significantly higher SUVmax and TBR values were found with FAPI PET/CT (primary lesion SUVmax and TBR, P = 0.001 and P < 0.001, respectively; lymph node SUVmax and TBR, P = 0.016 and P = 0.005, respectively). With FAPI PET/CT, upstage was observed according to tumor-node-metastasis staging in a total of seven patients including three patients with pleural origin, three patients with peritoneal origin and one patient with pericardial origin.

CONCLUSION: In addition to the stage change with 68Ga-FAPI-04 PET/CT in malignant mesothelioma patients, a statistically significant superiority was observed in SUVmax, TBR and volumetric parameters in primary tumors and metastases.

PMID:37114422 | DOI:10.1097/MNM.0000000000001702

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Letter to the Editor: statistics and clinical perception of patients’ reported outcomes for palbociclib and abemaciclib: a sliding doors story

J Comp Eff Res. 2023 Apr 28:e220212. doi: 10.57264/cer-2022-0212. Online ahead of print.

NO ABSTRACT

PMID:37114420 | DOI:10.57264/cer-2022-0212

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CT-based migration analysis is more precise than radiostereometric analysis for tibial implants: a phantom study on a porcine cadaver

Acta Orthop. 2023 Apr 27;94:207-214. doi: 10.2340/17453674.2023.12306.

ABSTRACT

BACKGROUND AND PURPOSE: Radiostereometric analysis (RSA) is the gold standard for migration analysis, but computed tomography analysis methods (CTRSA) have shown comparable results in other joints. We attempted to validate precision for CT compared with RSA for a tibial implant.

MATERIAL AND METHODS: RSA and CT were performed on a porcine knee with a tibial implant. Marker-based RSA, model-based RSA (MBRSA), and CT scans from 2 different manufacturers were compared. CT analysis was performed by 2 raters for reliability evaluation.

RESULTS: 21 double examinations for precision measurements for RSA and CT-based Micromotion Analysis (CTMA) were analysed. Mean (95% confidence interval) precision data for maximum total point motion (MTPM) using marker-based RSA was 0.45 (0.19-0.70) and 0.58 (0.20-0.96) using MBRSA (F-statistic 0.44 [95% CI 0.18-1.1], p = 0.07). Precision data for total translation (TT) for CTMA was 0.08 (0.03-0.12) for the GE scanner and 0.11 (0.04-0.19) for the Siemens scanner (F-statistic 0.37 [0.15-0.91], p = 0.03). When comparing the aforementioned precision for both RSA methods with both CTMA analyses, CTMA was more precise (p < 0.001). The same pattern was seen for other translations and migrations. Mean effective radiation doses were 0.005 mSv (RSA) (0.0048-0.0050) and 0.08 mSv (CT) (0.078-0.080) (p < 0.001). Intra- and interrater reliability were 0.79 (0.75-0.82) and 0.77 (0.72-0.82), respectively.

CONCLUSION: CTMA is more precise than RSA for migration analysis of a tibial implant, has overall good intra- and interrater reliability but higher effective radiation doses in a porcine cadaver.

PMID:37114404 | DOI:10.2340/17453674.2023.12306

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Fecal immunochemical test for haemoglobin versus fecal calprotectin to monitoring endoscopic activity in inflammatory bowel disease

Rev Esp Enferm Dig. 2023 Apr 28. doi: 10.17235/reed.2023.9536/2023. Online ahead of print.

ABSTRACT

AIM: Endoscopy identifies inflammatory activity, however it is an unpleasant test and is not always accessible. The aim of the study was to compare the usefulness of quantitative fecal immunochemical test (FIT) versus fecal calprotectin (FC) to determine endoscopic activity in patients with inflammatory bowel disease (IBD).

METHODS: Cross-sectional prospective observational study. The stool samples were collected within 3 days before starting the preparation for the colonoscopy. We used the Mayo index for ulcerative colitis (UC) and the simplified endoscopic index for Crohn’s disease (CD). Mucosal healing (MH) was defined as the score 0 points in each of the endoscopic indices.

RESULTS: 84 patients were included, 40 (47.6%) with UC. In patients with IBD, FIT and FC showed a significant correlation with the presence of inflammatory activity/MH on endoscopy; without showing statistical differences between the two receiver-operating characteristic (ROC) curves. Both tests improved their diagnostic performance when assessing patients with UC, the Spearman correlations between FIT and FC and endoscopic inflammatory activity were r = 0.6 (p = 0.0001) and r = 0.7 (p = 0.0001), respectively. In Crohn´s disease, the diagnostic utility of both tests was lower.

CONCLUSIONS: FIT is an alternative to monitor endoscopic activity among ulcerative colitis patients. In Crohn´s disease, more studies are needed to determine the role of fecal biomarkers.

PMID:37114398 | DOI:10.17235/reed.2023.9536/2023

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Transumbilical laparoscopic-assisted appendectomy versus laparoscopic appendectomy in children: a single center experience

Pediatr Med Chir. 2023 Apr 27;45(1). doi: 10.4081/pmc.2023.306.

ABSTRACT

Laparoscopic Appendectomy (LPSA) is the first choice for appendectomy in pediatric surgery. Trans-Umbilical Laparoscopic Assisted Appendicectomy (TULAA) is another used technique. We compared both these procedures used for the treatment of acute appendicitis. The study was conducted between January 2019 to December 2020. Patients were divided into two groups: LPSA and TULAA groups. The collected data were: operative time, number of conversions, time of canalization and hospital stay. A total of 181 patients were included: 73 were kept in the LPSA and 108 in the TULAA group. Mean operative time was 70.9 minutes (range 45-130 min) for LPS and 56.4 (30-145 min) for TULAA group (p <0.0001). Complications rate showed no statistically significant difference between both the two groups. However, conversions showed a statistically significant difference (p=0.04). Both techniques showed similar results. TULAA technique takes a significantly shorter operating time. The selection between LPSA and TULAA techniques depends on the experience of the surgeon’s work and the personal laparoscopic learning curve. In our experience LPSA was a useful technique to improve the laparoscopic skill of the pediatric surgery residents.

PMID:37114377 | DOI:10.4081/pmc.2023.306

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Oral candidiasis in patients hospitalised in the intensive care unit: Diagnosis through clinical and cytopathological examinations

Cytopathology. 2023 Apr 28. doi: 10.1111/cyt.13243. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the prevalence and clinical aspects of oral candidiasis in patients hospitalised in the intensive care unit.

METHODS: This is a longitudinal and prospective study that included 48 participants hospitalised in the intensive care unit. Sociodemographic data, presence of systemic disorders, use of medications, laboratory tests, cause of hospital admission, type of breathing, and length of hospital stay were obtained from medical records. Oral clinical inspection and cytopathological examinations were performed on all participants. The diagnosis of clinical candidiasis was based on the presence of clinical alterations together with positive cytopathological examination results. The diagnosis of subclinical candidiasis was based on the absence of clinical lesions and a positive cytopathological examination. The absence of oral candidiasis was considered when the participant did not present oral lesions and had a negative cytopathological examination.

RESULTS: Clinical candidiasis was present in 18.8% of the 48 participants, and 45.8% of them had the subclinical form. Levels of urea (P = 0.005), creatinine (P = 0.009), haemoglobin (P = 0.009), haematocrit (P = 0.011), bands (P = 0.024), international normalised ratio (INR; P = 0.034), types of breathing (P = 0.017), length of hospital stay (P = 0.037), and outcome (P = 0.014) demonstrated statistically significant differences between the groups with and without oral candidiasis.

CONCLUSIONS: Clinical and subclinical forms of oral candidiasis are frequent in intensive care unit patients. Levels of urea, creatinine, haemoglobin, haematocrit, bands, INR, type of breathing, length of hospital stay, and outcome can be associated with the presence of candidiasis.

PMID:37114365 | DOI:10.1111/cyt.13243

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A minor metabolite from Curcuma longa effective against metabolic syndrome: results from a randomized, double-blind, placebo-controlled clinical study

Food Funct. 2023 Apr 28. doi: 10.1039/d2fo03627d. Online ahead of print.

ABSTRACT

Metabolic syndrome (MetS) is characterized by the presence of at least three interrelated risk factors, including central obesity, hypertension, elevated serum triglycerides, low serum high-density lipoproteins, and insulin resistance. Abdominal obesity is considered a predominant risk factor. Lifestyle changes with medications to lower cholesterol, blood sugar, and hypertension are the general treatment approaches. Functional foods and bioactive food ingredients represent versatile tools for addressing different aspects of MetS. In a randomized placebo-controlled clinical study, we evaluated the effect of Calebin A, a minor bioactive phytochemical from Curcuma longa, on metabolic syndrome in obese adults (N = 100), and 94 individuals completed the study (N = 47 in both groups). They were subjected to Calebin A supplementation for 90 days, which resulted in a statistically significant reduction in their body weight, waist circumference, body mass index, low-density lipoprotein-cholesterol, and triglyceride levels compared to those with the placebo. A small but significant increase in high-density lipoprotein-cholesterol levels was also observed in these individuals. Furthermore, Calebin A showed a positive effect on adipokines by reducing circulating leptin levels. Finally, C-reactive protein levels were significantly reduced in Calebin A-supplemented individuals, suggesting a beneficial impact on managing MetS-induced inflammation. Blood glucose levels, insulin resistance, and blood pressure levels were not affected by Calebin A. In conclusion, Calebin A may be an effective supplement for managing abdominal obesity, dyslipidemia, and systemic inflammation in individuals with metabolic syndrome. This study was prospectively registered on the Clinical Trial Registry of India (CTRI) with the registration number CTRI/2021/09/036495. https://ctri.nic.in/Clinicaltrials/advancesearchmain.php.

PMID:37114318 | DOI:10.1039/d2fo03627d