Reviews on recent clinical trials最新文献

Background: Human papillomavirus (HPV) is the most common sexually transmitted infection in the US.The first HPV vaccine was introduced in 2006. There are three different HPV vaccines that commonly target high-risk HPV types.

Objective: This study compares HPV vaccine efficacy based on alternative endpoints with the most recently available cervical cancer incidence data from the Surveillance, Epidemiology and End Results (SEER) program and SEER*Stat statistical software.

Methods: The incidence of cervical cancer, mined from the most recent April 2021 SEER data set, was stratified according to age and racial groups. Trend analysis reporting cervical cancer incidence percentage change (PC) and annual percentage change (APC) was calculated by SEER*Stat statistical software.

Results: A total of 46,583 cases of cervical cancer were reported, with an average of about 3,580 incidents of cervical cancer per year, with an overall decrement of about 60 cases over the period of 12 years. The percentage change according to age and race groups varied between -15.9 among 40- 44 years old (yo) and +13.8 among 30-34 yo, and from -12 among non-Hispanic White women to +13 among Hispanic women. Statistically significant APC was observed for five of the nine age groups and four of the five racial groups.

Conclusion: There seems to be little if any, correlation between cervical cancer incidence and the HPV vaccine program in the US. HPV vaccine efficacy based on alternative endpoints, such as nucleic acid testing and cytological, surgical, and seropositivity endpoints, is fair. Therefore, it is important to emphasize such alternative testing and surrogate endpoints.

Background: The increased prevalence of irritable bowel syndrome (IBS) among medical and nursing students is a global challenge. Unfortunately, data on the Italian medical and nurse student population are scarce. Therefore, this study was designed to assess the prevalence of IBS in this setting and to evaluate the demographic, university, Mediterranean diet adherence, and anxiety factors associated with its increased presence.

Objective: To assess the prevalence of IBS, anxiety levels, and adherence to the Mediterranean diet in medical and nursing university students.

Methods: An anonymous online questionnaire was sent to participants. Several demographic and educational variables were assayed, and the presence of symptoms associated with the definition of IBS (according to Rome IV criteria). In addition, anxiety levels and adherence to the Mediterranean diet were also assessed.

Results: Of 161 students, 21.11% met the Rome IV criteria for IBS. Some subgroups, the out-ofcourse students or no scholarship recipients, were found to have a higher percentage of IBS (p < 0.05). Being out-of-course was shown to be associated with an increased and unreported risk of presenting IBS (OR: 8.403, p < 0.001). Levels of anxiety and adherence to the Mediterranean diet were significantly worse in the IBS group (p < 0.01). Adherence to the Mediterranean diet was associated with a reduced risk of presenting IBS in our setting (OR 0.258, p = 0.002).

Conclusion: Our sample of Italian medical and nursing students recorded a non-negligible percentage of IBS. Therefore, screening and awareness campaigns could be suggested.

Objectives: We evaluated polypharmacy and possible drug-drug interactions (p-DDIs) in hospitalized patients before and after using the SIMDA Computerized Medical Decision Support System (CMDSS).

Materials and methods: We included the prescriptions of ≥ 18 years hospitalized patients in the internal medicine department. We developed and implemented the Hdc.DrApp Physician Order Entry System and the CMDSS SIMDA, which detects p-DDIs and signals dosage adjustment based on renal function. To evaluate the impact of the CMDSS, we made a comparison Before (Survey) / After (Intervention): Survey between Oct/22/2019, and Mar/21/2020, and Intervention between Apr/4/2020 and Sep/3/2020. We analyze prescriptions from the first day and after the first day. We compared the number of drugs, polypharmacy (≥ 5 drugs), excessive polypharmacy (≥ 10 drugs), and p-DDIs. We evaluated differences with the X2 test, Yates correction, Fisher's exact test, ANOVA, and post hoc tests according to their characteristics.

Results: We evaluated 2,834 admissions: Survey 1,211 and Intervention 1,623. The number of drugs per patient was 6.02 (± 3.20) in Survey and 5.17 (± 3.22) in Intervention (p < 0.001) on the first day and 9.68 (± 5.60) in Survey and 7.22 (± 4.93) in Intervention (p < 0.001) throughout the hospitalization. Polypharmacy was present in 64% of the Survey and 53% of Interventions (RR: 0.83 (0.78-0.88); and excessive polypharmacy in 14% of the Survey and 10% of Intervention (RR: 0.73, 0.60-0.90). The frequency of total p-DDIs was 1.91/patient (± 4.11) in Survey and 0.35 (± 0.81) in the Intervention (p < 0.001).

Conclusions: We developed and implemented the Hdc.DrApp and SIMDA systems that were easy to use and allowed us to quantify and reduce polypharmacy and p-DDIs.

Background: The hemostasis system has been extensively investigated in patients in the acute phase of coronavirus disease 2019 (COVID-19). In contrast, the post-COVID syndrome is a poorly known entity, and there is a lack of information on the mechanisms underlying the hemostasis abnormalities in the post-COVID period.

Aim: To analyze the potential changes in the parameters of the hemostasis system in the post- COVID period in the plasma of donors with different titers of anti-SARS-CoV-2 IgG.

Methods: The plasma from 160 donors who had recovered from COVID infection was used in the study. Based on the results of the Abbott SARS-CoV-2 IgG serological assay, all donors were divided into several groups: 5 ± 3 (n = 20); 55 ± 5 (n = 20); 65 ± 5 (n = 20); 75 ± 5 (n = 20); 85 ± 5 (n = 20); 95 ± 5 (n = 20); 125 ± 5 (n = 20); 175 ± 5 (n = 20) Index (S/C). A total of 20 healthy individuals without anti-SARS-CoV-2 IgG constituted the control group. Key laboratory parameters, such as fibrinogen concentrations, soluble fibrin monomer complex (SFMCs), and Ddimer, were investigated. In addition, the qualitative composition of the fraction of SFMCs was analyzed.

Results: The slight increase in the concentration of fibrinogen, SFMCs, and D-dimers in some donor groups have been found, which could cause the development of hemostasis disorders. In the fraction of SFMCs, the increase in the number of protein fragments with a molecular weight of less than 250 kDa and an increase in the level of proteins with a molecular weight of more than 270 kDa was revealed.

Conclusion: The obtained results indicated the relationship between the changes in the parameters of the hemostasis system and the titers of anti-SARS-CoV-2 IgG in donors in the post-COVID period. It can be assumed that donors with higher titers of anti-SARS-CoV-2 IgG (>55 ± 5 Index (S/C)) are more prone to hemostasis abnormalities in the post-COVID period since a pronounced imbalance in the levels of SFMCs and D-dimer characterizes them. The appearance of protein fragments of different molecular weights in the fraction of SFMC points to uncontrolled activation of biochemical processes involving molecules of fibrinogenic origin. Additional studies are required to elucidate the role of anti-SARS-CoV-2 IgG in the post-COVID period.

Background: We have recently confirmed that non-pain autonomic dysfunction symptoms occur in fibromyalgia and can be assessed with the 31-item Composite Autonomic Symptom Score (COMPASS 31) instrument. Fibromyalgia patients have been found to have higher scores than matched controls across all six domains of this instrument.

Objectives: To analyse the principal components of the autonomic COMPASS 31 domain scores in fibromyalgia patients to understand better the fundamental dimensions of dysautonomia in this disorder.

Methods: A principal component analysis of fibromyalgia autonomic domain scores was carried out using a varimax orthogonal rotation with decomposition being based on the correlation matrix and setting a threshold of greater than one for the eigenvalues.

Results: Three mutually orthogonal principal components, accounting for over 80% of the total variance, were identified. The first was a function of the secretomotor, orthostatic intolerance and pupillomotor domains; the second was a function of the vasomotor and urinary bladder domains; and the third was a function of the gastrointestinal and orthostatic intolerance domains. There was a positive correlation between symptom domain scores of the Revised Fibromyalgia Impact Questionnaire and the first principal component scores (r_s = 0.536, p = 0.006).

Conclusion: This analysis has reduced the dimensionality of autonomic dysfunction in fibromyalgia patients from six to three. The internal structure of the fibromyalgia dysautonomia data reflected by these results may help in the elucidation of the aetiology of this complex and difficult-to-treat disorder.

Background: Matrix metalloproteinases (MMPs) and their tissue inhibitors (TIMPS) play a key role in the pathogenesis of osteoarthritis (OA). Recent research showed the involvement of some MMPs in COVID-19, but the results are limited and contradictory.

Objective: In this study, we investigated the levels of MMPs (MMP-1, MMP-2, MMP-3, MMP-8, MMP-9, MMP-10) and TIMP-1 in the plasma of patients with OA after recovery from COVID- 19.

Methods: The experiment involved patients aged 39 to 80 diagnosed with knee OA. All study participants were divided into three research groups: the control group included healthy individuals, the group OA included patients with enrolled cases of OA, and the third group of OA and COVID-19 included patients with OA who recovered from COVID-19 6-9 months ago. The levels of MMPs and TIMP-1 were measured in plasma by enzyme-linked immunosorbent assay.

Results: The study showed a change in the levels of MMPs in patients with OA who had COVID- 19 and those who did not have a history of SARS-CoV-2 infection. Particularly, patients with OA who were infected with coronavirus established an increase in MMP-2, MMP-3, MMP-8, and MMP-9, compared to healthy controls. Compared to normal subjects, a significant decrease in MMP-10 and TIMP-1 was established in both groups of patients with OA and convalescent COVID-19.

Conclusion: Thus, the results suggest that COVID-19 can affect the proteolysis-antiproteolysis system even after a long postinfectious state and may cause complications of existing musculoskeletal pathologies.

Background: Pituitary neurosurgery executed via the transsphenoidal endonasal approach is commonly performed for pituitary adenomas. Reasons for prolonged hospital stay include postoperative headache and protracted nausea with or without vomiting. Bilateral superficial trigeminal nerve blocks of the supra-orbital V1 and infra-orbital V2 (SION) nerves performed intra-operatively as a regional anesthetic adjunct to general anesthesia were hypothesized to decrease 6 hours postoperative morphine PCA (patient-controlled analgesia) use by patients.

Methods: Forty-nine patients, following induction of general anesthesia for their transsphenoidal surgery, were prospectively randomized in a double-blinded fashion to receive additional regional anesthesia as either a block (0.5% ropivacaine with epi 1:200,000) or placebo/sham (0.9% normal saline). The primary endpoint of the study was systemic morphine PCA opioid consumption by the two groups in the first 6-hours postoperatively. The secondary endpoints included (1) pain exposure experienced postoperatively, (2) incidence of postoperative nausea and vomiting, and (3) time to eligibility for PACU discharge.

Results: Of the 49 patients that were enrolled, 3 patients were excluded due to protocol violations. Ultimately, there was no statistically significant difference between morphine PCA use in the 6 hours postoperatively between the block and placebo/sham groups. There was, however, a slight visual tendency in the block group for higher pain scores, morphine use p=0.046, and delayed PACU discharge. False discovery rate corrected comparisons at each time point and then revealed no statistically significant difference between the two groups. There were no differences between the two groups for secondary endpoints.

Conclusion: It was found that a 6-hour postoperative headache after endoscopic trans-sphenoidal pituitary surgery likely has a more complicated mechanism involving more than the superficial trigeminovascular system and perhaps is neuro-modulated by other brain nuclei.

Adenomyosis lacks approved pharmacological treatment even after decades of its identification. We performed this study to review the status of clinical research on adenomyosis for finding an effective drug therapy and to identify the most common endpoints used in adenomyosis trials. A systematic search was performed in the PubMed and Clinicaltrials.gov registries to identify interventional trials for analysis without any time and language restrictions. Our search revealed that barely 15 drugs have been assessed for the management of adenomyosis from 2001 to 2021. Among these, LNG-IUS was found to be the most evaluated drug, followed by dienogest. In these trials, the most commonly assessed endpoints included VAS, NPRS for pain, haemoglobin and PBAC for menstrual bleeding, uterine volume, and serum estradiol. There appears to be a need for developing a comprehensive score that takes into consideration all disease symptoms as well as incorporates some objective elements to evaluate the disease.

Background: One of the most important problems associated with the treatment of Rheumatoid Arthritis (RA) is erosive-ulcerative lesions (EUL) of the gastroduodenal zone, which is associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs).

Aims: Our research aims to study the clinical and histo-morphological criteria for forming the EUL of the gastroduodenal zone in patients with RA.

Methods: Patients were divided into 3 groups, depending on the presence of an EUL, according to Fibrogastroduodenoscopy (FGDS) data with a negative test for H. pylori. Group 1 included RA patients without EUL (n = 18), group 2 RA patients with erosive lesions of the gastroduodenal zone (n = 57), and group 3 consisted of RA patients with ulcerative lesions (n = 17). As a norm, we used data from a survey of 18 healthy donors corresponding to RA patient's age and sex distribution, where no somatic pathology was revealed. GSRS questionnaire was used for assessment of subjective symptoms. For histomorphological studies, biopsy specimens were taken during FGDS using an Olympus Evis Exera II digital video endoscope.

Results: Patients of RA with EUL in the gastro-duodenal zone were significantly different from the group of healthy donors and patients of group 1 by the severity of 5 symptoms related to the upper gastrointestinal tract according to the GSRS questionnaire, including abdominal pain, heartburn, belching acid, a feeling of sucking and burning in epigastria, nausea and vomiting. In general, there were no clinically significant differences between the frequency of occurrence and the severity of symptoms on the GSRS scale between group 2 and group 3, except for complaints of heartburn. So, RA patients of group 3 had a higher rate of heartburn feeling of 3.0 (2.0-3.0) points than patients of group 2 with 2.0 (1.0-2.0) points.

Conclusion: The development of a EUL of the gastroduodenal zone in patients with RA is associated with low activity of inflammation in all studied slides, regardless of structurally destructive changes in the stomach and duodenum and compensatory hyperplastic reactions in the superficial layer of mucosa membrane, which can be determined by minimal subjective sensations or even complete absence of clinical manifestations with the formation of "silent ulcers", complicated by bleeding and perforation.