Tag: nevin manimala

BMC Cancer. 2022 Nov 5;22(1):1139. doi: 10.1186/s12885-022-10225-y.

ABSTRACT

BACKGROUND: Triple negative breast cancer (TNBC) is clinically aggressive breast cancer with a poor prognosis. Approximately 20% of TNBC has been found to express programmed death ligand 1 (PD-L1), making it a potential therapeutic target. As a PD-L1 inhibitor, atezolizumab is a recently approved immunotherapeutic drug for TNBC, this meta-analysis (MA) was aimed to review the randomized controlled trial studies (RCTs) of combined atezolizumab and nab-paclitaxel in the treatment of TNBC and synthesize the evidence-based results on its effectiveness and safety.

METHOD: We searched PubMed, Embase, EBSCOhost and ClinicalTrials.gov for the eligible RCTs which compared the efficacy and safety of combined atezolizumab and nab-paclitaxel with nab-paclitaxel alone. The outcomes analyzed included overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and treatment-related adverse effects (AEs).

RESULTS: A total of six RCTs were included in this MA. For efficacy, although OS was not significantly prolonged with combined atezolizumab and nab-paclitaxel (HR 0.90, 95% CI [0.79, 1.01], p=0.08), this combination therapy significantly improved PFS (HR 0.72, 95% CI [0.59, 0.87], p=0.0006) and ORR (RR 1.25, 95% CI [0.79, 1.01] p<0.00001). For safety, any AEs, haematological, gastrointestinal, and liver AEs showed no statistically significant differences between the atezolizumab and nab-paclitaxel combination group and nab-paclitaxel alone group. However, serious AEs, high grade, dermatological, pulmonary, endocrine, and neurological AEs were significantly lower with nab-paclitaxel alone compared to atezolizumab and nab-paclitaxel combined (p-value range from <0.00001 to 0,02).

CONCLUSION: Atezolizumab combined with nab-paclitaxel was associated with improved outcomes in the treatment of TNBC; however, this combination resulted in more toxicity compared to nab-paclitaxel alone. While nab-paclitaxel alone produced chemotherapy-related AEs, the combination of atezolizumab with nab-paclitaxel produced AEs, especially immune-related AEs such as haematological, pulmonary, endocrine, and neurological AEs.

TRIAL REGISTRATION: This research work of systematic review has been registered on PROSPERO (Registration number: CRD42022297952).

PMID:36335316 | DOI:10.1186/s12885-022-10225-y

BMC Med Res Methodol. 2022 Nov 5;22(1):287. doi: 10.1186/s12874-022-01768-6.

ABSTRACT

BACKGROUND: The increased adoption of the internet, social media, wearable devices, e-health services, and other technology-driven services in medicine and healthcare has led to the rapid generation of various types of digital data, providing a valuable data source beyond the confines of traditional clinical trials, epidemiological studies, and lab-based experiments.

METHODS: We provide a brief overview on the type and sources of real-world data and the common models and approaches to utilize and analyze real-world data. We discuss the challenges and opportunities of using real-world data for evidence-based decision making This review does not aim to be comprehensive or cover all aspects of the intriguing topic on RWD (from both the research and practical perspectives) but serves as a primer and provides useful sources for readers who interested in this topic.

RESULTS AND CONCLUSIONS: Real-world hold great potential for generating real-world evidence for designing and conducting confirmatory trials and answering questions that may not be addressed otherwise. The voluminosity and complexity of real-world data also call for development of more appropriate, sophisticated, and innovative data processing and analysis techniques while maintaining scientific rigor in research findings, and attentions to data ethics to harness the power of real-world data.

PMID:36335315 | DOI:10.1186/s12874-022-01768-6

BMC Pediatr. 2022 Nov 5;22(1):641. doi: 10.1186/s12887-022-03675-7.

ABSTRACT

BACKGROUND: Primary intussusception in children is a common acute abdominal disease. The cause of this disease is still not fully understood. Many articles have reported that children with intussusception are often accompanied by hyperplasia of mesenteric lymph nodes and submucosal lymphoid tissue of the terminal ileum. Therefore, hyperplasia of intestinal-associated lymphoid tissue (mesenteric lymph nodes and submucosal lymphoid tissue of the intestinal tract) may be one of the main causes of intussusception. However, the characteristics and differences of intestinal-associated lymphoid tissues in healthy children and children with intussusception at different ages have not been reported. In addition, the relationship between mesenteric lymph nodes and intestinal submucosal lymphatic tissue also needs to be further understood.

METHODS: 73 patients with intussusception during the recovery phase who were treated in our hospital from October 2019 to October 2021 were collected as the observation group, while 101 children with healthy physical examination or diseases unrelated to intestinal lymphoid hyperplasia were collected as the control group. They were divided into different age groups of 1-6 months, 7-12 months, 13-18 months, 19-24 months, 25-36 months, 3-4 years, 5-6 years, and 7-8 years old. Ultrasonography was used to explore and scan mesenteric lymph nodes in fixed areas of the right lower abdomen and around the umbilicus. The size (cm³) and number (n) of detectable lymph nodes in each region were recorded and calculated, and the total mesenteric lymph node volume (cm³) of the right lower abdomen (RLTMLNV) and periumbilical region (PTMLNV) was calculated, respectively. The total mesenteric lymph node volume of each region in different ages of the two groups was analyzed.

RESULTS: (1) There were significant differences between the control group and the observation group in the right lower abdominal total mesenteric lymph nodes volume (RLTMLNV) and the periumbilical total mesenteric lymph nodes volume (PTMLNV) (P = 0.001). The mesenteric lymph nodes in the observation group showed severe hyperplasia. (2) Children with intussusceptions are usually accompanied by severe mesenteric lymphoid hyperplasia. The mean volume value of RLTMLNV was greater than that of PTMLNV. Especially within 2 years of age, the mean value of RLTMLNV was significantly higher than that of PTMLNV with statistical significance (P < 0.05). (3) In normal children (control group), lymph nodes in the right lower abdomen and periumbilical area showed low hyperplasia, and there was a significant difference between age groups of < 2 years old and 2-8 years old (p = 0.001). In the children with intussusception (observation group), the hyperplasia of mesenteric lymph nodes in the right lower abdomen and around the umbilicus was severe. There was no significant difference in the proliferation of mesenteric lymphoid tissue among different age groups in the right lower abdomen (P = 0.834). There was also no significant difference in hyperplasia of periumbilical mesenteric lymphoid tissue among different age groups (P = 0.097).

CONCLUSIONS: Our research shows: (1) The occurrence of primary intussusception in children is related to the hyperplasia of intestinal-associated lymphoid tissue. (2) Children with intussusceptions were usually accompanied by severe mesenteric lymphoid hyperplasia. The mesenteric lymphoid hyperplasia was more evident in the right lower abdominal ileocecal area than in the periumbilical area before 2 years of age. RLTMLNV has better predictability of intussusception than PTMLNV. The occurrence of intussusceptions was more closely related to the hyperplasia of intestinal-associated lymphoid tissue in the right lower abdomen. (3) Normal children showed a low degree of mesenteric lymphoid hyperplasia before 2 years old, moderate hyperplasia after 2 years old, and mesenteric lymphoid hyperplasia in the right lower abdominal ileocecal area was basically the same as the periumbilical area. The lymphatic tissue of the right lower abdomen and periumbilical mesentery in children with intussusceptions showed severe hyperplasia, and there were no significant differences among different age groups.

PMID:36335308 | DOI:10.1186/s12887-022-03675-7

BMC Ophthalmol. 2022 Nov 5;22(1):421. doi: 10.1186/s12886-022-02644-z.

ABSTRACT

BACKGROUND: To investigate the possible effect of implantable collamer lens (ICL) V4c on ocular biometric measurements by a new biometer Pentacam-AXL and partial coherence interferometry (PCI)-based IOLMaster 500 and intraocular lens power calculation using fourth-generation formula.

METHODS: We retrospectively enrolled patients who underwent ICL (EVO-V4c, STAAR Surgical Co. Nidau, Switzerland) implantation surgery from September 2020 to November 2021. The Pentacam-AXL and IOLMaster 500 biometers were used to measure axial length (AL), anterior chamber depth (ACD), keratometry (K), white to white (WTW), and central corneal thickness (CCT) values before and at least 2 months after ICL V4c implantation. The IOL power was calculated using the Barrett Universal II formula.

RESULTS: The study included 45 eyes in 28 patients. There was a significant increase in ALs (average 0.03 ± 0.07 mm, p = 0.01) and a significant decrease of ACDs (average 0.19 ± 0.17 mm, p < 0.001) based on Pentacam-AXL. Similar changes in ALs and ACDs were also found in IOLMaster 500. In addition, the difference in WTWs in the two devices and that of CCTs in Pentacam-AXL were statistically significant. However, the preoperative and postoperative K1 and K2 were separately comparable using either device. The IOL power calculated by the Barrett Universal II formula did not change significantly either by the software built in Pentacam-AXL or by manually putting the parameters of the IOLMaster 500 into the formula manually (p = 0.058, p = 0.675, respectively).

CONCLUSIONS: Ocular parameters including ALs, ACDs, WTWs, and CCTs using a new Pentacam-AXL and standard PCI-based IOLMaster 500 changed significantly before and after the ICL V4c implantation, while IOL power prediction using the Barrett Universal II formula was little affected.

PMID:36335303 | DOI:10.1186/s12886-022-02644-z

Eur J Surg Oncol. 2022 Oct 28:S0748-7983(22)00709-0. doi: 10.1016/j.ejso.2022.10.017. Online ahead of print.

ABSTRACT

INTRODUCTION: The oncological outcomes of low ligation (LL) compared to high ligation (HL) of the inferior mesenteric artery (IMA) during low-anterior rectal resection (LAR) with total mesorectal excision are still debated. The aim of this study is to report the 5 year oncologic outcomes of patients undergoing laparoscopic LAR with either HL vs. LL of the IMA MATERIALS AND METHODS: Between June 2014 and December 2016, patients who underwent elective laparoscopic LAR + TME in 6 Italian non-academic hospitals were randomized to HL or LL of IMA after meeting the inclusion criteria (HighLow trial; ClinicalTrials.gov Identifier NCT02153801). We analyzed the rate of local recurrence, distant metastasis, overall survival, disease-specific survival, and disease-free survival at 5 years of patients previously enrolled.

RESULTS: Five-year follow up data were available for 196 patients. Recurrence happened in 42 (21.4%) of patients. There was no statistically significant difference in the distant recurrence rate (15.8% HL vs. 18.9% LL; P = 0.970) and pelvic recurrence rate (4,9% HL vs 3,2% LL; P = 0.843). No statistically significant difference was found in 5-year OS (p = 0.545), DSS (p = 0.732) or DFS (p = 0.985) between HL and LL. Low vs medium and upper rectum site of tumor, conversion rate, Clavien-Dindo post-operative grade ≥3 complications and tumor stage were found statistically significantly associated to poor oncological outcomes in univariate analysis; in multivariate analysis, however, only conversion rate and stage 3 cancer were found to be independent risk factors for poor DFS at 5 years.

CONCLUSION: We confirmed the results found in the previous 3-year survival analysis, the level of inferior mesenteric artery ligation does not affect OS, DSS and DFS at 5-year follow-up.

PMID:36335077 | DOI:10.1016/j.ejso.2022.10.017

Rev Int Androl. 2022 Nov 2:S1698-031X(22)00090-5. doi: 10.1016/j.androl.2021.10.003. Online ahead of print.

ABSTRACT

BACKGROUND: Delays in embryo kinetics, implantation failures in ICSI treatments and recurrent miscarriages have been associated with high values of Double-Strand Breaks (DSB) in sperm DNA. While conventional methods for semen preparation have been shown to be inefficient reducing DSB values, Microfluidic Sperm Sorting (MSS) devices are promising tools to reduce this damage.

OBJECTIVE: To study the clinical utility of an MSS device in ICSI treatments when the male partner presents increased DSB values, as compared to the use of conventional methods based on sperm motility.

METHODS: This retrospective cohort study included 28 infertile couples undergoing ICSI treatments. Only couples where the male partner presented increased values of DSB were included. DSB values were evaluated in semen samples by the Neutral Comet assay. Couples performed a first ICSI cycle using conventional methods for semen preparation (Density Gradients and Swim-up) and a second ICSI cycle using the ZyMōt™ICSI (formerly named FertileChip®) microfluidic device. Embryology and clinical outcomes were compared between ICSI cycles.

RESULTS: Semen parameters and the number of obtained and fertilized oocytes did not show differences between ICSI rounds. Clinical outcomes were statistically better when MSS was used: the biochemical pregnancy rate increased 28.31%; the clinical pregnancy rate increased 35.56% and the number of live births increased 35.29%, as compared to the first ICSI cycle in this group of patients.

CONCLUSIONS: The ZyMōt™ICSI microfluidic device improved the reproductive outcomes in couples where the male partner presented increased DSB values, when compared to the use of conventional semen preparation techniques.

PMID:36335071 | DOI:10.1016/j.androl.2021.10.003

Explore (NY). 2022 Oct 27:S1550-8307(22)00201-4. doi: 10.1016/j.explore.2022.10.017. Online ahead of print.

ABSTRACT

OBJECTIVE: In our study, we investigated the effect of reflexology on patient satisfaction, pain and vital signs after abdominal surgery.

METHOD: This study was conducted as a randomized controlled trial with the participation of 156 abdominal surgery patients hospitalized in the general surgery unit of a training and research hospital. Personal Information Form, Visual Analogue Scale and Newcastle Nursing Care Satisfaction Scale were used in data collection. We performed the data analysis with One-way analysis of variance, Chi-squared test, paired samples t-test, and independent samples t-test.

RESULTS: When the pain, vital signs and satisfaction levels of the experimental and control groups were compared, the pain intensity of the experimental group was found to be lower and the level of satisfaction was higher after reflexology (p<0.01). After reflexology, the blood pressure was closer to 120/80 in the experimental group, the respiratory rate was between 16-22 (number/minute), the difference between the experimental and control groups were statistically significant (p<0.01). There was no statistically significant difference between the pulce oximetry values between the experimental and control groups.

CONCLUSION: Surgical pain and non-optimal vital signs that are not well managed after surgery causes various complications and decrease patient satisfaction. The results of our study emphasize the power of reflexology in effective surgical pain management and normalizing vital signs and increasing patient satisfaction. We suggest that reflexology be performed to patients following abdominal surgery.

PMID:36335059 | DOI:10.1016/j.explore.2022.10.017

J Foot Ankle Surg. 2022 Oct 4:S1067-2516(22)00272-1. doi: 10.1053/j.jfas.2022.09.007. Online ahead of print.

ABSTRACT

Lateral column deterioration and subsequent loss of function poses a challenge for limb preservation in patients with Charcot neuroarthropathy (CN). Application of “superconstructs” provides stability and clinical improvement to an often-ulcerated lateral foot. This study examines radiodensity in Hounsfield units (HU) to compare bone quality of lateral column fixation targets using computed tomography (CT) scans between patients with and without midfoot CN. A retrospective chart review identified control (nondiabetic, non-CN; n = 29) and midfoot CN (n = 21) groups. Patient demographics and medical history were collected. Two reviewers measured the mean HU of circular regions of interest centered on the fourth and fifth metatarsal heads as well as the anterior, middle, and posterior thirds of the calcaneus. Radiodensity was compared between groups, among calcaneal locations, Eichenholtz stages and Brodsky types. A p value ≤.05 was considered statistically significant. Age and body mass index were not significantly different between groups. The CN group exhibited greater HU than the control group at the metatarsal head and calcaneus (p < .001). The anterior calcaneus exhibited greater HU than the posterior calcaneus in the CN group (p = .02). The difference in HU was not statistically significant between Stages 0-1 and Stages 2-3 or midfoot Brodsky Types. Indirect bone density analysis revealed an increased density in CN compared to control patients with no significant difference between midfoot CN stages or types. The anterior calcaneus was the densest rearfoot bone among the CN patients, a result that may have implications in surgical fixation.

PMID:36335049 | DOI:10.1053/j.jfas.2022.09.007

Eur Urol Focus. 2022 Nov 2:S2405-4569(22)00238-3. doi: 10.1016/j.euf.2022.10.009. Online ahead of print.

ABSTRACT

BACKGROUND: Penile curvature is the most debilitating symptom of Peyronie’s disease (PD); the evaluation of the degree of angulation is essential for planning treatment strategy. However, the most used method of penile at-home autophotography (AHP) is associated with some potential pitfalls and discrepancies compared with different assessment methods.

OBJECTIVE: To compare the degree of penile curvature quantified by AHP and in-office intracavernosal alprostadil injection (ICI) prior to therapy.

DESIGN, SETTING, AND PARTICIPANTS: Data from 55 PD patients of a single tertiary referral center were analyzed. All patients provided standardized AHP of the erect phallus. Clinic-based assessment included ICI with curvature measurement and completion of the International Index of Erectile Function (IIEF-15).

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The Wilcoxon and/or chi-square test was used to compare the degree of curvature obtained using AHP and ICI, and to evaluate whether erectile dysfunction was a predictor of a relevant difference of >10° in curvature assessment between AHP and ICI.

RESULTS AND LIMITATIONS: Our study showed a significant (p < 0.001) difference in the degree of penile curvature between AHP (48° [38°; 55°]) and ICI (50° [40°; 65°]). Patients suffering from erectile dysfunction tend to have a higher difference in the degree of penile curvature between AHP and ICI than patients with good erectile function (p < 0.001). Our study is not devoid of limitations. First, we did not use Peyronie’s Disease Questionnaire, as suggested by the European Association of Urology guidelines. Second, we did not evaluate inter- and intraobserver variations in the measurements.

CONCLUSIONS: AHP tends to underestimate the extent of penile curvature compared to ICI. Erectile dysfunction is an independent predictor of measurement differences of >10° between AHP and ICI.

PATIENT SUMMARY: It is necessary to evaluate the degree of penile curvature in Peyronie’s disease prior to therapy decision. The at-home self-photography underestimates the real degree of penile curvature compared with an erection by in-office penile drug injection. Especially men suffering from erectile dysfunction carry the risk of a high difference in the measured degree of penile curvature, with a potential impact on the further treatment.

PMID:36335039 | DOI:10.1016/j.euf.2022.10.009

Obes Res Clin Pract. 2022 Oct 31:S1871-403X(22)00117-X. doi: 10.1016/j.orcp.2022.10.011. Online ahead of print.

ABSTRACT

OBJECTIVES: We investigated the association between metabolic syndrome (MetS) and mortality among coronavirus disease 2019 (COVID-19) patients in Korea.

METHODS: We analyzed 3876 individuals aged ≥ 20 years who were confirmed with COVID-19 from January 1 to June 4, 2020 based on the Korea National Health Insurance Service (NHIS)-COVID-19 database and had undergone health examination by NHIS between 2015 and 2017. Multivariable Cox proportional hazard regression analyses were performed.

RESULTS: Of total participants, the prevalence of MetS was 21.0% (n = 815). During 58.6 days of mean follow-up, 3.1 % (n = 120) of the participants died. Compared to individuals without MetS, COVID-19 patients with MetS had a significantly increased mortality risk after adjusting for confounders in total participants (hazard ratio [HR]: 1.68, 95 % confidence interval [CI]: 1.14-2.47) and women (HR: 2.41, 95 % CI: 1.17-4.96). A low high-density lipoprotein cholesterol level in total participants (HR: 1.63, 95 % CI: 1.12-2.37) and hyperglycemia in women (HR: 1.97, 95 % CI: 1.01-3.84) was associated with higher mortality risk. The mortality risk increased as the number of MetS components increased among total participants and women (P for trend = 0.009 and 0.016, respectively). In addition, MetS groups had higher mortality risk in aged ≥ 60 years (HR: 1.60, 95 % CI: 1.07-2.39), and never-smokers (2.08, 1.21-3.59).

CONCLUSIONS: The presence of MetS and greater number of its components were associated with increased mortality risks particularly in female patients with COVID-19. Managing MetS may contribute to better outcomes of COVID-19.

PMID:36335025 | DOI:10.1016/j.orcp.2022.10.011