Categories
Nevin Manimala Statistics

Intrauterine administration of G-CSF for promoting endometrial growth after hysteroscopic adhesiolysis: a randomized controlled trial

Hum Reprod. 2022 Feb 11:deac023. doi: 10.1093/humrep/deac023. Online ahead of print.

ABSTRACT

STUDY QUESTION: Does intrauterine infusion of granulocyte colony-stimulating factor (G-CSF) prevent adhesion reformation and promote endometrial growth after hysteroscopic adhesiolysis?

SUMMARY ANSWER: Intrauterine perfusion of G-CSF can increase endometrial thickness but does not prevent the recurrence of intrauterine adhesions (IUAs) in patients with Asherman syndrome (AS) after surgery.

WHAT IS KNOWN ALREADY: Intrauterine infusion of G-CSF has been used in attempts to treat patients with recurrent miscarriage and an idiopathic thin endometrium for either fresh or frozen-thawed embryo transfer cycles but without uniform efficacy. There have been no reports on the effect of G-CSF on the recurrence of IUAs, endometrial regrowth or pregnancy results in specific populations with AS.

STUDY DESIGN, SIZE, DURATION: This two-center prospective double-blind randomized controlled trial ran between April 2016 and August 2021. In it, 245 patients with moderate to severe AS were randomized to G-CSF and control groups at a 1:1 ratio; 229 women were included in the adhesion recurrence analysis; and 164 patients were analyzed for pregnancy outcomes.

PARTICIPANTS/MATERIALS, SETTING, METHODS: All eligible patients received the first hysteroscopic adhesion separation and balloon placement procedure. Patients who met our inclusion and exclusion criteria were randomized after surgery. These patients returned for balloon removal and underwent intrauterine perfusion with 300 µg (1.8 ml) G-CSF or 1.8 ml normal saline according to randomization at 7 days after surgery. A second-look hysteroscopy was carried out 1-2 months later. The primary outcome was the rate of formation of new adhesions at the second hysteroscopy. The secondary outcomes included endometrial thickness in the periovulatory period after surgery, as well as the clinical pregnancy and live birth rates.

MAIN RESULTS AND THE ROLE OF CHANCE: Age, menstrual cycle characteristics, pregnancy history and IUA score before surgery were similar between groups. There were no statistically significant differences in the adhesion reformation rate or median adhesion score reduction. However, G-CSF perfusion significantly improved endometrial thickness (7.91 ± 2.12 mm vs 7.22 ± 2.04 mm; P = 0.019, 95% CI for difference: -1.26 to -0.12), as well as cumulative pregnancy and live birth rate over time (P = 0.017 and P = 0.042). Furthermore, multivariate logistic regression analysis showed that postoperative endometrial thickness was an independent prognostic factor for pregnancy and live birth rates.

LIMITATIONS, REASONS FOR CAUTION: These results cannot be extended to older patients or those without AS, as our subjects had moderate or severe AS and were aged <40 years. The low number of patients included in the fertility analysis could lead to biased results.

WIDER IMPLICATIONS OF THE FINDINGS: Intrauterine perfusion of G-CSF could be an effective adjuvant therapy for patients with AS to increase endometrial thickness.

STUDY FUNDING/COMPETING INTEREST(S): This study was supported by grants from the National Key Research and Development Program of China (2018YFC1004800), the National Natural Science Foundation of China (82001624 and 81871209), the Natural Science Foundation of Zhejiang Province (LQ20H040004) and the provincial and ministerial construction project of Zhejiang Province (2017 WKJ-ZJ-1721). The authors declare that they have no conflicts of interest regarding this work.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT02855632).

TRIAL REGISTRATION DATE: 4 March 2016.

DATE OF FIRST PATIENT’S ENROLMENT: 13 April 2016.

PMID:35147195 | DOI:10.1093/humrep/deac023

Categories
Nevin Manimala Statistics

Comparative genomic analysis of Escherichia coli strains obtained from continuous imipenem stress evolution

FEMS Microbiol Lett. 2022 Feb 11:fnac015. doi: 10.1093/femsle/fnac015. Online ahead of print.

ABSTRACT

The carbapenem-resistant Escherichia coli (E. coli) has aroused increasing attention worldwide, especially in terms of imipenem (IMP) resistance. The molecular mechanism of IMP resistance remains unclear. This study aimed to explore the resistance mechanisms of IMP in E. coli. Susceptible Sx181-0-1 strain was induced into resistance strains by adaptive laboratory evolution. The drug resistance spectrum was measured using the disk diffusion and microbroth dilution methods. Whole-genome sequencing and resequencing were used to analyze the non-synonymous single-nucleotide polymorphisms (nsSNPs) between the primary susceptible strain and resistant strains. The expression levels of these genes with nsSNPs were identified by real-time quantitative PCR (RT-qPCR). Resistance phenotype appeared in the induced 15th generation (induction time = 183 h). Sx181-32 and Sx181-256, which had minimum inhibitory concentrations of IMP of 8 and 64 µg mL-1, were isolated during continuous subculture exposed to increasing concentrations of IMP, respectively. Nineteen nsSNPs were observed both in Sx181-32 and Sx181-256, including rpsU, sdaC, zwf, ttuC, araJ, dacC, mrdA, secF, dacD, lpxD, mrcB, ftsI, envZ, and two unknown function genes (orf01892 and orf01933). Among these 15 genes, five genes (dacC, mrdA, lpxD, mrcB, and ftsI) were mainly involved in cell wall synthesis. The mrdA (V338A, L378P, and M574I) and mrcB (P784L, A736V, and T708A) had three amino acid substitutions, respectively. The expression levels of rpsU, ttuC and orf01933 were elevated in both Sx181-32 and Sx181-256 compared to Sx181-0-1. The expression levels of these genes were elevated in Sx181-256, except for araJ. Bacteria developed resistance to antimicrobials by regulating various biological processes, among which the most involved is the cell wall synthesis (dacC, mrdA, lpxD, mrcB, and ftsI). The combination mutations of mrdA, envZ, and ftsI genes may increase the resistance to IMP. Our study could improve the understanding of the molecular mechanism underlying the IMP resistance of E. coli.

PMID:35147175 | DOI:10.1093/femsle/fnac015

Categories
Nevin Manimala Statistics

Weekly nanoparticle albumin-bound paclitaxel and paclitaxel for relapsed small cell lung cancer: A retrospective observational study

Medicine (Baltimore). 2022 Feb 11;101(6):e28863. doi: 10.1097/MD.0000000000028863.

ABSTRACT

In addition to advanced non-small cell lung cancer, nanoparticle albumin-bound paclitaxel (nab-PTX) may also harbor potential benefit for patients with relapsed small cell lung cancer (SCLC), since weekly paclitaxel (PTX) shows modest activity for relapsed SCLC. We evaluated the efficacy and safety of both weekly nab-PTX and PTX for relapsed SCLC.We retrospectively reviewed 52 consecutive relapsed SCLC patients who were treated with weekly nab-PTX or PTX at our hospital.The response rate, median progression-free survival and overall survival with nab-PTX and PTX were 5.6 vs 8.8%, 3.2 vs 1.7 months, and 5.4 vs 4.5 months, respectively. No statistically significant differences were observed. There was no statistical difference between the 2 groups for ≥Grade 3 adverse events.Weekly nab-PTX and PTX showed similar activity for relapsed SCLC. The toxicity profile of nab-PTX was equally tolerable to that of PTX.

PMID:35147134 | DOI:10.1097/MD.0000000000028863

Categories
Nevin Manimala Statistics

Orally consumed ginger and human health: an umbrella review

Am J Clin Nutr. 2022 Feb 11:nqac035. doi: 10.1093/ajcn/nqac035. Online ahead of print.

ABSTRACT

BACKGROUND: Emerging evidence supports the health benefits of ginger for a range of conditions and symptoms; however, there is a lack of synthesis of literature to determine which health indications are supported by quality evidence.

OBJECTIVES: This umbrella review of systematic reviews aimed to determine the therapeutic effects and safety of any type of ginger from the Zingiber family administered in oral form compared with any comparator or baseline measures on any health and wellbeing outcome in humans.

DESIGN: Five databases were searched to April 2021. Review selection and quality was assessed in duplicate using the Assessment of Multiple Systematic Reviews-2 (AMSTAR-2) Checklist and the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method, with results presented narratively.

RESULTS: Twenty-four systematic reviews were included with 3% overlap of primary studies. Strongest evidence was found for the antiemetic effects of ginger in pregnant women (effect size: large; GRADE: high), analgesic effects for osteoarthritis (effect size: small; GRADE: high), and glycemic control (effect size: none-to-very large; GRADE: very low-to-moderate). Ginger also had a statistically significant positive effect on blood pressure, weight management, dysmenorrhea, post-operative nausea, and chemotherapy-induced vomiting (effect size: moderate-to-large; GRADE: low-to-moderate) as well as blood lipid profile (effect size: small; GRADE: very low) and anti-inflammatory and antioxidant biomarkers (effect size: unclear; GRADE: very low-to-moderate). There was substantial heterogeneity and poor reporting of interventions; however, doses of 0.5-3 g per day in capsule form administered for up to three months was consistently reported as effective.

CONCLUSIONS: Dietary consumption of ginger appears safe and may exert beneficial effects on human health and wellbeing, with greatest confidence in antiemetic effects in pregnant women, analgesic effects in osteoarthritis, and glycemic control. Future randomized controlled and dose-dependent trials with adequate sample sizes and standardized ginger products are warranted to better inform and standardize routine clinical prescription. Registration: International Prospective Register of Systematic Reviews (PROSPERO) ID: CRD42020197925.

PMID:35147170 | DOI:10.1093/ajcn/nqac035

Categories
Nevin Manimala Statistics

Efficacy and safety of acupuncture for patients with pseudomyopia: A protocol for systematic review and meta-analysis

Medicine (Baltimore). 2022 Feb 11;101(6):e28859. doi: 10.1097/MD.0000000000028859.

ABSTRACT

BACKGROUND: Myopia are common health problems that people experience in daily life. Pediatric myopia has become a major international public health concern that has a negative impact on physical, mental health of patients, and quality of life. Currently, there is no cure available. Press needle as an adjuvant therapy is currently undergoing clinical trials in different medical centers. However, no relevant systematic review or meta-analysis has been designed to evaluate the effects of press needle patching on early myopia. There is also a lack of systematic evaluation and analysis of acupoints and thumbtack needle.

METHODS: We will electronically search Medline, Embase, PubMed, Web of Science, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific Journal Database, and Wan-Fang Database from their inception to October 2021. In addition, we will manually retrieve other resources including the reference lists of identified publications, conference articles, and gray literature. The clinical randomized controlled trials or quasi-randomized controlled trials related to press needle for the treatment of early myopia will be included in the study. The language is limited to Chinese and English. Research selection, data extraction, and research quality assessment will be independently completed by 2 researchers. Data were synthesized by using afixed effect model or random effect model depend on the heterogeneity test. The total effective rate was the primary outcomes. RevMan V.5.3 statistical software will be used for meta-analysis. If it is not appropriate for a meta-analysis, then a descriptive analysis will be conducted. Data synthesis will use the risk ratio and the standardized or weighted average difference of continuous data to represent the results.

RESULTS: This study will analyze the clinical effective rate, pesudomyopia outcomes, quality of life, improvement of clinical symptoms of pesudomyopia, and validity of thumbtack needle for patients with pesudomyopia.

CONCLUSION: This systematic review will provide evidence to judge whether thumbtack needle is an effective intervention for patients with early myopia.

SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021243151.

PMID:35147133 | DOI:10.1097/MD.0000000000028859

Categories
Nevin Manimala Statistics

Oral administration of East Asian herbal medicine for rheumatoid arthritis: A protocol for systematic review and meta-analysis

Medicine (Baltimore). 2022 Feb 11;101(6):e28819. doi: 10.1097/MD.0000000000028819.

ABSTRACT

BACKGROUND: Rheumatoid arthritis (RA) is a chronic, inflammatory, and painful joint disease. The aim of this review is to systematically evaluate the efficacy and safety of oral administration East Asian herbal medicine monotherapy for inflammatory pain of RA, and to explore core herb material information based on collected data.

METHODS: A comprehensive literature search will be conducted in 11 electronic databases including PubMed, Cochrane Library, Cumulative Index to Nursing & Allied Health Literature, Excerpta Medica database, Korean Studies Information Service System, Research Information Service System Oriental Medicine Advanced Searching Integrated System, Korea Citation Index, Chinese National Knowledge Infrastructure Database, Wanfang data, citation information by NII for randomized controlled trials from their inception until October 13, 2021. Statistical analysis will be performed in the software R version 4.1.1. and R studio program using the default settings of the “meta” and “metafor” package. When heterogeneity in studies is detected, the cause will be identified through subgroup analysis. Methodological quality will be assessed independently using the revised tool for risk of bias in randomized trials (Rob 2.0).

RESULTS: This study will provide more comprehensive and specific evidence of East Asian herbal medicine monotherapy for RA pain management.

CONCLUSIONS: Based on the results of this review, it is expected that the efficacy and safety of East Asian herbal medicine for inflammatory pain of RA may be confirmed. In addition, it will be possible to derivation of a core herb material information related to this research topic through additional data mining.

ETHICS AND DISSEMINATION: There are no ethical issues as there are no primary data collected by directly recruiting subjects. The results of this review will be reported in a peer-reviewed scientific journal.

PROSPERO REGISTRATION NUMBER: CRD42021273643.

PMID:35147122 | DOI:10.1097/MD.0000000000028819

Categories
Nevin Manimala Statistics

Serum osmolarity does not predict mortality in patients with respiratory failure

Medicine (Baltimore). 2022 Feb 11;101(6):e28840. doi: 10.1097/MD.0000000000028840.

ABSTRACT

We aimed to determine the parameters that affect mortality in pulmonary intensive care units that are faster and inexpensive to determine than existing scoring systems. The relationship between serum osmolarity and prognosis was demonstrated for predialysis patients, in acute pulmonary embolism, heart failure, acute coronary syndrome, myocardial infarction, and acute spontaneous intracerebral hemorrhage in the literature. We hypothesized that serum osmolarity, which is routinely evaluated, may have prognostic significance in patients with respiratory failure.This study comprised 449 patients treated in the Pulmonary Intensive Care Clinic (PICU) of our hospital between January 1, 2020, and December 31, 2020. The modified Charlson Comorbidity Index (mCCI), Acute Physiology and Chronic Health Assessment (APACHE II), Sequential Organ Failure Evaluation Score (SOFA), Nutrition Risk Screening 2002 (NRS-2002), and hospitalization serum osmolarity levels were measured.Of the 449 patients included in the study, 65% (n = 292) were female and the mean age of all patients was 69.86 ± 1.72 years. About 83.1% (n = 373) of the patients included in the study were discharged with good recovery. About 4.9% (n = 22) were transferred to the ward because their intensive care needs were over. About 6.9% (n = 31) were transferred to the tertiary intensive care unit after their status deteriorated. About 5.1% (n = 23) died in the PICU. In the mortality group, APACHE II (P = .005), mCCI (P < .001), NRS-2002 total score (P < .001), and SOFA score (P < .001) were significantly higher. There was no statistically significant difference between the groups in terms of serum osmolarity levels.Although we could not determine serum osmolarity as a practical method to predict patient prognosis in this study, we assume that our results will guide future studies on this subject.

PMID:35147129 | DOI:10.1097/MD.0000000000028840

Categories
Nevin Manimala Statistics

Prediction and types of dead-space fraction during exercise in male chronic obstructive pulmonary disease patients

Medicine (Baltimore). 2022 Feb 11;101(6):e28800. doi: 10.1097/MD.0000000000028800.

ABSTRACT

A high dead space (VD) to tidal volume (VT) ratio during peak exercise (VD/VTpeak) is a sensitive and consistent marker of gas exchange abnormalities; therefore, it is important in patients with chronic obstructive pulmonary disease (COPD). However, it is necessary to use invasive methods to obtain VD/VTpeak, as noninvasive methods, such as end-tidal PCO2 (PETCO2peak) and PETCO2 adjusted with Jones’ equation (PJCO2peak) at peak exercise, have been reported to be inconsistent with arterial PCO2 at peak exercise (PaCO2peak). Hence, this study aimed to generate prediction equations for VD/VTpeak using statistical techniques, and to use PETCO2peak and PJCO2peak to calculate the corresponding VD/VTpeaks (i.e., VD/VTpeakETVD/VTpeakJ).A total of 46 male subjects diagnosed with COPD who underwent incremental cardiopulmonary exercise tests with PaCO2 measured via arterial catheterization were enrolled. Demographic data, blood laboratory tests, functional daily activities, chest radiography, two-dimensional echocardiography, and lung function tests were assessed.In multivariate analysis, diffusing capacity, vital capacity, mean inspiratory tidal flow, heart rate, and oxygen pulse at peak exercise were selected with a predictive power of 0.74. There were no significant differences in the PCO2peak values and the corresponding VD/VTpeak values across the three types (both p = NS).In subjects with COPD, VD/VTpeak can be estimated using statistical methods and the PETCO2peak and PJCO2peak. These methods may have similar predictive power and thus can be used in clinical practice.

PMID:35147114 | DOI:10.1097/MD.0000000000028800

Categories
Nevin Manimala Statistics

Effects of vitamin D supplementation on ovarian reserve markers in infertile women with diminished ovarian reserve

Medicine (Baltimore). 2022 Feb 11;101(6):e28796. doi: 10.1097/MD.0000000000028796.

ABSTRACT

The purpose of this study was to evaluate the effects of vitamin D supplementation on ovarian reserve markers, including serum anti-Mullerian hormone (AMH) level, follicle-stimulating hormone (FSH) level, and antral follicle count (AFC), in infertile women with diminished ovarian reserve and vitamin D deficiency.A prospective, nonrandomized, cross-sectional study was conducted. Women aged 18 to 41 years who were unable to become pregnant after 12 months of sexual intercourse and had normal tubal patency, partners with normal semen analysis, diminished ovarian reserve, and 25-hydroxyvitamin D [25(OH)D] deficiency were included. Eligible patients’ AFC and serum levels of AMH, FSH, 25(OH)D, 1,25-dihydroxyvitamin D [1,25(OH)D], calcium, phosphate, alkaline phosphatase, and parathormone were assessed before and after administration of 300,000 IU of vitamin D ampules. Changes in the parameter values after vitamin D supplementation were compared with the initial levels.The study was conducted in 62 of the 142 participants. The AFC and AMH, 25(OH)D, 1,25(OH)D, phosphate (P < .01), and calcium levels (P < .05) were statistically significantly increased after vitamin D supplementation. Statistically significant decreases in FSH (P < .01) and alkaline phosphatase levels (P < .05) were observed after vitamin D supplementation. No statistically significant correlations were found between 25(OH)D level and AFC, 1,25(OH)D level, AMH level, and FSH level before and after supplementation (P > .05).As improvements in the ovarian reserve markers were obtained with vitamin D supplementation, vitamin D might be considered as a fertility treatment for patients with diminished ovarian reserve and vitamin D deficiency.

PMID:35147111 | DOI:10.1097/MD.0000000000028796

Categories
Nevin Manimala Statistics

Evaluation of efficacy and safety of rivaroxaban combined with aspirin in patients with chronic coronary artery disease: A protocol for systematic review and meta-analysis

Medicine (Baltimore). 2022 Feb 11;101(6):e28779. doi: 10.1097/MD.0000000000028779.

ABSTRACT

BACKGROUND: Coronary artery disease (CAD) is among the main causes of morbidities and mortalities globally. It is also considered to be an outcome of acute thrombotic events which entail activating platelets as well as coagulation proteins. In particular, rivaroxaban along with aspirin have been considered to reduce thrombotic events. However, they are yet to be evaluated by combining with or putting them against each other in patients experiencing CAD. This study intends to carry out an evaluation of whether combining rivaroxaben with aspirin will be effective and safe in treating patients experiencing chronic CAD.

METHODS AND ANALYSIS: We intend to search information from the following databases: MEDLINE, EMBASE, Web of Science, Cochrane library, WanFang, and China National Knowledge Infrastructure. In the search, we intend to regard randomized control trials written in either English or Chinese and only those published until December 2021, as well as only those that have assessed the effectiveness and safety of combining rivaroxaban and aspirin in treating patients suffering from chronic CAD. We intend to accompany the study identification with searching or relevant reference lists as well as citations. We will also contact respective authors to provide additional information or data were needful. From the search, we will collate all citations identified and remove all duplicates. Similarly, 2 independent authors will screen all the titles and abstracts and assess them against the inclusion criteria for the study. Only selected studies will be included for critical appraisal, extraction of data, and synthesis. We will then conduct statistical analyses by utilizing a random-effect model.

ETHICS AND DISSEMINATION: This study does not require ethical approval as the findings will be published in a peer-review journal.

REGISTRATION NUMBER: 10.17605/OSF.IO/WBGE4.

PMID:35147105 | DOI:10.1097/MD.0000000000028779