Background:As one of the most common endocrinal disorders for women at childbearing age, the diagnostic criteria of polycystic ovary syndrome (PCOS) have been defined differently among different international health organizations. Phenotypic heterogeneity of PCOS also brings about difficulties for its diagnosis and management assessment. Therefore, more efficient biomarkers representing the progression of PCOS are expected to be integrated into the monitoring of management process using metabolomic approaches.Methods:In this prospective randomized controlled trial, 117 PCOS patients were enrolled from December 2016 to September 2017. Classical diagnostic parameters, blood glucose, and metabolome were measured in these patients before and at 2 months and 3 months of different medical interventions. The receiver operating characteristic (ROC) curves were built based on multivariate statistical analysis using data at baseline and 3 months’ management, and combinational biomarkers with appreciable sensitivity and specificity were selected, which then validated with data collected at 2 months.Results:A set of metabolites including glutamic acid, aspartic acid, 1-methylnicotinamide, acetylcarnitine, glycerophosphocholine, and oleamide were filtered out with high performance in representing the improvement through 3-month management of PCOS with high sensitivity and specificity in ROC analysis and validation with other two groups showed an appreciable area under the curve over 0.96.Conclusions:The six metabolites were representative of the remission of PCOS through medical intervention, making them a set of potential biomarkers for assessing the outcome of PCOS management.Trial Registration:ClinicalTrials.gov, NCT03264638.
Background Iron supplement is the first-line treatment for gynecological anemia (GA). However, its performance is limited by common gastrointestinal reactions and some inadequate responses. Traditional Chinese medicine (TCM) has a long history in the treatment of gynecological conditions but has been restricted by limited high-quality research, unknown bioactive ingredients, and mechanisms. Objectives These studies aim to compare the clinical efficacy of Buxue Yimu Pills (BYP),ferrous sulfate, and the addition of BYP to ferrous sulfate on GA through oral administration, and to investigate the mechanisms of BYP using network pharmacology approach. Design: Prospective, open-label, comparative, randomized, multicenter clinical trial. Setting: Gynecology departments in three public hospitals. Patients: 170 patients with hemoglobin of 70–110 g/L were recruited and randomized into three groups: BYP group, oral iron group, and combined BYP & oral iron group. After a four-week treatment, the complete blood count (CBC) along with the markers for iron metabolism were determined for 138 patients. Furthermore, network pharmacology was performed to identify the active ingredients and potential mechanisms of BYP. Results While iron-treated groups showed elevated hemoglobin in accompany with significant changes in iron metabolism biomarkers, the BYP group exhibited hemoglobin improvement without apparent changes in iron metabolism markers. The network pharmacology identified 27 bioactive compounds and 145 targets of BYP on GA. A number of biological processes and pathways were identified, including regulation of inflammation, regulation of steroid hormone, angiogenesis and hemostasis, response to decreased oxygen levels, effects on myeloma cell, and response to metal ions. Conclusions BYP contributes to the practical improvement of gynecological anemia potentially through multi-target mechanisms independent from increasing hemopoietic raw material-iron.
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