Cardioprotective effect of saffron total glycoside tablets in patients with breast cancer receiving anthracycline-based chemotherapy: study protocol for a multicentre, randomised, parallel, double-blind, placebo-controlled clinical trial.

BACKGROUND: Breast cancer is the most common cancer worldwide. Anthracyclines, alone or in combination with other chemotherapeutic agents, are the most effective chemotherapy agents against breast cancer. However, the dose-dependent cardiotoxicity of anthracyclines is a serious drawback in clinical treatment. Considerable efforts have been made to establish suggestions to avoid anthracycline-induced cardiotoxicity. Crocin extracted from saffron has potential cardioprotective effects against anthracycline-induced cardiotoxicity. The aim of this study was to estimate the cardioprotective effects and safety of saffron total glycoside tablets relative to placebo in patients with breast cancer undergoing anthracycline-based chemotherapy. METHODS: This is a multicentre, randomised, double-blind, placebo-controlled clinical trial. A sample of 200 participants (100 per group) with breast cancer will be randomly assigned to receive either saffron total glycoside tablet or placebo (four tablets each time, three times each day) for 6 months. Each participant will be interviewed three times: baseline (visit 1), after 3 months (visit 2), and after 6 months (visit 3). The primary outcome is to confirm if administration of saffron total glycoside tablets reduces the rate of cardiotoxicity relative to that with placebo. Secondary outcomes include new arrhythmic events, and cardiac troponin I and N-terminal pro-B-type natriuretic peptide levels. The quantity, quality, and severity of the adverse events will be carefully documented. DISCUSSION: We look forward to obtaining high-quality evidence that can be used to formulate clinical practice guidelines. Thus, the findings of this study are expected to help fill the current gap in cardiotoxicity prevention drugs. TRIAL REGISTRATION: This trial was published in the Chinese Clinical Trial Registry (No. ChiCTR2000041134, registered on 19th December 2020).

A Vortex-Assisted Dispersive Liquid-Liquid Microextraction Followed by UPLC-MS/MS for Simultaneous Determination of Pesticides and Aflatoxins in Herbal Tea.

A method for detecting the organophosphorus pesticides residue and aflatoxins in China herbal tea has been developed by UPLC-MS/MS coupled with vortex-assisted dispersive liquid-liquid microextraction (DLLME). The extraction conditions for vortex-assisted DLLME extraction were optimized using single-factor experiments and response surface design. The optimum conditions for the experiment were the pH 5.1, 347 µL of chloroform (extraction solvent) and 1614 µL of acetonitrile (dispersive solvent). Under the optimum conditions, the targets were good linearity in the range of 0.1 µg/L⁻25 µg/L and the correlation coefficient above 0.9998. The mean recoveries of all analytes were in the ranged from 70.06%⁻115.65% with RSDs below 8.54%. The detection limits were in the range of 0.001 µg/L⁻0.01µg/L. The proposed method is a fast and effective sample preparation with good enrichment and extraction efficiency, which can simultaneously detect pesticides and aflatoxins in China herbal tea.