A Randomized, Open-Label, Multicenter, Phase 3 Study of High-Dose Vitamin C Plus FOLFOX ± Bevacizumab versus FOLFOX ± Bevacizumab in Unresectable Untreated Metastatic Colorectal Cancer (VITALITY Study).

PURPOSE: To compare the efficacy and safety of high-dose vitamin C plus FOLFOX ± bevacizumab versus FOLFOX ± bevacizumab as first-line treatment in patients with metastatic colorectal cancer (mCRC). PATIENTS AND METHODS: Between 2017 and 2019, histologically confirmed patients with mCRC (n = 442) with normal glucose-6-phosphate dehydrogenase status and no prior treatment for metastatic disease were randomized (1:1) into a control (FOLFOX ± bevacizumab) and an experimental [high-dose vitamin C (1.5 g/kg/d, intravenously for 3 hours from D1 to D3) plus FOLFOX ± bevacizumab] group. Randomization was based on the primary tumor location and bevacizumab prescription. RESULTS: The progression-free survival (PFS) of the experimental group was not superior to the control group [median PFS, 8.6 vs. 8.3 months; HR, 0.86; 95% confidence interval (CI), 0.70-1.05; P = 0.1]. The objective response rate (ORR) and overall survival (OS) of the experimental and control groups were similar (ORR, 44.3% vs. 42.1%; P = 0.9; median OS, 20.7 vs. 19.7 months; P = 0.7). Grade 3 or higher treatment-related adverse events occurred in 33.5% and 30.3% of patients in the experimental and control groups, respectively. In prespecified subgroup analyses, patients with RAS mutation had significantly longer PFS (median PFS, 9.2 vs. 7.8 months; HR, 0.67; 95% CI, 0.50-0.91; P = 0.01) with vitamin C added to chemotherapy than with chemotherapy only. CONCLUSIONS: High-dose vitamin C plus chemotherapy failed to show superior PFS compared with chemotherapy in patients with mCRC as first-line treatment but may be beneficial in patients with mCRC harboring RAS mutation.

[Optimization of extraction process of total alkaloids from radix of Aconitum flavum using response surface methodology].

OBJECTIVE: To study the technological parameters of the extraction process of total alkaloids from Radix of Aconitum flavum. METHODS: Using response surface methodology (RSM) of three factors and three levels to optimize ethanol heat reflux applied for alkaloids extraction from Radix of Aconitum flavum. RESULTS: A quadratic polynomial mathematical model with good correlation was constructed and employed to the optimization. The optimal extraction conditions were as follows: the extraction time was 1.72 h, the concentration of ethanol was 64.00%, the ratio of ethanol to raw material was 8.18 mL/g, under which the predictive value of the rate of extraction yield of alkaloids was 0.526% and the measured value was 0. 521%, respectively, and there was a good agreement with their predicted values. CONCLUSION: This reveals the good predictability of the mathematical model, the selected process also has a good reproducibility.

[Study on pharmacognosy of Sophora davidii].

The primary microscopic observation of several parts of Sophora davidii (Franch.) Pav. such as crude drug, fabric, powder characteristic was carried out, and the microstructure and powder characteristic pictures was drawn, in order to provide scientific references for its further research and comprehensive exploration of the resource.

[Study on pharmacognosy of Ginkgo leaf].

The primary study of Ginkgo leaf such as crude drug macroscopic and powder characteristics were carried out, and the flavonoids content in the leaf of Ginkgo in different areas of Gansu province was determined by HPLC, in order to provide scientific references for the exploitation of Ginkgo in Gansu province.

[Effects of Shenshuai Yangzhen capsule on lipid metabolism disorder in rats with chronic renal failure].

OBJECTIVE: To investigate the therapeutic effect of Shenshuai Yangzhen capsule, a preparation of traditional Chinese medicine, on lipid metabolism disorder in rats with chronic renal failure (CRF) and explore its mechanism. METHODS: Fifty male SD rats received 5/6 nephrectomy for preparation of CRF models and were randomized into CRF group, gemfibrozil group, high-, moderate- and low-dose Shenshuai Yangzhen groups, and normal control group. After 4-week treatment as indicated, myocardial lipoprotein lipase messenger RNA (LPL mRNA) level were measured by RT-PCR in rats with surgically induced renal failure (two-stage subtotal nephrectomy). The blood lipid parameters in CRF rats were also determined. RESULTS: Compared with those in the CRF group, the plasma total cholesterol, triglyceride, low-density lipoprotein cholesterol and very-low-density lipoprotein cholesterol concentrations in the treatment groups were significantly lower with substantially elevated plasma high-density lipoprotein cholesterol and LPL gene expression. No significant differences were noted between different dose groups of Shenshuai Yangzhen. CONCLUSION: Shenshuai Yangzhen capsule can regulate blood lipid levels in rats with renal insufficiency possibly by enhancing LPL gene expression.

[Determination of four alkaloids in Berberis plants by HPLC].

OBJECTIVE: In order to assess Berberis, a simple and effective high-performance liquid chromatographic (HPLC) method was established. METHOD: By applying HPLC with gradiation elution, this method was developed for determination of four kinds of alkaloids including berbamine, Jatrorrhizine, berberine and palmatine in methanolic extracts from root bark, root, stem bark and stem of Berberis. RESULT: The alkaloids berbamine, jatrorrhizine, berberine and palmatine shown good linear correlations in the range of 0.028-4.74 microg (r = 0.9998); 0.012-2.0 microg (r = 0.9996); 0.026-0.52 microg (r = 0.9999); 0.015-2.56 microg (r = 0.9998), respectively. The correlation coefficients of the calibration curve for the analytes exceeded 0.9998. CONCLUSION: The optimized HPLC method was applied to analyze various samples, and the results shown that the content of alkaloids were obvious difference in Berberis from different area, different species and different parts.

Progress of intervention of renal interstitial fibrosis with Chinese traditional herbal medicine.

This article reviews the current status of progress in the research of renal interstitial fibrosis therapy using traditional Chinese herbal medicine, which exerts its therapeutic effect through inhibiting cytokine expression and fibroblast proliferation, inducing apoptosis of the renal myofibroblasts and other mechanisms.