OBJECTIVETo develop an HPLC-ELSD method for the determination of 25 (R, S) ruscogenin 1-O-[beta-D-glucopyranosyl (1 --> 2)] [beta-D-xylopyranosyl (1 --> 3)] beta-D-fucopyranoside in the tuberous roots of Liriope muscari from different habitats and different harvest time.

METHODA Shimadzu C18 column (4.6 mm x 150 mm, 5 microm) with a solvent system consisting of acetonirile-water (46: 54) was used, and detected by ELSD. The temperature of drift tube was 94 degrees C and the nebulizer nitrogen flow rate was 2.5 L x min(-1).

RESULTThe calibration curve of 25 (R, S) ruscogenin 1-O-[beta-D-glucopyranosyl (1 --> 2)] [beta-D-xylopyranosyl (1 --> 3)] beta-D-fucopyranoside showed good linearity in the range of 1.02-12.228 microg and the average recovery was 100.80%, with RSD of 1.8%. 10 batches of L. muscari from different habitats were analyzed, and the contents were 0.25% - 0.41%. The contents of 15 batches from different harvest time were 0.13%-0.38%.

CONCLUSIONThe method is simple, rapid and sensitive, and can be used for determination of 25 (R, S) ruscogenin 1-O-[beta-D-glucopyranosyl (1 --> 2)] [beta-D-xylopyranosyl (1 --> 3)] beta-D-fucopyranoside in L. muscari. It provides the valuable basis for quality assessment of L. muscari.

Chromatography, High Pressure Liquid ; methods ; Ecosystem ; Liliaceae ; chemistry ; Liriope Plant ; chemistry ; Magnetic Resonance Spectroscopy ; methods ; Molecular Sequence Data ; Molecular Structure ; Plant Preparations ; analysis ; chemistry ; pharmacology ; Plant Roots ; chemistry ; physiology ; Plant Structures ; chemistry ; Saponins ; chemistry ; Spirostans ; analysis ; chemistry ; pharmacology ; Triterpenes ; isolation & purification

Objective To evaluate the clinical safety of the new tetracycline drugs,omadacycline and eravacycline,by analyzing adverse events(ADE)reported in FDA Adverse Event Reporting System(FAERS),to provide reference for clinical safety.Methods Extract ADE report data submitted to FAERS from first quarter 2018 to second quarter 2024.Signals were categorized and analyzed using system organ class(SOC)and preferred terms(PT)of Medical Dictionary for Regulatory Activities(MedDRA).Signal detection methods included the reporting odds ratio(ROR)method,Medicines and Healthcare products Regulatory Agency(MHRA)method,the Bayesian confidence interval propagation neural network(BCPNN)method and the multi-item gamma Poisson shrinker(MGPS)method.Results A total of 616 ADE cases were reported in which omadacycline was identified as the primary suspect drug,and the highest number of SOCs involved were reports of various types of injuries,poisonings,and surgical complications.While 85 cases were linked to eravacycline,and the SOCs were most frequent for systemic diseases and various reactions at the site of administration.Using the MHRA,ROR,BCPNN,and MGPS methods,omadacycline showed 32 positive signal PTs,while eravacycline showed 9.Omadacycline was frequently associated with ADE such as gastrointestinal disturbances and elevated liver enzyme levels.In contrast,eravacycline was commonly linked to increased lipase levels and pancreatitis.Notably,certain ADE were absent from the omadacycline prescribing information,including ototoxicity and tongue discoloration.Similarly,lactic acidosis and reduced fibrinogen levels were absent from the eravacycline preseribing information.Conclusion Using FAERS for ADE signal mining helps identify new side effects of tetracycline drugs.Omadacycline may cause ototoxicity and tongue discoloration,while eravacycline is linked to lactic acidosis and fibrinogen reduction,none of which are on product labels,and these effects should be monitored in clinical practice.

Objective:To investigate the influence of neoadjuvant chemotherapy on safety and prognosis of patients undergoing multivisceral resection for gastric cancer.Methods:The pro-pensity score matching (PSM) and retrospective cohort study was conducted. The clinicopathological data of 144 patients with gastric cancer who underwent multivisceral resection in the Fudan University Shanghai Cancer Center from December 2011 to December 2020 were collected. There were 95 males and 49 females, aged (56±13)years. Of 144 patients, 27 cases undergoing neoadjuvant chemotherapy and postoperative adjuvant chemotherapy were divided into the neoadjuvant chemotherapy group, and 117 cases undergoing postoperative adjuvant chemotherapy were divided into the adjuvant chemotherapy group. Observation indicators: (1) PSM and comparison of general data of patients between the two groups after matching; (2) surgical and postoperative conditions; (3) prognosis. PSM was done by the 1∶1 nearest neighbor matching method, with the caliper setting as 0.02. Measurement data with normal distribution were expressed as Mean± SD. Measurement data with skewed distribution were expressed as M(range), and comparison between groups was conducted using the rank sum test. Count data were expressed as absolute numbers, comparison between groups was conducted using the chi-square test. Comparison of ordinal data was conducted using the non-parameter test. The Kaplan-Meier method was used to draw survival curves and calculate survival rate, and the Log-Rank test was used for survival analysis. Results:(1) PSM and comparison of general data of patients between the two groups after matching. Of 144 patients, 46 cases were successfully matched, including 23 cases in the neoadjuvant chemotherapy group and 23 cases in the adjuvant chemotherapy group, respectively. The elimination of preoperative hemoglobin, clinical TNM staging confounding bias ensured comparability between the two groups after PSM. (2) Surgical and postoperative conditions. Of 46 patients, 26 cases underwent gastrectomy with one organ resection, 16 cases underwent gastrectomy with two organs resection, and 4 cases underwent gastrectomy with three organs resection. Of the patients with multivisceral resection, the proportion of patients undergoing combined splenectomy, pancreatectomy, colon resection, liver resection, and small intes-tinal resection was 69.6%(32/46), 39.1%(18/46), 32.6%(15/46), 8.7%(4/46), 2.2%(1/46), respectively. Cases with D 1 lymph node dissection, cases with D 2 lymph node dissection, cases with R 0 resection, cases with R 1 resection in the neoadjuvant chemotherapy group and the adjuvant chemotherapy group were 1, 22, 23, 0 and 0, 23, 23, 0, respectively, showing no significant difference in the above indicators between the two groups ( P>0.05). The number of lymph node dissected, the volume of intraoperative blood loss, duration of postoperative hospital stay in the neoadjuvant chemotherapy group and the adjuvant chemotherapy group were 28(range, 22-37), 150 (range, 100-200)mL, 11(range, 8-16)days and 25(range, 18-32), 150(range, 100-200)mL, 11(range, 9-18)days, respec-tively, showing no significant difference in the above indicators between the two groups ( Z=-1.13, -0.32, -0.50, P>0.05). Cases with complications ≥grade Ⅱ of Clavien-Dindo classification during the postoperative 30 days were 2 in the neoadjuvant chemotherapy group, including 1 case of abdominal abscess and 1 case of pneumonia. Cases with complications ≥grade Ⅱ of Clavien-Dindo classification during the postoperative 30 days were 8 in the adjuvant chemotherapy group, including 3 cases of abdominal abscess, 2 cases of anastomotic fistula, 1 case of pneumonia, 1 case of pancreatic fistula, 1 case of gastric emptying disability. There were significant differences in the complications ≥grade Ⅱ of Clavien-Dindo classification between the neoadjuvant chemotherapy group and the adjuvant chemotherapy group ( χ2=4.60, P<0.05). There was no significant difference in the abdominal abscess, anastomotic fistula, pneumonia, pancreatic fistula, gastric emptying disability between the two groups ( P>0.05). None of patient died in either of the neoadjuvant chemotherapy group and the adjuvant chemotherapy group. (3) Prognosis. Of 46 patients, 43 cases were followed up for 15.4(range, 3.0-84.0)months. The overall survival time of patients in the neoadjuvant chemotherapy group and the adjuvant chemotherapy group were (14±10)months and (24±22)months, showing no significant difference between them ( hazard ratio=0.82, 95% confidence interval as 0.28-2.40, P>0.05). Conclusion:Compared with postoperative adjuvant chemotherapy, neoadjuvant chemotherapy does not increase the surgical risk of locally advanced gastric cancer patients undergoing multivisceral and radical resection, and can reduce the incidence of complications ≥grade Ⅱ of Clavien-Dindo classification during the postoperative 30 days, but does not improve patient survival.

In this study, N-terminal site-specific mono-PEGylation of the recombinant lidamycin apoprotein (rLDP) of lidamycin (LDM) was prepared using a polyethyleneglycol (PEG) derivative (M w 20 kDa) through a reactive terminal aldehyde group under weak acidic conditions (pH 5.5). The biochemical properties of mPEG-rLDP-AE, an enediyne-integrated conjugate, were analyzed by SDS-PAGE, RP-HPLC, SEC-HPLC and MALDI-TOF. Meanwhile, in vitro and in vivo antitumor activity of mPEG-rLDP-AE was evaluated by MTT assays and in xenograft model. The results indicated that mPEG-rLDP-AE showed significant antitumor activity both in vitro and in vivo. After PEGylation, mPEG-rLDP still retained the binding capability to the enediyne AE and presented the physicochemical characteristics similar to that of native LDP. It is of interest that the PEGylation did not diminish the antitumor efficacy of LDM, implying the possibility that this derivative may function as a payload to deliver novel tumor-targeted drugs.