Objective:This study aims to analyze the efficacy and safety of anlotinib in the real world for patients with unresectable or metastatic bone and soft-tissue sarcomas(STSs). Methods:Clinical data of 124 patients with unresectable or metastatic bone and STSs treated with anlotinib in the First Affiliated Hospital of Zhengzhou University from January 2018 to December 2020 were retrospectively analyzed.Information on age,sex,performance status,lines of anlotinib,surgical history,reduction of anlotinib,adverse reaction,metastatic site,tumor location,pathological subtypes and combination chemotherapy was collected and analyzed.The objective response rate(ORR)and disease control rate(DCR)was analyzed for short-term efficacy.Kaplan-Meier method was performed for survival analysis,and the evaluation indexes were median progression-free survival(mPFS)and median overall survival(mOS). Results:The main pathological subtypes of 124 patients were Synovial sarcoma(SS),Leiomyosarcoma(LMS),liposarcoma(LPS).The median age was 48.5 years(9-83 years).The ORR and DCR of anlotinib used in first-line therapy were 26.8％and 82.1％,but in second-line therapy and beyond,the ORR and DCR only were 5.9％and 64.7％.There were improvement in mPFS and mOS with anlotinib in first-line therapy compared to second-line therapy and beyond(mPFS:22.0 months vs 7.0 months,P=0.001;mOS:51.0 months vs 32.0 months,P=0.035).Adverse reactions of anlotinib were well tolerated,and the main grades of adverse reactions were grade Ⅰ and Ⅱ.No new anlotinib-related adverse reactions were identified. Conclusion:Anlotinib has shown a definite effect in the treatment of unresectable or metastatic bone and STSs.The adverse events of anlotinib are minor and well tolerated,and the efficacy of first-line treatment is better.

Objective:To establish the fingerprints of Microctis Folium by ultra high performance liquid chromatography (UPLC); To determine the contents of three flavonoids in the Microctis Folium; To evaluate the quality difference of Microctis Folium from different producing areas. Methods:The fingerprints were performed on Agilent ZORBAX SB C18 column (2.1 mm×150 mm,1.8 μm). The mobile phase was acetonitrile - 0.1 % acetic acid solution with gradient elution at a flow rate of 0.30 ml/min. The column temperature was 30 ℃ and the detection wavelength was 315 nm. The common fingerprint peaks were identified by UPLC-mass spectrometry, and the identification results were confirmed by comparison of reference materials. Waters Cortecs T3 C18 chromatographic column (2.1 mm × 100 mm,1.6 μm) was used for content determination. The mobile phase was methanol-0.1 % formic acid solution with gradient elution at a flow rate of 0.35 ml/min. The column temperature was 30 ℃ and the detection wavelength was 339 nm. The contents of vitexin, isovitexin and narcissoside in 15 batches of Microctis Folium from different habitats were determine. Results:There were 11 common peaks in the fingerprint of Microctis Folium. Identified by mass spectrometry and confirmed by reference substance,10 chemical components were identified, including caffeic acid, p-hydroxycinnamic acid, ferulic acid, vitexin, isovitexin, kaempferol-3-O-rutoside, astragaloside, narcissoside, isorhamnetin-3-O-glucoside and linden glycoside. The similarity between the fingerprints of 15 batches of Microctis Folium and the control fingerprint was greater than 0.95, indicating that the overall similarity of the fingerprints of Microctis Folium from different producing areas was high. The total contents of three active components were 3.23-5.64 mg/g in Yangjiang City, Guangdong, 3.60-5.78 mg/g in Zhanjiang City, Guangdong, 4.68-5.73 mg/g in Yulin City, Guangxi and 3.87-5.21 mg/g in Wuzhishan City, Hainan . There was no significant difference in the content of three active components in different producing areas. Conclusion:The fingerprints and the determination method established in the study are stable and feasible, which can be used for the quality evaluation of Microctis Folium.