Objective The adverse drug reaction (ADR) reports of compound Kushen injection in Qingdao Central Hospital were analyzed to improve the level of safe and rational use of drugs.Methods We investigated 35 cases of severe ADR reports induced by compound Kushen injection in Qingdao Central Hospital from 2016.09 to 2018.03 retrospectively.Then the type of report,relevance evaluation and prognosis,ADR occurrence and recovered time,involved system/organs and main clinical manifestations were analyzed.Results The new moderate and new severe ADR incident were 51.4％ of 35 ADR reports.Twenty-nine cases of the ADR were occurred 30 minutes after injection.Twenty-three cases of ADR clinical symptoms can be recovered after 30 minutes.The main ADR was the digestive system reaction,followed by the neural system,respiratory system and cardiovascular system.Conclusions It is important to pay attention to the occurrence of compound Kushen injection ADR and strengthen its monitoring.

Objective To investigate the clinical effects and safety of bevacizumab combined with S-1 as the second-line treatment of recurrent and/or metastatic esophageal cancer after chemoradiation. Methods Patients with recurrent or metastatic esophageal cancer after chemoradiation were treated with bevacizumab and S-1. Bevacizumab was used by intravenous infusion, 7.5mg/kg body weight on day 1; S-1 was used by oral at 80mg/m·d on day 1-14, 21 days as a cycle of treatment and repeated until either pro- gressive disease or intolerable toxicity occurred. Chest CT were performed and RECIST 1.1 was used for response evaluation. Kaplan-Meier method was used for survival analysis. Side effects were recorded and analyzed. Results Totally 78 patients were enrolled in the study, including 67 squamous cell carcinoma and 11 adenocarcinoma histologically. The overall response (CR+PR) rate was 22.4% (17/76) and disease control (CR+PR+SD) rate was 61.8% (47/76) respectively. The median follow-up time was 20 months (range from 9 to 44 months). The median progression-free survival (PFS) was 4.9 months (95% CI 4.4-5.5) and the median overall survival (OS) was 8.1 months (95% CI 7.6-9.2). The median PFS and OS of patients with metastasis diseases were 6.2 months (95% CI 3.3 to 6.3) and 8.5 months (95% CI 5.8 to 11.2), where PFS was longer than that of patients with local regional recurrence (median 5.0 months, 95% CI 3.0 to 5.5, P=0.017) and OS was longer than that of patients with regional disease and metastasis (median 8.0 months, 95% CI 4.6 to 9.5, P=0.010). The common adverse effects were mild to moderate neutropenia (84.2%), grade I-II hand and foot syndrome (51.3%), grade I-II nausea (48.7%), mild epistaxis (30.1%) and mild vomiting (14.5%). Esophageal bleeding occurred in 7.9% of patients. One patient (1.3%) died from massive bleeding which was caused by esophageal perforation. Conclusion Bevacizumab combined with S-1 was effective and safe for esophageal cancer patients who had recurrent or metastatic diseases after chemoradiation.
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Bevacizumab ; administration & dosage ; adverse effects ; Drug Combinations ; Esophageal Neoplasms ; drug therapy ; mortality ; pathology ; Female ; Humans ; Male ; Middle Aged ; Oxonic Acid ; administration & dosage ; adverse effects ; Tegafur ; administration & dosage ; adverse effects

Carcinoma, Non-Small-Cell Lung ; drug therapy ; Humans ; Lung Diseases, Interstitial ; chemically induced ; diagnosis ; Male ; Middle Aged ; Protein Kinase Inhibitors ; adverse effects ; therapeutic use ; Pyrazoles ; adverse effects ; therapeutic use ; Pyridines ; adverse effects ; therapeutic use