Revaluation of post-marketing safety of kanglaite injection(康莱特注射液)

Abstract

Objective To understand the adverse reactions of Kanglaite injection and its incidence and explore the factors affecting the safety of Kanglaite Injection in clinical use. Methods A non-interventional and prospective hospital based monitoring study and nested case-control study were conducted. All hospitalized cancer patients receiving Kanglaite injections from 28 hospitals in northeast, north, central, east, south, southwest, northwest regions of China from September 2013 to September 2014 were enrolled in this study. The main monitoring contents included the general status of patients, the drug administration (including indications and combined use), medication safety, and so on. Patients developing adverse reactions related to Kanglaite injection distributed in the case group and patients who did not develop adverse reactions were randomly selected and distributed into the control group with a ratio of 1 ∶ 3, and the factors that affect the safe use of Kanglaite injection were analyzed. Results A total of 5 022 cancer patients were entered into the study, including 2 926 males and 2 096 females with age from 9 to 95 years and their average age was (60±12) years. The top five tumors were lung cancer (1 456 patients, 28.99%), intestinal cancer (867 patients, 17.26%), mammary cancer (372 patients, 7.41%), gastric cancer (346 patients, 6.89%), and liver cancer (335 cases, 6.67%). There were 3 863 patients (76.92%) with tumor stage III and IV, 348 patients with allergic history (6.93%); 2 524 patients were complicated with other diseases (50.26%); 4 687 patients (93.33%) had combined drug therapy. During the monitoring period, 751 (14.95%) of 5 022 patients developed adverse events and of them, 18 cases met the criteria of causality of adverse reactions, including 7 cases of phlebitis, 3 cases of nausea and vomiting, 3 cases of chills, 2 cases of rash, 1 case of palpitation, 1 case of transaminase increase, and 1 case of fever. The incidence of adverse reactions was 0.36%. Univariate analysis showed that the incidence of adverse reactions in patients with combined diseases was higher than that in patients without combined diseases (χ2=5.4723, P=0.019), the incidence of adverse reactions in patients with combined western medication was higher than that in patients with combined western and Chinese medication(P=0.002). Logistic regression analysis showed that the influencing factors of adverse reactions were coexisting diseases (OR=1.636, 95%CI: 1.100-2.433, P=0.013) and combined medication (OR=1.475, 95%CI: 1.108-1.965, P=0.027). Nested case-control study showed that the influencing factors of adverse reactions induced by Kanglaite injection were radiotherapy (OR=1.864, 95%CI: 0.930-3.736, P<0.01) and combined medication (OR=1.622, 95%CI: 1.102-2.389, P<0.01). Conclusions The incidence of adverse reactions of Kanglaite injection in clinical application is lower and the safety is good. Coexisting diseases, combined medication and radiotherapy are main factors affecting its clinical safety. Key words: Kanglaite injection; Safety; Evaluation studies