30097例注射用血塞通(冻干)真实世界应用分析

Analysis of Injection of Xuesaitong (lyophilized) in 30097 cases in real world

分析注射用血塞通(冻干)在临床"真实世界"应用的情况,为指导临床合理用药、完善药品说明书提供依据。该研究数据来源于一项前瞻性、多中心、大样本医院集中监测研究,分析纳入患者的一般信息,注射用血塞通(冻干)的用药相关信息等。数据采用SAS 9.1统计软件进行分析。纳入全国范围内的79家医院共计30 097例患者,其中31.18%的患者临床诊断为中风偏瘫,23.15%的患者临床诊断为胸痹心痛,0.53%的患者临床诊断为视网膜中央静脉阻塞;注射用血塞通(冻干)使用的最小单次剂量为20 mg,最大单次剂量1 000 mg,平均单次剂量(383.31±78.10) mg;69.96%的患者使用0.9%氯化钠作为溶媒,28.78%使用5%葡萄糖作为溶媒,0.19%使用10%葡萄糖作为溶媒;药液配置后放置时间最短0 min,最长120 min,平均放置时间(14.26±13.73) min;静脉滴注用药者占99.93%,滴速最慢10滴/min,最快80滴/min,平均滴注速度(43.91±10.77)滴/min;用药疗程最短1 d,最长80 d,平均疗程(8.22±5.12) d;80.67%的患者使用注射用血塞通(冻干)时联合其他注射剂,联用注射剂时冲管占47.14%,更换输液器占3.31%;注射用血塞通(冻干)不良反应40例,不良反应总体发生率为0.13%(0.09%~0.17%)。真实世界研究数据分析发现,注射用血塞通(冻干)在适应症、用药剂量、用药途径方面基本符合药品说明书要求,但溶媒类型、滴注速度、用药疗程、联合用药等方面的规范性尚需进一步加强。

To investigate the extensive application of Injection of Xuesaitong(lyophilized) in clinical real world study, and provide basis for clinical guidance on rational drug use and improvement of drug instructions. A prospective, multi-center, large-sample hospital centralized monitoring method was adopted to collect the general information and medication information of all patients who received Injection of Xuesaitong(lyophilized) during the study period in the respective monitoring units. Data analysis was performed using SAS 9.1 software. This study included 79 hospitals, with 30 097 patients being recruited. The patients who met the indications for stroke and hemiplegia accounted for 31.18%, those who experienced indications of chest pain and heartache accounted for 23.15%, and patients with central retinal vein occlusion indication accounted for 0.53%. The minimum single dose of Injection of Xuesaitong(lyophilized) was 20 mg, the maximum single dose was 1 000 mg, and the average single dose was(383.31±78.10) mg. 69.96% of the patients used 0.9% sodium chloride as the menstruum, 28.78% of the patients used 5% glucose as the menstruum, and 0.19% of the patients used 10% glucose as the menstruum. The minimum time for Injection of Xuesaitong(lyophilized) to dissolve is 0 min, 120 min maximally, and(14.26±13.73) min on an average basis. Patients using Injection of Xuesaitong(lyophilized) by intravenous drip accounted for 99.93%, with a slowest drip rate of 10 drops per min, fastest drip rate of 80 drops per min, and an average of(43.91±10.77) drops per min. Injection of Xuesaitong(lyophilized) was used for a minimum of 1 day and a maximum of 80 days, with an average of(8.22±5.12) days. Combined use with other injections accounted for 80.67%, 47.14% of them flushed the tube and 3.31% of them replaced infusion sets. The study found 40 cases of adverse reactions in patients with Injection of Xuesaitong(lyophilized), with an overall incidence of 0.13%(0.09% to 0.17%) for adverse reactions. In the real world application, the usage of Injection of Xuesaitong(lyophilized) basically meets the requirement of drug instructions in terms of indications, dosages, and methods of administration. However, it still needs to be improved in standardizing the selection of the menstruum, drip rate, course of treatment, and the combined usage of medicine.