2025 年第 8 期 第 20 卷

康莱特注射液临床应用合理性分析

Analysis of the rationality of Kanglaite injection in clinical application

作者：庄星星任佳秀高文超倪受东

英文作者：Zhuang Xingxing Ren Jiaxiu Gao Wenchao Ni Shoudong

单位：安徽医科大学附属巢湖医院药学部，合肥238000

英文单位：Department of Pharmacy Chaohu Hospital of Anhui Medical University Hefei 238000 China

关键词：康莱特注射液；超说明书用药；疗程；中药注射剂

英文关键词：Kanglaiteinjection;Off-labelmedication;Courseoftreatment;TraditionalChinesemedicineinjection

• 摘要：

• 目的 评价分析康莱特注射液临床应用合理性，以期为康莱特注射液的合理使用提供参考依据。方法 从安徽医科大学附属巢湖医院电子病历系统中随机抽取2023年1—4月（专项点评前）和9—12月（专项点评后）使用康莱特注射液的住院病历资料各120份进行回顾性分析。对患者的性别、年龄、临床科室、临床诊断、治疗疗程、用法用量等信息进行统计，分析使用规律，并进行临床使用合理性评价。对比专项点评前后该药应用合理性数据。结果 专项点评前，120例康莱特注射液使用所在科室肿瘤内科最多、77例（64.2%），呼吸内科次之、41例（34.2%）；诊断非小细胞肺癌最多（77例，占比64.2%），其次为原发性肝癌（10例，占比8.3%），应用适应证与药品说明书相符。患者使用康莱特注射液给药途径均为静脉滴注，给药频次均为1次/d，符合说明书推荐；单次用量为200 ml的有108例（90.0%），符合说明书推荐。共有4例（3.3%）患者存在脂肪代谢异常，属于禁忌证用药。专项点评后的120例患者超说明书无适应证用药比例明显低于专项点评前、用药疗程合理比例明显高于专项点评前［13.3%（16/120）比27.5%（33/120）、25.0%（30/120）比1.7%（2/120）］，差异均有统计学意义（均P<0.05）。专项点评后未发现禁忌证用药的情况。结论  康莱特注射液临床使用存在一定的不合理现象，主要表现为超说明书适应证用药、用药疗程偏短、单次剂量偏小等，临床医师应严格遵循药品说明书及相关指南用药，提高康莱特注射液临床使用合理性。

• Objective To evaluate and analyze the rationality of clinical application of Kanglaite injection, in order to provide reference for the rational use of Kanglaite injection. Methods From the electronic medical record system of Chaohu Hospital of Anhui Medical University, 120 medical records using Kanglaite injection from January to April (before the special review) and 120 medical records from September to December 2023 (after the special review) were randomly selected for retrospective analysis. The gender, age, clinical department, clinical diagnosis, treatment course, usage and dosage of the patients were statistically analyzed, the use rule was analyzed, and the rationality of clinical use was evaluated. The rationality data of the drug application before and after the special review were compared. Results Before the special review, the oncology department had the highest number of 120 hospitalized patients who received Kanglaite injection, with 77 cases (64.2%), followed by the respiratory department with 41 cases (34.2%); non-small cell lung cancer was the most commonly diagnosed disease (77 cases, accounting for 64.2%), followed by primary liver cancer (10 cases, accounting for 8.3%). The indications for use were consistent with the drug instructions. The route of administration of Kanglaite injection was intravenous drip, and the frequency of administration was once a day, which was in line with the recommendation of the instructions. There were 108 cases (90.0%) with a single dose of 200 ml, which met the recommendation of the manufacturer′s instructions. Four patients (3.3%) had abnormal fat metabolism, which was a contraindication. The proportion of off-label use without indications in 120 patients after the special review was significantly lower than that before the special review, and the proportion of reasonable medication course was significantly higher than that before the special review ［13.3%(16/120) vs 27.5%(33/120), 25.0%(30/120) vs 1.7%(2/120)］(both P<0.05). No contraindications were found after the special review. Conclusions There are some unreasonable phenomena in the clinical use of Kanglaite injection, mainly manifested as off-label indication, short course of medication, and small single dose. Clinicians should strictly follow the drug instructions and relevant guidelines to improve the rationality of clinical use of Kanglaite injection.