注射用甘露聚糖肽不良反应因素分析

Analysis of the Factors of Adverse Reaction of Mannatide for Injection

关键词:  注射用甘露聚糖肽  肿瘤  安全性  Logistic回归  肺癌

Key words:  mannatide for injection  tumor  clinical safety  Logistic regression  lung cancer

摘要:

目的 探讨影响注射用甘露聚糖肽不良反应发生的相关因素，为临床用药提供参考。方法 回顾性分析2012年至2016年郑州大学附属肿瘤医院上报的注射用甘露聚糖肽药品不良反应（adverse drug reactions，ADR）病例72例，采用Stata软件对患者的临床特点和用药信息进行Logistic回归分析。结果 注射用甘露聚糖肽常见的ADR是皮肤系统损伤（41.7%），具体临床表现为皮疹；其次是呼吸系统ADR（36.1%），临床表现为胸闷和呼吸困难。肺癌患者更易发生呼吸系统ADR，与其他肿瘤相比具有统计学意义（P<0.05）。高龄和溶媒可能是影响注射用甘露聚糖肽安全性的危险因素，老年患者应谨慎用药，配伍溶媒建议选择0.9%氯化钠。结论 临床使用注射用甘露聚糖肽应严格把握适应证，对存在潜在风险的患者谨慎用药，确保临床用药安全。

Abstract:

OBJECTIVE To investigate the factors affecting the adverse drugs reaction (ADR) of mannatide for injection in cancer patients, in order to provide reference for the reasonable clinical application. METHODS Retrospective analized of 72 cases of ADR in Affiliated Cancer Hospital of Zhengzhou University from 2012 to 2016, and the clinical characteristics and medication information of patients were analized by Logistic regression using Stata software. RESULTS The common ADR of mannatide for injection was skin system damage (41.7%), the specific clinical manifestation was skin rash; followed by respiratory system ADR (36.1%), the clinical manifestations were chest tightness and dyspnea. Lung cancer patients were more susceptible to ADR in the respiratory system, which had statistically significant compared with other tumors (P<0.05). Advanced age and solvent might be a risk factor for mannatide for injection's safety. Elderly patients should be cautious of medication, and 0.9% sodium chloride was recommended to choose as solvent. CONCLUSION Indications are strictly grasped in clinical use of mannatide for injection. Attention shall be paid for patients with potential risks to ensure the safety of clinical medication.