普瑞巴林治疗神经病理性癌痛的疗效和安全性研究

Efficacy and safety of pregabalin in neuropathic cancer pain： a randomized control multicentre trial

目的探讨普瑞巴林治疗神经病理性癌痛的疗效和安全性。方法采用前瞻性、随机、对照、多中心的研究方法，将中日友好医院、协和医院、北京大学人民医院、北京大学第三医院、北京空军总医院5家医院自2015年1月至2016年1月收治的122例门诊和住院神经病理性癌痛患者分为普瑞巴林组m=60）和对照组（n=62）。普瑞巴林组患者在原阿片类药物的基础上应用普瑞巴林，对照组患者则增加原阿片类药物的剂量。治疗14d后观察2组患者的疼痛评分（NRS）、感觉异常评分、每日处理爆发痛的即释吗啡剂量、汉密尔顿抑郁量表（HAMD）评分、满意度评分和不良反应的发生。结果普瑞巴林组和对照组患者NRS评分分别下降（2．3±1．1）分和（1．3±1．5）分，感觉异常评分分别下降（1．6±0．6）分和f0．4±0．3）分，HAMD抑郁评分分别下降（4．4±1．2）分和（2．4±1．0）分，差异均有统计学意义（P〈0．05）。普瑞巴林组患者每天使用即释吗啡剂6[（30．6±3．5）mg／d]低于对照组[（70．9±12.31mg／d]，差异有统计学意义（P〈0．05）。普瑞巴林组患者满意度评分高于对照组，差异有统计学意义（P（0．051。与对照组（10／59，16．1％1比较，普瑞巴林组患者因严重不良反应导致的停药发生率（3／56，5％）较低，差异有统计学意义（P〈0．05）。结论对于神经病理性癌痛，辅助用普瑞巴林而非加大阿片类药物的剂量，更有利于疼痛缓解和情绪改善。

Objective To examine the efficacy and safety of pregabalin in patients with neuropathic cancer pain （NCP）. Methods A prospective randomized control multicenter trial was conducted in five hospitals; from January 2015 to January 2016, one hundred and twenty two eligible inpatients and outpatients were divided into pregablin treatment group （n=60） and control group （n=62）. Patients in the pregablin group added pregablin to opiod background analgesia, while those in the control group raised opioid dose instead. The Numerical Pain Rating Scale （NRS） scores, paraesthesia scale scores, Hamilton＇s Depression （HAMD） scale scores, analgesia dose, patiends satisfaction, and adverse events were recorded 14 d after each treatment. Results After each treatment, the NRS scores were decreased by （2.3±1.1） and （1.3 ±1.5）, the paraesthesia scale scores were decreased by （1.6±0.6） and （0.4±0.3）, and the HAMD scale scores were decreased by （4.4±1.2） and （2.4±1.0） in the pregablin treatment group and control group, respectively, with significant differences （P〈0.05）. Morphine dose for breakthrough pain in pregabalin group was statistically less than that in control group （[30.6±3.5] mg/d vs. [70.9±12.3] rag/d, P〈0.05）. Patients satisfaction in the pregablin treatment group was significantly higher than that in the control group （P〈0.05）. Pregabalin treatment group had less severe adverse effects （3/56, 5%） as compared with control group （10/59, 16.1%, P〈0.05）. Conclusion Pregabalin has positive roles in patients with NCP already receiving opioid; pregabalin has better pain-control and mood improvement.