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目的:系统评价参附注射液预防化疗致周围神经毒性(CIPN)的疗效及安全性。方法:全面检索Pub Med,Embase,Cochrane Libraries,CNKI,万方和维普数据库中收录的参附注射液预防CIPN疗效的随机对照试验(RCTS),检索时限均从建库至2015年6月。在资料提取和质量评价后,采用Rev Man 5.3软件进行Meta分析。结果:共纳入9个RCTS,包括1 047例患者。Meta分析结果显示,1参附注射液能有效减少肿瘤患者化疗后CIPN总发生率[RR=0.53,95%CI(0.36,0.77),P=0.000 8]及严重CIPN发生率[RR=0.48,95%CI(0.31,0.74),P=0.000 8];2参附注射液组与对照组在化疗疗效的客观缓解率方面无统计学差异。亚组分析显示,1参附注射液能有效减少奥沙利铂致周围神经毒性(OIPN)总发生率[RR=0.59,95%CI(0.43,0.82),P=0.001]及严重OIPN发生率[RR=0.45,95%CI(0.26,0.78),P=0.005];2参附注射液对其他方案(不含奥沙利铂)致CIPN方面没有影响。结论:参附注射液在预防OIPN方面具有明显优势。
Objective: To systematically evaluate the efficacy and safety of Shenfu Injection in preventing chemotherapy-induced peripheral neurotoxicity (CIPN). Methods: A comprehensive randomized controlled trial (RCTS) was conducted in PubMed, Embase, Cochrane Libraries, CNKI, Wanfang and VIP databases for the prevention of CIPN. The search period was from the database to June 2015. After data extraction and quality evaluation, Meta-analysis was performed using Rev Man 5.3 software. Results: A total of 9 RCTS were included, including 1 047 patients. Meta-analysis showed that 1 Shenfu injection can effectively reduce the incidence of CIPN after chemotherapy (RR = 0.53,95% CI (0.36,0.77), P = 0.0008] and severe CIPN incidence [RR = 0.48, 95% CI (0.31,0.74), P = 0.0008]; 2 Shenfu injection group and the control group in the objective response rate of chemotherapy response was no significant difference. A subgroup analysis showed that 1 Shenfu injection can effectively reduce the overall incidence of peripheral neurotoxicity (OIPN) caused by oxaliplatin (RR = 0.59, 95% CI 0.43, 0.82, P = 0.001) and the incidence of severe OIPN [RR = 0.45, 95% CI (0.26, 0.78), P = 0.005]; 2 Shenfu injection had no effect on CIPN in other regimens (excluding oxaliplatin). Conclusion: Shenfu injection has obvious advantages in preventing OIPN.