回生口服液上市后用药安全性系统评价

Post-Marketing Systematic Review of Drug Safety of Huisheng Oral Solution

目的:系统评价回生口服液上市后的用药安全性。方法:计算机检索相关数据库,筛选回生口服液(试验组)与常规治疗(对照组)对患者不良反应影响的随机对照研究,使用Review Manager5.3软件进行质量评价并提取相关资料进行Meta分析。评价指标为肿瘤治疗后常见不良反应,包括肝功能异常、肾功能异常、骨髓抑制、消化道不良反应及全身不适症状。结果:共纳入39项随机对照研究,Meta分析结果显示:回生口服液降低了肿瘤治疗期间(1)白细胞减少(OR=0.36,95%CI[0.28,0.47],P<0.01);(2)血小板减少(OR=0.36,95%CI[0.20,0.65],P<0.01);(3)血红蛋白减少(OR=0.38,95%CI[0.22,0.66],P<0.01);(4)骨髓抑制(OR=0.43,95%CI[0.29,0.62],P<0.01);(5)肝功能损伤(OR=0.50,95%CI[0.35,0.71],P<0.01);(6)肾功能损伤(OR=0.42,95%CI[0.25,0.72],P<0.05);(7)消化道不良反应(OR=0.54,95%CI[0.38,0.75],P<0.01)发生的风险。肿瘤治疗期间,在缓解全身不适症状方面(OR=0.51,95%CI[0.19,1.37],P>0.05)结果尚未显示出统计学差异,可能与纳入研究较少有关。结论:回生口服液可能具有降低肿瘤常规治疗后不良反应发生的风险。但现有文献质量欠佳,结论尚需进一步验证。

Objective:To systematically evaluate the post-marketing drug safety of Huisheng Oral Solution.Methods:Databases were searched for randomized controlled trials(RCTs)on adverse reactions of Huisheng Oral Solution(the experimental group)and conventional treatment(the control group).RevMan 5.3 was used for quality assessment,and related data were summarized for Meta-analysis.The evaluation indicators were common adverse reactions after tumor treatment,including abnormal liver and renal functions,bone marrow suppression,adverse reactions of the digestive tract,and general discomfort symptoms.Results:Thirty-nine RCTs were included.Meta analysis results showed that Huisheng Oral Solution reduced the risk of leukocyte decrease(OR=0.36,95%CI[0.28,0.47],P<0.01),blood platelet decrease(OR=0.36,95%CI[0.20,0.65],P<0.01),hemoglobin decrease(OR=0.38,95%CI[0.22,0.66],P<0.01),bone marrow suppression(OR=0.43,95%CI[0.29,0.62],P<0.01),liver function injury(OR=0.50,95%CI[0.35,0.71],P<0.01),renal function injury(OR=0.42,95%CI[0.25,0.72],P<0.05),and gastrointestinal adverse reaction(OR=0.54,95%CI[0.38,0.75],P<0.01)during the treatment.No statistically significant difference was observed in reducing general discomfort symptoms during the treatment(OR=0.51,95%CI[0.19,1.37],P>0.05),which might be related to the small sample size of this study.Conclusion:Huisheng Oral Solution has the potential effect of reducing the risk of adverse reactions after conventional treatment of tumors.However,the existing trials are low in quality and the conclusions need to be further verified.