Jiang De-Qi, Zang Qing-Min, Jiang Li-Lin, Wang Yan, Li Ming-Xing, Qiao Jing-Yi
Department of Biology and Pharmacy, Guangxi Key Laboratory of Agricultural Resources Chemistry and Biotechnology, Yulin Normal University, Yulin, 537000, China.
Department of Pharmacy, Guangdong Province Hospital of Integrated Traditional Chinese and Western Medicine, Foshan, 528200, China.
Naunyn Schmiedebergs Arch Pharmacol. 2021 Sep;394(9):1893-1905. doi: 10.1007/s00210-021-02089-z. Epub 2021 May 7.
The purpose of this research was to evaluate the clinical efficacy and safety of pramipexole plus levodopa/benserazide (P+LB) combination therapy in the treatment of Parkinson's disease (PD) compared to that of LB monotherapy, in order to confer a reference for clinical practice. Randomized controlled trials (RCTs) of P+LB for PD published up to April 2020 were retrieved. Heterogeneity and sensitivity analysis were executed. Twenty-nine RCTs with 3017 participants were included. Clinical efficacy of P+LB combination therapy was significantly better than LB monotherapy (RR 1.27, 95% CI 1.22 to 1.32, P<0.00001). Compared with LB monotherapy, the pooled effects of P+LB combination therapy on UPDRS score were (SMD -1.41, 95% CI -1.71 to -1.11, P<0.00001) for motor UPDRS score, (SMD -1.65, 95% CI -2.25 to -1.04, P<0.00001) for activities of daily living UPDRS score, (SMD -2.20, 95% CI -3.32 to -1.09, P=0.0001) for mental UPDRS score, and (SMD -1.60, 95% CI -2.06 to -1.15, P<0.00001) for complication UPDRS score. The HAMD score showed significant decrease in the P+LB combination therapy compared to LB monotherapy (SMD -1.32, 95% CI -1.80 to -0.84, P<0.00001). In contrast to LB monotherapy, P+LB combination therapy decreased the number of any adverse events obviously in PD patients (RR 0.53, 95% CI 0.45 to 0.63, P<0.00001). In conclusion, P+LB combination therapy is superior to LB monotherapy for improvement of clinical symptoms in PD patients. Moreover, the safety profile of P+LB combination therapy is better than that of LB monotherapy. Further well-designed, multi-center RCTs needed to identify these findings.
本研究旨在评估普拉克索联合左旋多巴/苄丝肼(P+LB)与左旋多巴/苄丝肼单药治疗(LB)相比,在帕金森病(PD)治疗中的临床疗效和安全性,为临床实践提供参考。检索了截至2020年4月发表的关于P+LB治疗PD的随机对照试验(RCT)。进行了异质性和敏感性分析。纳入了29项RCT,共3017名参与者。P+LB联合治疗的临床疗效显著优于LB单药治疗(RR 1.27,95%CI 1.22至1.32,P<0.00001)。与LB单药治疗相比,P+LB联合治疗对帕金森病统一评分量表(UPDRS)得分的合并效应为:运动UPDRS得分为(标准化均数差SMD -1.41,95%CI -1.71至-1.11,P<0.00001),日常生活活动UPDRS得分为(SMD -1.65,95%CI -2.25至-1.04,P<0.00001),精神UPDRS得分为(SMD -2.20,95%CI -3.32至-1.09,P=0.0001),并发症UPDRS得分为(SMD -1.60,95%CI -2.06至-1.15,P<0.00001)。汉密尔顿抑郁量表(HAMD)得分显示,与LB单药治疗相比,P+LB联合治疗有显著下降(SMD -1.32,95%CI -1.80至-0.84,P<0.00001)。与LB单药治疗相比,P+LB联合治疗明显减少了PD患者任何不良事件的发生数量(RR 0.53,95%CI 0.45至0.63,P<0.00001)。总之,P+LB联合治疗在改善PD患者临床症状方面优于LB单药治疗。此外,P+LB联合治疗的安全性优于LB单药治疗。需要进一步设计良好的多中心RCT来验证这些发现。