El-Atawi Khaled, De Luca Daniele, Ramanathan Ranagasamy, Sanchez Luna Manuel, Alsaedi Saad, Abdul Wahab Muzafar Gani, Hamdi Moataz, Saleh Maysa
Department of Pediatrics, Latifa Women and Children Hospital, Dubai, ARE.
Division of Pediatrics and Neonatal Critical Care, "Antoine Béclère" Hospital, Paris Saclay University Hospitals, APHP (Assistance Publique Hôpitaux de Paris), Paris, FRA.
Cureus. 2023 Dec 31;15(12):e51375. doi: 10.7759/cureus.51375. eCollection 2023 Dec.
This systematic review and meta-analysis aimed to summarize the current evidence regarding the efficacy and safety of palivizumab as a prophylaxis for respiratory syncytial virus (RSV) disease. We searched MEDLINE via PubMed, Scopus, Cochrane, Web of Science, Embase, and Science Direct from inception till November 2023. Studies that assessed the efficacy and safety of palivizumab in infants aged between 28 days and three months of age were included. We analyzed the data using Review Manager 5.4 software, with results pooled across studies and expressed as risk ratios (RR) with 95% confidence intervals (CI). A total of 10 studies were included. The effect estimates favored palivizumab over placebo regarding the hospitalization for RSV infection (RR=0.51, 95% CI: 0.40 to 0.65; P<0.00001) and ICU admission (RR=0.49, 95% CI: 0.30 to 0.81; P=0.005). On the other hand, the effect estimate showed no significant difference between palivizumab and placebo regarding all-cause mortality (RR=0.69, 95% CI: 0.42 to 1.15; P=0.16), lower respiratory tract infection (RR=0.42, 95% CI: 0.11 to 1.69; P=0.22), and need for mechanical ventilation (RR=0.75, 95% CI: 0.34 to 1.67; P=0.48). Palivizumab can be considered a prophylaxis for RSV disease in young children as it is safe, well-tolerated, and effective in reducing RSV hospitalizations. However, further research through high-quality randomized controlled trials is required to determine its efficacy as a therapeutic agent for established RSV infections.
本系统评价和荟萃分析旨在总结目前关于帕利珠单抗预防呼吸道合胞病毒（RSV）疾病的疗效和安全性的证据。我们通过PubMed、Scopus、Cochrane、Web of Science、Embase和Science Direct检索了MEDLINE数据库，检索时间从建库至2023年11月。纳入评估帕利珠单抗在28天至3个月龄婴儿中疗效和安全性的研究。我们使用Review Manager 5.4软件分析数据，研究结果合并后以风险比（RR）及95%置信区间（CI）表示。共纳入10项研究。在RSV感染住院治疗方面（RR = 0.51，95%CI：0.40至0.65；P < 0.00001）和重症监护病房（ICU）入院方面（RR = 0.49，95%CI：0.30至0.81；P = 0.005），疗效评估显示帕利珠单抗优于安慰剂。另一方面，在全因死亡率（RR = 0.69，95%CI：0.42至1.15；P = 0.16）、下呼吸道感染（RR = 0.42，95%CI：0.11至1.69；P = 0.22）以及机械通气需求（RR = 0.75，95%CI：0.34至1.67；P = 0.48）方面，疗效评估显示帕利珠单抗与安慰剂之间无显著差异。帕利珠单抗可被视为预防幼儿RSV疾病的药物，因为它安全、耐受性良好且能有效减少RSV住院率。然而，需要通过高质量随机对照试验进行进一步研究，以确定其作为已确诊RSV感染治疗药物的疗效。
