Department of Biology, Faculty of Basic Sciences, Hakim Sabzevari University, P.O. Box 397, Sabzevar, Iran.
Liver Transplantation Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Eur J Clin Pharmacol. 2020 May;76(5):611-622. doi: 10.1007/s00228-019-02827-6. Epub 2020 Feb 4.
Although studies have shown the efficacy of laquinimod (LAQ) on disease progression in patients with multiple sclerosis (MS), there is some controversy about whether it improves the types of outcomes and side effects. The main purpose of the present study was to systematically review and meta-analyze the efficacies and side effects of LAQ in patients with relapsing-remitting MS (RRMS).
PubMed, Scopus, and Web of Science databases were searched with relevant keywords for articles published up to June 2019. Six randomized control trials that examined LAQ vs. placebo in adult patients with MS were included. Information on the effectiveness and side effects of LAQ were extracted. The quality of the included studies was appraised using Jadad scores, and the data were divided into subgroups according to different doses and periods.
Efficacy of LAQ: The number of Gadolinium-enhancing (GDE) lesions significantly decreased after treatment with LAQ (SMD = -0.15, 95% CI: -0.23, -0.07), but there was no significant reduction in the number of T2 lesions (SMD = -0.38, 95% CI: -1.04, 0.28). The relapse rate (SMD = -0.13, 95% CI: -0.21, -0.04) and MS Functional Composite (MSFC) score significantly decreased with LAQ treatment (SMD =0.14, 95% CI: 0.05, 0.23). Risk of adverse events: The risk of diarrhea, nausea, abdominal pain, and all adverse events did not significantly increase (p > 0.05) with treatment with LAQ; however, the risk of back pain, headache, and vomiting significantly increased (p < 0.05). The change in mortality rate was not significant (OR = 0.25, 95% CI: 0.04, 1.50).
LAQ can considerably improve clinical and imaging outcomes in RRMS patients. The most effective dose of LAQ with lower side effects may be 0.6 mg/day for at least 2 years, but more evidence is needed to confirm these results.Laquinimod can improve clinical and imaging outcomes in patients with multiple sclerosis.Back pain and headache are probable side effects of laquinimod in patients with multiple sclerosis.The most effective and safe dose of laquinimod for patients with multiple sclerosis may be 0.6 mg/day for 2 years.
虽然已有研究表明拉喹莫德（LAQ）可减缓多发性硬化症（MS）患者的疾病进展，但关于其是否能改善疾病结局类型和副作用仍存在一定争议。本研究的主要目的是系统评价和荟萃分析 LAQ 在复发缓解型 MS（RRMS）患者中的疗效和副作用。
检索截至 2019 年 6 月，在 PubMed、Scopus 和 Web of Science 数据库中使用相关关键词检索文章。纳入了 6 项 LAQ 与安慰剂治疗成人 MS 患者的随机对照试验。提取 LAQ 的有效性和副作用信息。使用 Jadad 评分评估纳入研究的质量，并根据不同剂量和治疗周期将数据分为亚组。
LAQ 的疗效：LAQ 治疗后钆增强（GDE）病变数量明显减少（SMD=-0.15，95%CI：-0.23，-0.07），但 T2 病变数量无明显减少（SMD=-0.38，95%CI：-1.04，0.28）。LAQ 治疗后复发率（SMD=-0.13，95%CI：-0.21，-0.04）和 MS 功能综合评分（MSFC）显著降低（SMD=0.14，95%CI：0.05，0.23）。不良事件风险：腹泻、恶心、腹痛和所有不良事件的风险无显著增加（p>0.05）；然而，背痛、头痛和呕吐的风险显著增加（p<0.05）。死亡率的变化无统计学意义（OR=0.25，95%CI：0.04，1.50）。
LAQ 可显著改善 RRMS 患者的临床和影像学结局。最有效的 LAQ 剂量可能为 0.6mg/天，至少 2 年，但需要更多证据来证实这些结果。拉喹莫德可改善多发性硬化症患者的临床和影像学结局。背痛和头痛可能是多发性硬化症患者使用拉喹莫德的副作用。多发性硬化症患者最有效和安全的拉喹莫德剂量可能为 0.6mg/天，治疗 2 年。
