目的:评估他汀类药物(3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂)是否在多发性硬化症(MS)中发挥疾病缓解作用。
方法:进行了系统评价和荟萃分析,包括在MS中使用他汀类药物的随机对照临床试验(RCTs)。应用随机效应模型来计算具有相应95%置信区间(CI)的合并估计和比值比(OR),在比较单独使用他汀类药物或辅助疾病改善治疗(DMT)的患者与非他汀类药物治疗的患者时。
结果:我们确定了7项RCT,包括789例复发缓解型MS(RRMS)患者,所有这些人都接受了额外的DMT和IFN-β。继发性进展性MS(SPMS)中的单个识别RCT,临床孤立综合征(CIS)和视神经炎(ON)未进行荟萃分析.在RRMS中,添加他汀类药物的使用与临床复发(OR=1.30,95CI:0.901.87)或EDSS相对于基线的进展风险无关,两者均未出现与新的对比增强或T2病变的风险相关(OR=1.28,95CI:0.364.58),和MRI上全脑容量减少的风险。对IFN-β添加他汀类药物是安全且耐受性良好的。在SPMS中,单用辛伐他汀可显著降低全脑容积减少的年化率.InCIS和ON,他汀类药物与新的T2病变风险降低和视力恢复改善相关,分别。
结论:我们在RRMS中检测到他汀类药物作为IFN-β的附加治疗没有获益。然而,在SPMS中的潜在有益效果,CIS和ON值得在有足够动力的随机对照试验中进行独立确认和进一步评估。
OBJECTIVE: To assess whether statins (3‑hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) exert disease-modifying effects in multiple sclerosis (MS).
METHODS: A systematic
review and meta-analysis was performed including randomized-controlled clinical trials (RCTs) on statin use in MS. A random-effects model was applied to calculate pooled estimates and odds ratios (ORs) with corresponding 95% confidence intervals (CIs), when comparing patients treated with statins alone or adjunct to disease modifying treatment (DMT) to non-statin-treated patients.
RESULTS: We identified 7 RCTs including 789 patients with relapsing-remitting MS (RRMS), all of whom received additional DMT with IFN-β. Single identified RCTs in secondary-progressive MS (SPMS), clinically isolated syndrome (CIS) and optic neuritis (ON) were not meta-analyzed. In RRMS, add-on statin use was not associated with the risk of clinical relapse (OR=1.30, 95%CI: 0.901.87) or EDSS-progression from baseline, neither appeared related to the risk of new contrast-enhancing or T2 lesions (OR=1.28, 95%CI: 0.364.58), and the risk of whole-brain volume reduction on MRI. Add-on statins to IFN-β were safe and well-tolerated. In SPMS, stand-alone simvastatin led to significantly reduced annualized rate of whole-brain volume reduction. In CIS and ON, statins were associated with reduced risk for new T2 lesions and improved visual recovery, respectively.
CONCLUSIONS: We detected no benefit from statin treatment as add-on to IFN-β in RRMS. However, a potential beneficial effect in SPMS, CIS and ON deserves independent confirmation and further evaluation within adequately powered RCTs.