纤维肌痛症的药物治疗：随机试验的系统综述与网络荟萃分析。
完整摘要 · 中文译文
目的：比较药物治疗纤维肌痛的有效性。 设计：随机试验的系统综述与网状荟萃分析。 数据来源：Medline、Embase、AMED（联合与补充医学数据库）、PsycInfo、CINAHL和Cochrane CENTRAL（Cochrane对照试验中心注册库），检索时间自建库至2025年1月13日。 选择研究的纳入标准：平行组、交叉和整群随机试验，纳入根据任何已发表的诊断标准或由医生诊断的成人（年龄≥18岁）纤维肌痛患者。试验将市售、在研或已停用的药物治疗与另一种药物、不同剂量或给药方案的同一药物、安慰剂或标准治疗进行比较。治疗还包括特定的维生素和补充剂，如褪黑素、维生素D、维生素B6和ω-3脂肪酸。 结果：本系统综述共纳入151项符合条件的试验（32 592名参与者）。与安慰剂或常规治疗相比，低确定性证据提示羟丁酸钠、选择性去甲肾上腺素（去甲肾上腺素）再摄取抑制剂（NRIs）、5-羟色胺-去甲肾上腺素再摄取抑制剂（SNRIs）和加巴喷丁类药物可能提高患者报告的有意义改善或康复的可能性（风险差为每1000名患者多105至283例）。基于纤维肌痛影响问卷的评分，低确定性证据进一步提示羟丁酸钠（均数差-8.81，95%置信区间（CI）-11.78至-5.84）和选择性5-羟色胺再摄取抑 选择性5-羟色胺再摄取抑制剂（SSRIs）（平均差-8.02，95% CI -13.40至-2.64）可能减轻纤维肌痛症状，而三环类抗抑郁药、羟丁酸钠和加巴喷丁类药物可能改善睡眠质量。没有任何药物在疼痛、躯体健康或心理健康方面的汇总效应达到或超过临床重要性阈值。对于羟丁酸钠、选择性去甲肾上腺素再摄取抑制剂（NRIs）、5-羟色胺和去甲肾上腺素再摄取抑制剂（SNRIs）以及环苯扎林，应答者分析表明，可能有重要比例的患者实现了至少30%的疼痛减轻（风险差为每1000例患者多111至202例）。此外，没有任何药物增加停药或严重不良事件的风险。 结论：本系统综述和网络荟萃分析提供了低确定性证据，表明羟丁酸钠、选择性NRIs、SNRIs、加巴喷丁类药物、三环类抗抑郁药和SSRIs可能对纤维肌痛患者的特定结局提供通常较小的获益。 系统综述注册：PROSPERO CRD42012003291。
完整摘要 · 英文原文
OBJECTIVE: To compare the effectiveness of drug treatments for the management of fibromyalgia. DESIGN: Systematic review and network meta-analysis of randomised trials. DATA SOURCES: Medline, Embase, AMED (Allied and Complementary Medicine Database), PsycInfo, CINAHL, and Cochrane CENTRAL (Cochrane Central Register of Controlled Trials), from inception to 13 January 2025. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Parallel, crossover, and cluster randomised trials that enrolled adults (aged ≥18 years) with fibromyalgia, according to any published diagnostic criteria or as diagnosed by a physician. Trials compared commercially available, investigational, or discontinued drug treatments with another drug, the same drug at a different dose or regimen, placebo, or standard care. Treatments also included select vitamins and supplements, such as melatonin, vitamin D, vitamin B6, and omega 3 fatty acids. RESULTS: 151 eligible trials (32 592 participants) were included in this systematic review. Compared with placebo or usual care, low certainty evidence suggested that sodium oxybate, selective noradrenaline (norepinephrine) reuptake inhibitors (NRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), and gabapentinoids may increase the likelihood of patient reported meaningful improvement or recovery (risk difference 105 to 283 more per 1000 patients). Based on scores from the fibromyalgia impact questionnaire, low certainty evidence further suggested that sodium oxybate (mean difference -8.81, 95% confidence interval (CI) -11.78 to -5.84) and selective serotonin reuptake inhibitors (SSRIs) (mean difference -8.02, 95% CI -13.40 to -2.64) may reduce fibromyalgia symptoms, whereas tricyclic antidepressants, sodium oxybate, and gabapentinoids may improve sleep quality. No drug showed pooled effects on pain, physical health or mental health that met or exceeded a threshold for clinical importance. For sodium oxybate, selective NRIs, SNRIs, and cyclobenzaprine, responder analyses indicated that a potentially important proportion of patients achieved a reduction in pain of at least 30% (risk difference 111 to 202 more per 1000 patients). In addition, no drug increased the risk of discontinuing treatment or serious adverse events. CONCLUSIONS: This systematic review and network meta-analysis provides low certainty evidence that sodium oxybate, selective NRIs, SNRIs, gabapentinoids, tricyclic antidepressants, and SSRIs may provide typically small benefits in select outcomes for people with fibromyalgia. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42012003291.