疏肝中药治疗纤维肌痛综合征的系统评价

Systematic Evaluation of Liver-smoothing Chinese Medicine in the Treatment of Fibromyalgia Syndrome

目的采用系统评价方法评价疏肝中药治疗纤维肌痛综合征(Fibromyalgia syndrome,FMS)的有效性和安全性。方法检索中国知网(China national knowledge infrastructure,CNKI)、中文科技期刊数据库(China science and technology journal database)、万方数据库(Wanfang database,WanFang)、中国生物医学文献数据库(China biology medicine disc,CBMdisc)等自建库以来至2024年5月关于疏肝中药治疗FMS的随机对照试验(Randomized controlled trials,RCT)的文献,依据纳入和排除标准,进行文献筛选、数据提取及质量评价,使用RevMan 5.3软件进行分析。结果共检索到96篇文献,最终纳入11项研究,共751例FMS患者。Meta分析显示,与西药组相比,疏肝中药组(包括单用中药和中西药联用)治疗FMS可显著提高临床有效率[RR=1.33,95%CI(1.24,1.43),Z=7.63,P<0.01],降低疼痛视觉模拟评分(Visual analogue scale,VAS)[SMD=-1.67,95%CI(-2.34,-1.00),Z=4.87,P<0.01]与汉密顿抑郁量表评分(Hamilton depression scale,HAMD)[SMD=-0.78,95%CI(-1.50,-0.07),Z=2.15,P=0.03],减少中医证候积分[SMD=-0.74,95%CI(-1.04,-0.44),Z=4.85,P<0.01]与不良反应发生率[RR=0.44,95%CI(0.24,0.82),Z=2.59,P=0.01]。亚组分析发现,中药组和中西药联用组提高总有效率和缓解疼痛VAS评分优于西药组(P<0.01),中药组不良反应发生率低于西药组(P=0.03)。漏斗图显示两侧不完全对称,可能存在发表偏倚。结论疏肝中药单用或中西药联用治疗FMS疗效优于西药,且疏肝中药治疗安全性好。

Objective To evaluate the efficacy and safety of liversoothing Chinese medicine in the treatment of fibromyalgia syndrome(FMS)using a systematic review approach.Methods Asearch was conducted in Chinese National Knowledge Infrastructure(CNKT),China Science and Technology Journal Database,Wanfang Data,and China Biology Med-icine disc(CBMdisc)for randomized controlled trials(RCTs)on the treatment of FMS with liver-soothing Chinese medi-cine from the inception of these databases to May 2024.Studies were screened and selected based on inclusion and exclu-sion criteria.Data extraction and quality assessment were performed,and analysis was carried out using RevMan 5.3 soft-ware.Results Atotal of 96 studies were retrieved,and 11 studies involving 751 FMS patients were included.Meta-anal-ysis showed that compared to the Western medicine group,the liver-soothing Chinese medicine group(including Chinese medicine alone and a combination of Chinese medicine and Western medicine)significantly improved the clinical efficacy rate[RR=1.33,95%CI(1.24,1.43),Z=7.63,P<0.01],reduced pain as measured by the Visual Analogue Scale(VAS)[SMD=-1.67,95%CI(-2.34,-1.00),Z=4.87,P<0.01],decreased Hamilton Depression Scale(HAMD)scores[SMD=-0.78,95%CI(-1.50,-0.07),Z=2.15,P=0.03],reduced traditional Chinese medicine(TCM)syndrome scores[SMD=-0.74,95%CI(-1.04,-0.44),Z=4.85,P<0.01],and lowered incidence of ad-verse reactions[RR=0.44,95%CI(0.24,0.82),Z=2.59,P=0.01].Subgroup analysis indicated that both the Chinese medicine group and the Chinese medicine plus Western medicine group had superior total efficacy and pain relief(VAS)compared to the Western medicine group(P<0.01),and the incidence of adverse reactions in the Chinese medicine group was lower than in the Western medicine group(P=0.03).The funnel plot showed slight asymmetry,indicating po-tential publication bias.Conclusion Liver-soothing Chinese medicine,either used alone or in combination with Western medicine,is more effective than Westermn medicine in treating FMS and has good safety.