活血化瘀类中成药治疗神经根型颈椎病临床疗效和安全性的Meta分析及GRADE证据等级评价

Meta-analysis and GRADE evaluation of clinical efficacy and safety of Chinese patent medicine for activating blood circulation and removing blood stasis in treatment of cervical spondylotic radiculopathy

目的系统评价活血化瘀类中成药治疗神经根型颈椎病(cervical spondylotic radiculopathy,CSR)的临床有效性及安全性。方法通过检索建库以来至2021年4月数据库(中国知网、万方、维普、中国生物医学文献数据库、PubMed、EMbase、Cochrane Library)中符合纳入和排除标准的活血化瘀类中成药治疗CSR随机对照试验(randomized controlled trials,RCTs),提取筛选出的文献数据,采用Cochrane偏倚风险评估工具对文献进行质量评价,采用Review Manager 5.3软件对临床总有效率、治愈率、视觉疼痛模拟量表(visual analogue scale,VAS)评分、疼痛等级评定指数(pain rating index,PRI)评分、现时疼痛强度(pesent pain intensity,PPI)评分、不良反应结局指标进行Meta分析,对于研究数目≥10的结局指标以漏斗图和Egger’s回归图表示发表偏倚,按照GRADE标准对结局指标进行证据质量评价。结果共纳入23项RCTs,总样本数量为2110例,其中治疗组1063例,对照组1047例。Meta分析结果显示,活血化瘀类中成药联合非药物组在提高总有效率[OR=4.16,95%CI (3.02,5.72),P<0.000 01]、提高治愈率[OR=2.31,95%CI (1.84,2.89),P<0.000 01]、降低VAS评分[SMD=-2.28,95%CI (-3.19,-1.38),P<0.000 01]、降低PPI评分[SMD=-0.58,95%CI (-0.88,-0.29),P=0.000 1]方面均优于非药物组治疗,并且不良反应较少[OR=0.22,95%CI (0.11,0.45),P<0.000 1]。两组在降低PRI评分方面差异无统计学意义[SMD=-1.35,95%CI (-3.13,0.43),P=0.14]。总有效率和治愈率2项结局指标发表偏倚结果提示,总有效率的纳入文献可能存在潜在的发表偏倚。结论活血化瘀类中成药联合非药物治疗CSR对比非药物不仅在临床疗效方面具有优势,而且更加安全。但目前研究的样本量较少,文献证据等级较低。因此需要大样本、多中心、高质量的RCTs,以提高验证结论的准确性。

Objective To systematically evaluate the clinical efficacy and safety of Chinese patent medicine for activating blood circulation and removing blood stasis in the treatment of cervical spondylotic radiculopathy(CSR). Methods Randomized controlled trials(RCTs) of Chinese patent medicines for activating blood circulation and removing blood stasis in the treatment of CSR were searched in databases(CNKI, Wanfang, VIP, China Biomedical Literature Database, PubMed, EMbase, Cochrane Library) from the establishment to April 2021, the selected literature data were extracted, and the Cochrane bias risk assessment tool was used to evaluate the quality of the literature. Review Manager 5.3 software was used to perform Meta-analysis on outcome indicators such as total effective rate, recovery rate, visual analogue scale(VAS) score, pain rating index(PRI) score, pesent pain intensity(PPI) score, and adverse reactions. For outcome indicators with study number ≥ 10, publication bias was indicated by funnel plot and Egger’s regression plot. The quality of evidence for outcome indicators was evaluated according to GRADE standard. Results A total of 23 RCTs were included with a total sample size of 2110 cases, including 1063 cases in the treatment group and 1047 cases in the control group. Metaanalysis results showed that the total effective rate [OR = 4.16, 95% CI(3.02, 5.72), P < 0.000 01], the recovery rate [OR = 2.31, 95%CI(1.84, 2.89), P < 0.000 01], the VAS score [SMD =-2.28, 95% CI(-3.19,-1.38), P < 0.000 01], the PPI score [SMD =-0.58, 95%CI(-0.88,-0.29), P = 0.000 1] in the group of Chinese patent medicines for activating blood circulation and removing blood stasis combined with non-drugs were better than those in non-drugs group, and the incidence of adverse reactions was less [OR = 0.22, 95%CI(0.11, 0.45), P < 0.000 1]. There was no statistical significance in reducing the PRI score between the two groups [SMD =-1.35,95% CI(-3.13, 0.43), P = 0.14]. Funnel plot and Egger’s regression plot were drawn for publication bias test of the total effective rate and the recovery rate. The results suggested that the included studies of the total effective rate may have potential publication bias.Conclusion Chinese patent medicine for activating blood circulation and removing blood stasis combined with non-drug therapy has advantages in clinical efficacy and safety than non-drug therapy in the treatment of CSR. However, the sample size of the current studies are small and the level of studies evidence are low. Therefore, large-sample, multi-center and high-quality RCTs are needed to improve the accuracy of verification conclusions.