标题：中药复方辅助治疗腰椎管狭窄症围手术期临床疗效的系统评价及试验序贯分析

      作者：卜献忠 1，钟远鸣 2，秦百君 1，卜保献 3，麦威 1，赵权 4，黄子彦 1    1.广西中医药大学研究生学院，广西 南宁 530001；2.广西中医药大学第一附属医院骨科(脊柱外科)，广西 南宁 530023；3.河南省洛阳正骨医院(河南省骨科医院)，河南 洛阳 471002；4.防城港市中医院，广西 防城港 538021

      卷次： 2021年32卷20期

      【摘要】 目的 系统评价中药复方辅助治疗腰椎管狭窄症(LSS)围手术期临床疗效，并以试验序贯分析(TSA)解决传统Meta分析在反复更新中出现随机误差的问题。方法 计算机检索中国知网、万方、维普、中国生物医学文献数据库、The Cochrane library、PubMed、EMBASE等7个国内外数据库有关中药复方辅助治疗LSS症围手术期临床疗效的随机对照试验(RCT)文献，并以手工检索相关论文。检索时限均为建库至2021年1月20日。由两位评价员独立筛选文献、提取资料、评价纳入研究的方法学质量，再分别选用Stata/SE 12.0、TSA0.9.5.10 Beta软件对结局指标进行Meta分析和试验序贯分析(TSA)。结果 共纳入 24个RCT，共包含 1 645例，研究组与对照组分别为 821例、824例患者。Meta分析结果表明：与对照组相比，研究组在提高治疗后总有效率(RR=1.13，95%CI：1.09~1.18，P<0.05)，改善 JOA评分(SMD=4.62，95%CI：2.82~6.43，P<0.05)，降低VAS评分(SMD=-0.83，95%CI：-1.13~-0.54，P<0.05)、ODI评分(MD=-5.65，95%CI：-9.94~-1.35，P<0.05)方面均优于对照组。TSA结果显示：治疗后 JOA评分、VAS评分累计的Z值均穿越了RIS；治疗后总有效率、ODI评分累计Z值均穿越了传统界值和TSA界值，但未穿越RIS。结论 中药复方辅助治疗LSS围手术期患者获得了较好的临床疗效，其能够有效地提高治疗后总有效率，改善 JOA评分，降低VAS评分、ODI评分，从而促进患者术后快速康复。鉴于纳入文献的质量有限，上述结论尚需更多高质量、多中心的RCT为临床提供证据支持。
      【关键词】 腰椎管狭窄症；中药复方；Meta分析；试验序贯分析
      【中图分类号】 R681.5 【文献标识码】 A 【文章编号】 1003—6350（2021）20—2699—09

Clinical efficacy of traditional Chinese medicine compound in the treatment of lumbar spinal stenosis duringperioperative period: a meta-analysis and a trial sequential analysis.
BU Xian-Zhong 1, ZHONG Yuan-ming 2, QINBai-Jun 1, BU Bao-xian 3, MAI Wei 1, ZHAO Quan 4, HUANG Zi-yan 1. 1. Graduate School, Guangxi University of ChineseMedicine, Nanning 530001, Guangxi, CHINA; 2. Department of Orthopedics (Spinal Surgery), the First Affiliated Hospital ofGuangxi University of Chinese Medicine, Nanning 530023, Guangxi, CHINA; 3. Luoyang Zhenggu Hospital of HenanProvince/Orthopedic Hospital of Henan Province, Luoyang 471002, Henan, CHINA; 4. Fangchenggang Hospital ofTraditional Chinese Medicine, Fangchenggang 538021, Guangxi, CHINA
【Abstract】 Objective To evaluate the clinical efficacy of traditional Chinese medicine compound in the adju-vant treatment of lumbar spinal stenosis (LSS) during the perioperative period with a meta-analysis, and to solve theproblem of random error in the repeated update of traditional meta-analysis with a trial sequential analysis (TSA).Methods The randomized controlled trial (RCTs) articles about the perioperative clinical efficacy of traditional Chi-nese medicine in the adjuvant treatment of LSS was retrieved by computer from 7 domestic and foreign databases, in-cluding CNKI, Wanfang, VIP, China Biomedical Literature Database (CBM), the Cochrane Library, PubMed, and EM-BASE, and the relevant papers were retrieved manually. The search time limit is from the inception of the databases toJanuary20, 2021. The selection of articles, extraction of data, and evaluation of the methodological quality about articleswere completed independently by two evaluators. Then, the meta-analysis and sequential analysis (TSA) of outcome in-dicators were carried out by using Stata/SE 12.0 and TSA0.9.5.10 Beta software respectively. Results A total of 1 645patients were included from 24 RCTs, including 821 in the treatment group and 824 in the control group. The results ofmeta-analysis showed that compared to control group, treatment group had significantly improved total effective rate(RR=1.13, 95%CI: 1.09-1.18, P<0.05)，improved JOA scores (SMD=4.62, 95%CI: 2.82-6.43, P<0.05), reduced VASscores (SMD=-0.83, 95%CI: -1.13 to -0.54, P<0.05), and reduced ODI scores (MD=-5.65, 95%CI: -9.94 to -1.35, P<·荟萃分析·doi:10.3969/j.issn.1003-6350.2021.20.031基金项目：国家自然科学基金(编号：81760874)；广西重点研发计划(编号：桂科AB20159018)；河南省中医药科学研究专项课题(编号：20-21ZY2083)；广西中医药大学2021年博士研究生科研创新项目(编号：YCBXJ2021009)