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back pain response to integrated traditional Chinese and Western medicine in clinical studies with response rate as a composite
outcome indicator，offering a reference for appropriately selecting composite outcome indicators of this disease. Methods
Databases including Web of Science，PubMed，EMBase，Cochrane Library，CNKI，CQVIP，Wanfang Data and SinoMed
were searched for clinical studies of chronic low back pain treated by integrated traditional Chinese and Western medicine
published from January 2015 to December 2019. Two researchers independently enrolled studies according to inclusion and
exclusion criteria，extracted data according to the BPICOS principles，and reviewed and summarized the criteria for defining the
response rate as a composite outcome indicator. Results Among 830 included studies，lumbar muscle degeneration had been
studied the most 〔178（21.4%）〕，followed by the third lumbar transverse process syndrome〔103（12.4%）〕，lumbar
disc herniation〔91（11 .0%）〕，low back pain〔89（10.7%）〕，lumbodorsal myofasciitis〔72（8.7%）〕，lumbar
spinal stenosis〔69（8.3%）〕，and lumbar spondylolisthesis〔61（7.3%）〕. 808 studies（97.3%） described the reference
for the definition of response rate or explained the definition of response rate developed by the author. Specifically，different
versions of Criteria for the Diagnosis，Syndrome Differentiation，and Response Assessment of Diseases by Chinese Medicine was
referred the most〔271（32.7%）〕. Clinical symptoms，level of daily life activities，pain，signs and work & living ability，
these five indictors were used most frequently as composite outcome indicators，and 2-5 of them were often randomly used in
combination as the third or fourth level of response criteria. In addition，common low back pain measurement tools were also
used. Conclusion Due to the lack of unified standard，composite outcome indicators used for response assessment in clinical
studies about chronic low back pain treated by traditional Chinese and Western medicine might have many problems，such as
various definitions，division criteria，and assessment items. In view of this，it is suggested to standardize the composite outcome
indicators for response assessment in accordance with the CORE Outcome Measurement and Evaluation Tool，and to improve their
validity to be used in clinical studies regarding integrated traditional Chinese and Western medicine as unified indicators，thereby
improving the quality and value of such studies.
【Key words】 Low back pain；Pain；Signs and symptoms；Traditional Chinese medicine therapy；Integrated Chinese
traditional and Western medicine therapy；Treatment outcome；Outcome index；Scoping review

腰痛是由多种病因造成的以腰部一侧或双侧疼痛或 发表的文献；（2）诊断标准及疗效评价不明确；（3）
伴活动受限为主的一种常见病症 ［1］ ，是导致全球残疾 动物实验或其他非人体临床试验；（4）无法获取全文。
或生产力下降的主要原因 ［2］ 。腰痛发病率逐年增高， 1.2 文献检索 以“chronic low back pain”“chronic back
呈年轻化趋势，7~10 岁儿童发病率为 1%~6%，青少年 pain”“low back ache”“low backache”“lumbago”
发病率为 18%，40~69 岁人群发病率为 28%~42%，是 “pains，lower back”“backaches，low”“lumbar disc
威胁人类健康的重要病症 ［3］ 。因此，国内外开展了大 herniation ”“lumbar spondylolisthesis ”“ the third lumbar
量针对腰痛的临床研究，有效率 / 总有效率作为常用的 vertebral transverse process”“degenerative changes in the
结局指标，在临床研究中广泛应用 ［4］ ，然而由于有效 lumbar spine”“lumbar spinal stenosis”“lumbar spine
率在研究中的组成缺乏一致性或本身定义不清等因素， surgery”为英文检索词，以“慢性腰背痛”“腰痛”“腰
导致中西医结合干预腰痛缺少高质量的循证医学证据。 腿痛”“下腰痛”“腰椎病变”“腰椎间盘突出”“腰
本研究基于 DAUDT 等 ［5］ 推荐的概况性评价框架系统 椎滑脱”“第三腰椎横突综合征”“腰椎退行性改变”“腰
检索、筛选和整理近 5 年的腰痛临床研究中以有效率为 背肌筋膜炎”“腰椎滑脱”“腰椎管狭窄”“腰肌劳
结局指标的研究，分析有效率作为结局指标的应用情况 损”“腰椎术后”为中文检索词，采用主题词和自由词
及其定义，为腰痛临床试验中有效率的定义提供理论支 结合的检索方式在 Web of Science、PubMed、EMBase、
持和研究思路。 Cochrane Library、中国知网、维普网、万方数据知识服务
1 资料与方法 平台和中国生物医学文献服务系统进行检索，检索时限
1.1 文献纳入与排除标准 根据研究目的和 PICOS 原 为 2015—2019 年。
则，制订文献纳入标准：（1）研究对象是确诊的慢性 1.3 方法 将检索到的文献导入文献管理软件 Note
腰背痛患者，不限制国家、地区、种族、性别及年龄； Express 3.4 中，由 2 名研究者独立对检索到的文献根据
（2）干预和对照措施均不限，结局指标中包含有效率； 题目和摘要进行阅读，排除不符合纳入标准的文献，初
（3）研究类型包括随机对照试验（RCT）、队列研究、 筛后下载原文，根据纳入、排除标准进行复筛并交叉核
病例对照研究及病例报道。文献排除标准：（1）重复 对，若产生分歧经讨论或由第三方协助解决，最终确定