Page 97 - 中国全科医学2022-20

·2526· http://www.chinagp.net E-mail:zgqkyx@chinagp.net.cn

massage-related research advances，numerous randomized controlled trials（RCT） concerning massage therapy in CSR have
been published，but high-quality evidence is still limited due to some problems in the choice of outcomes. Objective To
evaluate the outcomes used in RCTs in recent 10 years regarding CSR treated using massage，providing a basis for the choice
of core outcomes used in studies about massage in CSR. Methods RCTs regarding CSR treated using massage were searched
in databases of CNKI，Wanfang Data，CQVIP，SinoMed，PubMed，EMBase and Cochrane Library from January 2011 to
May 2021. Literature screening，data extraction，and risk of bias assessment were performed by two researchers separately. A
qualitative analysis was conducted to analyze the outcomes used in the RCTs. Results In all，66 RCTs were included，in which
the outcomes were categorized into 7 categories based on functional attributes：quality of life（95 times，41.48%），symptoms
and signs（64 times，27.95%），physical and chemical examinations（39 times，17.03%），safety events （12 times，5.24%），
economic assessment（12 times，5.24%），long-term prognosis（5 times，2.18%），and TCM symptoms/syndromes
（2 times，0.87%）. The most frequently used five outcomes were overall response rate，Visual Analogue Scale（VAS）
score，Neck Disability Index score，adverse reactions and adverse events，symptom and sign score，and the measurement time
points for which were 17 in total in a period from one day after treatment to the sixth month of follow-up. The above-mentioned
outcome indexes are mainly measured at 14 days（27.08%），14 days（26.67%），14 days（29.17%），28 days（28.57%）
and 14 days（33.33%）after treatment. The number of RCTs using one，two，three，and at least four outcomes was 5，20，
14，and 27，respectively. Forty-eight RCTs reported the overall response rate. Conclusion We found many problems existing
in the choice of outcomes used in RCTs assessing massage for CSR. The problems are as follows：primary and secondary outcomes
were not defined；alternative outcomes received more attention while endpoint outcomes were neglected；the blinding method was
ignored in RCTs using subjective outcomes；there was tremendous heterogeneity between RCTs in the number or combination of
outcomes used，composite outcomes were mostly used；there was non-uniformity in measurement times of outcomes. We suggest
that further relevant studies should pay attention to sufficient top-level design and preliminary research，and actively take actions
to establish a set of core outcomes.
【Key words】 Cervical spondylosis；Bone setting manipulation；Cervical spondylotic radiculopathy；Randomized
controlled trial；Patient reported outcome measures；The core outcome set

神经根型颈椎病（cervical spondylotic radiculopathy， 证据产生及循证能力建设 ［10］ 。本研究通过分析近十年
CSR）是由于颈椎间盘组织退变及其继发性病理改变累 手法治疗 CSR 的 RCT 中结局指标的应用情况，分析存
及神经根，出现相应节段的上肢放射性疼痛、麻木、 在的问题并提出相关建议，以期为该领域临床研究结局
无力等临床症状 ［1］ 。中国人群颈椎病的患病率高达 指标的选择和应用提供参考。
17.3% ［2］ ，且呈年轻化趋势，严重影响患者生活质量。 1 资料与方法
CSR 在各型颈椎病中发病率最高，为 60%~70% ［3］ 。中 1.1 纳入标准 （1）研究类型为手法治疗 CSR 的
医学认为 CSR 属于“项痹病”范畴，作为保守治疗的 RCT，且不受语种限制；（2）研究对象为 CSR 患者；（3）
重要组成部分，手法治疗可通过放松颈项部肌肉，解除 干预措施为任何中医手法类治疗，如手法、推拿、正骨、
局部痉挛，纠正关节移位与紊乱，调节颈椎内外源性结 整脊、按摩等。单用手法或手法联用其他中西医干预措
构稳定，恢复动静态力学平衡，有效调整“筋出槽，骨 施治疗的研究均被纳入。对照组干预措施不进行限定。
错缝”的病理状态 ［4］ 。近年来，随着手法治疗 CSR 的 纳入研究报告中的所有结局指标。
临床研究和循证评价不断增加，其有效性和安全性逐步 1.2 排除标准 （1）未明确指出研究对象为 CSR 者；
被证实 ［5-6］ 。以颈椎扳动类手法为代表的研究成果被纳 （2）合并有其他类型颈椎病或其他疾病者；（3）篇幅
入 2017 年美国物理治疗学会发布的《颈痛治疗国际循 为单页纸的文献；（4）关键信息缺失、重复报告文献；
证临床实践指南》 ［7］ ，已获得国际认可。 （5）中文文献中非中文核心期刊或科技核心期刊文献。
随机对照试验（randomized controlled trial，RCT） 1.3 检索策略 计算机检索中国知网、万方数据知
是临床实践指南形成推荐意见的基础证据，是临床疾 识服务平台、维普网、中国生物医学文献服务系统、
病疗效评价的金标准 ［8］ ，目前采用 RCT 评价手法治疗 PubMed、EMBase 和 Cochrane Library 数据库，检索手法
CSR 的有效性和安全性的报道较多。选择合适的结局指 治疗 CSR 的 RCT，检索时限为 2011 年 1 月至 2021 年 5
标可增加研究一致性、减少选择性报告偏倚、提高研究 月。追溯纳入文献的参考文献以补充获取相关文献。中
质量和价值 ［9］ 。目前同类临床研究结局指标普遍存在 文数据库采用题名或关键词和主题词相结合的方式进行
不规范、不适用、不公认等问题，影响高质量临床研究 检索，检索词包括“手法”“推拿”“正骨”“整脊”“按摩”“神