保守疗法治疗脊髓型颈椎病效果的系统评价

Effects of conservative treatment on cervical myelopathy:A systematic evaluation

背景:脊髓型颈椎病保守疗法很多,每一种治疗方案目前尚未统一,有必要将各疗法的相关研究予以总结评价。目的:运用Cochrane评价系统的方法评价当前国内保守疗法对脊髓型颈椎病的有效性与安全性。设计、时间及地点:随机对照试验(RCT)和半随机对照试验(CCT),于2008-03/06在四川大学华西医院中国循证中心完成。对象:来源于1978-01/2008-04CCBM、CNKI、VIP3个数据库及辅以手工检索相关文献,选择其中4篇542例,年龄30～71岁,采用随机分组的文章。方法:计算机检索CCBM、CNKI、VIP数据库。电话访问标称随机对照试验作者证实是否真正RCT;纳入保守疗法治疗脊髓型颈椎病的随机对照试验并对其进行质量评价。由于纳入研究的干预手段不统一,未能进行合并分析。只能进行单个研究的MeTa分析。采用随机方法-选择性偏倚评估、隐蔽分组-选择性偏倚评估、盲法-实施偏倚与测量偏倚、剔除、失访、退出-损耗性偏倚评价。主要观察指标:①针灸、电针、拔罐与氯唑沙宗、心痛定,胞二磷胆碱相比较其有效率。②针灸、推拿、中药与扶他林(双氯芬酸)相比较其有效率。③角度选择性牵引与0°牵引相比较其有效率。④中药与弥可保相比较其有效率。⑤不良反应。结果:所有研究均有选择性偏倚、实施测量性偏倚、损耗性偏倚的高度可能性,质量等级均为"C"级。且只有1个研究证明实验组的有效率优于对照组。研究1表明,针灸、电针、拔罐治疗脊髓型颈椎病的显效率及有效率优于氯唑沙宗、心痛定,胞二磷胆碱。研究2表明,针灸、推拿、中药治疗脊髓型颈椎病的显效率及有效率优于扶他林(双氯芬酸)。研究3表明,角度选择性牵引治疗脊髓型颈椎病的显效率优于及好转率略于0°牵引,而无足够证据证明有效率优0°牵引。研究4表明,无足够证据证明中药治疗脊髓型颈椎病优于弥可保。4个研究均未出现不良反应而终止试验。结论:所纳入的4个研究中,由于目前保守疗法的不统一,质量不高,诊断标准、随访时间、结果测量标准不一致,因此需要开展大样本、多中心,方法学规范的高质量随机对照试验进一步验证。

BACKGROUND： It was necessary to summarize and evaluate many conservative treatments for cervical myelopathy, while no a classical therapy was widely accepted nowadays. OBJECTIVE： To evaluate the effect and safety of conservative treatment for treating cervical myelopathy by Cochrane evaluation systems. DESIGN, TIME AND SETTING： Randomized controlled trial and quasi-randomized controlled trial were performed at the Chinese Evidence-Based Medical Center of West China Hospital of Sichuan University from March to June 2008. PARTICIPANTS： 542 patients, aged from 30 to 71 years, were randomly selected from 4 papers in the CCBM, CNKI and VIP databases and related partial documents searched by hands from January 1978 to April 2008. METHODS： Most data were searched from CCBM, CNKI and VIP databases by computer. Telephone interview with original authors were used to identify reality of randomized controlled trial; random control trial was adopted in course of conservative treatment for cervical myelopathy and its quality was assessed. Those date could not be analyzed together for lack of the same intervention method, so single MeTa analysis was used. Some evaluations such as random method--selection bias, allocation concealment-selection bias, blind method-performance bias and measurement bias, exclusion, lose to follow-up, withdraw-attrition bias were chosen. MAIN OUTCOME MEASURES： （1）Curative effects between acupuncture, electroacupuncture, cupping and chlorzoxazone, nifedipine, citicoline; （2）Curative effects between acupuncture, massage, traditional Chinese medicine and diclofenac; （3）Curative effects between selective angle traction and traction of zero angle; （4）Curative effects between traditional Chinese medicine and mikebao; （5）Adverse reaction. RESULTS： Studies fitted with C grade all included possibilities of selection bias, measurement basis and attrition bias, while only one study exceeded the control group compared with the experimental group in curative effects. Study 1 showed that acupuncture, electroacupuncture, cupping was better to chlorzoxazone, nifedipine, citicoline in effect of the cervical myelopathy. Study 2 indicated that acupuncture, massage, traditional Chinese medicine were more excited than diclofenac. Study 3 revealed that selective angle traction was supper to traction of zero angle in rate of cure and improvement. Study 4 indicated the effect of traditional Chinese medicine was inferior to mikebao. Above studies did not been stopped for adverse reaction. CONCLUSION： Low quality of above studies mainly originated from absence of a unified curative method, small samples, difference of follow-up time and judgment standard. So more samples, future multicenter and more regular randomized controlled trial should be performed.