CAJ | 학술논문

目的：系统评价活血化瘀中药制剂治疗脊髓型颈椎病的有效性和安全性。方法：计算机检索Cochrane Library、PubMed、EMbase英文数据库及中国知网（CNKI）、中国科技期刊数据库（VIP）、万方数据库，并手工检索，收集活血化瘀中药制剂治疗脊髓型颈椎病的临床随机对照试验。采用Cochrane Handbook 5.1.0推荐标准对纳入研究的方法学质量进行评价和GRADE profiler进行证据质量评估，使用Rev Man5.0进行Meta分析。结果：共纳入文献14篇，1140例患者。 Meta分析结果显示：活血化瘀中药制剂组治愈率[OR＝4.65，95％CI（2.65，7.49）]，总有效率[OR＝3.94，95％CI（2.42，6.41）]均优于西药组；活血化瘀中药制剂联合手术组治愈率[OR＝1.67，95％CI（0.97，2.88）]同手术组相当，总有效率[OR＝3.06，95％CI（1.06，8.84）]优于手术组；活血化瘀中药制剂结合非药物疗法治愈率[OR＝1.55，95％CI（0.93，2.53）]同非药物疗法组相当，总有效率[OR＝2.91，95％CI（1.54，5.47）]优于非药物疗法组；治疗结束后活血化瘀中药制剂脊髓功能状态评分（40分）[MD＝3.15，95％CI（2.11，4.18）]、(JOA)脊髓型颈椎病功能评分[MD＝1.51，95％CI（1.13，1.89）]均优于对照组；活血化瘀中药制剂组不良反应发生率低于西药组。 GRADE证据质量等级为低级。结论：现有临床证据表明，活血化瘀中药制剂治疗脊髓型颈椎病有效，不良事件发生率低于西药。由于纳入研究质量总体不高，上述结论尚需严格设计的高质量大样本随机对照试验进一步验证。
목적：계통평개활혈화어중약제제치료척수형경추병적유효성화안전성。방법：계산궤검색Cochrane Library、PubMed、EMbase영문수거고급중국지망（CNKI）、중국과기기간수거고（VIP）、만방수거고，병수공검색，수집활혈화어중약제제치료척수형경추병적림상수궤대조시험。채용Cochrane Handbook 5.1.0추천표준대납입연구적방법학질량진행평개화GRADE profiler진행증거질량평고，사용Rev Man5.0진행Meta분석。결과：공납입문헌14편，1140례환자。 Meta분석결과현시：활혈화어중약제제조치유솔[OR＝4.65，95％CI（2.65，7.49）]，총유효솔[OR＝3.94，95％CI（2.42，6.41）]균우우서약조；활혈화어중약제제연합수술조치유솔[OR＝1.67，95％CI（0.97，2.88）]동수술조상당，총유효솔[OR＝3.06，95％CI（1.06，8.84）]우우수술조；활혈화어중약제제결합비약물요법치유솔[OR＝1.55，95％CI（0.93，2.53）]동비약물요법조상당，총유효솔[OR＝2.91，95％CI（1.54，5.47）]우우비약물요법조；치료결속후활혈화어중약제제척수공능상태평분（40분）[MD＝3.15，95％CI（2.11，4.18）]、(JOA)척수형경추병공능평분[MD＝1.51，95％CI（1.13，1.89）]균우우대조조；활혈화어중약제제조불량반응발생솔저우서약조。 GRADE증거질량등급위저급。결론：현유림상증거표명，활혈화어중약제제치료척수형경추병유효，불량사건발생솔저우서약。유우납입연구질량총체불고，상술결론상수엄격설계적고질량대양본수궤대조시험진일보험증。
Objective:To systematically evaluate the effect and safety of Chinese herbs of activating blood cir-culation and removing blood stasis in treating cervical spondylosis myelopathy (CSM). Methods:The clinical ran-domized controlled trials of Chinese prescriptions of activating blood circulation and removing blood stasis were col-lected and reviewed by manual and computer retrieval in English database of Cochrane Library and Embase as well as Chinese database of CNKI, VIP and Wanfang. The qualities of methodology used to study were evaluated accord-ing to the standard recommended by Cochrane Handbook 5.1.0;the evidence qualities were examined by GRADE profiler;the Meta analyses were conducted by Rev Man5.0. Results:Totally 14 literatures were selected in the re-search, including 1140 patients. The Meta-analysis results:the cure rate was [OR=4.65, 95%CI(2.65, 7.49)] and the total effective rate was [OR=3.94, 95%CI (2.42, 6.41)], both of which in the Chinese herbs group were better than that in the western medicine group; in the group of combining the Chinese herbs with operation, the cure rate of [OR=1.67, 95%CI (0.97, 2.88)] equaled that in the operation group, while the total effective rate of [OR=3.06, 95%CI (1.06, 8.84)] was better;the cure rate in the group of combining the Chinese herbs with non-medical therapy was [OR=1.55, 95%CI (0.93, 2.53)] which was equal to that in the non-medical group, while the total effective rate was [OR=2.91, 95%CI (1.54, 5.47)] which was better than that in the non-medical group;in the end of the treat-ment by the Chinese herbs the score of spinal function and conditions (40 grades) was [MD=3.15, 95%CI (2.11, 4.18)] and the score of CSM function by JOA was [MD=1.51, 95%CI (1.13, 1.89)], both of which were superior to that in the control group;the incidence of adverse reactions in the Chinese herbs group was lower than that in the western medicine group. The evidence qualities measured by GRADE profiler were classified into the low class. Conclusion: The existing evidences indicate that the Chinese herbs of activating blood circulation and removing blood stasis are effective and the occurrence of adverse reactions of the Chinese herbs is lower than the western medicine. Due to the low quality of the proof, the results of the above research need to be further validated strictly by the clinical randomized controlled trials with high quality samples.