针刺治疗强直性脊柱炎随机对照试验Meta分析
|
摘要
目的:系统评价针刺治疗强直性脊柱炎(AS)的临床疗效,为针刺治疗AS的临床实践提供循证医学证据。方法:运用计算机检索国内外5大数据库(CNKI、VIP、中国生物医学文献数据库、万方数据库、PubMed),收集2000年1月—2018年2月期间有关针刺治疗AS组(试验组)对比单用药物治疗AS组(对照组)的临床随机对照试验(RCT)的相关文献。由2位研究人员各自独立进行文献筛选、资料提取和纳入研究质量评价,质量评价采用Cochrane协作网的偏倚风险评价标准和改良Jadad量表。并使用RevMan 5.3进行数据分析,其中二分类变量采用危险度(RR)或比值比(OR)及其95%置信区间(CI)表示,连续性变量则采用加权均数差(MD)及其95%置信区间(CI)表示。结果:最终纳入临床随机对照试验文献11篇,均为中文文献,共767例患者,其中纳入试验组395例,对照组372例。Meta分析结果显示,试验组治疗AS的总有效率[RR=1.26,95%CI(1.17,1.35),P<0.000 01]明显高于对照组,差异有统计学意义(P<0.05);并在改善扩胸距[MD=0.41,95%CI (0.26,0.56),P <0.000 01]、指地距[MD=-4.97,95%CI (-9.06,-0.89),P=0.02]、ESR [MD=-8.46,95%CI(-14.00,-2.92),P=0.003]、CRP[MD=-23.20,95%CI(-40.68,-5.73),P=0.009]方面均优于对照组,差异有统计学意义(P<0.05);但在改善BASDAI评分[MD=-5.36,95%CI(-12.99,-2.26),P=0.17]、BASFI评分[MD=-4.25,95%CI(-8.81,0.31),P=0.07]、不良反应发生率[OR=0.12,95%CI(0.01,1.64),P=0.11]方面,与对照组比较则无明显优势,差异无统计学意义(P>0.05)。采用逐一去除其中1项后重新合并效应量分析的方法对总有效率进行敏感性分析,Meta分析结果显示,依次剔除其中1项文献后,总有效率的差异均具有统计学意义(P<0.05),其中合并效应量为RR,得到的RR都较为稳定,说明纳入的各项研究之间的同质性较强且Meta分析结果比较稳定。结论:针刺治疗AS有一定优势,有助于改善AS患者的胸廓活动度、腰椎活动度及炎症指标(ESR、CRP),值得临床推广使用。但由于本研究基于文献数据,所以文献的质量及数量对最终的结果会有较大影响,因而有必要进行更多高质量、大样本的研究,从而为针刺治疗AS提供更加可靠的循证依据。
Objective: To evaluate the clinical effect of acupuncture in the treatment of ankylosing spondylitis and provide evidence-based medical evidence for clinical practice. Methods: Randomized controlled trials(RCT) about acupuncture(trial group)compared with medicines(control group) in the treatment of ankylosing spondylitis were collected from five major databases at home and abroad(CNKI, VIP database, Chinese Biomedical Database, Wanfang database, PubMed) from January 2000 to February 2018.Two independent reviewers screened the articles, extracted data and assessed the risk of bias. The evaluation of the quality was performed using Cochrane Risk of Bias evaluation criterion and Modified Jadad Scales; besides the data was analyzed by using RevMan5.3 software. Bi-categorized variables were represented by risk rate(RR) or odds ratio(OR) and its 95% confidence interval(CI) and continuous variables were represented by weighted mean difference(MD) and its 95% CI. Results: Finally, 11 clinical randomized controlled trials were included. All of them were Chinese literatures. A total of 767 participants involving 395 patients were included in the trial group and 372 patients in the control group. According to meta analysis, the total effective rate of acupuncture in the treatment of ankylosing spondylitis was higher than that of the control group [RR=1.26, 95%CI(1.17, 1.35), P<0.000 01], and the difference was statistically significant(P<0.05). Thoracic distance [MD=0.41, 95%CI(0.26,0.56), P<0.000 01], finger distance [MD=-4.97, 95%CI(-9.06,-0.89), P=0.02], erythrocyte sedimentation rate [MD=-8.46, 95%CI(-14.00,-2.92), P=0.003], C-reactive protein [MD=-23.20,95%CI(-40.68,-5.73), P=0.009] of the trial group were significantly improved better than those of the control group, and the differences were statistically significant(P<0.05). However, there were no significant differences in improving the disease activity index of ankylosing spondylitis score [MD=-5.36, 95%CI(-12.99,-2.26), P=0.17], the functional index of ankylosing spondylitis score [MD=-4.25,95%CI(-8.81, 0.31), P=0.07] and the adverse reaction rate [OR=0.12, 95%CI(0.01, 1.64), P=0.11] between the two groups(P>0.05).The sensitivity analysis of the total effective rate was carried out by removing one of them one by one and then merging the effect quantity analysis. Meta analysis results showed that the difference of total effective rate had statistical significance(P<0.05) after eliminating one of the documents in turn. The merging effect was determined by RR and the obtained RR was relatively stable. Sensitivity analysis showed that the research was homogeneous and the results of the meta analysis were stable. Conclusion: Acupuncture has certain advantages in the treatment of ankylosing spondylitis, and it is helpful to improve the activity of thoracic spine, the activity of lumbar spine and the inflammatory markers(erythrocyte sedimentation rate, C-reactive protein) in patients with ankylosing spondylitis as a result. So acupuncture in the treatment of ankylosing spondylitis is worthy of clinical use. However, this study is based on literature data;the quality and quantity of literature maybe have significant influence on the final results. Therefore, it is necessary to conduct more high-quality and large-sample studies, so as to provide a more reliable evidence-based basis for the treatment of ankylosing spondylitis by acupuncture.
Objective: To evaluate the clinical effect of acupuncture in the treatment of ankylosing spondylitis and provide evidence-based medical evidence for clinical practice. Methods: Randomized controlled trials(RCT) about acupuncture(trial group)compared with medicines(control group) in the treatment of ankylosing spondylitis were collected from five major databases at home and abroad(CNKI, VIP database, Chinese Biomedical Database, Wanfang database, PubMed) from January 2000 to February 2018.Two independent reviewers screened the articles, extracted data and assessed the risk of bias. The evaluation of the quality was performed using Cochrane Risk of Bias evaluation criterion and Modified Jadad Scales; besides the data was analyzed by using RevMan5.3 software. Bi-categorized variables were represented by risk rate(RR) or odds ratio(OR) and its 95% confidence interval(CI) and continuous variables were represented by weighted mean difference(MD) and its 95% CI. Results: Finally, 11 clinical randomized controlled trials were included. All of them were Chinese literatures. A total of 767 participants involving 395 patients were included in the trial group and 372 patients in the control group. According to meta analysis, the total effective rate of acupuncture in the treatment of ankylosing spondylitis was higher than that of the control group [RR=1.26, 95%CI(1.17, 1.35), P<0.000 01], and the difference was statistically significant(P<0.05). Thoracic distance [MD=0.41, 95%CI(0.26,0.56), P<0.000 01], finger distance [MD=-4.97, 95%CI(-9.06,-0.89), P=0.02], erythrocyte sedimentation rate [MD=-8.46, 95%CI(-14.00,-2.92), P=0.003], C-reactive protein [MD=-23.20,95%CI(-40.68,-5.73), P=0.009] of the trial group were significantly improved better than those of the control group, and the differences were statistically significant(P<0.05). However, there were no significant differences in improving the disease activity index of ankylosing spondylitis score [MD=-5.36, 95%CI(-12.99,-2.26), P=0.17], the functional index of ankylosing spondylitis score [MD=-4.25,95%CI(-8.81, 0.31), P=0.07] and the adverse reaction rate [OR=0.12, 95%CI(0.01, 1.64), P=0.11] between the two groups(P>0.05).The sensitivity analysis of the total effective rate was carried out by removing one of them one by one and then merging the effect quantity analysis. Meta analysis results showed that the difference of total effective rate had statistical significance(P<0.05) after eliminating one of the documents in turn. The merging effect was determined by RR and the obtained RR was relatively stable. Sensitivity analysis showed that the research was homogeneous and the results of the meta analysis were stable. Conclusion: Acupuncture has certain advantages in the treatment of ankylosing spondylitis, and it is helpful to improve the activity of thoracic spine, the activity of lumbar spine and the inflammatory markers(erythrocyte sedimentation rate, C-reactive protein) in patients with ankylosing spondylitis as a result. So acupuncture in the treatment of ankylosing spondylitis is worthy of clinical use. However, this study is based on literature data;the quality and quantity of literature maybe have significant influence on the final results. Therefore, it is necessary to conduct more high-quality and large-sample studies, so as to provide a more reliable evidence-based basis for the treatment of ankylosing spondylitis by acupuncture.
引文
[1] DASHTI N,MAHMOUDI M,ASLANI S,et al. HLA-B*27 subtypes and their implications in the pathogenesis of ankylosing spondylitis[J]. Gene,2018,670:15-21.
[2]杨晓松.强直性脊柱炎诊疗进展[J].中国全科医学,2017,20(S3):218-221.
[3]夏青,李晓娜,杨晓,等.强直性脊柱炎患者疾病活动度影响因素的有序多分类Logistic回归分析[J].安徽医科大学学报,2016,51(12):1808-1812.
[4]周芹,刘勋. IL-23对强直性脊柱炎的诊断意义及其受体表达的研究[J].现代医学,2017,45(2):229-233.
[5]刘艳娟,孙志强.白细胞介素23与血液系统疾病关系的研究进展[J].重庆医学,2017,46(8):1131-1133.
[6]林滇恬,李晓琳,齐晨越,等.强直性脊柱炎患者血清IL-27水平的测定及临床意义[J].中国医科大学学报,2014,43(1):19-21.
[7]朱元悦,张玲,孙柔,等.强直性脊柱炎患者外周血T细胞亚群及相关免疫分子的变化[J].现代免疫学,2017,37(1):14-19.
[8] ZOCHLING J,BOHL-BUHLER M H,BARALIAKOS X,et al.Infection and work stress are potential triggers of ankylosing spondylitis[J]. Clin Rheumatol,2006,25(5):660-666.
[9] MARTINE Z A,PACHECO-TENA C,VAZQUEZ-MELLADO J,et al. Relationship between disease activity and infection in patients with spondyloarthropathies[J]. Ann Rheum Dis,2004,63(10):1338-1340.
[10]徐子琦,宋俊垚,刘宏潇.中医药治疗强直性脊柱炎现代研究新进展[J].世界中医药,2016,11(11):2467-2471.
[11]唐上德,陈冠华,吕洲明,等.腹针配合药物疗法治疗强直性脊柱炎的临床疗效评价[J].中国中医基础医学杂志,2015,21(8):1046-1047,1054.
[12]左芳,刘维.腰痹通胶囊配合针刺治疗强直性脊柱炎38例[J].天津中医药,2011,28(1):35-36.
[13]张海龙,张俊英,晋学英,等.针刺华佗夹脊穴和督脉穴对强直性脊柱炎患者相关实验指标及炎性因子检测研究[J].医学综述,2015,21(9):1678-1680.
[14]朱峪英,凌雄,吴小红.针刺夹脊穴治疗强直性脊柱炎30例[J].山东中医杂志,2009,28(11):787-788.
[15]陈冠华.薄氏腹针配合药物疗法治疗强直性脊柱炎的临床疗效评价[D].广州:广州中医药大学,2011:22-30.
[16]魏丽萍,宋红旗,冀春丽.针刺联合补肾强脊汤治疗肝肾亏虚型强直性脊柱炎30例[J].中医研究,2015,28(8):34-36.
[17]何庆勇.针刺配合中药内服治疗强直性脊柱炎30例临床研究[J].江苏中医药,2006,27(8):43-44.
[18]赵俊龙.针刺穴位在改善强直性脊柱炎患者病情活动及功能活动的效果观察[J].陕西中医,2016,37(7):907-908.
[19]吴毅军.针刺治疗强直性脊柱炎的临床观察[J].湖北中医杂志,2013,35(8):58.
[20]薛斌,刘维.针刺治疗强直性脊柱炎临床疗效评价分析[J].中华中医药杂志,2016,31(6):2328-2330.
[21]黄永杰.针刺治疗强直性脊柱炎随机平行对照研究[J].实用中医内科杂志,2016,30(4):98-100.
[22]尹逊路,朱立国,冯敏山,等.针刺治疗神经根型颈椎病疗效Meta分析[J].康复学报,2018,28(4):63-69.
[23]宿丽心.针灸综合疗法运用于强直性脊柱炎的临床疗效观察[J].中国医药指南,2012,10(27):266-267.
[24]张杰,玉璐.针刺治疗强直性脊柱炎36例[J].中国针灸,2007,27(1):22.
[25]侯春英,刘强.温针灸治疗强直性脊柱炎33例[J].中医研究,2004,17(3):52-53.
[26]刘维,张磊,刘滨,等.针灸治疗强直性脊柱炎60例疗效观察[J].中国针灸,2002,22(10):665-666.
[27]朱略英,凌雄,吴小红.针刺夹脊穴治疗强直性脊柱炎30例[J].山东中医杂志,2009,28(11):787-788.
[28]王英杰,丘文静.浮针疗法治疗早期强直性脊柱炎疗效观察[J].上海针灸杂志,2017,36(9):1088-1091.
[2]杨晓松.强直性脊柱炎诊疗进展[J].中国全科医学,2017,20(S3):218-221.
[3]夏青,李晓娜,杨晓,等.强直性脊柱炎患者疾病活动度影响因素的有序多分类Logistic回归分析[J].安徽医科大学学报,2016,51(12):1808-1812.
[4]周芹,刘勋. IL-23对强直性脊柱炎的诊断意义及其受体表达的研究[J].现代医学,2017,45(2):229-233.
[5]刘艳娟,孙志强.白细胞介素23与血液系统疾病关系的研究进展[J].重庆医学,2017,46(8):1131-1133.
[6]林滇恬,李晓琳,齐晨越,等.强直性脊柱炎患者血清IL-27水平的测定及临床意义[J].中国医科大学学报,2014,43(1):19-21.
[7]朱元悦,张玲,孙柔,等.强直性脊柱炎患者外周血T细胞亚群及相关免疫分子的变化[J].现代免疫学,2017,37(1):14-19.
[8] ZOCHLING J,BOHL-BUHLER M H,BARALIAKOS X,et al.Infection and work stress are potential triggers of ankylosing spondylitis[J]. Clin Rheumatol,2006,25(5):660-666.
[9] MARTINE Z A,PACHECO-TENA C,VAZQUEZ-MELLADO J,et al. Relationship between disease activity and infection in patients with spondyloarthropathies[J]. Ann Rheum Dis,2004,63(10):1338-1340.
[10]徐子琦,宋俊垚,刘宏潇.中医药治疗强直性脊柱炎现代研究新进展[J].世界中医药,2016,11(11):2467-2471.
[11]唐上德,陈冠华,吕洲明,等.腹针配合药物疗法治疗强直性脊柱炎的临床疗效评价[J].中国中医基础医学杂志,2015,21(8):1046-1047,1054.
[12]左芳,刘维.腰痹通胶囊配合针刺治疗强直性脊柱炎38例[J].天津中医药,2011,28(1):35-36.
[13]张海龙,张俊英,晋学英,等.针刺华佗夹脊穴和督脉穴对强直性脊柱炎患者相关实验指标及炎性因子检测研究[J].医学综述,2015,21(9):1678-1680.
[14]朱峪英,凌雄,吴小红.针刺夹脊穴治疗强直性脊柱炎30例[J].山东中医杂志,2009,28(11):787-788.
[15]陈冠华.薄氏腹针配合药物疗法治疗强直性脊柱炎的临床疗效评价[D].广州:广州中医药大学,2011:22-30.
[16]魏丽萍,宋红旗,冀春丽.针刺联合补肾强脊汤治疗肝肾亏虚型强直性脊柱炎30例[J].中医研究,2015,28(8):34-36.
[17]何庆勇.针刺配合中药内服治疗强直性脊柱炎30例临床研究[J].江苏中医药,2006,27(8):43-44.
[18]赵俊龙.针刺穴位在改善强直性脊柱炎患者病情活动及功能活动的效果观察[J].陕西中医,2016,37(7):907-908.
[19]吴毅军.针刺治疗强直性脊柱炎的临床观察[J].湖北中医杂志,2013,35(8):58.
[20]薛斌,刘维.针刺治疗强直性脊柱炎临床疗效评价分析[J].中华中医药杂志,2016,31(6):2328-2330.
[21]黄永杰.针刺治疗强直性脊柱炎随机平行对照研究[J].实用中医内科杂志,2016,30(4):98-100.
[22]尹逊路,朱立国,冯敏山,等.针刺治疗神经根型颈椎病疗效Meta分析[J].康复学报,2018,28(4):63-69.
[23]宿丽心.针灸综合疗法运用于强直性脊柱炎的临床疗效观察[J].中国医药指南,2012,10(27):266-267.
[24]张杰,玉璐.针刺治疗强直性脊柱炎36例[J].中国针灸,2007,27(1):22.
[25]侯春英,刘强.温针灸治疗强直性脊柱炎33例[J].中医研究,2004,17(3):52-53.
[26]刘维,张磊,刘滨,等.针灸治疗强直性脊柱炎60例疗效观察[J].中国针灸,2002,22(10):665-666.
[27]朱略英,凌雄,吴小红.针刺夹脊穴治疗强直性脊柱炎30例[J].山东中医杂志,2009,28(11):787-788.
[28]王英杰,丘文静.浮针疗法治疗早期强直性脊柱炎疗效观察[J].上海针灸杂志,2017,36(9):1088-1091.