Chinese Journal of Tissue Engineering Research ›› 2020, Vol. 24 ›› Issue (18): 2879-2887.doi: 10.3969/j.issn.2095-4344.2641
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Meta-analysis of the effect of acupoint injection on pain
improvement and joint function in patients with knee osteoarthritis
Deng Kaifeng1, Shang Xinyang1, Zhu Shengwang1, Li Shuzhen2, Zhu Ying2, Chen Rilan2
- 1Guangxi University of Chinese Medicine, Nanning 530001, Guangxi Zhuang Autonomous Region, China; 2Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011, Guangxi Zhuang Autonomous Region, China
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Received:2019-10-21Revised:2019-10-25Accepted:2019-12-05Online:2020-06-28Published:2020-04-07 -
Contact:Chen Rilan, Chief physician, Professor, Master’s supervisor, Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011, Guangxi Zhuang Autonomous Region, China -
About author:Deng Kaifeng, Master candidate, Guangxi University of Chinese Medicine, Nanning 530001, Guangxi Zhuang Autonomous Region, China -
Supported by:the National Natural Science Foundation of China, No. 81460763 and 81960908; the Natural Science Foundation of Guangxi Zhuang Autonomous Region, No. 2017JJA140564z; the Guangxi Medical and Health Appropriate Technology Development and Promotion Project of Health and Family Planning Commission of Guangxi Zhuang Autonomous Region, No. S2017057
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Cite this article
Deng Kaifeng, Shang Xinyang, Zhu Shengwang, Li Shuzhen, Zhu Ying, Chen Rilan.
Meta-analysis of the effect of acupoint injection on pain
improvement and joint function in patients with knee osteoarthritis
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2.1 文献检索结果 共检索出864篇相关文献，软件去重后获得412篇文献，通过阅读摘要排除综述、动物实验、会议记录、护理记录、个案或专家经验、非随机对照试验等文献，共获得穴位注射治疗膝骨关节炎的文献137篇。根据研究限定的纳入及排除标准最终纳入符合标准的文献共16篇[11-26]，中文文献15篇，英文文献1篇。文献检索流程见图1。 "
2.2 纳入文献的基本特征 共纳入16篇随机对照试验研究，涉及患者1 287例，其中观察组合计648例，对照组合计639例。此16项研究在临床疗效判定上主要以总体有效率、治愈率、目测类比评分[27]、WOMAC评分[28]、Lequesne指数评分[29]、Lysholm评分[30]、日本膝关节功能评分7种疗效指标为标准[31]，而此7项指标均涉及膝关节功能恢复状况，故可认为纳入的各项独立研究疗效判断标准大体一致。临床疗效分级包括临床治愈、显效、有效和无效4级标准，总体有效率作为结局指标包括临床治愈率、显效率及有效率3者之和，见表1。 "
2.3 纳入研究的质量评价 采用Jadad评分量表(≤2分判定为低质量，≥3分判定为高质量)对纳入的16项研究进行评估，结果显示：1项为高质量研究[11]，得分为3分，其余15项均为低质量研究[12-26]，9项研究得分为2分[12，14，16，18-21，25-26]，其余6项研究均为1分[13，15，17，22-24]。8项试验使用随机数字表法[11-12，14，16，18-19，25-26]，1项研究采用抽签法[20]，其余7项试验只提及了随机字样[13，15，17，21-24]。所有研究皆未提及随访时间，所有研究皆报告了两组之间基线相似性一致。但以上文献均未将原始数据进行呈现，只能通过研究者的总结报告进行评价，使分析存在信息偏倚的可能。由于大部分穴位注射疗法的文献均未对研究人员及受试人员施盲，导致实施性偏倚风险评估大部分为风险较高，见表2，图2，3。 "
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2.4 干预措施比较 在16项试验研究中，观察组分别为穴位注射、穴位注射结合对照组治疗，对照组包括药物口服、药物静滴、关节腔注射、针刺、推拿、理疗等。 2.5 Meta分析结果 2.5.1 总体有效率 14项研究报道了总体有效 率[11-13，15-17，19-26]，异质性检验结果为P=0.51、I2=0%，采用固定效应模型分析，结果显示：观察组总体有效率高于对照组[OR=3.23，95%CI(2.19，4.76)，Z=5.91，P < 0.000 01]，见图4。 "
2.5.2 治愈率 10项研究皆报道了治愈率[11，15-17，19，21-22，24-26]，异质性检验显示P=0.64、I2=0%，采用固定效应模型分析，结果显示：观察组临床治愈率高于对照组[OR=1.86，95%CI(1.35，2.58)，Z=3.74，P=0.000 2]，见图5。 "
2.5.3 治疗前后目测类比评分差值 5项研究报道了目测类比评分[14，16，18，24，26]。其差值异质性检验显示P < 0.000 01、I2=96%，采用随机效应模型分析，结果显示：两组降低目测类比评分效果相当[MD=-1.11，95%CI(-2.29，0.07)，Z=1.84，P=0.07]，见图6。 "
2.5.4 治疗前后WOMAC评分差值 2项研究报道了WOMAC评分[11，18]。其差值进行异质性检验显示P < 0.000 01、I2=99%，采用随机效应模型分析，结果显示：两组降低WOMAC评分效果相当[MD=-7.56，95%CI (-17.26，2.14)，Z=1.53，P=0.13]，见图7。 "
2.5.5 治疗前后Lequesne指数评分差值 2项研究报道了Lequesne指数评分[17，23]。其差值异质性检验显示P=0.15、I2=51%，采用随机效应模型分析，结果显示：两组Lequesne指数评分差值比较差异无显著性意义[MD= -0.46，95%CI(-1.62，0.71)，Z=0.77，P=0.44]，见图8。 "
2.5.6 治疗前后Lysholm评分差值 2项研究报道了Lysholm评分[12，16]。其差值异质性检验显示P < 0.000 01、I2=97%，采用随机效应模型分析，结果显示：观察组Lysholm评分差值高于对照组[MD=7.87，95%CI(2.66，13.08)，Z=2.96，P=0.003]，见图9。 "
2.5.7 治疗前后日本膝关节功能评分评分差值 2项研究报道了日本膝关节功能评分[14，25]。其差值异质性检验显示P=0.06、I2=71%，采用随机效应模型分析，结果显示：观察组日本膝关节功能评分差值高于对照组[MD=9.16，95%CI(4.18，14.13)，Z=3.61，P=0.000 3]，见图10。 "
2.5.8 安全性分析 5项研究报道了治疗过程的不良反应事件[12-14，19，23]，纳入总样本量为323例，其中观察组合计154例，不良反应事件4例，占比2.6%，主要表现为局部皮肤瘙痒、皮肤潮红、出汗等；对照组合计169例，不良反应事件3例，占比1.8%，主要表现为皮肤瘙痒、关节肿痛加重等。异质性检验结果显示P=0.23、I2=29%，提示各个研究之间同质性良好，采用固定效应模型合并分析，结果显示：两组不良反应发生率比较差异无显著性意义[OR=1.31，95%CI(0.31，5.57)，Z=0.37，P=0.71]，见图11。 "
2.6 发表偏倚 图12漏斗图分布并不完全对称，提示此次研究纳入的文献存在发表性偏倚。再结合纳入研究大部分样本量小且质量偏低等特点，提示存在发表性偏倚的可能。除此之外，次次纳入研究文献的结局指标并未完全统一，所有研究均未提及后期随访，这些因素同样是其潜在发表性偏倚的来源。 "
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