中药对照软骨保护剂改善膝骨关节炎功能活动的系统评价
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摘要
[目的]系统评价中药对照软骨保护剂改善膝骨关节炎的功能活动及药物安全性。[方法]检索中国知识资源总库(Chinese National KnowledgeInfrastructure, CNKI)、维普期刊数据库(VIP Journal Database,VIP)、万方数据知识服务平台(Wan-fang Data Knowledge Service Platform,Wan-Fang)、中国生物医学文献数据库(China Biology Medicine, CBM)中有关中药与软骨保护剂的随机和半随机对照临床试验,检索时限至2018年6月30日。由2名研究者依据纳入排除标准独立筛选文献、提取数据、并行文献质量评价,运用RevMan5.3软件进行统计分析。[结果]共纳入9项研究,合计689例膝骨性关节炎患者。6项研究因较大异质性仅采用描述性分析,2项研究Meta分析结果显示口服中药汤剂膝关节功能活动评分与软骨保护剂比较有统计学差异[SMD=-0.33,95%CI(-0.62,-0.33), P<0.05]。[结论]口服中药汤剂在约3个月时对膝关节功能活动的改善优于软骨保护剂,但基于现有研究缺陷,结论尚需高质量的随机对照试验予以证实。
[Objective] To assess the efficacy and safety of Chinese herbal medicine versus Chondroprotective Agents in improving knee joint function of knee osteoarthritis.[Methods] CNKI, VIP, Wan-Fang, and CBM databases were searched up to November 30, 2014 for relevant randomized and quasirandomized controlled clinical trials of addressing the efficacies of Chinese herbal medicines versus Chondroprotective Agents in the treatment of knee osteoarthritis. Two reviewers independently selected literature, extracted data, and assessed the quality of included trials. Data extraction from eligible studies was pooled and meta-analyzed using RevMan 5.3 software. [Results] A total of 9 studies involving 689 patients with knee osteoarthritis were included. The characteristics of six studies were summarized through descriptive analysis, because of the significant heterogeneity.The Meta-analysis results of two studies indicated that Chinese herbal medicines had better impact on measure of knee joint function in knee osteoarthritis patients in comparison to the Chondroprotective Agents[SMD=-0.33,95%CI(-0.62,-0.33),P<0.05].[Conclusion] The effect of Chinese herbal medicines on knee joint function is better than Chondroprotective Agents at about 3 months. However, owing to the research defects, further work based on high-quality randomized controlled trials is needed to determine the role of Chinese herbal medicines in the treatment of knee osteoarthritis.
[Objective] To assess the efficacy and safety of Chinese herbal medicine versus Chondroprotective Agents in improving knee joint function of knee osteoarthritis.[Methods] CNKI, VIP, Wan-Fang, and CBM databases were searched up to November 30, 2014 for relevant randomized and quasirandomized controlled clinical trials of addressing the efficacies of Chinese herbal medicines versus Chondroprotective Agents in the treatment of knee osteoarthritis. Two reviewers independently selected literature, extracted data, and assessed the quality of included trials. Data extraction from eligible studies was pooled and meta-analyzed using RevMan 5.3 software. [Results] A total of 9 studies involving 689 patients with knee osteoarthritis were included. The characteristics of six studies were summarized through descriptive analysis, because of the significant heterogeneity.The Meta-analysis results of two studies indicated that Chinese herbal medicines had better impact on measure of knee joint function in knee osteoarthritis patients in comparison to the Chondroprotective Agents[SMD=-0.33,95%CI(-0.62,-0.33),P<0.05].[Conclusion] The effect of Chinese herbal medicines on knee joint function is better than Chondroprotective Agents at about 3 months. However, owing to the research defects, further work based on high-quality randomized controlled trials is needed to determine the role of Chinese herbal medicines in the treatment of knee osteoarthritis.
引文
[1]王斌,邢丹,董圣杰,等.中国膝骨关节炎流行病学和疾病负担的系统评价[J].中国循证医学杂志,2018,18(2):134-142.
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[3]梁桂洪,梁祖建,林勇凯,等.补肾活血中药对比塞来昔布治疗膝骨性关节炎疗效与安全性的Meta分析[J].中国药房,2016,27(7):3810-3814.
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[6] Liu W, Wu Y H, Liu X Y, et al. Metabolic regulatoryand anti-oxidative effects of modified bushen huoxue de-coction on experimental rabbit model of osteoarthritis[J].Chinese Journal of Integrative Medicine, 2013, 19(6):459.
[7]张冲,王恒树,王艳君,等. TNF-α、i NOS在中药补肾固筋方治疗羊膝骨性关节炎中的表达及修复意义[J].中国骨质疏松杂志, 2015,21(6):687-690.
[8]苏达明,赵军华,黄志远,等.健膝强骨丸对膝骨关节炎家兔模型关节软骨病理改变的影响[J].中国组织工程研究,2014, 18(5):657-662.
[9]肖萍.软骨保护剂对原发性骨关节炎影响的实验研究[D].上海:复旦大学, 2008:89.
[10]唐长华,李富玉.解毒益肾法治疗膝骨性关节炎临床研究[J].中华中医药学刊, 2010,28(1):217-219.
[11]曹月龙,郑昱新,石印玉,等.养血软坚胶囊治疗膝骨关节炎疗效及安全性评价的随机对照试验[J].中国药物与临床,2004,4(6):423-427.
[12]朱芳晓,周润华,石宇红,等.正清风痛宁治疗膝骨关节炎的临床研究及对细胞因子的影响[J].当代医学,2013,19(12):1-3.
[13]由克举,由莉萍.疏肝活血散治疗膝关节骨性关节炎57例[J].河南中医,2012,32(4):466-467.
[14]姜玉祥.补肾活血汤治疗膝关节骨性关节炎的临床疗效观察[J].中国中医骨伤科杂志,2009,17(6):18-19.
[15]李加斌,周亚,董松林.柔肝活血方治疗膝关节骨性关节炎的临床研究[J].中国伤残医学,2010,18(4):20-22.
[16]汤俊,吴文虎,倪卫祖.阳和汤治疗轻中度疼痛膝关节炎临床疗效探讨[J].中国现代药物应用,2014,8(11):149-150.
[17]尹晓华.桑豆松节汤加减治疗膝骨关节炎的临床疗效分析[D].广州:广州中医药大学, 2009:94.
[18]李丹毅.独活寄生汤治疗早期膝骨性关节炎的34例临床疗效观察[D].成都:成都中医药大学, 2013:89.
[19]徐凌霄,王芳,郭敦明,等.左归丸对间充质干细胞向软骨细胞分化过程中Ⅱ型胶原及蛋白多糖基因表达的影响[J].中国中西医结合杂志,2011,31(12):1662-1668.
[20]梁祖建.补肾活血方调控Wnt/β-catenin信号通路保护关节软骨的机制研究[J].中华中医药杂志,2010,25(12):2327-2330.
[21]丰哲.探讨独活寄生汤对兔膝骨关节炎软骨保护作用机制研究[D].福州:福建中医药大学, 2016:52.
[22]郑颂华,吴泰相,商洪才,等.中药复方临床随机对照试验报告规范2017:CONSORT声明的扩展、说明与详述[J]. AnnIntern Med,2017,167(2):W21-W34.
[2]刘明,孙利华,刘国恩.中国城镇居民5种慢性疾病的经济负担和经济风险[J].北京大学学报(医学版),2014,46(5):782-789.
[3]梁桂洪,梁祖建,林勇凯,等.补肾活血中药对比塞来昔布治疗膝骨性关节炎疗效与安全性的Meta分析[J].中国药房,2016,27(7):3810-3814.
[4]徐明焱,王文岳.补肾中药与非甾类抗炎药治疗膝骨性关节炎比较的Meta-分析[J].贵阳中医学院学报,2014,36(2):68-72.
[5]黄绥心,林洁,李西海.补肾壮筋汤治疗膝骨性关节炎疗效的系统评价[J].康复学报, 2017,27(3):56-60.
[6] Liu W, Wu Y H, Liu X Y, et al. Metabolic regulatoryand anti-oxidative effects of modified bushen huoxue de-coction on experimental rabbit model of osteoarthritis[J].Chinese Journal of Integrative Medicine, 2013, 19(6):459.
[7]张冲,王恒树,王艳君,等. TNF-α、i NOS在中药补肾固筋方治疗羊膝骨性关节炎中的表达及修复意义[J].中国骨质疏松杂志, 2015,21(6):687-690.
[8]苏达明,赵军华,黄志远,等.健膝强骨丸对膝骨关节炎家兔模型关节软骨病理改变的影响[J].中国组织工程研究,2014, 18(5):657-662.
[9]肖萍.软骨保护剂对原发性骨关节炎影响的实验研究[D].上海:复旦大学, 2008:89.
[10]唐长华,李富玉.解毒益肾法治疗膝骨性关节炎临床研究[J].中华中医药学刊, 2010,28(1):217-219.
[11]曹月龙,郑昱新,石印玉,等.养血软坚胶囊治疗膝骨关节炎疗效及安全性评价的随机对照试验[J].中国药物与临床,2004,4(6):423-427.
[12]朱芳晓,周润华,石宇红,等.正清风痛宁治疗膝骨关节炎的临床研究及对细胞因子的影响[J].当代医学,2013,19(12):1-3.
[13]由克举,由莉萍.疏肝活血散治疗膝关节骨性关节炎57例[J].河南中医,2012,32(4):466-467.
[14]姜玉祥.补肾活血汤治疗膝关节骨性关节炎的临床疗效观察[J].中国中医骨伤科杂志,2009,17(6):18-19.
[15]李加斌,周亚,董松林.柔肝活血方治疗膝关节骨性关节炎的临床研究[J].中国伤残医学,2010,18(4):20-22.
[16]汤俊,吴文虎,倪卫祖.阳和汤治疗轻中度疼痛膝关节炎临床疗效探讨[J].中国现代药物应用,2014,8(11):149-150.
[17]尹晓华.桑豆松节汤加减治疗膝骨关节炎的临床疗效分析[D].广州:广州中医药大学, 2009:94.
[18]李丹毅.独活寄生汤治疗早期膝骨性关节炎的34例临床疗效观察[D].成都:成都中医药大学, 2013:89.
[19]徐凌霄,王芳,郭敦明,等.左归丸对间充质干细胞向软骨细胞分化过程中Ⅱ型胶原及蛋白多糖基因表达的影响[J].中国中西医结合杂志,2011,31(12):1662-1668.
[20]梁祖建.补肾活血方调控Wnt/β-catenin信号通路保护关节软骨的机制研究[J].中华中医药杂志,2010,25(12):2327-2330.
[21]丰哲.探讨独活寄生汤对兔膝骨关节炎软骨保护作用机制研究[D].福州:福建中医药大学, 2016:52.
[22]郑颂华,吴泰相,商洪才,等.中药复方临床随机对照试验报告规范2017:CONSORT声明的扩展、说明与详述[J]. AnnIntern Med,2017,167(2):W21-W34.