非甾体抗炎药联合氨基葡萄糖及关节镜手术治疗膝骨性关节炎的临床研究
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摘要
第一部分选择性环氧化酶-2抑制剂与非选择性非甾体抗炎药联合质子泵抑制剂治疗骨性关节炎的Meta分析
目的：系统评价选择性环氧化酶-2抑制剂与非选择性非甾体抗炎药联合质子泵抑制剂治疗骨性关节炎的安全性。
方法：全面检索Cochrane Library, EMBASE, PubMed, Web of science,中国生物医学文献数据库,中国期刊全文数据库,中文科技期刊数据库,万方数据库,临床试验注册平台和相关学位论文及会议论文数据库,并追踪纳入文献的参考文献,提取相关数据。从随机方法、分配隐藏、盲法、结果数据完整性,选择性报告结果及其它偏倚6个方面对纳入研究进行方法学质量评价,并进行异质性检验,合并效应量。采用RevMan5.1软件进行统计分析,利用GRADEpro对测量指标进行推荐分级。
结果：总共纳入6个随机对照试验(6219例患者),结果显示口服选择性环氧化酶-2抑制剂与非选择性非甾体抗炎药联合质子泵抑制剂治疗骨性关节炎在上消化道不良事件(比值比为0.61,95%可信区间为0.34-1.09),胃肠道症状(比值比为1.10,95%可信区间为0.88-1.39)和心血管不良事件(比值比为1.67,95%可信区间为0.78-3.59)差异无统计学意义。上消化道不良事件、胃肠道症状及心血管不良事件GRADE评价结果为中等,降级因素为不一致性。
结论：目前证据表明与非选择性非甾体抗炎药联合质子泵抑制剂相比,选择性环氧化酶-2抑制剂并不能降低上消化道不良事件,胃肠道症状及心血管不良事件的发生。临床医生在选择用药治疗骨性关节炎时应结合患者意愿,并仔细考虑和权衡胃肠道和心血管不良事件的风险,以便作出非选择性非甾体抗炎联合质子泵抑制剂或单独应用选择性环氧化酶-2抑制剂的选择。第二部分非甾体抗炎药联合氨基葡萄糖治疗膝骨性关节炎的临床研究
目的：观察非选择性非甾体抗炎药联合质子泵抑制剂对比选择性环氧化酶-2抑制剂及其分别联合氨基葡萄糖治疗膝骨性关节炎的有效性、安全性和经济性。
方法：纳入来自兰州大学第一医院共140例临床诊断为膝骨性关节炎的患者,按随机分配原则分别分配入非选择性非甾体抗炎药联合质子泵抑制剂组(A组),选择性环氧化酶-2抑制剂组(B组),非选择性非甾体抗炎药联合质子泵抑制剂和氨基葡萄糖组(C组),选择性环氧化酶-2抑制剂联合氨基葡萄糖组(D组),分别于治疗2周、6周、12周和24周后进行临床疗效评定(膝关节指数评分和膝关节功能Lysholm评分)、安全性及成本效果评价,采用SPSS19.0软件进行统计分析,全面评价各组用药的有效性、安全性及经济性。
结果：①以膝关节指数评分进行有效率判定：组间比较,治疗后2周,4组之间有效率的差异无统计学意义(P>0.05)；治疗6、12、24周后服用氨基葡萄糖的2组(C组和D组)与未服用氨基葡萄糖的2组(A组和B组)有效率的差异有统计学意义(P<0.05)；治疗2、6、12、24周后A组与B组有效率的差异无统计学意义(P>0.05),C组与D组有效率的差异无统计学意义(P>0.05)。组内比较,A组,B组组内治疗前、治疗2、6、12、24周后两两比较,有效率差异均有统计学意义(P<0.05)；C组,D组组内两两比较,12周与24周有效率的差异无统计学意义(P>0.05),其余时间点两两比较,有效率差异均有统计学意义(P<0.05)。②膝关节功能Lysholm评分：组间比较,治疗2周后4组间评分差异无统计学意义(P>0.05)；在治疗6、12、24周后,联合服用氨基葡萄糖的2组(C组和D组)与未服用氨基葡萄糖的2组(A组和B组)评分的差异有统计学意义(P<0.05)；治疗6、12、24周后A组与B组评分差异无统计学意义(P>0.05),C组与D组差异无统计学意义(P>0.05)。组内比较,各组内治疗前、治疗2、6、12、24周后两两比较Lysholm评分的差异均有统计学意义(P<0.05)。③4组安全性差异无统计学意义(P>0.05)。④成本效果分析,4种方案中非选择性非甾体抗炎药联合质子泵抑制剂和氨基葡萄糖的成本效果最佳。
结论：①与传统单独使用非甾体抗炎药相比,治疗膝骨性关节炎服用非甾体抗炎药联合氨基葡萄糖治疗在缓解症状,改善关节功能方面更具优势。②非甾体抗炎药联合氨基葡萄糖的远期疗效(>24周)尚不明确。③非甾体抗炎药联合氨基葡萄糖治疗膝骨性关节炎与单独使用非甾体抗炎药相比,并未增加不良事件的发生,联合用药安全性较佳。④非选择性非甾体抗炎药联合质子泵抑制剂和氨基葡萄糖的成本效果最佳。
第三部分关节镜手术联合口服药物治疗膝骨性关节炎的临床研究
目的：应用关节镜手术(广泛清理术与重点清理术)联合使用非甾体抗炎药和氨基葡萄糖治疗膝骨性关节炎患者,观察临床疗效及安全性。为临床医师选择手术及联合用药方案提供依据。
方法：60例患者均来自于兰州大学第一医院住院患者,按随机分配原则分配入膝关节镜手术广泛清理组和膝关节镜手术重点清理组,每组30例患者,术后口服非选择性非甾体抗炎药联合质子泵抑制剂和氨基葡萄糖2个月。分别于术后2、6、12、24周观察膝关节活动度,采用Lysholm评分及Judet疗效评定标准评价膝关节功能,同时进行安全性评价。采用SPSS19.0统计软件进行统计分析。
结果：①膝关节功能Lysholm评分：组间比较,术后2周时广泛清理组与重点清理组Lysholm评分的差异无统计学意义(P>0.05),其余时间点(6、12、24周)2组间Lysholm评分差异均具有统计学意义(P<0.05)。组内比较,各组组内12周与24周Lysholm评分差异无统计学意义(P>0.05),其余各时间点两两比较Lysholm评分的差异均有统计学意义(P<0.05)。②膝关节活动度评定：组间比较,术后2周时2组膝关节活动优良率的差异未见统计学意义(P>0.05),其余观察时间点(6、12、24周)膝关节活动优良率的差异均有统计学意义(P<0.05)。组内比较,各组12周与24周优良率的差异无统计学意义(P>0.05),其余各时间点两两比较优良率的差异均有统计学意义(P<0.05)。③两组手术相关并发症的差异有统计学意义(P<0.05),两组口服药物相关不良反应差异无统计学意义(P>0.05)。
结论：①结合术前评估的重点清理术在临床疗效方面优于广泛清理术。②两种手术方案的手术安全性存在差异,重点清理术较广泛清理术有较低的手术并发症。③关节镜下清理术联合非甾体抗炎药、质子泵抑制剂和氨基葡萄糖治疗膝骨性关节炎可取得满意疗效。
Part Ⅰ Meta-analysis:Comparison of cyclooxygenase-2inhibitors alone with nonselective non-steroidal anti-inflammatory drugs plus proton pump inhibitors in regard to safety in osteoarthritis
Objectives To compare cyclooxygenase-2(COX-2) inhibitors alone with nonselective nonsteroidal anti-inflammatory drugs(NSAIDs) plus proton pump inhibitors(PPIs) in preventing gastrointestinal adverse events:upper gastrointestinal(UGI) adverse events, gastrointestinal symptoms and cardiovascular adverse events in osteoarthritis.
Methods PubMed, the Cochrane library, EMBASE, Web of science, Chinese Biomedical Literature Database, National Knowledge Infrastructure, Wanfang Database, Clinical Trials Registry Platform, and reference lists of relevant papers for articles published were searched. The related data matching standards set for this study were extracted. The methodological qualities of included studies were evaluated from the random method, allocation concealment, blinding, the results data integrity, selective bias in reporting results and other factors. The heterogeneity was tested and effect size was combined. Statistical analyses were carried out using RevMan(5.0) software. Recommended grade of measuring indicators were carried out using GRADEpro.
Results The meta-analysis of six randomized controlled trials with a total of6219patients revealed that there was no difference in the UGI adverse events between COX-2inhibitors and nonselective NSAIDs with concurrent use of PPIs(OR0.61,95%confidence interval(CI)0.34-1.09). There was no significant difference in gastrointestinal symptoms(OR1.10,95%CI:0.88-1.39) and the cardiovascular adverse events(OR1.67,95%CI:0.78-3.59) between the two groups. The evaluations of GRADE system were moderate due to inconsistency.
Conclusions COX-2inhibitors are no better than nonselective NSAIDs with PPIs in regard to UGI adverse events, gastrointestinal symptoms and cardiovascular adverse events in osteoarthritis arthritis. On the basis of the current evidence and the combined wishes of the patient, clinicians should carefully consider and weigh both gastrointestinal and cardiovascular risk before selecting NSAID plus PPIs or COX-2inhibitors.
Part Ⅱ Clinical study of non-steroidal anti-inflammatory drugs combined glucosamine in patients with knee osteoarthritis
Objectives The aims of this study were to assess the efficacy, safety and economy of non-selective non-steroidal anti-inflammatory drugs(NSAIDs) plus proton pump inhibitors(PPIs) and cyclooxygenase-2(COX-2) inhibitors, and those medications in combination with glucosamine respectively in patients with knee osteoarthritis.
Methods A total of140patients with knee osteoarthritis were randomized to receive NSAIDs plus PPIs(gourp A), COX-2inhibitors(group B), NSAIDs plus PPIs in combination with glucosamine(group B) or COX-2inhibitors plus glucosamine(group D). Efficacy was assessed with the Japanese orthopaedic association(JOA) knee index and knee lysholm score at prior to treatment and at2,6,12and24weeks post-treatment. Medication-related complications and cost-effectiveness were also observed. Statistical analyses were carried out using SPSS19.0.
Results Significant differences in JOA knee index and knee lysholm score were detected between the A, B groups and the C, D groups at6,12and24weeks post-treatment (P<0.05) but not at weeks2post-treatment (P>0.05). Significant differences in these indices were not detected at2,4,6,12,24weeks between group A and group B, group C and group D. Significant differences in JOA knee index were detected at different time-points in group A and group B(P<0.05). Significant differences in JOA knee index were also detected at different time-points in group C and group D(P<0.05), except between weeks12and24(P>0.05). Significant differences in lysholm score were detected at different time-points in each group(P<0.05). Significant differences in complications were not detected between four groups(P<0.05). Cost-effectiveness analysis showed group C was the best among four groups.
Conclusions NSAIDs in combination with glucosamine is superior to NSAIDs alone in treatment of knee osteoarthritis although without clear long-term effect. NSAIDs alone are no better than NSAIDs plus glucosamine in regard to medication-related complications. The best cost-effectiveness is non-selective NSAIDs in combination with PPIs and glucosamine.
Part III Clinical study of arthroscopic debridement surgery in combination with oral medication in patients with knee osteoarthritis
Objectives The aims of this study were to assess the efficacy and safety of arthroscopic debridement in combination with oral medication for the treatment of knee osteoarthritis, and to provide evidence for selection of surgical approach with oral medication.
Methods A total of60patients with knee osteoarthritis were randomized to receive either arthroscopic extensive cleanup in combination with oral medication group or focus cleanup in combination with oral medication group. Efficacy was assessed with the angle of knee fextion, lysholm score. Surgery-and medication-related complications were observed. Statistical analyses were carried out using SPSS19.0.
Results Significant differences in flexion and lysholm scores of the knee-joint were detected between the two groups at2,6,12and24weeks post-treatment(P<0.05) but not at weeks2post-treatment(P>0.05). Significant differences in these indices were detected at different time-points in each group(P<0.05), except between weeks24and48(P>0.05). Significant differences in surgery-related complications were detected between two groups(P<0.05). Significant differences in medication-related complications were not detected between two groups(P>0.05).
Conclusions Arthroscopic focus cleanup surgery, with fewer surgical complications, in combination with oral medication is superior to arthroscopic extensive cleanup surgery in combination with oral medication in the flexion and lysholm score
目的：系统评价选择性环氧化酶-2抑制剂与非选择性非甾体抗炎药联合质子泵抑制剂治疗骨性关节炎的安全性。
方法：全面检索Cochrane Library, EMBASE, PubMed, Web of science,中国生物医学文献数据库,中国期刊全文数据库,中文科技期刊数据库,万方数据库,临床试验注册平台和相关学位论文及会议论文数据库,并追踪纳入文献的参考文献,提取相关数据。从随机方法、分配隐藏、盲法、结果数据完整性,选择性报告结果及其它偏倚6个方面对纳入研究进行方法学质量评价,并进行异质性检验,合并效应量。采用RevMan5.1软件进行统计分析,利用GRADEpro对测量指标进行推荐分级。
结果：总共纳入6个随机对照试验(6219例患者),结果显示口服选择性环氧化酶-2抑制剂与非选择性非甾体抗炎药联合质子泵抑制剂治疗骨性关节炎在上消化道不良事件(比值比为0.61,95%可信区间为0.34-1.09),胃肠道症状(比值比为1.10,95%可信区间为0.88-1.39)和心血管不良事件(比值比为1.67,95%可信区间为0.78-3.59)差异无统计学意义。上消化道不良事件、胃肠道症状及心血管不良事件GRADE评价结果为中等,降级因素为不一致性。
结论：目前证据表明与非选择性非甾体抗炎药联合质子泵抑制剂相比,选择性环氧化酶-2抑制剂并不能降低上消化道不良事件,胃肠道症状及心血管不良事件的发生。临床医生在选择用药治疗骨性关节炎时应结合患者意愿,并仔细考虑和权衡胃肠道和心血管不良事件的风险,以便作出非选择性非甾体抗炎联合质子泵抑制剂或单独应用选择性环氧化酶-2抑制剂的选择。第二部分非甾体抗炎药联合氨基葡萄糖治疗膝骨性关节炎的临床研究
目的：观察非选择性非甾体抗炎药联合质子泵抑制剂对比选择性环氧化酶-2抑制剂及其分别联合氨基葡萄糖治疗膝骨性关节炎的有效性、安全性和经济性。
方法：纳入来自兰州大学第一医院共140例临床诊断为膝骨性关节炎的患者,按随机分配原则分别分配入非选择性非甾体抗炎药联合质子泵抑制剂组(A组),选择性环氧化酶-2抑制剂组(B组),非选择性非甾体抗炎药联合质子泵抑制剂和氨基葡萄糖组(C组),选择性环氧化酶-2抑制剂联合氨基葡萄糖组(D组),分别于治疗2周、6周、12周和24周后进行临床疗效评定(膝关节指数评分和膝关节功能Lysholm评分)、安全性及成本效果评价,采用SPSS19.0软件进行统计分析,全面评价各组用药的有效性、安全性及经济性。
结果：①以膝关节指数评分进行有效率判定：组间比较,治疗后2周,4组之间有效率的差异无统计学意义(P>0.05)；治疗6、12、24周后服用氨基葡萄糖的2组(C组和D组)与未服用氨基葡萄糖的2组(A组和B组)有效率的差异有统计学意义(P<0.05)；治疗2、6、12、24周后A组与B组有效率的差异无统计学意义(P>0.05),C组与D组有效率的差异无统计学意义(P>0.05)。组内比较,A组,B组组内治疗前、治疗2、6、12、24周后两两比较,有效率差异均有统计学意义(P<0.05)；C组,D组组内两两比较,12周与24周有效率的差异无统计学意义(P>0.05),其余时间点两两比较,有效率差异均有统计学意义(P<0.05)。②膝关节功能Lysholm评分：组间比较,治疗2周后4组间评分差异无统计学意义(P>0.05)；在治疗6、12、24周后,联合服用氨基葡萄糖的2组(C组和D组)与未服用氨基葡萄糖的2组(A组和B组)评分的差异有统计学意义(P<0.05)；治疗6、12、24周后A组与B组评分差异无统计学意义(P>0.05),C组与D组差异无统计学意义(P>0.05)。组内比较,各组内治疗前、治疗2、6、12、24周后两两比较Lysholm评分的差异均有统计学意义(P<0.05)。③4组安全性差异无统计学意义(P>0.05)。④成本效果分析,4种方案中非选择性非甾体抗炎药联合质子泵抑制剂和氨基葡萄糖的成本效果最佳。
结论：①与传统单独使用非甾体抗炎药相比,治疗膝骨性关节炎服用非甾体抗炎药联合氨基葡萄糖治疗在缓解症状,改善关节功能方面更具优势。②非甾体抗炎药联合氨基葡萄糖的远期疗效(>24周)尚不明确。③非甾体抗炎药联合氨基葡萄糖治疗膝骨性关节炎与单独使用非甾体抗炎药相比,并未增加不良事件的发生,联合用药安全性较佳。④非选择性非甾体抗炎药联合质子泵抑制剂和氨基葡萄糖的成本效果最佳。
第三部分关节镜手术联合口服药物治疗膝骨性关节炎的临床研究
目的：应用关节镜手术(广泛清理术与重点清理术)联合使用非甾体抗炎药和氨基葡萄糖治疗膝骨性关节炎患者,观察临床疗效及安全性。为临床医师选择手术及联合用药方案提供依据。
方法：60例患者均来自于兰州大学第一医院住院患者,按随机分配原则分配入膝关节镜手术广泛清理组和膝关节镜手术重点清理组,每组30例患者,术后口服非选择性非甾体抗炎药联合质子泵抑制剂和氨基葡萄糖2个月。分别于术后2、6、12、24周观察膝关节活动度,采用Lysholm评分及Judet疗效评定标准评价膝关节功能,同时进行安全性评价。采用SPSS19.0统计软件进行统计分析。
结果：①膝关节功能Lysholm评分：组间比较,术后2周时广泛清理组与重点清理组Lysholm评分的差异无统计学意义(P>0.05),其余时间点(6、12、24周)2组间Lysholm评分差异均具有统计学意义(P<0.05)。组内比较,各组组内12周与24周Lysholm评分差异无统计学意义(P>0.05),其余各时间点两两比较Lysholm评分的差异均有统计学意义(P<0.05)。②膝关节活动度评定：组间比较,术后2周时2组膝关节活动优良率的差异未见统计学意义(P>0.05),其余观察时间点(6、12、24周)膝关节活动优良率的差异均有统计学意义(P<0.05)。组内比较,各组12周与24周优良率的差异无统计学意义(P>0.05),其余各时间点两两比较优良率的差异均有统计学意义(P<0.05)。③两组手术相关并发症的差异有统计学意义(P<0.05),两组口服药物相关不良反应差异无统计学意义(P>0.05)。
结论：①结合术前评估的重点清理术在临床疗效方面优于广泛清理术。②两种手术方案的手术安全性存在差异,重点清理术较广泛清理术有较低的手术并发症。③关节镜下清理术联合非甾体抗炎药、质子泵抑制剂和氨基葡萄糖治疗膝骨性关节炎可取得满意疗效。
Part Ⅰ Meta-analysis:Comparison of cyclooxygenase-2inhibitors alone with nonselective non-steroidal anti-inflammatory drugs plus proton pump inhibitors in regard to safety in osteoarthritis
Objectives To compare cyclooxygenase-2(COX-2) inhibitors alone with nonselective nonsteroidal anti-inflammatory drugs(NSAIDs) plus proton pump inhibitors(PPIs) in preventing gastrointestinal adverse events:upper gastrointestinal(UGI) adverse events, gastrointestinal symptoms and cardiovascular adverse events in osteoarthritis.
Methods PubMed, the Cochrane library, EMBASE, Web of science, Chinese Biomedical Literature Database, National Knowledge Infrastructure, Wanfang Database, Clinical Trials Registry Platform, and reference lists of relevant papers for articles published were searched. The related data matching standards set for this study were extracted. The methodological qualities of included studies were evaluated from the random method, allocation concealment, blinding, the results data integrity, selective bias in reporting results and other factors. The heterogeneity was tested and effect size was combined. Statistical analyses were carried out using RevMan(5.0) software. Recommended grade of measuring indicators were carried out using GRADEpro.
Results The meta-analysis of six randomized controlled trials with a total of6219patients revealed that there was no difference in the UGI adverse events between COX-2inhibitors and nonselective NSAIDs with concurrent use of PPIs(OR0.61,95%confidence interval(CI)0.34-1.09). There was no significant difference in gastrointestinal symptoms(OR1.10,95%CI:0.88-1.39) and the cardiovascular adverse events(OR1.67,95%CI:0.78-3.59) between the two groups. The evaluations of GRADE system were moderate due to inconsistency.
Conclusions COX-2inhibitors are no better than nonselective NSAIDs with PPIs in regard to UGI adverse events, gastrointestinal symptoms and cardiovascular adverse events in osteoarthritis arthritis. On the basis of the current evidence and the combined wishes of the patient, clinicians should carefully consider and weigh both gastrointestinal and cardiovascular risk before selecting NSAID plus PPIs or COX-2inhibitors.
Part Ⅱ Clinical study of non-steroidal anti-inflammatory drugs combined glucosamine in patients with knee osteoarthritis
Objectives The aims of this study were to assess the efficacy, safety and economy of non-selective non-steroidal anti-inflammatory drugs(NSAIDs) plus proton pump inhibitors(PPIs) and cyclooxygenase-2(COX-2) inhibitors, and those medications in combination with glucosamine respectively in patients with knee osteoarthritis.
Methods A total of140patients with knee osteoarthritis were randomized to receive NSAIDs plus PPIs(gourp A), COX-2inhibitors(group B), NSAIDs plus PPIs in combination with glucosamine(group B) or COX-2inhibitors plus glucosamine(group D). Efficacy was assessed with the Japanese orthopaedic association(JOA) knee index and knee lysholm score at prior to treatment and at2,6,12and24weeks post-treatment. Medication-related complications and cost-effectiveness were also observed. Statistical analyses were carried out using SPSS19.0.
Results Significant differences in JOA knee index and knee lysholm score were detected between the A, B groups and the C, D groups at6,12and24weeks post-treatment (P<0.05) but not at weeks2post-treatment (P>0.05). Significant differences in these indices were not detected at2,4,6,12,24weeks between group A and group B, group C and group D. Significant differences in JOA knee index were detected at different time-points in group A and group B(P<0.05). Significant differences in JOA knee index were also detected at different time-points in group C and group D(P<0.05), except between weeks12and24(P>0.05). Significant differences in lysholm score were detected at different time-points in each group(P<0.05). Significant differences in complications were not detected between four groups(P<0.05). Cost-effectiveness analysis showed group C was the best among four groups.
Conclusions NSAIDs in combination with glucosamine is superior to NSAIDs alone in treatment of knee osteoarthritis although without clear long-term effect. NSAIDs alone are no better than NSAIDs plus glucosamine in regard to medication-related complications. The best cost-effectiveness is non-selective NSAIDs in combination with PPIs and glucosamine.
Part III Clinical study of arthroscopic debridement surgery in combination with oral medication in patients with knee osteoarthritis
Objectives The aims of this study were to assess the efficacy and safety of arthroscopic debridement in combination with oral medication for the treatment of knee osteoarthritis, and to provide evidence for selection of surgical approach with oral medication.
Methods A total of60patients with knee osteoarthritis were randomized to receive either arthroscopic extensive cleanup in combination with oral medication group or focus cleanup in combination with oral medication group. Efficacy was assessed with the angle of knee fextion, lysholm score. Surgery-and medication-related complications were observed. Statistical analyses were carried out using SPSS19.0.
Results Significant differences in flexion and lysholm scores of the knee-joint were detected between the two groups at2,6,12and24weeks post-treatment(P<0.05) but not at weeks2post-treatment(P>0.05). Significant differences in these indices were detected at different time-points in each group(P<0.05), except between weeks24and48(P>0.05). Significant differences in surgery-related complications were detected between two groups(P<0.05). Significant differences in medication-related complications were not detected between two groups(P>0.05).
Conclusions Arthroscopic focus cleanup surgery, with fewer surgical complications, in combination with oral medication is superior to arthroscopic extensive cleanup surgery in combination with oral medication in the flexion and lysholm score
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