【摘要】 目的 探讨消肿止痛散外敷联合依托考昔口服治疗膝骨性关节炎(KOA)的疗效及对患者血清炎症介质和骨代谢分子水平的影响,以期为优化KOA患者的治疗策略提供参考。方法 选取江苏省海安市中医院2021年3月—2024年3月收治的148例KOA患者,采用随机信封法分为单药组(n=74)与联合组(n=74)。单药组患者给予依托考昔口服治疗,联合组患者给予消肿止痛散外敷联合依托考昔口服治疗,均治疗4周。比较2组患者的临床疗效、膝关节疼痛程度、血清炎症介质水平、骨代谢分子水平及不良反应发生情况等指标。结果 联合组患者的治疗总有效率为93.24%(69/74),高于单药组的81.08%(60/74),差异有统计学意义(χ~2=4.891,P=0.027)。治疗前,2组患者膝关节视觉模拟评分法(VAS)评分比较,差异无统计学意义(P>0.05);治疗后,2组患者膝关节VAS评分均低于治疗前,且联合组低于单药组,差异均有统计学意义(P<0.05)。治疗前,2组患者血清肿瘤坏死因子-α(TNF-α)、C反应蛋白(CRP)、白介素-6(IL-6)及基质金属蛋白酶-3(MMP-3)水平比较,差异均无统计学意义(P>0.05);治疗后,2组患者血清TNF-α、CRP、IL-6、MMP-3水平均低于治疗前,且联合组均低于单药组,差异均有统计学意义(P<0.05)。治疗前,2组患者血清骨钙素(OC)、骨碱性磷酸酶(BALP)及总I型胶原氨基端延长肽(PINP)水平比较,差异均无统计学意义(P>0.05);治疗后,2组患者血清OC、BALP、PINP水平均高于治疗前,且联合组均高于单药组,差异均有统计学意义(P<0.05)。单药组与联合组患者不良反应发生率分别为9.46%(7/74)和14.86%(11/74),差异无统计学意义(χ~2=1.012,P=0.314)。结论 消肿止痛散外敷联合依托考昔口服应用于KOA患者治疗中,有助于提高治疗总有效率,缓解患者膝关节疼痛程度,改善患者血清炎症介质和骨代谢分子水平,且未增加不良反应发生风险,值得在临床推广。更多还原

【Abstract】 Objective To investigate the clinical efficacy of external application of Xiaozhong Zhitong San combined with oral etoricoxib in treating knee osteoarthritis(KOA) and its effects on patients serum inflammatory mediators and bone metabolic molecule levels,so as to provide a reference for optimizing KOA treatment strategies.Methods From March 2021 to March 2024,148 KOA patients admitted to Haian Traditional Chinese Medicine Hospital were enrolled and randomized by sealed-envelope method into a monotherapy group(n=74) and a combination group(n=74).The monotherapy group received oral etoricoxib,while the combination group received external application of Xiaozhong Zhitong San plus oral etoricoxib;both regimens were given for 4 weeks.Clinical efficacy,knee pain,serum inflammatory mediators,bone metabolic molecule levels,and adverse events were compared between the two groups.Results The overall response rate in the combination group was significantly higher than that in the monotherapy group(93.24% [69/74] vs.81.08% [60/74];χ~2=4.891,P=0.027).Baseline knee pain assessed by the visual analogue,scale(VAS) did not differ significantly between groups(P>0.05);after treatment,VAS scores in both groups decreased from baseline,and the combination group’s scores were lower than those of the monotherapy group,with statistically significant differences(P<0.05).Baseline serum levels of tumor necrosis factor-a(TNF-α),C-reactive protein(CRP),interleukin-6(IL-6),and matrix metalloproteinase-3(MMP-3) did not differ significantly between groups(P>0.05);after treatment,these inflammatory markers decreased in both groups and were lower in the combination group than in the monotherapy group,with statistically significant differences(P<0.05).Baseline serum osteocalcin(OC),bone-specific alkaline phosphatase(BALP) and total procollagen type I N-terminal propeptide(PINP) levels were similar between groups(P>0.05);after treatment,OC,BALP and PINP increased in both groups and were higher in the combination group than in the monotherapy group,with statistically significant differences(P<0.05).Adverse event rates were 9.46 %(7/74) in the monotherapy group and 14.86 %(11/74) in the combination group,with no statistically significant difference(χ~2=1.012,P=0.314).Conclusion External application of Xiaozhong Zhitong San combined with oral etoricoxib in KOA patients promotes overall clinical efficacy,relieves knee pain,favorably modulates serum inflammatory mediators and bone metabolic molecule levels,and does not increase the risk of adverse events,justifying its wider clinical application.更多还原