鸡胚地龙贴膏联合双醋瑞因治疗早中期膝骨关节炎的临床观察

Clinical observation of Jipei dilong ointment combined with diacerein in the treatment of knee osteoarthritis in the early and mid-term stage

目的探讨鸡胚地龙贴膏联合双醋瑞因治疗早中期膝骨关节炎(KOA)的临床疗效及安全性。方法将100例KOA患者按随机数字表法分为对照组和试验组,每组50例。对照组患者口服双醋瑞因胶囊,每次50 mg,每日2次;试验组患者在对照组治疗基础上给予鸡胚地龙贴膏外贴,每日1次。两组疗程均为4周,疗程结束后3个月随访。观察两组患者的临床疗效,治疗前后及疗程结束后3个月随访时的视觉模拟评分法(VAS)评分、西安大略和麦克马斯特大学骨关节炎指数量表(WOMAC)评分、Lysholm膝关节功能评分,检测膝关节液中肿瘤坏死因子α(TNF-α)、白细胞介素1β(IL-1β)、IL-6、超氧化物歧化酶(SOD)、丙二醛(MDA)、一氧化氮(NO)、软骨寡聚基质蛋白(COMP)、基质金属蛋白酶13(MMP-13)和Ⅱ型胶原C端肽(CTX-Ⅱ)的水平,并记录不良反应发生情况。结果治疗4周后,试验组患者的总有效率为96.0%,对照组为90.0%,两组比较差异无统计学意义(P>0.05);疗程结束后3个月随访时,试验组患者的总有效率(94.0%)显著高于对照组(62.0%)(P<0.05)。治疗4周后和疗程结束后3个月随访时,两组患者的VAS评分、WOMAC评分和膝关节液中TNF-α、IL-1β、IL-6、MDA、NO、COMP、MMP-13、CTX-Ⅱ水平均显著低于治疗前,Lysholm评分和膝关节液中SOD活性均显著高于治疗前,且同一时期试验组指标均显著优于对照组(P<0.05)。两组患者不良反应发生率比较差异无统计学意义(P>0.05)。结论鸡胚地龙贴膏联合双醋瑞因治疗早中期KOA,可通过抑制炎症反应、减少氧化应激反应、抑制软骨细胞及基质降解来减轻患者疼痛症状,改善患者膝关节功能,且不良反应发生率较低。

OBJECTIVE To investigate clinical efficacy and safety of Jipei dilong ointment combined with diacerein in the treatment of knee osteoarthritis(KOA)in the early and mid-term stage.METHODS Totally 100 KOA patients were randomly divided into control group and trial group,with 50 cases in each group.Control group received Diacerein capsules orally,50 mg every time,bid.Trial group additionally received Jipei dilong ointment,once a day,on the basis of control group.Both groups had a treatment course of 4 weeks,and were followed up for 3 months after treatment.The clinical efficacy of 2 groups,visual analogue scale(VAS),Western Ontario and McMaster University osteoarthritis index(WOMAC)score,Lysholm scores before and after treatment,at 3-month follow-up after treatment were all observed;the levels of tumor necrosis factor-α(TNF-α),interleukin 1β(IL-1β),IL-6,superoxide dismutase(SOD),malondialdehyde(MDA),nitric oxide(NO),cartilage oligomeric matrix protein(COMP),matrix metalloproteinase-13(MMP-13)and C-telopeptide of typeⅡcollagen(CTX-Ⅱ)were detected in knee joint fluid.The incidence of adverse drug reactions was recorded.RESULTS After 4 weeks of treatment,total effective rate was 96.0%in trial group and 90.0%in control group,without statistical significance between 2 groups(P>0.05).At 3-month follow-up after treatment,total effective rate of trial group was 94.0%,and was higher than 62.0%of control group(P<0.05).After 4 weeks of treatment and at 3-month followup after treatment,VAS score,WOMAC score,the contents of TNF-α,IL-1β,IL-6,MDA,NO,COMP,MMP-13 and CTX-Ⅱin knee joint fluid of two groups were significantly lower than before;Lysholm score and SOD activity of knee joint fluid were significantly higher than before,and the trial group was significantly better than the control group during the same period(P<0.05).And there was no statistical significance in the incidence of adverse drug reactions between two groups(P>0.05).CONCLUSION For the treatment of KOA in early and midterm stage,Jipei dilong ointment combined with diacerein relieve pain,improve knee function by inhibiting inflammatory reaction,reducing oxidative stress and inhibiting chondrocyte and matrix degradation,and have low incidence of adverse drug reactions.