透明质酸钠联合膝痹通汤治疗膝关节骨性关节炎的临床研究

Efficacy observation of sodium hyaluronate combined with xibitong decoction on osteoarthritis of knee joint

目的:观察透明质酸钠联合膝痹通汤治疗膝关节骨性关节炎患者的临床疗效。方法:选取在我院骨科就诊的膝关节骨性关节炎患者120例,按照随机数字表法随机分为对照组(透明质酸钠膝关节腔注射)和观察组(透明质酸钠联合膝痹通汤),每组60例。治疗期8周,治疗前后观察指标:WOMAC评分,透明质酸(HA)、肿瘤坏死因子-α(TNF-α)、白细胞介素-1β(IL-1β)水平,关节肿胀、压痛评分,并进行临床疗效评定。结果:观察组总有效率为95.00%(95%CI=85.83%~98.93%),对照组为81.67%(95%CI=71.88%~91.46%),两组综合疗效比较(u=2.011 2,P=0.044 5),差异有显著性意义;与对照组比较,观察组可降低WOMAC评分参数(P<0.01),降低膝关节肿胀和压痛评分参数(P<0.01),升高患者关节液中HA水平参数(P<0.01),降低患者关节液中TNF-α,IL-1β水平参数(P<0.01)。结论:采用透明质酸钠联合膝痹通汤治疗膝关节骨性关节炎患者的疗效优于单纯应用透明质酸钠,其收益为OR=0.23(95%CI=0.06~0.89),NNT=8(95%CI=4.03~54.35)。

Objective： To observe the clinical effect of sodium hyaluronate combined with xibitong decoction on osteoarthritis of knee joint. Methods： 120 cases of seleced patients with osteoarthritis of knee joint treated in our hospital were divided randomly into control group（ knee articular cavity injection with sodium hyaluronate） and observation group（ sodium hyaluronate combined with xiaotong decoction）,60 cases in each group. The treatment period was 8 weeks. The following indexes of WOMAC score,the levels of hyaluronic acid（ HA）,tumor necrosis factor-α（ TNF-α） and interleukin-1β（ IL-1β）,the scores of joint swelling and tenderness were observed before and after treatment. The clinical efficacy was evaluated. Results： The total effective rate of observation group was95. 00%（ 95% CI = 85. 83%- 98. 93%）,while the total effective rate of control group was 81. 67%（ 95% CI =71. 88%- 91. 46%）. Compared the comprehensive efficacy in two groups（ u = 2. 011 2,P = 0. 044 5）,the difference was significant. Compared with control group,in observation group,the parameter of WOMAC score was decreased（ P〈0. 01）,the parameter of joint swelling and tenderness score was decreased（ P〈0. 01）,the parameter of level of HA in patients＇ synovial fluid was increased（ P〈0. 01）,the parameters of levels of TNF-α and IL-1βin patients＇ synovial fluid were decreased（ P〈0. 01）. Conclusion： The effect of sodium hyaluronate combined with xibitong decoction on osteoarthritis of knee joint is better than that of pure sodium hyaluronate,its benefit is OR =0. 23（ 95% CI = 0. 06- 0. 89） and NNT = 8（ 95% CI = 4. 03- 54. 35）.