仙灵骨葆胶囊联合透明质酸钠对膝骨关节炎患者关节功能、炎症因子及生活质量的影响

Effect of Xianlinggubao Capsule Combined With Sodium Hyaluronate on Joint Function, Inflammatory Factors and Quality of Life in Patients With Knee Osteoarthritis

目的:观察仙灵骨葆胶囊联合透明质酸钠对膝骨关节炎(KOA)患者关节功能、炎症因子及生活质量的影响,为临床用药提供依据。方法:选取我院骨科于2014年12月-2016年12月间收治的72例KOA患者作为研究对象。采用随机数字表法将患者分为透明质酸钠组(采用透明质酸钠治疗,n=36)和联合组(采用仙灵骨葆胶囊与透明质酸钠联合治疗,n=36)。检测并比较两组患者治疗前及治疗1个月后的超敏C反应蛋白(hs-CRP)水平、肿瘤坏死因子-α(TNF-α)水平。分别于治疗前、治疗1个月后以及治疗6个月后采用生活质量调查表(SF-36)中文版评价患者生活质量,同时采用视觉模拟评估法(VAS)以及膝关节功能评定量表(Lysholm)对膝关节功能进行综合评定。治疗结束后随访半年,观察患者不良反应发生情况。结果:治疗1个月后,两组患者hs-CRP、TNF-α水平均明显下降,且联合组患者hs-CRP、TNF-α水平明显低于透明质酸钠组患者(P<0.05)。两组治疗6个月后的VAS评分明显低于治疗1个月后的VAS评分,Lysholm评分均明显高于治疗1个月后的Lysholm评分(P<0.05)。治疗1个月后和治疗6个月后,联合组患者VAS评分均明显低于透明质酸钠组患者同期VAS评分,而Lysholm评分均明显高于透明质酸钠组患者同期Lysholm评分(P<0.05)。两组治疗6个月后SF-36量表各维度评分均高于治疗1个月后的评分(P<0.05)。联合组患者治疗1个月后及治疗6个月后的躯体功能、躯体角色功能、躯体疼痛、总体健康、社会功能和心理健康评分均明显高于透明质酸钠组(均P<0.05)。两组均无严重不良反应发生,且不良反应发生情况无明显差异(P>0.05)。结论:仙灵骨葆胶囊联合透明质酸钠治疗膝骨关节炎对患者炎症反应、关节功能及生活质量有持续的改善作用,同时安全可靠,值得推广应用。

Objective： To observe the effect of Xianlinggubao capsule combined with sodium hyaluronate on joint function,inflammatory factors and quality of life in patients with knee osteoarthritis（KOA）,so as to provide the basis for clinical medication.Methods： 72 cases of patients with KOA treated in the department of orthopaedics in our hospital during December 2014 and December2016 were selected as subjects. According to the random number table method, the patients were divided into sodium hyaluronate group（treated with sodium hyaluronate, n=36） and combination group（Xianlinggubao capsule combined with sodium hyaluronate treatment,n=36）. The levels of hypersensitivity C reactive protein（hs-CRP） and tumor necrosis factor-α（TNF-α） were measured and compared between the two groups before treatment and 1 month after treatment. Before treatment, 1 month and 6 months after treatment, the quality of life was evaluated by the Chinese version of the quality of life questionnaire（SF-36）, and the knee function was assessed by means of visual analogue assessment（VAS） and knee function rating scale（Lysholm）. The patients were followed up for half a year after treatment, and the adverse reactions were observed. Results： After 1 months of treatment, the levels of hs-CRP and TNF-α in the two groups were obviously decreased, and the levels of hs-CRP and TNF-α in the combined group were significantly lower than those in the sodium hyaluronate group（P〈0.05）. The VAS scores of the two groups after treatment for 6 months were significantly lower than the VAS scores after 1 months treatment, and the Lysholm scores were significantly higher than the Lysholm scores after 1 months treatment（P〈0.05）. After 1 months of treatment and 6 months after treatment, the VAS scores of the combination group were significantly lower than those of the sodium hyaluronate group in the same period, and Lysholm score were significantly higher than those of the sodium hyaluronate group in the same period（P〈0.05）. The scores of each dimension of SF-36 scale 6 monts after treatment were higher than 1 month after treatment in the two groups（P〈0.05）. The scores of body function, physical role, physical pain,general health, social function and mental health of the patients in the combination group were significantly higher than those in the sodium hyaluronate group 1 month and 6 months after treatment（P〈0.05）. There were no serious adverse reactions in the two groups, and there was no significant difference in the incidence of adverse reactions between the two groups（P〈0.05）. Conclusion： Xianlinggubao capsule combined with sodium hyaluronate in the treatment of knee osteoarthritis has a continuous improvement effect on inflammatory reaction, joint function and quality of life, and it is safe and reliable. It is worthy of popularization and application.