益气化瘀补肾方治疗早中期原发性膝骨关节炎临床研究

The Clinical Research into Treating Primary Osteoarthritis of the Knee During Early and Middle Stages with Decoction for Tonifying Qi and Removing Blood Stasis and Nourishing Kidney

目的:观察益气化瘀补肾方治疗膝骨关节炎的临床疗效,比较益气化瘀补肾方与美洛昔康治疗早中期膝骨关节炎的临床疗效差异。方法:128例早中期膝骨关节炎患者随机分为治疗组和对照组各69例。治疗组采用益气化瘀补肾方汤剂每日1剂分2次口服;对照组口服美洛昔康片7.5 mg,每日1次,两组均治疗6周。分别于治疗前、治疗3周、治疗6周结束后、12周和24周随访,评定西安大略麦克马斯特大学骨性关节炎指数(The Western Ontario and Mc Master University Osteoarthritis Index,WOMAC)量表、疼痛视觉模拟量表(Visual Analo g Scale for Pain,VAS)、5次坐立试验、生存质量SF-36量表及有效率。结果:两组早中期原发性膝骨关节炎治疗后WOMAC量表各项积分均下降(P<0.01),治疗组较对照组下降更明显(P<0.01);两组早中期原发性膝骨关节炎治疗后较治疗前疼痛视觉模拟量表评分均显著降低(均P<0.01),治疗组较对照组降低更明显(P<0.05);两组早中期原发性膝骨关节炎治疗后5次坐立试验所用时间较治疗前均缩短(均P<0.05),治疗组较对照组缩短更明显(P<0.05);两组治疗后生存质量评分较治疗前明显提高(均P<0.05),治疗组较对照组提高更明显(P<0.01);治疗6周后治疗组有效率为95.65%,对照组有效率为89.71%。结论:益气化瘀补肾方与美洛昔康片治疗早中期膝骨关节炎均有效,益气化瘀补肾方既可以明显的缓解患者疼痛又可以一定程度的改善膝关节活动度;益气化瘀补肾方在缓解疼痛、改善功能及恢复膝关节内部力学平衡方面疗效明显优于口服美洛昔康片。

Objective： To observe the clinical curative effect characteristics of Decoction for Tonifying Qi and Removing Blood Stasis and Nourishing Kidney,and compare clinical effects of Decoction for Tonifying Qi and Removing Blood Stasis and Nourishing Kidney and meloxicam in treating primary osteoarthritis of the knee during early and middle stages. Methods： One hundred and thirty-eight patients with knee osteoarthritis in the early and middle stages were randomly divided into the treatment group and the control group,with 69 cases in each group. The treatment group received Decoction for Tonifying Qi and Removing Blood Stasis and Nourishing Kidney for oral administration,one agent,twice a day. The ones in the control group were treated with 7. 5 mg of Meloxicam Tablets,once a day. Both the two groups were treated for 6 weeks. The follow-up was carried out before the treatment,3 weeks,6 weeks,12 weeks and 24 weeks after the treatment respectively,The Western Ontario and Mc Master University Osteoarthritis Index scale（ WOMAC）,Visual Analo g Scale for Pain,（ VAS）,5 times’ sitting-to-standing test and the quality of life scale of SF-36 and the total efficiency were estimated. Results： The WOMAC scale scores were decreased after the treatment in the two groups（ P 〈 0. 01）,the treatment group decreased more significantly than the control group（ P 〈 0. 01）. After the treatment,the two groups’ VAS scores were significantly lower（ P 〈 0. 01）,the treatment group decreased more significantly than that in the control group（ P 〈 0. 05）. Each time length for sitting-to-standing test in the 5 times was shorter than that before the treatment（ P 〈 0. 05）,the treatment group significantly shortened than the control group（ P 〈 0. 05）. The quality of life scores significantly improved compared with before treatment（ P 〈 0. 05）,and the treatment group improved more significantly than the control group（ P 〈 0. 01）. After 6 weeks’ treatment,the total effective rate of treatment group 95. 65%,while that of the control group was89. 71%. Conclusion： Both Decoction for Tonifying Qi and Removing Blood Stasis and Nourishing Kidney and meloxicam have remarkable clinical curative effects on primary osteoarthritis of the knee during early and middle stages. Decoction for Tonifying Qi and Removing Blood Stasis and Nourishing Kidney can obviously not only relieve the pain of the patient,but also improve the degree of knee joint activity to a certain extent. In terms of relieving pain,improve function and recovering knee joint internal mechanical balance,its effect is obviously better than that of meloxicam.