摘要
目的以传统艾灸疗法为对照,采用电子温灸仪(DZWJY-1型)治疗膝骨关节炎,评价该仪器的临床疗效及安全性。方法将124例膝骨关节炎患者随机分为电子温灸仪组与传统艾灸组,每组62例。电子温灸仪组采用DZWJY-1型电子温灸仪治疗,传统艾灸组采用传统艾灸疗法。两组疗程均为4周,观察临床疗效及安全性,比较膝痛VAS评分、WOMAC评分(总分及分项评分)的变化情况。结果 (1)试验期间,电子温灸仪组完成试验60例,脱落2例;传统艾灸组完成试验58例,脱落3例,剔除1例。(2)FAS分析结果显示,电子温灸仪组的显效率为75.81%、有效率为91.94%,传统艾灸组的显效率为68.85%、有效率为90.16%;组间临床疗效比较,差异无显著统计学意义(P>0.05)。电子温灸仪组与传统艾灸组有效率差值的95%可信区间为-9.05~12.77,按照预设15%非劣标准,非劣效检验合格。(3)治疗前及治疗2周、治疗4周组内分别比较,两组膝痛VAS评分差异均有统计学意义,均明显下降(P<0.01)。组间治疗2周、治疗4周比较,膝痛VAS评分差异均无统计学意义(P>0.05)。(4)治疗前及治疗2周、治疗4周组内分别比较,两组WOMAC总分及疼痛评分、僵直评分、活动难度评分差异均有统计学意义,均明显下降(P<0.01)。组间治疗2周、治疗4周比较,WOMAC总分及疼痛评分、僵直评分、活动难度评分差异均无统计学意义(P>0.05)。(5)两组不良反应发生率均为0%。结论电子温灸仪(DZWJY-1型)治疗膝骨关节炎的临床疗效不劣于传统艾灸疗法,可明显缓解疼痛,改善关节功能。
Objective To evaluate efficacy and safety of DZWJY-type 1 electronic moxibustion apparatus in treating patients of knee osteoarthritis with traditional moxibustion therapy as control. Methods One hundred and twenty-four patients with knee osteoarthritis were randomly divided intoelectronic moxibustion group and traditional moxibustion group with62 cases in each group. The electronic moxibustion group was treated with DZWJY-1 electronic moxibustion apparatus,and the traditional moxibustion group with traditional moxibustion therapy.The course of treatment in both groups was 4 weeks. The clinical efficacy and safety were observed and the changes of VAS score,WOMAC score( total score and sub-score) of knee pain were compared between the two groups. Results(1)The remarkablyeffective rate was 75.81% and the effective rate was 91.94%% in the electronic moxibustion group,and the remarkably effective rate was 68.85% and the effective rate was 90. 16% in the traditional moxibustion group. There was no significant difference between the two groups( P>0.05). The 95%confidence interval of the effective rate difference between the electronic moxibustion group and the traditional moxibustion group was-9. 05-12. 77.According to the 15% non-inferiority standard,the non-inferiority test was qualified.(2)There were significant differences in VAS scores between the two groups before and after 2 weeks and 4 weeks of treatment( P<0.01). But there was no significant difference in VAS score of knee pain between the two groups after 2 weeks and 4 weeks of treatment( P>0.05).(3)There were significant differences in total WOMAC score,pain score,rigidity score and activity difficulty score between the two groups before and after treatment for 2 weeks and 4 weeks( P<0.01). There was no significant difference in total WOMAC score,pain score,rigidity score and activity difficulty score between the two groups after 2 weeks and 4 weeks of treatment( P>0.05).(4)There were no adverse reactions occurring in both groups. Conclusion The clinical effect of electronic moxibustion apparatus( DZWJY-1) in the treatment of knee osteoarthritis is not inferior to that of traditional moxibustion therapy,which can obviously relieve pain and improve joint function.
引文
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