刘世敏1 施茵1,2 王春艳1 薛世勇1 李涛1
（1 上海中医药大学 上海032；上海市针灸经络研究所 上海200030）
摘要：目的： 通过临床随机对照试验，客观观察不同产地（湖北省蕲春县和河南省南阳市）的艾条灸治对中重度膝骨关节炎的 WOMAC OA、VAS 和 SF-36 生活量表的影响，以评价不同产地艾条的治疗效果和近期疗效。方法：本试验采用临床随机对照试验方法，在上海市针灸经络研究所门诊部招募符合纳入标准的原发性中重度膝骨关节炎患者 60 例，并随机分配至蕲春艾灸组（以下简称蕲春组）和南阳艾灸组（以下简称南阳组），每组各 30 例。患者治疗前签署知情同意书，并按规定进行药物洗脱三天后开始治疗。蕲春组采用产自湖北省蕲春县 3年陈艾叶，南阳组采用产自河南省南阳市 3 年陈艾叶，以相同方式按叶绒比 10:1 加工成直径为 1.75cm，长为 20cm 的艾条。两组均取犊鼻穴、内膝眼穴和鹤顶穴进行灸治，每次治疗 20 分钟，每周 3 次，治疗 2 周，共 6 次。收集基线（第 0 周，W0）、治疗结束时（第 2 周，W2）和随访两周（第 4 周，W4）的评价信息，以观察疗效。本试验采用 WOMAC 骨关节炎量表、视觉模拟评分（VAS）量表和 SF-36 简明生活质量量表来评价两组的疗效差异以及近期临床疗效。临床试验结束后对所有临床资料汇总上传，将数据类信息建里数据库，使用 SPSS23.0 进行统计学分析。客观评价两组治疗前后总疗效和比较两组间总疗效差异，总结临床疗效和安全性。疗效评定：临床控制：治疗后 WOMAC 骨关节炎评分比治疗前减少≥80%。显效：评分减少≥50%，但＜80%。有效：评分减少≥25%，但＜50%。无效：评分减少＜25%。结果：1. 基线研究：蕲春组和南阳组在性别、年龄、发病部位、病程、WOMAC 疼痛项目、VAS 量表、SF-36 的生理机能(PF)和躯体疼痛(BP)评分比较均无显着差异( P >0.05)。 2. 蕲春组疼痛项目横向比较：在治疗结束时，蕲春组的 WOMAC 疼痛项目、VAS 量表、SF-36 的 PF 和 BP 较基线相比具有明显差异 ( P <0.01) 。随访两周时，WOMAC 疼痛项目、VAS 量表较基线相比具有明显差异 ( P <0.01) ，SF-36 的 PF 和 BP 较基线比较差异具有统计学意义( P <0.05)。3. 南阳组疼痛项目横向比较：在治疗结束时，南阳组的 WOMAC 疼痛项目、VAS 量表、SF-36 的 PF 和 BP 较基线相比具有明显差异 ( P <0.01) 。随访两周时，WOMAC 疼痛项目、VAS 量表较基线相比具有明显差异 ( P <0.01) ，SF-36 的 PF 和 BP 较基线比较差异具有统计学意义( P <0.05)。4. 试验干预：两组间纵向比较，蕲春组和南阳组在治疗结束时的 WOMAC 疼痛项目、VAS 量表、SF-36 的 PF 评分降低幅度差异没有统计学意义 ( P >0.05) ，SF-36的 BP 维度评分有统计学差异( P <0.05)。在随访两周时，蕲春组和南阳组的 WOMAC 疼痛项目、VAS 量表评分差异没有统计学意( P >0.05)。结论：1. 艾灸治疗中重度膝骨关节炎能显着改善患者疼痛、僵硬的症状，提高活动功能和生活质量，有确切的临床疗效。2. 不同产地（湖北蕲春县和河南南阳市）的艾条灸治中重度膝骨关节炎的疗效无显着性统计学差异，对于近期疗效差异需进一步研究。
关键词：不同产地；艾灸；中重度膝骨关节炎；临床疗效
Comparative Study on the Clinical Therapeutic Effect of Moxibustion from Different Origins in the Treatment of Moderate to Severe Knee Osteoarthritis
Shimin Liu1 Yin Shi1,2 Chunyan Wang1 Shiyong Xue1 Tao Li1
(1 Shanghai University of Traditional Chinese Medicine, Shanghai, 03; 2 Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai, 200030)
Abstract Objectives: Based on the clinical randomized controlled trial, treating moderate to severe knee osteoarthritis by using mugwort stick from different place of origin (Qichun county, Hubei province VS Nanyang city, Henan province). Evaluating the clinical efficacy by WOMAC OA, VAS and SF-36 to reveal the therapeutic effect and short-term effects of different origin mugwort used.Methods: 60 patients with moderate to severe KOA were randomly assigned to 2 groups, which are consisted of Qichun moxibustion group (here in after referred to as Qichun group) and Nanyang moxibustion group (hereinafter referred to as the Nanyang group), with each group 30 cases. All patients informed consent before treatment, and according to the criteria, the treatment starts three days after the discontinuation of all kind of medication related to KOA. Qichun group uses the 3-year-old mugwort from Qi-Chun County, Hubei Province group as the Nanyang group also uses the 3-year-old mugwort from Nanyang city, Henan Province. The 10:1 mugwort processed into a diameter of 1.75cm, 20cm long Moxa. Du Bi (ST-35), Nei Xi Yan (EX-LE4), He Ding (EX-LE2) were selected, moxibustion applied to each acupoints for 20 minutes, three times a week, two weeks in a total of six treatments. Observation of the effect was taken at the time of recruitment (0 weeks, W0), by the end of treatment (2 weeks, W2) and a follow-up for two weeks (4 weeks, W4). This study uses WOMAC OA scales, visual analog scale (VAS) scale and the SF-36 quality-of-life scale to evaluate the effect of the two group differences and the recent efficacy. A database was created after the trial ended, statistical analysis by the SPSS v.23.0. Assessment: Cure: WOMAC OA score lowered than 80% before treatment. Significantly effective: score lowered between 50% and 80%. Slightly effective: score lowered between 25% and 50%. Ineffective: score lowered <25%.Results: 1. Baseline studies: Gender, age, lesion site, duration, WOMAC pain subjects, VAS scale, the physiological functions (PF) and body pain (BP) score of SP-36 showed no significant difference (P >0.05) in both groups. 2. Qichun pain subjects comparison: At the end of the treatment, WOMAC pain subjects, VAS scale, SF-36 PF and BP scores have significant difference compared to the baseline (P <0.01). In two weeks of follow-up, WOMAC pain subjects, VAS scale have significant difference compared to the baseline (P <0.01), SF-36 PF and BP scores have significant difference compared to the baseline (P <0.05). 3. Nanyang group pain subjects comparison: At the end of treatment, WOMAC pain subjects, VAS scale, SF-36 PF and BP scores have significant difference compared to the baseline (P <0.01). In two weeks of follow-up, WOMAC pain subjects, VAS scale has significant difference compared to the baseline (P <0.01), SF-36 PF and BP scores has significant difference compared with baseline(P <0.05). 4. Trial interventions: vertical comparison: the decreasing of scores in WOMAC pain subjects, VAS scale, SF-36 PF of both groups showed no significant differences (P >0.05). The increasing scores in SF-36 BP showed significant difference (P <0.05). In two weeks of follow-up, the decreasing of scores in WOMAC pain subjects, VAS scale of both groups showed no significant differences (P >0.05).
Conclusion: 1. Moxibustion treatment for moderate to severe osteoarthritis of the knee can significantly relieve patients’ pain, stiffness and improve knee functions and quality of life. 2. There is no significant difference of treating effect between using mugwort from two different origins in the treatment. The difference of the short-term treatment needs further studies.
Key words: Different origins; Moxibustion; Moderate to severe osteoarthritis of the knee; Therapeutic effect
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