摘要
本研究采用内服独活寄生颗粒配合耳穴贴压的治疗方法与天然保健品相比较,通过对60例患者,进行为期4周的治疗,观察静息痛评分、平地走痛评分、膝关节功能评分、中医证候评分,探讨独活寄生颗粒配合耳穴贴压治疗膝骨性关节炎的有效性和安全性,为治疗膝骨性关节炎提供新的方法。方法
(1)观察对象：共60例,为加拿大霖达诊所2009年12月-2010年9月的门诊病人,均按照1986年美国风湿病协会推荐的膝骨性关节炎诊断标准及按照中华人民共和国卫生部制定发布的《中药新药临床研究指导原则》(1997年第3辑),肝肾亏虚型诊断标准,来确定入选观察对象,男18例,女42例。
(2)病例分组：采用简单随机原则将60例病人分为中医组30例；天然保健品组30例。
(3)治疗方法：中医组采用独活寄生颗粒配合耳穴贴压治疗；天然保健品组采用非水解胶原蛋白Ⅱ治疗。疗程4周。
(4)检测指标：检测关节静息痛评分、平地行走痛评分、中医证候评分、膝关节功能评分(Lysholm评分表)。
(5)数据处理：数据采用SPSS18.0进行统计学分析。
(1)中医证候：两组患者治疗后2周的中医证候评分差异有统计学意义(P<0.05)。分组对于患者治疗后2周的中医证候评分有交互作用(P<0.05)。校正后两组各时点中医证候评分差异均有统计学意义(P<0.05)。
(2)膝关节功能评分：校正后两组治疗前后各时点比较差异均有统计学意义(P<0.05)。
(3)静息痛评分：校正后两组治疗前后各时点的静息痛评分差异有统计学意义(P<0.05)。
(4)平地走痛评分：两组患者治疗前后各个观察时点的平地走疼评分差异有统计学意义(P<0.05)；校正后两组各时点平地走痛评分差异有统计学意义(P<0.05)。
(5)中医证候疗效评价：两组患者治疗后2周和治疗后4周的中医证候疗效评价差异均有统计学意义(P<0.05)；中医组患者治疗后2周中医证候总有效率23.33%,治疗后4周的总有效率为70.00%；天然保健品组患者治疗后2周中医证候总有效率3.33%,治疗后4周中医证候总有效率40.00%。
中医疗法较天然保健品能够有效的改善中医证候评分,膝关节功能评分,静息痛评分,但是对平地走痛评分的改善没有天然保健品组的疗效好。中医疗法的总体疗效优于天然保健品。
To compare the symptom severity, pain rating and complications in patients with knee osteoarthritis and a concurrent liver kidney deficiency receiving Traditional Chinese medicine Du huo Ji Sheng Granule and auricular therapy with those receiving treatment with natural supplements (unhydrolyzed typeⅡcollagen, glucosamine, chondroitin, and hyaluronic acid) therapy.
Sixty patients with knee osteoarthritis were enrolled in a randomized trial to compare the effectiveness of TCM versus natural supplements therapy. All patients in the study also meet criteria for the diagnosis of liver kidney deficiency, as per the guidelines of the Ministry of Health of the People's Republic of China. Thirty patients were included in the traditional Chinese medicine group and received Du Huo Ji Sheng Granule along with auricular seed therapy. Thirty patients were randomized to the other treatment group and were treated with unhydrolyzed typeⅡcollagen. Pain ratings of the affected joint were assessed using the visual analogue scale (VAS) and function of the joint was assessed using the Lysholm Knee rating scale. Patient quality of life was determined using the Traditional Chinese Medicine (TCM) symptom score. Data was collected at the first visit and at 2 and 4 weeks after initiation of treatment. Data processing:Statistical analysis was done using SPSS18.0
1. TCM symptom complex score:there was a statistically significant difference in both treatment groups from baseline to 2 weeks (p<0.05). Grouping all the observed patients, the scores before and after had interaction (p>0.05). After correction(Greenhouse-Geisser), both treatment groups from baseline to four weeks had a statistically significant difference (p<0.05).
2. Lysholm knee function score:After correction(Greenhouse-Geisser), there was a statistically significant improvement before and after treatment in both groups.
3. Resting pain score:Both groups of patients rated their resting knee pain as having decreased after treatment-this was shown to be statistically significant (p<0.05).
4. Flat ground walking pain score:there was a statistically significant decrease in pain scores after two weeks of treatment in both groups when compared with baseline (p<0.05). After correction, there was a statistically significant difference in scores for both groups from baseline to four weeks (p<0.05)
5. Evaluation of TCM syndromes progress:there was a statistically significant difference in both groups after two and four weeks of treatment (p<0.05). There was a decrease of 23.33% in the TCM symptom complex score after 2 weeks, and a 70.00% decrease after 4 weeks of treatment with TCM. In contrast, for the natural supplement group, the total effectiveness of treatment was a decrease in the TCM symptom complex score after 2 weeks of 3.33%, and 40% after 4 weeks.
TCM does effectively decrease pain symptoms in patients who have knee osteoarthritis during a four-week period. A combination of Du Huo Ji Sheng Tang and auricular seed therapy improves the TCM complex score, the knee pain at rest and knee joint function. However, TCM does not improve knee pain as much as natural supplement group during flat ground walking. Although natural supplement was also shown to improve the pain associated with knee osteoarthritis at rest and with activity, the data indicates that TCM offers the advantage of alleviating knee pain over natural supplement therapy. Especially, for the evaluation of TCM complex score, the TCM group had a significant advantage over the unhydrolyzed typeⅡcollagen.
引文
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