穴位离子导入联合中药敷贴治疗膝骨性关节炎疼痛的临床疗效评价研究

发布时间：2018-02-28 12:37

本文关键词： 膝骨性关节炎中医外治法穴位离子导入中药敷贴临床疗效评价　出处：《成都中医药大学》2016年博士论文　论文类型：学位论文

【摘要】：目的通过开展多中心随机对照试验,综合评价穴位离子导入联合中药敷贴治疗膝骨性关节炎关节疼痛的临床疗效,为制定膝骨性关节炎的中医外治方案提供可靠的临床试验依据。方法采用多中心、随机、对照研究方法,将符合纳入排除标准的117例膝骨性关节炎患者随机分为试验组和对照组。试验组采用穴位中药离子导入联合中药巴布膏敷贴,对照组采用扶他林乳胶剂导入联合酮洛芬贴片敷贴,两组受试者每天接受1次治疗,连续治疗14次。以疼痛强度、疼痛频度、疼痛持续时间等疼痛相关指标为主要指标,以压痛指数、关节功能、生活质量等疾病相关指标为次要指标,依据各指标治疗前后组内比较及治疗后组间比较,综合评价中医外治方案治疗膝骨性关节炎关节疼痛的临床疗效。结果1、基线情况：两组受试者基线均衡,具有可比性(P0.05)。2、所有疼痛相关指标,试验组治疗后较治疗前均有极显著改善(P0.01)。①疼痛强度：WOMAC疼痛强度总分及“平地走路时”、“上下山”得分治疗结束时试验组低于对照组(P0.05),经治疗后各项改善值组间无显著性差异(P0.05),连续观测显示WOMAC疼痛强度总分在治疗第4-14天试验组低于对照组(P0.05)；治疗期14天的疼痛平均缓解百分数试验组高于对照组(P0.01),治疗第8-14天的疼痛缓解百分数试验组高于对照组(P0.05)；疼痛开始缓解时间组间无显著性差异(P0.05)；疼痛完全消失比率试验组高于对照组(P0.05)。②疼痛频度：在治疗7天、治疗结束时试验组低于对照组(P0.05),经治疗后改善值试验组高于对照组(P0.05)；③疼痛持续时间：治疗结束时试验组低于对照组(P0.05),经治疗后改善值组间无显著性差异(P0.05)。3、所有疾病相关指标,试验组治疗后较治疗前均有极显著改善(P0.01)。①压痛指数：在治疗3天、7天后试验组低于对照组(P0.05),经治疗后改善值组间无显著性差异(P0.05)；②关节功能：WOMAC关节功能总分在治疗7天、治疗结束时试验组低于对照组(P0.05),经治疗后改善值组间无显著性差异(P0.05)；③生活质量：AIMS2-SF总分及症状方面得分治疗后试验组高于对照组(P0.05),经治疗后AIMS2-SF总分、躯体功能、症状、工作方面改善值试验组高于对照组(P0.05)。4、随访期各指标试验组均较治疗前极显著改善(P0.01),WOMAC疼痛强度总分在12周、24周随访时试验组优于对照组(P0.05)。疼痛频度、WOMAC关节功能总分、AIMS2-SF总分在12周随访时试验组优于对照组(P0.05)。5、两组均未出现严重不良事件,组间无显著性差异(P0.05)。两组依从性均90%,组间无显著性差异(P0.05)。结论1.穴位离子导入联合中药敷贴能有效改善膝骨性关节炎患者疼痛症状、功能活动障碍及生活质量,且具有较好的远期效应,其在降低疼痛强度和疼痛频度、提高治疗期疼痛平均缓解程度、促进疼痛完全消失、改善生活质量方面优于“扶他林乳胶剂导入疗法+酮洛芬贴片剂敷贴疗法”组成的西医外治方案。2.该治疗方案安全有效,操作简便,具有较强的临床适用性。
[Abstract]:Objective to carry out multicenter randomized controlled trials, comprehensive evaluation of acupoint iontophoresis combined with traditional Chinese medicine acupoint application clinical curative effect of treatment of osteoarthritis of the knee joint pain, provide a reliable basis for clinical trials to develop knee osteoarthritis TCM external treatment program. Methods a multicenter, randomized, controlled study method, will meet the inclusion criteria 117 cases of knee osteoarthritis were randomly divided into experimental group and control group. The experimental group was treated with acupoint iontophoresis combined with traditional Chinese medicine Babu paste application, the control group using Votalin emulgel import joint Ketoprofen Patch applicator, two groups of subjects received daily treatment for 1 times, for 14 consecutive times. Pain intensity, pain frequency the duration of pain, pain and other related indicators as the main index, the pain index, joint function, disease related quality of life indicators as secondary indexes on the basis of each index before and after treatment Within the group and between two groups after treatment, the clinical curative effect of comprehensive evaluation of traditional Chinese medicine treatment of osteoarthritis of knee joint pain. Results: 1. Baseline: two groups of subjects baseline, comparable to.2 (P0.05), all the pain index, the test group after treatment than before treatment were extremely significant improvement (P0.01). The pain intensity: WOMAC pain intensity score and "flat walk", "end down" treatment scores of the experimental group than the control group (P0.05), after treatment, the improvement of value did not differ between the two groups (P0.05), continuous observation showed WOMAC score in the treatment of pain intensity 4-14 days in the experimental group than the control group (P0.05); pain treatment period of 14 days the average remission percentage of experimental group were higher than control group (P0.01), the 8-14 day of the treatment of pain relief percentage of experimental group were higher than control group (P0.05); the pain began to ease the time between the two groups Significant differences (P0.05); the ratio of pain disappeared completely in experimental group were higher than control group (P0.05). The frequency of pain: in the treatment of 7 days, at the end of treatment, the experimental group than the control group (P0.05), after treatment to improve the value of experimental group was higher than control group (P0.05); the pain duration: at the end of treatment the experimental group than the control group (P0.05), after treatment, improve the values did not differ between the two groups (.3, P0.05) of all disease related index, the test group after treatment than before treatment were significantly improved (P0.01). The pain index: in the treatment of 3 days, 7 days after the test group was lower than the control group (P0.05), after treatment improved value did not differ between the two groups (P0.05); the joint function: WOMAC joint function score in the treatment of 7 days, at the end of treatment, the experimental group than the control group (P0.05), after treatment, improve the values did not differ between the two groups (P0.05); quality of life: the total score of AIMS2-SF and symptoms The scores of the experimental group after treatment was higher than the control group (P0.05), the AIMS2-SF score after treatment, symptoms, physical function, work to improve the value of experimental group was higher than control group (P0.05.4), the test groups during the follow-up period than before treatment significantly improved (P0.01), WOMAC pain intensity score at week 12, 24 week of follow-up test group than the control group (P0.05). The frequency of pain, WOMAC joint function score, the total score of AIMS2-SF in the test group than the control group after 12 weeks (P0.05.5), the two groups were no serious adverse events, no significant difference between groups (P0.05). The two groups were 90% non compliance. Significant differences between the groups (P0.05). Conclusion 1. acupoint iontophoresis combined with traditional Chinese medicine plaster can effectively improve the patients with knee osteoarthritis pain symptoms, functional disorder and quality of life, and has better long-term effect, the reduction in pain intensity and pain frequency, improve the treatment of pain level Both the degree of ease, promote the pain completely disappeared, which improve the quality of life is better than "Votalin emulgel iontophoresis + Ketoprofen Patch agent applicator therapy of the western medicine the treatment scheme of.2. is safe and effective, simple operation, clinical has strong applicability.

【学位授予单位】：成都中医药大学
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R274.9

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