【作者】 曹喜俊；

【导师】 李万瑶；

【作者基本信息】 广州中医药大学 ， 针灸推拿学（专业学位）， 2015， 博士

【摘要】 背景：膝骨性关节炎是指膝关节软骨出现原发性或继发性的一种退行性改变,并伴有髌骨软化和骨质增生,从而出现疼痛和功能障碍,甚至畸形的退行性疾病。研究显示,在慢性致残性疾病中,骨性关节炎仅次于心血管疾病。国外的临床流行病学研究显示,针对中老年人群,膝骨性关节炎在女性发病谱系排列第四,男性则排列第八。随着老龄化加重和肥胖率增高,患病人数不断增高。尽管膝骨性关节炎的临床治疗方法很多,但是最终目的还是缓解患者的临床症状,改善患者的关节功能,减缓和阻止病情的进一步恶化。因此,如何提高治疗膝骨性关节炎的临床疗效、减少患者的疼痛和致残率,降低相关疾病的医疗支出,就成为全世界医学研究者的关注重心。穴位直流电药物离子导入疗法不但能实现治疗的无创性,还能导入体内有治疗作用的药物成分,融合穴位、药物及其电效应于一体,直达病所。近年来,该疗法在膝骨性关节炎的临床治疗中日益受到重视,具有简便易行,疗效确切,价格低廉,不良反应少等诸多优势。目的：1.从现代医学对膝骨性关节炎的认识、中医学对膝骨性关节炎的认识以及直流电药物离子导入在膝骨性关节炎的临床研究进展三个角度进行文献回顾,为后续研究奠定理论基础。2.采用随机对照试验方法,本研究以川芎、制草乌为导入药物,观察穴位直流电离子导入疗法治疗膝骨性关节炎的临床疗效。方法：1.文献研究从现代医学角度,系统回顾膝骨性关节炎的定义、流行病学、病因学、病理学、发病机制和常见治疗。从中医学角度,系统回顾膝骨性关节炎的中医病名、病因病机,同时总结近年来中药离子导入的临床应用情况。2.川芎、制草乌离子导入液质量控制研究通过失重法测定浸泡时间对川芎、制草乌离子导入液中醇溶性浸出物含量影响,确定川芎、制草乌离子导入液最佳浸泡时间及醇溶性浸出物的最低限量；通过高效液相色谱法测定浸泡时间对川芎离子导入液中阿魏酸含量影响,确定其最佳浸泡时间及阿魏酸的最低限量；通过紫外可见分光光度法测定浸泡时间对制草乌离子导入液中总乌头碱含量影响,确定其最佳浸泡时间及总乌头碱的最低限量。3.临床研究纳入90例符合标准的膝骨性关节炎患者。随机分为三组。分别用单纯直流电离子导入(n=30)、单纯电针(n=30)、电针联合离子导入(n=30)进行治疗。观察患者治疗前后麦吉尔疼痛量表(MPQ)、Lysholm膝关节评分、膝关节周径等,比较三组的之间临床疗效差异。结果：1.基本资料三组受试者在年龄、性别、体重、麦吉尔疼痛量表(MPQ)、Lysholm膝关节评分、膝关节周径等方面均没有统计学意义,具有可比性。2.川芎、制草乌离子导入液质量控制研究川芎、制草乌离子导入液中醇溶性浸出物随浸泡时间增加,含量不断上升,但增长率不断降低,浸泡40天时,醇溶性浸出物增长率几乎不变,故两者浸泡40天即可,川芎醇溶性浸出物含量应不低于4.50%；制草乌浸出物含量应不低于1.70%。川芎离子导入液中阿魏酸随浸泡时间增加,含量不断上升,但增长率不断降低,浸泡40天时,阿魏酸增长率几乎不变,故浸泡40天即可,川芎离子导入液浸泡40天,其阿魏酸含量应不低于38.01μg/mL。制草乌离子导入液中总生物碱随浸泡时间增加,含量不断上升,但增长率不断降低,浸泡40天时,总生物碱增长率几乎不变,故浸泡40天即可,制草乌离子导入液浸泡40天,其总生物碱含量应不低于323.06μg/mL。3.治疗后PRI评分比较治疗2个疗程后,电针组PRI评分下降到8.71±2.29,与治疗前比较有统计学意义(P<0.01)；离子导入组PRI评分下降到6.15±2.10,与治疗前比较有统计学意义(P<0.01)；联合组PRI评分下降到5.32±2.18,与治疗前比较有统计学意义(P<0.01)。治疗后三组间PRI评分,方差分析显示P=-19.51,P=0.0000,有统计学意义(P<0.01)。可见,联合组在降低PRI分值方面显著优于电针组和离子导入组。4.治疗后VAS评分比较治疗2个疗程后,电针组VAS评分下降到5.11±1.29,与治疗前比较有统计学意义(p<0.01)；离子导入组VAS评分下降到5.30±1.37,与治疗前比较有统计学意义(p<0.05)；联合组VAS评分下降到4.19±1.22,与治疗前比较有统计学意义(P<0.01)。治疗后三组间VAS评分,方差分析显示F=6.30,P=0.0028,有统计学意义(P<0.01)。可见,联合组在降低VAS分值方面显著优于电针组和离子导入组。5.治疗后PPI评分比较治疗2个疗程后,电针组PPI评分下降到4.00±1.18,与治疗前比较有统计学意义(P<0.05)；离子导入组PPI评分下降到3.90±1.21,与治疗前比较有统计学意义(p<0.05)；联合组PPI评分下降到2.32±1.30m与治疗前比较有统计学意义(P<0.01)。治疗后三组间PPI评分,方差分析显示F=-18.01,P=0.0000,有统计学意义(p<0.01)。可见,联合组在降低PPl分值方面显著优于电针组和离子导入组。6.治疗后Lysholm膝关节评分比较治疗2个疗程后,电针组Lysholm膝关节评分升高到61.20±4.30,与治疗前比较有统计学意义(P<0.01)；离子导入组Lysholm膝关节评分升高到64.50±4.50,与治疗前比较有统计学意义(P<0.01)；联合组Lysholm膝关节评分升高到69.30±4.28,与治疗前比较有统计学意义(P<0.01)。治疗后三组间Lysholm膝关节评分,方差分析显示F=18.01,P=0.0000,有统计学意义(P<0.01)。可见,联合组在升高Lysholm膝关节评分方面显著优于电针组和离子导入组。7.治疗后膝关节周径比较治疗2个疗程后,电针组膝关节周径降至37.50±2.05,与治疗前比较有统计学意义(P<0.05)；离子导入组膝关节周径降至37.36±2.11,与治疗前比较有统计学意义(P<0.01)；联合组膝关节周径降至35.43±2.16,与治疗前比较有统计学意义(P<0.01)。治疗后三组间膝关节周径,方差分析显示F=9.04,P=0.0003,有统计学意义(P<0.01)。可见,联合组在降低膝关节周径方面显著优于电针组和离子导入组。8.临床疗效经过2个疗程的治疗,电针组治愈3例,显效8例,有效9例,无效10例,总有效率66.67%；离子导入组治愈4例,显效16例,有效5例,无效5例,总有效率83.33%；联合组治愈6例,显效18例,有效3例,无效3例,总有效率90.00%,采.用Ridit分析,R=0.50,卡方值=8.37,P=0.0392<0.05。这表明,联合组的临床疗效优于电针组和离子导入组。结论：1.单纯电针治疗膝骨性关节炎临床疗效肯定,能有效改善患者的疼痛、功能障碍。2.单纯穴位离子导入疗法治疗膝骨性关节炎临床疗效肯定,能有效改善患者的疼痛、功能障碍。3.电针联合离子导入治疗膝骨性关节炎的临床疗效优于单一疗效,在改善患者疼痛和功能障碍上更为显著。更多还原

【Abstract】 BackgroundKnee osteoarthritis is refers to the knee joint cartilage appears primary or secondary a degenerative changes, along with patella softening and bone hyperplasia, resulting in pain and dysfunction, and even deformed degenerative disease. Research shows that in chronic disabling disease, osteoarthritis after cardiovascular disease. Foreign clinical epidemiological studies have shown that, in view of the middle-aged and old people, KOA arrange the fourth on the spectrum of women, men are arranged on the eighth. Increased with aging and obesity, increasing number of cases. Although the clinical treatment of knee osteoarthritis, but the final purpose or relieve the clinical symptoms, improve joint function in patients with, slow down and stop further deterioration. Therefore, how to raise the clinical curative effect of treatment of KOA, reduce the patient’s pain and disability, reduce the medical expenses of related disease, becomes the focus of the world’s medical researchers.Acupoints direct current drug iontophoresis treatment not only can realize the non-invasive, can also import has a therapeutic effect in vivo drug ingredients, fusion point, drugs and electrical effects at an organic whole, to the disease. In recent years, the treatment in the clinical treatment of knee osteoarthritis is becoming more and more be taken seriously, is simple, exact curative effect, low cost, less adverse reaction, and many other advantages. This study in rhizoma ligustici wallichii, kusnezoff monkshood root, for imported drugs, observation point direct current iontophoresis treatment clinical curative effect for the treatment of knee osteoarthritis.Objective1. From the modern medicine understanding of knee osteoarthritis, traditional Chinese medicine understanding of knee osteoarthritis, and direct current drug iontophoresis on knee osteoarthritis clinical research progress of the three angles of literature review, lay a theoretical foundation for follow-up study.2. Using a randomized controlled trial law, this research in rhizoma ligustici wallichii, kusnezoff monkshood root, for imported drugs, observation point direct current iontophoresis treatment clinical curative effect for the treatment of knee osteoarthritis.Methods1. Literature researchFrom the perspective of modern medicine, systematic review of the knee osteoarthritis definition, epidemiology, etiology, pathology, pathogenesis and common treatment. From the medical point of view, a systematic review knee osteoarthritis disease, etiology and pathogenesis of TCM, and to summarize the clinical application of the Chinese medicine iontophoresis in recent years2. Lontophoresis fluid of Ligusticum chuanxiong Hort. and prepared kusnezoff monshood root quality control researchTo measure soaking time effecting on lontophoresis fluid of Ligusticum chuanxiong Hort. and prepared kusnezoff monshood root alcohol-soluble extract content by weight loss. Determine the best time to soak and the lowest limit alcohol soluble extract of lontophoresis fluid of Ligusticum chuanxiong Hort. and prepared kusnezoff monshood root. Determination the soaking time effect on the content of ferulic acid in lontophoresis fluid of Ligusticum chuanxiong Hort. by high performance liquid chromatography, and determine the best soaking time and lowest limit of ferulic acid. Determination the soaking time effect on the content of total aconitine in lontophoresis fluid of prepared kusnezoff monshood root by uv-vis spectrophotometry, and determine the best soaking time and lowest limit, of total aconitine.3. Clinical researchInto the 90 accord with standard of knee osteoarthritis patients. Using the random number table method were randomly divided into three groups. With simple direct current iontophoresis (n= 30), including pure (n= 30), iontophoresis plus cupping treatment (n= 30).Observed before and after treatment in patients with McGill pain scale (MPQ) week, Lysholm knee scores, knee joint diameter, etc., to compare between the three groups of clinical curative effects.Results1. The baseline dataThree groups of subjects in age, sex, weight, McGill pain scale (MPQ), Lysholm knee scores, knee weeks diameter etc were not statistically significant, comparable.2. Lontophoresis fluid of Ligusticum chuanxiong Hort. and prepared kusnezoff monshood root quality control researchThe content of alcohol-soluble extract in lontophoresis fluid of Ligusticum chuanxiong Hort. and prepared kusnezoff monshood root increase with the increasing of immersion time, but growth rates continue to decrease. Soak 40 days, growth rates of alcohol-soluble extract almost unchanged, so they can be soaked in 40 days, alcohol-soluble extract content of Ligusticum chuanxiong Hort. should not be less than 4.50%; Kusnezoffii extract content of prepared kusnezoff monshood root should not be less than 1.70%. Ferulic acid in lontophoresis fluid of Ligusticum chuanxiong Hort. increase with the increasing of immersion time, but growth rates continue to decrease. Soak 40 days, growth rates of ferulic acid content almost unchanged, so they can be soaked in 40 days, ferulic acid content of lontophoresis fluid of Ligusticum chuanxiong Hort. should not be less than 38.01μg/mL. total aconitine in lontophoresis fluid of Ligusticum chuanxiong Hort. increase with the increasing of immersion time, but growth rates continue to decrease. Soak 40 days, growth rates of total aconitine content almost unchanged, so they can be soaked in 40 days, total aconitine content of lontophoresis fluid of prepared kusnezoff monshood root should not be less than 323.06μg/mL.3. The PRI score comparison after treatmentPRI score after treatment 2 period of treatment, the curative group dropped to 8.71+/-2.29, compared with before treatment was statistically significant (P< 0.01);Iontophoresis group PRI score dropped to 6.15+/-2.10, compared with before treatment was statistically significant (P< 0.01);Joint group of PRI score dropped to 5.32+/-2.18, compared with before treatment was statistically significant (P< 0.01). PRI score between the three groups after treatment, the variance analysis showed that F= 19.51, P= 0.0000, with statistical significance (P< 0.01).Visible, the joint group in lower PRI score significantly superior to electric acupuncture group and iontophoresis group.4. The VAS score comparison after treatmentVAS score after treatment 2 period of treatment, the curative group dropped to 5.11+/-1.29, compared with before treatment was statistically significant (P< 0.01);Iontophoresis group of VAS score dropped to 5.30+/-1.37, compared with before treatment was statistically significant (P< 0.05);Joint group of VAS score dropped to 4.19+/-1.22, compared with before treatment was statistically significant (P< 0.01). VAS score between the three groups after treatment, the variance analysis showed that F= 6.30, P= 0.0028, with statistical significance (P< 0.01).Visible, the joint group in lower VAS score significantly superior to electric acupuncture group and iontophoresis group.5. The PPI scores after treatmentAfter treatment 2 period of treatment, the curative group of PPI scores dropped to 4.00+/-1.18, compared with before treatment was statistically significant (P< 0.05);Iontophoresis group of PPI scores dropped to 3.90+/-1.21, compared with before treatment was statistically significant (P< 0.05);Joint group of PPI scores dropped to 2.32+/-1.30, compared with before treatment was statistically significant (P< 0.01). PPI scores between the three groups after treatment, the variance analysis showed that F= 18.01, P= 0.0000, with statistical significance (P< 0.01).Visible, the joint group in reducing PPI scores significantly superior to electric acupuncture group and iontophoresis group.6. Lysholm knee score comparison after treatmentAfter treatment 2 period of treatment, the curative group Lysholm knee score increased to 61.20+/-4.30, compared with before treatment was statistically significant (P< 0.01);Iontophoresis group Lysholm knee score increased to 64.50+/-4.50, compared with before treatment was statistically significant (P< 0.01);The Lysholm knee joint group score increased to 69.30+/-4.28, compared with before treatment was statistically significant (P< 0.01). Lysholm knee score between the three groups after treatment, the variance analysis showed that F= 18.01, P= 0.0000, with statistical significance (P< 0.01). Visible, higher Lysholm knee joint group scores significantly superior to electric acupuncture group and iontophoresis group.7. Knee weeks diameter compared after treatmentWeek of knee joint after treatment 2 period of treatment, the curative group diameter down to 37.50+/-2.05, compared with before treatment was statistically significant (P< 0.05);Iontophoresis group week of knee joint diameter down to 37.36+/-2.11, compared with before treatment was statistically significant (P< 0.01);Week of knee joint group diameter down to 35.43+/-2.16, compared with before treatment was statistically significant (P< 0.01).Week of knee joint diameter, between the three groups after treatment of variance analysis showed that F= 9.04, P= 0.0003, with statistical significance (P< 0.01). Visible, the joint group in reducing diameter is significantly superior to the knee joint weeks electric acupuncture group and iontophoresis group.8. Clincal effectAfter 2 courses of treatment, the curative group cured in 3 patients, 8 cases were markedly effective, effective 9 cases,10 had no effect, the total effective rate was 66.67%;Iontophoresis group of 4 cases were cured, 16 cases were markedly effective, effective in 5 cases, invalid in 5 cases, total effective rate was 83.33%;Joint group of 6 cases cured,18 cases were markedly effective, effective in 3 cases,3 had no effect, the total effective rate 90.00%, the Ridit analysis, R= 0.50, chi-square value= 8.37, P< 0.0392= 0.05. This suggests that the clinical curative effect of joint group is better than that of electric acupuncture group and iontophoresis group.Conclusion1. Pure electric acupuncture treatment of knee osteoarthritis clinical curative effect, can effectively improve the patient’s pain and dysfunction.2. Simple acupoint iontophoresis therapy for knee osteoarthritis clinical curative effect, can effectively improve the patient’s pain and dysfunction.3. Electric acupuncture joint acupoint iontophoresis treatment of knee osteoarthritis clinical efficacy is better than that of single treatment, in improving patients’ pain and dysfunction.更多还原