不同时间间隔对膝骨性关节炎针刺效应研究
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摘要
膝骨性关节炎(Knee of Osteoarthritis, KOA)又称退行性膝骨关节炎是一种多发于中老年人的慢性退行性病变,其多分布中医的“膝痛”、“痰证”、“痿”、“痹”、“历节”等。自古到今,膝骨性关节炎对患者带来一定的生活不便、痛苦及经济负担,而采用中医治疗手段疗效较好,尤其是针灸,对于膝骨性关节炎不良反应小,起效明显,是广大患者最乐意接受的疗法。针灸治疗的疗效受多种因素的影响,如患者病情严重程度、取穴位置、治疗间隔、针灸疗程等都会影响疗效。国内大量研究从各种方面对针灸治疗膝骨性关节炎的疗效进行了研究,并得到了有价值的结论,但有关针灸间隔时间对治疗效果的影响的研究并不多见,大部分针刺治疗膝骨性关节炎研究为每天1次、隔天1次或隔2天1次。所以如能找到最好的时间间隔去治疗膝骨性关节炎,为使针灸治疗膝骨性关节炎发挥最大效率。
     目的:
     本研究通过对不同针刺间隔时间下膝骨性关节炎的临床疗效的比较,以探寻针刺治疗膝骨性关节炎的最佳间隔时间,为临床膝骨性关节炎提供一定的参考资料和临床试验依据,以形成更好的临床方案,进一步方便患者并且提高疗效。以便在此基础上,逐渐形成统一的标准化治疗方案。
     方法:
     本研究参照中华医学会骨科学分会2007年修订并发表于《中华骨科杂志》的《骨关节炎诊治指南(2007年版)》中膝骨关节炎的诊断标准,在香港私人诊所就诊的患者进行病例收集,采用前瞻性队列研究的方法,将患者分别纳入隔天治疗1次组和隔2天1次组,实际共纳入60例,隔天治疗1次组30例,隔2天治疗1次组30例,均针双侧主穴用血海、梁丘、内外膝眼穴,配穴以行痹:风池、隔俞穴;痛痹:肾俞、关元穴;着痹:阴陵泉、足三里穴;热痹:大椎、风池穴。每次取主穴4个、配穴2个使用,治疗时穴位常规消毒后,取1.5寸毫针进行治疗,得气后用泻法行针1分钟,留针30分钟,同时使用TDP,3周为1个疗程,共治疗2个疗程。治疗结结束后,观察其总有效率及Lequesne MG、JOA、WOMAC index of OA量表、MPQ及膝关节功能量表,两组治疗前、治疗3周和治疗6周后症状评分,并计算有效率,计量资料用均数士标准差(x±s)表示,计数资料用构成比(%)表示,两个样本均数比较用t检验或Wilcoxon秩和检验,自身前后比较是用配对t检验或Wilcoxon配对秩和检验使用统计软件SPSS17.00进行完成统计结果。
     结果:
     (1)本研究60例合格受试者均完成临床试验,无脱落、剔除病例。其中,男性8例,女性52例;年龄41岁-69岁;病程最短1个月,最长72个月。其中隔天1次组30例(男性5例,女性25例),平均年龄为61.40±1.338岁,隔2天1次组30例(男性3例,女性27例),平均年龄为59.97±1.291岁,治疗前两组患者的性别、年龄、病程、LequesneMG计分、WOMAC Index of OA积分、MPG, JOA以及关节活动疼痛、关节僵硬情况、关节压痛、关节肿胀、关节活动度、遇寒加重、腰膝酸软、屈伸不利、怕冷、夜尿等主要临床症状比较差异均无显着性意义,提示影响两组预后的主要因素具有一定的均衡性,两组治疗结果具有可比性。
     (2)治疗3周后,研究结果表明,隔日1次组30例,其中痊愈0例、显效10例(33.33%)、有效12例(40%)、无效7例(23.33%),总有效率73.33%,隔2天1次组30例,其中痊愈0例、显效8例(26.67%)、有效9例(30%)、无效13例(43.33%),总有效率56.66%。隔天1次组治疗前后评分比较、隔2天1次组治疗前后评分比较,差异均有统计学意义,说明膝骨性关节炎隔天治疗1次和隔2天治疗1次,均有良好的临床疗效。治疗6周后,隔天1次组30例,其中痊愈6例(20%)、显效19例(63.33%)、有效3例(10%)、无效2例(6.67%),总有效率92.28%。隔2天1次组30例,其中痊愈1例(3.33%)、显效11例(36.67%)、有效10例(33.33%)、无效8例(26.67%),总有效率73.33%。隔天1次组治疗前后评分比较、隔2日1次组治疗前后评分比较,差异均有统计学意义,说明膝骨性关节炎隔天治疗1次和隔2天治疗1次,均有良好的临床疗效。
     (3)两组治疗后症状量化积分,Lequesne MG计分、JOA、MPQ、WOMAC Index ofOA计分较治疗前明显改善,隔天1次治疗优于隔2天治疗1次(P<0.05,P<0.05)。
     (4)两组主要临床症状消失率(关节活动疼痛、关节压痛、关节肿胀、关节活动度、遇寒加重、腰膝酸软、屈伸不利、怕冷、夜尿)比较,隔天1次组优于隔2天1次组(P<0.05)。
     结论:
     针刺治疗膝骨性关节炎安全有效。治疗膝骨性关节炎中,采用隔天针刺1次与隔2天1次均有效果,而隔天针刺1次效率更高,各项活动疼痛、活动僵硬及其他功能得到很大的改善,这或许是受针刺效应的累加的影响,针灸次数与效应以正比关系共同增长。每隔一天针刺一次,或许是改变耐受性的一种方法,能提高针刺效应的远期疗效。
Knee Osteoarthritis (OA Knee), also known as degenerative osteoarthritis of the knee, is a chronic degenerative disease in those past middle life, which are widely associated with and distributed in "knee pain","phlegm","atrophy","arthralgia","arthritis". The presence of OA knee has caused pain and much inconvenience to patients in their daily activities and economic burden, but the use of Traditional Chinese Medicine (TCM) treatment was well accepted by the patients as it has shown a positive effect on OA knee, particularly the acupuncture, to relieve the adverse reactions. The efficacy of acupuncture is varied and affected by several factors, such as the severity of patients'condition, the location of acupoints, treatment interval, etc. Many local studies in China have extensively researched in the effect of various aspects
     of acupuncture treatment to OA knee and most have shown a remarkable result. However, studies focused on the treatment interval of acupuncture were limited but most popular was once a day, every two days or twice a week. Therefore, the effect of acupuncture to OA knee could be maximized if the optimal treatment interval is found.
     Objective:
     The present study aims to investigate the effect of different treatment interval of acupuncture on OA knee, and hence providing an optimal interval for clinical application in the treatment of OA knee, which can serve as a reference to standardize a treatment protocols later.
     Methods:
     Taking reference from the diagnostic criteria of the treatment guideline of Osteoarthritis published and revised by the Chinese Medical Orthopedics Division in2007, the patients were recruited from a private clinic in Hong Kong to enroll this prospective study. Th ey will be assigned to two treatment groups-alternative day vs. every two days. A total of60subjects were recruited, with half (n=30) assigned to the alternative day while the remaining half (n=30) to the every two days group. Treatment focused on different location of main acupoints such as both Xue Hai(SP10), LiangQiu (ST34),Nei Xi Yan (EX-LE4),Tu Pi (ST35), plus alternative acupoints migratory arthralgia:Feng Chi GB20, Ge She(BL17); cold arthralgia:Shen Shu(BL13),GuanYuan(CV4, RN4); damp arthralgia:Yin Ling Quan(SP9), ZuZan Li(ST36);heat arthralgia:Da Zhui(DU14), Feng Chi GB20.4main acupoints plus2alternative acupoints are used each treatment. Routine disinfection was performed by using1.5-inch needle treatment for30minutes while using TDP,3weeks for a course of treatment and a total of two courses per treatment cycle. After the completion of the treatment period, the following parameters were tested:Lequesne MG, JOA, WOMAC index of0A Scale, MPQ and knee function scale, the two groups before treatment and3weeks and6weeks after treatment symptom score, and count efficiency, measurement data with the mean±standard deviation (x±s), count data with composition ratio (%), the t-test or Wilcoxon rank sum test by using a statistical software SPSS17.00for statistical analysis.
     Results:
     (1) In this study,60cases were eligible subjects and completed the clinical trials with no dropout and exclusion case. Among these subjects,8were males and52were females, with age ranging from41to69years old; the shortest duration of disease was from a month up to4years.30cases were selected to the treatment group of alternative day (5males and25females) with mean age61.40±1.338years old whereas another30cases were assigned to the treatment group of every two days (3males and27females) with mean age59.97±1.291years old. No significant difference was observed between two treatment groups in term of their gender, age, duration of disease, LequesneMG scoring, WOMAC Index of0A integration, MPG, JOA and several clinical symptoms such as degree of joint pain, joint stiffness, joint tenderness, joint swelling, joint mobility, more serious in cold weather, soreness of waist and knees, flexion and extension movement, feeling cold and nocturia clinical symptoms.
     (2) After3weeks of the treatment, the results showed that patients from alternative treatment group (n=30) had a total of73.3%efficiency rate (no case for a complete recovery,10cases with effect,12cases with markedly effect,7cases with no effect) while the treatment group of every2days (n=30) had56.67%efficiency rate (no case for a complete recovery,8cases with effect,9cases with markedly effect and13cases with no effect). Both treatment groups had significantly indicated a positive effect of using acupuncture to treat0A knee in clinical setting. After6weeks of the treatment, the alternative treatment group (n=30) showed a total of92.28%efficiency rate with6cases for a complete recovery,19cases with effect,3cases with markedly effect and2cases with no effect whereas the treatment group of every2days (n=30) had73.33%efficiency rate with one case for a complete recovery,11cases with effect,10cases with markedly effect and8cases with no effect. Again, both treatment groups of using acupuncture had showed a significant effect to treat0A knee.
     (3) In term of the quantitative calculations (Lequesne MG scoring, JOA, MPQ, WOMAC Index of OA) before and after treatment between groups, the treatment group of alternative day was significantly improved when compared with the other group (once every two days) with p-valve less than0.05.
     (4) For the reduction rate of the observed clinical symptoms (such as joint pain, joint tenderness, joint swelling, joint mobility, more serious in cold weather, soreness of waist and knees, flexion and extension movement, feeling cold, nocturia), the treatment group of alternative day was significantly better than that of the other group (once every two days) with p-valve less than0.05.
     Conclusion:
     The use of acupuncture for OA knee was a safe and effective treatment. In the present study, both treatment groups (alternative day and once every2days) have significantly shown positive improvements in many aspects, such as joint pain, joint mobility and stiffness, and other functions. This might be related to the cumulative effects of acupuncture and its treatment frequency that was proportionally associated with the outcomes measured. In the conclusion, the application of acupuncture on alternative basis might help to increase the patients'tolerance and enhance their acceptance to a long-term treatment effect of acupuncture.
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