摘要
目的
本课题采用临床流行病学、临床科研方法学及数理统计分析方法,进行临床随机对照研究,以单纯中药组为对照,观察在中药口服治疗的基础上加用温针灸治疗膝骨性关节炎的临床疗效,以期为膝骨性关节炎的临床治疗提供更有效、安全的方案。
方法
选取2009年2月至2010年2月期间在台湾中医诊所治疗的,符合西医“膝骨性关节炎”诊断标准和中医“痹证”的临床患者70例。采用简单随机(随机数字)的方法分组,将70例合格受试者以1：1的比例分配至治疗组(温针灸+中药)和对照组(单纯中药),每组35例。对照组选用独活寄生汤加减,按照每日剂量分型制成GMP中药制剂,一日份9g以0号胶囊分10粒装,早晚各服5粒。10日为1疗程,共治疗3个疗程。治疗组在口服中药(同对照组)的基础上加用温针灸灸,针灸主穴取内、外膝眼、鹤顶、膝阳关、梁丘、足三里、委中、阿是穴；风邪偏盛者加风市、血海；寒邪偏盛者加关元,气海；湿邪偏盛者加阴陵泉、阳陵泉。每次取主穴4个、配穴1个,各穴轮流使用。治疗时取华佗牌30号1.5~2寸毫针进行治疗,得气后用泻法行针1分钟,留针30分钟,同时使用温针灸法(加燃清艾条2壮,每壮1cm)。每日1次,10次为1疗程,共治疗3个疗程。治疗结束后,观察其总有效率及膝骨性关节炎症状分级量化表、Lequkesne MG膝关节炎严重程度积分表、WOMAC index of OA量表及SF-36简明生活量表积分的变化情况。治疗前后进行安全性检测。
用Epi Data软件建立数据库,进行统一数据管理。计量资料用均数±标准差(x±S)表示,计数资料用构成比(%)表示。分类资料用χ2检验,等级资料用两样本比较Wilcoxon秩和检验(校正),两样本均数比较用t检验或Wilcoxon秩和检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。用SPSS17.0统计软件完成统计分析。结果
(1)本研究中70例合格受试者均完成临床试验,无脱落、剔除病例。其中,男性15例,女性55例；年龄17岁-68岁；病程最短8个月,最长6年。其中治疗组35例(男性9例,女性26例),平均年龄为42.40±13.07岁,对照组35例(男性6例,女性29例),平均年龄为42.44±12.67岁。治疗前两组患者的性别、年龄、病程、中医辨证、LequesneM G计分、WOMAC Index of OA积分、SF-36积分,以及关节疼痛、关节肿胀、屈伸不利、关节压痛、腰膝酸软、纳差、疲倦等主要临床症状比较,差异均无显著性意义。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)治疗后,两组总体疗效经比较,治疗组临床痊愈13例,显效12例,有效6例,无效4例；对照组临床痊愈5例,显效13例,有效9例,无效8例；经Ridit分析,治疗组的疗效明显优于对照组(P=0.046<0.05)。且治疗组临床痊愈率37.14%,对照组临床痊愈率14.29%,说明在口服中药基础上加用温针灸灸治疗可以显著提高临床痊愈率。
(3)两组治疗后症状量化积分、Lequesne M G计分,WOMAC Index of OA计分较治疗前明显改善,治疗组优于对照组(P<0.05)。
(4)两组主要临床症状消失率(关节疼痛、关节肿胀、关节压痛、畏寒肢冷)比较,治疗组优于对照组(P<0.05)。
(5)两组治疗后简明生活质量量表(SF-36)较治疗前明显改善,治疗组优于对照组(P<0.05)。
结论
单纯中药治疗膝骨性关节炎临床有效,在口服中药基础上加用温针灸治疗膝骨性关节炎,可以显著提高总体疗效及临床痊愈率,并显著改善患者临床症状和日常生活质量,值得临床推广应用。
Objective
The subject Adopted the clinical epidemiological methods, clinical research methods and randomized controlled clinical study, putting Chinese group to simply control to observe clinical efficacy and safety of treating knee osteoarthritis with warming needle combined with Traditional Chinese Medicine by randomized control study. To explore the clinical efficacy difference and mechanism of the the warm and simple acupuncture combined with Chinese medicine treatment of knee osteoarthritis. To provide reliable clinical basis for the acupuncture treatment of knee osteoarthritis. In order to provide more effective clinical treatment and safety program to the osteoarthritis of the knee.
Method
Select patients for treatment from February 2009 to February 2010 in Taiwan during the Chinese medicine clinic. The clinical patients were consistent with Western medicine diagnostic of "knee osteoarthritis" and TCM diagnostic of "Arthralgia". By using simple randomized (random number) method, the 70 clinical patients were assigned to treatment group (warming needle combined with Traditional Chinese Medicine) and the control group (Traditional Chinese Medicine)with 1:1 ratio with 35 cases in each group. The control group used Duhuojisheng Decoction with every 10 days a course and total for 3 courses. The treatment group use warm acupuncture (the main point:the inner and outer Xi Yan points, He Ding point, Xi Yang Guan point, Qu Quan point, Ashi points, Liang Qiu point, Zu San Li point) based on taking Chinese medicine(the same as the control group) with once 1 day,10 times as a course and total for 3 courses. After treatment, We observed total effective and symptoms of knee osteoarthritis grade quantization table, Lequkesne MG severity of knee arthritis points table, the change of WOMAC index of OA scale. Using Epi Data software to establish databases to unify data management. Testing Category information withχ2 test, relatively level data with Wilcoxon rank test (correction).Comparing two sample mean byχ2 test or Wilcoxon rank test, Comparing itself before and after treatment paired T test or Wilcoxon paired rank test. Using statistical software SPSS17.0 to complete statistical analysis.
Results
(1) 70 patients in this study subjects were eligible to complete clinical trials, no drop in the deletion cases. Among them,15 males and 55 females; age of 17 years old-68 years old; the shortest course of disease is 8 months, up to 6 years. One treatment group of 35 patients (9 males, female 26 cases), the average age is 42.40±13.07 years, control group 35 patients (6 males and 29 females), mean age is 42.44±12.67 years. Before treatment of sex, age, course of disease, TCM, Lequesne MG score, WOMAC Index of OA integral, SF-36 points, and joint pain, joint swelling, flexion and extension negative, joint tenderness, weak waist, lack of appetite, fatigue and other major clinical symptoms compared with no significant difference. Suggest that the main factors affecting the prognosis of the two groups have some balance, two groups was comparable.
(2) After treatment, by comparison the overall efficacy of the two groups. Treatment group,13 cases recovered,12 cases markedly effective in 6 cases, 4 cases inefficacy; control group,5 cases of clinical recovery,13 cases were markedly effective in 9 cases,8 cases; by Ridit analysis of the efficacy of the treatment group than the control group (P=0.046<0.05). And the cure rate in treatment group 37.14%, control group, the cure rate was 14.29%, indicating that on the basis of oral medicine and the warming acupuncture can significantly improve the clinical cure rate.
(3) After treatment, symptoms quantization points, Lequesne MG score, WOMAC Index of OA score were significantly improved comparing with before. the treatment group was superiorer than the control group (P<0.05).
(4) As to the disappearance rate of major clinical symptoms (joint pain, joint swelling, joint tenderness, aversion to cold), the treatment group was better than the control group (P<0.05).
(5) SF-36 scale of after treatmen for two groups were significantly improved comparing with before. the treatment group was superiorer than the control group (P<0.05).
Conclusion
Pure Chinese medicine treatment of knee osteoarthrit is is clinically effective, based on the increase in oral Chinese medicine with the warm needle treatment of knee osteoarthrit is can significantly improve the overall efficacy and clinical cure rate, and significantly improve the clinical symptoms and quality of life.It is worthy of expanding in the clinical applicat ions.
引文
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