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推拿结合药物治疗膝关节大骨节病的理论和临床研究

The Theoretical and Clinical Research on Kashin-Beck Disease of Knee Joint with Tuina and Drug

【作者】 张红参

【导师】 罗才贵;

【作者基本信息】 成都中医药大学 , 针灸推拿学, 2011, 博士

【摘要】 大骨节病(KBD)是一种以关节病变为主的全身性疾病,病因及发病机制至今仍不清楚,目前尚无特效疗法。本文从理论和临床两个方面对推拿结合药物治疗大骨节病进行探讨和研究。理论研究本研究从大骨节病的流行病学、中医学文献、现代医学文献对大骨节病进行分析,同时对中医“整体调理”思想理论基础-背部经络腧穴理论及“局部松动”思想理论基础-关节松动术理论进行探讨和研究,在此基础上,从导师罗才贵教授的“整体调理”、“辨证论治”、“局部松动”学术思想出发,提出大骨节病的治疗原则应为“背腧关节、标本同治”,并结合名老中医临床经验,根据大骨节病病机和主要症状特点,去粗取精,筛选、整合、制定出推拿结合药物治疗膝关节大骨节病的临床方案,为临床研究提供依据。临床研究目的:评价在“背腧关节、标本同治”治疗原则指导下制定的推拿结合药物治疗方案与西药联合治疗方案治疗膝关节大骨节病的有效性及安全性。方法:采用随机、单盲、对照试验,试验入组150例,分为推拿结合药物治疗组(简称治疗组,以下同)及西药联合对照组(简称对照组,以下同)两组,每组75例;以SF-MPQ评分、膝关节活动度、生活质量评分及膝关节x线评分为观察指标,各组治疗三个月后观察临床疗效及安全性,同时随访观察停止治疗三个月、六个月后的临床疗效。结果:1.观察指标评价结果:(1) SF-MPQ评分:两组治疗三个月后与治疗前组内FAS、PPS分析比较,差异有统计学意义(p<0.01);组间FAS、PPS分析比较,差异无统计学意义(p>0.05),说明两组均有较好的止痛作用;停止治疗三个月后两组组间PPS分析比较,差异有统计学意义(p<0.01),说明两组均还有较好的止痛作用,但治疗组优于对照组;停止治疗六个月两组组间PPS分析比较,差异有统计学意义(p<0.01),说明两组均还有止痛作用,但治疗组仍优于对照组。(2)膝关节活动度:两组治疗三个月后与治疗前组内FAS、PPS分析比较,差异有统计学意义(p<0.01),组间FAS、PPS分析比较:双膝关节屈曲角度、屈伸差值比较差异有统计学意义(p<0.05),伸展角度比较差异无统计学意义(p>0.05),提示两组近期均能改善膝关节活动功能,但在膝关节屈曲功能治疗组优于对照组,而其伸展功能两组相当:停止治疗三个月后两组组间PPS分析比较.差异有统计学意义(p<0.01),提示治疗组对于改善患者的膝关节活动功能远期疗效优于对照组;停止治疗六个月两组组间PPS分析比较,差异有统计学意义(p<0.01),说明治疗组比对照组远期改善膝关节活动度效果维持得更久。(3)生活质量评分:两组患者治疗三个月后与治疗前组内、组间FAS、PPS分析比较.差异有统计学意义(p<0.01),提示两组均能改善患者生活质量,但治疗组优于对照组;停止治疗三个月后两组组间PPS分析比较,差异有统计学意义(p<0.01),提示两组在停止治疗三个月后均还能改善患者生活质量,但治疗组仍优于对照组;停止治疗六个月,两组组间PPS分析比较,差异有统计学意义(p<0.01),提示停止治疗六个月后两组均还能改善患者生活质量,但治疗组仍然优于对照组。(4)x线指标评分:两组治疗三个月后、停止治疗六个月后与治疗前组内、组间FAS、PPS分析比较,差异均无统计学意义(p>0.05),提示两种治疗方案对患者的x线改变效果不明显。2.总体疗效评价结果:(1)两组治疗三个月后,两组总体疗效FAS、PPS分析比较,差异无统计学意义(p>0.05),但两组治愈率FAS、PPS分析比较差异有统计学意义(p<0.01),提示治疗组治愈率明显优于对照组。(2)两组停止治疗三个月后,两组总体疗效FAS、PPS分析比较,差异有统计学意义(p<0.01),且两组治愈率FAS、PPS分析比较差异有统计学意义(p<0.01),提示治疗组总体疗效、治愈率均明显优于对照组;(3)两组停止治疗六个月后,两组总体疗效FAS、PPS分析比较差异有统计学意义(p<0.01),且两组治愈率FAS、PPS分析比较差异有统计学意义(p<0.01),提示治疗组总体疗效、治愈率均明显优于对照组。3.安全性评价结果:治疗组在治疗过程中有2例不良反应,不良反应发生率为2.70%;对照组共有9例不良反应,不良反应发生率12.33%,两组比较,差异有统计学意义(x2=4.9186,P=0.0266<0.05),提示治疗组安全性优于对照组。提出的“背腧关节、标本同治”的治疗原则对膝关节大骨节病的治疗作用的立论成立。2.在“背腧关节、标本同治“治疗原则指导下制定的推拿结合药物治疗方案与西药联合治疗方案治疗膝关节大骨节病均有较好临床疗效,但两种治疗方案比较,推拿结合药物治疗方案近期治愈率、安全性、远期疗效优于西药联合治疗方案。

【Abstract】 Kashin-Beck Disease (KBD) is a systemic disease dominated by joint disease. The etiology and pathogenesis of it remain to be unclear so far. And there is no effective therapy at present. In this paper, treating KBD with Tuina and drug both in theoretical and clinical aspects is discussed and researched.Theoretical ResearchThis research analyses KBD from its epidemiology, Chinese medical literature, and modern medical literature. Simultaneously, explore and research "overall conditioning" KBD of TCM in ideological and theoretical basis-back theory of meridians and acupoints, and "Partial loosening" in ideological and theoretical basis-Theory of joint mobilization. On this basis, propose that the principle of treating KBD should be "treating Biao and Ben with the same therapeutic principle of joint and back Shu", of which is from the academic thought of "overall conditioning", "syndrome differentiation", "partial loosening" of the tutor Professor Luo Caigui. And combine it to the clinical practice of the old TCM doctor as well as basing on the pathogenesis of KBD and the characteristics of the main symptoms, to retain the useful part, select, integrate and develop a clinical treatment of KBD of knee joint by Tuina and drug therapy, to provide experimental basis for further research.Clinical ResearchObjective:To evaluate the efficacy and safety of Tuina combined with drug therapy and that of Western medicine combination therapy as the clinical treatment of KBD of knee joint under the principle in the treatment of "treating Biao and Ben with the same therapeutic principle of joint and back Shu".Methods:Take a randomized, single-blinded, and controlled trial, with 150 patients divided into two groups in which 75 cases in treatment group of Tuina and drug therapy (that is TG) and 75 cases in control group of Western medicine combination therapy (that is CG). Having the SF-MPQ Index, range of knee movement, quality of life index (QOLI) and knee X-ray score as the clinical observation indexes to observe the efficacy and safety of each group after treatment for three months. Simultaneously, observe the efficacy of stopping treatment after three months and six months.Results:1. Evaluation results of the observing indexes:(1)SF-MPQ index:①Comparing it before treatment to three months after treatment within groups with FAS and PPS analysis, the difference of both groups was statistically significant (p<0.01). But when compared it between groups, the difference was not statistically significant (p> 0.05). It suggested that both groups have good analgesic effect.②When compared it three months after stopping treatment between groups with FAS and PPS analysis, the difference was statistically significant (p<0.01), which indicated that both groups have good analgesic effect, but TG is better than CG.③Comparing it six months after stopping treatment between groups with FAS and PPS analysis, the difference was statistically significant (p<0.01), which illustrated that both groups still have good analgesic effect, but TG is still superior to CG.(2)Range of knee movement:①Comparing it before treatment to three months after treatment within groups with FAS and PPS analysis, the difference was statistically significant (p<0.01). But when compared both sides of knee flexion angle and the difference of flexion angle and extension angle of it between groups, the difference was statistically significant (p<0.05), while knee extension angle was not statistically significant (p> 0.05). The above implied that both groups play a good role in improving short-term knee function, but TG is better than CG in improving flexion function while their capabilities of improving knee extension function are comparable.②Comparing it three months after stopping treatment between groups with FAS and PPS analysis, the difference was statistically significant (p<0.01), which indicated that TG is better than CG in improving the function of knee joint of long-term efficacy.③Comparing it six months after stopping treatment between groups with FAS and PPS analysis, the difference was statistically significant (p<0.01). It suggested that TG maintains longer in long-term effect of improving the knee joint movement than (3)Quality of life index (QOLI):①Comparing it before treatment to three months after treatment within and between groups with FAS and PPS analysis, the difference was statistically significant (p<0.01), suggesting that both groups can improve life quality of patients, but TG is better than CG.②Comparing it three months after stopping treatment between groups with FAS and PPS analysis, the difference was statistically significant (p<0.01). It implied that both groups can improve life quality of patients three months after stopping treatment, and TG is still superior to CG.③Comparing it six months after stopping treatment between groups with FAS and PPS analysis, the difference was statistically significant (p<0.01). It indicated that although both groups could improve life quality of patients six months after stopping treatment, TG is still superior to CG.(4)knee X-ray score:Comparing it before treatment to three months after treatment, three months after stopping treatment and six months after stopping treatment with FAS and PPS analysis, the difference was not statistically significant (p>0.05), indicating that both therapies have little efficacy in X-ray Change. 2. The results of the overall efficiency evaluation:(1)Three months after treatment, there was no statistically significant difference between two groups in the total effective rate (p>0.05) with FAS and PPS analysis, while cure rate between two groups was statistically significant (p<0.01), indicating that the cure rate in TG is better than CG.(2)Three months after stopping treatment, the difference of the total effective rate and the cure rate of TG and CG were statistically significant (p<0.01) with FAS and PPS analysis, indicating that both total effective rate and cure rate in TG are better than CG.(3)Six months after stopping treatment, the difference of the total effective rate and the cure rate of TG and CG were statistically significant (p<0.01) with FAS and PPS analysis, indicating that both total effective rate and cure rate in TG are better than CG.3. Safety evaluation results: 2 cases of adverse reaction occurred in TG, the adverse reaction rate was 2.70%; 9 cases of adverse reactions occurred in CG, the adverse reaction rate was 12.33%. Comparing the incidence of adverse reactions of the two groups, the difference was statistically significant (x2= 4.9186, P= 0.0266<0.05), which suggested that the safety of TG is better than CG.Conclusion:1. The principle in the treatment of "treating Biao and Ben with the same therapeutic principle of joint and back Shu" under the academic thought of "overall conditioning", "syndrome differentiation" and "partial loosening" is tenable to the efficacy of KBD of knee joint. 2. Both Tuina combined with drug therapy under the principle in the treatment of "treating Biao and Ben with the same therapeutic principle of joint and back Shu" and Western medicine combination therapy have good efficiency in treating knee KBD. When it comes to short-term cure rate, long-term clinical efficacy and safety, Tuina combined with drug therapy is superior to Western medicine combination therapy.

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