体外冲击波疗法对绝经后女性早中期膝骨关节炎的疗效观察

发布时间：2018-08-16 19:06

【摘要】：背景:膝骨关节炎是影响人类健康的重要疾病,产生的疼痛及功能障碍严重地影响了人们的生活与工作,特别是绝经后女性人群有着很高的发病率,而此类患者往往伴有不同程度的骨量减低及骨质疏松症,目前仍无有效的治疗方法。体外冲击波(Extracorporeal Shock Wave,ESW)作为一种有效的力学刺激可以促进骨生成及软骨下骨重塑越来越被人们所重视,并应用于膝骨关节炎的临床及基础研究,我们课题组在国内首次将体外冲击波应用于绝经后女性膝骨关节炎患者的治疗。目的:从疼痛,功能角度评估体外冲击波疗法(Extracorporeal Shock Wave Therapy,ESWT)对绝经后女性膝骨关节炎的有效性及安全性,并分析ESWT对膝骨关节炎患者步态学的影响,为膝骨关节炎防治提供新思路,为临床体外冲击波疗法治疗膝骨关节炎患者提供临床依据。方法:将2014年8月至2015年6月在我科收治的通过X线检查为2、3级(Kellgren-Lawrence分级)的86例绝经后女性膝骨关节炎患者为研究对象,详细登记患者人口学资料如受试者的年龄、职业、婚况、身高、体重。本试验采取随机、对照、单盲、前瞻性临床研究设计,在患者签订知情同意的前提下通过SAS统计软件的PROC PLAN过程编程产生随机数字,根据数字的奇偶性随机分为两组:体外冲击波治疗组(ESWT组)44例患者与对照组(Contral组)42例。冲击波组患者通过膝关节核磁共振来确定软骨缺损部位并结合膝关节标记疼痛的具体位点来治疗,随后应用气压弹道式冲击波治疗仪,将枪头对准标记的痛点,接受冲击频率为7Hz,能量1~2 bar的发散式体外冲击波治疗,每个部位冲击2000次,1次/周,8次为1疗程,冲击波治疗中,未使用任何麻醉药物和镇静剂。对照组以无能量的假冲击波对患侧关节进行治疗方法同上。治疗过程中患者取坐位,膝关节屈曲90°或者伸直180°,治疗过程中要主动避让膝关节周围重要神经及血管。两组患者在0月(治疗前)及1月(治疗中期),2月(疗程结束后),3月(疗程结束后1个月)、6月(疗程结束后4个月)通过(VAS)视觉模拟疼痛评分;(WOMAC)膝关节功能评分;对治疗的满意程度;50米快速走时间监测及步态分析(步速、步长、站立期及摆动期百分比)等指标进行统计学研究分析。结果:在0月(治疗前)及1月(疗程中期),2月(疗程结束后),3月(疗程结束后1个月)、6月(疗程结束后4个月)对患者进行随访,结果显示:体外冲击波治疗组(ESWT组)的疼痛及功能相对与对照组都明显改善(P0.01)在治疗1月、2月、3月。1 VAS评分结果:在3月时,ESWT组的平均VAS评分(2.5±1.0)相比与治疗前VAS评分(4.3±1.4)及对照组VAS评分(4.0±1.3)(P0.01)相比明显改善。在6月时(治疗结束后4个月)ESWT组的平均VAS评分(3.6±1.3)相比与治疗前VAS评分(4.3±1.4)(P=0.53)及对照组VAS评分(4.1±1.2)(P=0.93)没有统计学差异。2 WOMAC评分结果:膝关节功能评分(WOMAC评分)中疼痛评分在1月,2月,3月与VAS评分得到相同结果(P0.01),而在评分中的僵直评分在治疗及随访的时间里没有改善(P0.05),而膝关节的功能情况在1月,2月,3月都得到很大程度改善(P0.01)。3满意度评价:治疗前Control组和ESWT组患者治疗的满意程度(差/中/好)为(7/21/11)与(7/21/10)(P0.05)。ESWT组患者在2月和3月时满意程度分别为(3/22/14)和(4/23/12),而对于Control组患者2月和3月时满意程度分别为(15/16/7)与(16/15/7),ESWT组患者满意度明显高于Control对照组患者(P0.05)。4 50米快速走时间:在ESWT组患者只有在2月时(35.5±7.0s)相对于Control组(39.8±7.3s)及ESWT组治疗前(41.2±7.6s)有统计学差异(P0.05)。5步态分析结果:步长Stride Length(cm)在随访6个月时间内ESWT组与Control组及治疗前相比无统计学差异P0.05,ESWT组步速Wailing Speed(m/s)只有在2月(1.25±0.18m)相对与Control组(0.97±0.24m)及治疗前(1.12±0.22m)相比具有统计学差异P0.001、站立期stance[%gait cycle]、摆动期Swing[%gait cycle]的数据显示在2月时ESWT组与治疗前及对照组相比较都有统计学差异P0.05,而其他时间的随访没有明显统计学差异。6相关性分析:通过临床实践及统计学分析发现患者的主观感受与患者的体重指数成正相关(BMI),患者体重指数越大经过冲击波治疗后的效果越明显,疼痛及功能缓解幅度越大。结论:通过客观及主观评价的指标统计学分析得出体外冲击波疗法对绝经后女性特定人群膝骨关节炎安全有效,可以有效缓解患者疼痛及改善功能,并发现体外冲击波疗法的治疗效果与患者的体重指数成正相关。为该类人群膝骨关节炎防治提供新思路和新靶点,是治疗绝经后女性早中期膝骨关节炎的有效方法之一。
[Abstract]:BACKGROUND: Osteoarthritis of the knee is an important disease affecting human health. Pain and dysfunction have seriously affected people's life and work. Especially in postmenopausal women, there is a high incidence of osteoarthritis, which is often accompanied by different degrees of osteopenia and osteoporosis. Extracorporeal Shock Wave (ESW), as an effective mechanical stimulus to promote bone formation and subchondral bone remodeling, has been paid more and more attention and applied to the clinical and basic research of knee osteoarthritis. Objective: To evaluate the efficacy and safety of Extracorporeal Shock Wave Therapy (ESWT) in postmenopausal women with knee osteoarthritis from the perspective of pain and function, and to analyze the effect of ESWT on the gait of knee osteoarthritis patients, so as to provide a new idea for the prevention and treatment of knee osteoarthritis, and to provide a new way for clinical application of ESWT in the treatment of knee osteoarthritis. Methods: From August 2014 to June 2015, 86 postmenopausal women with knee osteoarthritis (Kellgren-Lawrence grade) who had undergone X-ray examination in our department were enrolled in this study. The demographic data of the patients, such as age, occupation, marital status, height and weight, were recorded in detail. Contrast, single-blind, prospective clinical study design. Random numbers were generated by PROC PLAN process programming with SAS statistical software on the premise of informed consent. According to the parity of the numbers, the patients were randomly divided into two groups: the extracorporeal shock wave therapy group (ESWT group) 44 patients and the control group (Control group) 42 patients. Magnetic resonance imaging (MRI) was used to determine the location of cartilage defect and to identify the specific site of pain marking in the knee joint. Then, the gun head was pointed at the marking pain point by pneumatic ballistic shock wave therapy instrument. The gun was treated with a 7 Hz, 1-2 bar, diffuse extracorporeal shock wave therapy. Each site was impacted 2000 times, once a week, 8 times as a course of treatment. No anesthetics or sedatives were used during the treatment. The control group received the same treatment as the control group with an energetic pseudoshock wave. During the treatment, the patients were seated, flexed 90 degrees or stretched 180 degrees, and the important nerves and blood vessels around the knee joint were avoided actively. The two groups were treated in October (before treatment) and January (before treatment). In the middle period of treatment, 2 months (after the course), 3 months (one month after the course), 6 months (4 months after the course) through (VAS) visual analogue pain score; (WOMAC) knee joint function score; treatment satisfaction; 50 meters of fast walking time monitoring and gait analysis (pace, step length, standing period and percentage of swing period) and other indicators were statistically studied. Results: The patients were followed up in October (before treatment) and January (middle course), February (after treatment), March (one month after treatment), and June (four months after treatment). The results showed that the pain and function of ESWT group were significantly improved compared with the control group (P 0.01) in January, February and March.1 VAS scores. Results: At March, the average VAS score of ESWT group was significantly improved compared with pre-treatment VAS score (4.3 + 1.4) and control VAS score (4.0 + 1.3) (P = 0.93) and pre-treatment VAS score (3.6 + 1.3) in 6 months (4 months after treatment) compared with pre-treatment VAS score (4.3 + 1.4) (P = 0.53) and control VAS score (4.1 + 1.2) (P = 0.93). There was no significant difference in WOMAC scores. The pain scores in January, February, March and VAS scores were the same (P 0.01), while the stiffness scores in the scores did not improve during treatment and follow-up (P 0.05), while the knee function improved significantly in January, February, and March (P 0.05). Satisfaction evaluation: Before treatment, the degree of satisfaction of the control group and the ESWT group was (7/21/11) and (7/21/10) (P 0.05). The degree of satisfaction of the ESWT group was (3/22/14) and (4/23/12) in February and March, respectively, while that of the control group was (15/16/7) and (16/15/7) in February and March, respectively. Degree was significantly higher than that of control group (P 0.05). 450-meter walking time: In ESWT group, there was significant difference (P 0.05). 5 gait analysis: Stride Length (cm) of step length between ESWT group and Control group at 2 months (35.5 + 7.0s) compared with control group (39.8 + 7.3s) and ESWT group (41.2 + 7.6s) before treatment (P 0.05). There was no significant difference in P 0.05. Wailing Speed (m/s) in ESWT group was only significantly different from that in Control group (0.97 + 0.24m) and pre-treatment (1.12 + 0.22m) in 2 months (1.25 + 0.18m), standing period (stance [% gait cycle], swing period (Swing [% gait cycle] in ESWT group in 2 months (compared with pre-treatment and control group). There was a significant difference between the two groups (P 0.05), but there was no significant difference in other time follow-up. 6 Correlation analysis: Through clinical practice and statistical analysis, it was found that the subjective feelings of patients were positively correlated with body mass index (BMI), the greater the body mass index, the more obvious the effect of shock wave treatment, and the pain and function relief was greater. Conclusion: Extracorporeal shock wave therapy is safe and effective for postmenopausal women with knee osteoarthritis, can effectively relieve pain and improve the function of patients, and the therapeutic effect of extracorporeal shock wave therapy is positively correlated with body mass index. The prevention and treatment of osteoarthritis of the knee provides new ideas and new targets, and is one of the effective methods to treat osteoarthritis of the knee in postmenopausal women.
【学位授予单位】：河北医科大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R684.3

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