中药奄包、透明质酸钠治疗膝关节骨性关节炎的临床研究
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摘要
骨性关节炎(Osteoarthritis, OA)是一种以关节软骨变性、破坏及骨质增生为特征,出现以骨关节疼痛、活动障碍为主要症状,或伴有重着、肿胀甚至畸形、失用等表现的一类疾病,本病又称退行性关节病、增生性骨关节炎。本病可累及全身多个关节,而最常累及膝关节。因本病的发生率随年龄的增长而增高,故又称老年性关节炎,是导致中老年人生活质量降低的一种常见病、多发病。其发病机制复杂,一般认为与衰老、劳损、肥胖、外伤、骨密度、遗传等因素关系最密切。其病理上表现为局灶性关节软骨的退行性变、软骨下骨质变密(硬化),影像学上多表现为骨软骨边缘性骨赘形成,晚期可见关节畸形。传统多采用非甾体类消炎镇痛药,但由于膝关节复杂的结构特点及药物的药理特点,多只能暂时缓解症状,无法延缓病情的进展,故常近期效果好,远期效果不理想,且易复发。
     笔者选择武汉市第一医院住院部骨关节科自2009年1月至2009年6月收治的膝骨关节炎患者共分为两组,分别予中药奄包外敷及中药奄包外敷结合关节腔注射透明质酸钠治疗。并将入院时、治疗两周后(出院时)、治疗三月后(出院两月半后)分别根据美国西部Ontario和McMaster大学骨关节炎指数评分(WOMAC骨关节炎指数评分)标准予以评分,观察比较,客观评价两种治疗方法的临床治疗效果。
     目的:
     评价比较运用中药奄包外敷及中药奄包外敷结合关节腔注射透明质酸钠治疗膝关节骨性关节炎的安全性及临床疗效.
     方法:
     本研究病例均来源于武汉市第一医院住院部骨关节科自2009年1月至2009年6月收治膝关节骨性关节炎患者共32例,分为两组:治疗组1:中药奄包外敷治疗;治疗组2:中药奄包外敷结合关节腔注射透明质酸钠治疗。入院时二组患者分别予以WOMAC骨关节炎指数评分的标准予以评分,同时对患者进行血、尿常规、肝肾功能、电解质及心电图等检查,摄膝关节正侧位片,治疗两周后(出院时)、治疗三月后(出院两月半后)再分别行WOMAC评分及临床疗效评定,并予以统计学分析。疗效评定标准:临床控制:疼痛、肿胀等症状消失,关节活动正常,WOMAC总积分下降≥90%;显效:疼痛、肿胀等症状基本消失,关节活动基本正常,能参加正常活动和工作,WOMAC总积分下降≥70%;有效:疼痛、肿胀等症状基本消失,关节活动轻度受限,参加活动或工作的能力有改善,WOMAC总积分下降≥30%;无效:疼痛、肿胀等症状无明显改善,总积分下降<30%.
     【注:计算公式:(治疗前积分-治疗后积分)/治疗前积分*100%】
     结果:
     1.WOMAC指数积分统计
     治疗组1治疗前WOMAC积分X±S=45.56±3.69,治疗两周后X±S=13.19±9.78,治疗三月后X±S=18.06±10.51,治疗两周后较治疗前积分比较有显著性差异,p<0.01,治疗三月后较治疗前积分比较有显著性差异,p<0.01,且治疗三月后较治疗两周后积分比较也有显著性差异,p<0.05。
     治疗组2治疗前WOMAC积分X±S=45.13±4.54,治疗两周后X±S=13.75±9.56,治疗三月后X±S=12.50±10.25,治疗两周后较治疗前积分比较有显著性差异,p<0.01,治疗三月后较治疗前积分比较有显著性差异,p<0.01,而治疗三月后较治疗两周后积分比较无显著性差异,p>0.05。
     两组治疗两周后WOMAC指数相比,无显著性差异,P>0.05。两组治疗三月后WOMAC指数相比,有显著性差异,P<0.05。2.临床疗效评定统计
     治疗组1治疗两周后疗效评定:临床控制2例,显效9例,有效4例,无效1例,有效率93.75%;治疗三月后疗效评定:临床控制1例,显效6例,有效6例,无效3例,有效率81.25%;治疗组1治疗三月后较两周后疗效比较,有显著性差异,P<0.05。
     治疗组2治疗两周后疗效评定:临床控制2例,显效10例,有效3例,无效1例,有效率93.75%;治疗三月后疗效评定:临床控制2例,显效9例,有效4例,无效1例,有效率93.75%;治疗组2治疗三月后较两周后疗效比较,无显著性差异,P>0.05。
     两组治疗两周后疗效比较,无显著性差异,P>0.05,两组治疗三月后疗效比较,有显著性差异,P<0.05。
     结论:
     治疗两周后,两组WOMAC指数积分及临床有效率较治疗前均有显著性差异,组间比较无显著性差异,说明两种方法在临床治疗膝骨性关节炎上均有确切的效果。治疗三月后,两组WOMAC指数积分及临床有效率较治疗前均有显著性差异,但治疗组1治疗三月后较两周后比较有显著性差异,治疗组2治疗三月后较两周后比较无显著性差异,且治疗三月后两组间比较有显著性差异,说明两种方法治疗后疗效均有较好的持久性,而中药奄包外敷结合透明质酸钠关节腔注射疗效更持久。
Osteoarthritis (Osteoarthritis, OA) is a kind of diseases that is characterized by degeneration and destruction of the articular cartilage,hyperosteogeny, and marked symptomatically especially by pain, motility disorders, or accompanied by heaviness, swelling, or even deformity, uselessness. It is also known as degenerative or proliferative osteoarthritis. The disease can affect multiple body joints, and involve the knee joints as the most commonly. The incidence of this disease increases with age growth, so it's otherwise called senile arthritis which is a common disease leading to reduced quality of life in the elderly. It is generally recognized that this disease is due to aging, strain, obesity, trauma, bone density, genetic and so on. It has expressions sucn as degeneration of the articular cartilage, sclerosis of the bone under the cartilage in pathologic and osteophyte formation, joint deformities in the late in radiographic. Because of the complicated construction of knees and pharmacological characteristics of drugs, traditional treatment that uses non-steroidal anti-inflammatory analgesic drugs can only temporarily alleviate symptoms, but it's unable to slow the progress of disease. Most patients generally subjective symptoms appear to be improved at short-term follow-up, but Long-term result responses are still unsatisfactory.
     The patients with OA admitted at the orthopedic in-patient department of Wuhan First Hospital since January 2009 to June 2009, were divided into two groups and respectively received two treatment. Group 1 were given om package external application of Chinese medicine and group 2 treated with om package external application of Chinese medicine and HA injection by arthrocentesis. on admission, two weeks after treatment (at discharge)and three months after treatment(post-discharge two Halfmoon), according to the standard the WOMAC scoring system, we evaluate and compare the clinical effects between the two therapeutic methods.
     Objective:the aim of the clinical study is to evaluate and compare the clinical effects and safety of the the two therapeutic methods: om package external application of Chinese medicine, om package external application of Chinese medicine and HA injection by arthrocentesis.
     Methods:In this study patients with OA had a total of 32 cases, all admitted at the orthopedic in-patient department of Wuhan First Hospital since January 2009 to June 2009 and divided into two groups and respectively received two treatment. Group 1 were given om package external application of Chinese medicine and group 2 treated with om package external application of Chinese medicine and HA injection by arthrocentesis. Before the therapy, the two group of patients were estimated according to the standard the WOMAC scoring system and were given some laboratory tests including blood routine, urine routine, liver and kidney function, electrolytes. The electrocardiogram and the X-ray films of AP view and lateral view of the knee joint were checked, too. On two weeks and three months after the treatment the WOMAC scores and clinical effects were evaluated againand and analyzed statistically. The evaluation standard of clinical effects is as follows, Clinical control: symptoms such as pain, swell etc vanish, the function of knee joint normal, the total scores of WOMAC decrease more than 90 percent; markedly effective:symptoms such as pain, swell etc disappear, the function of knee joint normal and the patients can take part in daily work, the total scores of WOMAC decrease more than 70 percent, effective:symptoms such as pain, swell etc disappear, the function of knee joint limited and the ability to take part in daily work improve, the total scores of WOMAC decrease more than 30 percent; invalid:symptoms such as pain, swell etc don't improve obviously, the total scores of WOMAC decrease less than 30 percent.
     【Note:The calculation formula:(the scores before treatment)-the scores after treatment/the scores before treatment* 100%】
     Results:
     1.Statistics of the WOMAC scores:
     The WOMAC scores of group 1:before treatment X±S=45.56±3.69, two weeks after treatment X±S=13.19±9.78, three months after treatment X±S=18.06±10.51.The scores of two weeks after treatment comparing with the scores before treatment were different significantly, p<0.01; the scores of three months after treatment comparing with the scores before treatment were difference significantly, p<0.01. the scores of three months after treatment comparing with the scores of two weeks after treatment were different significantly, too, p<0.05.
     The WOMAC scores of group 2:before treatment X±S=45.13±4.54, two weeks after treatment X±S=13.75±9.56 three months after treatment X±S=12.50±10.25. The scores of two weeks after treatment comparing with the scores before treatment were different significantly, p<0.01; the scores of three months after treatment comparing with the scores before treatment were different significantly, p<0.01; The scores of three months after treatment comparing with the scores of two weeks after treatment were no significant difference, p>0.05.
     Between the WOMAC scoresof the two groups, there was no significant difference after treatment on two weeks, but had difference significantly after treatment on three months.
     2.Evaluation and Statistics of the clinical effects:
     The clinical effects of group 1:two weeks after treatment,2 cases were achieved clinical control,9 as markedly effective,4 as effective and 1 as invalid, the effective rate was 93.75%; three months after treatment,1 case was achieved clinical control,6 as markedly effective,6 as effective and 3 as invalid, the effective rate was 81.25%. Compared with the effective rate after treatment on two weeks, there had difference significantly, P<0.05.
     The clinical effects of group 2:two weeks after treatment,2 cases were achieved clinical control,10 as markedly effective,3 as effective and 1 as invalid, the effective rate was 93.75%; three months after treatment 2 cases were achieved clinical control,9 as markedly effective,4 as effective and 1 as invalid, the effective rate was 93.75%. Compared with the effective rate after treatment on two weeks, there was no significant difference, P>0.05.
     Between the clinical effects of the two groups, there was no significant difference after treatment on two weeks, but had significant difference after treatment on three months.
     Conclusion:
     Two weeks after treatment, the WOMAC scores and the clinical effective rate of the two groups were different significantly comparing with the treatment before, and there had significant difference between the two groups. The results show that both of the two methods have obvious effects in clinical treatment of knee osteoarthritis.
     Three months after treatment, the WOMAC scores and the clinical effective rate of the two groups were different significantly comparing with the treatment before, and there had significant difference between the two groups. The data of group 1 after treatment on three months were different significantly comparing with those after treatment on two weeks, but there had no significant difference in group 2. and there were different significantly between the two groups after treatment on three months. Results show that the effects of both the two methods have good durability, while the method with om package external application of Chinese medicine and HA injection by arthrocentesis has more lasting effect.
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