温肾宣痹汤治疗膝关节骨性关节炎的临床疗效观察

2020-08-21 08:52:38 中国现代医生 2020年18期

刘金柱 夏天卫 沈计荣

[摘要] 目的 觀察口服温肾宣痹汤治疗膝关节骨性关节炎的临床疗效。 方法 选取2018年9月~2019年12月江苏省中医院骨伤科门诊80例膝关节骨性关节炎患者作为研究对象,随机分成两组,治疗组40例,口服温肾宣痹汤加减治疗,对照组40例,口服痹祺胶囊治疗。两组经治疗2个疗程后,评估临床疗效,观察治疗后总有效率、视觉模拟疼痛评分(VAS)及WOMAC(包括疼痛、僵硬、活动度、有效性)评分方面的情况变化。 结果 ①中医诊疗标准方面,治疗组总有效率92.50%,对照组75.00%,差异有统计学意义(P<0.05);②两组患者VAS评分均降低,较治疗前差异有统计学意义(P<0.05);治疗组VAS评分明显低于对照组,差异有统计学意义(P<0.05);③与治疗前比较,两组患者在疼痛、僵硬、日常活动度、WOMAC总分方面均有改善,差异有统计学意义(P<0.05),其中治疗组改善明显;尤其在疼痛评分方面,治疗组明显优于对照组,差异有统计学意义(P<0.05),其他指标组间比较差异均无统计学意义(P>0.05)。④两组在WOMAC评分改善方面比较差异无统计学意义(P>0.05),但治疗组总有效率87.50%,明显高于对照组72.50%。 结论 温肾宣痹汤治疗寒湿痹阻型膝关节骨性关节炎疗效确切,可显著缓解疼痛,改善膝关节活动度,总有效率优于痹祺胶囊,值得临床推广应用。

[关键词] 温肾宣痹汤;膝关节骨性关节炎;寒湿痹阻型;痹祺胶囊

[中图分类号] R684.3          [文献标识码] B          [文章编号] 1673-9701(2020)18-0139-04

An observation of clinical efficacy of Wenshen Xuanbi decoction in treating knee osteoarthritis

LIU Jinzhu   XIA Tianwei   SHEN Jirong

Department of TCM Orthopedics & Traumatology, the Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing   210029, China

[Abstract] Objective To observe clinical efficacy of Wenshen Xuanbi decoction taken orally in treating knee osteoarthritis(KOA). Methods 80 patients with KOA receiving outpatient service in the Department of TCM Orthopedics and Traumatology of Jiangsu Province Hospital of Chinese Medicine from September 2018 to December 2019 were selected as the subjects of research and randomly divided into two groups, with 40 patients in the treatment group treated with modified Wenshen Xuanbi decoction, and 40 patients the control group treated with Biqi capsule. After two courses of treatment, the clinical efficacy in the two groups was evaluated and the changes after treatment in the total effective rate, visual analogue pain scale(VAS) scores and WOMAC scores(including pain, stiffness, mobility, and effectiveness) were observed. Results(1)In terms of TCM diagnosis and treatment standards, the total effective rate of the treatment group was 92.50%, while that of the control group was 75.00%, and the difference was statistically significant(P<0.05).(2)The VAS scores of the two groups of patients were decreased, and the differences were both statistically significant(P<0.05). The VAS scores of the treatment group were significantly lower than those of the control group, with statistically significant difference(P<0.05). (3)Compared with those before treatment, the pain, stiffness, daily mobility and total WOMAC scores of the two groups of patients were ameliorated with statistically significant differences(P<0.05), of which those of the treatment group were more obvious. Especially in terms of pain scores, the treatment group was obviously superior to the control group, and the difference was statistically significant(P<0.05), and there was no statistically significant difference between the two groups in other indexes(P>0.05). (4)There was no statistically significant difference in the improvement of WOMAC scores between the two groups(P>0.05), but the total effective rate of the treatment group was 87.50%, which was significantly higher than the 72.50% the control group. Conclusion Wenshen Xuanbi decoction has definite efficacy against cold-dampness arthralgia KOA. It can significantly relieve pain and improve the mobility of knee joint. Its total effective rate is higher than that of Biqi capsule. It is worthy of clinical promotion and application.

[Key words] Wenshen Xuanbi decoction; Knee osteoarthritis; Cold-dampness arthralgia; Biqi capsule

骨性关节炎(Osteoarthritis)是成人中最常见的慢性退行性骨关节疾病,久治难愈,且易复发,临床调查显示,在65岁以上老人中,有手关节退变的约占60%,而33%的患者有不同程度的膝关节骨性关节炎症状[1-2]。膝关节骨性关节炎(Knee osteoarthritis,KOA)主要表现为疼痛、肿胀、畸形、功能障碍,与风湿性、类风湿性关节炎、强直性脊柱炎等炎症性风湿病相反,目前西医几乎没有任何有效治疗方法可以阻止KOA的病程,其高发病率与高致残率不仅给患者带来巨大经济压力,也严重影响患者的生活质量[3],晚期只能通过人工单髁置换、全膝关节置换等外科手术来矫正畸形、缓解疼痛、改善功能,但同时不得不面临术后感染、松动、假体周围骨折、翻修等带来的问题[4]。

KOA在祖国医学中属于“膝痹”、“骨痹”,中医中药在治疗骨痹方面疗效显著,价格低廉,且不良反应少。本文应用温肾宣痹汤治疗寒湿痹阻型KOA,取得较好的疗效,现报道如下。

1 资料与方法

1.1 一般资料

所有受试者均来源于江苏省中医院骨伤科门诊,收集时间从2018年9月~2019年12月,全部受试者均符合病例纳入标准。按照随机对照原则,将受试者分为治疗组(温肾宣痹汤)40例、对照组(痹祺胶囊组)40例。其中治疗组年龄39~78岁,男9例,女31例,平均年龄(58.48±10.30)岁,平均病程(25.43±10.85)个月;对照组40~71岁,男14例,女26例,平均年龄(53.33±8.31)岁,平均病程(24.83±10.06)个月。两组患者一般资料比较,差异无统计学意义(P>0.05)。

1.2 诊断标准

西医诊断标准:根据中华医学会骨科学分会《骨关节炎诊治指南》(2018年版)中的KOA诊断标准[5]:①近1个月内反复发作的膝关节疼痛;②X线片(站立或负重位)示关节间隙变窄、软骨下骨硬化和(或)囊性变、关节缘骨赘形成;③年龄≥50岁;④晨僵≤30 min;⑤活动时有骨摩擦音(感);满足诊断标准①+(②、③、④、⑤标准中的任意2条)可诊断KOA。中医诊断标准:参考《中医病证诊断疗效标准》:骨痹(寒湿痹阻型);主症:膝关节疼痛、怕冷;次症:膝部肿胀,屈伸不利,遇寒加重,得热减轻;舌质淡,苔白,脉沉细缓[6]。

纳入标准:①同时符合上述中醫诊断标准和西医KOA诊断标准;②无药物过敏史,能配合完成治疗。排除标准:①合并膝关节类风湿性关节炎、韧带及半月板损伤等疾病;②合并肝肾功能不全、消化道溃疡及严重心肺疾病;③正在参加其他药物临床试验;④妊娠期及哺乳期妇女。所有患者均知情同意,并经伦理委员会通过。

1.3方法

治疗组口服温肾宣痹汤加减治疗,方剂组成:天麻、狗脊、桂枝、附子、炒白术、白芍、木香、甘草、泽泻各10 g,茯苓12 g,葛根、薏苡仁各15 g,细辛6 g。疼痛剧烈者加鸡血藤、延胡索,纳谷不香者加砂仁、鸡内金,腰膝酸楚者加补骨脂、紫丹参。每日1剂,煎成400 mL,早晚温服,治疗2周为1个疗程。

对照组口服痹祺胶囊(天津达仁堂达二药业有限公司,国药准字Z10910026),每日3次,每次4粒,2周为1个疗程。

1.4 疗效判定标准

1.4.1 总体有效率评估  参照《中医病证诊断疗效标准》[6],治愈:膝关节疼痛症状完全消失,关节恢复正常,日常工作与生活不受影响;好转:关节疼痛、肿胀减轻,活动功能好转;无效:临床症状治疗前后无改善,甚至恶化趋势。

1.4.2 视觉模拟评分法(Visual Analogue Scale,VAS)  采用VAS[7]评估KOA疼痛程度:在一条10 cm直线两端分别标明0和10,0分一端表示无痛,10分一端表示无法忍受的剧烈疼痛。

1.4.3 西大略湖麦克马斯特大学骨关节炎调查表(The Western Ontario and McMaster Universities Osteoarthritis,WOMAC)  WOMAC评分包括疼痛、僵硬、关节日常活动度三方面共24个项目,评估膝关节结构和功能[8]。评分方法:每个项目分为5级,0分为无,1分为轻度,2分为中度,3分为重度,4分为极重;疼痛分值0~20分,僵硬0~8分,关节活动度0~68分;总分最小分值为0分,最大分值为96分,评分越高,代表病情越重。WOMAC评分有效性=(治疗前积分-治疗后积分)/治疗前积分×100%:①临床治愈:WOMAC评分减少≥95%;②显效:70%≤WOMAC评分减分<95%;③有效:30%≤WOMAC评分减分<70%;④无效:WOMAC评分减分<30%。总有效=临床治愈+显效+有效。

1.5统计学方法

采用SPSS26.0统计学软件进行处理,计量资料以(x±s)表示,若符合正态分布和方差齐性,组内比较采用配对t检验,组间比较采用独立t检验,反之采用Mann-Whitney U检验;计数资料比较采用χ2检验,P<0.05为差异有统计学意义。

2 结果

2.1 两组患者中医诊疗标准疗效比较

治疗后,治疗组总有效率92.50%,显著高于对照组75.00%,差异有统计学意义(χ2=4.501,P<0.05),见表1。

2.2 两组患者VAS评分比较

两组患者治疗前VAS评分比较,差异无统计学意义(P>0.05);治疗2个疗程后,两组患者VAS评分均降低,较治疗前差异有统计学意义(P<0.05);治疗组患者VAS评分较对照组明显降低,差异有统计学意义(P<0.05),见表2。

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(收稿日期:2020-03-18)