Page 90 - 2023-02-中国全科医学

2023年1月 第26卷 第2期 http: //www.chinagp.net E-mail: zgqkyx@chinagp.net.cn ·211·

From October 2020 to June 2021，67 KOA patients who met the requirements were recruited from the Massage Department of
Dongzhimen Hospital，Beijing University of Chinese Medicine. They were randomly divided into royal TCM-based tendon-
regulation manipulation（n=33）and joint mobilization（n=34）. The two groups of patients received 10 treatments for 4 weeks，
4 cases fell off midway，and 63 patients were finally included. A mixed method of quantitative and qualitative analysis was
adopted. Quantitative data collected were pre- and post-treatment assessment of the clinical responses in two groups with Western
Ontario and McMaster Universities Osteoarthritis Index（WOMAC）. Qualitative data were collected using semi-structured
individual interviews conducted in the participants based on topics of the efficacies and assessment of the two treatments for
KOA，and understanding of the massage therapy. The similarities and differences between the two treatments were compared，
and analyzed using thematic analysis. Parallel comparison and joint display were used for integrative analysis of the mixed data.
Results Efficacy evaluation：there was no statistically significant difference in the total score of WOMAC between the two
groups after 4 weeks of treatment（P>0.05），the total scores of WOMAC in both groups were lower than those before treatment
（P<0.05）. According to the interview，there were no significant differences in patient-assessed efficacies（positive，neutral
or negative evaluation）between the two treatments. Besides that，patients' positive，neutral and negative perceptions of massage
were basically the same before and after treatment，but after treatment，patients' perception of massage inclined to be positive.
The results of quantitative analysis showed that the curative effect was not related to previous hospital treatment with massage
therapy. The efficacy was also not related to the success of blinding. There was no significant correlation between the success of
blinding and the type of treatment or previous massage treatment. Patients' perceptions of massage were not associated with the
efficacy，and the type of treatment received by them. Manipulation evaluation：There were no significant differences in the two
treatments assessed by patients in terms of strength，pain degree，manipulation characteristics，onset time of curative effect
and number of times with the most obvious perceived curative effect after the first or fourth week of treatment. Conclusion
Quantitative and qualitative studies show that both the royal TCM-based tendon-regulation manipulation and joint mobilization are
safe and effective for KOA，and they have no significant differences in patient-assessed efficacy and manipulation skills，as well
as patients' perceptions of them.
【Key words】 Osteoarthritis，knee；Musculoskeletal manipulations；Science of Tuina（TCM）；Comparative
research on Traditional Chinese Medicine with Western medicine；Evaluation studies as topic；Royal TCM-based tendon-
regulation manipulation；Joint mobilization

膝骨关节炎（knee osteoarthritis，KOA）是一种多 传承与发展。
因素导致的全关节疾病，典型表现为膝关节疼痛及压痛、 1 对象与方法
肿胀、僵硬、骨摩擦音（感）、关节活动受限等 ［1-2］ 。 1.1 研究对象 选取 2020 年 10 月至 2021 年 6 月于北
中国健康与养老追踪调查数据库的数据显示，我国症状 京中医药大学东直门医院推拿科门诊招募的 KOA 患者
性 KOA 的患病率为 8.1%，西南地区（13.7%）和西北 72 例为研究对象，依据纳排标准纳入合格受试者 67 例，
地区（10.8%）较高，华北地区（5.4%）和东部沿海地 随机分为宫廷理筋术手法组（33 例）和关节松动术手
区（5.5%）相对较低，其较高的患病率及致残率给患 法组（34 例）。本研究已通过北京中医药大学东直门
者和社会造成了巨大的经济和社会负担 ［3］ 。《膝骨关 医院伦理审查（DZMEC-KY-2019-06）。
节炎中医诊疗指南（2020 年版）》 ［4］ 及相关研究证实 纳入标准：（1）符合 KOA 诊断标准 ［15-16］ ；（2）
手法作为补充替代疗法治疗 KOA 的临床疗效明确，且 年龄 40~75 岁；（3）KOA 的 KL 分级 ［17］ 为Ⅱ、Ⅲ级；（4）
安全性较高 ［5-9］ 。手法在中国主要指中医的推拿按摩技 疼痛程度为中重度〔采用数字评价量表（NRS） ［18］ 评
术；现代医学手法主要以关节松动术、软组织松动 / 松 分≥４分〕；（5）签署知情同意书自愿受试。排除标准：
解术为主，由于两者经常联合应用常统称为关节松动 （1）计划进行关节置换手术者；（2）伴有非原发性关
术 ［10］ 。临床证据表明中医传统推拿手法与现代医学手 节炎、纤维肌痛、其他疼痛或残障影响到膝关节者；（3）
法治疗 KOA 均具有良好的临床疗效 ［11-14］ ，但目前两者 伴有严重原发性疾病、恶性肿瘤、传染病及精神疾病者；
干预 KOA 的临床特点比较研究鲜见报道。因此，本研 （4）施术部位关节红肿、灼热、全身发热或皮肤红斑、
究以 KOA 为例，在随机对照试验（RCT）基础上，从 硬结者；（5）入组前３个月内口服糖皮质激素或关节
客观数据与患者主观感受上对于不同手法的疗效进行比 腔糖皮质激素注射者；（6）入组前６个月关节腔内注
较研究，探索两种手法的异同。通过挖掘手法自身的规 射玻璃酸钠者；（7）膝关节明确损伤或开放性损伤者；（8）
律特点，促进世界范围内手法医学的规范化、标准化， 入组前 1 年内进行关节重塑手术者；（9）KOA 致残后
进而规范、优化 KOA 治疗方案，有利于中医外治法的 行器械支持治疗者；（10）失访或参加其他临床研究者。