研究自拟独活寄生汤结合体外冲击波(ESW)治疗对风寒湿痹型膝骨关节炎患者关节功能恢复及血清葡萄糖磷酸异构酶(GPI)、转化生长因子β(TGF-β)的影响。

纳入标准：符合风寒湿痹症诊断标准；在加入此次研究前3个月内没有相关治疗；无用药禁忌证；对冲击波耐受；单侧膝盖患病；依从性佳，可以随访；知情同意。排除标准：外伤导致损伤半月板、神经血管；合并系统重大疾病；处于妊娠期或者哺乳期；合并膝关节肿瘤者；关节骨性强直。根据标准选取159例2019年6月至2020年6月期间在首都医科大学附属北京康复医院就诊的风寒湿痹型膝骨关节炎患者。抓阄法将患者分3组：对照组(塞来昔布)、ESW治疗组(塞来昔布+ESW)和中药联合组(自拟独活寄生汤+ESW)，每组53例。3组均连续治疗4周。记录治疗后中医症状积分，治疗前后Lysholm功能评分、视觉模拟评分(VAS)、GPI、TGF-β等。采用t检验、卡方检验、单因素方差分析比较3组临床疗效。

治疗后在乏力、关节僵硬、腰背酸痛等中医症状方面中药联合组得分最低(F＝108.1、22.73、32.30、45.02、45.92，均为P<0.05)；与对照组、ESW组相比差异有统计学意义(均为P<0.05)，对照组、ESW组之间得分比较差异无统计学意义(P>0.05)。治疗后3组患者在Lysholm功能评分均较治疗前增加(t＝2.48、2.41、3.43，均为P<0.05)，且3组间差异有统计学意义(F＝27.15，P<0.05)；组间两两比较，中药联合组评分优于对照组、ESW组(均为P<0.05)。治疗后，3组患者的VAS评分比治疗前均明显下降(t＝4.98、5.11、7.91，均为P<0.05)，且3组间差异有统计学意义(F＝19.92, P<0.05)；组间两两比较，中药联合组VAS评分低于对照组、ESW组(均为P<0.05)。对照组、ESW组患者优良率分别为64.2%、62.3%，差异无统计学意义(χ²＝0.04，P>0.05)，中药联合组患者优良率为84.9%，明显高于对照组和ESW组(χ²＝6.01、6.99，均为P<0.05)。治疗后，中药联合组血清GPI与治疗前比较降低(t＝3.14，P<0.05)，TGF-β比治疗前升高(t＝2.03，P<0.05)；组间两两比较，中药联合组血清GPI低于对照组和ESW组，中药联合组血清TGF-β高于对照组和ESW组(均为P<0.05)。

对风寒湿痹型膝骨关节炎患者采取自拟独活寄生汤、ESW联合治疗，促进患者缓解功能恢复，降低血清GPI水平，提高血清TGF-β水平；与传统塞来昔布或塞来昔布联合ESW的疗效更佳。

To study the effects of homemade Duhuo-jisheng decoction combined with extracorporeal shock wave (ESW) on the recovery of joint function and serum glucose phosphate isomerase (GPI), transforming growth factor(TGF)-β in patients with rheumatoid and dampness arthritis of knee.

Inclusion criteria: meeting the diagnostic criteria for wind-cold-dampness Bi type arthralgia; no other treatment within three months; no drug contraindications; tolerance to shock waves; unilateral knee disease; good compliance, able to be followed up; be informed and voluntarily agree the participation. Exclusion criteria: meniscus and neurovascular damage caused by trauma; the patients with major systemic diseases; pregnant or breastfeeding pateints; knee joint tumors; bony ankylosis. A total of 159 patients with wind-cold-dampness Bi type knee osteoarthritis who were treated in Beijing Rehabilitation Hospital Affiliated to Capital Medical University from June 2019 to June 2020 were randomly divided into three groups by lots drawing: the control group (accepting celecoxib), the ESW treatment group (accepting celecoxib+ ESW) and the traditional Chinese medicine (TCM) combination group (accepting self prepared Duhuojisheng decoction+ ESW), 53 patients in each group. All three groups were treated continuously for four weeks. The symptom score of TCM, Lysholm function score, visual analogue scale(VAS) score, serum GPI and TGF-β before and after treatment were recorded. The data of the three groups were recorded and analyzed by t test, chi square test and single factor analysis of variance to compare the clinical efficacy.

The scores of the TCM combination group were the lowest in fatigue, joint stiffness, lumbago and back pain (F=108.1, 22.73, 32.30, 45.02, 45.92, all P<0.05) , the differences were statistically significant comparing with the control group and ESW group (both P<0.05); the difference between the control group and ESW group was not statistically significant (both P >0.05). After the treatment the Lysholm functional score increased in the three groups comparing to the data before treatment(t=2.48, 2.41, 3.43, all P<0.05), and the difference among the groups was statistically significant (F=27.15, P<0.001); compared with the ESW group and the control group, the Lysholm score of TCM combined group was better (both P<0.05). The VAS scores of the three groups were significantly lower than those before the treatment(t=4.98, 5.11, 7.91, all P<0.05), and the difference among the three groups was statistically significant (F=19.92, P<0.001). Compared with the ESW group and the control group, the VAS score of TCM combined group was less(both P<0.05). The excellent rates of the control group and ESW group were 64.2% and 62.3% respectively, with no statistically significant difference (χ²=0.04, P>0.05). The excellent rate of the patients in the TCM combination group was 84.9%, which was higher than that of the control group and the ESW group (χ²=6.01, 6.99, both P<0.05). After the treatment, GPI level of the TCM combined group was lower than that before the treatment(t=3.14, P=0.003); GPI level of the TCM combined group was lower than the ESW group and the control group (both P<0.05). After the treatment, TGF- β level increased in the TCM combined group compared with that before the treatment (t=2.03, P=0.047) ; TGF- β of the TCM combined group was higher than the ESW group and the control group (both P<0.05).

The combination of self-designed single active parasitic decoction and ESW may promote the recovery of remission function, reduce serum GPI level and improve TGF-β level. The efficacy of combination with celecoxib or celecoxib with ESW is better.