云克静脉滴注联合活血通络方口服治疗距骨骨软骨损伤的临床研究

Clinical study on intravenous drip of Yunke( 云克) combined with oral application of Huoxue Tongluo Fang( 活血通络方) for treatment of talar osteochondral injury

目的：观察云克静脉滴注联合自拟活血通络方口服治疗距骨骨软骨损伤的临床疗效。方法：将75例距骨骨软骨损伤患者随机分为3组,每组25例,分别采用单纯静脉滴注云克、单纯口服自拟活血通络方及云克静脉滴注联合自拟活血通络方口服治疗。云克注射液静脉滴注每日1次,每分钟40滴,连续治疗30 d;自拟活血通络方口服每日1剂,连续口服30 d。治疗结束后6个月采用自拟影像学评价标准、美国足与踝关节外科协会（American orthopaedic foot and ankle society,AOFAS）踝与后足功能评分标准及疼痛数字评价量表（numerical rating scale,NRS）评分法评定3组患者的临床疗效。结果：1踝关节NRS疼痛评分结果。治疗前3组患者踝关节NRS疼痛评分比较,差异无统计学意义[（3.000±0.577）分,（3.160±0.624）分,（3.080±0.759）分,F=0.369,P=0.693]。治疗结束后6个月,3组患者踝关节NRS疼痛评分比较,差异有统计学意义[（1.120±0.332）分,（1.640±0.757）分,（1.680±0.690）分,F=6.310,P=0.003];云克联合活血通络方组踝关节NRS疼痛评分低于云克组和活血通络方组（P=0.004,P=0.002）;云克组与活血通络方组比较,差异无统计学意义（P=0.821）。2踝关节AOFAS功能评分结果。云克联合活血通络方组1例患者自行退出试验。治疗结束后6个月,活血通络方组显效7例,有效10例,无效8例;云克组显效9例,有效10例,无效6例;云克联合活血通络方组显效15例,有效6例,无效3例。3组患者踝关节AOFAS功能评分比较,差异有统计学意义（χ^2=6.316,P=0.043）;进一步两两比较（校正α＇=0.025）,云克联合活血通络方组优于活血通络方组（u=162.000,P=0.003）;云克组与云克联合活血通络方组、活血通络方组比较,差异均无统计学意义（u=218.000,P=0.045;u=251.000,P=0.232）。3影像学评价结果。3组均有患者拒绝影像学检查,其中活血通络方组2例、云克组2例、云克联合活血通络方组1例。治疗结束后6个月,活血通络方组显效4例,有效10例,无效9例;云克组显效6例,有效9例,无效8例;云克联合活血通络方组显效11例,有效10例,无效3例。3组患者影像学评价结果比较,差异有统计学意义（χ^2=6.588,P=0.037）;进一步两两比较（校正α＇=0.025）,云克联合活血通络方组优于活血通络方组（u=99.000,P=0.018）;云克组与云克联合活血通络方组、活血通络方组比较,差异均无统计学意义（u=113.500,P=0.033;u=195.500,P=0.513）。结论：云克静脉滴注联合自拟活血通络方口服,能够缓解踝关节疼痛,改善踝关节功能,其综合疗效优于单纯口服自拟活血通络方,在缓解踝关节疼痛方面优于单纯静脉滴注云克和单纯口服自拟活血通络方,值得临床推广应用。

Objective： To observe the clinical curative effects of intravenous drip of Yunke（ 云克） combined with oral application of Huoxue Tongluo Fang（ 活血通络方,HXTLF） in the treatment of talar osteochondral injury. Methods： Seventy-five patients with talar osteochondral injury were randomly divided into 3 groups,25 cases in each group. The patients were treated with intravenous drip of Yunke（ Yunke group,once a day for consecutive 30 days）,oral application of self-made HXTLF（ HXTLF group,one dose a day for consecutive 30days） and combination therapy of intravenous drip of Yunke and oral application of self-made HXTLF（ combination therapy group） respectively. The clinical curative effects were evaluated and compared between the 3 groups at 6 months after the end of the treatment by using self-designed radiographic evaluation criterion,ankle-hindfoot scale made by American orthopaedic foot and ankle society（ AOFAS） and pain numerical rating scale（ NRS）. Results： There was no statistical difference in ankle NRS pain scores between the 3 groups before treatment（ 3. 000 ＋/- 0. 577,3. 160 ＋/- 0. 624,3. 080 ＋/- 0. 759 points,F = 0. 369,P = 0. 693）. There was statistical difference in ankle NRS pain scores between the 3 groups at 6 months after the end of the treatment（ 1. 120 ＋ /- 0. 332,1. 640 ＋ /- 0. 757,1. 680 ＋ /- 0. 690 points,F =6. 310,P = 0. 003）. The ankle NRS pain scores were lower in combination therapy group compared to Yunke group and HXTLF group（ P =0. 004,P = 0. 0020）. There was no statistical difference in ankle NRS pain scores between Yunke group and HXTLF group（ P = 0. 821）.One patient dropped out in combination therapy group. Seven patients got a good result,10 fair and 8 poor in HXTLF group; 9 patients got a good result,10 fair and 6 poor in Yunke group; while 15 patients got a good result,6 fair and 3 poor in combination therapy group at 6months after the end of the treatment. There was statistical difference in AOFAS ankle function scores between the 3 groups（ χ^2= 6. 316,P = 0. 043）. Further pairwise comparison（ α＇ = 0. 025） showed that combination therapy group surpassed HXTLF group（ u = 162. 000,P =0. 003） and there was no statistical difference between Yunke group and combination therapy group（ u = 218. 000,P = 0. 045） and between Yunke group and HXTLF group（ u = 251. 000,P = 0. 232） in AOFAS ankle function scores. Five patients refused radiographic examination.At 6 months after the end of the treatment,4 patients got a good result,10 fair and 9 poor in HXTLF group; 6 patients got a good result,9fair and 8 poor in Yunke group; while 11 patients got a good result,10 fair and 3 poor in combination therapy group. There was statistical difference in radiographic evaluation results between the 3 groups（ χ-2= 6. 588,P = 0. 037）. Further pairwise comparison（ α＇ = 0. 025）showed that combination therapy group surpassed HXTLF group（ u = 99. 000,P = 0. 018） and there was no statistical difference between Yunke group and combination therapy group（ u = 113. 500,P = 0. 033） and between Yunke group and HXTLF group（ u = 195. 500,P =0. 513）. Conclusion： Intravenous drip of Yunke combined with oral application of self-made HXTLF can relieve the ankle pain and improve the ankle function,and its comprehensive curative effect is better than that of monotherapy of oral application of self-made HXTLF,and it also surpasses the monotherapy of intravenous drip of Yunke and the monotherapy of oral application of self-made HXTLF in relieving ankle pain,so it is worthy of popularizing in clinic.