迈之灵预防桡骨头骨折伴内侧副韧带前束损伤术后异位骨化的临床研究

Clinical study of aescuven fort in the prevention of heterotopic ossification after operative treatment of radial head fractures with anterior bundle of medial collateral ligament injury

目的 探讨迈之灵与吲哚美辛预防桡骨头骨折伴肘内侧副韧带前束（AMCL）损伤术后异位骨化的早期临床疗效.方法 将41例桡骨头骨折伴AMCL损伤致肘外翻不稳定行手术治疗的患者,按照分层随机分组化法分为观察组（口服迈之灵）21例、对照组（口服吲哚美辛）20例.分别给予迈之灵600 mg/d或吲哚美辛75 mg/d,连续服用6周.用药期间统计两组胃肠道不良反应发生率,并给予对症处理.6周后行肘关节X射线检查统计异位骨化发生率,记录肘关节活动度（ROM）、改良肘关节美国特种外科医院（HSS）评分优良率.结果 胃肠道不良反应发生率观察组和对照组分别为9.5％和35.0％,两组差异有统计学意义（x2=4.651,P=0.027）.观察组异位骨化发生率为14.3％,对照组异位骨化发生率为15.0％,两组差异无统计学意义（x2 =0.206,P=0.948）.观察组肘关节活动度及改良肘关节HSS评分优良率分别为（119.2±19.7）°和86.9％,对照组分别为（120.8±16.3）°和88.7％,两组差异无统计学意义（=2.023,P=0.613;x2=0.176,P =0.675）.结论 口服迈之灵可有效预防桡骨头骨折伴AMCL损伤治疗术后异位骨化的形成,临床疗效与吲哚美辛相当,但胃肠道不良反应发生率明显低于吲哚美辛.

Objective To compare the clinical efficacy of aescuven fort and indomethacin in the prevention of heterotopic ossification （HO） after operative treatment of radial head fractures with anterior bundle of medial collateral ligament（AMCL） injury.Methods A total of 41 patients with radial head fracture combined with AMCL injury leading to elbow valgus instability were randomly divided into 21 cases of the observation group（aescuven fort） and the 20 cases of control group（indomethacin）,and were treated with aescuven fort of 600rng/d and indomethacin of 75rng/d for 6 weeks respectively.The incidence of adverse reactions of gastrointestinal tract in the two groups was statistically analyzed,and symptomatic treatment was given.Six weeks later,the incidence of HO was recorded by X-ray examination of the elbow joint.The range of motion （ROM） was recorded,and the excellent and good rate of the improved HSS score was calculated.The results were statistically analyzed.Results The incidence rates of gastrointestinal side effects in the observation group and control group were 9.5％ and 35.0％,respectively,and the difference was statistically significant between the two groups（x2 =4.651,P =0.027）.The incidence rate of HO in the observation groupwas 14.3％,which in the control group was 15.0％,there was no significant difference between the two groups（x2 =0.206,P =0.948）.The ROM and excellent and good rate of the improved HSS score in the observation group and control group were [（119.2 ± 19.7） ° and 86.9％]and [（120.8 ± 16.3） ° and 88.7％],respectively,and the differences were statistically significant（t =2.023,P=0.613;x2 =0.176,P =0.675）.Conclusion Aescuven fort can effectively prevent the formation of HO after operative treatment of radial head fracture with AMCL injury,similar with indomethacin.But the incidence rate of gastrointestinal side effects of aescuven fort is significantly lower than indomethacin.