疼痛方外敷治疗踝关节骨折后急性软组织损伤的临床研究

Clinical research of Tengtong Formula with external application in the treatment of acute soft tissue injury after ankle fracture

目的观察疼痛方外敷治疗踝关节B型骨折(AO分型)后急性软组织损伤的临床疗效。方法将60例踝关节B型骨折患者随机分为扶他林组和疼痛方组,每组30例;两组均给予抬高患肢、制动固定等常规处理措施,扶他林组同时给予扶他林乳剂外涂,疼痛方组给予中药疼痛方外敷。分别于治疗前、伤后24 h、伤后48 h,测定患肢的肢体周径差、疼痛评分、血清创伤指标(CK)、血清炎症指标(CRP、IL-6),并随访观察不良事件(皮肤过敏、切口感染、切口延迟愈合)的发生情况。结果 (1)扶他林组伤后的肢体周径差在48 h内呈进行性升高;疼痛方组肢体周径差在伤后24 h时达到峰值,伤后48 h时显著下降,不仅低于本组伤后24 h和治疗前,同时也显著低于同期扶他林组(均P<0.05)。扶他林组与疼痛方组的止痛效果均确切,且差异无统计学意义(P>0.05)。(2)扶他林组各观察时点的血清CK值差异无统计学意义(P>0.05),而疼痛方组伤后48 h较本组伤后24 h和治疗前显著降低(均P<0.05);扶他林组伤后24 h和伤后48 h时的CRP、IL-6水平均显著高于治疗前(均P<0.05),而疼痛方组伤后48 h时的CRP、IL-6水平均显著低于本组治疗前及同期扶他林组(均P<0.05)。(3)组间不良事件发生情况比较,差异无统计学意义(P>0.05)。结论疼痛方可有效减轻踝关节B型骨折后急性软组织损伤患者的疼痛和肢体肿胀程度,改善血清创伤和炎症指标;在消肿和抑制炎症方面,效果优于扶他林乳剂;不良反应发生率无明显增加。

Objective To observe the clinical efficacy of Tengtong Formula with external application in the treatment of acute soft tissue injury after type B ankle fracture( AO classification). Methods 60 patients with type B ankle fracture were randomly divided into the Voltaren group and Tengtong Formula group,30 cases in each group. Both groups were treated with conventional measures including lifting affected limbs,stopping activities and immobilization. Meanwhile the Voltaren group was treated with Votalin Emulgel( diclofenac diethylamine emulgel) by external application,and the Tengtong Formula group was treated with Tengtong Formula by external application. Before treatment,24 and 48 hours after injury,the limb circumference difference of affected limb,visual analogue scale( VAS) score,serum trauma indicator creatine kinase( CK),serum inflammation indicators including C-reactive protein( CRP) and interleukin-6( IL-6) were determined,and the adverse events( skin allergy,incisional infection,incision delayed union) were observed during follow-up. Results(1)In the Voltaren group,the limb circumference difference was increased progressively during 48 hours after injury. In the Tengtong Formula group,the limb circumference difference was up to peak at 24 h and was significantly decreased at 48 h after injury,and the limb circumference difference at 48 h was lower than that at 24 h or before treatment( P < 0. 05). 48 hours after injury,the limb circumference difference in the Tengtong Formula group was also significantly lower than that in the Voltaren group( P< 0. 05). There was definite analgesic effect in the Voltaren group and Tengtong Formula group,with no statistical difference( P > 0. 05).(2) There were no statistically significant differences on serum CK level among each observation timepoint in the Voltaren group( P > 0. 05); while in the Tengtong Formula group,the serum CK level at 48 h was significantly lower than that at 24 h or before treatment( P < 0. 05). Compared with treatment before,the levels of CRP and IL-6 were significantly increased at 24 h and 48 h in the Voltaren group( P < 0. 05),and the levels of CRP and IL-6 were significantly decreased at 48 h in the Tengtong Formula group( P < 0. 05). 48 hours after injury,the levels of CRP and IL-6 in the Tengtong Formula group were significantly lower than those in the Voltaren group( P < 0. 05).(3) There was no statistically significant difference on the incidence of adverse events between the two groups( P > 0. 05). Conclusion Tengtong Formula can effectively reduce the pain and limb swelling of patients with acute soft tissue injury after type B ankle fracture,improve the serum trauma and inflammation indicators. Its effects of relieving swelling and suppressing inflammation are better than that of Votalin Emulgel,with no obvious increasing on incidence of adverse events.