盐酸曲马多缓释片联合鹿瓜多肽注射液用于胫骨骨折患者术后的临床研究

Clinical trial of tramadol hydrochloride sustained-release tablets combined with cervus and cucumis polypeptide injection in the treatment of patients with tibial fracture

目的观察盐酸曲马多缓释片联合鹿瓜多肽注射液用于胫骨骨折患者术后的临床疗效及安全性。方法将78例胫骨骨折手术患者随机分为对照组和试验组,每组39例。对照组予以鹿瓜多肽每次8～12 mL,qd,静脉滴注;试验组在对照组治疗的基础上,予以盐酸曲马多首剂50 mg,后以50 mg的剂量递增,单日剂量不超过400 mg,bid,口服。2组患者均治疗15 d。比较2组患者的临床疗效,骨源性碱性磷酸酶(BALP)、Ⅰ型前胶原羧基端肽(PICP)和血清骨钙素(BGP)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为92. 31%(36例/39例)和71. 79%(28例/39例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的BALP分别为(276. 98±14. 76)和(225. 53±22. 66) U·L^(-1),PICP分别为(57. 25±21. 32)和(82. 53±25. 43)μg·L^(-1),BGP分别为(4. 54±0. 68)和(3. 48±0. 47)μg·L^(-1),差异均有统计学意义(均P <0. 05)。2组患者发生的药物不良反应均以恶心呕吐、头昏和嗜睡为主,试验组和对照组的总药物不良反应发生率分别为10. 26%和12. 82%,差异无统计学意义(P> 0. 05)。结论盐酸曲马多缓释片联合鹿瓜多肽注射液用于胫骨骨折患者术后的临床疗效显著,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of tramadol hydrochloride sustained-release tablets combined with cervus and cucumis polypeptide injection in the treatment of patients with tibial fracture. Methods A total of 78 patients with tibial fracture were randomly divided into control and treatment groups with 39 cases per group. Control group was given cervus and cucumis polypeptide injection 8-12 mL per time,qd,intravenous drip. Treatment group was given the first dose of tramadol hydrochloride 50 mg,then the dose was increased by 50 mg,and the daily dose should not exceed 400 mg,bid,orally,on the basis of control group. The clinical efficacy,levels of bone alkaline phosphatase( BALP),type I-precollagen carboxyl-terminal peptide( PICP) and osteocalcin( BGP),and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 92. 31%( 36 cases/39 cases) and71. 79%( 28 cases/39 cases) with significant difference( P < 0. 05).After treatment,the main indexes of treatment and control groups were compared: BALP were( 276. 98 ± 14. 76) and( 225. 53 ± 22. 66) U·L-1,PICP were( 57. 25 ± 21. 32) and( 82. 53 ± 25. 43) μg·L-1,BGP were( 4. 54 ± 0. 68)and( 3. 48 ± 0. 47) μg·L-1,the differences were statistically significant( all P < 0. 05). The adverse drug reactions of two groups were mainly nausea,vomiting,dizziness and drowsiness. The total incidences of adverse drug reactions in the treatment and control groups were 10. 26% and 12. 82% without significant difference( P > 0. 05). Conclusion Tramadol hydrochloride sustained-release tablets combined with cervus and cucumis polypeptide injection have a definitive clinical efficacy in the treatment of patients with tibial fractures,without increasing the incidence of adverse drug reactions.