骨康胶囊用于促进鼻骨骨折恢复的临床研究

Clinical trial of Gukang capsules for promoting the recovery of nasal bone fracture

目的观察骨康胶囊用于促进鼻骨骨折恢复的临床疗效及安全性。方法将80例外伤性闭合性鼻骨骨折患者随机分为对照组40例和试验组40例。对照组予以双氯芬酸钠每次75 mg,qd,口服;试验组予以骨康胶囊每次1. 2 g,tid,口服。2组患者均治疗8周。比较2组患者鼻周软组织和鼻骨骨折的愈合情况,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的皮肤光亮消退时间分别为(3. 50±0. 88)和(5. 50±1. 41) d,淤血消退时间分别为(9. 63±3. 43)和(18. 25±8. 10) d,皮纹出现时间分别为(13. 48±6. 98)和(18. 20±8. 50) d,骨痂初现时间分别为(17. 15±3. 53)和(28. 25±9. 18) d,骨折线模糊时间分别为(29. 80±9. 40)和(35. 75±12. 54) d,骨折线消失时间分别为(42. 80±12. 51)和(55. 50±6. 97) d,差异均有统计学意义(均P <0. 05)。试验组治疗期间未见药物不良反应,对照组的药物不良反应以胃部不适为主。试验组和对照组的总药物不良反应发生率分别为0和12. 50%,差异有统计学意义(P <0. 05)。结论骨康胶囊在促进鼻周软组织和鼻骨骨折愈合方面的临床疗效确切,且短期用药安全。

Objective To observe the clinical efficacy and safety of Gukang capsules in promoting the recovery of nasal bone fractures.Methods Eighty patients with traumatic closed nasal bone fractures were randomly divided into control group and treatment group with 40 cases per group. Control group was given diclofenac sodium 75 mg per time,qd. Treatment group was given Gukang capsule 1. 2 g per time,tid,orally. Two groups were treated for 8 weeks. The healing of nasal soft tissue and nasal bone fracture,and adverse drug reactions were compared between two groups. Results After treatment,the main indexes of treatment and control groups were compared： time of skin light fade was（ 3. 50 ± 0. 88） and（ 5. 50 ± 1. 41） d,time of congestion disappearance was（ 9. 63 ± 3. 43） and（ 18. 25 ± 8. 10） d,time of appearance of striae was（ 13. 48 ± 6. 98） and（ 18. 20 ± 8. 50） d,time of initial appearance of osteophytes was（ 17. 15 ± 3. 53） and（ 28. 25 ± 9. 18） d,time of fracture line blurring was（ 29. 80 ± 9. 40） and（ 35. 75 ± 12. 54）d,time of fracture line disappeared was（ 42. 80 ± 12. 51） and（ 55. 50 ± 6. 97） d,the differences were statistically significant（ all P〈0. 05）. There were no adverse drug reactions during the treatment period in the treatment group,and the adverse drug reactions of control group were gastric upsets. The total incidences of adverse drug reactionsin treatment and control groups were 0 and 12. 50% with significant difference（ P〈0. 05）. Conclusion Gukang capsules have a definitive clinical efficacy and safety in promoting the healing of nasal soft tissue and nasal bone fractures.