摘要
目的:观察治伤消瘀丸治疗急性软组织损伤的治疗效果及安全性,为其临床应用及推广提供科学依据。方法:参照《中药新药临床研究指导原则》中Ⅲ期临床试验有关要求,临床上采用多中心、随机、对照的研究方法,将428例创伤后急性软组织损伤的病人随机分为治伤消瘀丸治疗组及三七片对照组,疗程为12d,观察记录治疗前后及过程中的主要症状、体征(压痛、肿胀、功能障碍等)及不良反应,进行自身治疗前后比较及两组间治疗效果比较。结果:各项观察指标治疗前后比较均有显著性差异,治疗组总显效率100%,对照组总显效率99.5%,两组统计学无明显差异(P>0.05)。两组均未见明显毒副反应。结论:两组比较治伤消瘀丸及三七片治疗急性软组织损伤均有显著效果,治伤消瘀丸能明显减轻患者伤后疼痛症状及较快消除肢体肿胀,治疗急性软组织损伤具有显著效果,且无明显的不良反应。
Objective： To observe curative effect and safety of ZHISAHNGXIAOYUWAN （ZSXYW, a TCM composition） to cure acute soft tissue injury, and provide scientific basis for it＇s clinical application and generalization, nethode： In accordance with the related requirement of clinical test in Ⅲ period from guideline of clinical investigation on new drug of TCM, according to the method of muhicentre, trabant and contrast, 428 cases of patients with acute soft tissue injury post - injury, were randomly divided into two groups, group A （therapy group, ZSXYW used） and group B （control group, Panax pseudo - ginseng pill used）. The course of treatment was 12 days. Then they were observed and recorded cardinal symptoms, objective signs （tenderness, swell and functional disturbance） and adverse effects pre - , in the corse of and post - treatment. The therapeutic efficacy of them were compared by self and interclass pre - and post - treatment. Results ：There had significant difference on all indexes observed in two groups pre - and post - treatment. The total excellence rate of group A was 100% , and that of group B was 99.5%, there had no obvious discrepancy on statistics （P 〉 0.05 ）. There had no obvious poisonous or adverse reaction. Conclusions： Both ZSXYW and Panax pseudo -ginseng pill had significant effect on curing acute soft tissue injury. ZSXYW could obviously ease pain of patients post - wound, and eliminate the swell of limbs quickly, and had no conspicuous adverse effect.
出处
《中医正骨》
2009年第8期14-16,共3页
The Journal of Traditional Chinese Orthopedics and Traumatology
