目的 研制三七骨康王胶囊,并对其治疗军事训练软组织损伤的有效性和安全性进行评价。方法 以中药三七、血竭为主要成分制备胶囊剂,并进行质量控制;将130例军事训练软组织损伤患者随机分为三七骨康王胶囊治疗组与对照组,两组均饭后服药,3粒/次,3次/d,15 d为一疗程。观察患者治疗前后临床症状、体征的变化。结果 两组治疗后第15天,VAS评分和ADL评分比治疗前明显改善,差异有统计学意义(P<0.05),治疗后第11天、15天治疗组ADL评分高于对照组,VAS低于对照组,差异有统计学意义(P<0.05)。治疗组总有效率(81.5%)明显优于对照组(55.4%),差异有统计学意义(P＜0.05)。结论 三七骨康王胶囊质量稳定,治疗军事训练软组织损伤疗效确切、安全可靠。

Objective To prepare the Sanqi Gukangwang capsules and evaluate its clinical efficacy and safety for treatment of acute soft tissue injury dur to military training. Methods Traditional Chinese Medicine containing Panax notoginseng and Resina dragonis were used as main components, accompanied by other medicines. The quality control of the capsules was made. By the randomized,double-blind, placebo-controlled parallel method, 130 patients with military training caused injuries of acute soft tissue were randomly divided into Sanqi Gukangwang capsules treatment group and control group, both orally after meal,3 capsules/time, 3 times/d,15 d for a course of treatment, and to observe the clinical symptoms and signs of change before and after treatment. Results The total effective rate was 81.5% in the treatment group,55.4% in the control group, the effect in treatment group was better than in the control group (P＜0.05); and after treatment,the pain,tenderness,swelling points ,ecchymosis, dysfunction points significantly decreased compared with the control group (P＜0.05),daily living (ADL) total score improved than in the control group (P＜0.05). The patients had no adverse events before and after treatment. Conclusions Sanqi Gukangwang capsules have the scientific and reasonable technology, the stable quality; its treatment of military training caused acute soft tissue injury is effectives safe and reliable.