灵通胶囊治疗原发性痛经随机双盲对照临床研究

Treating Primary Dysmenorrhea by Lingtong Capsule:a Randomized Double-blind Clinical Observation

目的观察灵通胶囊治疗原发性痛经(primary dysmenorrhea,PD)的临床疗效。方法采用灵通胶囊治疗PD 59例,与安慰剂组59例对照,分别于痛经时即刻服用灵通胶囊2粒和安慰剂胶囊2粒,将疼痛程度分级量化,于服药时及服药后2h内采用疼痛视觉模拟评分法(visual analogue scale/score,VAS)评价每30min疼痛评分,以服药后2h疼痛减轻程度≥50%作为有效。结果灵通胶囊组、安慰剂组的总有效率分别为69.49%(41/59)和20.34%(12/59),差异有统计学意义(P<0.01);服药60min后,灵通胶囊组的止痛效果明显优于安慰剂组(P<0.01);灵通胶囊组对轻、中和重度的PD均有显著疗效,且显著优于安慰剂组(P<0.05)。结论灵通胶囊对PD有明显的止痛疗效。

Objective To observe the clinical effect of Lingtong Capsule （LC） in treating primary dysmenorrheal （PD）. Methods Totally 59 PD patients took LC, while 59 patients in theplacebo group took placebo capsule, two pills immediately when they felt dysmenorrhea. Their pain levels were quantitatively classified. The pain score was assessed at an interval of 30 rain using visual analogue scale/score （VAS） while taking medicine and within two h after taking medicine. It was assessed as effective when the pain level was reduced by more than or equal to 50% within 2 h. Results The total effective rate was 69.49% （41/ 59） in the LC group and 20.34% （12/59） in the placebo group （P 〈0.01 ）. The analgesia effect was obviously superior in the LC group 60 min after taking medicine （P 〈0.01 ）. LC showed better effect in treating mild, moderate, and severe PD （P 〈0.05）. Conclusion LC showed obvious analgesia effect on PD.