妥塞敏治疗宫内节育器置入后出血的随机对照临床研究

Randomized Clinical Trials Of Transamin In Post-IUD Patients With Massive Bleeding

目的:探讨妥塞敏用于治疗放置宫内节育器(IUD)后出血过多的临床有效性和安全性。方法:将63例放置IUD后出血过多妇女随机分为妥塞敏组、妇科千金片组和维生素K组,每组21例,均在月经开始1～5d服药,连续服用2个周期,统计月经失血图评分,用药前进行血常规、凝血功能、肝功能和肾功能指标等检测。结果:月经失血图评分妥塞敏组用药后2月(112.58±73.61)较用药前(273.62±142.69)明显降低(P<0.01),与其他两组比较,差异也有显著性意义(P<0.05),妇科千金片组和维生素K组用药后无明显改善(P>0.05)。妥塞敏使用2个周期后血常规、凝血功能、肝功能和肾功能指标无明显改善(P>0.05)。结论:妥塞敏用于治疗放置IUD后出血过多,有较好的效果和安全性,值得临床应用。

Objective： Comparing with the Chinese traditional medicine Fu - Ke - Qian - Jin Tablets and vitamin K, the present study investigated the efficacy and safety of Transamin in post - IUD patients with massive bleeding. Methods： Sixty -three post -IUD female patients with massive bleeding was divided randomizedly into three groups： group A （ Transamin, n = 21 ）, group B （ Fu - Ke - Qian - Jin, n = 21 ） and group C （vitamin K, n =21 ）. Blood lose during menstruation was observed for two cycles. White blood cells count- ing, platelet counting, haematoglobin, hepatic function and renal function were evaluated before and after Transamin administration. Results： Scores of blood lose decreased significantly 2 months after（ 112.58 ± 73. 61 ） Transamin used than that before（ 273.62 ± 142.69 ） it administed （P 〈 0.01 ） , which showed significant difference compared with Group B or Group C （ P 〈 0.05 ） , but no significant difference was showed between group B and group C before and after drug used（ P 〉 0.1 ）. In addition, Transamin did not influenced the indicators of White blood cells counting, platelet counting, haematoglobin, hepatic function and renal function during two cycles. Conclusion： Transamin has better efficacy and safety for post - IUD female patients with massive bleeding which is worth being extended in clinical practice.