戊酸雌二醇片用于宫腔黏连术后的临床研究

Clinical trial of estradiol valproate tablets in the treatment of postoperative intrauterine adhesion

目的比较戊酸雌二醇片经阴道及口服给药用于宫腔黏连(IUA)术后的临床疗效及安全性。方法将300例IUA术后患者随机分为对照组168例和试验组132例。对照组予以戊酸雌二醇片每次2 mg,bid,口服;试验组予以戊酸雌二醇片每次1 mg,qd,阴道放置。2组患者均治疗21 d。比较2组患者的临床疗效,血清转化生长因子-β(TGF-β)和基质金属蛋白酶抑制因子-1(TIMP-1)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为91.67%(121例/132例)和87.50%(147例/168例),差异无统计学意义(P>0.05)。治疗后,试验组和对照组的TGF-β分别为(1373.80±105.83)和(1363.70±170.74)ng·L-1,TIMP-1分别为(134.89±11.46)和(131.85±18.98)μg·L-1,差异均无统计学意义(均P>0.05)。2组患者的药物不良反应均以消化道不适、乳房胀痛、阴道炎和宫腔黏连为主。试验组和对照组的总药物不良反应发生率分别为11.36%和29.76%,差异有统计学意义(P<0.05)。结论戊酸雌二醇片经阴道及口服给药对IUA术后患者的临床疗效相似,但前者的安全性更高。

Objective To compare the clinical efficacy and safety of estradiol valproate tablets administered orally and vaginally in the treatment of postoperative intrauterine adhesion(IUA).Methods A total of 300patients after IUA were randomly divided into control group(n=168 cases)and treatment group(n=132 cases).Control group was treated with estradiol valproate tablets 2 mg per time,bid,orally.Treatment group received estradiol valproate tablets 1 mg per time,qd,vaginally.Two groups were treated for 21 days.The clinical efficacy,serum levels of transforming growth factor-β(TGF-β)and tissue inhibitor of matrix metalloproteinase-1(TIMP-1),and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 91.67%(121 cases/132cases)and 87.50%(147 cases/168 cases)without significant difference(P>0.05).After treatment,the main indexes of treatment and control groups were compared:TGF-βwere(1373.80±105.83)and(1363.70±170.74)ng·L-1,TIMP-1 were(134.89±11.46)and(131.85±18.98)μg·L-1,the differences were not statistically significant(all P>0.05).The adverse drug reactions of two groupswere gastrointestinal discomfort,breast pain,vaginitis and uterine cavity adhesion.The total incidences of adverse drug reactions in treatment and control groups were 11.36%and 29.76%with significant difference(P<0.05).Conclusion The clinical efficacy of transvaginal administration of estradiol valproate tablets is similar to that of oral administration in patients after IUA,but the safety of the former is higher.