亮丙瑞林注射液治疗子宫肌瘤的临床研究
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摘要
目的比较亮丙瑞林注射液和曲普瑞林注射液治疗子宫肌瘤的临床疗效和安全性。方法将127例子宫肌瘤患者随机分为对照组56例和试验组71例。对照组予以曲普瑞林注射液每次3. 75 mg,肌内注射,每4周1次(月经期第2天);试验组予以亮丙瑞林注射液每次3. 75 mg,皮下注射,每4周1次(月经期第2天)。2组患者均治疗3次。比较2组患者的临床疗效、血清瘦素(Leptin)、血管内皮生长因子(VEGF)和白细胞介素-8(IL-8)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90. 14%(64例/71例)和75. 00%(42例/56例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的血清Leptin水平分别为(8. 40±1. 17)和(10. 33±1. 28)μg·L~(-1),VEGF分别为(72. 59±8. 41)和(92. 66±14. 05)pg·m L~(-1),IL-8分别为(22. 45±2. 62)和(28. 51±3. 73) pg·m L~(-1),差异均有统计学意义(均P <0. 05)。2组患者的药物不良反应均以阴道轻微出血、潮热和皮疹为主,试验组和对照组的总药物不良反应发生率分别为18. 31%和25. 00%,差异无统计学意义(P>0. 05)。结论亮丙瑞林注射液治疗子宫肌瘤的临床疗效确切,其能有效地降低血清Leptin、VEGF和IL-8水平,且不增加药物不良反应的发生率。
Objective To compare the clinical efficacy and safety of leuprorelin injection and triptorelin injection in the treatment of uterine fibroids. Methods A total of 127 patients with uterine fibroids were randomly divided into control group( n = 56 cases) and treatment group( n = 71 cases). Control group received triptorelin injection 3. 75 mg per time,intramuscular injection,once every 4 weeks( day 2 of menstrual period). Treatment group was given leuprorelin injection 3. 75 mg per time,subcutaneous injection,once every 4 weeks( day 2 of menstrual period). Two groups were treated for 3 times. The clinical efficacy,levels of serum Leptin,vascular endothelial growth factor( VEGF) and interleukin-8( IL-8),and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 90. 14%( 64 cases/71 cases) and75. 00%( 42 cases/56 cases) with significant difference( P < 0. 05).After treatment,the main indexes of treatment and control groups were compared: serum Leptin were( 8. 40 ± 1. 17) and( 10. 33 ± 1. 28)μg·L~(-1),VEGF were( 72. 59 ± 8. 41) and( 92. 66 ± 14. 05)pg·m L~(-1),IL-8 were( 22. 45 ± 2. 62) and( 28. 51 ± 3. 73)pg·m L~(-1),the differences were statistically significant( all P < 0. 05).The adverse drug reactions of two groups were minor bleeding,hot flushes and skin rashes. The total incidences of adverse drug reactions in the treatment and control groups were 18. 31% and 25. 00% without significant difference( P > 0. 05). Conclusion Leuprorelin injection has a definitive clinical efficacy in the treatment of uterine fibroids,which can significantly reduce the levels of Leptin,VEGF and IL-8,without increasing the incidences of adverse drug reactions.
Objective To compare the clinical efficacy and safety of leuprorelin injection and triptorelin injection in the treatment of uterine fibroids. Methods A total of 127 patients with uterine fibroids were randomly divided into control group( n = 56 cases) and treatment group( n = 71 cases). Control group received triptorelin injection 3. 75 mg per time,intramuscular injection,once every 4 weeks( day 2 of menstrual period). Treatment group was given leuprorelin injection 3. 75 mg per time,subcutaneous injection,once every 4 weeks( day 2 of menstrual period). Two groups were treated for 3 times. The clinical efficacy,levels of serum Leptin,vascular endothelial growth factor( VEGF) and interleukin-8( IL-8),and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 90. 14%( 64 cases/71 cases) and75. 00%( 42 cases/56 cases) with significant difference( P < 0. 05).After treatment,the main indexes of treatment and control groups were compared: serum Leptin were( 8. 40 ± 1. 17) and( 10. 33 ± 1. 28)μg·L~(-1),VEGF were( 72. 59 ± 8. 41) and( 92. 66 ± 14. 05)pg·m L~(-1),IL-8 were( 22. 45 ± 2. 62) and( 28. 51 ± 3. 73)pg·m L~(-1),the differences were statistically significant( all P < 0. 05).The adverse drug reactions of two groups were minor bleeding,hot flushes and skin rashes. The total incidences of adverse drug reactions in the treatment and control groups were 18. 31% and 25. 00% without significant difference( P > 0. 05). Conclusion Leuprorelin injection has a definitive clinical efficacy in the treatment of uterine fibroids,which can significantly reduce the levels of Leptin,VEGF and IL-8,without increasing the incidences of adverse drug reactions.
引文
[1]LAUGHLIN-TOMMASO S K,HESLEY G K,et al.Clinical limitations of the international federation of gynecology and obstetrics(FIGO)classification of uterine fibroids[J].Int J Gynaecol Obstet,2017,139(2):143-148.
[2]SOLIMAN A M,BONAFEDE M,FARR A M,et al.Analysis of adherence,persistence,and surgery among endometriosis patients treated withleuprolide acetate plus norethindrone acetate add-back therapy[J].J Manag Care Spec Pharm,2016,22(5):573-587.
[3]何红霞,段钊.子宫肌瘤患者血清细胞因子与MMPs相关性分析[J].中国妇幼健康研究,2014,25(3):416-417,447.
[4]张敏.妇科肿瘤学[M].北京:科学技术文献出版社,2013:79-80.
[5]JOO B S,PARK M J,KIM C W,et al.Differential expression of visfatin,leptin,stromal cell derived factor-1α,endothelial nitric oxide synthase,and vascular endothelial growth factor in human leiomyomas[J].Gynecol Endocrinol,2017,33(4):306-310.
[2]SOLIMAN A M,BONAFEDE M,FARR A M,et al.Analysis of adherence,persistence,and surgery among endometriosis patients treated withleuprolide acetate plus norethindrone acetate add-back therapy[J].J Manag Care Spec Pharm,2016,22(5):573-587.
[3]何红霞,段钊.子宫肌瘤患者血清细胞因子与MMPs相关性分析[J].中国妇幼健康研究,2014,25(3):416-417,447.
[4]张敏.妇科肿瘤学[M].北京:科学技术文献出版社,2013:79-80.
[5]JOO B S,PARK M J,KIM C W,et al.Differential expression of visfatin,leptin,stromal cell derived factor-1α,endothelial nitric oxide synthase,and vascular endothelial growth factor in human leiomyomas[J].Gynecol Endocrinol,2017,33(4):306-310.