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醋酸亮丙瑞林微球治疗子宫内膜异位症患者的临床研究

Clinical trial of leuprolide acetate microspheres in the treatment of patients with endometriosis

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【作者】 吴春爱张琴罗文群

【Author】 WU Chun-ai;ZHANG Qin;LUO Wen-qun;Department of Obstetrics and Gynecology,Jingdezhen Hospital of Traditional Chinese Medicine;Department of Gynecology,Jiangxi Provincial People’s Hospital of Gynecology;

【通讯作者】 吴春爱;

【机构】 景德镇市中医医院妇产科江西省人民医院妇科

【摘要】 目的 观察醋酸亮丙瑞林微球对子宫内膜异位症患者血清糖类抗原125(CA125)、血管内皮生长因子(VEGF)表达的影响及临床疗效。方法 将子宫内膜异位症患者随机分为对照组和试验组。对照组给予孕三烯酮胶囊治疗,每次2.5 mg,每周2次;试验组在对照组治疗的基础上,皮下注射注射用醋酸亮丙瑞林微球,每次3.75 mg,每4周1次。比较2组患者临床疗效、血清因子水平、疼痛视觉模拟(VAS)评分、生活质量、雌激素水平[孕激素(P)、雌二醇(E2)、卵泡刺激素(FSH)及黄体生成素(LH)水平)]及药物不良反应。结果 试验过程中共脱落6例患者。治疗后,试验组和对照组的总有效率分别为93.75%(45例/48例)和74.47%(35例/47例),差异有统计学意义(P<0.05)。治疗6个月后,试验组和对照组的VAS评分分别为(1.01±0.18)和(3.25±0.28)分,血清VEGF分别为(108.23±21.01)和(134.21±27.45)ng·L-1,焦虑评分分别为(14.85±1.39)和(10.36±1.75)分,机体功能的评分分别为(14.86±2.31)和(12.23±1.85)分,社会关系评分分别为(12.38±3.05)和(9.85±1.57)分,CA125分别为(16.85±1.92)和(21.20±2.31)U·mL-1,E2分别为(243.16±31.05)和(261.23±36.47)pmol·L-1,FSH分别为(5.11±1.24)和(6.47±1.26)U·L-1,P分别为(16.12±5.21)和(18.54±6.26)nmol·L-1,差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有潮热、腰痛、腹痛,对照组的药物不良反应主要有潮热、腰痛、腹痛。试验组和对照组的总药物不良反应发生率分别为10.42%(5例/48例)和19.15%(9例/47例),差异无统计学意义(P>0.05)。结论 亮丙瑞林治疗子宫内膜异位患者有效缓解患者病情,降低患者炎症,提升患者生活质量。

【Abstract】 Objective To observe the effect of leprerelin acetate microspheres on the expression of serum carbohydrate antigen 125(CA125) and vascular endothelial growth factor(VEGF) in patients with endometriosis and its clinical efficacy. Methods The patients with endometriosis were randomly divided into control group and treatment group. The control group was treated with gestrinone capsules, 2.5 mg each time, twice a week. Treatment group received subcutaneous injection of leuprolide acetate microspheres, once every 4 weeks, 3.75 mg each time on the basis of the control group. The clinical efficacy, serum factor level, visual analogue scale(VAS)score of pain, quality of life, estrogen level [progesterone(P), estradiol(E2), follicle stimulating hormone(FSH) and luteinizing hormone(LH) levels] and adverse drug reactions were compared between the two groups.Results A total of 6 cases wereshed during the trail. After treatment, the overall response rate was 93. 75%(45 cases/48 cases) and 74. 47%(35cases/47 cases) in the treatment group and the control group, respectively, and the difference was statisticallysignificant(P< 0. 05). After treatment, the serum VEGF and levels were(108. 23 ± 21. 01) and(134. 21 ± 27. 45)ng·L-1in the treatment and the control group, the serum CA125 levels of the treatment and the control group were(16. 85 ± 1. 92) and( 21. 20 ± 2. 31) U·mL-1, respectively, and the difference was statistically significant(P< 0. 05). At 6 months after treatment, the VAS scores of the treatment group and the control group were(1. 01 ± 0. 18) and(3. 25 ± 0. 28) points, respectively; the anxiety scores of the treatment group and the control groupwere( 14. 85 ± 1. 39) and( 10. 36 ± 1. 75) points; the scores of body function were( 14. 86 ± 2. 31) and(12. 23 ± 1. 85) points; the scores of social relationship were( 12. 38 ± 3. 05) and( 9. 85 ± 1. 57) points,respectively; the E2 levels of the treatment group and the control group were(243. 16 ± 31. 05) and(261. 23 ± 36. 47)pmol·L-1; FSH levels in the treatment and control groups were(5. 11 ± 1. 24) and(6. 47 ± 1. 26) U·L-1, and Plevels in the treatment and control groups were(16. 12 ± 5. 21) and(18. 54 ± 6. 26) nmol·L-1, and the differenceswere statistically significant(allP< 0. 05); the adverse drug reactions in the treatment group were mainly hot flashes,low back pain, and abdominal pain, and the adverse drug reactions in the control group were mainly hot flashes, lowback pain, and abdominal pain, and the total incidences in the treatment group and the control group were 10. 42%(5cases/48 cases) and 19. 15%(9 cases/47 cases), respectively, and the differences were no statistically significant(allP> 0. 05).Conclusion Leuprorelin in the treatment of endometriosis patients effectively relieves the patient’ scondition, reduces the inflammation of the patient, and improves the quality of life of the patient.

  • 【文献出处】 中国临床药理学杂志 ,The Chinese Journal of Clinical Pharmacology , 编辑部邮箱 ,2023年03期
  • 【分类号】R711.71
  • 【下载频次】35
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