手术联合人参皂苷Rg3治疗Ⅲ-Ⅳ期子宫内膜异位症的临床对照研究

Ginsenoside Rg3 in combination with surgery in patients with stage Ⅲ-Ⅳ endometriosis: a clinical control trial

目的比较人参皂苷Rg3与孕三烯酮治疗术后Ⅲ-Ⅳ期子宫内膜异位症的临床疗效及不良反应。方法 62例Ⅲ-Ⅳ期子宫内膜异位症保守手术后患者分为2组:人参皂苷Rg3组(研究组)32例,口服人参皂苷Rg320mg,每日1次,连续3个月为1个疗程。孕三烯酮组(阳性对照组)30例,口服孕三烯酮2.5mg,每周2次,连续3个月为1疗程,比较两组用药后的症状及体征的缓解情况、血清血管内皮生长因子(VEGF)及CA125的变化、肝功能的变化及药物不良反应发生情况。于术后1个月和3个月进行随访。结果 2组治疗后痛经和性交痛较治疗前得到明显缓解(P<0.05);2组患者治疗后体征均比治疗前明显缓解,血清CA125随用药时间的增加而下降(P<0.05),2组间差异无统计学意义(P>0.05);研究组血清VEGF在用药治疗3个月时比术前明显下降(P<0.05),与对照组比差异有统计学意义(P<0.05);研究组用药后丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、谷氨酰胺转肽酶(GGT)均比用药前无明显变化(P>0.05),阳性对照组在用药后ALT和AST均升高,治疗前与治疗后1个月和3个月之间相比差异有统计学意义(P<0.05),GGT在用药3个月时稍微升高(P<0.05);2组之间比较差异有统计学意义(P<0.05)。研究组用药期间药物不良反应发生率低于阳性对照组(P<0.01)。结论子宫内膜异位症术后使用药物治疗疗效好;人参皂苷Rg3对子宫内膜异位症的疗效与孕三烯酮相当,且不良反应少,对肝功能、月经无影响,是临床上子宫内膜异位症保守手术后的安全辅助药物。

Objective To compare the effects of ginsenoside Rg3 and gestrinone on clinical outcomes and sideeffects in patients with stage Ⅲ-Ⅳ postoperative endometriosis. Methods A cohort of 62 consecutive patients with stage Ⅲ-Ⅳ postoperative endometriosis were assigned into study group （n=32） to recetve ginsenoside Rg3 therapy （20 mg, orally, once daily） for 3 successive months as a treatment course, and positive control group （n=30） to be treated with gestrinone （2.5 rag, orally, twice weekly） for 3 consecutive months as a treatment course, respectively. Remission of symptoms and signs, alteration in serum CA125 and VEGF, variation in liver function and side-effects were compared for assessment of efficacy and safety. Follow-up studies were scheduled at months 1 and 3 postoperatively. Resuits Both groups yielded marked amelioration in dysmenorrhea and dyspareunia （both P〈0.05）, no considerable difference was revealed between both groups （all P〉0.05）. Treatments were associated with marked remission of signs （P〈 0.05） in spite of statistically insignificant between-group difference （P〉0.05）. Serum CA125 declined with time （P〈 0.01）, yet lacking statistical significance （P〉0.05） for between-group comparison. At month 3 postoperatively, study group was found to present lower serum VEGF than preoperative level and control group （both P〈0.05）. Study group did not show evidence of altered serum ALT, AST and GGT after treatment （all P〉0.05）, and by contrast, positive con- trol group was noted as having elevated serum ALT and AST at months 1 and 3 after treatment （all P〈0.05）. Between- group comparison yielded statistical difference （P〈0.05） in the slight increase in GGT at month 3 after treatment （P〈 0.05）. Lower incidence of side-effects （P〈0.01） was reported in the study group, but not in positive control group. Conclusion Postoperative administration of adjuvant medication is associated with satisfactory outcomes in patients with endometriosis. Ginsenoside Rg3 achieved equivalently high efficacy, low incidence rate of side-effects in addition to absence of adverse impact on liver function and menstruation as compared with gestrinone, thus allowing it to be considered as clinically effective adjuvant medication in patients with endometriosis who underwent conservative operation.