自拟行气解毒方联合戈舍瑞林治疗子宫内膜异位症的临床研究

Clinical study of self-made Xingqi Jiedu Decoction combined with goserelin in the treatment of endometriosis

目的评价自拟行气解毒方联合戈舍瑞林治疗子宫内膜异位症(EMT)的疗效。方法随机对照试验研究。选取2019年7月-2021年7月本院84例EMT患者作为观察对象,按随机数字表法分为2组,每组42例。对照组皮下注射戈舍瑞林,观察组在对照组基础上服用自拟行气解毒方。2组均持续治疗6个月。分别于治疗前后进行中医证候评分,采用VAS量表评估盆腔痛程度;采用全自动化学发光免疫分析仪检测血浆FSH、LH和雌二醇(E2)水平,ELISA法检测血清IL-1β、IL-8和TNF-α水平;记录不良反应,评价临床疗效。结果观察组总有效率为95.24%(40/42)、对照组为80.95%(34/42),2组比较差异有统计学意义(χ^(2)=4.09,P=0.043)。观察组治疗后中医证候积分、VAS评分低于对照组(t值分别为14.30、7.32,P<0.01)。治疗后,观察组血浆FSH[(5.36±1.03)U/L比(6.20±1.35)U/L,t=3.21]、E2[(230.57±36.84)pmol/L比(265.28±37.53)pmol/L,t=4.28]、LH[(8.15±1.18)U/L比(9.24±2.01)U/L,t=3.03]水平低于对照组(P<0.01);血清IL-1β、IL-8、TNF-α水平低于对照组(t值分别为5.05、5.07、3.82,P<0.01)。治疗期间,对照组不良反应发生率为19.05%(8/42)、观察组为4.76%(2/42),2组比较差异有统计学意义(χ^(2)=4.09,P=0.043)。结论自拟行气解毒方联合戈舍瑞林可有效改善EMT患者的激素水平,抑制机体炎症反应,提高临床疗效。

Objective To evaluate the curative effect of self-made Xingqi Jiedu Decoction combined with goserelin for endometriosis(EMT).Methods Randomized controlled trial.A total of 84 patients with EMT in the hospital were enrolled as observation objects between July 2019 and July 2021.According to random number table method,they were divided into the control group(subcutaneous injection of goserelin)and the observation group(self-made Xingqi Jiedu Decoction on basis of control group),42 in each group.All were treated for 6 months.TCM syndromes were scored before and after treatment.The severity of pelvic pain was evaluated by VAS.The levels of FSH,LH and estradiol(E2)were detected by full-automatic chemiluminescence immunoassay and corresponding reagents,and levels of serum IL-1β,IL-8 and TNF-αwere detected by ELISA.The adverse events were recorded,and clinical curative effect was evaluated.Results The differences in total response rate between observation group and control group was statistically significant[95.24%(40/42)vs.80.95%(34/42);χ^(2)=4.09,P=0.043].After treatment,scores of TCM syndromes and VAS in observation group were significantly lower than those in the control group(t=14.30,7.32,P<0.01).After treatment,FSH[(5.36±1.03)U/L vs.(6.20±1.35)U/L,t=3.21],E2[(230.57±36.84)pmol/L vs.(265.28±37.53)pmol/L,t=4.28]and LH[(8.15±1.18)U/L vs.(9.24±2.01)U/L,t=3.03]in the observation group were significantly lower than those in the control group(P<0.01).The levels of IL-1β,IL-8 and TNF-αin the observation group were significantly lower than those in the control group(t=5.05,5.07,3.82,P<0.01).During treatment,differences in incidence of adverse reactions between observation group and control group was statistically significant[19.05%(8/42)vs.4.76%(2/42);χ^(2)=4.09,P=0.043].Conclusion The self-made Xingqi Jiedu Decoction combined with goserelin can improve hormone level,inhibit inflammatory response and improve clinical curative effect in EMT patients.