首页|调冲化瘀方治疗卵巢子宫内膜异位囊肿的双盲、随机、安慰剂对照研究

调冲化瘀方治疗卵巢子宫内膜异位囊肿的双盲、随机、安慰剂对照研究

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目的 评估调冲化瘀方治疗气滞血瘀型卵巢子宫内膜异位囊肿的有效性和安全性.方法 从2020年9月-2023年8月就诊于江西中医药大学第二附属医院的气滞血瘀型卵巢子宫内膜异位囊肿患者中选择符合条件的受试者64例,按1:1的比例随机分配到治疗组或对照组.治疗组予以调冲化瘀方颗粒口服,对照组予以安慰剂颗粒口服,治疗3个月后比较2组囊肿大小、疼痛VAS评分、血清CA125水平、生活质量[采用子宫内膜异位症健康相关生命质量量表(EHP-30)评估],统计2组不良事件发生情况.结果 对照组30例、治疗组31例完成研究.与治疗前比较,治疗组治疗3个月后囊肿缩小(P<0.05),疼痛VAS评分和生活质量EHP-30量表中各项评分均明显下降(P均<0.05),血清CA125水平无明显变化(P>0.05),对照组上述指标均无明显变化(P均>0.05);治疗后,治疗组疼痛VAS评分和EHP-30量表中的疼痛、控制和无力感、情感健康3个维度的评分均明显低于对照组(P均<0.05),2组囊肿大小、血清CA125水平和EHP-30量表中的社会支持、自我形象维度评分比较差异均无统计学意义(P均>0.05).治疗期间2组均无明显不良事件发生.结论 调冲化瘀方可以减轻气滞血瘀型卵巢子宫内膜异位囊肿患者的疼痛,改善其生活质量,且无明显不良反应.
Efficacy of decoction for regulating thoroughfare vessel and resolving stasis on ovarian endometriosis cyst:a randomized double-blind placebo-controlled trial
Objective It is to evaluate the efficacy and safety of decoction for regulating thoroughfare vessel and resol-ving stasis in the treatment of ovarian endometriosis cyst of type of Qi stagnation and blood stasis.Methods Sixty-four eligi-ble subjects were selected from the patients with ovarian endometriosis cyst of type of Qi stagnation and blood stasis treated in the Second Affiliated Hospital of Jiangxi University of Chinese Medicine from September 2020 to August 2023,and were randomly assigned to either the treatment group or the control group in a 1∶1 ratio.The treatment group was treated with granules of decoction for regulating thoroughfare vessel and resolving stasis,and the control group was treated with granules of placebo,both groups were treated for 3 months.The cyst size,pain VAS score,serum level of CA125,and quality of life[assessed by Endometriosis Health Profile-30(EHP-30)]after 3 months of treatment were compared between the two groups,and the adverse events in both groups were counted.Results Thirty cases in the control group and 31 cases in the treatment group completed the study.Compared with before treatment,the cyst size was decreased(P<0.05),the pain VAS score and all scores of items of EHP-30 were significantly decreased(all P<0.05),but there was no significant change in the serum level of CA125 in the treatment group after 3 months of treatment(P>0.05),and there was no signif-icant change in the above indexes in the control groupafter 3 months of treatment(all P>0.05).After treatment,the pain VAS score and the scores of 3 dimensions of pain,control and powerlessness and emotional health in the EHP-30 scale in the treatment group were significantly lower than those in the control group(all P<0.05),but the differences in cyst size,serum CA125 level,and scores of dimensions of social support and self-image in the EHP-30 scale were not statistically sig-nificant between the two groups(all P>0.05).No significant adverse events occurred in the two groups during treatment.Conclusion Decoction for regulating thoroughfare vessel and resolving stasis can relieve pain and improve quality of life without obvious side effect in women with ovarian endometriosis cyst of type of Qi stagnation and blood stasis.

ovarian endometriosis cystendometriosisdecoction for regulating thoroughfare vessel and resolving sta-sispainquality of life

彭雪梅、彭佳华、徐玲、梁瑞宁

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江西中医药大学第二附属医院,江西南昌 330012

江西中医药大学中医妇产科学研究所,江西 南昌 330006

卵巢子宫内膜异位囊肿 子宫内膜异位症 调冲化瘀方 疼痛 生活质量

江西省重点研发计划项目江西省中医药管理局科技计划项目

20202BBGL730092022B249

2024

现代中西医结合杂志
中国中西医结合学会河北分会,中华中医药学会

现代中西医结合杂志

CSTPCD
影响因子:1.775
ISSN:1008-8849
年,卷(期):2024.33(12)
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