朱氏清热化瘀方治疗瘀热互结型子宫内膜异位症盆腔相关性疼痛的多中心随机对照研究

Zhu's Qingre Huayu Recipe in the treatment of pelvic related pain due to endometriosis with syndrome of intermingled blood stasis and heat: A Multicenter,randomized and controlled trial

目的观察朱氏清热化瘀方治疗瘀热互结型子宫内膜异位症盆腔相关性疼痛的临床疗效。方法将120例瘀热互结型子宫内膜异位症相关性疼痛患者随机分为治疗组和对照组,每组60例。治疗组予朱氏清热化瘀方,对照组予血府逐瘀胶囊。两组疗程均为3个月,观察比较盆腔相关性疼痛评分、中医证候积分、血清糖类抗原125(CA-125)、细胞间黏附相关因子(ICAM-1)及盆腔囊肿的变化情况。结果 (1)最终完成试验者117例,治疗组60例,对照组57例。(2)组间治疗后比较,痛经、非经期下腹痛、排便痛评分差异有统计学意义,治疗组比对照组下降更加明显(P<0.05)。(3)组间治疗前后差值比较,治疗组中医证候积分下降程度明显强于对照组(P<0.05)。(4)组间治疗后比较,ICAM-1水平差异有统计学意义,治疗组明显低于对照组(P<0.05),而CA-125水平差异无统计学意义(P>0.05)。(5)中医瘀热互结证证候积分与血清ICAM-1存在直线正相关关系。(6)组间治疗前后差值比较,盆腔囊肿径线差异无统计学意义(P>0.05)。结论朱氏清热化瘀方治疗瘀热互结型子宫内膜异位症盆腔相关性疼痛的疗效满意,可明显减轻疼痛,改善临床症状,其机制可能与降低盆腔炎症黏附相关因子(ICAM-1)有关。

Objective To observe the clinical efficacy of Zhu＇s Qingre Huayu Recipe in the treatment of pelvic related pain due to endometriosis with syndrome of intermingled blood stasis and heat. Methods 120 endometriosis patients of intermingled blood stasis and heat syndrome with pelvic related pain were randomly divided into the treatment group and control group,60 cases in each group. The treatment group was treated with Zhu＇s Qingre Huayu Recipe,and the control group was treated with Xuefu Zhuyu Capsule,with a course of 3 months. The changes on the scores of pelvic related pain,Chinese medical syndrome score,serum carbohydrate antigen-125（ CA-125）,intercellular adhesion molecule-1（ ICAM-1） and pelvic cyst were observed and compared. Results （1）Finally 117 cases completed the trial,among 60 cases in the treatment group and 57 cases in the control group.（2） After treatment,there were statistically significant differences on the scores of dysmenorrhea,hypogastralgia in nonmenstrual period and dyschezia between the two groups,and the scores of the treatment group were obviously lower than those of the control group（ P 0. 05）.（3） For the comparison of difference of treatment before and after,the difference on Chinese medical syndrome score in the treatment group was more greater than that in the control group（ P 0. 05）.（4）After treatment,there was statistically significant difference on the ICAM-1 level between the two groups,and the ICAM-1 level of the treatment group was obviously lower than that of the control groups（ P 0. 05）. But there was no statistically significant difference on the CA-125 level between the two groups（ P 0. 05）.（5）There was a linear and positive correlation between the syndrome score of intermingled blood stasis and heat and serum ICAM-1 level.（6）For the comparison of difference of treatment before and after between the two groups,the difference on radial line of pelvic cyst was not statistically significant（ P 0. 05）. Conclusion Zhu＇s Qingre Huayu Recipe shows good efficacy in the treatment of pelvic related pain due to endometriosis with syndrome of intermingled blood stasis and heat,which can significantly alleviate the pain and improve the clinical symptoms. Its mechanism may be associated with reduction of ICAM-1 that related to pelvic inflammatory adhesion.