【目的】观察养血散寒通脉方（由当归四逆加吴茱萸生姜汤加减而成）治疗血虚寒凝型子宫内膜异位症（EMS）的临床疗 效。【方法】将120例血虚寒凝型EMS患者随机分为研究组和对照组，每组各60例。研究组给予养血散寒通脉方治疗，对照 组给予少腹逐瘀颗粒治疗，疗程为3个月，并于疗程结束后随访1年。观察2组患者治疗前后各种疼痛评分[包括经期腹痛视 觉模拟量表（VAS）评分和痛经、非经期盆腔痛、性交痛、盆腔压痛、骶韧带结节触痛分级评分]、卵巢子宫内膜异位囊肿大 小及血清糖类抗原125（CA125）、血管内皮生长因子（VEGF）、可溶性细胞间黏附分子1（SICAM-1）、基质金属蛋白酶9 （MMP-9）、组织金属蛋白酶抑制因子2（TIMP-2）水平的变化情况，并观察2组患者的临床疗效、安全性、复发情况及妊娠情 况。【结果】（1）研究过程中，研究组脱落3例，对照组脱落5例，最终共112例患者纳入统计分析，其中研究组57例，对照 组55例。（2）治疗3个月后，研究组的总有效率为92.98%（53/57），对照组为85.45%（47/55），组间比较，研究组的疗效明显 优于对照组（P＜0.05）。（3）治疗后，2组患者的各种疼痛评分（包括经期腹痛VAS评分和痛经、非经期盆腔痛、性交痛、盆腔 压痛、骶韧带结节触痛分级评分）均较治疗前明显下降（P＜0.05），且研究组的下降幅度均明显优于对照组（P＜0.05）。（4）治 疗后，2组患者的卵巢子宫内膜异位囊肿均略有缩小，但组内治疗前后及治疗后组间比较，差异均无统计学意义（P＞ 0.05）。（5）治疗后，2组患者血清CA125、VEGF、SICAM-1、MMP-9水平均较治疗前下降（P＜0.05），血清TIMP-2水平均较 治疗前升高（P＜0.05），且研究组对血清CA125、VEGF、SICAM-1、MMP-9水平的下降幅度及对血清TIMP-2水平的升高幅 度均明显优于对照组（P＜0.05）。（6）随访1年，研究组的复发率为30.19%（16/53），明显低于对照组的68.09%（32/47），组间 比较，差异有统计学意义（P＜0.05）。研究组21例有生育要求，其中14例妊娠，妊娠率为66.67%（14/21）；对照组20例有生 育要求，其中4例妊娠，妊娠率为20.00%（4/20）；组间比较，研究组的妊娠率明显高于对照组，差异有统计学意义（P＜ 0.05）。（7）治疗期间，2组患者均无明显不良反应发生，且患者的血、尿、大便常规及心电图、肝肾功能等安全性指标均无异 常变化。【结论】养血散寒通脉方治疗血虚寒凝型EMS患者疗效确切，能够显著缓解患者各种疼痛症状，改善妊娠结局，有 效调节血清CA125、VEGF、SICAM-1、MMP-9、TIMP-2水平。

Objective To observe the clinical efficacy of Yangxue Sanhan Tongmai Prescription（derived from the modification of Danggui Sini plus Wuzhuyu Shengjiang Decoction， i.e.， Danggui Sini Decoction with Euodiae Fructus and Zingiberis Rhizoma Recens added）for the treatment of endometriosis（EMS）of blood deficiency and cold coagulation type. Methods A total of 120 cases of EMS with blood deficiency and cold coagulation syndrome were randomly divided into the study group and the control group，with 60 cases in each group. The study group was treated with Yangxue Sanhan Tongmai Prescription， and the control group was treated with Shaofu Zhuyu Granules. Both groups were treated for a period of 3 months，and were followed up for one year after the completion of the treatment. The two groups were observed in the changes of the visual analogue scale（VAS） scores of menstrual abdominal pain，the grading scores of dysmenorrhea，non-menstrual pelvic pain，pain during sexual intercourse，pelvic pressure pain and sacral ligament tenderness，the size of ovarian endometriosis cysts，and the serum levels of carbohydrate antigen 125（CA125）， vascular endothelial growth factor（VEGF）， soluble intercellular adhesion molecule 1（SICAM- 1）， matrix metalloproteinase 9（MMP- 9） and tissue inhibitor of metalloproteinase 2（TIMP-2）. After treatment，the clinical efficacy and safety，recurrence and pregnancy in the two groups were evaluated. Results （1）In the course of the trial，3 cases fell off in the study group and 5 cases fell off in the control group，and a total of 112 patients were eventually included in the statistical analysis，including 57 cases in the study group and 55 cases in the control group.（2）After 3 months of treatment，the total effective rate in the study group was 92.98%（53/57）and that in the control group was 85.45%（47/55），and the intergroup comparison showed that the efficacy of the study group was significantly superior to that of the control group（P＜ 0.05）.（3）After treatment， VAS scores of menstrual abdominal pain and the grading scores of dysmenorrhea， non-menstrual pelvic pain，pain during sexual intercourse，pelvic pressure pain and sacral ligament tenderness in the two groups were significantly reduced compared with those before treatment（P＜0.05），and the reduction in the study group was significantly superior to that in the control group（P＜0.05）.（4）After treatment， the ovarian endometriosis cysts of the two groups were slightly reduced，but the intragroup pre- and post-treatment differences and the intergroup post-treatment differences were not statistically significant（P＞0.05）.（5）After treatment，the levels of serum CA125，VEGF，SICAM-1 and MMP-9 were decreased and the serum TIMP-2 level was increased in both groups compared with those before treatment（P＜0.05）. And the decrease of serum CA125， VEGF， SICAM- 1 and MMP- 9 as well as the increase of serum TIMP- 2 in the study group were significantly superior to those in the control group（P＜0.05）.（6）The results of one-year follow-up showed that the recurrence rate of the study group was 30.19%（16/53）， which was significantly lower than that of the control group（68.09%，32/47），and the difference was statistically significant between the two groups（P＜0.05）. In the study group， there were 21 patients having the fertility desire， and then 14 cases of them were pregnant after treatment，with a pregnancy rate of 66.67%（14/21）；in the control group，there were 20 cases having fertility desire， and then 4 cases of them were pregnant after treatment， with a pregnancy rate of 20.00%（4/20）. The intergroup comparison showed that the pregnancy rate of the study group was significantly higher than that of the control group，and the difference was statistically significant（P＜0.05）.（7）During the treatment period，there were no obvious adverse reactions in the two groups，and there were no abnormal changes in the safety indexes of blood， urine， and stool routine test， electrocardiogram， and liver and kidney function. Conclusion Yangxue Sanhan Tongmai Prescription exerts certain effect in treating patients with endometriosis of blood deficiency and 第3期 黄艳辉，等． 养血散寒通脉方治疗血虚寒凝型子宫内膜异位症的临床研究 619 cold coagulation type， which can significantly alleviate various pain symptoms， improve pregnancy outcomes， and effectively regulate the levels of serum CA125，VEGF，SICAM-1，MMP-9 and TIMP-2 of the patients.

R271.9

：国家中医药管理局第五批全国中医临床优秀人才研修项目（编号：国中医药人教函[2022]1 号）； 武汉市科技计划项目（编号： 2020020601012300）；武汉市卫生健康委员会医学科研项目（编号：MZ20M02）