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坤泰胶囊联合促性腺激素释放激素激动剂治疗中重度子宫内膜异位症的临床观察

[Kuntai capsule combined with gonadotropin releasing hormone agonist in treatment of moderate-severe endometriosis: a clinical observation].

作者信息

Liu Chang-Qing, Qin Zi-Xin, Jiang Fang-Fang, Hong Ting, Wang Feng

机构信息

Department of Obstetrics and Gynecology, Sun Yat-sen University, Guangdong, China.

出版信息

Zhongguo Zhong Xi Yi Jie He Za Zhi. 2014 Nov;34(11):1288-91.

PMID:25566615
Abstract

OBJECTIVE

To observe the effect of Kuntai Capsule (KC), a Chinese patent medicine, in add-back therapy for gonadotropin-releasing hormone agonist (GnRH-a) treatment for moderate-severe endometriosis (EM).

METHODS

Totally 100 patients suffering from stage III/IV EM, who were confirmed by laparoscopic surgery were randomly assigned to the GnRH-a group (A) and the KC combined GnRH-a group (B), 50 in each group. Patients in Group A were hypodermically injected with goserelin (3.6 mg), once per 4 weeks. Those in Group B additionally took KC, 4 pills each time, three times per day. The therapeutic course for all was 12 weeks. Serum levels of estradiol (E2), follicle stimulating hormone (FSH), bone gamma-carboxyglutamic-acid-containing proteins (BGP) were measured respectively. Kupperman Menopausal Index (KMI) and bone mineral density (BMD) of the lumbar vertebra were also compared between the two groups.

RESULTS

Serum levels of E2 and FSH both significantly decreased in the two groups at week 12 of the treatment (P < 0.05), when compared with pre-treatment. Compared with before treatment in the same group, KMI increased in the two groups (P < 0.05). Compared with before treatment in the same group, BMI decreased in the two groups with no statistical difference (P > 0.05). Serum BGP increased after 12-week treatment (P < 0.05). Compared with Group A after treatment, serum levels of E2 and FSH both significantly increased in Group B (P < 0.05). There was no statistical difference in KMI between the two groups (P > 0.05). As for the incidence of menopausal symptoms, better effects in improving symptoms such as hot flashes, sleep disorders, and vaginal dryness were obtained in Group B than in Group A (P < 0.05). There was no significant difference in the post-pre-treatment difference of BMI between the two groups, but with statistical post-pre-treatment difference in the BGP level (P < 0.05).

CONCLUSIONS

HKC combined GnRH-a could effectively reduce GnRH-a treatment induced partial low estrogen symptoms, improve increased serum BGP levels after GnRH-a therapy.

摘要

目的

观察中成药坤泰胶囊(KC)在促性腺激素释放激素激动剂(GnRH-a)治疗中重度子宫内膜异位症(EM)的补充治疗中的作用。

方法

选取100例经腹腔镜手术确诊为Ⅲ/Ⅳ期EM的患者,随机分为GnRH-a组(A组)和KC联合GnRH-a组(B组),每组50例。A组患者皮下注射戈舍瑞林(3.6mg),每4周1次。B组患者在此基础上口服KC,每次4粒,每日3次。两组疗程均为12周。分别测定血清雌二醇(E2)、卵泡刺激素(FSH)、骨γ-羧基谷氨酸蛋白(BGP)水平。比较两组的Kupperman绝经指数(KMI)及腰椎骨密度(BMD)。

结果

治疗12周时,两组血清E2、FSH水平均较治疗前显著降低(P<0.05)。与治疗前比较,两组KMI均升高(P<0.05)。与治疗前比较,两组BMI均降低,但差异无统计学意义(P>0.05)。治疗12周后血清BGP升高(P<0.05)。治疗后,B组血清E2、FSH水平均较A组显著升高(P<0.05)。两组KMI差异无统计学意义(P>0.05)。在绝经症状发生率方面,B组在改善潮热、睡眠障碍及阴道干涩等症状方面的效果优于A组(P<0.05)。两组BMI治疗前后差值比较差异无统计学意义,但BGP水平治疗前后差异有统计学意义(P<0.05)。

结论

坤泰胶囊联合GnRH-a可有效减轻GnRH-a治疗所致的部分低雌激素症状,改善GnRH-a治疗后血清BGP水平升高的情况。

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引用本文的文献

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Comparative efficacy and safety of traditional Chinese patent medicine for endometriosis: A Bayesian network meta-analysis protocol.用于子宫内膜异位症的中成药的比较疗效与安全性:一项贝叶斯网络Meta分析方案
Medicine (Baltimore). 2019 Jul;98(29):e16473. doi: 10.1097/MD.0000000000016473.