Page 99 - 《中国药房》2022年3期

of 1 ∶ 1，with 54 patients in each group. Dydrogesterone group was treated with dydrogesterone 10 mg orally，twice a day，on the
5th-25th day of menstrual cycle，for 3 menstrual cycles. Control group received Guizhi fuling capsule 0.93 g orally，three times a
day，since the end of menstrual bleeding to the third day of the next menstruation，for 3 menstrual cycles. Main results were the
changes of visual analogue scale（VAS）scores in 2 groups after 3 menstrual cycles；secondary results were the changes of COX
menstrual symptom scale（CMSS），quality life of 36-item short form（SF-36），levels of carbohydrate antigen 125（CA125）and
interleukin 6（IL-6）after 3 menstrual cycles；other findings included additional benefits and drug safety. RESULTS The results of
intention to analysis data set and the follow-up study protocol analysis data set showed that VAS scores of 2 groups after treatment
of dysmenorrhea for 1，2 and 3 menstrual cycles were lower than those before treatment，the longer the treatment time，the more
obvious the decrease of VAS score（P＜0.05），and VAS score decline of dydrogesterone group was better than that of control
group（P＜0.05）. After 3 menstrual cycles，both the two group showed significant reduction in the severity and duration scores of
CMSS（P＜0.05）；and the decrease of the above scores in the dydrogesterone group was superior than in the control group（P＜
0.05）. After 3 menstrual cycles，among 8 dimensions of SF-36 scale，the scores of 7 dimensions in dydrogesterone group were
significantly higher than those before treatment，such as the scores of physiological function，physical role，physical pain，
emotional function，social function，general health status and energy（P＜0.05）；the increase of the scores of four dimensions were
higher than those in the control group，such as physical pain，social function，general health status，energy（P＜0.05）. There was
no significant difference in the levels of CA125 and IL-6 between 2 groups before and after treatment（P＞0.05）. After 3 menstrual
cycles，the menstrual cycle and menstrual period in the dydrogesterone group were shorter than those before treatment，and the
menstrual volume decreased（P＜0.05）；but there was no significant change in the above indexes of control group（P＞0.05）. After
3 menstrual cycles，the incidence of adverse drug events and adverse reactions in dydrogesterone group was 32.69％（17/52）and
28.85％（15/52）；no serious adverse drug events or adverse reactions such as thrombosis occurred in both groups. CONCLUSIONS
Dydrogesterone can effectively reduce the VAS score，also relieve dysmenorrhea-related symptoms，and improve the quality of life.
The efficacy of dydrogesterone is superior than that of Guizhi fuling capsule in treatment for dysmenorrheal，without serious
adverse reactions. It is well tolerated.
KEYWORDS dydrogesterone；dysmenorrhea；effectiveness；safety；visual analogue scale；COX menstrual symptom scale

[1]
痛经主要指与月经相关的、发生于行经前后或经期 物可增加血栓、骨质丢失等的发生风险 。
的下腹部疼痛、坠胀，部分患者伴有严重的背痛和（或） 在痛经的长期管理中，需兼顾药物的有效性、近期
[1]
大腿痛，也可伴有恶心、腹泻、疲乏、头痛等症状 。痛经 和远期安全性。地屈孕酮是孕酮的立体异构体，其最接
可分为原发性痛经和继发性痛经，原发性痛经是生殖器 近天然孕酮的分子结构，具有单纯孕激素活性，无雌激
无器质性病变引起的疼痛，而继发性痛经是与子宫内膜 素、雄激素或盐皮质激素活性，长期用药发生血栓的风
[8]
异位症、盆腔炎、平滑肌瘤和间质性膀胱炎等盆腔器质 险低，不影响骨代谢 。中医药是中国医学的瑰宝，在长
性疾病相关的疼痛。痛经作为女性特有的病理现象，发 期没有现代医学参与的临床实践中，古人积累了丰富的
病率为41.7％～77.4％ [2－3] ，严重影响女性的生活和工作 对抗各种疾病行之有效的临床经验。痛经在古代医疗
质量 [4－5] 。 过程中也是特别常见的疾病，属于妇科“经带胎产”四大
痛经的治疗药物包括非甾体类抗炎药（nonsteroidal 证之一，各种中医药疗法非常丰富。目前，我国地屈孕
anti-inflammatory drugs，NSAIDs）、复 方 口 服 避 孕 药 酮治疗痛经的有效性研究较少，尚缺乏随机对照研究，
（combined oral contraceptives，COC）、高效孕激素、促性 亦缺乏地屈孕酮与中成药治疗痛经疗效差异的对照研
腺激素释放激素激动剂（gonadotropin releasing hormone 究 [9－10] 。为评价地屈孕酮治疗痛经的有效性及安全性，
agonist，GnRH-a）、左炔诺孕酮宫内缓释系统、中成药 本研究将临床上痛经治疗常用的中成药桂枝茯苓胶囊
等 [1，6] 。NSAIDs 为治疗痛经的一线药物，可通过环氧合 作为阳性对照药物，开展了1项前瞻性、随机对照、开放
酶抑制外周前列腺素的产生，缓解痛经疗效确切，但长 标签、多中心的临床研究，现报道如下。
期使用会对胃黏膜造成损伤，引起胃糜烂、胃溃疡、胃肠 1 资料与方法
道出血，易引起恶心、消化不良、头痛、头晕、嗜睡或口干 1.1 一般资料
[7]
等症状 。激素类药物治疗痛经的机制主要与抑制子宫 1.1.1 研究对象 选择2020年12月至2021年7月因痛
内膜增生、抑制排卵、减少前列腺素和白三烯的产生有 经就诊治疗的 116 例患者为研究对象，其中广州医科大
关，但长期使用 GnRH-a、COC、高效孕激素等激素类药 学附属广东省妇幼保健院52例，深圳市龙岗区第七人民

中国药房 2022年第33卷第3期 China Pharmacy 2022 Vol. 33 No. 3 ·345 ·