From af547ee408c0e49d347eee6932d4c4c3c311f7ce Mon Sep 17 00:00:00 2001 From: Bersella Date: Mon, 29 Apr 2024 21:47:28 +0800 Subject: [PATCH] Added label of Estrana Tapes --- content/misc/_index.md | 1 + content/misc/estrana-tapes/estrana-1.png | Bin 0 -> 9345 bytes content/misc/estrana-tapes/estrana-2.webp | Bin 0 -> 13274 bytes content/misc/estrana-tapes/estrana-3.webp | Bin 0 -> 12572 bytes content/misc/estrana-tapes/estrana-4.webp | Bin 0 -> 10108 bytes content/misc/estrana-tapes/estrana-5.webp | Bin 0 -> 50604 bytes content/misc/estrana-tapes/estrana-6.webp | Bin 0 -> 49378 bytes content/misc/estrana-tapes/index.md | 511 ++++++++++++++++++++++ 8 files changed, 512 insertions(+) create mode 100644 content/misc/estrana-tapes/estrana-1.png create mode 100644 content/misc/estrana-tapes/estrana-2.webp create mode 100644 content/misc/estrana-tapes/estrana-3.webp create mode 100644 content/misc/estrana-tapes/estrana-4.webp create mode 100644 content/misc/estrana-tapes/estrana-5.webp create mode 100644 content/misc/estrana-tapes/estrana-6.webp create mode 100644 content/misc/estrana-tapes/index.md diff --git a/content/misc/_index.md b/content/misc/_index.md index 1b782c0..54924f7 100644 --- a/content/misc/_index.md +++ b/content/misc/_index.md @@ -47,6 +47,7 @@ layout: single - [雌二醇片(诺坤复)说明书]({{< ref "estrofem" >}}) - [雌二醇凝胶(美国 Estrogel)说明书]({{< ref "estrogel-us" >}}) - [雌二醇外用贴片(Estraderm)说明书]({{< ref "estraderm" >}}) +- [雌二醇透皮贴片(日本久光 Estrana Tapes)说明书]({{< ref "estrana-tapes" >}}) - [戊酸雌二醇注射剂(Estraproval Depot)说明书]({{< ref "estraproval-depot" >}}) - [戊酸雌二醇注射剂(Progynon Depot/富士日雌)说明书]({{< ref "progynon-depot" >}}) diff --git a/content/misc/estrana-tapes/estrana-1.png b/content/misc/estrana-tapes/estrana-1.png new file mode 100644 index 0000000000000000000000000000000000000000..0f90ecfd605542e8546896e87d2904e8bdee360a GIT binary patch literal 9345 zcmZvCWk6Nk^Yx`Wq#FV0mX?z4?rxASk&*`K5~Nc~Lb{QbknS#}ySx6I=lAh_KLD3= z@4098?3uOJ%X%Tpm)Fg 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+**请仔细阅读说明书并在医师指导下使用** + + + +经皮吸收型雌二醇制剂 + +## エストラーナ®テープ 0.09/0.18/0.36/0.72mg {#name} + +### ESTRANA® Tapes 0.09/0.18/0.36/0.72mg {#name2} + +| | エストラーナ®テープ
0.09mg | エストラーナ®テープ
0.18mg | エストラーナ®テープ
0.36mg | エストラーナ®テープ
0.72mg | +|-|-|-|-|-| +| **批准文号** | 22700AMX00357000 | 22700AMX00356000 | 22700AMX00355000 | 21900AMX01357000 | +| **上市日期** | 2015 年 9 月 | 2015 年 9 月 | 2015 年 9 月 | 2000 年 2 月 | + +日本标准商品分类编号:872473\ +**贮存方法**:室温保存,远离高温\ +**有效期**:2.5 年\ +**处方药**(注) + +(注) **注意:谨遵医师等处方笺使用** + +2023 年 5 月修订(第四版)\ +2022 年 3 月修订(第三版,适应症、用法用量变更) + +-------- + +## 二、禁忌症 {#contraindications} + +
+ +**有以下症状的患者不得给予本品:** + +(*以下对一切适应症适用*) + +1. **现有或疑似雌激素依赖性恶性肿瘤(如乳腺癌、子宫内膜癌等)。**\ + 本品可能导致相关肿瘤恶化或显性化。——参见 8.3 节 +1. **有乳腺癌既往史。** 1)\ + 本品可能导致乳腺癌复发。——参见 8.3 节 +1. **未治疗的子宫内膜增生。**\ + 子宫内膜增生可能与细胞异型有关。——参见 8.3 节 +1. **血栓性静脉炎、肺栓塞,或有既往史。**\ + 已有雌激素引起凝血因子增加,从而增强血栓形成倾向的报告。——参见 11.1.2 节 +1. **动脉血栓栓塞(如冠心病、脑卒中等),或有既往史。**——详见 15.1.4 节、15.1.5 节 +1. **既往对本品任一成分过敏。** +1. **哺乳。**——参见 9.6 节 +1. **重度肝脏疾病。**——详见 9.3.1 节 +1. **未确诊的生殖器异常出血。**\ + 如该症状由子宫内膜癌引起,本品可诱导癌症恶化或显性化。——参见 8.3 节 + +(*以下适用于适应症“更年期和卵巢缺乏综合征并发症:潮热和发汗等血管舒缩性症状、泌尿生殖器萎缩症状”“绝经后骨质疏松症”“性腺功能不足、性腺摘除或原发性卵巢发育不全引起的低雌激素血症”“辅助生育中卵巢刺激调节开始时的激素调整”*) + +10. **现有或疑似妊娠。**——参见 9.5.1 节 + +
+ +## 三、成分·性状 {#qualitative} + +### 3.1 成分 {#strength} + +- **有效成分**:每片含雌二醇 0.09/0.18/0.36/0.72 mg +- **辅料**:氯胺酮、二丁基羟基甲苯、氢化丁二烯酯、苯乙烯-异戊二烯-苯乙烯嵌段共聚物、聚异丁烯、液体石蜡,和一种其它成分。 + +### 3.2 制剂性状 {#dosage-form} + +**性状**:椭圆形贴片,内有透明膏体,平摊于浅栗色支撑体表面。\ +**外形**:{{< figure src="estrana-1.png" width="40%" >}} + +**大小**: + +- 0.09 mg 贴片:长 13.0 mm、宽 11.0 mm,面积 1.125 cm2(识别码:HP374T) +- 0.18 mg 贴片:长 18.5 mm、宽 15.5 mm,面积 2.25 cm2(识别码:HP373T) +- 0.36 mg 贴片:长 26.1 mm、宽 22.0 mm,面积 4.5 cm2(识别码:HP372T) +- 0.72 mg 贴片:长 37.0 mm、宽 31.0 mm,面积 9 cm2(识别码:HP371T) + + +## 四、适应症 {#indications} + +> *以下适用于一切剂型* + +【甲】**更年期和卵巢缺乏综合征并发症:潮热和发汗等血管舒缩性症状、泌尿生殖器萎缩症状**\ +【乙】**绝经后骨质疏松症**\ +【丙】**性腺功能不足、性腺摘除或原发性卵巢发育不全引起的低雌激素血症** + +> *以下适用于 0.72 mg 剂型* + +【丁】**辅助生育中卵巢刺激调节开始时的激素调整** + +> *以下适用于 0.36、0.72 mg 剂型* + +【戊】**冻融胚胎移植中的激素替代周期** + + +## 五、与适应症有关的注意事项 {#indications-note} + +> *适用于“辅助生育中卵巢刺激调节开始时的激素调整”“冻融胚胎移植中的激素替代周期”* + +在妊娠率和出生成活率报告中发现,如于卵巢刺激调节开始时合用本品所含的雌激素和一种孕激素,或于冻融胚胎移植前进行激素替代,则妊娠率和出生成活率可能会较无卵巢刺激调节或无激素替代时有所下降;故此,应就此向患者进行说明,且应根据每位患者的治疗必要性和危险性,慎重判断是否需给予本品。——参见 15.1.11、15.1.12 节 + +## 六、用法用量 {#dosage} + +> *适用于“更年期和卵巢缺乏综合征并发症:潮热和发汗等血管舒缩性症状、泌尿生殖器萎缩症状”“绝经后骨质疏松症”* + +通常用于成人的雌二醇等效剂量为 0.72 mg;将本品贴于下腹部或臀部任一处,每两日更换一次。 + +> *适用于“性腺功能不足、性腺摘除或原发性卵巢发育不全引起的低雌激素血症”* + +用于成人时,通常以 0.72 mg 为初始雌二醇等效剂量;将本品贴于下腹部或臀部任一处,每两日更换一次,并依症状程度调整剂量。 +用于儿童时,通常以 0.09 mg 为初始雌二醇等效剂量。将本品贴于下腹部或臀部任一处,每两日更换一次。此后,依 0.18、0.36、0.72 mg 之顺序逐步增加雌二醇剂量。 + +> *适用于“辅助生育中卵巢刺激调节开始时的激素调整”* + +通常剂量为 0.72 mg。在 21~28 日内,将本品贴于下腹部或臀部任一处,每两日更换一次;用药周期的后半段,加用一种孕激素制剂。 + +> *适用于“冻融胚胎移植中的激素替代周期”* + +通常剂量为 0.72~5.76 mg。将本品贴于下腹部或臀部任一处,每两日更换一次;待子宫内膜充分增厚之后,加用一种孕激素,持续用药至妊娠第 8 周。 + + +## 七、与用法用量相关的注意事项 {#dosage-note} + +> *适用于“绝经后骨质疏松症”* + +1. 用药 6 个月至一年后,应测定骨密度;如发现未产生预期效果,应停用本品,并考虑其它疗法。 + +> *适用于“性腺功能不足、性腺摘除或原发性卵巢发育不全引起的低雌激素血症”* + +2. 用于成人时,应定期判断是否停用本品或逐渐减量,且应以最小剂量治疗。 +3. 用于儿童时,考虑在用药 6 个月至一年后增加剂量。此外,应定期检查症状程度、雌二醇血药浓度等,判断是否增量、停药或逐渐减量。 + +> *适用于“冻融胚胎移植中的激素替代周期”* + +4. 妊娠成功后,在用药期间,应综合本品预期风险和患者状态,进行谨慎判断;不得长期盲目用药,且最长不得使用至妊娠第 10 周之后。 + + +## 八、重要提示 {#important-notices} + +> *对一切适应症适用* + +1. 本品可能会引起静脉血栓栓塞或血栓性静脉炎;因此,应事先告知患者,如发现任何异常,应立即向医师等咨询。——参见 9.1.7、11.1.2 节 + +> *适用于“更年期和卵巢缺乏综合征并发症:潮热和发汗等血管舒缩性症状、泌尿生殖器萎缩症状”“绝经后骨质疏松症”“性腺功能不足、性腺摘除或原发性卵巢发育不全引起的低雌激素血症”* + +2. 据外国报告,女性长期合用雌激素与孕激素制剂后,发生乳腺癌的风险高于对照组女性,且该风险随用药时长增大;因此,使用本品时,应对患者详细告知风险及收益,且以最小必要剂量使用。不得长期盲目使用本品。——参见 15.1.3、15.1.9 节 +3. 使用本品前,必须采集患者个人病史和家族史,进行乳房及妇科检查(有子宫的患者应进行子宫内膜活检,并以超声波对子宫内膜厚度进行检查)。\ + 开始使用本品后,应定期进行血压、乳房及妇科检查。——参见 2.1-2.3、2.9 节,9.1.1-9.1.4、9.2.1 节 + +> *适用于“辅助生育中卵巢刺激调节开始时的激素调整”“冻融胚胎移植中的激素替代周期”* + +4. 应在具备丰富的生育治疗知识和经验的医师指导下使用本品。应事先就使用本品时的预期风险和需要留意的症状,向患者进行说明。 + + +# 九、有特殊情况的患者之注意事项 {#warnings-precautions} + +### 9.1 有并发症、既往史等的患者用药 {#disadvantages} + +1. **子宫肌瘤:**\ + 本品可能诱导子宫肌瘤发展。——参见 8.3 节 +1. **子宫内膜症:**\ + 本品可能导致症状恶化。——参见 8.3 节 +1. **有乳腺癌家族性风险;乳房结节;乳腺疾病;或乳腺扫描结果异常:**\ + 本品可能导致相关症状恶化。——参见 8.3 节 +1. **高血压、心脏病,或有既往史:**\ + 过量给予雌激素可引起体液潴留,并导致以上症状恶化。——参见 8.3 节 +1. **糖尿病:**\ + 用药时需密切监视。本品可能导致糖耐量下降。 +1. **偏头痛、癫痫:**\ + 密切观察。本品可能导致以上症状恶化。 +1. **术前,或长期卧床不动:**\ + 本品导致凝血功能增强,可能使心血管副作用风险增大。——参见 8.1、11.1.2 节 +1. **全身性红斑狼疮:**\ + 本品可能导致症状恶化。 + +### 9.2 肾功能不全患者用药 {#renal-impairment} + +1. **肾病,或有既往史:**\ + 过量给予雌激素可引起体液潴留,并导致肾病恶化。——参见 8.3 节 + +### 9.3 肝功能不全患者用药 {#hepatic-impairment} + +1. **重度肝脏疾病:**\ + 不得使用本品。代谢功能不全时,本品可增加肝脏负担,使相关症状加重。——参见 2.8 节 +1. **肝脏疾病(非重度):**\ + 密切观察,包括定期检查肝功能等。本品可能导致肝脏疾病恶化。 + +### 9.5 妊娠妇女用药 {#pregnancy} + +> *适用于“更年期和卵巢缺乏综合征并发症:潮热和发汗等血管舒缩性症状、泌尿生殖器萎缩症状”“绝经后骨质疏松症”“性腺功能不足、性腺摘除或原发性卵巢发育不全引起的低雌激素血症”“辅助生育中卵巢刺激调节开始时的激素调整”* + +1. 妊娠或有妊娠可能的妇女禁用本品。——参照 2.10 节 + +> *对一切适应症适用* + +2. 已有雌激素制剂(己烯雌酚)用于妊娠动物(小鼠)之后,后代生殖器官出现异常的报告。虽然迄今尚无雌二醇用于人体后的致畸性报告,但已有雌二醇用于妊娠动物(大鼠)之后出现后代生殖器官异常的报告。已有报告表明,妊娠妇女给予女性激素制剂(如口服避孕药)导致婴儿先天性异常(先天性心脏畸形、肢体缺陷)的风险增加。 +3. 已有报告表明雌激素制剂用于妊娠动物(小鼠)之后,后代成长后的阴道上皮及子宫内膜发生癌性病变。另外,已有报告证实雌激素制剂用于新生儿(小鼠)后,其成长后的阴道上皮有癌性病变。 + +### 9.6 哺乳期妇女用药 {#lactation} + +禁用本品。本品已知可分泌到人类母乳中。此外,已有动物试验报告,新生儿(小鼠)给予雌激素制剂之后,其成长后的阴道上皮有癌性病变。 + +### 9.7 儿童用药 {#pediatric} + +对青春期前儿童长期、反复给予大剂量雌激素制剂,可能导致其骨骺闭合、身高低矮。 + +### 9.8 老年用药 {#geriatric} + +慎用本品,同时密切观察患者状态。此类患者的生理功能一般较为低下。 + + +## 十、药物相互作用 {#drug-interactions} + +本品主要经细胞色素酶 P450(CYP3A4)进行代谢;因此,如将本品与影响 CYP3A4 活性之药物合用,应密切留意。 + +### 10.2 与其它药物合用的注意事项 {#concomitant-use} + +| 药品名 | 临床症状·处置方法 | 作用机理·风险因素 | +| - | - |- | +| **利福平**
**抗癫痫药**,包括
- 苯巴比妥
- 苯妥英
- 卡马西平
**HIV 逆转录酶抑制剂**,包括
- 依非韦伦
**含贯叶连翘(圣约翰草)的食品**
**甾体激素** | 本品代谢可能加快;
血药浓度可能降低。 | 此类药物可诱导细胞色素 P450(CYP3A4),
从而可能使本品代谢加快,血药浓度下降。 | +| **蛋白酶抑制剂**,包括
- 利托那韦
- 奈非那韦 | 本品血药浓度可能受影响。 | 此类药物可能诱导或抑制
细胞色素 P450(CYP3A4)。 | + + +## 十一、不良反应 {#undesirable-effects} + +以下不良反应可能会出现;应密切观察,发现异常时应对症处置,例如停用本品。 + +### 11.1 严重不良反应 {#serious-side-effects} + +1. **超敏反应**(频率不详) +1. **静脉血栓栓塞、血栓性静脉炎**(频率均不详) + 如出现下肢疼痛和浮肿、胸痛、急性气短、急性视力损伤等初期症状,应停用本品,并对症处置。——参见 2.4、8.1、9.1.7 节 + +### 11.2 其它不良反应 {#other-side-effects} + +| 分类/发生率 | 5% 以上 | 0.1~5% | 小于 0.1% | 频率不详 | +|-|-|-|-|-| +| **皮肤** | 一过性接触性皮肤炎
(红斑、瘙痒等) | 皮疹
疱疹
色素沉积 | | | +| **生殖器** | 不规律出血
撤退性出血 | 白带
外阴肿胀
外阴瘙痒
子宫内膜增生 | | | +| **乳房** | 乳房紧张感 | 乳房疼痛
乳头触痛
乳腺病 | | | +| **精神神经类** | | 头痛
嗜睡
眩晕 | 失眠 | 偏头痛 | +| **循环系统类** | | 心悸 | 胸闷
血压升高 | 静脉瘤恶化
血栓 | +| **消化系统** | | 呕吐
胀气
下痢
腹胀
便秘
上腹部痛 | | | +| **代谢和电解质类** | | 浮肿 | | 体液潴留 | +| **过敏** | | 全身性瘙痒
皮疹
面部瘙痒、红斑 | 荨麻疹 | 过敏性接触性皮肤炎 | +| **肝脏** | | 肝功能损伤
(AST/ALT/AI-P/LDH 上升等) | | 胆结石
胆囊疾病
胆汁郁积性黄疸 | +| **其它** | | 腹痛
下腹部痛
关节痛
腰痛
耳鸣
体重增加
背痛
疲乏
甘油三酯上升
纤维蛋白原增加 | 体重减少
发热 | 下肢痛
卟啉病恶化
哮喘恶化
耳硬化 | + +注) 发生频率采纳了上市后调查资料。 + +## 十四、通用注意事项 {#general-info} + +### 14.1 交付药剂时的注意事项 {#precautions-usage} + +1. 将本品连同包装交付患者,告知其使用时将本品从包装中取出。 +1. **粘贴部位** + - 如将本品贴于背部,则雌二醇血药浓度相较贴于下腹部可能更高。 + - 避免粘贴于腰线,因其可能会受衣物摩擦而脱落。此外,不得粘贴于胸部。 + - 避免粘贴于有创伤、湿疹或炎症的皮肤部位。 + - 为避免皮肤刺激,建议轮换粘贴部位。 +1. **粘贴时的事项** + - 粘贴前,应先将粘贴部位擦拭干净,除去上面一切水分。 + - 请勿裁切本品。 +1. 使用本品 0.09 mg、0.18 mg 剂型时,应告知患者:如有未使用的贴片,应放回原包装,将包装开口处对折两次并保管,并于开封后 30 日内使用。 + + +## 十五、其它注意事项 {#other-precautions} + +### 15.1 临床应用资料 {#clinical-studies} + +#### 15.1.1 *用药方案* {#usage-in-studies} + +对于更年期和卵巢缺乏综合征并发症、绝经后骨质疏松症的治疗,可采取连续给药或序贯给药(如连续给药三周、停药一周)的方式。\ + 【参考】与孕激素制剂合用的方法列于下方。 + +> (1) **(日本)国内临床试验中采用的方案** + +采用以下方案后,本品 0.72 mg 对更年期综合征、卵巢缺乏症状的有效性和安全性得以验证。 + +- **长期给药(六个月以上)**\ + 使用本品 0.72 mg,每两日更换一次,持续三周,此后停药一周。使用本品期间的后半段,即后 12 日内加用一种孕激素。原则上以醋酸甲羟孕酮(MPA)5 mg/天作为孕激素给药。 + +{{< figure src="estrana-2.webp" width="50%" >}} + +采用以下方案后,本品 0.72 mg 对绝经后骨质疏松症的有效性和安全性得以验证。 + +- 持续使用本品 0.72 mg,每两日更换一次,无停药间期。每四周的前半段,即前 12 日内加用一种孕激素。原则上以醋酸甲羟孕酮(MPA)5 mg/天作为孕激素给药。 + +{{< figure src="estrana-3.webp" width="50%" >}} + +> (2) **其他给药方案** + +除上述临床试验所用方案外,其余方案见下。 + +- **雌激素·孕激素连续给药法**\ + 即连续给予雌激素和孕激素的治疗方案。 + +{{< figure src="estrana-4.webp" width="50%" >}} + +#### 15.1.2 激素替代疗法(HRT)与子宫内膜癌风险 {#endometrial-cancer} + +流行病学调查报告显示,绝经后妇女长期使用雌激素制剂(约一年以上),发生子宫内膜癌的风险较对照组妇女偏高,且该风险随使用时长增大(1~5 年风险率 2.8 倍,10 年以上风险率 9.5 倍);与孕激素制剂合用时,可抑制子宫内膜癌风险(0.8 倍于对照组妇女)2)。 + +#### 15.1.3 HRT 与乳腺癌风险 {#breast-cancer} + +1. 在美国进行、针对绝经后妇女的随机对照试验(“女性健康倡议”,WHI 试验)的结果显示,结合雌激素—孕激素联合治疗组的乳腺癌风险,相较安慰剂组有统计意义的增长(风险比率:1.24)3)。\ + 同时进行的、针对已摘除子宫的妇女的试验结果显示,结合雌激素单药治疗组的乳腺癌风险,相较安慰剂组无统计意义的差异(风险比率:0.80)4)。 + ——参见 8.2 节 +1. 在英国进行的流行病学调查(“百万女性研究”,MWS)的结果显示,雌激素—孕激素联合治疗的妇女的乳腺癌风险,较对照组有统计意义的增长(2.00 倍)。该风险随治疗时长增大(一年以下 1.45 倍;一至四年 1.74 倍;五至九年 2.17 倍;十年以上 2.31 倍)5)。——参见 8.2 节 + +#### 15.1.4 HRT 与冠心病风险 {#coronary-heart-disease} + +美国 WHI 试验结果显示,结合雌激素—孕激素联合治疗组的冠心病风险,较安慰剂组有偏高趋势,尤其在治疗一年后有统计意义的增长(风险比率:1.81)。6)\ +同时进行的、针对已摘除子宫的妇女的试验结果显示,结合雌激素单药治疗组的乳腺癌风险,相较安慰剂组无统计意义的差异(风险比率:0.91)7)。\ +——参见 2.5 节 + +#### 15.1.5 HRT 与脑卒中风险 {#stroke} + +美国 WHI 试验结果显示,结合雌激素—孕激素联合治疗组的脑卒中(主要为脑梗塞)之风险,相较安慰剂组有统计意义的增长(风险比率:1.31)8)。\ +同时进行的、针对已摘除子宫的妇女的试验结果显示,结合雌激素单药治疗组的脑卒中(主要为脑梗塞)风险,相较安慰剂组有统计意义的增长(风险比率:1.37)9)。\ +——参见 2.5 节 + +#### 15.1.6 HRT 与认知障碍风险 {#recognition-impairment} + +在美国进行、针对 65 岁以上绝经后妇女的随机对照试验(WHI 认知研究,WHIMS)的结果显示,结合雌激素—孕激素联合治疗组的认知障碍(含阿尔茨海默症)发生风险,较安慰剂组有统计意义的增长(风险比率:2.05)10, 11)。\ +同时进行的、针对已摘除子宫的妇女的试验结果显示,结合雌激素单药治疗组的认知障碍(含阿尔茨海默症)风险,相较安慰剂组虽无统计意义的差异,但有增长趋势(风险比率:1.49)12, 13)。 + +#### 15.1.7 HRT 与卵巢癌风险 {#ovarian-cancer} + +1. 流行病学调查结果显示,绝经后妇女长期使用雌激素制剂后,卵巢癌风险较对照组偏高14-16)。 +1. 美国 WHI 试验显示,结合雌激素—孕激素联合治疗组的卵巢癌风险,相较安慰剂组虽无统计意义的差异,但有增长趋势(风险比率:1.58)17)。 + +#### 15.1.8 HRT 与胆囊疾病风险 {#gallbladder-disease} + +美国 WHI 试验显示,结合雌激素—孕激素联合治疗组的胆囊疾病风险,相较安慰剂组有统计意义的增长(风险比率:1.59)。\ +同时进行的、针对已摘除子宫的妇女的试验结果显示,结合雌激素单药治疗组的胆囊疾病风险,相较安慰剂组有统计意义的增长(风险比率:1.67)18)。 + +#### 其他说明 {#studies-note} + +**15.1.9** 虽然迄今尚不清楚雌激素治疗和乳腺癌发生之间的因果关系,但已有流行病学调查显示其和使用时长具有相关性19)。——参见 8.2 节 + +**15.1.10** 已有人体长期使用雌激素后出现肝脏肿瘤的报告。 + +**15.1.11** 已有报告指出,如在卵巢刺激调节前周期中使用低剂量雌激素、孕激素复方制剂,则出生成活率和再妊娠率均较未使用时有所降低20)。——参见第五章 + +**15.1.12** 已有报告指出,如在冻融胚胎移植中进行激素替代,则妊娠成功率和出生成活率较遵循自然排卵周期时有所降低,且流产率有所增加21)。——参见第五章 + +### 15.2 非临床试验资料 {#nonclinical-trials} + +动物实验报告中,皮下(含植入)给予雌激素导致了小鼠出现淋巴瘤;大鼠出现垂体腺瘤;仓鼠出现肾肿瘤。 + + +## 十六、药代动力学特性 {#pharmacokinetics} + +### 16.1 血药浓度 {#plasma-concentration} + +健康绝经后女性单次给予本品 0.72 mg 一片,粘贴 48 小时。粘贴后,雌二醇(E2)血浆浓度缓慢上升;第 8~12 小时之后,E2 浓度基本维持稳定(52.0~53.8 pg/mL);移除后,浓度迅速下降。\ +对于雌酮(E1),粘贴前检出一定量的 E1 血浆浓度,粘贴本品 0.72 mg 之后未发现明显的浓度上升。\ +此外,移除贴片后 E2 的清除半衰期约为 2 小时22)。 + +{{< figure src="estrana-5.webp" width="90%" >}} + +### 16.5 排泄 {#excretion} + +#### 16.5.1 蓄积性 {#accumulation} + +健康绝经后女性给予本品 0.72 mg 一片,于 14 日内重复给予 7 次。E2 血浆浓度于第二次粘贴后达到稳态;每次粘贴后 48 小时的浓度平均为 52.5~60.5 pg/mL。\ +此外,相较初次用药时,第七次用药后经尿液排泄的 E2、E1 总量平均值分别达 1.21 ± 0.24 倍和 1.34 ± 0.37 倍;未发现有蓄积倾向23)。 + +{{< figure src="estrana-6.webp" width="90%" >}} + +## 十七、临床研究结果 {#clinical-results} + +### 17.1 有效性和安全性研究资料 {#efficacy-safety} + +#### 17.1.1 日本国内临床试验(更年期综合征、卵巢缺乏症状) {#efficacy-in-menopause} + +一般临床试验和对照试验发现,更年期综合征和卵巢缺乏综合征患者给予本品 0.72 mg 之后,症状得到总体改善(中等以上改善)的分别有 86.5%(211/244)和 84.2%(85/101);观察到的症状类目(血管舒缩症状、泌尿生殖器萎缩症状)均有较大改善24-27)。 + +#### 17.1.2 日本国内临床试验(绝经后骨质疏松症) {#efficacy-in-osteoporosis} + +已确认 146 例绝经后骨质疏松症患者用药后,骨密度有所改善;经 DXA 法检验,骨密度平均有 4.83 ± 0.389% 的增加28)。 + + +## 十八、药效学特性 {#pharmacodynamics} + +### 18.1 作用机理 {#mechanism-actions} + +由卵巢功能减退或丧失引起的雌激素缺乏,会导致潮热、发汗等血管舒缩症状,以及泌尿生殖器萎缩症状等。 + +此外,“性腺功能不足、性腺摘除或原发性卵巢发育不全”均表现为卵巢功能不全或缺失及其引起的雌激素缺乏症状,加之老年女性长期处于低雌激素状态中,使得骨质疏松症风险升高、血管壁功能受损,从而有更高的冠心病预期风险;这种情况下,必须给予雌激素替代。 +还有,在以 Turner 综合征为代表的原发性卵巢发育不全当中,卵巢本身的功能不全——而非下丘脑、脑垂体功能异常——会引起雌激素产生和分泌不足,从而不能在第二性征发育时达到性成熟,且骨骼发育和矿物质含量不足;这是相当严重的临床问题。 + +本品给予的 17β-雌二醇经皮直接进入全身循环,维持雌二醇血浆浓度于正常范围,从而使上述症状缓解。 + +在辅助生育中,进行卵巢刺激调节:以雌二醇刺激子宫内膜增殖,再以孕激素抑制其增殖,改变子宫内膜为分泌期态。此后,令雌二醇和孕激素的血浆浓度快速下降,使子宫内膜脱落,出现刺激调节初始阶段所要求的撤退性出血。 + +在冻融胚胎移植中,进行激素替代:以雌二醇刺激子宫内膜增厚,随后以孕激素改变子宫内膜为分泌期态,从而使其具备妊娠建立和维持的条件。 + +### 18.2 对血管舒缩症状的影响 {#effects-on-vasomotor} + +1. 摘除卵巢的大鼠以渗透压小泵,经皮下持续给予雌二醇 0.3 或 1.0 μg/天,可显著抑制摘除卵巢引起的尾部皮肤温度升高29)。 +1. 有更年期症状的绝经后妇女给予雌二醇贴片制剂,其潮热发生率和雌二醇血浆浓度呈负相关;据线性回归法测算,潮热发生率降低 50% 和降低 100% 所需雌二醇血浆浓度分别为 61 pg/mL 和 122 pg/mL30)(基于外国人数据)。 + +### 18.3 对骨代谢的影响 {#effects-on-bone} + +1. 摘除卵巢的大鼠连续 35 日皮下给予雌二醇 10 μg/kg/天;其破骨细胞面、成骨细胞面和骨形成速率均得到正常化,且松质骨的减少倾向得以抑制31)。 +1. 实验中摘除卵巢的大鼠(6 月、12 月、30 月龄)连续 59 日皮下给予雌二醇 10 μg/kg/48 h;结果显示,摘除卵巢所导致的骨转化之加快得到抑制,从而骨质流失得以抑制,且随月龄增长而减少的骨量得以回复32)。 +1. 雌二醇通过影响单核骨髓细胞、成骨细胞和骨髓间质细胞,对骨再吸收性细胞因子的产生有抑制作用;借此,雌二醇可抑制破骨细胞的分化成熟和活性,并加快其凋亡。此外,雌二醇被认为可直接作用于破骨细胞,抑制骨再吸收活性。通过上述骨再吸收抑制作用,雌二醇被认为可调节因雌激素缺乏而加快的骨转化,改善骨密度33-38)。 + +## 十九、本品有效成分的物化特性 {#physiochemical-properties} + +- 通用名称:雌二醇(Estradiol) +- 化学名称:雌甾-1,3,5(10)-三烯-3,17β-二醇 +- 分子式:C18H24O2 +- 分子量:272.38 +- 化学结构式:见下 +- 性状:白色至微黄色结晶或微晶粉末,无臭。\ + 本品易溶于 1,4-二氧六环或 N,N-二甲基甲酰胺,较易溶于丙酮,较难溶于乙醇(95),难溶于乙醚,几乎不溶于水。溶于硫酸。有吸水性。 +- 熔点:175~180℃ +- 矿物油/水分配系数(30°C):12 +- *CAS 代码:[50-28-2](https://commonchemistry.cas.org/detail?ref=50-28-2)* + +{{< figure src="https://img.guidechem.com/casimg/50-28-2.gif" width="30%" >}} + + +## 二十二、包装规格 {#packages} + +- 0.09 mg 剂型:每盒 5 袋,每袋 7 片,共 35 片 +- 0.18 mg 剂型:每盒 5 袋,每袋 7 片,共 35 片 +- 0.09 mg 剂型:每盒 70 袋,每袋 1 片,共 70 片 +- 0.09 mg 剂型:每盒 70/140 袋,每袋 1 片,共 70/140 片 + + +## 二十三、参考文献 {#references} + +1. Holmberg L, et al.: Lancet 2004; 363(9407): 453-5. +1. Grady D, et al.: Obstet Gynecol 1995; 85(2): 304-13. +1. Chlebowski RT, et al.: JAMA 2003; 289(24): 3243-53. +1. Stefanick ML, et al.: JAMA 2006; 295(14): 1647-57. +1. Beral V, et al.: Lancet 2003; 362(9382): 419-27. +1. Manson JE, et al.: N Engl J Med 2003; 349(6): 523-34. +1. Anderson GL, et al.: JAMA 2004; 291(14): 1701-12. +1. Wassertheil-Smoller S, et al.: JAMA 2003; 289(20): 2673-84. +1. Hendrix SL, et al.: Circulation 2006; 113(20): 2425-34. +1. Shumaker SA, et al.: JAMA 2003; 289(20): 2651-62. +1. Rapp SR, et al.: JAMA 2003; 289(20): 2663-72. +1. Shumaker SA, et al.: JAMA 2004; 291(24): 2947-58. +1. Espeland MA, et al.: JAMA 2004; 291(24): 2959-68. +1. Rodriguez C, et al.: JAMA 2001; 285(11): 1460-5. +1. Lacey JV Jr, et al.: JAMA 2002; 288(3): 334-41. +1. Beral V, et al.: Lancet 2007; 369(9574): 1703-10. +1. Anderson GL, et al.: JAMA 2003; 290(13): 1739-48. +1. Cirillo DJ, et al.: JAMA 2005; 293(3): 330-9. +1. Beral V, et al.: Lancet 1997; 350(9084): 1047-59. +1. Farquhar C, et al.: Cochrane Database Syst Rev 2017; Issue 5. +1. Saito H, et al.: Human Reproduction 2019; 34(8): 1567-75. +1. 中道昇: 臨床医薬 1996; 12(16): 3477-95. +1. 中道昇: 臨床医薬 1996; 12(16): 3497-534. +1. 友田豊 ほか: 臨床医薬 1996; 12(16): 3535-49. +1. 武谷雄二 ほか: 臨床医薬 1996; 12(18): 4047-80. +1. 武谷雄二 ほか: 臨床医薬 1996; 12(18): 4097-121. +1. 伊吹令人 ほか: 臨床医薬 1996; 12(18): 4081-96. +1. 久光製薬社内資料. 閉経後骨粗鬆症の臨床試験のまとめ(2002年4月11日承認、申請資料概要ト.2.1). +1. 久光製薬社内資料. 卵巣摘出ラットの尾部皮膚温上昇に対する17β-estradiolの作用. +1. Steingold KA, et al.: J Clin Endocrinol Metab 1985; 61(4): 627-32. +1. Wronski TJ, et al.: Endocrinology 1988; 123(2): 681-6. +1. Gaumet N, et al.: Gerontology 1998; 44(3): 132-9. +1. Kimble RB, et al.: Endocrinology 1995; 136(7): 3054-61. +1. Kimble RB, et al.: J Biol Chem 1996; 271(46): 28890-7. +1. Jilka RL, et al.: Science 1992; 257(5066): 88-91. +1. Girasole G, et al.: J Clin Invest 1992; 89(3): 883-91. +1. Hughes DE, et al.: Nat Med 1996; 2(10): 1132-6. +1. Mano H, et al.: Biochem Biophys Res Commun 1996; 223(3): 637-42. + + +## 二十四、文献请求和问询联系方式 {#contact} + +久光製薬株式会社 お客様相談室\ +〒135-6008 東京都江東区豊洲三丁目3番3号\ +TEL.0120-381332\ +FAX.(03)5293-1723\ +服务时间:9:00~17:50(周六、节日、本社假日除外) + +## 二十六、生产和销售等企业信息 {#company} + +### 26.1 生产、销售企业 {#manufacturer} + +**久光製薬株式会社**\ +〒841-0017 鳥栖市田代大官町408番地 + +--------- + +## 说明书原文和译文修订记录 {#revision} + +```csv +原文修订日期,翻译日期 +2020 年 6 月(第二版),– +2022 年 3 月(第三版),– +2023 年 5 月(第四版),2024 年 4 月 28 日 +``` \ No newline at end of file