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+ +**译者按:** 本文为美国辉瑞公司的螺内酯(Aldactone)处方说明书的中文翻译。说明书原文:([备用链接](https://labeling.pfizer.com/ShowLabeling.aspx?format=PDF&id=520)) + +初次批准日期:1960 年\ +修改日期:2022 年 12 月\ +**请仔细阅读说明书并在医师指导下使用** +
+ +# 品名 {#name} + +**Aldactone® (螺内酯)口服片** *(以下简称“本品”)*\ +**美国初次批准日期:1960 年** + +## 说明书摘要 {#highlights} + +**以下摘要内容不足以确保本品使用的安全性与有效性。请参见[说明书详情]({{< ref "#full-info" >}})。** + +### 适应症 {#highlights-indications} + +本品为醛固酮拮抗剂,用于: + +- 治疗纽约心功能分级(NYHA)为 III–IV 级的心衰竭和低射血分数,以达到提高生存率、控制水肿、减少心衰引起的住院需求的目的。([1.1]({{< ref "#indications-heart-failure" >}})) +- 辅助治疗高血压,使血压降低。这可降低致命性与非致命性心血管事件、原发性卒中和心肌梗死发生的风险。([1.2]({{< ref "#indications-hypertension" >}})) +- 控制以下成年患者的水肿: + + 水分及钠摄入控制无效的肝硬化患者。 + + 基础疾病治疗、水分和钠摄入控制以及其它利尿剂效力均不足的肾病综合征患者。([1.3]({{< ref "#indications-edema" >}})) +- 治疗原发性高醛固酮血症,分为: + + 术前短期治疗; + + 不宜手术的离散型醛固酮分泌型肾上腺腺瘤患者,以及双侧肾上腺微小或大结节增生患者的长期维持治疗。([1.4]({{< ref "#indications-hyperaldosteronism" >}})) + +### 用法用量 {#highlights-dosage} + +- **心衰**:以 25 mg/天为初始剂量。([2.2]({{< ref "#treatment-heart-failure" >}})) +- **高血压**:以 25~100 mg/天为初始剂量,每日一次或多次服用。([2.3]({{< ref "#treatment-hypertension" >}}) +- **水肿**:开始时遵医嘱服药,缓慢调整。建议以 100 mg/天为初始剂量,每日一次或多次服用。([2.4]({{< ref "#treatment-edema" >}})) +- **原发性高醛固酮血症**:术前以 100~400 mg/天为初始剂量治疗。不宜手术的,视个人情况以最低有效剂量治疗。([2.5]({{< ref "#treatment-hyperaldosteronism" >}})) + +### 性状及成分含量 {#highlights-forms} + +本品分为 25、50、100 mg 三种片剂。([3]({{< ref "#forms" >}})) + +### 禁忌症 {#highlights-contraindications} + +**有以下情况的患者禁用本品:**([4]({{< ref "#contraindications" >}})) + +- **高钾血症** +- **阿狄森氏病** +- **与伊普利酮并用** + +### 警告和注意事项 {#highlights-warnings} + +- **高钾血症**:治疗开始后一周内,密切监测血钾,此后改为定期监测。([5.1]({{< ref "#hyperkalemia" >}})) +- **低血压和肾功能恶化**:定期监测血容积状态和肾功能。([5.2]({{< ref "#hypotension" >}})) +- **电解质和代谢紊乱**:定期监测血清电解质、尿酸和血糖。([5.3]({{< ref "#electrolyte-abnormalities" >}})) +- **男性乳房发育**:本品可引起男性乳房发育。([5.4]({{< ref "#gynecomastia" >}})) + +### 不良反应 {#highlights-adverse-reactions} + +本品治疗期间最常见的不良反应为男性乳房发育。([5.4]({{< ref "#gynecomastia" >}}),[6]({{< ref "#adverse-reactions" >}})) + +**如需报告任何疑似不良反应,请致电辉瑞公司:1-800-438-1985,或致电美国 FDA:1-800-FDA-1088。另可登录 。** + +### 药物相互作用 {#highlights-drug-interactions} + +- **促血钾药物**:与此类药物合用可引起高钾血症。([5.1]({{< ref "#hyperkalemia" >}}), [7.1]({{< ref "#potassium-supplements" >}})) +- **锂**:本品可增加锂毒性风险。([7.2]({{< ref "#lithium" >}})) +- **非甾体抗炎药(NSAID)**:此类药物可能会降低本品的利尿、利尿钠和抗高血压作用。([7.3]({{< ref "#nsaid" >}})) +- **地高辛**:本品可对地高辛暴露的放射免疫法检测结果造成干扰。([7.4]({{< ref "#digoxin" >}})) +- **考来烯胺**:已有与本品合用时引起高血钾型代谢性酸中毒的报告。([7.5]({{< ref "#cholestyramine" >}})) +- **阿司匹林(ASA)**:ASA 可能降低本品的效力。([7.6]({{< ref "#acetylsalicylic-acid" >}})) +- **阿比特龙**:可能提高前列腺特异性抗原(PSA)水平。([7.7]({{< ref "#abiraterone" >}})) + +### 特殊人群用药 {#highlights-specific-populations} + +- **妊娠妇女**:动物研究资料表明,本品可能影响雄性胚胎的性器官分化。([8.1]({{< ref "#pregnancy" >}})) + +**对患者的劝告提示请参见[第十七章]({{< ref "#patient-counseling" >}})。** + +**修订日期:2022 年 12 月** + +-------- + +# 说明书详情 {#full-info} + +## 一、适应症 {#indications} + +### 1.1 心衰竭 {#indications-heart-failure} + +本品可用于治疗纽约心功能分级(NYHA)为 III、IV 级的心衰竭和低射血分数,以达到提高生存率、控制水肿、降低心衰引起的住院需求的目的。\ +本品通常与其它心衰疗法合用。 + +### 1.2 高血压 {#indications-hypertension} + +本品可在其它药物不能良好控制血压的情况下,作为高血压的辅助疗法,用以降低血压。这可降低致命性与非致命性心血管事件、原发性卒中和心肌梗死发生的风险。在有关多种隶属于不同药理分类的抗高血压药物的对照试验中,可见螺内酯的上述收益。 + +高血压的控制应当作为心血管风险综合管理的一部分:其中还包括酌情控制血脂、糖尿病管理、抗血栓治疗、戒烟、运动、限制钠摄入等。有的患者可能需要多种药物来控制血压。有关高血压管理和目标的建议,请参见已发表指南资料;例如由全美高血压教育项目旗下的高血压预防、检测、评估和治疗联合委员会(JNC)发表的指南。 + +随机对照试验中,来自不同药理分类、药理作用各异的多种抗高血压药物,可降低心血管发病率和致死率;由此可见,对这些药物而言,上述收益主要来自对血压的降低作用,而非其它药理特性。此类药物最显著、一致性最高的心血管结局收益,是卒中风险的降低;但也频见心肌梗死和心血管致死率的降低。 + +收缩压和舒张压的升高可导致心血管风险增加,且每单位毫米汞柱引起的绝对风险增长在较高血压下会更大;因此,在重度高血压下,即使较小的血压降幅也可带来较大收益。处于不同绝对风险的人群因血压降低所得的相对风险收益相仿;因此,如患者处于更大的非高血压因素(糖尿病、高血脂等)引起的风险,则其绝对风险收益更大,给予积极治疗后有望使血压降至较低目标。 + +部分抗高血压药物(在单药疗法下)对黑人患者的血压控制作用较弱;多种药物除抗高血压作用外,还有被批准的其它适应症和作用(例如对心绞痛、心衰或糖尿病性肾病的治疗)。以上可作为选择治疗方案时的指导。 + +### 1.3 肝硬化或肾病综合征引起的水肿 {#indications-edema} + +本品可用于有以下情况的水肿的管理: + +- 肝硬化,如水分及钠摄入控制对水肿无效时。 +- 肾病综合征,如基础疾病治疗、水分和钠摄入控制以及其它利尿剂效力均不足时。 + +**本品可引起血钾升高,因此如已有服用其它利尿药引起低钾血症的经历,可使用本品治疗水肿。** + +### 1.4 原发性高醛固酮血症 {#indications-hyperaldosteronism} + +本品适用于以下情况: + +- 原发性高醛固酮血症患者的术前短期治疗; +- 不宜手术的离散型醛固酮分泌型肾上腺腺瘤患者的长期维持治疗; +- 双侧肾上腺微小或大结节增生(先天性高醛固酮血症)患者的长期维持治疗。 + + +## 二、用法用量 {#dosage} + +### 2.1 用法 {#general-considerations} + +本品可餐后服用,也可不伴食物服用;但应与就餐习惯保持一致。——*参见“药理毒理”[12.3 节]({{< ref "#pharmacokinetics" >}})* + +### 2.2 心衰竭的治疗 {#treatment-heart-failure} + +血钾 ≤5.0 mEq/L、肾小球滤过率(eGFR)>50 mL/min/1.73 m2 的患者,以每日一次、每次 25 mg 开始治疗。如患者对此耐受,可酌情增至每日一次 50 mg;如出现高钾血症,可降至隔日一次 25 mg。——*参见“警告与注意事项”[5.1 节]({{< ref "#hyperkalemia" >}})*\ +对于 eGFR 介乎 30~50 mL/min/1.73 m2 的患者,出于高钾血症风险,考虑以隔日一次 25 mg 开始治疗。——*参见“特殊人群用药”[8.6 节]({{< ref "#renal-impairment" >}})* + +### 2.3 原发性高血压的治疗 {#treatment-hypertension} + +建议初始时以每日 25~100 mg 的剂量,分一次或多次服用本品。每隔两周可调整一次剂量。高于 100 mg/天的剂量基本无额外的降血压作用。 + +### 2.4 水肿的治疗 {#treatment-edema} + +肝硬化患者初始时遵医嘱用药,剂量缓慢调整(*参见“特殊人群用药”[8.7 节]({{< ref "#hepatic-impairment" >}})*)。建议以每日 100 mg 为初始剂量,但可改为 25~200 mg 之间;分一次或多次服用本品。\ +如本品为唯一使用的利尿剂,为获得预期疗效,每次增加剂量前应连续服药至少五日。 + +### 2.5 原发性高醛固酮血症的治疗 {#treatment-hyperaldosteronism} + +术前以 100~400 mg/天的剂量服用本品。\ +不宜手术的,视个人情况以最低有效剂量进行长期维持治疗。 + + +## 三、性状与成分含量 {#forms} + +- 25 mg 片剂为淡黄色圆形包衣片,一面刻有“SEARLE”“1001”字样,另一面刻有“ALDACTONE”“25”字样。 +- 50 mg 片剂为亮橘色椭圆形包衣片,一面刻有“SEARLE”“1041”字样,另一面刻有“ALDACTONE”“50”字样。 +- 100 mg 片剂为粉色圆形包衣片,一面刻有“SEARLE”“1031”字样,另一面刻有“ALDACTONE”“100”字样。 + + +## 四、禁忌症 {#contraindications} + +**有以下情况的患者禁用本品:** + +- **高钾血症** +- **阿狄森氏病** +- **与伊普利酮并用** + + +## 五、警告与注意事项 {#warnings-precautions} + +### 5.1 高钾血症 {#hyperkalemia} + +本品可引起高钾血症。如肾功能不全,或与钾补剂、含钾代用盐或保钾剂(如血管紧张素转化酶抑制剂,血管紧张素受体阻断剂等)合用,则患病风险更高。——*参见“药物相互作用”[7.1 节]({{< ref "#potassium-supplements" >}})* + +治疗开始后一周内,密切监测血钾,此后改为定期监测。\ +若本品与其它可引起高钾血症的药物合用,或将本品用于肾功能不全患者,则可能需更频繁地监测血钾。 + +如发生高钾血症,应减少本品剂量或停用本品,并对症治疗。 + +### 5.2 低血压与肾功能恶化 {#hypotension} + +过度利尿可引起症状性脱水、低血压与肾功能恶化;尤其是对于盐分摄入不足的患者,或是正服用血管紧张素转化酶(ACE)抑制剂和血管紧张素 II 受体阻断剂(ARB)的患者,症状会更严重。此外,与具有肾毒性的药物(如氨基糖苷类、顺铂、NSAID 等)合用时,也可引起肾功能恶化。\ +应定期监测血容积状态和肾功能。 + +### 5.3 电解质与代谢紊乱 {#electrolyte-abnormalities} + +本品除引起高钾血症之外,还可引起低钠血症、高镁血症、低钙血症、低氯性碱中毒和高血糖等。本品可能引起无症状性高尿酸血症,并可罕见地导致痛风。\ +应定期监测血清电解质、尿酸和血糖。 + +### 5.4 男性乳房发育 {#gynecomastia} + +本品可引起男性乳房发育。据 Aldactone 随机评价研究(RALES)结果,心衰竭患者以螺内酯(平均剂量 26 mg/天,每日一次)治疗后,有约 9% 的男性患者出现乳房发育。男性乳房发育的风险随剂量增长,发生时间分布很广,从 1~2 个月至一年以上。此效果通常可逆。 + + +## 六、不良反应 {#adverse-reactions} + +以下有临床显著性的不良反应已于他处列出: + +- **高钾血症**(*参见“警告与注意事项”[5.1 节]({{< ref "#hyperkalemia" >}})*) +- **低血压与肾功能恶化**(*参见“警告与注意事项”[5.2 节]({{< ref "#hypotension" >}})*) +- **电解质与代谢紊乱**(*参见“警告与注意事项”[5.3 节]({{< ref "#electrolyte-abnormalities" >}})*) +- **男性乳房发育**(*参见“警告与注意事项”[5.4 节]({{< ref "#gynecomastia" >}})*) +- **造成肝功能不全、肝硬化、腹水患者的神经系统受损/昏迷**(*参见“特殊人群用药”[8.7 节]({{< ref "#hepatic-impairment" >}})*) + +在临床试验中或上市后识别的有关螺内酯的不良反应如下。这些不良反应来自使用者自发报告,规模不明,故无法准确估计其发生率、或建立与药物暴露的病理关系。 + +- **消化系统疾病**:胃出血、胃溃疡、胃炎、腹泻和腹绞痛、恶心、呕吐 +- **生殖系统疾病**:性欲降低、勃起障碍、月经不调或停经、绝经后出血、乳房和乳头疼痛 +- **血液疾病**:白细胞减少(含粒细胞减少)、血小板减少 +- **超敏反应**:发热、荨麻疹、皮肤斑疹或红疹、过敏性反应、血管炎 +- **代谢疾病**:高钾血症、电解质紊乱(*参见“警告与注意事项”[5.1 节]({{< ref "#hyperkalemia" >}})、[5.3 节]({{< ref "#electrolyte-abnormalities" >}})*)、低钠血症、血容积过低 +- **肌肉骨骼疾病**:腿绞痛 +- **神经系统与精神类疾病**:嗜睡、意识模糊、运动障碍、眩晕、头痛、困倦 +- **肝胆疾病**:有罕见的使用螺内酯时引起混合淤胆性/肝细胞性中毒的病例报告,其中一例死亡 +- **肾脏疾病**:肾功能不全(含肾衰竭) +- **皮肤疾病**:Stevens-Johnson 综合征(SJS)、中毒性表皮坏死松解症(TEN)、伴有嗜酸性粒细胞增多和系统性症状的药疹(DRESS)、脱发、瘙痒 + + +## 七、药物相互作用 {#drug-interactions} + +### 7.1 与促血钾药物和补剂的相互作用 {#potassium-supplements} + +本品与钾补剂或促血钾药物合用时,可引起重度高钾血症。对于心衰竭患者,开始本品治疗前一般应停用钾补剂。——*参见“警告与注意事项”[5.1 节]({{< ref "#hyperkalemia" >}})、“药理毒理”[12.3 节]({{< ref "#pharmacokinetics" >}})*\ +如本品治疗期间改变了 ACE 抑制剂或 ARB 疗法,应检查血钾水平。 + +其它促血钾药物有: + +- ACE 抑制剂 +- 血管紧张素受体阻断剂 +- 非甾体消炎药(NSAID) +- 肝素、小分子肝素 +- 甲氧苄啶 + +### 7.2 与锂的相互作用 {#lithium} + +与其它利尿剂相似,本品可降低锂的肾清除率,从而使锂毒性风险增加。如与本品合用,应定期监测锂水平。——*参见“药理毒理”[12.3 节]({{< ref "#pharmacokinetics" >}})* + +### 7.3 和非甾体消炎药(NSAID)的相互作用 {#nsaid} + +在部分患者中,NSAID 可降低利尿剂的利尿、利尿钠和抗高血压作用。因此,如将本品与 NSAID 合用,应密切监测并判断利尿剂是否起到预期作用。——*参见“药理毒理”[12.3 节]({{< ref "#pharmacokinetics" >}})* + +### 7.4 与地高辛的相互作用 {#digoxin} + +螺内酯及其代谢物可对地高辛的放射免疫法检测结果造成干扰,使地高辛表暴露量的检出值增加。尚不清楚螺内酯以何种程度增加地高辛暴露量(如有)。\ +如患者同时服用地高辛,应换以不受螺内酯影响的检测法。 + +### 7.5 与考来烯胺的相互作用 {#cholestyramine} + +已有以本品与考来烯胺合用时发生高血钾型代谢性酸中毒的报告。 + +### 7.6 与阿司匹林的相互作用 {#acetylsalicylic-acid} + +阿司匹林可降低螺内酯的效力。因此,如将本品与阿司匹林合用,可能需将本品调整至较高的维持剂量,且应密切观察以判断本品是否起到预期作用。——*参见“药理毒理”[12.3 节]({{< ref "#pharmacokinetics" >}})* + +### 7.7 与阿比特龙的相互作用 {#abiraterone} + +在接受阿比特龙治疗的前列腺癌患者当中,螺内酯可与雄激素受体结合,从而可能引起前列腺特异性抗原(PSA)水平的升高。不建议将螺内酯与阿比特龙合用。 + + +## 八、特殊人群用药 {#specific-populations} + +### 8.1 妊娠妇女用药 {#pregnancy} + +> **风险概述** + +据动物试验中螺内酯的作用以及结果,螺内酯可能会影响雄性胚胎的性器官分化(*参见“研究资料”小节*)。大鼠胚胎—胎儿研究显示,雄性胚胎在子宫暴露于螺内酯后发生雌性化;曾在子宫暴露于螺内酯的雌性发生内分泌紊乱。迄今有限的病例报告和系列病例资料未表明螺内酯与胎儿重大畸形或其它不良妊娠结局有任何联系。\ +妊娠期间,如患有心衰、肝硬化和控制不当的高血压,则孕妇和胎儿会有与此相关的风险(*参见“临床对策”小节*)。\ +出于男性胎儿可能受螺内酯的抗雄激素特性影响的风险,以及现有动物试验资料的缘故,请勿向妊娠妇女给予螺内酯;或者,提醒妇女该药对男性胎儿的潜在风险。 + +尚不清楚适用人群出现重大先天缺陷和流产的大致背景风险。任何妊娠都会有先天缺陷、流产或其它不良结局的背景风险。在美国一般人群中,临床认可的妊娠出现重大先天缺陷和流产的背景风险,大致分别为 2~4% 和 15~20%。 + +> **临床对策** + +*疾病引起的产妇和/或胎儿风险:*\ +如妊娠妇女患有充血性心衰竭,则有更高的早产风险。妊娠期间(尤其是妊娠早期),心搏量和心跳增加,从而心输出量增加;心脏疾病的临床分级可能恶化,并导致孕妇死亡。应对妊娠妇女因心衰引起的不稳定性进行密切观察。 + +如妊娠妇女患有症状性肝硬化,则通常会有不良结局,包括肝衰竭、静脉曲张出血、早产、胎儿发育不良、孕妇死亡等。如同时患有食管静脉曲张,则上述结局会加重。\ +应对患有肝硬化的妊娠妇女进行密切观察,并作相应处置。 + +妊娠期间,高血压导致孕妇发生先兆子痫、妊娠糖尿病、早产、分娩并发症(如需要剖腹产,产后出血)的风险增加。\ +同时,高血压导致胎儿发育不良和死胎的风险增加。 + +> **研究资料** + +*动物试验资料:*\ +迄今已进行本品对小鼠、兔致畸性的研究,其中本品剂量最大为 20 mg/kg/天。从体表面积看,小鼠剂量远低于人体最大建议剂量,而兔剂量基本与人体最大建议剂量相当。小鼠中未观察到任何致畸性和胚胎毒性作用,但兔中 20 mg/kg 剂量导致了再吸收率提高、活胎数下降。由于雄性胚胎在形态发生期间需睾酮参与,而本品有抗雄激素活性,因此本品可能会对雄性胚胎的性器官分化造成不良影响。\ +大鼠在妊娠 13 天、21 天(胚胎形成晚期至胎儿发育期)给予本品 200 mg/kg/天,观察到雄性胎儿出现雌性化。妊娠晚期暴露于本品 50、100 mg/kg/天之后,后代出现生殖道病变并持续到成年,其中包括:雄性后代腹侧前列腺与精囊重量减小(依剂量而异),雌性后代卵巢、子宫增大,其它内分泌紊乱征象等。\ +本品已知对动物有内分泌作用,包括孕前作用和抗雄激素作用。 + +### 8.2 哺乳期妇女用药 {#lactation} + +> **风险概述** + +螺内酯不会分泌到乳汁中;然而,在有关一名产后 17 日的哺乳期妇女的有限资料中,从其乳汁检测到本品的活性代谢物:坎利酮,含量很低,被认为无临床相关性。该病例中,短期暴露于螺内酯对被哺乳的婴儿无不良影响,但尚不清楚长期暴露对被哺乳婴儿的影响。\ +尚无有关螺内酯对乳汁分泌之影响的资料。\ +应综合考虑母乳喂养对婴儿发育和健康的益处和哺乳妇女对螺内酯的临床需求,以及螺内酯或哺乳妇女的其它基础状况对被哺乳婴儿的任何潜在不良影响。 + +### 8.4 儿童用药 {#pediatric} + +本品对儿童患者的安全性和有效性尚未确立。 + +### 8.5 老年用药 {#geriatric} + +本品主要经肾脏排出;对于肾功能不全患者,本品的不良反应可能会加重。因老年患者出现肾功能减退的可能较大,故应监测肾功能。 + +### 8.6 肾功能不全者用药 {#renal-impairment} + +本品主要经肾脏排出;对于肾功能不全患者,本品的不良反应可能会加重,出现高钾血症的风险更高。应密切监测血钾。 + +### 8.7 肝功能不全者用药 {#hepatic-impairment} + +本品可导致体液和电解质平衡的急性改变;对于肝硬化和腹水患者,这可能引起神经功能损伤,使肝性脑病恶化,导致昏迷等。这类患者应在医院接受本品治疗。——*参见“用法用量”[2.4 节]({{< ref "#treatment-edema" >}})、“药理毒理”[12.3 节]({{< ref "#pharmacokinetics" >}})* + +肝硬化患者中,螺内酯及其代谢物的清除率降低。肝硬化患者应以最低初始剂量开始治疗,并缓慢调整剂量。——*参见“用法用量”[2.4 节]({{< ref "#treatment-edema" >}})、“药理毒理”[12.3 节]({{< ref "#pharmacokinetics" >}})* + + +## 十、药物过量 {#overdosage} + +本品口服对小鼠、大鼠、兔的半数致死剂量(LD50)为 1000 mg/kg 以上。 + +急性过量服用本品,可导致困倦、意识模糊、斑疹或红疹、恶心、呕吐、眩晕、腹泻等。重度肝病患者可罕见地引起低钠血症、高钾血症或肝性昏迷,但这些症状很可能与急性药物过量无关。高钾血症可能会发生,而肾功能不全者的几率更大。 + +**治疗措施:** 催吐或洗胃。本品尚无特效抗毒药。给予水分、电解质平衡和生命功能支持治疗。如肾功能不全患者出现高钾血症,停用本品。 + + +## 十一、成分详情 {#description} + +本品每片含 25 mg、50 mg 或 100 mg 螺内酯。螺内酯为醛固酮的拮抗剂,化学名称为 17β-羟基-7α-(乙酰硫基)-3-氧代-17α-孕甾-4-烯-21-羧酸 γ-内酯,化学结构式如下: + +{{< figure src="https://scimg.chem960.com/cas/0/52-01-7.png" width="40%" >}} + +螺内酯几乎不溶于水,溶于乙醇,易溶于苯和氯仿。 + +本品其余无活性成分包括: + +- 硫酸钙 +- 玉米淀粉 +- 香料 +- 羟丙甲纤维素 +- 氧化铁 +- 硬脂酸镁 +- 聚乙二醇 +- 聚维酮 +- 二氧化钛 + + +## 十二、药理毒理 {#clinical-pharmacology} + +### 12.1 作用机理 {#mechanism-action} + +螺内酯及其活性代谢物是醛固酮的特异性拮抗剂,其主要通过与肾远曲小管钠—钾交换位点的醛固酮依赖性受体竞争性结合来发挥作用。螺内酯使钠、水分排泄增加,钾排泄减少。借此,螺内酯起到利尿、抗高血压作用。螺内酯可单用,也可与作用于肾近曲小管的其它利尿剂合用。 + +### 12.2 药效学特性 {#pharmacodynamics} + +醛固酮拮抗活性:在原发性和继发性高醛固酮血症当中,醛固酮(一种盐皮质激素)水平升高。继发性高醛固酮血症通常涉及的水肿状态包括:充血性心衰竭、肝硬化、肾病综合征等。这种情况下,螺内酯通过与醛固酮竞争受体位点,可有效治疗水肿和腹水。\ +螺内酯可阻止由现有利尿剂治疗引起血容积过低、血钠减少而诱发的继发性高醛固酮血症。 + +### 12.3 药代动力学特性 {#pharmacokinetics} + +> **吸收** + +在健康志愿者中,螺内酯及其活性代谢物:坎利酮的血药水平平均达峰时间分别为 2.6、4.3 小时。 + +*食物对吸收率的影响:* 食物可增加螺内酯的生物利用度(以曲线下面积 AUC 测定),增幅约 95.4%。患者应按就餐规律养成服药习惯。——*参见“用法用量”[2.1 节]({{< ref "#general-considerations" >}})* + +> **分布** + +螺内酯及其代谢物有 90% 以上与血浆蛋白结合。 + +> **清除** + +螺内酯的平均半衰期为 1.4 小时。坎利酮、7-α-硫甲基螺内酯(TMS)和 6β-羟基-7α-硫甲基螺内酯(HTMS)等代谢物的平均半衰期分别为 16.5、13.8 和 15 小时。 + +*代谢:* 螺内酯代谢迅速。代谢物分为两种:去硫物(如坎利酮)和含硫物(如 TMS、HTMS)。人体中 TMS 和 7-α-硫代螺内酯扭转氟氢可的松(一种合成盐皮质激素)对尿液电解质成分之影响的效力,约为螺内酯的三分之一。然而,由于以上类固醇的血药水平未被测定,不能排除其体内活性的降低是受到吸收不完全和/或首过代谢的影响的。 + +*排泄:* 代谢物主要经尿排出,其余经胆汁排出。 + +> **特殊人群提示** + +尚未就年龄、性别、人种和肾功能不全对螺内酯药代动力学的影响进行专门研究。 + +*肝功能不全患者:* 在肝硬化性腹水患者中,已有螺内酯的清除半衰期延长的报告。——*参见“特殊人群用药”[8.7 节]({{< ref "#hepatic-impairment" >}})* + +> **药物相互作用研究** + +*利钾药物和补剂:* 将本品与钾补剂、含钾代用盐、富钾食品或利钾药物(如 ACE 抑制剂,血管紧张素 II 拮抗剂,非甾体消炎药,肾素,小分子肾素等)合用,可引起重度高钾血症。——*参见“警告与注意事项”[5.1 节]({{< ref "#hyperkalemia" >}})、“药物相互作用”[7.1 节]({{< ref "#potassium-supplements" >}})* + +*锂:* 本品降低锂的肾清除率,使锂毒性风险升高。——参见“药物相互作用”[7.2 节]({{< ref "#lithium" >}}) + +*非甾体消炎药(NSAID):* 对于部分患者,NSAID 可能会降低亨利氏环利尿剂、保钾利尿剂和噻嗪类利尿剂的利尿、利尿钠和抗高血压作用。——*参见“药物相互作用”[7.3 节]({{< ref "#nsaid" >}})* + +*阿司匹林:* 单次服用阿司匹林 600 mg 可抑制螺内酯的促尿钠作用,估计与坎利酮从肾小管的排泄被抑制有关。这使得螺内酯的有效性降低。——*参见“药物相互作用”[7.6 节]({{< ref "#acetylsalicylic-acid" >}})* + + +## 十三、非临床毒理研究资料 {#nonclinical-toxicology} + +### 13.1 致癌性、致突变性和致不育性 {#carcinogenesis} + +> **致癌性** + +对象为 Sprague Dawley 大鼠的膳食给药研究显示,本品口服后呈致癌性,在内分泌组织和肝脏中有促增生作用。\ +一项为期 18 个月的研究中,约 50、150、500 mg/kg/天的剂量对甲状腺良性腺瘤产生有统计意义的增长作用;雄性大鼠中造成了肝脏组织增生作用(含肝细胞肥大和增生性结节)。\ +一项为期 24 个月的研究中,大鼠给予本品约 10、30、100、150 mg/kg/天,造成多种组织增生作用:包括雄性大鼠的肝细胞腺瘤和睾丸间质细胞瘤的明显增加,雌、雄性大鼠的甲状腺滤泡细胞瘤、甲状腺癌的明显增加等。此外,雌性的良性子宫内膜基质息肉同样有统计意义的增加。 + +> **致突变性** + +细菌和真菌试验中,本品和坎利酸钾均未产生致突变性作用。\ +体外哺乳类细胞致突变性试验中,本品和坎利酸钾在未被代谢时,均未造成致突变性作用。正常代谢时,本品的致突变性结果在部分试验中呈阴性,而在另一部分试验中无明确结论(略倾向于阳性)。正常代谢时,坎利酸钾的致突变性结果在部分试验中呈阳性,部分无明确结论,其余呈阴性。 + +> **致不育性** + +一项三胎繁殖研究中,雌性大鼠以 15、50 mg/kg/天的饮食剂量给予本品,未发现对配偶和生育力有任何影响,但死胎发生率在 50 mg/kg/天下有小幅增加。\ +雌性大鼠经静脉注射本品(连续 7 日 100 mg/kg/天)之后,发现本品使发情间期延长,并在治疗后两周的观察期内持续促导发情间期,从而使发情周期延长。以上作用与卵泡发育延迟、循环雌激素水平下降有关,可能会损害配偶能力、生育力和繁殖力。\ +雌性小鼠经静脉注射本品(100 mg/kg/天)之后,与未治疗的雄性小鼠同居两周;发现本品使配偶并受精的小鼠减少(该作用由排卵受抑制造成),而妊娠小鼠中着床成功的胚胎数也减少(该作用由着床受抑制造成);200 mg/kg 剂量下,配偶潜伏期增加。 + + +## 十四、临床研究资料 {#clinical-studies} + +### 14.1 心衰竭 {#studies-heart-failure} + +Aldactone 随机评价研究(RALES)是一项有关螺内酯对患有重度症状性心衰竭和低射血分数的患者死亡率之影响的双盲安慰剂对照研究。患者需满足以下条件方可参试: + +- 射血分数 ≤ 35%; +- 心衰症状的 NYHA 分级为 III–IV 级; +- 参试前六个月以内曾出现 NYHA 分级为 IV 级的症状。 + +如患者基线肌酐 >2.5 mg/dL 或近期增加 25%,或者基线血钾 >5.0 mEq/L,不予参试。 + +治疗开始后 12 周内,每四周进行一次随访和实验室测定;此后,初始一年内每三个月进行一次;满一年后,改为每六个月进行一次。\ +螺内酯的初始剂量为每日一次 25 mg。一至四周内对初始剂量不耐受的,调整为隔日一次 25 mg;八周内对每日一片耐受的,酌情调整为每日 50 mg。研究结束时,受试者的平均剂量为 26 mg/天。 + +共有 1663 名患者被随机分配到螺内酯组或安慰剂组。其中,87% 为白人,7% 为黑人,2% 为亚裔。男性占 73%;平均年龄为 67 岁。患者的射血分数中位数为 26%。NYHA 分级为 III 级的占 70%,IV 级占 29%。心衰竭分类为缺血性的占 55%,非缺血性的占 45%。有心肌梗死既往史的占 28%,有高血压既往史的占 24%,有糖尿病既往史的占 22%。基线肌酐中位数为 1.2 mg/dL;基线肌酐清除率中位数为 57 mg/min。\ +受试前,有 100% 的患者正服用亨利氏环利尿剂,有 95% 正服用 ACE 抑制剂。其余曾在研究中使用的药物有:地高辛(78%)、抗凝剂(58%)、阿司匹林(43%)与 β-受体阻断剂(15%)。 + +RALES 的主要终点为任意原因死亡发生前的存活时间。由于计划中期分析发现死亡率有明显收益,故 RALES 被提前终止。相较于安慰剂,螺内酯使死亡风险降低 30%(*P* <0.001;95% 置信区间 18~40%);螺内酯还使需住院处置心脏疾病的风险降低 30%(*P* <0.001;95% 置信区间 18~41%;心脏疾病包括心衰恶化、心绞痛、室性心律失常、心肌梗死等)。 + +两个治疗组的生存曲线见图一。 + +
+ +**「图一」RALES 诸治疗组的生存曲线** + +虚线:螺内酯组;实线:安慰剂组\ +横轴:治疗时间;纵轴:生存概率 + +{{< figure src="aldactone-1.jpg" width="80%" >}} + +
+ +部分细分组别的死亡危险比率见图二。螺内酯对死亡率的改善作用可见于男性、女性,也可见于除 55 岁以下患者以外的所有年龄组。参与 RALES 试验的非白人数量过少,无法评价不同人种之间是否有不同疗效。在基线血钾较低的患者中,螺内酯的收益更高;在射血分数 <0.2 的患者中,螺内酯的收益更低。以上子组分析须予以谨慎说明。 + +
+ +**「图二」RALES 诸细分组别的任意原因死亡危险比率** + +{{< figure src="aldactone-2.png" width="100%" >}} + +注:矩形大小与该组别的样本规模和发生率成正比。 + +*译者注:本图引自 [2008 年版说明书](https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/012151s062lbl.pdf),内容除缺少“占比”一列外,与本版一致,且清晰度更高。* + +
+ +### 14.2 高血压 {#studies-hypertension} + +高血压对螺内酯治疗剂量的反馈迄今未得到充分评价。高血压患者中,25~100 mg/天范围内的剂量可降低其收缩压。高于 100 mg/天的剂量基本无额外的降血压作用。——*参见“用法用量”[2.3 节]({{< ref "#treatment-hypertension" >}})* + + +## 十六、包装规格和贮藏事项 {#how-supplied} + +- 本品 25 mg 片剂为淡黄色圆形包衣片,一面刻有“SEARLE”“1001”字样,另一面刻有“ALDACTONE”“25”字样。每瓶 100 片。(NDC 编号:0025-1001-31) +- 本品 50 mg 片剂为亮橘色椭圆形包衣片,一面刻有“SEARLE”“1041”字样,另一面刻有“ALDACTONE”“50”字样。每瓶 100 片。(NDC 编号:0025-1041-31) +- 本品 100 mg 片剂为粉色圆形包衣片,一面刻有“SEARLE”“1031”字样,另一面刻有“ALDACTONE”“100”字样。每瓶 100 片。(NDC 编号:0025-1031-31) + +77°F(25°C)以下保存。 + + +## 十七、对患者的劝告提示 {#patient-counseling} + +提醒患者,服用本品时避免摄入钾补剂和富钾食品,如代用盐。 + +-------- + +本产品说明书可能已有新的版本。请访问 获取最新说明书。 + +销售企业:**Pfizer Labs**\ +辉瑞公司(Pfizer Inc.)隶属子公司\ +New York, NY 10017 + +LAB-0231-16.0 \ No newline at end of file