专家不建议娱乐性用药,因为“没有获益”。
撰文 | 燕小六
近日,广药白云山发布2023年年报,在其4大类9款药物中,国产“伟哥”枸橼酸西地那非片再度成为“销冠”,销售额达12.895亿元,较上一年度增长22.6%。毛利率高达91.76%,直逼茅台。
这款药用于治疗男性勃起功能障碍(ED)。产销量及库存量分析显示,其一年卖出1亿多片。根据第七次全国人口普查数据,我国15岁以上男性人口为5.93亿。
“这是不是说明,‘不行’的人越来越多了?”有网友戏称。
图源/白云山:2023年年度报告全文
男科药,卖得好
截至2023年年中,我国枸橼酸西地那非(以下简称西地那非)相关批文共37条,生产企业约20家。还有新选手不断进场。
其中,广药白云山的国产“伟哥”位列头部梯队。2014年上市当年,其销量为2.92万片。到2022年,营收首次破10亿元。根据米内网今年2月底发布的《中国城市实体药店中端竞争格局》蓝皮书,它已成为生殖泌尿系统药物类别的销量TOP1。
胜利来得并不轻松。就药理学分类看,西地那非和他达拉非、伐地那非、阿伐那非等,都属于PDE5抑制剂,作用机理相似:都能诱导平滑肌松弛,改善男性关键部位的供血,让ED患者不再力不从心。
目前,我国获批上市的国产PDE5抑制剂超过50款。不同“非”类都有众多仿制药,有的还进了集采目录。
图源网络
男人不行了?
有预测指出,今年我国抗ED类药物市场规模将达百亿元。惊人的造富能力背后或是巨大的需求。
我国《勃起功能障碍诊断与治疗指南》显示,ED是成年男性的常见疾病。一项对我国30个省和自治区的40岁以上男性调查显示,ED患病率达40.6%。“目前没有ED最新的流行病学数据,但一般不会突然升高。”北京大学国际医院生殖医学中心主任医师周善杰告诉“医学界”。
若以全年龄成年男性为样本,ED发生率会被稀释。比如,张庆江等对北京、重庆、广州3地2226名成年男性进行调查,发现ED总患病率达26.1%。而樊云井等访谈山东省5个县市区3991名成年男性,得到的ED总患病率是25.8%。
究其原因,ED大多和年龄、慢性基础病等因素密切相关。年龄越大,患病率越高。根据《中华男科学杂志》一组数据,40-49岁的患病率就明显低于70岁以上者(18.1%∶81.6%)。
但到医院门诊一瞧,去看病的ED患者往往“很年轻”。上海、广州、南京等地多名男科医生告诉“医学界”,ED主要就诊人群以30-50岁为主,能占到门诊量一半。北京大学第一医院党委书记、中国性学会会长姜辉在出席活动时也表示:“西地那非在我国的使用,以40岁以下人群为主,可能占到总使用量的七到八成。”
一方面,现代中青年男性确实不易。工作压力大、过度劳累、紧张焦虑、加班熬夜、抽烟喝酒、代谢疾病提前等,都可能让他们“提前不行”。
自1980年以来,我国18岁以上成人糖尿病患病率从0.67%迅速升至11.2%,男性患病率高于女性。《糖尿病合并男性性功能障碍多学科中国专家共识》指出,与同龄一般人群相比,ED在糖尿病人群中发病更早,发病率更高。我国一项基于糖尿病门诊的多中心调查显示,ED发生比例为75.1%。不光“不行”,糖尿病患者的射精功能障碍、高潮缺乏、性欲低下等患病率也更高。
另一方面,这或是因为中青年男性更关注自己的卧房表现。以简化版“国际勃起功能评分表”(IIEF-5)为例,一共有5个问题,要求男性根据过去3个月的生活实际给自己评分,总分≤21就跨入轻度ED级别。
在问题描述中,“信心”“能够”“困难”“满足”等代表自我价值、自我尊重、自我理解的词汇频繁出现。这说明,评价ED不止关乎“能力”,更取决于个人对性的自信心和满意度。
假设一个男性在生理问题上全给自己打满分,但自信和满意度只达到“中等”“有时”,那最终得分刚好21分,属于轻度ED。
“不能说男性越来越不行了。”周善杰告诉“医学界”,他倾向于认为,现代男性的就诊意愿高了,主动寻求治疗、愿意用药的人在增加。
简化版“国际勃起功能评分表”(IIEF-5)。图源/中华男科学杂志
娱乐性用药“没意义”
关于抗ED药销量“雄起”,周善杰看到积极变化,也会有些担忧。
“过往,PDE5抑制剂存在一些认知误区,包括担心副作用、成瘾性。很多人是不接受用药的。”周善杰说。
口服此类药物的副作用通常比较温和。妙佑医疗国际(又名梅奥诊所)的患者教育单页显示,主要包括皮肤潮红、头痛、胃部不适,眩晕感等,有些人会出现视力变化,比如看啥都是蓝色调的,对光线敏感或视力模糊。
极少数情况下,可能出现严重副作用,包括突然丧失部分听力或视力。目前尚不清楚这是药物导致的,还是源于患者已经存在的健康问题。此外,日常服用硝酸酯类药物属于绝对禁忌,不能和PDE5抑制剂合用。
周善杰担心的是“娱乐性用药”。
由于不少院外药房、电商网购能无障碍购药,一些人纯出于好奇,或仅仅是因为“最近感觉状态不太好”,就自行吞药。
“没有ED的人,不建议用药,没有获益。简单说,就是本来好好的,吃了也没用。”周善杰表示。ED包括心理性原因和复杂的器质性原因,比如内分泌异常、血管功能异常等。要先经过规范检查、找到确切病因,才能对症用药。而且,用药应遵医嘱,不要轻易改变剂量。
不同“非”,特点不一
“每种口服抗ED药物的化学成分略有不同。这些微小的差异影响着药物作用方式。”妙佑医疗国际的患者教育单页称,选择药物时,要将自己的偏好,包括费用、易用性、药效持续时间和副作用等,告知医护人员。
西地那非是上市时间最长的PDE5抑制剂,用药后30-60分钟起效,高脂大餐或饮酒会影响吸收。一般情况下,药效能维持4-5小时,在这段时间内男性受到刺激,就能竖小旗。但它并不意味着用药后能“金枪不倒”达4小时。假使是后者,就属于严重不良反应,要尽快就医。
伐地那非的特点是起效时间短。《勃起功能障碍诊断与治疗指南》称,在10mg和20mg剂量下,多达1/3患者在摄入后15分钟内,能看到满意效果,有效率分别为76%和80%。
他达拉非不受进食与饮酒影响。其半衰期明显长于西地那非和伐地那非,达17.5小时。半衰期越长,意味着药效维持更久。
阿伐那非的特点也是快。按需使用的推荐剂量为100mg和200mg,给药后约15分钟起效,有效率分别为74%和77%。
值得一提的是,因为能扩张血管平滑肌、增加输出量,西地那非在全球多地获得第二个适应证:治疗肺动脉高压。一些有经验的医生还会根据药理作用,“超标签”地用于治疗高原反应。
近年,关于西地那非的拓展研究还深入到肿瘤治疗领域。2020年1月的一篇文章显示,西地那非或具有潜在的抗肿瘤活性,单独使用或与其他抗肿瘤化合物合用,能促进肿瘤细胞凋亡、抑制增殖。
资料来源:
1.白云山:2023年年度报告全文
2.第七次全国人口普查公报
3.勃起功能障碍诊断与治疗指南. 中华男科学杂志. 2022,28(8):722-755.doi:10.13263/j.cnki.nja.2022.08.009
4.糖尿病合并男性性功能障碍多学科中国专家共识. 中国男科学杂志. 2022年第36卷第1期
5.勃起功能障碍. Mayo clinic
来源:医学界
:田栋梁
:赵 静
*“医学界”力求所发表专业、可靠,但不对的准确性做出承诺;请相关各方在采用或以此作为决策依据时另行核查。
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#000;--weui-BG: #fff;--weui-TAG-TEXT-RED: rgba(250, 81, 81, .6);--weui-TAG-BACKGROUND-RED: rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: #e17719;--weui-TAG-BACKGROUND-ORANGE: rgba(225, 119, 25, .1);--weui-TAG-TEXT-GREEN: #06ae56;--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: #007dbb;--weui-TAG-BACKGROUND-BLUE: rgba(0, 125, 187, .1);--weui-TAG-TEXT-BLACK: rgba(0, 0, 0, .5);--weui-TAG-BACKGROUND-BLACK: rgba(0, 0, 0, .05)}}@media screen and (min-width:1024px){body:not(.pages_skin_pc) .wx-root[data-weui-mode=care][data-weui-theme=dark],body:not(.pages_skin_pc) body[data-weui-mode=care][data-weui-theme=dark]{--weui-BG-0: #111;--weui-BG-1: #1e1e1e;--weui-BG-2: #191919;--weui-BG-3: #202020;--weui-BG-4: #404040;--weui-BG-5: #2c2c2c;--weui-FG-0: rgba(255, 255, 255, .85);--weui-FG-HALF: rgba(255, 255, 255, .65);--weui-FG-1: rgba(255, 255, 255, .55);--weui-FG-2: rgba(255, 255, 255, .35);--weui-FG-3: rgba(255, 255, 255, .1);--weui-FG-4: rgba(255, 255, 255, .15);--weui-FG-5: rgba(255, 255, 255, .1);--weui-RED: #fa5151;--weui-ORANGERED: #ff6146;--weui-ORANGE: #c87d2f;--weui-YELLOW: #cc9c00;--weui-GREEN: #74a800;--weui-LIGHTGREEN: #3eb575;--weui-BRAND: #07c160;--weui-BLUE: #10aeff;--weui-INDIGO: #1196ff;--weui-PURPLE: #8183ff;--weui-WHITE: rgba(255, 255, 255, .8);--weui-LINK: #7d90a9;--weui-TEXTGREEN: #259c5c;--weui-FG: #fff;--weui-BG: #000;--weui-TAG-TEXT-RED: rgba(250, 81, 81, .6);--weui-TAG-BACKGROUND-RED: rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: rgba(250, 157, 59, .6);--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: rgba(6, 174, 86, .6);--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: rgba(16, 174, 255, .6);--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(255, 255, 255, .5);--weui-TAG-BACKGROUND-BLACK: rgba(255, 255, 255, .05)}}@media screen and (min-width:1024px){body:not(.pages_skin_pc) .wx-root,body:not(.pages_skin_pc) body{--appmsgExtra-BG: 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.8);--weui-LINK: #7d90a9;--weui-TEXTGREEN: #259c5c;--weui-FG: #fff;--weui-BG: #000;--weui-TAG-TEXT-RED: rgba(250, 81, 81, .6);--weui-TAG-BACKGROUND-RED: rgba(250, 81, 81, .1);--weui-TAG-TEXT-ORANGE: rgba(250, 157, 59, .6);--weui-TAG-BACKGROUND-ORANGE: rgba(250, 157, 59, .1);--weui-TAG-TEXT-GREEN: rgba(6, 174, 86, .6);--weui-TAG-BACKGROUND-GREEN: rgba(6, 174, 86, .1);--weui-TAG-TEXT-BLUE: rgba(16, 174, 255, .6);--weui-TAG-BACKGROUND-BLUE: rgba(16, 174, 255, .1);--weui-TAG-TEXT-BLACK: rgba(255, 255, 255, .5);--weui-TAG-BACKGROUND-BLACK: rgba(255, 255, 255, .05)}}@media screen and (min-width:1024px) and (prefers-color-scheme:dark){body:not(.pages_skin_pc) .wx-root:not([data-weui-theme=light]),body:not(.pages_skin_pc) body:not([data-weui-theme=light]){--appmsgExtra-BG: #121212}}@media(prefers-color-scheme:dark){body:not([data-weui-theme=light]).my_comment_empty_data{background-color:#111}}body,.wx-root{--weui-BG-6: rgba(0, 0, 0, .05);--weui-ACTIVE-MASK: rgba(0, 0, 0, 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