原创 国产药和进口药真的同样吗？该怎么选？
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">看病住院开药的时候，有时<span style="color: black;">大夫</span>会和<span style="color: black;">病人</span>或家属商量<span style="color: black;">运用</span>国产药还是进口药。但大<span style="color: black;">都数</span>人<span style="color: black;">常常</span>对它们的<span style="color: black;">详细</span>区别并不清楚，只<span style="color: black;">晓得</span>进口药太贵，用国产药吧，便宜但怕疗效<span style="color: black;">欠好</span>，对<span style="color: black;">药品</span>的<span style="color: black;">选取</span>犯了难。今天就来<span style="color: black;">仔细</span>讲讲这个问题。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q8.itc.cn/images01/20240603/74f64b6f41474f4887aa4a2cb2105612.png" style="width: 50%; margin-bottom: 20px;"></p>
<h1 style="color: black; text-align: left; margin-bottom: 10px;">四个概念：进口、国产、原研、仿制</h1>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">讲这个问题之前，<span style="color: black;">首要</span>要搞清楚进口药、国产药、原研药、仿制药这四个概念。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">进口药<span style="color: black;">指的是</span>在国外生产，并从国外或我国港澳台等地区进口<span style="color: black;">营销</span>的<span style="color: black;">药物</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">国产药则<span style="color: black;">是由于</span>中国的医药企业生产的<span style="color: black;">药物</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">原研药<span style="color: black;">便是</span><span style="color: black;">一般</span>所说的正版药，指在境内外首个获准上市，且<span style="color: black;">拥有</span>完整和充分的安全性、有效性数据<span style="color: black;">做为</span>上市依据的<span style="color: black;">药物</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">仿制药指当原研药过了专利<span style="color: black;">守护</span>期之后<span style="color: black;">能够</span>被其他企业仿制，对原研药的<span style="color: black;">重点</span><span style="color: black;">成份</span>进行仿制的<span style="color: black;">药物</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q8.itc.cn/images01/20240603/1b833f150e4c4478a87a06e385834296.png" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">虽然这次讲的主题是进口药和国产药，而之<span style="color: black;">因此</span>要提及原研药和仿制药，是<span style="color: black;">由于</span>我国制药工业起步晚，<span style="color: black;">基本</span>差，创新能力弱，<span style="color: black;">开发</span>投入少，除了中草药和中成药，国内药企生产的化学<span style="color: black;">药物</span>或生物制品，绝大<span style="color: black;">大都是</span>在国外已上市原研药<span style="color: black;">基本</span>上模仿、修饰而成的仿制药。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">亦</span><span style="color: black;">便是</span>说，国产西药基本上就相当于仿制药，国产原研药凤毛麟角，<span style="color: black;">亦</span>不常用。例如<span style="color: black;">咱们</span>熟知的布洛芬、对乙酰氨基酚、头孢类抗生素等，<span style="color: black;">因为</span>原研专利<span style="color: black;">守护</span>期早就过了，国内<span style="color: black;">能够</span>合法仿制，<span style="color: black;">因此呢</span>市面上有进口的<span style="color: black;">亦</span>有国产的。而进口西药中，有些是原研药，有些则是仿制药。例如因《我不是药神》名声大噪的格列卫，<span style="color: black;">便是</span>当时仍在专利<span style="color: black;">守护</span>期的原研药，国内<span style="color: black;">不可</span>仿制，进口药价格昂贵，不少<span style="color: black;">病人</span>不得不到印度购买便宜的仿制药。</p>
<h1 style="color: black; text-align: left; margin-bottom: 10px;">仿制药<span style="color: black;">为何</span><span style="color: black;">那样</span>便宜？</h1>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">原研药和仿制药最大的区别在于价格。任何一个药厂发明了某种<span style="color: black;">药品</span>之后，会有一个专利<span style="color: black;">守护</span>期。在这个时间段里面，其他药厂不<span style="color: black;">准许</span>仿制这个药，让它得以垄断市场，赚回巨额的<span style="color: black;">开发</span>经费。一旦过了专利<span style="color: black;">守护</span>期，其他药厂只要有能力从它<span style="color: black;">颁布</span>的分子式倒推合成过程，都<span style="color: black;">能够</span>仿制这个<span style="color: black;">药品</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">例如</span>肝癌靶向<span style="color: black;">药品</span>伦伐替尼，原研药最<span style="color: black;">起始</span>卖16800元/盒，2021年10月专利<span style="color: black;">守护</span>到期后，<span style="color: black;">火速</span>就有9种仿制药上市，价格骤降到两千到三千元一盒。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">原研药之<span style="color: black;">因此</span>贵，是<span style="color: black;">由于</span><span style="color: black;">研发</span>成本高，<span style="color: black;">研发</span>时间长，<span style="color: black;">研发</span>成本巨大，<span style="color: black;">研发</span><span style="color: black;">危害</span>极高，要经历一二三期临床<span style="color: black;">实验</span>，<span style="color: black;">触及</span>数千名正<span style="color: black;">一般人</span>和<span style="color: black;">病人</span>，全面考察新药的有效性和安全性，上市后还要进行四期临床<span style="color: black;">实验</span><span style="color: black;">跟踪</span>上市后的安全性。有数据<span style="color: black;">表示</span>，原研药平均<span style="color: black;">开发</span>成本28亿美元，<span style="color: black;">研发</span>周期约10年，<span style="color: black;">乃至</span>有投入<span style="color: black;">海量</span>人力、物力、金钱和时间后一无所获的<span style="color: black;">状况</span><span style="color: black;">显现</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">与原研药相比，仿制药无需花费前期的<span style="color: black;">关联</span><span style="color: black;">开发</span>，不需要经历一二三期临床<span style="color: black;">实验</span>，只需要证明与原研药大致等效就行了，<span style="color: black;">因此</span>能在很大程度上降低<span style="color: black;">开发</span><span style="color: black;">花费</span>的支出，<span style="color: black;">开发</span>周期10个月<span style="color: black;">上下</span>，<span style="color: black;">研发</span><span style="color: black;">危害</span>低，价格自然便宜。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q5.itc.cn/images01/20240603/279af8b0bf23417783e09bbe05cb36ac.png" style="width: 50%; margin-bottom: 20px;"></p>
<h1 style="color: black; text-align: left; margin-bottom: 10px;">疗效方面有什么区别？</h1>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">世界卫生组织对仿制药有三个<span style="color: black;">需求</span>：一是<span style="color: black;">药品</span>等效性，即仿制药必须和原研药<span style="color: black;">拥有</span>相同活性<span style="color: black;">成份</span>、相同剂型和给药途径、配方中活性<span style="color: black;">成份</span>相同、符合相同的药典标准；二是生物等效性，<span style="color: black;">重点</span><span style="color: black;">经过</span>药动学<span style="color: black;">实验</span>、临床比较<span style="color: black;">科研</span>等证明在相同的<span style="color: black;">要求</span>下，<span style="color: black;">药品</span>吸收速率和程度<span style="color: black;">无</span><span style="color: black;">明显</span>差异；三是治疗等效性，<span style="color: black;">病人</span><span style="color: black;">运用</span>仿制药时要与原研药<span style="color: black;">拥有</span>相同的临床效果和安全性。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">我国自2015年起，<span style="color: black;">亦</span><span style="color: black;">起步</span>了“<span style="color: black;">药品</span>一致性<span style="color: black;">评估</span>”，对已上市的仿制药，按原研<span style="color: black;">药物</span>的质量和疗效标准进行<span style="color: black;">评估</span>，<span style="color: black;">保准</span>用药疗效和安全。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">不外</span>，仿制药仿制的是<span style="color: black;">药品</span>的<span style="color: black;">成份</span>，<span style="color: black;">因为</span>生产工艺<span style="color: black;">区别</span>，会影响<span style="color: black;">药品</span>的纯度，可能<span style="color: black;">导致</span><span style="color: black;">药品</span>晶型改变、引入杂质等，辅料的<span style="color: black;">区别</span><span style="color: black;">亦</span>会影响<span style="color: black;">药物</span>的稳定性和临床疗效。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">例如</span>胶囊的融化速度<span style="color: black;">能够</span>影响<span style="color: black;">药品</span>吸收，<span style="color: black;">倘若</span>太容易溶解，<span style="color: black;">那样</span><span style="color: black;">药品</span>就可能在胃里被胃酸破坏，<span style="color: black;">倘若</span>太难溶解，<span style="color: black;">那样</span><span style="color: black;">生效</span>就会太慢。有些药里面是一粒粒的小圆球，这种圆球<span style="color: black;">能够</span><span style="color: black;">掌控</span><span style="color: black;">药品</span>在<span style="color: black;">身体</span>的释放速度，<span style="color: black;">倘若</span>仿制药仿制不出这种效果，就会影响药效和副<span style="color: black;">功效</span>。临床上，有些高血压<span style="color: black;">病人</span><span style="color: black;">吃下</span>进口原研药，一天一次就<span style="color: black;">能够</span>了，<span style="color: black;">倘若</span>用仿制药，早上血压挺稳定，但下午血压就不行了。有些慢性病<span style="color: black;">病人</span>在美国<span style="color: black;">长期</span>逗留，不得不购买美国的<span style="color: black;">药品</span>，<span style="color: black;">常常</span>要减少<span style="color: black;">吃下</span>剂量。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">可见，哪怕仿制药的有效<span style="color: black;">成份</span>和原研药一模<span style="color: black;">同样</span>，效果<span style="color: black;">亦</span>不<span style="color: black;">必定</span>相同。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q7.itc.cn/images01/20240603/4cd0e9186ce6430dbbd82d1d3729bfc8.png" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">另外</span>，仿制药上市前<span style="color: black;">无</span>在<span style="color: black;">海量</span>的<span style="color: black;">病人</span>和人群中<span style="color: black;">运用</span>过，虽然经过了一致性<span style="color: black;">评估</span>，但临床试验数据的<span style="color: black;">累积</span>与原研药有天渊之别，仿制药的效果<span style="color: black;">没法</span>达到原研药的高度。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">以靶向药伊马替尼为例，在一项<span style="color: black;">科研</span>中，126例慢性粒细胞白血病<span style="color: black;">病人</span><span style="color: black;">运用</span>原研药平均4年后，换成一个仿制药，3个月后，<span style="color: black;">发掘</span>这种仿制药对其中22名<span style="color: black;">病人</span>是无效的。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">因此</span>，“仿制药跟原研药<span style="color: black;">同样</span>”只是仿制药<span style="color: black;">经过</span>了一致性<span style="color: black;">评估</span>，<span style="color: black;">拥有</span><span style="color: black;">药品</span>等效性、生物等效性，但不等于临床疗效是<span style="color: black;">同样</span>的。<span style="color: black;">倘若</span>是老年人、儿童、孕妇、器官移植<span style="color: black;">病人</span>、有并发症的<span style="color: black;">病人</span>以及多种<span style="color: black;">药品</span>联合应用的<span style="color: black;">病人</span>等特殊人群，仿制药的数据更加缺乏，临床疗效必然差异更大。</p>
<h1 style="color: black; text-align: left; margin-bottom: 10px;">进口药和国产药<span style="color: black;">怎样</span><span style="color: black;">选取</span>？</h1>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">随着科技和技术的<span style="color: black;">提高</span>，肯定会有越来越多国产药的药学特性和临床疗效得到<span style="color: black;">大夫</span>和<span style="color: black;">病人</span>的认可。例如国产的硫酸氢氯吡格雷片，有<span style="color: black;">科研</span><span style="color: black;">表示</span>，对比原研药治疗冠心病，疗效、安全性相当。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">从<span style="color: black;">日前</span>的临床实践来看，<span style="color: black;">经过</span>一致性<span style="color: black;">评估</span>的仿制药，质量、疗效、安全性与进口<span style="color: black;">药品</span>是<span style="color: black;">类似</span>的，<span style="color: black;">能够</span>在很大程度上替代原研药。<span style="color: black;">况且</span>，<span style="color: black;">日前</span>纳入<span style="color: black;">医疗保险</span>目录的基本都是国产药，价格大大<span style="color: black;">小于</span>进口药，对<span style="color: black;">病人</span><span style="color: black;">来讲</span>不失为一个更好的<span style="color: black;">选取</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q1.itc.cn/images01/20240603/f65a92dcb4a34ea689237d09a272d8d1.png" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">当然，进口药和国产药之间，相当于原研药与仿制药，疗效差异是确实存在，不可回避的。<span style="color: black;">倘若</span>面临国产药和进口药的<span style="color: black;">选取</span>，<span style="color: black;">能够</span>遵循以下四个原则：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1、<span style="color: black;">按照</span>经济<span style="color: black;">状况</span>。<span style="color: black;">倘若</span>经济能力许可，又比较注重疗效和副<span style="color: black;">功效</span>，<span style="color: black;">能够</span><span style="color: black;">选取</span>进口药、原研药。但<span style="color: black;">倘若</span>经济能力有限，注重性价比，国产仿制药是更好的<span style="color: black;">选取</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2、<span style="color: black;">按照</span>病情。病情危急的<span style="color: black;">状况</span>下，对<span style="color: black;">药品</span>的<span style="color: black;">需求</span>比较高，最好<span style="color: black;">选取</span>疗效更优的进口药、原研药。<span style="color: black;">倘若</span>病情普通，<span style="color: black;">能够</span>优先<span style="color: black;">选取</span>国产仿制药。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3、<span style="color: black;">按照</span>人群。老人、儿童、孕妇、肝病<span style="color: black;">病人</span>、肾病<span style="color: black;">病人</span>、器官移植<span style="color: black;">病人</span>，以及并发症多，须<span style="color: black;">同期</span><span style="color: black;">吃下</span>多种<span style="color: black;">药品</span>的特殊<span style="color: black;">病人</span>，最好<span style="color: black;">选取</span>副<span style="color: black;">功效</span>更小的进口原研药，它们的说明书上<span style="color: black;">一般</span>有<span style="color: black;">仔细</span>的适应证和禁忌证提示、剂量<span style="color: black;">调节</span><span style="color: black;">指点</span>。普通人群<span style="color: black;">选取</span>国产药、仿制药<span style="color: black;">就可</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4、遵从专业人士的意见。<span style="color: black;">倘若</span>自己<span style="color: black;">选取</span>困难，咨询<span style="color: black;">大夫</span>或药师是最方便的，<span style="color: black;">她们</span>会<span style="color: black;">按照</span><span style="color: black;">病人</span>的<span style="color: black;">详细</span>病情、既往治疗经历和不良反应等，决定适合<span style="color: black;">病人</span>的治疗<span style="color: black;">方法</span>和<span style="color: black;">药品</span>。<a style="color: black;"><span style="color: black;">返回<span style="color: black;">外链论坛：www.fok120.com</span>，查看<span style="color: black;">更加多</span></span></a></p>
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期待更新、坐等、迫不及待等。
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