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耐药结核病的防治困境:中国耐药率排全球第二
双击自动滚屏 发布者:admin 发布时间:2010/4/6 10:21:37 阅读:16965次 【字体:

科学新闻4月5日报道 

    40年代,链霉素;50年代,异烟肼;70年代,利福平……

    上世纪80年代,当这些治疗结核病的基本药物陆续问世后,几乎全世界都相信,结核病已经有药可医,彻底消灭结核病指日可待。

    然而到了90年代,结核病却又卷土重来,在治疗上且比以往变得更加棘手。流动人口、合并HIV感染,尤其是随着耐多药结核和广泛耐药结核的出现,人类赫然发现自己对结核病原来知之甚少,应对结核病威胁的手段又非常有限。

    “如果不能应对耐多药结核,则它们将会取代当前占世界95%的药物敏感性结核杆菌,将把我们带回到没有抗生素的岁月。”2009年4月1日,在耐多药和广泛耐多药结核病高负担国家部长级会议上,世界卫生组织总干事陈冯富珍说。

    相对于半年即能治愈、费用为几百元、治疗率超过90%的普通肺结核病,耐药结核的治疗时间为2~3年,费用为普通结核病人的200倍。

    治疗的不规范使得普通的结核病转变成耐多药结核,在更加恶劣的情形下,耐多药结核进一步转变为广泛耐多药结核。由于对目前绝大部分一线、二线抗结核药物均有耐药性,广泛耐药结核几乎成为不治之症。

中国总耐药率37.79%

    2008年,根据对耐多药结核病调查的81个国家的数据,WHO发表了《第四次世界耐抗结核病药物报告》。俄罗斯以40%的总耐药率排第一,中国以20%~40%的总耐药率排名第二。但由于中国人口基数巨大,中国耐多药人数已是世界第一。

    1996~2008年,中国13个省份先后参加WHO/国际防痨和肺部疾病联盟的全球结核病耐药监测项目。2008年始,全球基金资助中国部分省(自治区)开展结核病耐药性监测。但由于项目局限于部分省区,且时间不一,难以反映全国的耐药水平。

    如今,从2007年4月正式启动,历时近3年,覆盖中国31个省的70个调查点的《全国结核病耐药性基线》调查报告(2007~2008年)正式出版。该报告显示,全国肺结核病患者的单耐药率21%,多耐药为8.32%,广泛耐药率为0.68%,总耐药率37.79%。据此估计,中国现有耐药结核病患者56万,占到世界耐药结核病患者的1/4;每年新发耐多药肺结核病患者约12万,其中广泛耐药肺结核病患者近1万。

    除了巨大的基数,中国耐药结核病的分布亦非常广泛。耐多药结核的分布以农村为主、青壮年占的比例较高,无明显性别差异,且东、中、西部不同地区耐药率并无显著差异。

耐多药形成的诸多因素

    究竟有哪些因素会影响到结核病患者使之产生耐药性呢?治疗管理不规范及患者治疗依从性差长期被认为是最直接的因素,在此次调查报告中再次被认为是耐药结核病发生的主要危险因素。

    除此之外,性别、职业、经济收入、年龄,甚至民族都被认为可能与耐药的产生有着某种关联,但这些因素要么没有研究证据的支持,要么各个国家之间的研究存在不一致的结论。比如,这次调查显示,在家待业、下岗、从事商业服务、收入水平低可增加复治结核病患者发生耐药、耐多药的风险,但是俄罗斯和法国的研究结果却没有发现这样的关联。

    欧洲有关耐多药结核病危险因素的研究显示,有既往治疗史的患者发生耐多药的风险较从未治疗的患者高10.23倍。俄罗斯、土耳其、巴基斯坦、日本等国的研究也得到相似的结论。本次的调查也印证了这一结论。

    调查同时显示,复治结核患者首次在私人医院、个体诊所治疗可增加发生耐多药结核病的风险。同样,巴基斯坦的一项研究表明,30例耐多药结核患者有43.3%在非正规机构进行初次抗结核药物治疗,这些治疗未完成疗程并缺乏有效督导。

    “由于医疗条件落后,有些机构根本无法开展药敏试验,致使医生把耐药病人也当做一般病人来治。”四川大学中国循证医学中心主任李幼平说。

诊断和治疗困境

    诊断耐多药、广泛耐药结核病,往往需要高质量的装备、精良的实验室,最理想的要在卫生安全、生物安全三级实验室进行。如果是广泛耐药结核,则需要进行十分昂贵、时间较长的二线药的药敏测试,而目前大多数国家的结核药敏测试都只能进行一线药的药敏测试。目前,新的诊断技术,可以将诊断时间由六周缩短至一天。虽然这种技术确认是行之有效的,但是技术向高负担国家的转让却非常缓慢。

     不选择正式的机构会带来延迟诊断,但就诊延误这一同样关键的因素,从发病学的角度却似乎是不可避免的。“可能咳嗽一声、两声,人们不会认为得了结核病,可能咳嗽更长时间以后,才会怀疑是感冒,再以后可能才考虑是不是结核病。”北京市结核病胸部肿瘤研究所研究员赵雁林参加“中英公共卫生的科学决策研讨会”时告诉《科学新闻》。这次研讨会由《科学新闻》杂志与英国大使馆、协和医科大学于3月19日共同举办。

    如今,对于初治的结核患者,只要2~4片药的固定剂量复合剂便可以达到以前吃散装的13片药同样的效果,但不幸的是,这种复合剂并没有在高负担国家中使用。这种复合剂不仅在物流上较为容易分发,且价格同散装药的费用一样或略高。但如果是耐多药的治疗,其费用与一般的费用相比,要高出100~200倍;如果完全按照市场价值,费用应该是1000倍。

    2009年,WHO出台了11种结核病药物(剂型、剂量及药物组合),在补充清单中列出了治疗耐多药结核病的7种二线药物(剂型、剂量)。而中国国家基本药物目录2009年版抗结核药物部分给出了6种(剂型);对于耐多药结核病治疗新方案的研究,作为“艾滋病和病毒性肝炎等重大传染病防治”重大专项的课题,现在仍在进行当中。

无期的新药与疫苗

    “结核病的疫情出现了比较大幅度下降——不是中国、不是印度,而是西方国家出现比较大幅度下降的情况下,居然在长达40年时间内,没有任何新药。除了治疗不彻底转为耐药结核的情况以外,细菌发生耐药是很自然的。”在北京市结核病胸部肿瘤研究所研究员傅瑜看来,造成耐药的重要原因在于长期缺乏治疗结核的新药。

    早在上世纪,欧洲、美国、加拿大等发达国家和地区,采取手术切除病灶的方法来治疗结核,几乎根治了当地所有患者,使得本国人口发病率大大降低。但是,对于中国的结核患者,在没有那么多钱做手术的情形下,只能依靠药物进行治疗。

    需要说明的是,这里的新药研发指的是治疗耐药结核的二线药物,因为一线药已经不需要再研发了。WHO早已证明,如果严格治疗,现有的几种一线药物对普通初治病人的治愈率在85%以上。

“一个新药的研发需要十几年时间,花费13亿到15亿美元,结核作为一个穷人和穷国的病,发达国家的药厂都不愿意对此进行投入。而中国也没有能力进行新药研发。”上海交通大学教授、张江生物基地有限公司副总经理魏晓林告诉《科学新闻》。

    不过考虑到每一位耐药结核病人的治疗大约需要2000~5000美元,因此二线药的研发也应该具备一定市场价值。“既然患结核的人都比较穷,那么对于研究出来的新药是不是在医保上会有一个促进使用的机制?另外现在很多钱都投在防治上,以后对于新药研发会不会加强支持?”魏晓林说。

    与药物研发相比,各国对于疫苗的研究更有热情,中国也参与其中。“不过中国疫苗都还处于非常前期的状态,世界上到现在也没有哪支疫苗进入二期临床的”,魏晓林表示,“疫苗和药物的研发现在几乎都处于停滞状态。”

不必要的花费

    上世界90年代初,中国运用世界银行的贷款来给予结核病人免费医治。如今,尽管抗结核药物在全国已经可以免费服用,但由于医疗体制的问题,病人的花费并没有降低多少,主要原因在于辅助药物的花费。

    中国免费使用的一线抗结核药物,医疗实践证明了其有效性;但对于辅助药物则没有规定说明哪些是辅助药物,也缺乏监管。李幼平告诉记者,中国有一些号称能“保肝”的药物,而世界卫生组织有明确规定,“保肝”药物是不能用的。

    “全国正规的结核病医院,正规的防治所和防治站全都是以免费药为主的。但是基层,县级以下可能会用一些辅助药,辅助药的费用可能达到它的一半,甚至达到和它相平的价格。有这样的现象,但不是普遍的。”傅瑜说。

    除了辅助性的药物,不少患者都曾经接受CT检查,这种情况的发生与利益驱动机制紧密关联,但医疗界“举证倒置”的规矩,也似乎是一个强劲的助推器。

    所谓举证倒置,就是在面临患者指控时,不是由患者来证明医院的过失,而是由医院来证明自己无过错。这一看似保护病人权益的措施,让各个医院唯恐检查不到位成为出现医患争端时病人指控自己的凭据。

    “举证倒置的结果,就是医院必须拼命给病人检查。如果医院为了省钱、为了节约,最终医院有可能赔付很大。”傅瑜说。

(本文来源:科学新闻 作者:袁玥 邸利会)
 
 

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