掺着西药的中成药，由于临床上往往不知道中药里含有的西药成分的剂量，所以如果与西药同时服用，容易过量。新京报记者 王远征 摄

Mixing proprietary Chinese medicine with western medicine,Because clinically often don't know in Chinese medicine with western medicine ingredient dose,So if taken in conjunction with western medicine,Easy to too much.The Beijing news reporter Wang Yuanzheng perturbation

　　近日，微博红人急诊科女医生于莺炮轰“中医和中成药”，提出一串质疑，其中对于中成药“千人一方”、“西医开中成药”、“中成药的临床试验”的质疑更是激化了“一个争议多年仍无结论的大问题”。在中医的针对病患整体的“辨证施治”和西医的针对特定疾病“循证医学”的分歧外，一些医界人士还对中成药的成分、成效、安全性及药物上市审批提出质疑，认为传统中医和中药产业得到了“非理性支持”和“过大的特权”。这些丸、散、膏、丹的中成药，究竟是否有效安全？

In recent days,Microblogging sensation female doctors in the emergency department warbler"And proprietary Chinese medicine of traditional Chinese medicine",Put forward a series of questions,For proprietary Chinese medicine"One thousand people one side"/"Western medicine on proprietary Chinese medicine"/"Proprietary Chinese medicine clinical trials"The question is intensified"A controversy for many years is still no conclusion".In Chinese medicine for the patient as a whole"Evidence-based medicine"And western medicine against a particular disease"Evidence-based medicine"Divide outside,Some people in the profession is also on the proprietary Chinese medicine ingredients/results/Security and drug listing approval,Believe that traditional Chinese medicine and traditional Chinese medicine industry"Irrational support"and"The privilege of too much".These pills/scattered/cream/Dan's proprietary Chinese medicine,Whether security effectively?

　

　含西药成分的中成药在消炎药和感冒药中常见 Proprietary Chinese medicine with western medicine ingredients in common anti-inflammatory drugs and medicine

　　日前，香港卫生署从市场监测中发现：“仙然湿特疗追风透骨丸”及“仙然百痛敌追风透骨丸”的中成药（均为内地制造）含有微量未标示的西药成分“扑热息痛”，不适当服用“扑热息痛”可使肝脏及肾脏受损。

recently,Hong Kong department of health found that from the market surveillance:"Fairy but wet, cure zhuifeng TouGu pill"and"Fairy however the pain enemy zhuifeng TouGu pill"The proprietary Chinese medicine(Made in China)Western medicine composition containing trace is not labeled"paracetamol",Inappropriate use"paracetamol"Can make the liver and kidney damage.

　　尽管这些中成药并没有在内地出售，但是中成药里会含有“西药”成分，让许多笃信天然草药毒副作用小药性温和的人大跌眼镜，这究竟是不是中医的一种“欺骗行为”？

Although these proprietary Chinese medicine is not sold in the mainland,But can contain proprietary Chinese medicine"Western medicine"composition,Many believe in natural herbal medicine side effects of small's mild,This actually is a kind of Chinese medicine"cheating"?

　　“常见的VC银翘片、银翘解毒片药物成分中就含有扑尔敏，再和其他含有扑尔敏的西药混用，就会使药量加大并可能出现副作用。”一位不愿透露姓名的临床药师说。银翘解毒片实际是中药中掺和西药，而这样的“混血儿”，在消炎镇痛、感冒药中非常常见。

"VC common pieces of fructus forsythiae/Fructus forsythiae detoxification pills containing chlorpheniramine maleate in composition,And other western medicine combination containing chlorpheniramine maleate,Makes the dose increasing and possible side effects."A clinical pharmacist said on condition of anonymity.Fructus forsythiae antidotal tablet is actually in the traditional Chinese medicine with western medicine,And such"hybrids",In anti-inflammatory analgesic/A very common in cold medicines.

　

　掺有西药的中成药与西药同服容易过量 Mixed with the proprietary Chinese medicine with western medicine of western medicine take easy too much

　　“以中草药为原料，经制剂加工成各种不同剂型的中药制品，被称为中成药。尽管中药和西药可以同时服用，但是掺和着西药的中成药，由于临床上往往不知道中药里含有的西药成分的剂量，所以如果与西药同时服用，不好掌握剂量，容易过量。比如中成药里含有降压降糖的西药成分，和西药同服，会造成病人血糖不稳定等，达不到治疗效果或出现不良反应。所以，我不赞成在中成药里添加西药成分。”中日友好医院心脏血管病中心、中西医结合心脏内科主任、北京中医药大学兼职教授黄力说。

"Using Chinese herbal medicine as raw materials,The preparations made into various dosage forms of Chinese medicine products,Known as proprietary Chinese medicine.Although Chinese medicine and western medicine can be taken at the same time,But with proprietary Chinese medicine with western medicine,Because clinically often don't know in Chinese medicine with western medicine ingredient dose,So if taken in conjunction with western medicine,Bad master dose,Easy to too much.Such as proprietary Chinese medicine contain step-down hypoglycemic western medicine ingredients,Serve with western medicine,Will cause the patient blood sugar is not stable, etc,Reach therapeutic effect and adverse reactions.so,I don't agree with add western medicine ingredients in proprietary Chinese medicine."China-japan friendship hospital cardiac vascular disease center/Combine traditional Chinese and western medicine medical director of the heart/Adjunct professor of Beijing university of Chinese medicine Huang Li said.

　　“中医中药从‘人体是一个整体’的思想辨证施治，在某些疾病尤其是慢性病的治疗、调理上有一定优势。在临床具体实践中，却往往被错误理解成‘中西药结合’——在中药里添加西药，变成了既不是中药也不是西药的东西，中医中药的君臣佐使的配伍理念与西药的添加标准是完全两回事，搞得临床上非常混乱，容易出事。”卫生部全国合理用药监测网专家孙忠实教授说，大夫们不了解这款中成药里添加了什么西药或有多少西药，老百姓们更是相信其100％的血统纯正。

"Traditional Chinese medicine from the‘The human body as a whole’Ideas of evidence-based medicine,In the treatment of certain diseases, especially chronic diseases/Regulate the has certain advantages.In clinical practice,Often be wrong understanding‘Chinese and western medicine combined’- add western medicine in traditional Chinese medicine (TCM),Turned out to be neither medicine nor western medicine,Compatibility of Chinese medicine fujin made the idea with western medicines added standard is completely different,Clinically very confusion,Easy to an accident."The ministry of health of the national rational drug use monitoring network expert professor loyal sun says,Doctors don't know what added in the proprietary Chinese medicine or western medicine how many western medicines,Folks who believes that a 100% pure.

　

　■ 质疑秘方安全 S for safety

　　名方就能不通过临床安全试验？ Parties can't passed the test of the clinical safety?

　　类似云南白药这种“祖传秘方”却被证明含有有毒成分，药监部门是否对这样“目前仍在广泛应用、具有明显特色与优势”的“经典名方”开了绿灯？

Such as yunnan baiyao"Ancestral secret recipe"Is known to contain toxic ingredients,If the agency about this"Is still widely used/With obvious characteristics and advantages"the"Classic square"The green light?

　　微博上一位叫“棒棒医生”的人，连发三篇质疑中药得到“非理性官方支持”的博文《中药有多大的特权？》。其中提到《关于印发中药注册管理补充规定的通知》（国食药监注[2008]3号）第七条：“来源于古代经典名方的中药复方制剂，是指目前仍广泛应用、疗效确切、具有明显特色与优势的清代及清代以前医籍所记载的方剂”，并规定符合条件的该类中药复方制剂，可仅提供非临床安全性研究资料，并直接报生产。

Weibo on a call"Bump of the doctor"The people who,Repeating three questions about traditional Chinese medicine"Irrational official support"The blog post[The privilege of how traditional Chinese medicine (TCM)?].The mentioned[Informed about supplementary provisions issued by the Chinese medicine registration management](The drug safety note [2008] no. 3)Article 7.:"From ancient classic square compound preparation of traditional Chinese medicines,Refers to is still widely used/Curative effect/Has obvious characteristic and advantages of prescriptions written medical books of qing dynasty and the qing dynasty before",And conform to the conditions of the traditional Chinese medicine compound preparations,Can only provide non-clinical safety study data,And directly report to production.

　　“棒棒医生”解释说：一种新药要获批进入市场，必须经过动物试验和临床试验两个层次的安全性检验，“非临床安全性研究”即是通过动物试验检验药物的安全性。任何新药的开发在进入人体试验之前，首先要进行非临床试验（即动物试验），为将进行的临床试验提供安全支持。临床安全性评价才是新药安全性的最终保证，非临床安全性试验绝对不能代替临床安全性试验。

"Bump of the doctor"explains:A new drug to be approved to enter the market,Must go through animal experiments and clinical trials of two levels of security inspection,"Non-clinical safety studies"Is testing the safety of the drug by animal experiment.Any development before getting into human trials of new drugs,First of all to the clinical trials(The animal testing),Support for clinical trials will provide safety.Clinical safety evaluation is the final guarantee the safety of new drugs,Non-clinical safety testing is absolutely no substitute for clinical safety testing.

　　所谓古代经典名方到底指什么呢？在《补充规定》规定，其具体目录“由国家食品药品监督管理局协助有关部门制定并发布”，然而，四年过去了，直到今天也没有制定出这么个目录来。就是说，这几年获批的“古代经典名方”都是报批者自己认定的。

The so-called ancient classic square what mean?In the[Supplementary provisions]provisions,The specific directory"By the state food and drug administration to assist relevant departments to formulate and publish",however,Over the past four years,Until today, no to work out such a directory.That is to say,Approved in recent years"The ancient classical square"Have identified themselves as approval.

　　“在中医中药政策上，存在有时严格，有时宽松的现象。如果出问题了，就重视质量提高。但目前来说，政策还是对安全性问题有所重视，中成药审批的门槛提高了。”孙忠实说，中医中药的现代化进程中，有不同的意见和声音，面临的阻力也很大。有人认为中医中药的现代化不是西化，不能拿西医标准要求中医中药，而是中医理论指导下的现代化。

"In traditional Chinese medicine policy,There are sometimes strict,Sometimes loose phenomenon.If we have a problem,It attaches great importance to the quality improvement.But for the moment,Policy still attaches great importance to the security questions,The threshold of the proprietary Chinese medicine approval increased."Loyal sun says,The modernization process of Chinese medicine,Have different opinions and voices,The resistance of the face is very big also.Some people think that traditional Chinese medicine modernization is not westernization,Can't take western medicine Chinese medicine standards requirements,But the modernization under the guidance of TCM theory.

　　今年1月时，葛兰素史克中国研发中心总裁臧敬五博士在其公司年度媒体见面会上也表示，“中药学是通过经验来配合用药，它的瓶颈在于，缺乏循证医学的临床证据。这是中药发展以及寻求全球发展的最关键问题。”

In January this year,GSK China r&d centre meet President Dr ZangJing five at the company's annual media also said at the meeting,"Cooperate to use Chinese materia medica is through experience,It lies in the bottleneck,Lack of clinical evidence of evidence-based medicine.This is Chinese traditional medicine development and the development of the world to seek the most critical problem."

　　■ 热点问答 S hot spot question and answer

　　不能轻易否定中药的辅助治疗作用 You can't deny the auxiliary therapeutic effect of Chinese traditional medicine easily

　　Q中成药很多是运用在辅助治疗上，所谓的“辅助疗效”是否意味着含糊的“疗效”甚至“无效”？或只是“心理安慰”？

Many Q proprietary Chinese medicine were used in the adjuvant therapy,The so-called"Auxiliary curative effect"Does that mean vague"Curative effect"even"invalid"?Or just"Psychological comfort"?

　　黄力：有大量数据证明中西药结合治疗比单纯的西药或中药治疗效果好，生活质量得到了明显提高。比如治疗高血压方面，有些西药的确可以降压，但是还有些症状缓解不了的情况，比如用了大量西药降不下压来，使用中药调理，降压效果会很好；有些高血压患者会有失眠等症状，失眠也可造成血压波动很大，影响治疗效果，用中药调整后，对降压有很好作用。

Huang Li:There is a large amount of data to prove that Chinese and western medicine combined treatment than simple western medicine or Chinese medicine treatment effect is good,The quality of life improved significantly.Such as the treatment of high blood pressure,Some western medicine can indeed step-down,But still have some symptoms is not the case,With a large number of western medicine for instance fall not come down,Using Chinese medicine regulate,Antihypertensive effect will be very good;Some hypertensive patients have symptoms such as insomnia,Insomnia can also cause fluctuations in blood pressure is very big,Affect the treatment effect,Adjusted with Chinese traditional medicine,Has good effect to step down.

　　中成药一般在西药治疗效果不好时或单纯用西药解决不了问题时使用，不代表它一定有用或一定无用。比如冠心病病人心脏安了支架或搭桥，按照相关指南进行抗缺血治疗等，但是患者还是非常疼，需要配合中药治疗来改善内循环，效果也非常好。

In traditional Chinese therapy or with western medicine alone cannot solve the problem,Does not mean that it must be useful or useless.Such as coronary heart disease (CHD) patients with heart stents or bypass,Carried out in accordance with the relevant guidelines against ischemic treatment, etc,But patients are very painful,Need to cooperate with Chinese medicine treatment to improve the inner loop,Effect is also very good.

　　中山大学附属肿瘤医院内科副主任、SFDA药审专家张力：从癌症治疗角度来说，合适的中医和中成药在辅助治疗方面还是有效的，能改善患者的生存质量。但是涉及医保中中药所占比例问题，我认为中药所占比例还是过高。

, deputy director of zhongshan medical university affiliated tumor hospital/The SFDA human medicinal experts tension:From the perspective of cancer treatment,Right and proprietary Chinese medicine of traditional Chinese medicine is effective in terms of adjuvant therapy,Can improve patients' quality of life.But involving proportion of traditional Chinese medicine health care problems,I think Chinese medicine proportion is too high.

　　孙忠实：不能一棍子打死中药和轻易否定辅助治疗。中药、中成药在调理、整体治疗思想指导下，有很重要的作用和优势。比如在癌症患者继续治疗可能造成破坏之前，使用一些中药来提升患者对化疗和放疗的承受能力，这种辅助治疗改善了患者治疗期间的生活质量，是完全应该的。

Sun loyal:Not a stick kill traditional Chinese medicine (TCM) and easily deny adjuvant therapy.Traditional Chinese medicine/Proprietary Chinese medicine in nursing/Under the guidance of overall treatment ideas,Have very important role and advantage.For instance in cancer patients before treatment may cause damage,Use some Chinese medicine to improve patients tolerance to chemotherapy and radiotherapy,This auxiliary treatment to improve the quality of life of patients during treatment,Is completely should be.

　　Q中药一直讲究辨证施治，一人一方，但为何到了中成药这里就成了“千人一方”？

Qq Chinese medicine has been pay attention to evidence-based medicine,One man, one party,But why the proprietary Chinese medicine is here"One thousand people one side"?

　　黄力：中医讲辨证论治，对药物使用也是因人而异。中成药也需要因人而异使用。但是的确中成药不像汤药那样是量体裁衣，可以调整，中成药更像是按号买衣，大体合适，但也有可能有些地方不是完全对症。

Huang Li:The doctor of traditional Chinese medicine treatment based on syndrome differentiation,Drug use is also vary from person to person.Proprietary Chinese medicine also needs vary from person to person.But indeed proprietary Chinese medicine herb tea is not like that is adapted,Can be adjusted,More like a traditional Chinese according to the number to buy clothes,In the right,But it is also possible that some places are not completely suit the.

　

　西医对中成药的处方权可能造成滥用 Western medicine ChuFangQuan may cause misuse of proprietary Chinese medicine

　　Q根据有关报道，我国约70%的中成药是由综合医院的西医医师开出。而2008年由北京市中医药管理局与中医药学会组织的西医使用中成药现状的大规模调查研究发现，临床中成药不合理使用率最高达四成。没有接受过中药理论知识培训的西医医生是否会造成中成药误用和滥用？

Q according to the relevant report,About 70% of the proprietary Chinese medicine in our country by western medicine physicians prescribe general hospital.And in 2008 by the Beijing administration of traditional Chinese medicine and the present condition of the institute of traditional Chinese medicine, western medicine use proprietary Chinese medicine to an extensive investigation study found,Proprietary Chinese medicine clinical unreasonable utilization rate up to forty percent.No western medicine doctor of traditional Chinese medicine theory knowledge training will cause misuse and abuse of the traditional Chinese?

　　黄力：的确，西医对中成药的处方权也有可能造成误用和滥用。比如老年性尿失禁，中医认为是肾虚造成的，西医认为是膀胱肌的肌肉松弛造成的，但发生过西医大夫给这样的患者开了清热解毒的治疗尿路感染的药物，不但没有治好，反而发生溏泄。

Huang Li:indeed,Western medicine of proprietary Chinese medicine ChuFangQuan might also cause misuse and abuse.Such as senile urinary incontinence,TCM holds that is caused by kidney empty,Western medicine thinks that is caused by the muscle of the bladder muscle relaxation,But happened in western medicine the doctor gave the patient of heat-clearing and detoxifying drug treatment of urinary tract infection,Not only did not cure,Instead, pond drainage.

　　广安门医院药剂科主任杨响光：国家中医药管理局和卫生部组织制定了《中成药临床应用指导原则》并于2010年6月印发，供各级医疗机构在临床使用中成药时参考；北京市据此开展了全市二级以上西医师的中成药合理使用规范化培训和考核。这些工作促进了中成药合理使用水平的提升，从一个方面减少了部分中成药不良反应的发生。

The gate of hospital pharmacy department director Yang ring light:The state administration of traditional Chinese medicine and the ministry of health to make[Proprietary Chinese medicine clinical practice guidelines]And in 2010 issued by June,Provide the reference for the medical institutions at all levels in clinical use of proprietary Chinese medicine;Beijing accordingly carried out of the city's second class above XiYiShi proprietary Chinese medicine rational use of standardized training and assessment.These work to promote the rational use of traditional Chinese level of ascension,Reduces the part from the aspects of a proprietary Chinese medicine adverse reaction.

　　Q目前对西药上市审批所需要的严格的四期临床试验，都不会加之于中成药。很多医学界人士认为这是对传统中药毫无理性的支持，请问您怎么看中成药和中药注射剂的审批？

Q is required for approval of western medicine listed strict phase iv clinical trials,Won't be imposed on proprietary Chinese medicine.Many people think that it is irrational support for traditional medicine,Could you tell me what do you think of proprietary Chinese medicine and Chinese medicine injection for approval?

　　黄力：经过一段时间的混乱后，现在的审批门槛还是挺高的，以前批的很多中成药现在都停掉了。目前申请新的中成药，一样需要大型、多中心的四期临床试验。比如我们这里，先需要拿下严格的院内制剂的审批，在院内使用，总结多少病例后再申报新药。

Huang Li:After a period of confusion,Now the examination and approval threshold is very high,Previous batch of many proprietary Chinese medicine are stopped now.Now apply for new proprietary Chinese medicine,As to large/Multicenter phase iv clinical trials.For example, we here,First need to take strict examination and approval of hospital preparations,To use in the home,Summarize how many cases before declaration of new drugs.

　　孙忠实：对疗效和安全性的评估方面，中成药的说明很少有符合要求的说明书。符合国家要求的药品说明书，是建立在认真科研和临床研究的基础上的。

Sun loyal:Evaluation of efficacy and safety,Proprietary Chinese medicine shows that there are few conform to the requirement of specification.Meet the requirements of the state drug specifications,Is built on the basis of scientific research and clinical research.

　　本版采写/新京报记者 潘波

This edition is concludes Pan Bo/Beijing news reporter