美国卫生署：中药可以帮助新冠肺炎患者更快康复（全文）

Traditional Chinese Medicine Can Help COVID-19 Patients Recover Faster — US Health Agency

SEP 1, 2020

2020年9月1日

缅华网 翻译整理

The Lianhua Qingwen capsules being sold in Manila

By ONE News

The United States’ National Center for Biotechnology Information (NCIB) stated in a May 16 study that the traditional Chinese medicine Lianhua Qingwen (also Lianhuaqingwen) “could be considered to ameliorate clinical symptoms” of coronavirus disease 2019.

美国国家生物技术信息中心（NCIB）在5月16日的一项研究中表示，传统中药连花清温（连花清温胶囊）“可以缓解新冠肺炎病毒的临床症状”。

According to the NCIB, which is part of the United States National Library of Medicine, a branch of the National Institutes of Health, 284 COVID-19 patients were randomized to receive the usual treatment alone or in combination with Lianhua Qingwen, with four capsules taken three times a day for 14 days.

根据美国国立卫生研究院分支机构美国国家医学图书馆的NCIB的数据，将284例COVID-19患者随机分配接受常规治疗，或与连花清瘟胶囊合用，每天3次每次4粒，共服用14天。

“The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery,” NCIB said.

NCIB说：“主要目的是测试症状（发烧，疲劳，咳嗽）的恢复率。”

It reported that “overall,” the 14-day treatment using the Chinese herbal medication for 142 patients “resulted in a significantly higher rate of, and a shorter time to, symptom recovery than the control group” of 142 patients who received the usual treatment without Lianhua Qingwen.

报道说，总体来说，使用中药连花清瘟胶囊治疗的142名患者治疗组和没使用中药的142名对照组经过14天的治疗，相比之下“其症状恢复率显着提高，并且恢复时间更短”

“The rate of recovery of fever, fatigue and coughing was also higher in treatment group,” the study read. “(Lianhua Qingwen) capsule had a favorable safety profile for the treatment of (COVID-19).”

研究表明：“治疗组的发烧，疲劳和咳嗽症状的恢复率更高。” “连花清瘟胶囊对（COVID-19）的治疗具有良好的安全性。”

“To our knowledge, this is the first multicenter randomized clinical trial that demonstrates the safety and efficacy” of Lianhua Qingwen capsules, the NCIB said.

NCIB表示：“据我们所知，这是第一个证明连花清温胶囊的安全性和有效性的多中心随机临床试验。”

The Severe Acute Respiratory Syndrome coronavirus 2 or SARS-CoV-2 that causes COVID-19 has been shown to result in injuries to the respiratory tract, nervous system, liver, heart, esophagus, kidney, urinary bladder and the jejunum or the middle segment of the small intestine.

已证明新冠肺炎病毒会对呼吸道、神经系统、肝脏、心脏、食道、肾脏、膀胱和小肠中间部分造成伤害。

Based on a nationwide study with 1,099 COVID-19 patients from 552 hospitals throughout mainland China, the NCIB said those with fever accounted for 88.7 percent while those with cough accounted for 67.8 percent after hospital admission.

NCIB说，根据一项来自全国552家医院的1,099名COVID-19患者的全国性研究，入院后发烧的病人占88.7％，而咳嗽的占67.8％。

“In light of the lack of validated effective therapeutic approaches, the medications that could ameliorate fever, fatigue and coughing would be valuable for the clinical management of (COVID-19). (Lianhua Qingwen) capsules, which is a patented product, have been marketed since the outbreak of SARS in 2003 in China,” the NCIB said.

连花清瘟胶囊，这是一种专利产品，自2003年非典SARS在中国爆发以来，一直在销售，临床经验表明它具有缓解发烧疲劳和咳嗽症状，这对新冠肺炎的临床应用有很大的价值。

Overall, the NCIB concluded that the capsules shortened the duration of fever, fatigue and coughing by one, three and three days, respectively.

总体而言，NCIB的结论是，这些胶囊分别将发烧、疲劳和咳嗽的持续时间缩短了一至三天。

“The higher rate of clinical cure and recovery of chest CT (computed tomography) manifestations could also be associated with the activity against SARS-CoV-2, and probably, the anti-inflammatory effects. There was a lack of statistical significance for the difference in the rate of, and the time to, conversion of viral assays (or sample to measure virus quantity),” NCIB said.

“经胸部CT（计算机断层扫描）显示，临床治疗和恢复率较高，这可能与抑制新冠肺炎病毒的活动有关，也可能与抗炎作用有关。病毒测定（或样本测量病毒数量）转化率和转化时间的差异缺乏统计学意义，”NCIB说。

The NCIB also discussed the key components of Lianhua Qingwen, including Lonicera japonica (Japanese honeysuckle and golden-and-silver honeysuckle) and Forsythia suspense, one of the 50 fundamental herbs used in traditional Chinese medicine that could block the binding of SARS-CoV-2 with the angiotensin-converting enzyme, which controls blood pressure by regulating the volume of fluids in the body.

NCIB还讨论了连花清瘟胶囊的关键成分，包括金银花连翘，认为这是50种可以抑制新冠肺炎病毒的基本草药之一，它们具有调节人体免疫力的作用。

“The exploration of repurposed Chinese herb product would be valuable to the treatment of (COVID-19) because, apart from convalescent plasma, no other medications with proven efficacy exist. Our findings indicated that (Lianhua Qingwen) capsules could be recommended to patients with (COVID-19) for reducing the symptom burden and improving clinical outcomes,” the NCIB said.

“探索中成药产品对新冠肺炎的治疗很有价值，因为除了康复血浆之外，没有其他具有疗效的药物。我们的发现表明，连花清瘟胶囊可以推荐给新冠肺炎患者，以减轻症状和改善临床结果。”NCIB说。

“However, there are some limitations of the study design. No blinding was implemented because of the urgency of the outbreak that entailed a timely treatment, and placebo-controlled trial would be unethical in light of the rapid outbreak of communicable diseases such as (COVID-19). The duration of treatment was established empirically, and whether a prolonged duration would translate into the greater efficacy warrants further investigation. An extended study would be needed to thoroughly explore the effects of (Lianhua Qingwen) capsules on the viral shedding and the resolution of all symptoms,” it added.

因为疫情爆发需要及时治疗，因此，采用安慰剂对照试验是不道德的。因此，研究设计存在一些局限性，用连花清瘟胶囊治疗时间根据经验所定，如果增加使用时间是否会有更好的效果，以及治愈后有无后遗症等问题，需要进一步进行研究。（编按：根据中国的经验，采用中医药治疗的对照组，基本没有后遗症，特别是没有肺纤维化和脑梗等后遗症。）

FDA clarification

FDA澄清

In the Philippines, the Food and Drug Administration (FDA) clarified on Thursday, Aug. 13, that Lianhua Qingwen was approved not as a drug for COVID-19 treatment.

在菲律宾，美国食品药品监督管理局（FDA）于8月13日星期四澄清说，连花清瘟胶囊并未被批准为COVID-19治疗药物。

FDA director general Eric Domingo said Lianhua Qingwen was approved only as a traditional Chinese medicine and prescription drug, and not as a therapeutic drug.

美国食品和药物管理局总干事埃里克多明戈说，莲花青文只被批准为中药和处方药，而不是作为治疗药物。

“We approved it specifically for the indications stated in the CPR (certificate of product registration),” Domingo said.

多明戈说：“我们根据CPR（产品注册证书）中指出的适应症说明，专门特别批准了它。”

The FDA stressed it is indicated in the CPR that the Chinese drug can help remove heat toxin invasion of the lungs, including symptoms such as fever, aversion to cold, muscle soreness, and stuffy and runny nose.

FDA强调，在CPR中表明，这种中药可以帮助消除热毒素入侵肺部，包括发烧、严重感冒、肌肉酸痛、鼻塞和流鼻涕等症状。

The Chinese embassy in Manila, however, expressed its government’s hope that the medicine would “contribute to the fight against the spread of COVID-19” in the Philippines.

不过，中国驻马尼拉大使馆表示，菲律宾政府希望这种药物能够“有助于新冠肺炎疫情在菲律宾的蔓延。”

Domingo said local distributors cannot place in the product’s label that it can be a cure for COVID-19.

多明哥说，当地分销商不能在产品上贴上可以治愈COVID-19的标签。

He discounted the possibility that the Philippines might include the medicine in the protocol for treatment of mild COVID-19 patients in the immediate future.

他不认为菲律宾可能在不久的将来将这种药物纳入治疗轻度COVID-19患者的方案中。

“To have it included in the DOH (Department of Health) protocol will take a lot of health processes. It has to undergo health assessment, it has to be double-checked as a medicine,” Domingo explained.

“要将它纳入DOH（卫生署）协议中将需要很多检测过程。它必须经过健康评估，必须作为药物进行仔细的双重检查。”多明戈解释道。

He also noted that the drug manufacturer is restricted from putting in the packaging that it is an anti-COVID product because “there’s no medicine yet for us labeled” as such. (Source: ONE News)

他还指出，药品制造商不得在包装中插入它是抗COVID产品，因为它还没有药品标记”。

 （来源：ONE新闻）

原文链接：

https://sovereignph.com/2020/09/01/traditional-chinese-medicine-can-help-covid-19-patients-recover-faster-us-health-agency/