中药可以帮助 COVID-19 患者更快康复
Photo taken by The Philippine STAR’s Edd Gumban shows Lianhua Qingwen capsules being sold in Manila on Aug. 13, 2020.
The US National Center for Biotechnology Information said “overall,” treatment with the Chinese herbal medicine Lianhua Qingwen for 14 days resulted in a “significantly higher rate of, and a shorter time to, symptom recovery.”
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.
菲律宾星报的 Edd Gumban 拍摄的照片显示,2020 年 8 月 13 日在马尼拉出售的连花清瘟胶囊。
美国国家生物技术信息中心表示,“总体而言”,使用中草药连花清瘟治疗 14 天导致“症状恢复率显着提高,症状恢复时间更短”。
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,中药连花清瘟(又名连花清瘟)“可被视为改善 2019 年冠状病毒病的临床症状”。
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.
“The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery,” NCIB said.
根据隶属于美国国立卫生研究院下属的美国国家医学图书馆的 NCIB 的数据,284 名 COVID-19 患者被随机分配接受单独或与连花清瘟联合使用的常规治疗,服用四粒胶囊 每天三次,持续 14 天。
“主要终点是症状(发烧、疲劳、咳嗽)的恢复率,”NCIB 说。
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.
“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).”
报告称,“总体而言”,在接受常规治疗的 142 名患者中,对 142 名患者进行为期 14 天的中草药治疗,“导致症状恢复率显着高于对照组,且症状恢复时间更短” 没有莲花清纹。
“治疗组的发烧、疲劳和咳嗽的恢复率也更高,”研究中写道。 “(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.
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.
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.
“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.
NCIB 表示:“据我们所知,这是第一个证明连花清瘟胶囊安全性和有效性的多中心随机临床试验”。
已证明导致 COVID-19 的严重急性呼吸系统综合症冠状病毒 2 或 SARS-CoV-2 会导致呼吸道、神经系统、肝脏、心脏、食道、肾脏、膀胱和空肠或中段受伤 的小肠。
根据对来自中国大陆 552 家医院的 1,099 名 COVID-19 患者进行的一项全国性研究,NCIB 表示,入院后发烧患者占 88.7%,咳嗽患者占 67.8%。
“鉴于缺乏经过验证的有效治疗方法,可以改善发烧、疲劳和咳嗽的药物对于 (COVID-19) 的临床管理将是有价值的。 (连花清瘟)胶囊是一种专利产品,自 2003 年 SARS 在中国爆发以来一直在市场上销售,”NCIB 表示。
Overall, the NCIB concluded that the capsules shortened the duration of fever, fatigue and coughing by one, three and three days, respectively.
“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.
总体而言,NCIB 得出的结论是,这些胶囊分别将发烧、疲劳和咳嗽的持续时间缩短了 1 天、3 天和 3 天。
“较高的临床治愈率和胸部 CT(计算机断层扫描)表现的恢复率也可能与抗 SARS-CoV-2 的活性以及可能的抗炎作用有关。 病毒检测(或样本以测量病毒数量)的转化率和时间的差异缺乏统计学意义,”NCIB 说。
[Members of the Makati Health Department conduct house-to-house injection of anti-flu and anti-pneumonia vaccines among 70-year-old residents of the city’s Barangay Pembo. The Department of Health said the vaccines can provide protection for the elderly amid the COVID-19 pandemic as those with pneumonia or have a history of the disease are more vulnerable to the coronavirus. Photo by Edd Gumban, The Philippine STAR.] [马卡蒂卫生部门的成员在该市的 Barangay Pembo 的 70 岁居民中挨家挨户注射抗流感和抗肺炎疫苗。 卫生部表示,这些疫苗可以在 COVID-19 大流行期间为老年人提供保护,因为患有肺炎或有病史的人更容易感染冠状病毒。 照片由菲律宾之星 Edd Gumban 拍摄。]
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.
“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.
“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.
NCIB 还讨论了连花清瘟的关键成分,包括 Lonicera japonica(日本金银花和金银花)和连翘,这是中药中 50 种可以阻断 SARS-CoV-结合的基本草药之一。 2 含有血管紧张素转换酶,通过调节体内液体的量来控制血压。
“探索再利用的中草药产品对治疗 (COVID-19) 很有价值,因为除了恢复期血浆外,没有其他有效的药物存在。 我们的研究结果表明,(连花清瘟)胶囊可以推荐给(COVID-19)患者,以减轻症状负担并改善临床结果,”NCIB 说。
“然而,研究设计存在一些局限性。 由于爆发的紧迫性需要及时治疗,因此没有实施盲法,鉴于(COVID-19)等传染病的迅速爆发,安慰剂对照试验将是不道德的。 治疗的持续时间是根据经验确定的,延长持续时间是否会转化为更大的疗效值得进一步研究。 需要进行进一步的研究,以彻底探索(连花清瘟)胶囊对病毒脱落和所有症状消退的影响,”它补充说。
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.
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.
“We approved it specifically for the indications stated in the CPR (certificate of product registration),” Domingo said.
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.
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.
Domingo said local distributors cannot place in the product’s label that it can be a cure for COVID-19.
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.
“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.
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.
在菲律宾,食品药品监督管理局 (FDA) 于 8 月 13 日星期四澄清说,连花清瘟未获批准作为治疗 COVID-19 的药物。
FDA 总干事 Eric Domingo 表示,连花清瘟仅被批准为中药和处方药,而不是治疗药物。
“我们专门针对 CPR(产品注册证书)中所述的适应症批准了它,”多明戈说。
FDA强调,CPR中指出,该中药可以帮助清除热毒侵入肺部,包括发烧、恶寒、肌肉酸痛、鼻塞和流鼻涕等症状。
然而,中国驻马尼拉大使馆表示,其政府希望这种药物能够“有助于对抗 COVID-19 在菲律宾的传播”。
多明戈说,当地经销商不能在产品标签上注明它可以治愈 COVID-19。
他认为菲律宾可能在不久的将来将该药物纳入治疗轻度 COVID-19 患者的方案中的可能性。
“将其纳入 DOH(卫生部)协议将需要大量的卫生流程。 它必须经过健康评估,必须作为药物进行双重检查,”多明戈解释说。
他还指出,药品制造商被限制在包装上注明它是一种抗 COVID 产品,因为“我们还没有这样的药品标签”。
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