Clinical observation of Suhexiang Pills in treatment of patients infected with SARS-CoV-2

Objective To explore the clinical effect and safety of Suhexiang Pills () in the treatment of patients infected with SARS-CoV-2. Methods A total of 192 patients infected with SARS-CoV-2 admitted to 17 hospitals including Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University from December 2022 to January 2023 were randomly divided into control group and treatment group, with 89 patients in the treatment group and 103 in the control group. The patients in control group received basic treatment according to the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 10). The patients in treatment group were oral administered with Suhexiang Pills on the basis of the control group, one pill each time, twice day. The patients in two groups were treated for 5 d. The clinical efficacy of the two groups after treatment was compared. The differences in scores of headache, chest pain, limb pain and inflammatory indexes before and after treatment were compared. Results After treatment, the total clinical effective rate of the treatment group was 95.51%, which was significantly higher than that of the control group (81.55%, P < 0.05). After treatment, headache, chest pain and limb pain scores were significantly decreased in both groups (P < 0.05), the headache score of the treatment group was significantly lower than that of the control group from the first day of treatment (P < 0.05), the chest pain score of the treatment group was significantly lower than that of the control group on the fifth day of treatment (P < 0.05), the limb pain score of the treatment group was significantly lower than that of the control group from the third day of treatment (P < 0.05). After treatment, the levels of C-reactive protein (CRP), procalcitonin (PCT), interleukin-6 (IL-6) in the two groups were decreased significantly (P < 0.05) and the levels of CRP and IL-6 in the treatment group were significantly lower than those of the control group (P < 0.05). There was no significant difference in the incidence of adverse events between the two groups. Conclusion Suhexiang Pills have a certain effect on headache, chest pain and limb pain, inhibiting the inflammatory response in patients infected with SARS-CoV-2, with good safety.Copyright © 2023 Editorial Office of Chinese Traditional and Herbal Drugs. All rights reserved.

Clinical observation of Suhexiang Pills in treatment of patients infected with SARS-CoV-2.

Objective To explore the clinical effect and safety of Suhexiang Pills () in the treatment of patients infected with SARS-CoV-2. Methods A total of 192 patients infected with SARS-CoV-2 admitted to 17 hospitals including Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University from December 2022 to January 2023 were randomly divided into control group and treatment group, with 89 patients in the treatment group and 103 in the control group. The patients in control group received basic treatment according to the Diagnosis and Treatment Protocol for COVID-19 (Trial Version 10). The patients in treatment group were oral administered with Suhexiang Pills on the basis of the control group, one pill each time, twice day. The patients in two groups were treated for 5 d. The clinical efficacy of the two groups after treatment was compared. The differences in scores of headache, chest pain, limb pain and inflammatory indexes before and after treatment were compared. Results After treatment, the total clinical effective rate of the treatment group was 95.51%, which was significantly higher than that of the control group (81.55%, P < 0.05). After treatment, headache, chest pain and limb pain scores were significantly decreased in both groups (P < 0.05), the headache score of the treatment group was significantly lower than that of the control group from the first day of treatment (P < 0.05), the chest pain score of the treatment group was significantly lower than that of the control group on the fifth day of treatment (P < 0.05), the limb pain score of the treatment group was significantly lower than that of the control group from the third day of treatment (P < 0.05). After treatment, the levels of C-reactive protein (CRP), procalcitonin (PCT), interleukin-6 (IL-6) in the two groups were decreased significantly (P < 0.05) and the levels of CRP and IL-6 in the treatment group were significantly lower than those of the control group (P < 0.05). There was no significant difference in the incidence of adverse events between the two groups. Conclusion Suhexiang Pills have a certain effect on headache, chest pain and limb pain, inhibiting the inflammatory response in patients infected with SARS-CoV-2, with good safety.Copyright © 2023 Editorial Office of Chinese Traditional and Herbal Drugs. All rights reserved.

Problems faced in the operation of clinical trials for diseases involving fever during the regular COVID-19 prevention and control period and countermeasures.

During the regular COVID-19 prevention and control period, the running of fever-related clinical trial projects faces many problems, which will affect the development of new drugs. How to coordinate the regular COVID-19 prevention and control with the clinical trial process is the key to ensure that the clinical trial participants are successfully enrolled. In this paper, taking the influenza project as an example, combined with the practice of operation and management of the influenza clinical trial project in our hospital, the problems faced in the operation of fever-related clinical trial projects during the regular COVID-19 prevention and control period were discussed and the countermeasures and suggestions were proposed. In order to meet the dual needs of infectious disease prevention and control and clinical trials, it is recommended that in low-risk areas for COVID-19, the subject screening process be integrated with the COVID-19 exclusion process, the starting time of subject screening be moved forward, clinical trial enrollment be conducted while waiting for COVID-19 screening results, in addition, the clinical trial process after COVID-19 screening results are returned should be established in advance. Copyright © 2022, Chinese Journal of New Drugs Co. Ltd. All right reserved.

The Evolution Law of the Global Bioeconomy and the Suggestions for the Development of Chinese Bioeconomy

With the increasing exhaustion of global resources, various countries have explored bioeconomy as an economic model that can cope with environmental, climate，resource problems and food security crisis. China recently released the " 14th Five-Year Plan for Bioeconomy Development", raising the bioeconomy to the level of national strategic development for the first time. Based on the innovation of life science and biotechnology, emerging industries have come into being in bioeconomy including biomedicine, bioagriculture, biomanufacturing and bioenergy. Bioeconomy is an economic development model with great potential for sustainable development in the future. This paper summarizes the evolution law of the global bioeconomy, the development of the bioeconomy worldwide and the industrial development of Chinese bioeconomy. Moreover, under the complex situation in a time of unprecedented global changes in a century and the COVID-19 epidemic, the relevant countermeasures to cope with challenges and suggestions on Chinese future are put forward. © 2022, China Biotechnology Press. All rights reserved.

Ethical issues of clinical research on sudden infectious diseases and countermeasures

In December 2019, a new type of Corona Virus Disease 2019 (COVID-19) broke out and rapidly spreaded all over the world. Up to now, there is no proven effective antiviral treatment. In an overall climate of scientific uncertainty, social and institutional chaos, fear and mistrust, clinical research of COVID-19 face numerous challenges of ethical issues. This paper takes COVID-19 as an example to discuss the ethical problems and countermeasures of clinical research on outbreaking infectious diseases, such as the challenge to the traditional ethical review way, balancing the conflict between treating patients as a doctor under the outbreak and participating in clinical study as a researcher, informed consent of subjects, and additional study risk. It was proposed that even in an outbreak of infectious disease, we also need to follow common clinical research regulations and ethical norms, manage the problems brought by the outbreak, protect the safety of subjects, ensure the smooth conduct of clinical research, and promote the development of medical science.

Thoughts on the registration of new traditional Chinese medicines in the COVID-19 epidemic situation

Traditional Chinese medicine has played an important role in the prevention and control of epidemic of novel coronavirus pneumonia (NCP). In the context of severe epidemic situation and priority in treatment, clinical research on NCP is carried out in stages and at different levels. Therefore, TCM clinical research positioning should be viewed from the perspective of development. At the same time, it is supposed to take a developmental view of the clinical research and the clinical research evidence obtained on NCP and make good use of these research findings. Combining with a series of new drug registration review policies issued by the State, this paper proposed some considerations on the registration review of new drugs for emerging major infectious diseases from the aspects of registration review evidence, empirical evidence for human use of traditional Chinese medicine, approval of ancient famous prescriptions, research and development of drugs for syndromes, and application of traditional Chinese medicine network pharmacology. © 2020, Chinese Journal of New Drugs Co. Ltd. All right reserved.