Real-world insights into the efficacy and safety of tyrosine kinase inhibitors against thyroid cancers.

Based on clinical trials demonstrating favorable short-term efficacy and tolerable toxicity, several tyrosine kinase inhibitors have been approved for treating locally recurrent or metastatic, progressive radioiodine-refractory differentiated thyroid cancer, BRAFV600E-mutant anaplastic thyroid cancer, and advanced or progressive medullary thyroid cancer. Longer term efficacy and safety of these treatments have been investigated in multiple real-world studies, demonstrating indispensable complementary value. Hereby, we summarize data from a total of 27 real-world studies with a focus on long-term survival data and rare but life-threatening adverse effects. An overall picture of current real-world study was drawn, and integrated experience of multiple centers would be helpful to clinical practice and further research.

[Series of group standards of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions].

Drug instructions,the statutory and technical documents recording effectiveness and safety information,are an important basis for guiding doctors,pharmacists,and patients to use drugs rationally,and their scientificity,standardization,and accuracy directly affect the medication safety of the public. The sections of adverse drug events,contraindications,precautions,warnings,and application for specific populations in drug instructions directly express safety information and measures for rational use of drugs. In the drug life cycle,marketing authorization holders( MAHs) need to update safety information in the instructions promptly to ensure the safety and effectiveness of clinical drug medication. At present,revising instructions is an important measure to control drug risks. In the drug life cycle,in order to standardize the revision of safety information in the instructions by MAHs and eliminate inexact terms such as " unclear",the Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,have been established under the guidance of Standardization Department,China Association of Chinese Medicine. Therefore,on the basis of the existing rules and regulations,the standardized technical procedures for revising instructions came into being to help clinical safe and rational medication of drugs,and implement the strategy of " Healthy China".

[Interpretation of Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions].

Technical Specifications for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions,a series of group standards,were proposed by Professor ZHANG Bing from Research Center for Pharmacovigilance and Rational Use of Traditional Chinese Medicine,and underwent centralized management by Chinese Association of Chinese Medicine. They were officially released on July 23 and implemented on July 31,2021. The series of group standards consist of six sections,including general principles,adverse drug events,contraindications,precautions,application for special populations,and warnings. The section of general principles is comprised of holistic and programmatic expressions,which explain the general technical requirements for revising the marketed Chinese patent medicine instructions. The other five sections focus on information collection,screening,transformation,and illustration of specific items,forming a standardized revision technical process. This series of standards is the result of multiple rounds of research and the suggestions of more than 200 experts in different professional fields of " medicine-pharmacy-management-law-enterprise" have been gathered therein to reach a consensus. With the purposes of establishing standardized technical specifications for the revision of safety information in the marketed Chinese patent medicine instructions,guiding marketing authorization holders in revising the instructions,filling the gaps in the research of Chinese patent medicine instructions,promoting the deve-lopment of pharmaceutical care and academic research,and encouraging the rational and safe medication of Chinese patent medicine,the series of group standards is of great significance.

[Technical specification for Instructions for Clinical Application of Chinese Patent Medicines in China Association of Chinese Medicine].

In order to solve the problems of confusion in clinical medication and imperfect instructions in Chinese patent medicines(CPMs), the Standardization Department of the China Association of Chinese Medicine and Center for Pharmacovigilance and Rational use of Chinese Medicine in Beijing University of Chinese Medicine jointly compiled the Instructions for Clinical Application of Chinese Patent Medicines(CPMs). As the interpretation and supplement of drug instruction information, it aims to guide clinical safety and rational use of CPMs. In addition, the technical specification for clinical application description of CPMs has been formulated, which covers the seven processes of "carding instructions, clinical investigation, data retrieval, data screening, evidence classification, path transformation and writing format". It will enable readers of Instructions for Clinical Application of Chinese Patent Medicines to understand the work behind the compilation.

Unexplained Hyperthyroglobulinemia in Differentiated Thyroid Cancer Patients as an Indication for Radioiodine Adjuvant Therapy: A Prospective Multicenter Study.

The management for totally thyroidectomized differentiated thyroid cancer (TT-DTC) patients with unexplained hyperthyroglobulinemia remains indeterminate because of evidence scarcity. This multicenter study aimed at prospectively evaluating the response to radioiodine (131I) adjuvant therapy (RAT) and its potential role in risk stratification and causal clarification. Methods: TT-DTC patients with stimulated serum thyroglobulin levels greater than 10 ng/mL but no structurally evident disease were consecutively enrolled in 5 tertiary-care institutions. After the administration of 5.55 GBq of 131I, the risk of persistent, recurrent, or metastatic differentiated thyroid cancer (prmDTC) was compared with that before RAT. The causes of hyperthyroglobulinemia were explored-and the response to RAT assessed-6-12 mo after RAT. The change in suppressed thyroglobulin level was reported. Results: A cohort of 254 subjects with a median stimulated thyroglobulin level of 27.1 ng/mL was enrolled for the analyses. Immediately after RAT, low, intermediate, and high risk were identified in 5.9%, 88.6%, and 5.5% patients, respectively, with no significant difference in risk stratification compared with that before RAT (P = 0.952). During the follow-up (median, 10.6 mo), hyperthyroglobulinemia was ultimately attributed to a thyroid remnant, biochemical disease, and structural or functional disease in 17.3%, 54.3%, and 28.4% of subjects, respectively. In addition, responses that were excellent, indeterminate, biochemically incomplete, and structurally or functionally incomplete were achieved in 18.1%, 27.2%, 36.2%, and 18.5% of patients, respectively. Notably, the distribution for either cause of hyperthyroglobulinemia or response to RAT was comparable among the 3 postoperative risk groups. Suppressed thyroglobulin levels in patients who merely received RAT declined significantly over time. Conclusion: Our study demonstrated that over 90% of TT-DTC patients with unexplained hyperthyroglobulinemia are stratified as being at intermediate to high risk, and RAT using 5.55 GBq of 131I reveals biochemical, functional, or structural disease and yields a non-structurally or -functionally incomplete response in more than 80% patients, suggesting that TT-DTC patients with unexplained hyperthyroglobulinemia are explicit candidates for RAT.

The clinical benefits of Chinese patent medicines against COVID-19 based on current evidence.

The outbreak of emerging infectious pneumonia caused by 2019 Novel Coronavirus (2019-nCoV) has posed an enormous threat to public health, and traditional Chinese medicine (TCM) have made vast contribution to the prevention, treatment and rehabilitation of coronavirus disease 19 (COVID-19) among Chinese population. As an indispensable part of TCM, Chinese patent medicines (CPMs) are highly valued and critically acclaimed in their campaign to contain and tackle the epidemic, they can achieve considerable effects for both suspected cases under medical observation period, and confirmed individuals with serious underlying diseases or critical conditions. Given this, based on the Guideline on Diagnosis and Treatment of Coronavirus Disease 2019 in China, the present review summarized the basic information, clinical evidence and published literatures of recommended CPMs against COVID-19. The details were thoroughly introduced involving compositions, therapeutic effects, clinical indications, medication history of CPMs and the profiles of corresponding research. With regard to infected patients with different stages and syndrome, the preferable potentials and therapeutic mechanism of CPMs were addressed through the comprehensive collection of relevant literatures and on-going clinical trials. This study could provide an insight into clinical application and underlying mechanism of recommended CPMs against COVID-19, with the aim to share the Chinese experience in clinical practice and facilitate scientific development of TCM, especially CPMs in the fierce battle of COVID-19.

[Study on the dynamic variations of Z-ligustilide and n-butylidenephthalide content in essential oil of radix angelicae sinensis from different growth period].

OBJECTIVE: To study the variation of the biomass of the root and active components of Angelica sinensis during different growth periods. METHODS: 27 batches of Angelica sinensis were harvested from different growth periods, and the biomass of underground parts were determined; The Gas Chromatography-Mass Spectrometry (GC-MS) was used for determining the contents of Z-ligustilide and n-Butylidenephthalide in essential oil of Radix Angelicae Sinensis. RESULTS: The average contents of n-Butylidenephthalide and Z-ligustilide were more than 1% and 40% in the total essential oil of Radix Angelicae sinensis respectively. Their contents showed larger difference during different growth period. CONCLUSION: The contents of Z-ligustilide and n-Butylidenephthalide of Radix Angelicae Sinensis is closely related to their growth period.