Latest ArticlesTo evaluate the detection performance of one kind of imported nitrofurantoin susceptibility test disk for antimicrobial susceptibility test by disk diffusion method.
A total of 118 strains of pathogenic bacteria were collected from a Class A tertiary comprehensive hospital in Beijing from 2016 to 2017, including 61 isolates of Enterobacterales, 48 isolates of Staphylococcus spp. and 9 isolates of Enterococcus spp. Antimicrobial susceptibility test was performed following Clinical and Laboratory Standards Institute (CLSI) documents M100ED30, using disk diffusion method. The differences of susceptibility between domestic disks and imported disks against 118 bacteria strains were detected according to the breakpoints described in CLSI documents M100ED30. The rate of categorical agreement (CA) of susceptibility conducted by the two kinds of disks was calculated.
Among the 118 isolates, 73, 4 and 41 were categorized as susceptible (S), intermediate (I), and resistant (R) to nitrofurantoin, respectively. The rate of categorical agreement of susceptibility to nitrofurantoin using imported disks and domestic disks was 100%.
The results of susceptibility test using imported nitrofurantoin disks are reliable, and consistent with the results by domestic nitrofurantoin disks. Imported nitrofurantoin disk can meet the requirements of clinical laboratory. The test results will provide direct reference data for clinical application for nitrofurantoin in infectious diseases.
To analyze the occurrence and clinical characteristics of skin adverse reactions caused by vemurafenib, and provide reference for clinical safe drug use.
The literatures about skin adverse reactions of vemurafenib were retrieved from Web of Science, PubMed, CNKI, VIP database and Wanfang data, and then analyzed and summarized.
A total of 41 cases of ADRs induced by vemurafenib were reported. Most of them aged from 41 to 70 years old (n=25, 61.0%). Most of them occurred within 15 d after medication (n=22, 53.7%). The main clinical manifestations of skin system ADRs induced by vemurafenib were lipiditis (12 cases, 29.3%), leukocytoclastic vasculitis (n=6, 14.6%), granulomatous dermatitis (n=5, 12.2%), photosensitive dermatitis (n=4, 9.8%), radioactive dermatitis (n=3, 7.3%), and hyperkeratosis (n=3, 7.3%). Thirty-four cases were cured or improved after ADRs, of whom 27 cases (65.9%) resumed vemurafenib treatment, and 7 cases discontinued, including granulomatous dermatitis (2 cases), toxic epidermal necrolysis (1 case), cutaneous vasculitis (2 cases), and photosensitive dermatitis (2 cases). Among the 27 patients who restarted vemurafenib treatment, 21 cases maintained the original dose, 5 cases reduced the original dose to 3/4, 1 case reduced the original dose by half, and ADRs occurred again in 9 patients.
Drug monitoring should be strengthened during the clinical use of vemurafenib, especially for the occurrence of ADR within 15 d after drug administration, potential ADRs should be detected in time, appropriate prevention and treatment measures should be taken, and the treatment risk after resumption of treatment should be carefully evaluated.
The incentive policy for orphan drugs was evaluated by statistical analysis of the R&D (research and development) and approval of orphan drugs in the United States during 1983—2019. The clinical trials funding, qualification and approval of orphan drugs were statistically analyzed by consulting the FDA official website, clinicaltrial.gov database and related literature. Since the implementation of the Orphan Drug Act in 1983, the United States has established a systematic R&D incentive system for orphan drugs up to now, which has played a huge role in promoting drug R&D and approval.
Based on comparison of the marketing time of vaccines approved through multi-regional clinical trials (MRCT) between the United States and China in the past 20 years, representative varieties were selected for case analysis. We systematically analyzed the necessity of conducting international MRCT of vaccines in China, and the system advantages and management strategy of prophylactic vaccine clinical trial, further providing suggestions on feasibility of putting it forward.
Lurbinectedin is an RNA polymerase Ⅱ inhibitor that inhibits oncogene transcription in tumor-associated macrophages. It belongs to an injectable alkylated drug that can be used for the treatment of small cell lung cancer (SCLC) in adult patients with disease progression during or after platinum chemotherapy. The common adverse reactions include reversible myelosuppression and liver toxicity. This review summarizes pharmacology, clinical evaluation, drug interaction, safety, pharmacokinetics and dosage regarding this drug.
Risankizumab is a humanized, monoclonal IgG1 class antibody, the action of which is based on binding to the p19 subunit of IL-23. It has been approved by the FDA in 2019 for the treatment of moderate to severe plaque psoriasis. This review summarizes the mechanism, the advantages compared with other biological agents, pharmacokinetics, drug interaction, clinical evaluation, safety and tolerability of risankizumab.
Antimicrobial preservatives, as a kind of common additives in non-solid drug preparations, play an important role in preventing microbial contamination and ensuring drug quality. Due to its toxicity, the application range and level of preservatives should be strictly concerned. Referring to ChP 2020 and EMA related guidelines, this article summarizes the related requirements of preservatives when being used in preparations in ChP and EMA. It is therefore proposed that necessity and level of the application of antimicrobial preservatives should be greatly concerned in developing new drug preparations. The scope of application is also discussed in this article, hoping a helpful reference will be provided for research and development of drugs.
The supplementary testing methods and items of traditional Chinese medicine are important contents to strengthen the quality research of traditional Chinese medicine after marketing, which reflect the concept of full-life cycle management of drug quality, aiming to find and solve the potential quality problem of the traditional Chinese medicine (TCM). It is the supplement and perfection of the current national drug standards, providing a strong technical support for cracking down on adulteration of traditional Chinese medicine and improvement of the quality of traditional Chinese medicine. This paper summarizes the supplementary testing methods and items of traditional Chinese medicine since 2003, discusses the problems existing in the testing methods and puts forward relevant suggestions for peer reference.
The risk control of viral contamination has always been an important part of the safety control of recombinant biotechnology products. At present, China has not issued technical guidelines for viral safety control in the clinical trial application stage for recombinant therapeutic biotech products, while the sources of technical guidelines in the marketing stage are complicated, which to some extent brings troubles to researchers and delays the development process of new drugs. Therefore, in order to improve the R&D quality of related products and accelerate the application process, this article will discuss the basic technical requirements for viral safety control of recombinant therapeutic biotechnology products in the clinical trial application phase from three aspects: the technical requirements of the current technical guidelines, the technical requirements of the Chinese Pharmacopoeia, and the review practice.
Under the background of big changes in drug regulatory policies, the ideas on research and development of investigational Chinese medicine are converting into “clinical value-oriented”, “safety and efficacy evaluation methods in line with the characteristics of TCM” and “highlighting the advantages of TCM in disease treatment”. Based on the overall research idea of clinical value orienting and the reflecting of characteristics of TCM, this article mainly discusses the key issues in clinical research of investigational chinese medicine in the treatment of mammary hyperplasia based on six aspects, including feasibility analysis of project approval, positioning of clinical research, overall considerations and key issues of clinical trial protocol design, safety assessment of investigational Chinese medicine, as well as quality control measures.
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