Latest ArticlesLactotol was first registered by Novartis in Switzerland in 1985. Its trade name is Importal. It is used for the treatment of hyperammonemia caused by hepatic encephalopathy. On February 12, 2020, it was approved by the US FDA for the treatment of chronic idiopathic constipation in adults. Its trade name is Pizensy. Latitol can increase the defecation frequency of patients, and the treatment efficacy for chronic idiopathic constipation in adults is not inferior to that of rubiprostone. The most common adverse reactions are upper respiratory tract infection, abdominal distension and diarrhea. The mechanism of action, pharmacokinetics, effectiveness, and safety of lactitol were reviewed in this article.
In August 2020, the Center for Drug Evaluation of National Medical Products Administration issued the “Guideline of the research and validation of the terminal sterilization and aseptic process of chemical injections (for trial implementation)”. In this article, based on the draft and revision of the guideline, some important glossaries of the steam sterilization process and decision tree for sterilization choices for chemical injections were clarified, concerns of the research and validation of the steam sterilization process were discussed, and the main points of amendments and the new contents were analyzed and sorted out, in order to provide more references for the follow-up study on consistency evaluation of generic chemical injections.
To study the anti-hyperuricemic efficacy, assess the safety of compound CC18013, and explore its possible mechanism related to xanthine oxidase (XOD) inhibition.
By establishing the acute and chronic hyperuricemic mice models and use of febuxostat as the positive control drug, the effect of CC18013 on serum uric acid levels was detected; the XOD inhibiting ability of CC18013 was determined using in vitro XOD model. The effect of CC18013 on serum and tissue XOD activity in hyperuricemic mice was measured. The interaction between CC18013 and XOD was analyzed by molecular-docking. The body weight change and general state of the mice were observe after a single dose treatment of CC18013.
CC18013 dose-dependently reduced serum uric acid levels in vivo, with the lowest effective dose of 0.5 mg·kg-1. Its IC50 value of XOD inhibition in vitro was 4.6 nmol·L-1. Moreover, it significantly inhibited XOD activity in liver and small intestine. Molecular-docking result indicated that it had a strong interaction with XOD. It showed no evident toxicity under the single dose of 500 mg·kg-1.
CC18013 is an XOD inhibitor with strong anti-hyperuricemic effect and high safety.
Depression is a type of mental illness that seriously endangers the physical and mental health of humans. The clinical manifestations are marked and lasting symptoms such as depressed mood, low mood, slow thinking and other symptoms. However, its pathogenesis and the therapeutic target is still unclear. Exosomes are lipid bilayer cystic vesicles carrying biological information molecules such as lipids, proteins, DNA, and miRNAs, which mediate information transmission between cells and regulate the expression of related signal pathways. At present, the study of exosomal miRNAs in depression is relatively extensive, providing new application prospects for early diagnosis and treatment of depression. In this paper, we mainly reviewed the latest research progress in exosomal miRNAs in depression.
In recent years, the incidence of malignant tumors has been increasing. After conventional treatments such as surgical resection, chemotherapy, and radiotherapy, many patients' conditions are still not effectively controlled. Therefore, exploring new treatment methods has become the focus of tumor prevention and control. The role of photoimmunotherapy (PIT) in solid tumor research is becoming more and more prominent. Photoimmunoconjugate (PIC) has the ability of tumor-specific recognition and high cytotoxicity. This article reviews the progress in the development of such novel molecular targeted drugs in the past decade, and the results from the study of using porphyrin, chlorin e6 (Ce6), phthalocyanine dye (IR700) and other photosensitizer conjugated monoclonal antibodies (MAbs) as photosensitizing drugs were discussed respectively.
As a new drug carrier, albumin nanoparticles have many characteristics, such as biodegradability, biocompatibility, non-toxicity and non-immunogenicity, and it has shown unique tumor targeting mechanism. Most of anti-tumor drugs are water-insoluble, poor drugability of preparation, and of high adverse reaction. For the purpose of changing its physical and chemical properties and reducing the adverse effects, albumin nanoparticles are often applied as carrier to deliver anti-tumor drug. The surface modification of albumin nanoparticles and coating of plasma membrane greatly enhance the drug targeting, improve the solubility, reduce the toxicity, prolong in vivo circulation, and even enhance the efficacy of drugs. In this paper, the preparation process and surface modification of albumin nanoparticles are reviewed in order to provide reference for the study of related drugs of albumin nanoparticles.
Hepatocellular carcinoma (HCC) is the main pathological type of primary liver cancer, accounting for 75%~85%, and most of the patients are diagnosed late with poor prognosis. The treatment choices of advanced HCC are limited, sorafenib and other targeted drugs can only prolong the overall survival of patients to about one year, which is difficult to meet the clinical needs, so it is urgent to develop new treatment methods. Nivolumab further prolongs the overall survival of patients, and it was the first immune checkpoint inhibitor (ICI) approved for the treatment of advanced HCC, which also opened the prelude of immunotherapy for advanced HCC. Subsequent clinical studies indicated that immune checkpoint inhibitors (ICIs) combined with other therapies such as targeted therapy, local treatment, systemic chemotherapy could not only enhance the efficacy, but also had no significant increase in adverse reactions. In conclusion, ICIs have broad application prospects in the treatment of advanced HCC, and combination therapy will be the main treatment for advanced HCC.
Paclitaxel, the first natural plant-derived chemical approved by the US FDA, is a broad-spectrum antitumor drug with good antitumor activity. However, due to its complex chemical structure, disadvantages such as poor water solubility and poor absorption limit its widespread clinical application. Therefore, how to improve its water solubility, bioavailability and targeting effect in tumor tissues has been a difficult and important issue to be solved. In this article, we briefly reviewed the research progress of paclitaxel prodrugs that improve its water solubility and targeting in recent years.
Rheumatism immunity disease is one of the chronic diseases which affect health seriously. A series of biological agents targeting cytokines have greatly improved the prognosis and quality of life of patients, but still can not meet the needs of disease treatment, thus searching new drugs has become an important task in the treatment of rheumatoid immune diseases. JAK-STAT is an important signaling pathway, which is involved in the development of many autoimmune diseases. JAK inhibitors can block the production of a variety of inflammatory cytokines and have anti-inflammatory and immunomodulatory effects. JAK inhibitors are gaining increasing attention in the field of rheumatologic disorders. In this review, the application status and prospect of these drugs in autoimmune diseases are summarized for the first time.
To summarize and analyze the current situation of safety reporting requirements of drug clinical trial institutions in China after the implementation of the new “Good Clinical Practice” (GCP).
Data processing and statistical analysis were conducted on the reporting procedures and management requirements of safety events issued by 98 drug clinical trial institutions.
Fifty institutions (51.0%) required investigators to submit suspected unexpected serious adverse reactions (SUSAR) to ethics committees. A high proportion of institutions did not specify the media and time limit for SUSAR submission. There were 36 (36.7%) institutions that differentiated the time limit for SUSAR submission from sponsors to at least one role of investigators, ethics or trial management departments. The time limit for SUSAR at own hospitals was shorter than that from other hospitals and 7 or 15 d was the most common time limit. Forty-two (42.9%) institutions required investigators to report severe adverse events (SAE) to ethics committees and/or trial management departments.
Drug clinical trial institutions have timely updated the safety reporting requirements which focus on SUSAR and other safety events at own hospitals. It is necessary to further improve the clarity and convenience of safety reporting procedures and explore the management mechanism of safety events at the institution level.