Latest ArticlesAIM To explore the clinical efficacy of Jia Wei Jingui Shengqi Pill (JWJSP) as a novel prophylaxis regimen for haemorrhagic cystitis (HC) in patients undergoing haploidentical hematopoietic stem cell transplantation. METHODS A prospective cohort analysis was conducted on 65 patients with hematological malignancies who underwent haploidentical hematopoietic stem cell transplantation from January 2020 to October 2023. Patients were divided into a JWJSP group (31 cases) and a control group (34 cases). The JWJSP group was administered JWJSP 5 g orally twice daily, while the control group received no specific prophylactic measures. The cumulative incidence of HC, clinical characteristics, and the positive rate of viruria in both groups were compared. The median follow-up duration was 277 (65, 624) days. RESULTS The cumulative incidence of HC in the JWJSP group was (29±3) %, significantly lower than that in the control group (53±3) % (P<0.01). There was no significant difference in the median onset time and duration of HC between the two groups (P>0.05). The median onset time of HC in the two groups of patients was 26 (20, 32) days and 37 (25, 45) days after transplantation, respectively, and the median duration was 13 (10, 24) days and 16 (14, 53) days, respectively, with no significant difference (P>0.05). The positive rate of BKV viruria in the JWJSP group after transplantation was 42%, significantly lower than that in the control group (68%) (P<0.05). CONCLUSION Prophylaxis with JWJSP may decrease the infection rate of BKV in urine and the overall incidence of HC in patients undergoing haploidentical hematopoietic stem cell transplantation.
Alzheimer’s disease (AD) is a progressive degenerative disease of the central nervous system. Lecanemab is a humanized IgG1 monoclonal antibody that preferentially targets soluble amyloid β-protein aggregates and can slow down the progression of AD. In January 2023, the U.S. Food and Drug Administration approved lecanemab to treat AD patients with mild cognitive impairment or mild dementia stage of disease. The common adverse drug reactions of lecanemab were infusion-related reactions, headache, and amyloid-related imaging abnormalities with edema. The mechanism of action, pharmacokinetics, clinical research, economic evaluation, and safety evaluation of lecanemab were reviewed in this article, so as to provide reference for rational clinical drug use.
To accelerate the development and market launch of new drugs that address unmet clinical needs, the European Medicines Agency (EMA) launched the “priority medicines (PRIME)” scheme in 2016. A range of supportive measures have been provided to drugs granted this qualification at various stages of development, including the appointment of dedicated personnel from EMA to assist applicants, multiple opportunities for applicants to engage in dialogue with regulatory authorities at key developmental stages, assistance in formulating or adjusting drug development plans and regulatory strategies, and facilitating the transition from drug development to market authorization review, thereby expediting the approval process for drug market applications. As of the first half of 2021, EMA had received a total of 384 PRIME qualification applications, of which 95 were approved, covering 19 therapeutic areas including antineoplastic medications, hematological medications, neurological medications, etc. It is suggested that relevant departments in China may draw on the practices of EMA to strengthen the construction in project management, management of communication and exchange meetings, utilization of review resources, and quality management of the review process, in order to improve the system for breakthrough therapeutic drugs in China.
Glaucoma, a leading cause of irreversible blindness worldwide, primarily involves pathological elevation of intraocular pressure （IOP）, which is its main risk factor, so the clinical goal in treating glaucoma is to reduce IOP to individual target levels. Currently, the classical local anti-glaucoma drugs include five categories: prostaglandin analogues（PGAs）, β-adrenergic receptor blockers, α2- adrenergic receptor agonists, carbonic anhydrase inhibitors, and cholinergic receptor agonists. These drugs mainly work by reducing aqueous humor production, increasing aqueous outflow through the trabecular pathway and the uveal scleral pathway, and contracting the pupil sphincter to open the chamber angle. Among these, PGAs have become the preferred choice for controlling IOP in primary open-angle glaucoma patients due to their efficacy and safety. In recent years, the introduction of novel glaucoma medications, including Rho kinase inhibitors and nitric oxide-donating anti-glaucoma drugs, along with the development of related drug-releasing formulations （intraocular and extraocular drug delivery systems）, offers new options for glaucoma treatment.
Risk minimisation measure （RMM） is a critical step to maximize the benefit-risk ratio of a medicinal product in pharmacovigilance activities. Through literature review and consulting the websites of major healthcare authorities in Europe Union, the USA, and Japan, this paper reviewed the RMM regulatory requirements and implementation status of these countries and regions. It was found that Europe, the USA, and Japan established relevant regulations earlier and accumulated valuable experience, and the specific implementation and supervision intensity of RMM varied among regions due to differences in medical systems. For example, additional risk minimization measures in Japan and the European Union are presented as risk evaluation and mitigation strategies in the USA. It is suggested that RMM-related regulations and supervision system should be continuously improved, and the marketing authorization holders in China should develop RMM implementation plans that conform to the actual conditions of China based on foreign experience and combined with the current situation of local medical system, and conduct feasible and efficient RMM effectiveness assessment to ensure patient medication safety.
To observe the difference of clinical efficacy and safety between regular hemodialysis （HD）and peritoneal dialysis （PD） uremic patients treated with roxadustat for renal anemia.
From December 2019 to March 2023, 102 renal anemia patients treated with roxadustat for uremic dialysis were selected. The initial dose of roxadustat was chosen based on weight, with 100 mg orally for patients weighing 45 to 60 kg and 120 mg for those weighing ≥60 kg. The medication was administered three times a week for 12 consecutive weeks, with dosage adjustments according to hemoglobin （Hb） levels. According to the dialysis method, there were 50 cases in the PD group and 52 cases in the HD group. Within the groups, those with high sensitive C-reactive protein （hs-CRP） ≥6 mg·L-1 were classified as high hs-CRP subgroup, while those with <6 mg·L-1 were considered the normal hs-CRP subgroup.Changes in anemia-related indicators, iron metabolism, lipid metabolism, and adverse reactions before and after roxadustat treatment were observed in both groups.
After 12 weeks of treatment with roxadustat, the levels of Hb, red blood cell count （RBC）, hematocrit （HCT）, and serum iron （SI） in the both groups all increased compared with before the treatment （P<0.05）, while the levels of serum ferritin （SF）, total cholesterol （TC）,triglyceride （TG）, and low-density lipoprotein cholesterol （LDL-C） all decreased （P<0.05）. After treatment, the levels of Hb, RBC, HCT, SI, TC, and LDL-C in the PD group were significantly higher than those in the HD group（P<0.05）. There were no significant differences in transferrin saturation （TSAT）, total iron-binding capacity （TIBC）,and high-density lipoprotein cholesterol （HDL-C） levels within and between the groups before and after the treatment（P>0.05）. There were no significant differences in TG and SF levels and the occurrence of adverse reactions between the two groups （P>0.05）. After 12 weeks of treatment, the average Hb level of the high hs-CRP subgroup and normal hs-CRP subgroup of the two groups significantly increased compared with before treatment （P<0.05）, and there was no significant difference between the two subgroups （P>0.05）.
Roxadustat is effective in improving renal anemia in uremia patients with HD or PD, and the short-term safety is good. Compared with HD patients, anemia is more significantly improved in PD patients.
To observe the anesthetic effect of ciprofol in intracranial aneurysm embolization.
One hundred and twenty patients undergoing intracranial aneurysm embolization, ASA Ⅰor Ⅱ, were randomly divided into control group and experimental group （n=60, each group）. During anesthesia induction, patients were given with midazolam 0.04 mg·kg-1, sufentanil 0.25 μg·kg-1, ciprofol 0.4 mg·kg-1 （experimental group） or propofol 2.0 mg·kg-1 （control group）, and rocuronium 0.6 mg·kg-1. During anesthesia maintenance, all patients were maintained with remifentanil 1 μg·kg-1·h-1 and cisatracurium 0.1 mg·kg-1·h-1, combined with ciprofol 0.8 mg·kg-1·h-1 （experimental group） or propofol 5 mg·kg-1·h-1 （control group）. The bispectral index （BIS） was maintained between 40 and 60 by adjusting the pumping speed during the operation. The changes of vital signs and BIS were observed. The anesthesia induction time,awakening time, and Ramsay sedation score after extubation were recorded. And the occurrence of adverse reactions was also observed.
There was no significant difference in systolic blood pressure （SBP）, diastolic blood pressure （DBP）,and heart rate （HR） between the two groups before anesthesia, after anesthesia induction, after tracheal intubation, at the end of operation, and after tracheal extubation. The BIS at the end of operation in the experimental group was lower than that in the control group （P<0.05）. The fluctuation value of SBP, DBP, and HR during anesthesia induction in the control group was significantly greater than that in the experimental group （P<0.05）. The recovery time of the experimental group was slightly longer while the use of sedatives was less than that of the control group （P<0.05）. The incidences of post-induced hypotension, hypertension after intubation, and injection pain in the experimental group were lower than those in the control group （P<0.05）.
Ciprofol can be used in intracranial aneurysm embolization with outstanding sedative efficacy. The hemodynamics of patient is more stable, and the incidence of postoperative adverse reaction is low.
In order to establish a technical evaluation system in line with the characteristics of traditional Chinese medicine （TCM） and promote the inheritance and innovative development of TCM, China is building a TCM registration and evaluation evidence system combining TCM theory, human experience, and clinical trials. Human experience is of great significance to support the registration and evaluation of new drugs of TCM. Based on the survey of 20 medical institutions in Shanghai, this paper analyzed the current situation and common problems of human experience collection of TCM. It was found that medical institutions had been aware of carrying out human experience collection for the development of TCM preparations or new drugs. However, the hardware conditions, personnel capabilities, and the importance of medical institutions in collecting human experience were still not optimistic. There were difficulties in the collection process. 90%of institutions believed that the quality of collected data did not meet the requirements of drug registration. Regulators and medical institutions should work together to improve and standardize the collection of human experience of TCM by improving collection methods, increasing research capabilities, strengthening the construction of information systems, and enhancing research quality management according to GCP principles, so as to ultimately obtain high-quality evidence materials to support the innovation and transformation of TCM.
To observe the influences of ginsenoside Rb1 （GsRb1） on the proliferation and osteogenic differentiation of human periodontal ligament stem cells （hPDLSCs）, and its molecular mechanism related to stromal cell-derived factor-1 （SDF-1）/CXC chemokine receptor 4 （CXCR4） pathway.
hPDLSCs were isolated and cultured by enzyme digestion method. Cell morphology was observed under an inverted microscope. Flow cytometry was used to detect the proportion of stromal cell antigen 1 （STRO-1） and cluster of differentiation 146 （CD146） positive cells. hPDLSCs were treated with 0, 0.5, 1.0, 2.0, 4.0, 6.0 μmol·L-1 GsRb1, respectively, and the optimal concentration was screened by CCK-8 method. hPDLSCs were divided into control group, GsRb1 （4.0 μmol·L-1） group, AMD3100 （5 μg·mL-1） group, and GsRb1+AMD3100 group, the cell proliferation and alkaline phosphatase （ALP） activity of each group were compared, the mRNA expression of Runt-related gene 2 （Runx2）, oxterix, and osteopontin （OPN） were detected by qRT-PCR, and the formation of mineralized nodules in hPDLSCs was detected by alizarin red staining and quantitative analysis. Western blot was used to detect the expression of SDF-1/CXCR4 signaling pathway-related proteins.
hPDLSCs were arranged radially, with long spindles, and the growth was relatively dense. The proportions of STRO-1 and CD146 positive cells were 97.19% and 98.01%, respectively. With the increase of GsRb1 concentration, the proliferation activity of hPDLSCs was enhanced in a dose-dependent manner （P<0.05）. Compared with the control group, the cell viability and ALP activity in the GsRb1 group were enhanced, and the mRNA expression of Runx2, oxterix, OPN, the amount of mineralized nodules, and the protein expression of SDF-1 and CXCR4 were increased （P<0.05）, while the AMD3100 group was the opposite （P<0.05）.Compared with the GsRb1 group, the cell viability and ALP activity in the GsRb1+AMD3100 group were decreased, and the mRNA expression of Runx2, oxterix, OPN, the amount of mineralized nodules, and the protein expression of SDF-1 and CXCR4 were decreased （P<0.05）.
GsRb1 can promote the proliferation and osteogenic differentiation of hPDLSCs, which may be related to the increased protein expression of SDF-1/CXCR4 signaling pathway.
To study the protective effect of cerebroprotein hydrolysate and its related mechanism of regulating endoplasmic reticulum stress in ischemic stroke based on network pharmacology and animal experiments.
GeneCards and OMIM databases were used to screen the targets related to ischemic stroke and endoplasmic reticulum stress, and Wayne diagram was drawn to get the intersection genes. The protein-protein interaction network diagram was downloaded from String database and visualized by Cytoscape software, and the top 10 genes were screened by cytoHubba plug-in. Finally, Gene Ontology （GO） and Kyoto Encyclopedia of Genes and Genomes （KEGG） were enriched and analyzed. Mouse models of ischemic stroke were made by the suture-occluded method, and randomly divided into sham group, model group, cerebroprotein hydrolysate 0.2 g·kg-1 group and 0.5 g·kg-1 group, and edaravone 8 mg·kg-1 group,with 11 mice in each group. The drug was administered continuously for 5 days after operation. The volume of cerebral infarction was measured by TTC staining, the contents of interleukin （IL）-6, IL-1β, γ-interferon （IFN-γ） and brain-derived neurotrophic factor （BDNF） in cerebral ischemic penumbra and serum were measured by ELISA, and the expression of Caspase-3 and AKT protein in brain tissue was observed by immunohistochemistry.
According to the results of network pharmacology, 41 intersection genes of ischemic stroke and endoplasmic reticulum stress were screened, and the top 10 genes screened were IL-6, ALB, INS, TNF, AKT1, CASP3, MAPK3, TP53, SIRT1 and VEGFA, respectively. GO enrichment resulted in 515 related entries. KEGG pathway enrichment involved lipid and atherosclerosis pathway, human cytomegalovirus infection, Alzheimer’s disease, phosphatidylinositol -3- kinase/ protein kinase B （PI3K/AKT） signaling pathway and so on. Compared with the model group, the cerebral infarction volume was significantly reduced （P<0.01）; the contents of IL-6, IL-1β and IFN-γ in serum and penumbra were decreased significantly （P<0.05）, and the contents of BDNF in serum and penumbra were increased significantly （P<0.05）; the expression of Caspase-3 in brain tissue was decreased significantly （P<0.05）, and the expression of AKT was increased significantly （P<0.05） in the two groups of cerebroprotein hydrolysate.
Based on the analysis of network pharmacology, the endoplasmic reticulum stress mechanism of ischemic stroke may be related to inflammation and apoptosis. The neuroprotective mechanism of cerebroprotein hydrolysate may be related to activating BDNF/PI3K/AKT pathway and inhibiting inflammation and apoptosis.
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