Latest ArticlesDespite the existence of preventive vaccines, hepatitis B virus infection remains a global health issue.In the past several years, significant progress has been made in the research and development of drugs for the treatment of chronic hepatitis B (CHB) , with the development of new targets and the adoption of new drug forms. On the basis of introducing the concept of functional cure of CHB, the paper elucidated the therapeutic targets of CHB and reviewed the important progress in developing antiviral drugs and immunotherapy drugs. The synergistic combination of these drugs with different mechanisms of action might be the key strategy and direction to achieve clinical cure of CHB.
To explore the effect of cyclosporin blood drug concentration on the efficacy and safety of cyclosporin on patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the transplant bin.
Clinical medical records of 94 allo-HSCT patients were collected. The first day of stem cell infusion was +1 day (d), and the transplantation time was divided into four groups: group A (-9 d to -1 d), group B (+1 d to +7 d,) group C (+8 d to +14 d) and group D (+15 d to +21 d). The plasma concentration of cyclosporin and its influencing factors,cell implantation, liver and kidney function indexes, acute graft-versus-host disease (aGVHD), and the occurrence of cyclosporin-related adverse reactions were observed in different periods and their relationships with the plasma concentration of cyclosporin were analysed. Receiver operating characteristic (ROC) curve was used to analyze the value of serum concentration of cyclosporin at different time periods in predicting safety.
The concentration of cyclosporin in allo-HSCT patients was 128 (99,160) ng·mL-1, with statistically significant differences between different time periods (P<0.001). In allo-HSCT patients, the implantation rate of leukocyte, platelet, and neutrophil in +21 d was 94%, 64%, and 51%, respectively. The incidence of liver injury, kidney injury, and aGVHD was 47% (44/94), 71% (67/94), and 16% (15/94), respectively. ROC analysis showed that the warning value of cyclosporin blood concentration in the group A for liver injury and kidney injury was 128.5 ng·mL-1 and 113.5 ng·mL-1, respectively, while the area under the curve was 0.712 (95%CI：0.578 to 0.847，P=0.002) and 0.752 (95%CI：0.637 to 0.868，P<0.001), respectively.
There are many factors affecting the blood concentration of cyclosporin which can affect the clinical efficacy and safety. Timely and accurate monitoring of cyclosporin blood concentration can better guide the clinical treatment of allo-HSCT patients in the transplant bin.
The diversity of clinical trial population is the key to ensure the generalizability of drug safety and efficacy assessment results obtained from clinical trials, and plays an important role in advancing research on new drugs and strengthening the regulation of marketed drugs to improve the quality of life for patients. The United States has accumulated rich experience in improving the diversity of clinical trial population. Regulatory authorities have established a policy system for improving research practice, reducing patient participation barriers, and promoting data collection and sharing, and have provided diversified clinical trial information to the public. Clinical trial institutions have promoted the participation of patients from different backgrounds in clinical trials by strengthening inter-agency cooperation, facilitating community involvement, and improving the cultural inclusiveness of employees. China can learn from the relevant experience of the United States, improve the supervision system of clinical trial population diversity, promote the capacity building of clinical trial institutions to serve diverse populations, and strengthen the publicity and education of clinical trials, so as to improve the diversity of clinical trial population.
A scale is an important tool for diagnosing and evaluating patients in the field of mental health. The vigorous development of decentralized clinical trials has promoted the rise of electronic scales. The electronization of scales refers to the process of converting clinical outcome assessment tools such as traditional paper scales or questionnaire survey tools into digital formats through electronic technology, making the administration of scales more convenient, timely, and accurate, and data-collecting more complete, regular, and secure. This article outlined the process of electronic migration of scales and proposed corresponding precautions, aiming to provide guidance and suggestions for the electronization of scales in clinical research on mental and psychological diseases in China.
As the first dual receptor agonist of glucose-dependent insulin-stimulating polypeptide and glucagon-like peptide-1 used for chronic weight management, tirzepatide achieves weight loss by delaying gastric emptying and reducing energy intake, and its therapeutic effect on obesity is significant and its safety is high. Tirzepatide can also improve a variety of cardiometabolic risk factors, such as reducing blood sugar, lowering blood pressure, and improving blood lipids. In the future,it is expected to treat obesity with cardiovascular and cerebrovascular diseases, respiratory diseases, liver diseases, etc, with broad application prospects. This article reviewed the pharmacokinetics, mechanism of weight loss, clinical application and safety of tirzepatide.
To evaluate the efficacy and safety of anlotinib combined with gemcitabine + docetaxel as second-line or later therapy in patients with lung metastasis of osteosarcoma.
Case data of 23 patients with lung metastasis of osteosarcoma received anlotinib combined with gemcitabine + docetaxel as second-line or later therapy in the department of oncology of Shanghai Sixth People’s Hospital from January 2016 to December 2022 were analysed retrospectively. The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate, disease control rate (DCR) and safety.
In the 23 patients with lung metastasis of osteosarcoma, 17 patients (74%)achieved stable disease and 6 patients (26%) achieved progress disease, with DCR 74%. Median PFS was 10.8 months (95% CI: 1.4 to 20.2 months). All 23 patients experienced adverse reactions. Grade 3 or 4 adverse reactions included thrombocytopenia (17%)，hypothyroidism (9%), hypertension (4%), hand-foot reaction (4%), fatigue (4%), diarrhea (4%), leukopenia (4%), and pneumothorax (4%).
Anlotinib combined with gemcitabine + docetaxel as second-line or later therapy can be used as an effective treatment with manageable toxicities for patients with lung metastasis of osteosarcoma.
Isavuconazole is the latest triazole broad-spectrum antifungal drug that has been approved for the treatment of invasive aspergillosis and mucormycosis in adults. When isavuconazole was initially marketed abroad, many international guidelines did not recommend or weakly recommended it for routine therapeutic drug monitoring. However, a number of recent studies and expert consensus have emphasized that specific populations can be monitored for the use of isavuconazole based on clinical needs. Based on domestic and international real-world studies, this article provided a review of the specific situations leading to therapeutic drug monitoring of isavuconazole, including liver insufficiency, abnormal body mass index, children, CYP3A5*1/*3 genotypes, multi-drug therapy, long-term medication, and receiving special treatment or medication regimens, in order to provide reference for the clinical rational application of isavuconazole.
To investigate the effects of cordycepin on cartilage repair, serum inflammatory factors and oxidative stress in rats with osteoarthritis.
Forty-five rats were randomly divided into control group, model group and low-,medium-, and high-dose cordycepin groups (10, 20, and 50 mg·kg·d-1 by gavage) . The knee osteoarthritis model has been established using Hulth method. One week after modeling, rats in each group were administered the corresponding doses of cordycepin by gavage for 28 days. HE staining and Alcian blue staining were used to observe and compare the cartilage morphology of each group. MicroCT was used to detect and calculate the bone volume fraction, bone area fraction, trabecular bone thickness and trabecular bone number. The expression of cartilage matrix protein was detected by Western blot. The contents of interleukin (IL)-6, tumor necrosis factor (TNF)-α, monocyte chemotactic protein (MCP)-1 and IL-10 in serum of rats were determined by ELISA. The levels of oxidative stress markers in serum were detected by the kits.
Compared with the control group, cartilage tissue were showed significant pathological damage in the model group, bone volume fraction and bone area fraction were increased, and trabecular thickness and number were decreased (P<0.05); the protein expression levels of sex determining region Y-frame protein 9 (SOX-9), aggrecan, and collagenⅡ were decreased (P<0.05); the levels of IL-6, TNF-α, and MCP-1 in serum were increased, SOD and GSH activity were decreased, and MDA content was increased (all P<0.05). Compared with the model group, the pathological damage of knee cartilage tissue were significantly alleviated in the medium- and high-dose cordycepin groups, the bone volume fraction and bone area fraction were decreased, and trabecular thickness and number were increased ( P<0.05); the protein expression levels of SOX-9, aggrecan, and collagen Ⅱ were increased (P<0.05); serum IL-6, TNF-α, MCP-1 contents were decreased, IL-10 content was increased, MDA content was decreased, and SOD and GSH activity were increased (all P<0.05), showing a dose-dependent trend.
Cordycepin can reduce cartilage damage in rats with osteoarthritis by reducing inflammation and oxidative stress.
Malignant lymphoma (ML) is a heterogeneous malignant tumor in the hematological system, the existing treatment methods can not meet the clinical needs, and the rapid rise of new treatment schemes has improved the survival benefits of patients with recurrent or refractory ML. Antibody-drug conjugate (ADC), as a new type of highly effective anti-tumor drug composed of monoclonal antibodies specifically targeting tumor cell surface antigens, coupled with small molecular cytotoxic loads through chemical connectors, has attracted much attention in the application prospect of malignant lymphoma. Several ADCs have been approved for the treatment of ML, including brentuximab vedotin, inotuzumab ozogamicin, moxetumomab pasudotox, polatuzumab vedotinands, loncastuximab tesirine, etc. These drugs can exert anti-tumor effects by targeting CD30, CD22, CD79b, CD19, etc. on the surface of tumor cells with good efficacy and safety.
Eravacycline is a new class of fully synthetic fluortetracycline antibiotics with broad-spectrum antibacterial activity. The existing clinical trials have shown that eravacycline has good efficacy and safety in the treatment of various complex infections, especially in the application of multi-drug resistant bacteria. In this paper, the chemical structure, mechanism of action, antibacterial spectrum, pharmacokinetics/pharmacodynamics, clinical application, and drug resistance of eravacycline were reviewed in order to provide basis and reference for clinical drug use.
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