Latest ArticlesTo scientifically construct the evaluation indicators for human use experience of traditional Chinese medicine (TCM) and provide reference for the formation of "triple combination" registration review evidence system.
Based on the Delphi method, after literature research and expert investigation, two rounds of expert consultation were carried out, and the expert consultation results were evaluated by the mean, variation index, coordination coefficient, etc., and the core indicators for human use experience evaluation of TCM were further screened and optimized.
22 experts in various fields were selected to conduct a questionnaire survey. The participation rates of experts in the 2 rounds of consultation were 100% and 95.46%, and the authority indicators of involved experts were 0.852 and 0.865. According to the mean value and coefficient of variation of the indicators, combined with the revision suggestions of experts, the core indicators of human use experience evaluation including 4 first-level indicators and 22 second-level indicators were finally formed.
The core indicators for human use experience evaluation of TCM could guide the standardized collection and summary of human use experience data, promote the formation of high-quality and evaluable human use experience evidence, and support the research and development of new TCM products.
To study venous thromboembolism associated with risperidone in the treatment of schizophrenia, so as to provide references for future clinical rational drug use.
A case of risperidone-associated pulmonary thromboembolism was presented and the cases of risperidone-associated venous thromboembolism, deep vein thrombosis and pulmonary thromboembolism were collected from Chinese VIP journal database, Wanfang and PubMed database and analyzed.
A total of 13 cases were retrieved. Risperidone-induced venous thromboembolism has been reported in all age groups, and the dose ranged from 1 to 6 mg. Adverse reactions occurred within 2 months after the medication (10/13 cases), and the clinical manifestations were mainly respiratory symptoms or symptoms related to lower limb venous thromboembolism, such as lower limb edema and pain. Severe cases led to syncope, cardiopulmonary arrest or even death.
Clinicians and pharmacists should be familiarized with the characteristics of pulmonary thromboembolism associated with risperidone, weigh the advantages and disadvantages, and use it with caution. To reduce the occurrence of adverse reactions, coagulation function monitoring and venous ultrasound examination of lower limbs should be strengthened, and CT pulmonary angiography should be performed if necessary.
Endocrine therapy is one of the treatment options for estrogen receptor-positive breast cancer. The therapeutic drugs include selective estrogen receptor modulators, selective estrogen receptor down-regulators and aromatase inhibitors. The resistance of tumor cells to endocrine therapy is one of the key factors limiting the clinical application of endocrine therapeutic drugs. Resistance includes intrinsic drug resistance and acquired drug resistance. The generation of acquired drug resistance may be related to the overexpression of ERα coactivators and the abnormal expression of cell cycle regulators mediated by ER, RTKs, PI3K and other pathways. This article mainly reviews the mechanism of breast cancer resistance to endocrine therapy and the treatment strategies.
Tissue repair is a process that involves coagulation reaction, inflammatory reaction, cell proliferation and remodeling induced by tissue injury. Bletilla striata is a traditional Chinese medicine with astringent and hemostatic effect. Its extract has pharmacological effects such as hemostasis, anti-inflammatory effect, antibacterial and antioxidant effect, so that it can promote tissue repair and reconstruction. This paper reviews the extract and pharmacological mechanism of Bletilla striata in tissue repair and reconstruction, so as to provide reference for its clinical medication and expand the scope of clinical application.
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products Draft Guidance for Industry was launched by FDA on March 21, 2022. It provides CAR-T cell specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, clinical study design, and other important aspects. To provide references for sponsors, this article mainly introduces the clinical considerations for early-phase development of CAR-T cells for patients with cancer (hematologic malignancies and solid tumors), including study population, treatment plan, clinical pharmacology considerations, safety evaluation and monitoring, CAR-T cell persistence and long term follow-up, and allogeneic CAR-T cells. This article also introduces the information of chimeric antigen receptor T cell products in China, and discusses the similarities and differences of the clinical review of such products by regulatory agencies between China and the United States.
In recent years, microneedle technology has been widely used in the research of transdermal drug delivery due to its unique mechanism of opening the stratum corneum barrier. Nanotechnology has also received extensive attention in the field of transdermal drug delivery due to its excellent solubility enhancement, high drug stability, targeted drug release, and sustained and controlled release properties. However, the researchers found that both technologies have obvious defects in transdermal drug delivery, such as inability of microneedle technology to improve the solubility of poorly soluble drugs, and poor stratum corneum penetration ability of nano-formulations, which will limit the application of the two technologies in transdermal drug delivery. At present, some scholars have tried to combine nano-formulations with microneedles to improve the physicochemical properties of drugs and achieve targeted drug delivery as well as controlled drug release, synergistically enhancing the effect of drug transdermal delivery and promoting the efficient application of drugs. Therefore, this article will briefly introduce the advantages and disadvantages of some microneedles and nano-formulations, and further summarize the advantages, applications, and prospects of nano-formulations combined with microneedles.
To analyze the effect of Wuzhi capsule on tacrolimus concentration and clinical efficacy.
The Chinese databases of Wanfang, CNKI and Weipu were searched to collect the relevant studies on the effect of Wuzhi capsule on the plasma concentration and clinical efficacy of tacrolimus in patients with nephrotic syndrome. The literatures that met the standards were included, and the effective data were extracted. SPSS 27.0 statistical software was applied for analysis.
A total of 4 studies were included, and the statistical analysis results showed that Wuzhi capsule improved the plasma concentration of tacrolimus and standardized plasma concentration, and the difference was statistically significant (P<0.05). The 24-hour urine protein level in drug combination group was lower than that in single drug group, and the plasma albumin level was higher.
Wuzhi capsule can significantly improve the plasma concentration of tacrolimus and clinical efficacy in patients with nephrotic syndrome.
To prepare and evaluate the polymer micellar thermosensitive gel of Chinese medicine chrysanthemum volatile oil.
The polymer micelles were prepared by the ethanol injection method, and the preparation process was optimized by orthogonal experiments. The morphology, particle size and zeta potential of the polymer micelles were evaluated. The thermosensitive gel was further prepared using poloxamer 407 and poloxamer 188 as the matrix. The rheological properties of the thermosensitive gel were measured by a flat plate rheometer, the irritability of the thermosensitive gel to rabbit eyes was investigated using Draize eye irritation score, and eye tissues were examined by pathological examination.
The optimal preparation process of Chinese medicine chrysanthemum volatile oil polymer micelles thermosensitive gel was as follows: the concentration of chrysanthemum volatile oil was 15 μL·mL-1, the mass ratio of surfactant (TPGS∶phospholipid) was 3∶2, the concentration of surfactant was 37.5 mg·mL-1, and the mass ratio of phospholipids (HSPC∶DSPE-PEG2000) was 1∶1. The polymer micelles were closely arranged, spherical or quasi-spherical with the average particle size of (58.60±2.37) nm and zeta potential of (0.197±0.045) mV. The thermosensitive gel prepared with 21% mass fraction of poloxamer 407 and 3% mass fraction of poloxamer 188 was a pseudoplastic fluid with good rheological properties. The gel was basically non-irritating to rabbit eyes and had no irreversible tissue damage.
The prepared TCM chrysanthemum volatile oil polymer micelle thermosensitive gel has little irritation and good stability.
As the latest generation of sodium-glucose cotransporter-2 inhibitors (SGLT2i), ertugliflozin (ERT) has stable molecular structure, long half-life, significant hypoglycemic effect and good tolerance. It also has the protective effect of heart independent of its hypoglycemic activity. It is recommended as a priority treatment for the patients with type 2 diabetes mellitus (T2DM) complicated with atherosclerotic cardiovascular disease (ASCVD) in China and abroad. In addition, ERT has a concrete effect on controlling the body weight of T2DM patients, thus also has the value in the treatment of T2DM patients with obesity. However, ERT is not recommended to be used in those T2DM patients with renal insufficiency due to low safety profile.
Primary biliary cholangitis (PBC) is a chronic progressive autoimmune cholestasis, which eventually leads to liver fibrosis and cirrhosis, but the pathogenesis is not totally clear. With the further under standing of the disease and the higher level of clinical diagnosis, the prevalence of PBC in China is on the rise. At present, only ursodeoxycholic acids and obeticholic acid are officially approved for the treatment of PBC around the world, therefore there are limited treatment options and unmet clinical needs. Several drugs with different targets are under development in China and abroad. This paper briefly summarizes the clinical development experiences of the drugs, in order to provide reference for research and evaluation.
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