Applying Untargeted Lipidomics to Evaluate the Efficacy of Combined Neoadjuvant Chemotherapy and Immunotherapy for Esophageal Squamous Carcinoma Treatment.

Esophageal squamous cell carcinoma (ESCC) is an aggressive malignant tumor with a poor prognosis due to insidious symptoms that make early diagnosis difficult. Despite the combination of multiple treatment modalities, the recurrence and mortality rates of ESCC remain high. Neoadjuvant chemotherapy combined with immunotherapy is an emerging treatment modality that improves the prognosis of patients with ESCC. However, owing to the presence of hyperprogression and pseudoprogression, the currently used methods cannot accurately evaluate the efficacy of this therapy in patients, thus creating an evaluation bias and depriving these patients of the opportunity to benefit. We used untargeted lipidomics to identify the differences in lipid composition between cancer specimens and normal tissue specimens in the neoadjuvant chemotherapy combined with the immunotherapy group and the surgery-alone group of esophageal cancer patients and constructed a prediction model based on sphingomyelin 12:1;2O/30:0 and triglyceride (TG) 60:3 | TG 18:0_24:1_18 using a machine learning approach, which helps to better evaluate the neoadjuvant efficacy of combination therapy and better guide the treatment of ESCC.

A novel approach to investigate severe asthma and COPD: the 3d ex vivo respiratory mucosa model.

Purpose: This article illustrates the replication of asthma and COPD conditions in a laboratory setting and the potential applications of this methodology.Introduction: Biologic drugs have been shown to enhance the treatment of severe asthma and COPD. Monoclonal antibodies against specific targets have dramatically changed the management of these conditions. Although the inflammatory pathways of asthma and COPD have already been clearly outlined, alternative mechanisms of action remain mostly unexplored. They could provide additional insights into these diseases and their clinical management.Aims: In vivo or in vitro models have thus been developed to test alternative hypotheses. This study describes sophisticated ex vivo models that mimic the response of human respiratory mucosa to disease triggers, aiming to narrow the gap between laboratory studies and clinical practice.Results: These models successfully replicate crucial aspects of these diseases, such as inflammatory cell presence, cytokine production, and changes in tissue structure, offering a dynamic platform for investigating disease processes and evaluating potential treatments, such as monoclonal antibodies. The proposed models have the potential to enhance personalized medicine approaches and patient-specific treatments, helping to advance the understanding and management of respiratory diseases.

Decoding active compounds and molecular targets of herbal medicine by high-throughput metabolomics technology: A systematic review.

Clinical experiences of herbal medicine (HM) have been used to treat a variety of human intractable diseases. As the treatment of diseases using HM is characterized by multi-components and multi-targets, it is difficult to determine the bio-active components, explore the molecular targets and reveal the mechanisms of action. Metabolomics is frequently used to characterize the effect of external disturbances on organisms because of its unique advantages on detecting changes in endogenous small-molecule metabolites. Its systematicity and integrity are consistent with the effective characteristics of HM. After HM intervention, metabolomics can accurately capture and describe the behavior of endogenous metabolites under the disturbance of functional compounds, which will be used to decode the bioactive ingredients of HM and expound the molecular targets. Metabolomics can provide an approach for explaining HM, addressing unclear clinical efficacy and undefined mechanisms of action. In this review, the metabolomics strategy and its applications in HM are systematically introduced, which offers valuable insights for metabolomics methods to characterizing the pharmacological effects and molecular targets of HM.

Evaluation of the clinical efficacy of using an inverted triangular cannulated compression screw in combination with positive or negative buttress reduction for the healing of femoral neck fractures.

OBJECTIVE: We aimed to compare the clinical efficacy of inverted triangular cannulated compression screws combined with Gotfried positive or negative buttress reduction in the healing of femoral neck fractures. METHODS: Between October 2017 and March 2021, 55 patients with femoral neck fractures underwent treatment using inverted triangular cannulated compression screws combined with Gotfried positive or negative buttress reduction. Among these patients, 29 received inverted triangular cannulated compression screws combined with Gotfried positive buttress reduction treatment. This group consisted of 16 males and 13 females, with an average age of 43.45 ± 8.23 years. Additionally, 26 patients received inverted triangular cannulated compression nails combined with Gotfried negative buttress reduction treatment. This group included 14 males and 12 females, with an average age of 41.96 ± 8.69 years. Postsurgery, various measurements were taken, including the degree of shortening of the femoral neck, degree of bone nonunion, degree of fixation failure, degree of ischemic necrosis of the femoral head, and Harris score of the hip joint. RESULTS: All patients were followed up for a minimum of 18 months. The group that underwent treatment with an inverted triangular cannulated compression screw combined with Gotfried positive buttress reduction did not experience any cases of bone nonunion, fixation failure, or ischemic necrosis of the femoral head. In the group that received treatment with inverted triangle cannulated compression screws combined with Gotfried negative buttress reduction, there was one case of bone nonunion, three cases of early fixation failure, and one case of ischemic necrosis. Ultimately, five patients (19.23% of the total) underwent joint replacement surgery. The average shortening lengths in the vertical plane were 4.07 ± 1.98 mm and 8.08 ± 3.54 mm, respectively. In the horizontal plane, the average shortening lengths were 3.90 ± 1.57 mm and 7.77 ± 3.31 mm, respectively. At the last follow-up, the group that received Gotfried positive buttress reduction had a greater Harris hip joint score. CONCLUSION: The success rate of combining inverted triangular cannulated compression screws with Gotfried positive buttress reduction surgery is relatively high. This surgical approach effectively prevents femoral neck shortening and improves hip joint function. Moreover, it is crucial to avoid negative buttress reduction when managing femoral neck fractures.

Clinical and biochemical evaluation of rituximab as add on therapy in neuromyelitis optica spectrum disorders.

OBJECTIVE: This study assesses the efficacy of rituximab in the treatment of neuromyelitis optica spectrum disorders (NMOSD). METHODS: The study initially included 40 patients with NMOSD diagnosed, after excluding patients who did not meet the complete inclusion criteria. Patients in the conventional group received routine clinical treatment, while patients in the study group received additional treatment with rituximab on the basis of the conventional treatment. Baseline data and clinically relevant indicators were collected for all patients, and the efficacy was compared between the two groups. RESULTS: Baseline data were comparable between the two groups (p > 0.05). The EDSS scores after clinical treatment in the study group were lower than those in the conventional group, and the difference in EDSS scores before and after treatment was higher than that in the conventional group (p < 0.05). The difference in visual acuity correction before and after treatment was not significant between the two groups (p > 0.05). Laboratory indicators in the study group after clinical treatment were superior to those in the conventional group (all p < 0.05). The recurrence rate after clinical treatment in the study group was significantly lower than that in the conventional group (p < 0.05). Adverse reactions after clinical treatment in the study group were less than those in the conventional group (p < 0.05). CONCLUSION: This study found that rituximab demonstrated significant efficacy in the acute attacks and recurrence prevention of NMOSD, emphasizing its relatively good safety and tolerability. It highlights the potential of rituximab in treating NMOSD and provides valuable insights for future disease management.

[Application of ARHGAP8 in Predicting the Efficacy of Neoadjuvant Chemotherapy for Locally Advanced Mid-Low Rectal Cancer].

Objective To analyze the sensitivity of ARHGAP8 in predicting the efficacy of neoadjuvant chemotherapy in the patients with locally advanced mid-low colorectal cancer and provide accurate evidence for the treatment of advanced colorectal cancer. Methods The differentially expressed gene ARHGAP8 was screened out by bioinformatics analysis.Cancer tissue and rectal tissue of 68 patients with primary rectal cancer were selected.The rectal cancer tissue samples and the rectal tissue samples were collected for clinical validation of ARHGAP8 expression by quantitative real-time PCR,Western blotting,and immunohistochemistry.The clinical and pathological features such as gender,age,tumor stage,differentiation degree,and pathological type of the patients were collected for functional validation.Forty-four patients with locally advanced mid-low rectal cancer who received neoadjuvant chemotherapy were selected for immunohistochemical examination of ARHGAP8 expression.The expression level of ARHGAP8 was compared between before and after chemotherapy and among different efficacy groups. Results The bioinformatics analysis revealed differences in the expression level of ARHGAP8 between the cancer tissue and rectal tissue (P<0.001).The expression level of ARHGAP8 was correlated with tumor stage (P=0.024),lymph node metastasis (P=0.007),and age (P=0.005).Quantitative real-time PCR results showed that the mRNA level of ARHGAP8 in the cancer tissue was higher than that in the rectal tissue (P<0.001).Western blotting and immunohistochemistry results demonstrated that the protein level of ARHGAP8 in the cancer tissue was higher than that in the rectal tissue (P=0.011).The expression of ARHGAP8 was correlated with tumor size (P=0.010) and pathological stage (P=0.005),while it showed no significant association with tumor differentiation degree,lymph node metastasis,liver metastasis,Ki-67,or microsatellite instability expression level.The 44 patients receiving neoadjuvant chemotherapy included 13,8,8,and 15 patients of tumor regression grades 0,1,2,and 3,respectively.Among them,65.91% (29/44) patients showed responses to the treatment.After neoadjuvant chemotherapy,the expression of ARHGAP8 in the cancer tissue was down-regulated in the patients who responded to the chemotherapy (P<0.001).The response rate in the patients with low protein level of ARHGAP8 was 92.86%,which was higher than that (53.33%) in the patients with high protein level of ARHGAP8 (P=0.033). Conclusion ARHGAP8 is highly expressed in the rectal cancer tissue.The patients with locally advanced mid-low rectal cancer and low ARHGAP8 expression are more sensitive to neoadjuvant chemotherapy with the XELOX protocol.ARHGAP8 can serve as a potential biomarker for the occurrence and development of rectal cancer and an important index for evaluating the efficacy of neoadjuvant chemotherapy with the XELOX protocol in the patients with locally advanced mid-low rectal cancer.

[Methods for traditional Chinese medicine syndrome-based efficacy evaluation: a review].

Traditional Chinese medicine(TCM) syndrome-based efficacy is an evaluation index which is unique to TCM and can reflect the advantages of TCM. The development of the methods and measurement tools for evaluating TCM syndrome-based efficacy can provide objective and quantitative evidence for the clinical efficacy evaluation of TCM and the development of new Chinese medicine preparations, being the exploration direction of innovative methods and technologies for evaluating TCM efficacy. The conventional evaluation methods are subjective and limited to the mitigation of symptoms and the improvement of physical signs, which make it difficult to form a unified evaluation standard. In addition, the evaluation methods lack unity, objectivity, and quantitative research. The scientific connotation, evaluation ideas and methods, and key technologies of the evaluation for the therapeutic effect on syndromes remain unclear, which leads to diverse evaluation modes, methods, and indexes. The syndrome-based efficacy scale provides a new idea for the objective quantification and standardization of TCM syndromes. This review systematically summarizes the methods and problems, introduces the research progress in the evaluation scales, and puts forward some thoughts on the characteristics of TCM syndrome-based efficacy evaluation, aiming to provide insights for the research in this field.

Clinical features and prognosis of cardiac metastatic tumors.

BACKGROUND: This study aimed to explore the clinical features and prognosis of cardiac metastatic tumors. In addition, whether continuing antitumor therapy after the development of cardiac metastases can benefit patients and the response of cardiac metastases were investigated. METHODS: A retrospective analysis was conducted on patients with malignancies who were admitted to Fujian Cancer Hospital and Fujian Provincial Hospital from January 2007 to September 2022, and the follow-up period ended in March 2023. Clinical data were gathered, treatment efficacy was evaluated, and survival analysis was performed. RESULTS: After the patients developed cardiac metastasis, the overall 30-day, 3-month, 6-month, and 12-month survival rates were 85.00%, 59.00%, 51.00% and 38.00%, respectively. With continued treatment, the average survival time was 27.33 months (95% confidence interval [CI]: 16.88-37.79), which exceeded the 6.6 months (95% confidence interval [CI]: 0.03-13.69) observed for patients who withdrew from treatment (P < 0.001). The responses of cardiac metastases corresponded to the responses of the primary tumors. Patients with a cardiac response had a median survival time of 55.60 months, which exceeded the 13.40 months observed for those without a cardiac response. However, there was no significant difference (P = 0.375). CONCLUSIONS: In conclusion, continuing antitumor therapy after the development of cardiac metastases can significantly prolong patient survival. Cardiac metastases and primary tumors respond consistently to antitumor treatment. The risk of death due to heart failure in cancer patients with cardiac metastases needs to be further investigated.

Detection of skin wrinkles and quantification of roughness using a novel image processing technique from a dermatoscope device.

OBJECTIVE: Cutaneous relief analysis is crucial in the development of new skincare products, as well as in the evaluation of dermatological treatments. The analysis can be performed by qualitative or quantitative methods. We propose a new algorithm to detect wrinkles and quantify skin roughness by image processing from a dermatoscope. METHODS: A clinical study was carried out with 33 research participants, and images were collected with the dermatoscope and PRIMOS equipment for wrinkle evaluation at two different times: Day 0 (D0) and 45 days (D45) after the use of a dermocosmetic product. Later, a new algorithm was developed to detect wrinkles in the acquired images by applying filters and image transformations that generate a segmented image highlighting the wrinkles. A roughness calculation method is proposed from the pixels belonging to wrinkles. RESULTS: Correlation between the values obtained by the PRIMOS equipment and the proposed system was verified. No correlation was found for data obtained at D0; however, there was correlation at time D45 by Spearman's similarity coefficient. By comparing roughness between times D0 and D45, the treatment was statistically significant for both PRIMOS and the proposed methodology data. CONCLUSION: The wrinkle detection algorithm, in addition to the roughness calculation, demonstrated a sensitivity comparable to the PRIMOS system in evaluating the effectiveness of the dermocosmetic treatment. SIGNIFICANCE: Considering the simplicity of the dermatoscope design compared to other established devices such as PRIMOS, the proposed system is promising as an alternative for dermatological evaluations.

The value of magnetic resonance blood oxygen level-dependent imaging in evaluating the efficacy of advanced cervical cancer combined with radiotherapy and chemotherapy.

BACKGROUND: Blood oxygen level-dependent magnetic resonance imaging (BOLD-MRI) is an imaging method used to analyze oxygenation status of the tumor. PURPOSE: To investigate the feasibility of BOLD-MRI in evaluating the efficacy of advanced cervical cancer combined with radiotherapy and chemotherapy. MATERIAL AND METHODS: This prospective study included 85 patients with advanced cervical cancer who received BOLD-MRI examination before and after concurrent chemoradiotherapy from October 2020 to December 2021. To investigate the changes of baseline R2* values and △R2* values of cervical cancers before and after treatment. RESULTS: 29 cases were complete response, 34 cases were partial response, and 22 cases showed progression. The baseline R2* values of the tumors were lower than that of the normal cervical muscle (P < 0.0001). After oxygen stimulation, the baseline R2* values of the tumors decreased (P = 0.012). After treatment, the baseline R2* values of the tumors increased (P = 0.007), and the dynamic △R2* values of the tumors decreased (P = 0.025). The baseline R2* value of the complete response was the highest (P = 0.000), the dynamic △R2* value of the complete response was the lowest (P = 0.017). CONCLUSION: BOLD-MRI can evaluate the efficacy of concurrent chemoradiotherapy for advanced cervical cancer.

Design and Performance Evaluation of a Novel Automatic Stapling Device for Knotless Barbed Suture in Laparoscopic Surgery.

NEED: This study developed a novel automatic stapling device for improving the speed and stability of suturing in laparoscopic surgery. TECHNICAL SOLUTION: The stapling device included 3 components: driver module, actuator module, and transmission module. PROOF OF CONCEPT: A negative water leakage test of the in vitro intestinal defect model preliminarily demonstrated the safety of the new automatic stapling device. The suturing time for skin and peritoneal defects through the automatic stapling device was significantly shorter than that through the ordinary needle-holder suture (P < .05). These 2 suture methods had good tissue alignment. The automatic suture showed less inflammatory cell infiltration and lower inflammatory response scores at the tissue incision on days 3 and 7 after surgery compared with the ordinary needle-holder suture, with statistically significant differences (P < .05). NEXT STEPS: In the future, the device needs to be further optimized and the experimental needs to be supplemented to provide some evidence for clinical use. CONCLUSION: This novel automatic stapling device for knotless barbed suture designed in this study has advantages of shorter suturing time and milder inflammatory responses than the ordinary needle-holder suture, safe and feasible in laparoscopic surgery.

[Improvement of high-quality evaluation criteria of Chinese patent medicines based on whole process control].

Chinese patent medicines(CPMs) are unique therapeutic drugs in China. Establishing and improving the evaluation criteria is an important measure to promote the high-quality development of CPMs. Based on the "evaluation criteria of high-grade CPMs with quality as the core index" established by our group in 2018, the "high-quality evaluation criteria for CPMs based on whole process control" was proposed in the present study in 2022. The scope of application and basic principles of the new criteria were clarified. A quality evaluation scoring table was established in the new criteria, including five parts: raw material selection, production process, quality control, efficacy evaluation, and brand building. The technical evaluation indexes involved have increased from 20% in the original criteria to 70% in the new criteria, and efficacy evaluation has been added in the new criteria. The subjective evaluation indicators account for a large proportion in the original criteria, which is prone to bias. The improved criteria overcome this shortcoming. It is expected that the new criteria as a basis can play a better role in the selection of high-quality products of CPMs, guide enterprises and institutions to participate actively in the evaluation and research of high-quality CPMs, and promote the high-quality development of CPMs.

Efficacy evaluation of albumin-bound paclitaxel combined with carboplatin as neoadjuvant chemotherapy for primary epithelial ovarian cancer.

OBJECTIVE: This study aimed to compare the efficacy of albumin-bound paclitaxel combined with carboplatin (Nab-TC) with that of traditional solvent-based paclitaxel combined with carboplatin (TC) as neoadjuvant chemotherapy (NAC) regimens for primary epithelial ovarian cancer. METHODS: Eighty patients with advanced primary epithelial ovarian cancer admitted for treatment at the Harbin Medical University Cancer Hospital from January 2015 to January 2020 were retrospectively selected. All patients underwent surgery after 1-4 courses of NAC with Nab-TC or TC regimen. Among the patients included for study, 40 patients in each group. RESULTS: The ORR in Nab-TC group was better compared to TC group (45% vs 40%), but the difference was not significant (P = 0.651). While the reduction rate of CA-125 value in the Nab-TC group was significantly better (P < 0.05). The postoperative complication rate such as postoperative blood transfusion (5% vs 35%) and postoperative infusion of human albumin (25% vs 55%) were significantly lower relative to the TC group. The median progression-free survival of the Nab-TC group was significantly longer relative to the TC group (20 months vs 13 months, P = 0.012), and the patient's quality of life was also better in the Nab-TC group (P < 0.05). Our study demonstrated that Nab-TC regimen and R0 represented the independent prognostic factors. CONCLUSION: The efficacy of the Nab-TC regimen as NAC for advanced primary epithelial ovarian cancer was non-inferior to that of the TC regimen along with a lower incidence of adverse reactions, a longer PFS and a higher quality of life, supporting its therapeutic value in the clinic.

Efficacy evaluation and treatment parameter optimization for laser surgery of Ota's nevus based on an advanced non-equilibrium bio-tissue heat transfer model.

This study was performed to better understand the laser-tissue interaction mechanism and optimize the laser wavelength and pulse duration for the laser treatment of Ota's nevus, thereby providing the precise theoretical guidance for clinician to improve the therapeutic effect. A non-equilibrium bio-tissue heat transfer model coupled with thermo-mechanical effect for the explosive vaporization of melanin granule induced by laser heating was developed to investigate the temperature and thermal damage distribution using alexandrite (755 nm) and Nd:YAG (1064 nm) lasers with the pulse width of 10-120 ns. Cryogen spray cooling (CSC) was introduced to prevent the epidermal thermal damage due to competitive laser absorption between epidermal and dermal melanin. Thermal injury of the epidermis with temperature in the melanin zone reaching 132.3 °C was induced by alexandrite laser. The optimal pulse durations were 50 and 30 ns, and the corresponding incident laser fluence thresholds were 6.45 and 19.5 J·cm-2 for alexandrite and Nd:YAG laser, respectively, with the pre-cooling of R32 spray. Using R32 spray cooling, the 1064-nm laser fluence threshold of melanin can be increased by 56.0%, resulting in an indirect increase (80.4%) of injury thickness. Nd:YAG laser (1064 nm) was highly suitable for the removal of melanin in the deep tissue owing to its deep penetration. Too short pulse duration should be avoided to prevent the epidermal thermal damage. The improvement of therapeutic effect by CSC demonstrates its high clinical application potential.

[Screening methods of traditional Chinese medicine for coronary heart disease and angina pectoris: an exploration based on core outcome set and fuzzy comprehensive evaluation].

It was pointed out in Opinions on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine issued by the State Council in 2019 that 100 varieties of traditional Chinese medicine(TCM) with unique curative effects should be screened out within about three years. Due to the multi-component and multi-target mechanisms of TCM varieties, it is difficult to directly and simply evaluate their multi-dimensional clinical value using methods applicable to chemical or biological agents. The heterogeneity of outcomes for similar TCM makes it difficult to determine the advantages of similar products. The fuzzy comprehensive evaluation method that is developed on the basis of core outcome set and fuzzy mathematics for clinical efficacy evaluation of TCM may solve these problems. This study developed a fuzzy comprehensive evaluation model for the clinical efficacy evaluation of Chinese patent me-dicines for coronary heart disease and angina pectoris, and selected the previous normative studies with complete or incomplete data for verifying the model application. The results showed that original studies with complete data failed to evaluate and compare the comprehensive efficacy of different interventions. The original research only mentioned the advantages and disadvantages of different interventions in different aspects. The comprehensive clinical efficacy of three different interventions obtained through fuzzy comprehensive evaluation was all graded as level Ⅱ. The original research with incomplete data drew the same conclusions as the fuzzy comprehensive evaluation, and the results of fuzzy comprehensive evaluation can provide more comprehensive information. Therefore, the fuzzy comprehensive evaluation shows the products with overall advantages of clinical efficacy, which may become a feasible method for the screening of TCM.

[Narrative evidence-based medicine:a strategy for evaluation of clinical efficacy of Chinese medicine].

Rich experience of clinical diagnosis and treatment has been accumulated in the developmental history of Chinese medicine, and the efficacy has been increasingly accepted by the public. However, the evaluation of clinical efficacy is currently based more on scientific evidence instead of merely the changes of patient symptoms. In Chinese medicine, the changes of major disease indicators, patient symptoms, and pathogenesis are the major criteria for the evaluation of clinical efficacy. The lack of well-accepted and uniform criteria and the uncertainty of subjective evaluation limit the development of clinical Chinese medicine. Evidence-based medicine combines clinical skills with the current best evidence. Narrative medicine, utilizing people's narratives in clinical practice, emphasizes patient feelings, willingness, and value orientation. The introduction of both evidence-based medicine and narrative medicine into the evaluation of clinical efficacy refers to the construction of the clinical efficacy evaluation system in a paradigm of participatory diagnosis and treatment. It can fully reflect the characteristics of Chinese medicine, respect the values of patients, and achieve universal clinical evidence. Therefore, it helps to improve the diagnosis and treatment, the relationship between doctors and patients, patients' life quality and decision-making awareness, and finally the new evaluation model of clinical efficacy of Chinese medicine.

Surgical efficacy analysis of tarsal tunnel syndrome: a retrospective study of 107 patients.

Tarsal tunnel syndrome (TTS) is an entrapment neuropathy of the posterior tibial nerve or its terminal branches compressed by its fibro-osseous tunnel beneath the flexor retinaculum on the medial side of the ankle. The current study was a retrospective study of 107 cases of patients with TTS, in which the onset characteristics were summarized, the factors that might affect the surgical treatment effects of TTS were discussed and analyzed. The syndrome diagnoses and treatment experiences of TTS were extracted and analyzed. In our cohort, TTS was more often found in middle-aged and older women. And the medial plantar nerve bundle was the most frequently affected nerve structure. The efficacy of surgical treatment were correlated to the causes of the disease, involved nerve bundles, methods of operation, and whether neurolysis of the epineurium was performed. Neurolysis of the epineurium is was recommended for patients with an enlarged tibial nerve due to impingement. The Singh method was recommended to release the tibial nerve and its branches. Patients with negative preoperative EMG results should carefully be cautious when considering their decision to undergo surgical treatment.

Homocystamide Conjugates of Human Serum Albumin as a Platform to Prepare Bimodal Multidrug Delivery Systems for Boron Neutron Capture Therapy.

Boron neutron capture therapy is a unique form of adjuvant cancer therapy for various malignancies including malignant gliomas. The conjugation of boron compounds and human serum albumin (HSA)-a carrier protein with a long plasma half-life-is expected to extend systemic circulation of the boron compounds and increase their accumulation in human glioma cells. We report on the synthesis of fluorophore-labeled homocystamide conjugates of human serum albumin and their use in thiol-'click' chemistry to prepare novel multimodal boronated albumin-based theranostic agents, which could be accumulated in tumor cells. The novelty of this work involves the development of the synthesis methodology of albumin conjugates for the imaging-guided boron neutron capture therapy combination. Herein, we suggest using thenoyltrifluoroacetone as a part of an anticancer theranostic construct: approximately 5.4 molecules of thenoyltrifluoroacetone were bound to each albumin. Along with its beneficial properties as a chemotherapeutic agent, thenoyltrifluoroacetone is a promising magnetic resonance imaging agent. The conjugation of bimodal HSA with undecahydro-closo-dodecaborate only slightly reduced human glioma cell line viability in the absence of irradiation (~30 µM of boronated albumin) but allowed for neutron capture and decreased tumor cell survival under epithermal neutron flux. The simultaneous presence of undecahydro-closo-dodecaborate and labeled amino acid residues (fluorophore dye and fluorine atoms) in the obtained HSA conjugate makes it a promising candidate for the combination imaging-guided boron neutron capture therapy.

Differences in efficacy evaluation endpoints in clinical trials for claiming reduction of post-prandial glycemic response between Japan and the European Union.

When evaluating the efficacy of foods with health claims (FHC), each country sets different standards for efficacy evaluation endpoints in clinical trials, which may result in a barrier, namely the case that the claim that is allowed in Japan cannot be used on the label in another region and vice versa. We aimed to investigate the efficacy evaluation endpoints used in clinical trials of FFCs containing ID and submitted in Japan, in reference to the EU requirements for substantiating the claim, namely "reduction of post-prandial glycemic responses". We detected only one difference in efficacy evaluation endpoints, which was insulin levels. We found 67 such clinical trials cited in systematic literature reviews on finished products or functional substance(s). Of these, 43 (64%) trials lacked insulin assessment. Particularly, for foods that were claimed to reduce post-prandial glycemic responses, the EU does not consider a claim to be substantiated unless insulin levels have been evaluated. Our findings suggest the need for standardization of requirements for FHC between Japan and the EU. This consideration will strengthen the evidence for clinical significance of ID and allow products labeled with this health claim to be more widely distributed.

Poly traditional Chinese medicine formulation prepared with skin moisturizing properties.

Many traditional Chinese medicine compositions can moisturize the skin and utilize in cosmetics. Using a combination of Chinese Medicine Materials and guided by Traditional Chinese Medicine principles, this study selected Echinacea purpurea to protect the skin barrier, Dendrobium nobile to clear heat and promote fluid production, Sophora flavescens to clear heat for diminished inflammation, and Aloe vera combined Lycium barbarum to nourish yin, to together form a "poly TCM moisturizing formulation." These poly plant extracts were investigated and optimized for the stability, safety, and moisturizing ability. The combination moisturizing effect was determined by measuring the expression of FLG mRNA, CLDN-1 mRNA, and AQP3 protein. Toxicological analysis included a red blood cell hemolysis test and a 3T3 phototoxicity test. It has been observed that by using polysaccharide yield as the evaluation criterion showed optimal extraction at a material-to-liquid ratio of 1:100, an extraction temperature of 100°C, and an extraction time of 3 hours. Moisturizing effect experiments showed that the expression of FLG mRNA, CLDN-1 mRNA, and AQP3 protein was significantly increased. Toxicological tests showed that the composition was safe and caused no irritating effects. Based on these results, this poly traditional Chinese medicine moisturizing formulation is safe within moisturizing effects and can be used as a moisturizing raw material in cosmetics.