3.Mechanism of Danggui Sini Decoction in improving kidney injury caused by blood stasis syndrome based on metabolomics and network pharmacology.
Lin-Lin FENG ; Si-Qi TANG ; Yun-Yuan NONG ; Ying HE ; Qian-Yi WANG ; Jing-Hua QIN ; Yue GUO ; Zhi-Heng SU
China Journal of Chinese Materia Medica 2023;48(24):6730-6739
This article analyzed the mechanism of Danggui Sini Decoction(DSD) in improving kidney injury caused by blood stasis syndrome(BSS) in rats. Firstly, 32 female SD rats were randomly divided into the following four groups: a normal group and a BSS group, both receiving an equal amount of distilled water by gavage; a normal+DSD group and a BSS+DSD group, both receiving 5.103 g·kg~(-1) DSD orally for a total of 14 days. Daily cold water bath was given to establish the BSS model, and on the 14th day, BSS rats were subcutaneously injected with 0.8 mg·kg~(-1) adrenaline. Normal rats were subjected to the water bath at 37 ℃ and injected with an equal volume of distilled water. After the experiment, 24-hour urine, serum, and kidney samples were collected for metabolomic analysis, biochemical measurements, and hematoxylin-eosin(HE) staining. The study then employed ~1H-NMR metabolomic technology to reveal the metabolic network regulated by DSD in improving BSS-induced kidney injury and used network pharmacology to preliminarily elucidate the key targets of the effectiveness of DSD. Pathological and biochemical analysis showed that DSD intervention significantly reduced inflammation and abnormal levels of blood creatinine, blood urea nitrogen, and urine protein in the kidneys. Metabolomic analysis indicated that DSD attenuated BSS-induced kidney injury primarily by regulating 10 differential metabolites and three major metabolic pathways(taurine and hypotaurine metabolism, citrate cycle, and acetaldehyde and dicarboxylic acid metabolism). Network pharmacology analysis suggested that the protective effect of DSD against BSS-induced kidney injury might be related to two key genes, ATP citrate lyase(ACLY) and nitric oxide synthase 2(NOS2), and two main metabolic pathways, i.e., arginine biosynthesis, and arginine and proline metabolism. This study, from the perspective of network regulation, provides initial insights and evidence into the mechanism of DSD in improving kidney injury induced by BSS, offering a basis for further investigation into the molecular mechanisms underlying its efficacy.
Rats
;
Female
;
Animals
;
Rats, Sprague-Dawley
;
Network Pharmacology
;
Drugs, Chinese Herbal/chemistry*
;
Metabolomics
;
Kidney
;
Arginine
;
Water
4.A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors.
Rong Rui LIU ; Shan Zhi GU ; Tie ZHOU ; Li Zhu LIN ; Wei Chang CHEN ; Dian Sheng ZHONG ; Tian Shu LIU ; Nong YANG ; Lin SHEN ; Si Ying XU ; Ni LU ; Yun ZHANG ; Zhao Long GONG ; Jian Ming XU
Chinese Journal of Oncology 2023;45(10):898-903
Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.
Humans
;
East Asian People
;
Neoplasms/pathology*
;
Antibodies, Monoclonal, Humanized/therapeutic use*
5.A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors.
Rong Rui LIU ; Shan Zhi GU ; Tie ZHOU ; Li Zhu LIN ; Wei Chang CHEN ; Dian Sheng ZHONG ; Tian Shu LIU ; Nong YANG ; Lin SHEN ; Si Ying XU ; Ni LU ; Yun ZHANG ; Zhao Long GONG ; Jian Ming XU
Chinese Journal of Oncology 2023;45(10):898-903
Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.
Humans
;
East Asian People
;
Neoplasms/pathology*
;
Antibodies, Monoclonal, Humanized/therapeutic use*
6.Progress of schistosomiasis control in People’s Republic of China in 2021
Li-juan ZHANG ; Zhi-min XU ; Fan YANG ; Jun-yi HE ; Hui DANG ; Yin-long LI ; Chun-li CAO ; Jing XU ; Shi-zhu LI ; Xiao-nong ZHOU
Chinese Journal of Schistosomiasis Control 2022;34(4):329-336
This report presented the endemic status of schistosomiasis and analyzed the data collected from the national schistosomiasis prevention and control system and national schistosomiasis surveillance sites in the People’s Republic of China at a national level in 2021. Among the 12 provinces (municipality and autonomous region) endemic for schistosomiasis in China, Shanghai Municipality, Zhejiang Province, Fujian Province, Guangdong Province and Guangxi Zhuang Autonomous Region continued to consolidate the achievements of schistosomiasis elimination, and Sichuan and Jiangsu provinces maintained the criteria of transmission interruption, while Yunnan, Hubei, Anhui, Jiangxi and Hunan provinces maintained the criteria of transmission control by the end of 2021. A total of 451 counties (cites, districts) were found to be endemic for schistosomiasis in China in 2021, with 27 571 endemic villages covering 73 250 600 people at risk of infections. Among the 451 endemic counties (cities, districts), 75.17% (339/451), 22.17% (100/451) and 2.66% (12/451) achieved the criteria of elimination, transmission interruption and transmission control of schistosomiasis, respectively. By the end of 2021, 29 037 cases with advanced schistosomiasis were documented in China. In 2021, 4 405 056 individuals received serological tests and 72 937 were sero-positive. A total of 220 629 individuals received stool examinations and 3 were positive. In 2021, snail survey was performed in 19 291 endemic villages in China and Oncomelania snails were found in 7 026 villages, accounting for 36.42% of all surveyed villages, with 12 villages identified with emerging snail habitats. Snail survey was performed at an area of 686 574.46 hm2 and 191 159.91 hm2 snail habitats were found, including 1 063.08 hm2 emerging snail habitats and 5 113.87 hm2 reemerging snail habitats. In 2021, 525 878 bovines were raised in the schistosomiasis endemic areas of China, and 115 437 received serological examinations, with 231 positives detected. Among the 128 719 bovines received stool examinations, no positives were identified. In 2021, there were 19 927 schistosomiasis patients receiving praziquantel chemotherapy, and 729 113 person-time individuals and 256 913 herd-time bovines were given expanded chemotherapy. In 2021, snail control with chemicals was performed in 117 372.74 hm2 snail habitats, and the actual area of chemical treatment was 65 640.50 hm2, while environmental improvements were performed in snail habitats covering an area of 1 244.25 hm2. Data from the national schistosomiasis surveillance sites of China showed that the mean prevalence of Schistosoma japonicum infections were both zero in humans and bovines in 2021, and no S. japonicum infection was detected in snails. The results demonstrate that the overall endemic status of schistosomiasis remained at a low level in China in 2021; however, the progress towards schistosomiasis elimination was slowed and the areas of snail habitats rebounded mildly. Strengthening researches on snail diffusion and control, and improving schistosomiasis surveillance and forecast are recommended to prevent reemerging schistosomiasis.
8.Preliminary study on the existing problems in health economic evaluation study of acupuncture in China.
Hui WANG ; Si-Qi LI ; Zhi-Miao MURONG ; Xiao-Nong FAN
Chinese Acupuncture & Moxibustion 2022;42(6):691-695
The literature of health economic evaluation study in the field of acupuncture in China was systematically summarized and analyzed, and the existing problems in the current research were discussed from the aspects of research perspective, cost calculation scope, data analysis method selection. Moreover, the key points of the health economic evaluation research were summarized, and the research objectives, the relationship between the expected research results and data analysis methods and the process of thinking were sorted out, and several suggestions for research report writing were proposed, aiming to provide a reference for the quality improvement of the acupuncture health economic evaluation research in China.
Acupuncture
;
Acupuncture Therapy
;
China
;
Cost-Benefit Analysis
;
Publications
9.Quality control in the implementation of multi-center acupuncture clinical trial.
Si-Qi LI ; Zhi-Miao MURONG ; Hui WANG ; Xiao-Nong FAN
Chinese Acupuncture & Moxibustion 2022;42(3):321-324
The paper introduced the experiences of quality management in the implementation of multi-center acupuncture clinical trials and the keys in training acupuncture operators. The process management was explained in view of the division of labor for researchers, protocol learning and the communication among sub-centers. Besides, specificity links of acupuncture research were summarized, i.e. meaning implementation brief of acupuncture operation training, control for quantity of stimulus in acupuncture and doctor-patient communication. It is anticipated to provide a valuable reference for the quality control and improvement of multi-center acupuncture clinical trial in future.
Acupuncture Therapy
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Clinical Trials as Topic
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Humans
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Multicenter Studies as Topic
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Quality Control
10.Treatment progress of non-small cell lung cancer with RET gene fusion
Xiaoxue LI ; Kejian SHI ; Shuyang YAO ; Jingying NONG ; Xiuyi ZHI
Cancer Research and Clinic 2022;34(7):547-550
Non-small cell lung cancer (NSCLC) is a malignant tumor with rapid progress and high malignancy, accounting for 85% of all lung cancers. Treatment has shifted from traditional surgery, radiotherapy and chemotherapy to targeted therapy. Targeted therapy can prolong the survival of patients with positive driver gene fusion. With the continuous progress of biological research, targets related to NSCLC have gradually been discovered. Among the many driving genes of NSCLC, RET fusion is an important emerging target discovered in recent years. It has been confirmed to have a high incidence in non-smoking, young and low-differentiated NSCLC patients. This article reviews RET gene fusion in NSCLC, the relationship between the two and the treatment progress.

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