1.Application of dynamic coronary roadmap in coronary artery low-dose mode
Xiaomin WU ; Zi YE ; Yaping WANG ; Yang LIU ; Yi'an YAO ; Fei CHEN ; Yiping WANG ; Yu TANG ; Yan LAI
Journal of Interventional Radiology 2024;33(3):236-239
Objective To clarify whether the use of dynamic coronary artery roadmap(DCR)technology in a low-dose mode with 7.5 frames per second during coronary intervention can further reduce the total radiation dose,fluoroscopy time,and contrast agent usage.Methods A total of 94 patients,who received coronary angiography at the Shanghai Tongji Hospital of China between July 2022 and December 2022,were enrolled in this study.The patients were randomly divided into DCR group(n=53)and control group(n=41).DCR technology was used in the DCR group to guide the performance of percutaneous coronary intervention(PCI),while low-dose mode coronary angiography was adopted in the control group.The total air kerma(AK),dose-area product(DAP),intraoperative fluoroscopy time,and contrast agent usage were compared between the two groups.Results In the DCR group AK was(597.9±222.8)mGy,which was significantly lower than(717.0±326.8)mGy in the control group(P=0.039);DAP was(33.2±13.3)Gycm2/s,which was also remarkably lower than(41.3±21.5)Gycm2/s in the control group(P=0.027).In the DCR group and the control group,the intraoperative fluoroscopy time was(9.8± 3.3)min and(12.1±4.3)min respectively(P<0.01),and the contrast agent usage was(122.3±19.0)mL and(130.5± 28.5)mL respectively(P=0.116).Conclusion In a low-dose mode during coronary intervention,the use of DCR technology can further reduce radiation dose,fluoroscopy time,and contrast agent usage.(J Intervent Radiol,2024,33:236-239)
2.Manufacturing classification system for oral solid dosage forms of traditional Chinese medicines (Ⅱ): classification of tablets disintegration behavior.
Xiao-Qing ZHAO ; Dong-Ling LIAO ; Fei-Yu QI ; Zi-Chen LIANG ; Xue-Fang TANG ; Sheng-Yun DAI ; Yan-Jiang QIAO ; Bing XU
China Journal of Chinese Materia Medica 2023;48(12):3180-3189
In this paper, 50 batches of representative traditional Chinese medicine tablets were selected and the disintegration time was examined with the method in Chinese Pharmacopoeia. The disintegration time and disintegration phenomenon were recorded, and the dissolution behaviors of water-soluble and ultraviolet-absorbent components during the disintegration process of tablets were characterized by self-control method. The results revealed that coating type and raw material type influenced the disintegration time of tablets. It was found that only 4% of traditional Chinese medicine tablets had obvious fragmentation during the disintegration process, while 96% of traditional Chinese medicine tablets showed gradual dissolution or dispersion. Furthermore, according to the disintegration speed, disintegration phenomenon, and whether the cumulative dissolution of measured components was > 90% at complete disintegration, a disintegration behavior classification system(DBCS) was created for the regular-release traditional Chinese medicine tablets. As a result, the disintegration behaviors of 50 batches of traditional Chinese medicine tablets were classified into four categories, i.e. ⅠA_2, ⅠB_1, ⅡB_1, and ⅡB_2. traditional Chinese medicine tablets(Class I) with disintegration time ≤ 30 min were defined to be rapid in disintegration, which can be the objective of optimization or improvement of Chinese herbal extract(semi extract) tablets. Different drug release models were used to fit the dissolution curve of traditional Chinese medicine tablets with gradual dissolution or dispersion phenomenon(i.e. Type B tablets). The results showed that the dissolution curves of water-soluble components in the disintegration process conformed to the zero order kinetics and the Ritger-Peppas model. It could be inferred that the disintegration mechanisms of type B tablets were a combination of dissolution controlled and swelling controlled mechanisms. This study contributes to understanding the disintegration behavior of traditional Chinese medicine tablets, and provides a reference for the design and improvement of disintegration performance of traditional Chinese medicine tablets.
Commerce
;
Medicine, Chinese Traditional
;
Tablets
;
Water
;
Drug Compounding
3.Patent application of intelligent quality control technology in traditional Chinese medicine production process: a review.
Xue-Fang TANG ; Fei-Yu QI ; Tuan-Jie WANG ; Zi-Chen LIANG ; Yan-Jiang QIAO ; Wei XIAO ; Bing XU
China Journal of Chinese Materia Medica 2023;48(12):3190-3198
In the new stage for intelligent manufacturing of traditional Chinese medicine(TCM) from pilot demonstration to in-depth application and comprehensive promotion, how to raise the degree of intelligence for the process quality control system has become the bottleneck of the development of TCM production process control technology. This article has sorted out 226 TCM intelligent manufacturing projects that have been approved by the national and provincial governments since the implementation of the "Made in China 2025" plan and 145 related pharmaceutical enterprises. Then, the patents applied by these pharmaceutical enterprises were thoroughly retrieved, and 135 patents in terms of intelligent quality control technology in the production process were found. The technical details about intelligent quality control at both the unit levels such as cultivation, processing of crude herbs, preparation pretreatment, pharmaceutical preparations, and the production workshop level were reviewed from three aspects, i.e., intelligent quality sensing, intelligent process cognition, and intelligent process control. The results showed that intelligent quality control technologies have been preliminarily applied to the whole process of TCM production. The intelligence control of the extraction and concentration processes and the intelligent sensing of critical quality attributes are currently the focus of pharmaceutical enterprises. However, there is a lack of process cognitive patent technology for the TCM manufacturing process, which fails to meet the requirements of closed-loop integration of intelligent sensing and intelligent control technologies. It is suggested that in the future, with the help of artificial intelligence and machine learning methods, the process cognitive bottleneck of TCM production can be overcome, and the holistic quality formation mechanisms of TCM products can be elucidated. Moreover, key technologies for system integration and intelligent equipment are expected to be innovated and accelerated to enhance the quality uniformity and manufacturing reliability of TCM.
Artificial Intelligence
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Medicine, Chinese Traditional
;
Reproducibility of Results
;
Quality Control
;
Intelligence
;
Pharmaceutical Preparations
4.Genetic Mutation Characteristics of Glucose-6-Phosphate Dehydrogenase Deficiency Patients in Wuhan.
Hui LI ; Yu-Fei JIANG ; Tang-Xin-Zi GAO ; Me-Qi YI ; Xiao-Yan WANG ; Run-Hong XU ; Jie-Ping SONG ; Li-Jun LIU
Journal of Experimental Hematology 2022;30(1):244-249
OBJECTIVE:
To explore the genotype mutation characteristics of patients with glucose-6-phosphate dehydrogenase(G6PD) deficiency in Wuhan.
METHODS:
A total of 1 321 neonates with positive screening and outpatients were received G6PD mutation detection, 12 kinds of common G6PD mutation in Chinese people was detected by using multicolor melting curve analysis (MMCA) method, for those with negative results, the enzyme activity and clinical information were analyzed, sequencing was recommended after informed consent when it is necessary.
RESULTS:
Among 1321 patients, a total of 768 mutations were detected out, with a detection rate of 58.1%. A total of 18 types of G6PD genotypes were identified, including c.1388G>A, c.1376G>T, c.95G>A, c.1024C>T, c.871G>A, c.392G>T, c.487G>A, c.1360C>T, c.1004C>A, c.517T>C, c.592C>T, c.94C>G, c.152C>T, c.320A>G, c.1028A>G, c.1316G>A, c.1327G>C and c.1376G>C, including 683 male hemizygotes, 3 female homozygotes, 80 female heterozygotes and 2 female compound heterozygous.
CONCLUSION
A total of 18 types of G6PD mutations are identified in the reaserch, and c.94C>G, c.1028A>G and c.1327G>C are first reported in Chinese population. The most common G6PD mutation types in Wuhan are c.1388G>A, c.1376G>T, c.95G>A.
Asians/genetics*
;
Female
;
Genotype
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Glucosephosphate Dehydrogenase/genetics*
;
Glucosephosphate Dehydrogenase Deficiency/genetics*
;
Heterozygote
;
Humans
;
Infant, Newborn
;
Male
;
Mutation
5.Application of limiting antigen avidity enzyme immunoassay for estimating HIV-1 incidence in men who have sex with men.
Xi Jia TANG ; Lei Jing DUAN ; Wen Li LIANG ; Si CHENG ; Ting Li DONG ; Zhen XIE ; Kang Mai LIU ; Fei YU ; Zi Huang CHEN ; Guo Dong MI ; Liang LIANG ; Hong Jing YAN ; Lin CHEN ; Li LIN ; Dian Min KANG ; Xiao Bing FU ; Mao Feng QIU ; Zhen JIANG ; Jie XU ; Zun You WU
Chinese Journal of Epidemiology 2022;43(1):72-77
Objective: To estimate the incidence of HIV-1 infection in men who have sex with men (MSM) in key areas of China through HIV-1 limiting antigen avidity enzyme immunoassay (LAg-Avidity EIA), analyze the deviation from the actual results and identify influencing factors, and provided reference for improving the accuracy of estimation results. Methods: Based on the principle of the cohort randomized study design, 20 cities were selected in China based on population size and the number of HIV-positive MSM. The sample size was estimated to be 700 according to the HIV-1 infection rate in MSM. MSM mobile phone app. was used to establish a detection appointment and questionnaire system, and the baseline cross-sectional survey was conducted from April to November 2019. LAg-Avidity EIA was used to identify the recent infected samples. The incidence of HIV-1 infection was calculated and then adjusted based on the estimation formula designed by WHO. The influencing factors were identified by analyzing the sample collection and detection processes. Results: Among the 10 650 blood samples from the participants, 799 were HIV-positive in initial screening, in which 198 samples (24.78%) missed during confirmation test. Only 621 samples were received by the laboratory. After excluding misreported samples, 520 samples were qualified for testing. A total of 155 samples were eventually determined as recent infection through LAg-Avidity EIA; Based on the estimation formula , the incidence of HIV-1 infection in MSM in 20 cities was 4.06% (95%CI:3.27%-4.85%), it increased to 5.53% (95%CI: 4.45%-6.60%)after the adjusting for sample missing rate. When the sample missing rate and misreporting rate were both adjusted, the incidence of HIV-1 infection in the MSM increased to 5.66% (95%CI:4.67%-6.65%). The actual incidence of HIV-1 infection in MSM in the 20 cities might be between 4.06% and 5.66%. Conclusions: Sample missing and misreporting might cause the deviation of the estimation of HIV-1 infection incidence. It is important to ensure the sample source and the quality of sample collection and detection to reduce the deviation in the estimation of HIV-1 infection incidence.
Cross-Sectional Studies
;
HIV Infections/epidemiology*
;
HIV-1
;
Homosexuality, Male
;
Humans
;
Immunoenzyme Techniques
;
Incidence
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Male
;
Sexual and Gender Minorities
6.Mechanism of Aconiti Kusnezoffii Radix Processed with Chebulae Fructus Against H9c2 Cardiomyocyte Toxicity Based on TRPV1 Channel
Shu HAN ; Li-yuan BAO ; Kai-yang LIU ; Xi-tao HAN ; Ya-nan TANG ; Zi-qin LIU ; Hong-yue WANG ; Ang-ran FAN ; Fei LI ; Hong DU
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(1):173-181
ObjectiveTo explore the role of transient receptor potential vanilloid 1 (TRPV1) channel in reducing cardiomyocyte toxicity of Aconiti Kusnezoffii Radix processed with Chebulae Fructus. MethodH9c2 cardiomyocytes cultured in vitro were used as a model to assess cell viability by methyl thiazolyl tetrazolium (MTT) assay, the expression of TRPV1 mRNA was detected by real-time fluorescence quantitative polymerase chain reaction (Real-time PCR), and the leakage rate of lactate dehydrogenase (LDH), the changes of nucleus, reactive oxygen species (ROS), mitochondrial membrane potential and Ca2+ contents were detected by enzyme linked immunosorbent assay (ELISA). ResultCompared with the blank group, when the concentration was ≥0.5 g·L-1, the cell viability was significantly decreased (P<0.01), the leakage rate of LDH, the release of ROS and Ca2+ were increased, the mitochondrial membrane potential was decreased, and the nucleus was pyknosis or even broken in raw Aconiti Kusnezoffii Radix and Aconiti Kusnezoffii Radix processed with Chebulae Fructus groups. When the concentration was ≥0.5 g·L-1, compared with the same mass concentration of raw Aconiti Kusnezoffii Radix group, the cell viability increased significantly (P<0.01), the leakage rate of LDH, the release of ROS and Ca2+ decreased, the mitochondrial membrane potential increased, and the nuclear morphology improved in Aconiti Kusnezoffii Radix processed with Chebulae Fructus group. Application of the same mass concentration of raw Aconiti Kusnezoffii Radix to H9c2 cardiomyocytes pretreated with the TRPV1 inhibitor BCTC significantly increased cell viability, decreased leakage rate of LDH, ROS and Ca2+ release, increased mitochondrial membrane potential and improved nuclear pyknosis compared with untreated H9c2 cardiomyocytes. Application of the same mass concentration of Aconiti Kusnezoffii Radix processed with Chebulae Fructus to H9c2 cardiomyocytes pretreated with BCTC decreased cell viability, increased LDH leakage rate, ROS and Ca2+ release, reduced mitochondrial membrane potential compared with untreated H9c2 cardiomyocytes. Real-time PCR results showed that both raw Aconiti Kusnezoffii Radix and Chebulae Fructus decoction could increase the expression of TRPV1 mRNA in cardiomyocytes in a concentration dependent manner. ConclusionRaw Aconiti Kusnezoffii Radix can induce cardiomyocyte apoptosis and cardiotoxicity by activating TRPV1 channel, while Aconiti Kusnezoffii Radix processed with Chebulae Fructus can attenuate the toxicity through TRPV1 channel, which may be related to the synergistic effect of acid components in Chebulae Fructus and alkaloids in Aconiti Kusnezoffii Radix on TRPV1 channel.
7.Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial.
Tong ZHANG ; Yu-Tong FEI ; Yun XU ; Ling-Yun SUN ; Bin HE ; Shao-Hua YAN ; Mo TANG ; Yun-Zi YAN ; Jun MAO ; Yu-Fei YANG
Chinese journal of integrative medicine 2021;27(12):891-895
BACKGROUND:
The side effects of chemotherapy-induced nausea and vomiting (CINV) and myelosuppression reduce the cancer patients' adherence to chemotherapy. Many Chinese patients choose Chinese medicine (CM) during chemotherapy to reduce side effects; however, the evidence is lacking. The efficacy of a CM herbal treatment protocol, Jianpi Bushen Sequential Formula (, JBSF) will be evaluated on chemotherapy completion rate among patients with colon cancer.
METHODS:
A multi-center double-blind randomized controlled trial (RCT) will be conducted on 400 patients with colon cancer who will receive 8 cycles of adjuvant chemotherapy with oxaliplatin and capecitabine (CAPEOX). Patients will be randomized 1:1 to receive the JBSF or placebo formula. The primary outcome is the overall chemotherapy completion rate. The secondary outcomes include individual chemotherapy completion rate, 4-cycle completion rate of chemotherapy, time to treatment failure, relative dose intensity and treatment toxicity. Follow-up visits will be scheduled before every and after last chemotherapy.
DISCUSSION
This study will provide evidence on whether JBSF can improve the chemotherapy completion rate and reduce side effects among patients with colon cancer. (Trial registration: ClinicalTrials.gov, No. NCT03716518).
Chemotherapy, Adjuvant
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Colonic Neoplasms/drug therapy*
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Double-Blind Method
;
Humans
;
Multicenter Studies as Topic
;
Nausea
;
Quality of Life
;
Randomized Controlled Trials as Topic
;
Treatment Outcome
;
Vomiting
8.Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial.
Jia-Bo WANG ; Zhong-Xia WANG ; Jing JING ; Peng ZHAO ; Jing-Hui DONG ; Yong-Feng ZHOU ; Guang YANG ; Ming NIU ; Xu ZHAO ; Tian-Jun JIANG ; Jing-Feng BI ; Zhe XU ; Ping ZHANG ; Dan WU ; Zhao-Fang BAI ; Yu-Ming GUO ; Si-Miao YU ; Yong-Qiang SUN ; Zi-Teng ZHANG ; Xiao-Yan ZHAN ; Peng-Yan LI ; Jin-Biao DING ; Peng-Fei ZHAO ; Xue-Ai SONG ; Jian-Yuan TANG ; Dong-Chu HE ; Zhu CHEN ; En-Qiang QIN ; Rui-Lin WANG ; Xiao-He XIAO
Chinese journal of integrative medicine 2020;26(9):648-655
OBJECTIVES:
To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.
METHODS:
A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.
RESULTS:
An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
CONCLUSIONS
Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).
Administration, Inhalation
;
Adult
;
China
;
Coronavirus Infections
;
diagnosis
;
drug therapy
;
mortality
;
Dose-Response Relationship, Drug
;
Drug Administration Schedule
;
Drugs, Chinese Herbal
;
administration & dosage
;
Female
;
Follow-Up Studies
;
Humans
;
Integrative Medicine
;
Interferon-alpha
;
administration & dosage
;
Lopinavir
;
administration & dosage
;
Male
;
Middle Aged
;
Pandemics
;
Pneumonia, Viral
;
diagnosis
;
drug therapy
;
mortality
;
Risk Assessment
;
Severe Acute Respiratory Syndrome
;
diagnosis
;
drug therapy
;
mortality
;
Severity of Illness Index
;
Survival Rate
10.Chemical variation in Aconti Kusnezoffii Radix before and after processing based on UPLC-Orbitrap-MS.
Mei-Ru ZHI ; Xin-Ru GU ; Shu HAN ; Kai-Yang LIU ; Zi-Qin LIU ; Ya-Nan TANG ; Xi-Tao HAN ; Fei LI ; Zhi-Gang YANG ; Peng TAN ; Hai-Yu ZHAO ; Hong DU
China Journal of Chinese Materia Medica 2020;45(5):1082-1089
Some Chinese herbal medicine needs to be processed before it can be used as medicine, especially toxic Chinese medicine. Highly toxic Aconti Kusnezoffii Radix(Caowu in Chinese) is widely used in traditional Chinese medicine and Mongolian medicine. In traditional Chinese medicine, Caowu is usually processed by boiling with water(CW) until no white part inside and being tasted without tongue-numbing. In Mongolian medicine, it is usually soaked in Chebulae Fructus(Hezi in Chinese) decoction for several days(CH). Both methods could reduce toxicity according to reports. The biggest difference between CW and CH is that CW needs to be heated for 4-6 h, while CH needs Hezi as processing adjuvants. To explore the toxicity reduction mechanism of CW and CH, we studied the contents of various compounds in Caowu processed by two methods by UPLC-Orbitrap-MS. The results indicated that CW had 14 new ingredients, such as 14-O-anisoylneoline and dehydro-mesaconitine, while N-demethyl-mesaconitine and aconitine disappeared. At the same time, it could significantly decrease the content of diester diterpenoid alkaloids and increase the contents of monoester diterpenoid alkaloids and amine-diterpenoid alkaloids. CH had 9 new ingredients from Hezi, like gallic acid, chebulic acid and shikimic acid. Neither the kinds nor the contents of compositions from Caowu in CH changed little. This suggested that the processing mechanism of CW reduced highly toxic components(diester diterpenoid alkaloids) and increased the content of lowly toxic components(monoester diterpenoid alkaloids and amine-diterpenoid alkaloids). Attenuated principle of CH may be related to the components of Hezi. In this experiment, the conclusion shows that the chemical constituents of CW and CH are essentially different, and the two methods have different toxicity reduction principles.
Aconitine
;
Aconitum/chemistry*
;
Alkaloids/analysis*
;
Chemistry, Pharmaceutical/methods*
;
Chromatography, High Pressure Liquid
;
Drugs, Chinese Herbal/analysis*
;
Mass Spectrometry
;
Medicine, Chinese Traditional

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