1.Reflections on supervision strategies of new Tibetan drug registration.
Dan LIANG ; Tsring PEMBA ; Jiang-Yong YU ; Jian-Yuan TANG ; Yue-Hua ZHOU ; Hua HUA ; Wei-Wu CHEN ; Yan-Ling AI ; Gang ZHOU ; Lei ZHANG ; Ting WANG ; Yong-Wen ZHANG ; Chong ZOU ; Wei-Xiong LIANG ; Jie-Lai XIA ; Nai-Qing ZHAO ; Xiao-Bo SUN ; Wei WEI ; Bao-He WANG ; Hong DING ; Guo-Chen WANG ; Tsring PUQIONG ; Phuntsok KELSNG ; Guo-Qiang WANG
China Journal of Chinese Materia Medica 2022;47(19):5383-5388
Tibetan medicine is an essential part of Chinese medicine and has unique theoretical experience and therapeutic advantages. According to the development principle of inheriting the essence, sticking to the truth, and keeping innovative, the supervision department should give clear and reasonable guidance considering the characteristics of Tibetan medicine, establish a standard system for quality control, clinical verification and evaluation, and accelerate the research and commercialization of new drugs. In view of the needs of drug supply-side reform and the current situation of Tibetan medicine and new pharmaceutical research, we ponder and provide suggestions on the confusion faced by the current supervision of Tibetan drug registration, hoping to contribute to the supervision strategy of Tibetan drug registration and the high-quality development of Tibetan medicine industry.
Tibet
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Medicine, Tibetan Traditional
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Quality Control
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Pharmaceutical Research
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Drug Industry
2.Birth weights of singleton neonates of 14 Chinese ethnic groups in 11 cities of China.
Xiao-Yun HUANG ; Yuan-Fang ZHU ; Hui-Long LIU ; Mian-Ai FU ; Chuan-Yong LIU ; Ding-Yuan ZENG ; Jun HE ; Qing-Xi SHI ; Chang-Shui CHEN ; Bin ZHU ; Gao-Xiong WANG ; Hao SHI ; Hao-Hua LU
Chinese Journal of Contemporary Pediatrics 2022;24(11):1219-1225
OBJECTIVES:
To develop the birth weight curves of the Chinese Han (26-41 weeks of gestation) and Zhuang (28-41 weeks of gestation) singleton neonates in 11 cities of China, as well as the birth weight means of full-term neonates of 14 Chinese ethnic groups.
METHODS:
The live singleton neonates who were born in 11 maternal and child health care hospitals from 11 cities of China between January 2017 and December 2020 were classified according to the mother's ethnic group. Birth weight means were calculated for the full-term neonates of each ethnic group. For the Han and Zhuang singleton neonates with a large sample size, the Lambda-Mu-Sigma (LMS) method was used to establish the birth weight percentile curves of the Han and Zhuang singleton neonates with different gestational ages.
RESULTS:
A total of 105 365 live singleton neonates were included, among whom the Han neonates had the highest number of 84 851 (26-41 weeks of gestation), followed by the Zhuang neonates (12 803 neonates with a gestational age of 28-41 weeks). The neonates of the other Chinese ethnic groups enrolled were live full-term singleton neonates, with a sample size of more than 100 neonates for each ethnic group. The 3rd-97th percentile curves of birth weight were established for the Han singleton neonates with a gestational age of 26-41 weeks and the Zhuang singleton neonates with a gestational age of 28-41 weeks. The birth weight curves of the Han singleton neonates at each gestational age were higher than those of the Zhuang singleton neonates. Birth weight means (3 199-3 499 g) and standard deviations were determined for 14 Chinese ethnic groups, i.e., Li, Mulao, Zhuang, Yao, Dong, Miao, Han, Buyi, Mongolian, Tujia, Yi, Hui, Man, and Korean ethnic groups. The Li ethnic group had the lowest birth weight, followed by the Mulao, Zhuang, Yao, Dong, Miao, Han, Buyi, Mongolian, Tujia, Yi, Hui, Man, and Korean ethnic groups.
CONCLUSIONS
The 3rd-97th percentile curves of birth weight are developed for the Han (26-41 weeks of gestation) and Zhuang (28-41 weeks of gestation) singleton neonates in 11 cities of China, and birth weight means are determined for the full-term neonates of 14 Chinese ethnic groups in 11 cities of China, which provides a reference for evaluating the intrauterine growth of neonates in these ethnic groups.
Infant, Newborn
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Male
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Child
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Humans
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Infant
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Birth Weight
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Ethnicity
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Cities
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Gestational Age
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China
3.Protocol on transcranial alternating current stimulation for the treatment of major depressive disorder: a randomized controlled trial
Wang HONG-XING ; Wang KUN ; Zhang WEN-RUI ; Zhao WEN-FENG ; Yang XIAO-TONG ; Wang LI ; Penn MAN ; Sun ZHI-CHAO ; Xue QING ; Jia YU ; Li NING ; Dong KAI ; Zhang QIAN ; Zhan SHU-QIN ; Min BAO-QUAN ; Fan CHUN-QIU ; Zhou AI-HONG ; Song HAI-QING ; Yin LU ; Si TIAN-MEI ; Huang JING ; Lu JIE ; Leng HAI-XIA ; Ding WEI-JUN ; Liu YUAN ; Yan TIAN-YI ; Wang YU-PING
Chinese Medical Journal 2020;133(1):61-67
Background:Transcranial alternating current stimulation (tACS) offers a new approach for adult patients with major depressive disorder (MDD).The study is to evaluate the efficacy and safety of tACS treating MDD.Methods:This is an 8-week,double-blind,randomized,placebo-controlled study.Ninety-two drug-naive patients with MDD aged 18 to 65 years will receive 20 daily 40-min,77.5-Hz,15-mA sessions of active or sham tACS targeting the forehead and both mastoid areas on weekdays for 4 consecutive weeks (week 4),following a 4-week observation period (week 8).The primary outcome is the remission rate defined as the 17-item Hamilton depression rating scale (HDRS-17) score ≤7 at week 8.Secondary outcomes are the rates of response at weeks 4 and 8 and rate of remission at week 4 based on HDRS-17,the proportion of participants having improvement in the clinical global impression-improvement,the change in HDRS-17 score (range,0-52,with higher scores indicating more depression) over the study,and variations of brain imaging and neurocognition from baseline to week 4.Safety will be assessed by vital signs at weeks 4 and 8,and adverse events will be collected during the entire study.Discussion:The tACS applied in this trial may have treatment effects on MDD with minimal side effects.
4. Suanzaoren Tang Exerts Neuroprotective Effect by Inhibiting Hippocampal Neuroinflammation in APP/PS1 Double Transgenic Mice
Qing-hua LONG ; Li DING ; Bin-bin ZHAO ; Bo XU ; Ai-hua TAN ; Ping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2019;25(20):1-6
Objective:To observe the effect of Suanzaoren Tang on hippocampal neuroinflammation in APP/PS1 mice and to explore its possible mechanism of neuroprotection. Method:The mice were randomly divided into blank group, model group, donepezil group(0.92 mg·kg-1), Suanzaoren Tang low and high-dose groups(12.96,25.92 g·kg-1). After 30 days of continuous administration in each group, pathological changes of dentate gyrus (DG) in hippocampus of mice in each group were observed by Nissl staining.The levels of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β) in serum of each group were detected by enzyme-linked immunosorbent assay (ELISA). Real-time quantitative polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression levels of TNF-α and IL-1β in hippocampus of each group. The expression levels of glial fibrillary acidic protein (GFAP) and ionic calcium binding protein 1 (IBA1) in hippocampus of each group were detected by immunohistochemical staining (ICH) and Western blot. Result:Compared with blank group, the granule cells in DG region were unevenly arranged in model group, with obvious cell loss, and the nissl bodies in some neurons disappeared or condensed, serum TNF-α and IL-1β content significantly increased (P<0.01), mice hippocampus of TNF-α and IL-1β mRNA expression quantity significantly increased (P<0.01), levels of GFAP and IBA1 in the hippocampal DG region were significantly up-regulated (P<0.01). Compared with model group,the granule cells in the hippocampal DG region were slightly aligned in donepezil group, Suanzaoren Tang low and high-dose groups, neuron loss of ease, and intracellular austenite disappear or pyknotic conditions improve,the expressions levels of TNF-α and IL-1β in the serum were decreased(P<0.05,P<0.01),the expression levels of TNF-α and IL-1β mRNA in the hippocampus were decreased(P<0.05,P<0.01), protein expression levels of GFAP and IBA1 in the hippocampal DG region were decreased(P<0.05,P<0.01). Conclusion:Suanzaoren Tang can improve neuronal loss in APP/PS1 double transgenic mice, and its mechanism may be related to the regulation of hippocampal neuroinflammation in mice.
5.Technical specification for clinical application of critical ultrasonography
Wanhong YIN ; Xiaoting WANG ; Dawei LIU ; Yangong CHAO ; Xiangdong GUAN ; Yan KANG ; Jing YAN ; Xiaochun MA ; Yaoqing TANG ; Zhenjie HU ; Kaijiang YU ; Dechang CHEN ; Yuhang AI ; Lina ZHANG ; Hongmin ZHANG ; Jun WU ; Lixia LIU ; Ran ZHU ; Wei HE ; Qing ZHANG ; Xin DING ; Li LI ; Yi LI ; Haitao LIU ; Qinbing ZENG ; Xiang SI ; Huan CHEN ; Junwei ZHANG ; Qianghong XU ; Wenjin CHEN ; Xiukai CHEN ; Daozheng HUANG ; Shuhan CAI ; Xiuling SHANG ; Jian GUAN ; Juan DU ; Li ZHAO ; Minjia WANG ; Song CUI ; Xiaomeng WANG ; Ran ZHOU ; Xueying ZENG ; Yiping WANG ; Liwen LYU ; Weihua ZHU ; Ying ZHU ; Jun DUAN ; Jing YANG ; Hao YANG ; Chinese Critical Ultrasound Study Group ; Gritical Hemodynamic Therapy Collabration Group
Chinese Journal of Internal Medicine 2018;57(6):397-417
Critical ultrasonography(CUS) is different from the traditional diagnostic ultrasound,the examiner and interpreter of the image are critical care medicine physicians.The core content of CUS is to evaluate the pathophysiological changes of organs and systems and etiology changes.With the idea of critical care medicine as the soul,it can integrate the above information and clinical information,bedside real-time diagnosis and titration treatment,and evaluate the therapeutic effect so as to improve the outcome.CUS is a traditional technique which is applied as a new application method.The consensus of experts on critical ultrasonography in China released in 2016 put forward consensus suggestions on the concept,implementation and application of CUS.It should be further emphasized that the accurate and objective assessment and implementation of CUS requires the standardization of ultrasound image acquisition and the need to establish a CUS procedure.At the same time,the standardized training for CUS accepted by critical care medicine physicians requires the application of technical specifications,and the establishment of technical specifications is the basis for the quality control and continuous improvement of CUS.Chinese Critical Ultrasound Study Group and Critical Hemodynamic Therapy Collabration Group,based on the rich experience of clinical practice in critical care and research,combined with the essence of CUS,to learn the traditional ultrasonic essence,established the clinical application technical specifications of CUS,including in five parts:basic view and relevant indicators to obtain in CUS;basic norms for viscera organ assessment and special assessment;standardized processes and systematic inspection programs;examples of CUS applications;CUS training and the application of qualification certification.The establishment of applied technology standard is helpful for standardized training and clinical correct implementation.It is helpful for clinical evaluation and correct guidance treatment,and is also helpful for quality control and continuous improvement of CUS application.
6. Analysis of the arthropathies on no-bleeding history joints in pre-school age severe hemophilia A children
Di AI ; Xiaojing LI ; Wanru YAO ; Qing ZHANG ; Min ZHOU ; Ling TANG ; Xiaobo LUO ; Ningning ZHANG ; Sheng YANG ; Yan WANG ; Ping DING ; Siyu CAI ; Zhenping CHEN ; Runhui WU
Chinese Journal of Pediatrics 2018;56(10):741-744
Objective:
To detect the arthropathies on no bleeding history joints in pre-school hemophilia A children in order to provide evidence for further prevention and control of joint disease in children with hemophilia A.
Methods:
This study was a cross-sectional study based on China Hemophilia Individualized prophylaxis study (CHIPS). The basic data of outpatients with hemophilia in Beijing Children's Hospital and Chengdu Women's and Children's Central Hospital between August 2016 and June 2017 were collected and a three-month follow-up was conducted. The target joints (six joints of bilateral elbows, knees and ankles) of thirty-four children aged 1-7 years old with severe hemophilia A were examined by ultrasound, X-ray and joint function examination (4-7 years old, hemophilia joint health score (HJHS)). To find out whether there are arthropathies in patient's joints with no bleeding history and analyze the relevant factors by chi-square test, rank sum test and other statistical methods.
Results:
There were 32 analyzable cases with 112 no-bleeding history target joints, 42.9% (48/112) were elbow joints. Arthropathies were revealed in 34.8% (39/112) of them by joint structural and functional examination and 46.2% (18/39) were ankles (χ2=8.379,
7.Effect of Qingfei Mixture () on pediatric mycoplasma pneumoniae pneumonia with phlegm heat obstructing Fei (Lung) syndrome.
Ai-Jun YANG ; Kun XI ; Yan-Qing YAO ; Ying-Xue DING ; Li-Jun YANG ; Hong CUI
Chinese journal of integrative medicine 2017;23(9):681-688
OBJECTIVETo explore the effect and mechanism of Qingfei Mixture (), a Chinese medicine, in treating mycoplasma pneumonia (MP) in MP patients and rat model METHODS: A total of 46 MP children with phlegm heat obstructing Fei (Lung) syndrome were randomly assigned to two groups by the method of random number table, with 23 children in each group. The control group was treated with intravenous infusion of azithromycin; the treatment group received intravenous infusion of azithromycin and oral administration of Qingfei Mixture. The treatment course was 7 days. Major symptoms and minor symptoms were observed and scored before and after treatments. A rat model of MP was also established. A total of 120 wistar rats were randomly divided into 5 groups: a normal group, infection group, Qingfei Mixture treatment group, azithromycin treatment group, and Qingfei Mixture + azithromycin treatment group. Each group contained 24 rats, from which every 6 were euthanatized 1, 3, 7 and 14 days after infection. MP DNA in pulmonary tissue homogenates was detected using real-time fluorescence quantitative polymerase chain reaction. Pathology was assessed after hematoxylin (HE) staining and lung tissue pathology scores were determined in pulmonary tissue. Transmission electron microscopic detection and electronic image analysis were performed on lung tissue 3 days after infection. Interleukin (IL)-17 was detected in serum using enzymelinked immunosorbent assay (ELISA) 7 days after infection.
RESULTSIn the clinical study, both control and the treatment group showed improved results on removing symptoms of phlegm heat syndrome compared to the control group (P<0.05). In animal experiments, On the 7th day after MP infection, as detected by electron microscopy, the pulmonary capillary basement membranes of the azithromycin + Qingfei Mixture treatment group were much thinner than those of the azithromycin or Qingfei mixture treatment groups (P<0.05). The level of serum IL-17 in the azithromycin + Qingfei Mixture treatment group was lower than that in the azithromycin or Qingfei Mixture groups (P<0.01).
CONCLUSIONBoth Qingfei Mixture and azithromycin have therapeutic effects on mycoplasma pneumoniae pneumonia, but the combination of both agents had the greatest effect.
8.Activation of γ-aminobutyric Acid (A) Receptor Protects Hippocampus from Intense Exercise-induced Synapses Damage and Apoptosis in Rats.
Yi DING ; Lan XIE ; Cun-Qing CHANG ; Zhi-Min CHEN ; Hua AI
Chinese Medical Journal 2015;128(17):2330-2339
BACKGROUNDOur previous study has confirmed that one bout of exhaustion (Ex) can cause hippocampus neurocyte damage, excessive apoptosis, and dysfunction. Its initial reason is intracellular calcium overload in hippocampus triggered by N-methyl-D-aspartic acid receptor (NMDAR) over-activation. NMDAR activation can be suppressed by γ-aminobutyric acid (A) receptor (GABAAR). Whether GABAAR can prevent intense exercise-induced hippocampus apoptosis, damage, or dysfunction will be studied in this study.
METHODSAccording to dose test, rats were randomly divided into control (Con), Ex, muscimol (MUS, 0.1 mg/kg) and bicuculline (BIC, 0.5 mg/kg) groups, then all rats underwent once swimming Ex except ones in Con group only underwent training. Intracellular free calcium concentration ([Ca2+]i) was measured by Fura-2-acetoxymethyl ester; glial librillary acidic protein (GFAP) and synaptophysin (SYP) immunofluorescence were also performed; apoptosis were displayed by dUTP nick end labeling (TUNEL) stain; endoplasmic reticulum stress-induced apoptosis pathway was detected by Western blotting analysis; Morris water maze was used to detect learning ability and spatial memory.
RESULTSThe appropriate dose was 0.1 mg/kg for MUS and 0.5 mg/kg for BIC. Ex group showed significantly increased [Ca2+]i and astrogliosis; TUNEL positive cells and levels of GFAP, B cell lymphoma-2 (Bcl-2) associated X protein (Bax), caspase-3, caspase-12 cleavage, CCAAT/enhancer binding protein homologous protein (CHOP), and p-Jun amino-terminal kinase (p-JNK) in Ex group also raised significantly compared to Con group, while SYP, synapse plasticity, and Bcl-2 levels in Ex group were significantly lower than those in Con group. These indexes were back to normal in MUS group. BIC group had the highest levels of [Ca2+]i, astrogliosis, TUNEL positive cell, GFAP, Bax, caspase-3, caspase-12 cleavage, CHOP, and p-JNK, it also gained the lowest SYP, synapse plasticity, and Bcl-2 levels among all groups. Water maze test showed that Ex group had longer escape latency (EL) and less quadrant dwell time than Con group; all indexes between MUS and Con groups had no significant differences; BIC had the longest EL and least quadrant dwell time among all groups.
CONCLUSIONSActivation of GABAA R could prevent intense exercise-induced synapses damage, excessive apoptosis, and dysfunction of hippocampus.
Animals ; Apoptosis ; physiology ; Body Weight ; physiology ; Endoplasmic Reticulum Stress ; physiology ; Hippocampus ; metabolism ; Male ; Physical Exertion ; physiology ; Rats ; Rats, Sprague-Dawley ; Receptors, GABA ; genetics ; metabolism ; Synapses ; pathology
9.Acute adverse effects of radiotherapy on HIV-positive patients with malignancy
Xiang DING ; Shuhui YU ; Qing LONG ; Qun XIA ; Yiqin AI ; Wenhui LI ; Jianguo CUI
Chinese Journal of Radiological Medicine and Protection 2015;35(9):687-689
Objective To observe and evaluate acute toxicities in a series of human immunodeficiency virus (HIV)-positive cancer patients receiving radiation therapy.Methods The study retrospectively reviewed the acute radiation reaction of radiation therapy of 14 HIV seropositive patients diagnosed with carcinoma between Feb 2008 and Dec 2013 at the Yunnan Tumor Hospital during the radiotherapy period and 1 month following treatment.Acute adverse effects were classified according to the site of radiation therapy and analyzed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.Results Seven patients experienced interruptions or delays in treatment,and 2 stopped treatment entirely.The most common acute adverse effects were skin reactions and mucous membrane reactions,including dermatitis,stomatitis or diarrhea.Eight patients had grade 3 acute adverse effects,including 6 patients with grade 3 skin reactions and 2 patients with grade 3 mucosa reactions.Conclusions Radiotherapy is an effective treatment for HIV positive patients with tumors,however it frequently induced severe acute radiation responses.
10.Impact of″Zao-ji-sui-yuan″ and Glycyrrhizae Compatibility on Ileum Tissue Permeability in Rats in vitro
Zhi-Xiang MA ; Yong-Qing HUA ; Ai-Hua DING ; Hong-Wei FAN ; Jin-Ao DUAN
Journal of Nanjing University of Traditional Chinese Medicine 2015;(6):536-540
OBJECTIVE To explore the mechanism of glycyrrhizae's incompatibility against″zao-ji-sui-yuan″(Sargassum, Euphorbia pekinensis,Euphorbia kansui and Daphne genkwa) in TCM ″Shibafan″,from the perspective of intestinal tissue permeability in vitro .METHODS Ussing chamber technique was used to observe the effect of Sargassum,Euphorbia pekin-ensis,Euphorbia kansui and Daphne genkwa,combined with glycyrrhizae on ileum tissue permeability in rats in vitro ,with FITC-dextran 4 kDa(FD4) and FITC-dextran 40 kDa(FD40)as indicators.RESULTS Glycyrrhizae and Daphne genkwa sig-nificantly increased the permeability of FD4 in ileum tissue,while Euphorbia pekinensis and Euphorbia kansui showed little im-pact.Compared with glycyrrhizae group,the FD4 permeability significantly decreased after Sargassum,Euphorbia pekinensis, Euphorbia kansui and Daphne genkwa combined with glycyrrhizae.Remarkable effects were not found in glycyrrhizae,Sargas-sum and Euphorbia kansui groups on FD40 permeability,while Euphorbia pekinensis and Daphne genkwa groups significantly increased.FD40 permeability was found unchanged or slightly decreased after glycyrrhizae was combined with Euphorbia pe-kinensis and Daphne genkwa,while FD40 permeability significantly increased after glycyrrhizae was combined with Sargassum and Euphorbia kansui.CONCLUSION ″Zao-ji-sui-yuan″ hinders the improvement effect of glycyrrhizae on intestinal permea-bility,which is likely to be one of the mechanisms of incompatibility.On the other hand,Euphorbia pekinensis and Daphne genkwa can damage in vitro intestinal barrier function obviously,but not improve significantly after combined with glycyrrhi-zae.Sargassum and Euphorbia kansui effect little on in vitro intestinal barrier function,but damage obviously after combined with glycyrrhizae.Above all,the changes of intestinal bypass transport capacity and barrier function after combining″zao-ji-sui-yuan″ with glycyrrhizae,possibly lead to toxicity or decreased effect in certain conditions.

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