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1.
Article in Chinese | WPRIM | ID: wpr-879082

ABSTRACT

Since "the implementation of good clinical practice"(GCP), especially after 2015, the overall quality of new drug cli-nical trials in China has made significant progress, but compared with developed countries, there are still some obvious quality problems in clinical trials in China. Clinical trials of new drugs of traditional Chinese medicine are an important part of clinical trials of new drugs in China. In addition to some common problems in all clinical trials, there are also some special quality problems. In terms of security data, such as the collection of human safety data is not standardized, the management and judgment of unexpected serious adverse reactions(SUSAR) were not professional and timely, the relationship between adverse events and trial drug was not fully judged by investigator, In terms of effective data, such as primary efficacy outcome of the scale cannot be traced, TCM syndrome data cannot meet the requirements of "source data" in the revised GCP and the quality of traditional Chinese medicine placebo is not high, in terms of overall quality system construction, the sponsors and research institutions have not established a quality assurance system that conforms to the characteristics of new drug research of traditional Chinese medicine, etc. The quality of clinical trials of new drugs of traditional Chinese medicine is based on the current GCP and ICH-GCP in China, we should also consider the characteristics of clinical trials of new traditional Chinese medicine drugs, and formulate targeted quality control measures according to the characteristics of these new drugs of traditional Chinese medicine, to improve the overall quality of clinical trials of new drugs of traditional Chinese medicine in China, which has important strategic significance for promoting the research and development of new drugs of traditional Chinese medicine in China.


Subject(s)
China , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Quality Control
2.
Article in Chinese | WPRIM | ID: wpr-879081

ABSTRACT

At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.


Subject(s)
Biomedical Research , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal , Ethical Review , Humans , Medicine, Chinese Traditional , Multicenter Studies as Topic , Pharmaceutical Preparations
3.
Article in Chinese | WPRIM | ID: wpr-879080

ABSTRACT

The relevant laws and regulations of drug clinical trials were introduced in this paper. It is pointed out that with drug re-gulatory laws and technological advances, clinical trials have become an important link in the development of new drugs of traditional Chinese medicines(TCM). Clinical trials of new drugs of TCM must comply with the requirement of "Good Clinical Practice for Trial on Medicinal Products". In view of the particularities of clinical trials of new drugs of TCM, China has established an ethical review system for clinical research in TCM and carried out ethical review and certification of TCM research. In order to guide the development of clinical trials of new drugs of TCM, relevant departments have promulgated a series of guidelines for clinical trials of it, and established a new review system and technical requirements for clinical trials. Since 1983, the "national clinical pharmacology base" has been established. At present, there are 96 drug clinical trial institutions and 32 phase I clinical research wards in TCM hospitals, which can meet the development of clinical trials of new drugs of TCM. In the long-term practice, the technical team has continued to grow and develop, the research experience and technical strength have been significantly improved, and a large number of experts have become the backbone of clinical research in Chinese medicine. It is pointed out that we should attach importance to risk and benefit assessment, human experience, select scientific, objective and appropriate effectiveness indexes, evaluate the efficacy of TCM syndromes, and encourage the use of electronic methods in clinical research of new drugs of TCM. Based on the analysis of clinical trials of TCM in recent five years, it is pointed out that the active degree of clinical trials of new drugs of TCM is not high, the innovation ability of it is insufficient and the ability and enthusiasm of all aspects need to be improved. It is of great significance to carry out clinical trials of new traditional Chinese medicines to upgrade the TCM industry and produce high-level evidence-based medicine evidences. The high quality development of TCM can be promoted by strengthening clinical trials of new drugs of TCM.


Subject(s)
China , Drugs, Chinese Herbal , Evidence-Based Medicine , Humans , Medicine, Chinese Traditional , Syndrome
4.
Article in Chinese | WPRIM | ID: wpr-879079

ABSTRACT

This article proposes that the research and development of new Chinese medicines should be based on the clinical values of traditional Chinese medicine(TCM), and expounds the multiple clinical values of new Chinese medicines such as therapeutic effects, adjuvant treatment effects, improvement of disease symptoms, improvement of quality of life, prevention of diseases, etc., so as to broaden the clinical indications of new Chinese medicines. It is pointed out that the clinical value of TCM determines the clinical efficacy evaluation method of new Chinese medicines, so as to construct a clinical evaluation system of new Chinese medicines with the characteristics of TCM. It is proposed that the clinical value of new Chinese medicines should be found under the guidance of TCM theo-ry and clinical practice, and the theoretical innovation of TCM should be emphasized. There is no difference in the clinical value of drugs, and the key is to meet the clinical needs of patients. The research and development of new Chinese medicines ignores the theoretical guidance of Chinese medicine, and relying solely on animal experiment data may lead to failure of clinical trials. Different from the individualized treatment of TCM clinical syndrome differentiation, summarizing the core pathogenesis of TCM is the basis for the development of new Chinese medicines. It is necessary to summarize the pathogenesis of the disease under the guidance of TCM theory and encourage the application of modern medical methods to clarify the diagnosis of the disease. In view of the characteristics of new Chinese medicine research and development, it is proposed that the supporting role of human experience should be emphasized, and the technical points of clinical trials of new syndrome-type Chinese medicines should be explained.The use of objective indicators for syndrome evaluation, the selection of appropriate scales, and the formulation of reasonable treatment courses are advocated. During the research and development of new Chinese medicines, it is not only necessary to pay attention to modern medical safety indicators, but also to observe the evolution of TCM syndromes and specific TCM symptoms.


Subject(s)
Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Quality of Life , Research , Syndrome
5.
Article in Chinese | WPRIM | ID: wpr-879030

ABSTRACT

In order to systematically evaluate the safety of Sanfu acupoint herbal patching, CNKI, SinoMed, VIP, Wanfang, PubMed, Medline, EMbase, and Cochrane Library were searched in accordance with PICOS principles, with a time limit from database establishment to December 2019. Meta-analysis was used for a single-group rate analysis and a weighted combination of these two groups on rates of adverse reactions. A total of 9 articles meeting the inclusion criteria were included in the analysis, involving 2 119 patients. The single-group rate Meta-analysis showed that the adverse reactions incidence was 9% in the treatment group(OR=0.10,95%CI[0.06, 0.19], P<0.000 01), and 9% in the control group(OR=0.10, 95%CI[0.07, 0.13], P<0.000 01). In combined statistics of all samples OR=1.81, 95%CI[1.04, 3.15], P=0.04, the incidence of adverse reactions in the treatment group was slightly higher than that of the control group. In the subgroup analysis, the incidence of adverse reactions in terms of both single-group rate and weighed rate in the treatment group was higher than that in the control group in the asthma subgroup, rhinitis subgroup, ≥18 years old subgroup, and application time 2 h subgroup, with statistically significant differences(P<0.05). The results of the Meta-analysis and systematic review suggested that the incidence of adverse reactions in clinical use of the Sanfu acupoints herbal patching was relatively low. The main types of adverse reactions were skin ulcers, blisters and other skin symptoms. The symptoms were relatively mild, which could be relieved by drug withdrawal or symptomatic treatment. It shows that the safety of the Sanfu acupoint herbal patching was relatively high, and the occurrence of adverse reactions was related to the original disease and age, mainly in asthma and rhinitis or patients over 40 years old. Affected by clinical heterogeneity, the conclusions of the application time subgroup need to be further improved.


Subject(s)
Acupuncture Points , Adolescent , Adult , Asthma , Databases, Factual , Drugs, Chinese Herbal/adverse effects , Humans , Incidence , Randomized Controlled Trials as Topic
7.
Article | WPRIM | ID: wpr-831076

ABSTRACT

Purpose@#Diabetes mellitus (DM) is associated with elevated cancer risk and poor survival outcome in malignancies. The objective of this study was to evaluate the prognostic value of preexisting DM in chronic lymphocytic leukemia (CLL). @*Materials and Methods@#Six hundred and thirty-three subjects with newly-diagnosed CLL between 2007 and 2016 were recruited. Propensity score-matched method was performed to balance baseline characteristics and eliminate possible bias. Univariate and multivariate Cox regression analyses screened the independent risk indicators for time-to-first-treatment (TTFT) and cancer-specific survival (CSS) of CLL. Receiver operator characteristic curves and the corresponding areas under the curve assessed the predictive accuracy of CLL–International Prognostic Index (IPI) together with DM. @*Results@#The results showed that 111 patients had pre-existing DM. In the propensity-matched cohort, DM was correlated with inferior TTFT and CSS in CLL patients, and it was an independent prognostic factor for both CSS and TTFT. Pre-diabetics also shared undesirable prognostic outcome compared with patients with no diabetic tendency, and a positive association between longer diabetic duration and poorer prognosis of CLL was identified. DM as one additional point to CLL-IPI had larger area under the curve compared with CLL-IPI alone in CSS prediction and could improve the prognostic capacity of CLL-IPI. @*Conclusion@#Pre-existing DM was found to be a valuable prognostic predictor and could help predict life expectancy and build refined prognostication models for CLL.

8.
Article in Chinese | WPRIM | ID: wpr-861715

ABSTRACT

Background: Intestinal microbiota dysbiosis is closely related to irritable bowel syndrome (IBS). Fecal bacterial smear is a simple and economical laboratory test for determining the severity of this condition. Aims: To explore the reference value of fecal bacterial smear for antibiotic treatment in IBS with diarrhea (IBS-D). Methods: A total of 130 IBS-D patients were enrolled and allocated into four groups according to the results of fecal bacterial smear: normal intestinal microbiota group and grade , Ⅱ and III dysbiosis groups. Patients with grade III dysbiosis were treated based on fecal bacterial culture and drug susceptible test; patients in other three groups were treated with rifaximin for 7 days. After 7-day rifaximin treatment, all patients were reviewed for fecal bacterial smear. The clinical efficacy and changes in fecal bacterial smear were assessed and the consistency of these two aspects was analyzed by Kappa coefficient. Results: Of the 130 IBS-D patients, 82.3% had intestinal microbiota dysbiosis, and those with grade , Ⅱ and III dysbiosis was 48.5%, 25.4%, and 8.5%, respectively. The overall efficacy of rifaximin in patients with grade +Ⅱ dysbiosis was significantly higher than that in patients with normal intestinal microbiota (57.3% vs. 30.4%, P<0.05). Furthermore, the overall efficacies in grade and grade Ⅱ dysbiosis groups, especially in grade Ⅱ dysbiosis group, were consistent with the changes in fecal bacterial smear (κ=0.653 and κⅡ=0.727, all P<0.05). Conclusions: Intestinal microbiota dysbiosis can be detected in a great proportion of patients with IBS-D, and antibiotic treatment is more effective in patients with dysbiosis. Fecal bacterial smear might be used to stratify the IBS-D patients for optimal selection of antibiotics.

9.
Chinese Journal of Pathology ; (12): 767-771, 2019.
Article in Chinese | WPRIM | ID: wpr-796830

ABSTRACT

Objective@#To investigate the clinicopathological characteristics of gastric mixed adenoneuroendocrine carcinoma (MANEC).@*Methods@#The clinical and pathologic data of 36 cases of gastric MANEC collected from January 2011 to December 2018 in the Department of Pathology, Fujian Provincial Hospital were retrospectively analyzed. Light microscopy and EnVision immunohistochemical (IHC) staining were used in the study. The results were compared with 40 cases of gastric neuroendocrine carcinoma collected within the same period.@*Results@#The 36 cases were collected, there were 29 males and 7 females. The patients′ age ranged from 43 to 87 years (mean 66 years). The tumor diameter ranged from 1.0 to 9.0 cm (mean 5.0 cm). Clinical staging showed that four cases were at T1+T2 stages and 32 cases were at T3+T4 stages. The main clinical manifestations were upper abdominal pain, abdominal distension and dysphagia. Complete follow-up data were obtained in 20 (eleven living and nine dead) patients. Pathologic analysis showed that all tumors were composed of neuroendocrine carcinoma and adenocarcinoma and each of the components was more than 30%. IHC staining showed that CK was expressed in adenocarcinoma; whereas the neuroendocrine carcinoma mainly expressed CD56 and Syn. There was no significant difference in age, sex, T stage and prognosis between gastric MANEC and gastric neuroendocrine carcinoma(P>0.05). Gastric neuroendocrine carcinoma predominantly occurred in the esophagogastric junction and the gastric body but only rarely in the gastric antrum; gastric MANEC mainly occurred in the esophagogastric junction and the gastric antrum but rarely in the gastric body. Gastric MANEC was more prone to lymph node metastasis than gastric neuroendocrine cancer(P<0.05).@*Conclusions@#Most of the gastric MANEC patients are middle-aged and elderly males, and the tumors predominantly occur in the esophagogastric junction and the gastric antrum. Most of the patients are found to have higher stages, and most of them have lymph node metastases and poor prognosis.

10.
Chinese Journal of Plastic Surgery ; (6): 1041-1044, 2019.
Article in Chinese | WPRIM | ID: wpr-796705

ABSTRACT

The new method of negative pressure wound therapy not only greatly improves the level of treatment on hard healing wounds in plastic surgery, but also widely used in the field of major surgery. The clinical efficacy of this technique in prevention of surgical incision complications, treatment of postoperative wound infection and fissure, treatment of postoperative infection and exposure of various implants, treatment of special burn wounds, and temporary closure of abdominal cavity after open abdominal surgery were reviewed. The impact of negative pressure wound therapy with instillation for infected wounds and the application of endoscope assisted negative pressure therapy in the treatment of complications after hollow viscera anastomosis were also reviewed. This review provides a new idea for the treatment of various refractory wounds and wound complications.

11.
Article in Chinese | WPRIM | ID: wpr-771855

ABSTRACT

OBJECTIVE@#To investigate the effects of Listeria monocytogenes infection on hematopoietic stem and progenitor cell (HSPC) composition, cell cycle and cell colony-forming ability in mouse bone marrow.@*METHODS@#The C57BL/6J mice were divided into infected group and control group. The mice in injected group were infected intraperitoneally with 6.7×10 CFU Listeria monocytogenes,while the mice in control group were injecfed with PBS of same volume.The serum levels of IFNγ were detected at different time points. After 24 hours, the HS/PC composition, cell cycle and cell colony-forming ability in bone marrow of mice were measured, and the difference between the control group and the infected group was statistically analyzed.@*RESULTS@#Serum IFNγ levels peaked at 24 hours after infection with Listeria monocytogenes. After 24 h, the proportion of LSK, LSK in S phase, and short-term hematopoietic stem cells (ST-HSC) in the infected group were significantly higher than those in the control group (P<0.001), long-term hematopoietic stem cells (LT-HSC) and the proportion of LT-HSC in S phase were significantly increased (P<0.01), and the cell colony-forming ability of bone marrow significantly decreased (P<0.01). [WTHZ]Conclusion: [WTB1]After infection with Listeria monocytogenes, bone marrow hematopoietic stem cells enter the proliferative state from rest, the cell colony-forming ability decreases, suggesting that Listeria monocytogenes infection can cause hematopoietic stem cell depletion.


Subject(s)
Animals , Bone Marrow , Bone Marrow Cells , Cell Differentiation , Cell Proliferation , Hematopoietic Stem Cell Transplantation , Hematopoietic Stem Cells , Mice , Mice, Inbred C57BL
12.
Article in English | WPRIM | ID: wpr-777103

ABSTRACT

OBJECTIVE@#To investigate the effect and safety of Guanxinning Tablet (, GXN) for the treatment of stable angina pectoris patients with Xin (Heart)-blood stagnation syndrome (XBSS).@*METHODS@#One hundred and sixty stable angina pectoris patients with XBSS were randomly assigned to receive GXN (80 cases) or placebo (80 cases, Guanxinning simulation tablets, mainly composed of lactose), 4 tablets (0.38 g/tablet), thrice daily for 12 weeks. After treatment, an exercise stress test (treadmill protocol), Chinese medicine (CM) syndrome score, electrocardiogram (ECG), and nitroglycerin withdrawal rate were evaluated and compared in the patients between the two groups. Meanwhile, adverse events (AEs) were evaluated during the whole clinical trial.@*RESULTS@#Compared with the control group, the time extension of exercise duration in the GXN group increased 29.28 ±17.67 s after treatment (P>0.05); moreover, the change of exercise duration in the GXN group increased 63.10 ±96.96 s in subgroup analysis (P<0.05). The effective rates of angina pectoris, CM syndrome and ECG as well as nitroglycerin withdrawal rate were 81.33%, 90.67%, 45.76%, and 70.73%, respectively in the GXN group, which were all significantly higher than those in the control group (40.58%, 75.36%, 26.92%, 28.21%, respectively, P<0.05).@*CONCLUSION@#GXN was a safe and effective treatment for stable angina pectoris patients with XBSS at a dose of 4 tablets, thrice daily.

13.
Chinese Journal of Cardiology ; (12): 197-203, 2019.
Article in Chinese | WPRIM | ID: wpr-810501

ABSTRACT

Objective@#Screen the pathogenic genes of a pedigree with clinical manifestation of familial dilated cardiomyopathy in Inner Mongolia.@*Methods@#A total of 3 patients with dilated cardiomyopathy and 20 family members from the same family were examined in Ordos Central Hospital in Inner Mongolia from October, 2003 to August, 2017. Data on medical history, physical examinations, electrocardiograms, and echocardiography were obtained. 5 ml peripheral blood was sampled for per person. Chip Capture Sequencing technology was used to capture all the exons and splice sites of the genes that associated with hereditary cardiomyopathy and hereditary arrhythmia. The mutations in these genes were detected by high-throughput sequencing. All suspected pathogenic loci identified by high-throughput sequencing were verified by Sanger sequencing used for mutation detection. One hundred and fifty gender, age and race matched healthy people were included as the control group.@*Results@#Pathogenic gene variations were detected in 3 symptomatic family members and 1 carrier from the pedigree. Five pathogenic gene variations were identified in the proband (Ⅱ1), a pSer236Gly and a pArg215Cys variation in the MYBPC3 gene, a pGln90Arg variation in the DSP gene, and pAsn2912Asp and pGlu2910Val variation in the DMD gene. One pathogenic variation was detected in Ⅲ3, which was a pArg215Cys variation in the MYBPC3 gene. Two pathogenic variations were detected in Ⅲ7, a pSer236Gly variation in the MYBPC3 gene and a pGln90Arg variation in the DSP gene. Two pathogenic variations were detected in the Ⅳ7, a pSer236Gly variation in the MYBPC3 gene and a pGln90Arg variation in the DSP gene. No gene variation loci were detected in the other family members and the control group.@*Conclusion@#MYBPC3 gene, DSP gene and DMD gene variations are present in the familial dilated cardiomyopathy pedigree from Inner Mongolia, and these variations may be related with familial dilated cardiomyopathy.

14.
Article in Chinese | WPRIM | ID: wpr-777524

ABSTRACT

The aim of this paper was to provide reference for the clinical safety use of aconite through the retrieval of literature about adverse reactions,predict its mechanism of cardiac toxicity by using network pharmacology,and provide ideas for the studies on toxicity mechanism of toxic Chinese medicines. The papers on adverse reactions of aconite were searched to established a database and summarize the adverse reactions of aconite. The results of literature review showed that the main causes for adverse reactions in clinical use of aconite included overdose use,short cooking time,consumption of medicinal liquor/medicinal diet,external use and misuse and so on. Therefore,the dosage of aconite should be strictly followed in clinical application,and the decoction method should be notified to the patients in detail to avoid taking the medicinal liquor and diet containing aconite,so as to prevent the occurrence of adverse reactions as much as possible,and make the best use of aconite in clinical application in avoid its toxicity. At the same time,based on the results of literature review,the network construction and visual analysis of cardio toxicity produced by aconite were carried out by using the network pharmacology technologies. RESULTS: showed that aconite can be applied to eight biological processes such as action potential of cardiac myocytes,cardiac conduction-related cell signal transduction,cardiac myocytes contraction,action potential involved in cardiac myocytes contraction,and signal transduction from atrial myocardial cells to atrioventricular node cells,and three target genes(SCN5 A,GJA1,GJA5). It was predicted that Aconiti Lateralis Radix Praeparata may influence cardiomyocyte depolarization,intercellular information transmission and material exchange by acting on three target genes(SCN5 A,GJA1,GJA5) and regulating the sodium channel protein and the expression of gap junction protein,thus affecting the heart rhythm as well as its structure and function and causing cardiac toxicity.


Subject(s)
Aconitum , Chemistry , Toxicity , Cardiotoxicity , Drugs, Chinese Herbal , Toxicity , Humans , Myocytes, Cardiac , Plant Roots , Chemistry , Toxicity
15.
Chinese Journal of School Health ; (12): 1464-1466, 2019.
Article in Chinese | WPRIM | ID: wpr-815878

ABSTRACT

Objective@#To examine sleep characteristics of preschool children who were born preterm, which could provide a reference for the future intervention in the risk population.@*Methods@#This retrospective cohort study was conducted from March 2017 to November 2018 in hospitals in cities of Guangzhou, Zhongshan, and Shenzhen, Guangdong Province, China, we recruited 202 preschool children aged 4-6 years, including 40 early-and moderate preterm (gestational age <34 weeks), 56 late preterm (34-36 weeks) , and 106 full-term preschool children (≥37 weeks). Caregivers reported children’s sleep time and habits using Chinese version of Children’s Sleep Habits Questionnaire (CSHQ).@*Results@#Compared to the full-term group, the very-or-moderate-preterm group had shorter nighttime sleep duration (9.07±0.75 vs 9.33±0.59 h; adjusted β=-0.33), shorter total sleep duration (10.39±0.86 vs 11.05±1.32 h; adjusted β=-0.70), higher sleep duration score of CSHQ (4.60 ± 1.57 vs 3.97 ± 1.25 points; adjusted β=0.58), and higher sleepdisordered breathing score of CHSQ (3.78±1.27 vs 3.41±0.71 points; adjusted β=0.49). The late preterm group had lower parasomnias score of CSHQ (8.40±1.65 vs 8.75±1.72 points; adjusted β=-0.57), than the full-term group(P<0.05). When gestational age was analyzed as a continuous variable, it was positively associated with the total sleep duration (adjusted β= 0.06), while was inversely associated with sleep-disordered breathing scores of CSHQ (adjusted β=-0.06).@*Conclusion@#Very-or-moderate preterm children have shorter sleep duration and more sleep disordered breathing problems than full-term children, and have more disorders of sleeping duration and sleeping breathing than full-term children, while the late preterm children have less sleeping disorders than full-term children. The children of lower gestational age can have shorter sleep duration and more sleep-disordered breathing which should be addressed in future intervention.

16.
Chinese Mental Health Journal ; (12): 271-277, 2018.
Article in Chinese | WPRIM | ID: wpr-704013

ABSTRACT

Objective:To understand the status of supervision of mental health service industry in Shanghai, and to provide reference for further strengthening the construction of mental health service system in Shanghai. Methods: In Shanghai, 107 mental health service agencies (including psychiatric institutions, non-specialist medical institutions, non-specialist enterprise and public institutions, social institutions) were selected from Shanghai psychological service industry association. The survey was conducted with the Questionnaire on Current Situation of Mental Health Professional Service Agencies in Shanghai (agency survey), including the "relevant information of agency" and the "management of the agency in the field of mental health services"(whether the agency had supervision requirements on the mental health service personnel, whether the agency organized supervision, the source of supervisors and payment method), and the Questionnaire on Current Situation of Mental Health Service Professionals in Shanghai (professional survey), including "basic information on demography "and" psychological professional work" (the number of hours of supervision in 2015, the cost of supervision, and the form of supervision and payment method). These two parts of questionnaire were selected and analyzed. Results: Agency survey results showed that 80% of non-specialist enterprises had no supervision requirements for mental health service personnel, supervisor in non-specialist medical institutions were mainly from psychiatric institution (52.9%). The cost of supervision in most psychiatric institutions was paid by the agency (39.1%) and the cost of supervision in most public institutions was paid by professional (37%). The professional institutions under the jurisdiction of other departments within the unit required less supervision of the professional staff than the independent institutions (P < 0.001). Professional survey results showed that the number of supervision hours of mental health service professional in social institutions was more than that in the other three types of institutions (P <0.001), of which 47.9% chosen to pay the cost of supervision by themselves. The proportion of their own payment in social institutions was higher than that in the other three types of institutions (P <0.001). Conclusion:The social institutions in Shanghai have the best supervision of social institutions, followed by the supervision of the medical institutions. The supervision of non-medical enterprises and their personnel needs to be improved.

17.
Chinese Mental Health Journal ; (12): 95-100, 2018.
Article in Chinese | WPRIM | ID: wpr-703986

ABSTRACT

Objective:To investigate the development status of mental health service of Shanghai mental health agencies,and to provide reference for further strengthening the standardized management of service agencies.Methods:In Shanghai,107 mental health service agencies (including psychiatric institutions,non-specialist medical institutions,non-specialist enterprise and public institutions,social institutions) were selected from Shanghai psychological service industry association.Each person in charge of these agencies was interviewed with an adapted 5 l-item questionnaire.A total of 89 valid questionnaires were collected.In this study,25 items of the questionnaire (belonging to the parts of agency information,mental health service situation and management of mental health service) were selected and analyzed.Results:All the surveyed agencies had been registered.The average age of these agencies for setting up mental health service was 8.9 years,and the average age of psychiatric institutions was the longest (18.6 years).Besides,psychiatric institutions attracted most of the clients (83.9%) in 2015.Among the professionals,only 32.5% were full time,74.0% were female,41.5% were between 31 and 40 years old and 63.8% were undergraduates.Psychiatrists,psychotherapists,counselors and psychometric person accounted for 78.0% of the professionals in these agencies.Only 52.3% of the agencies had full-time management personnel for mental health service.The most used method of assessing the quality of service and staff assessment was to obtain feedback from the client/family members (81.0%) and the assessment of the services (78.8%).Conclusion:The development of mental health service in Shanghai mental health agencies has been more normalized,but there is still a lack of full-time professionals.In addition,there is a lack of unified supervision and management mechanism for professionals.

18.
Chinese Journal of Immunology ; (12): 688-692, 2018.
Article in Chinese | WPRIM | ID: wpr-702798

ABSTRACT

Objective:To investigate the anticancer activity and mechanism of aconitine on cell proliferation,invasion and migration of hepatoma carcinoma cell(HCC).Methods:The effect of aconitine at different concentrations on proliferation was calculated by MTT assay.The effects of aconitine on invasion and migration of HCC were measured by Transwell and wound healing assay.Western blot was employed to detect the protein levels of P38MAPK signaling pathway-related proteins.Results:The concentrations of 5,10,20 μg/ml were selected according to the results of pre-experiment.Aconitine(10,20 μg/ml) inhibits proliferation and invasion of MHCC97 cells markedly after cells were treated with aconitine for 4 days.Treatment with aconitine down-regulated the ability of migration and decreased the ratio of p-P38/P38 and protein levels of p-MAPKAPK and p-HSP27.Conclusion:Aconitine inhibits prolif-eration,invasion and migration,and the mechanism may related with P38MAPK signaling pathway.

19.
Chinese Journal of Nursing ; (12): 230-233, 2018.
Article in Chinese | WPRIM | ID: wpr-708727

ABSTRACT

Objective To construct the rapid training program for auxiliary rescue personnel within the restricted area after major disasters,and to provide references for disaster rescue in China.Methods Based on literature review and group discussion,two rounds of consultation with experts using Delphi method were conducted to construct the rapid training program for post-disaster auxiliary rescue personnel.Results The authority coefficients of two rounds of consultations were 0.81 and 0.82,and the coordination coefficients ranged from 0.272 to 0.460.Conclusion Experts had consistent opinions on items of each level for the rapid training program for post-disaster auxiliary rescue personnel.Experts had high levels of enthusiasm and authority,and the rapid training program can meet training requirements for post-disaster auxiliary rescue personnel,and provide references for efficient rescue after major disasters in China.

20.
Article in Chinese | WPRIM | ID: wpr-278676

ABSTRACT

Graft-versus-host disease (GVHD) and infection are the frequently encountered complications after hematopoietic stem cell transplantation (HSCT), which influence the outcome and limit the widespread application of HSCT. Intestinal microbiota plays an important role in maintaining intestinal immune balance. The diverse levels of intestinal microbiota associated with the incidences of GVHD, infection and the prognosis of HSCT, thus remodeling intestinal microbiota can alleviate GVHD and infection after HSCT. Herein, the recent research progress about the role and the involved mechanisms of intestinal microbiota in HSCT, and the novel manipulation strategies of intestinal microbiota are systematically reviewed.

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