Effect of CKIP-1 on hepatocyte apoptosis in nonalcoholic fatty liver disease / 中华内科杂志

Objective:To explore the effect and underlying mechanism of casein kinase 2 interacting protein-1 (CKIP-1) on hepatocyte apoptosis in nonalcoholic fatty liver disease (NAFLD).Methods:Experimental study. An NAFLD cell model was established by inducing human hepatoma cell line, HepG 2 cells, with oleic acid (OA). Flag-CKIP-1 expression vector and shRNA-CKIP-1 were transfected into HepG 2 cells. Flow cytometry was used to detect the effect of CKIP-1 on the activity and apoptosis of NAFLD hepatocytes. The levels of apoptosis-related proteins were detected by Western blot. CKIP-1 knockout mice in C57BL/6 back-ground were fed with either standard or high-fat diet for 8 weeks. Apoptosis-related signal proteins in NAFLD hepatocytes were detected by immunohistochemistry. Results:After CKIP-1 was transfected into HepG 2 cells, the degree of OA induced cell liposis was significantly reduced ( P<0.05). Annexin V-FITC/PI flow cytometry showed that CKIP-1 reduced the apoptosis of steatotic hepatocytes. Overexpression of CKIP-1 could significantly inhibit the expression of caspase-3 and caspase-9 and increase the expression of Bcl-2/Bax ( P<0.05). Knockdown of CKIP-1 could increase the expression of caspase-3 and caspase-9 ( P<0.05). CKIP-1 knockout could further increase the expression of caspase-3 and caspase-9 in NAFLD mice ( P<0.01, P<0.05), and further decrease the expression of Bcl-2/Bax ( P<0.05). Conclusion:CKIP-1 inhibited the apoptosis of steatotic hepatocytes by up-regulating the expression of apoptosis inhibitor gene, Bcl-2/Bax, and affecting the proteases, caspase-3 and caspase-9.

Relationship between the number of peripheral blood endothelial progenitor cells and survival time in individuals aged 75 and older / 中华老年医学杂志

Objective:To investigate the relationship between the number of epithelial progenitor cells(EPCs)in peripheral blood and blood parameter values in order to clarify the relationship between peripheral blood EPCs and the length of survival in elderly individuals aged 75 and beyond.Methods:Analysis was conducted on 114 individuals ≥75 years recruited from the Department of Geriatrics, Tianjin Medical University General Hospital in 2008.Clinical data were collected with December 31, 2020 as the end of the follow-up.Associations between peripheral blood EPC numbers, blood parameter values and all-cause mortality were analyzed.Results:In low and high EPC groups based on orthogonal partial least squares-discriminant analysis(OPLS-DA), D-Dimer was found to be a potential classification marker[the variable importance in projection(VIP)=4.750], out of a panel of blood tests.Blood parameters such as red blood cells(RBC), hemoglobin(HGB), hematocrit(HCT), aspartate aminotransferase(AST), gamma-glutamyl transferase(GGT), lactate dehydrogenase(LDH)and D-Dimer showed statistically significant differences between groups with different levels of EPCs(all P<0.05). Blood EPC numbers were positively correlated with RBC, HGB and HCT and negatively correlated with GGT and D-Dimer in older individuals( r=0.364, 0.343, 0.336, -0.312, -0.312, P<0.05 for all). The number of circulating EPCs had a significant positive correlation with survival time in older individuals( r=0.234, P=0.017). Based on the data of the long-term(12-years)follow-up, Logistic regression analysis suggested that the number of EPCs, age, and HCT were associated with all-cause mortality events in older individuals( OR=0.971, 1.585, 1.231, P=0.013, 0.012, 0.029). Conclusions:EPCs in the peripheral circulation may be involved in the progression of various conditions such as anemia, cardiac, hepatic and renal injury, and coagulation.The number of circulating EPCs may influence the survival of elderly individuals ≥75 years.Age and HCT may be risk factors for all-cause mortality events, whereas the number of EPCs may be a protective factor.

Research on the determination of the limit value of perchlorate in the "Standards for Drinking Water Quality（GB5749-2022）" in China / 中华预防医学杂志

Perchlorate is an environmental pollutant that has been a focus of attention in recent years. It has been detected in many environmental water bodies and drinking water in China, with a high level of presence in some areas of the Yangtze River Basin. The human body may ingest perchlorate through exposure pathways such as drinking water and food, and its main health effect is to affect the thyroid's absorption of iodine. The "Standards for Drinking Water Quality" (GB5749-2022) includes perchlorate as an expanded indicator of water quality, with a limit value of 0.07 mg/L. This article analyzes the technical content related to the determination of hygiene standard limits for perchlorate in drinking water, including the environmental presence level and exposure status of perchlorate, main health effects, derivation of safety reference values, and determination of hygiene standard limits.

Research on the establishment of standard limits for perfluorooctanoic acid and perfluorooctane sulfonate in the "Standards for Drinking Water Quality（GB5749-2022）"in China / 中华预防医学杂志

Perfluorinated compounds, especially Perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), are widely detected in water environments in China. Considering the potential health risks of drinking water exposure routes, PFOA and PFOS have been added to the water quality reference index of the newly issued "Standards for Drinking Water Quality (GB5749-2022)", with limit values of 40 and 80 ng/L, respectively. This study analyzed and discussed the relevant technical contents for determining the limits of the hygiene standard, including the environmental existence level and exposure status of PFOA and PFOS, health effects, derivation of safety reference values, and determination of hygiene standard limits. It also proposed prospects for the future direction of formulating drinking water standards.

Technical points of human use experience of ethnic medicine / 中国中药杂志

Ethnic medicine has a rich history of application. Because of the large number of ethnic groups, wide geographical distribution, and unique medical systems in China, the research on the human use experience(HUE) of ethnic medicine should combine the characteristics of ethnic medicine, be based on practical experience, and respect folk practice and tradition. The clinical positioning of ethnic medicine should consider three factors, i.e., population region, dominant diseases, and clinical demand. We should consider the development of traditional preparations that meet the needs of ethnic regions and encourage the development of new drugs that can be popularized and used nationwide for the dominant diseases of ethnic medicines. Attention should be paid to the problems such as a large number of customary articles or substitutes of ethnic medicinal materials, the phenomena of foreign bodies with the same name and different names for the same substance, the different standards of medicinal materials, and the poor processing standards. The name, processing method, source, medicinal parts, and dosage of ethnic medicinal materials or decoction pieces should be determined, and resources should be carefully evaluated to ensure the safety of medicinal resources and ecology. The preparation of ethnic medicine is mostly in the form of pills, powder, ointment, etc., with simple processing technology. The problems of low-quality stan-dards of some preparations, different prescriptions with the same name, and inconsistent processing technology should be overcome, and the process route and main process parameters should be clarified to lay the foundation for the subsequent empirical research on HUE. In the collection and analysis of the HUE data of ethnic medicine, the core guiding ideology of "patient-centered" should be established, and the experience data of patients should be collected. The problems of weak links existing in the inheritance of ethnic medicine should be solved, and flexible and diverse methods should be adopted. Meanwhile, on the premise of complying with the requirements of the principles of medical ethics, we should respect the religion, culture, and customs of ethnic areas to obtain the key HUE information of ethnic medicine. On the basis of the patient preference information and differences in regional disease epidemiology, population characteristics, and medical practice, whether the HUE conclusions of ethnic medicine can be extrapolated to patients outside the region is evaluated from the aspects of clinical benefits, risk tolerance, risk acceptance, etc. The HUE research on ethnic medicine is carried out in a clear way to guide the research and development of new ethnic medicines.

Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version) / 中国中药杂志

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.

Diagnostic value of endoscopic ultrasonography for pancreatic cystic lesions / 中华胰腺病杂志

Objective:To explore the diagnostic value of endoscopic ultrasonography (EUS) for pancreatic cystic lesions (PCLs).Methods:Clinical data of 211 patients with PCLs, who underwent EUS at least once and were pathologically confirmed in First Affiliated of Naval Medical University from January 2011 to December 2021 was retrospectively analyzed. EUS imaging characteristics, biochemical analysis of cystic fluid and pathological data were recorded. The pathological diagnosis results of intraductal papillary mucinous neoplasms and mucinous cystic neoplasms were included in the mucinous lesion group, while pancreatic pseudocyst, serous cystic neoplasms, solid pseudopapillary neoplasms and pancreatic neuroendocrine tumors were included as non-mucinous lesions group; those with pancreatic ductal adenocarcinoma, adenocarcinoma or with atypical or cancer cells were included as malignant lesion group, and the else were included as benign lesions group. The level of CEA in cyst fluid between mucinous and non-mucinous lesions and the level of amylase in cyst fluid between benign and malignant lesion groups were compared, and the area under the curve (AUC) was calculated by drawing receiver operating characteristic curve (ROC), which was used to analyze the differential diagnosis efficiency of cyst fluid CEA and amylase test indexes. The basic characteristics and EUS imaging characteristics, and the diagnostic efficiency of EUS and liquid-based cytology and histopathology between benign and malignant lesions were studied and analyzed.Results:Among the 211 PCL patients, cyst fluid was obtained in 201 patients, of which 188 patients (93.5%) underwent cytological examination, and 33 patients were diagnosed with an accuracy rate of 17.6%; 41 cases were obtained for histological examination, and 23 cases were confirmed, with an accuracy rate of 56.1%. Among all confirmed cases, 45 cases had benign lesions, including 22 cases of mucinous lesions and 23 cases of non-mucinous lesions, with the cyst fluid CEA of 1458.16(19.80, 1500.00), 4.4(0.50, 341.14)ng/ml respectively, and the difference of cyst fluid CEA level between mucinous and non-mucinous lesions was statistically significant( P<0.05). The cyst fluid CEA<10.15 ng/ml could be used to diagnose non-mucinous PCLs with the sensitivity of 89.5%(95% CI0.686-0.981), and the specificity of 66.7%(95% CI0.438-0.837). The cyst fluid amylase levels in benign and malignant lesions were 379.00(50.00, 18405.50), 42.00(13.50, 340.00)U/L, and the difference was statistically significant ( P<0.05). The cyst fluid amylase>747.50 U/L might help to identify benign PCLs with the sensitivity of 91.7%(95% CI0.646-0.996), and the specificity of 48.0%(95% CI0.300-0.665). EUS showed that the proportion of cyst wall thickening, main duct dilatation and cystic solid components in patients with malignant lesions was significantly higher than that in patients with benign lesions, and the differences were statistically significant ( P<0.05), while there was no significant difference in the proportion of cyst wall nodules and cystic septum between the two groups. The accuracy of EUS combined with liquid-based cytology or histopathology in malignant lesions was over 80%. Conclusions:The cyst fluid CEA level can help to differentiate non-mucinous PCLs from mucinous PCLs, and the cystic amylase level could be useful to identify the benign and malignant PCLs. EUS combined with cytology or histology had high diagnostic value for malignant or potentially malignant PCLs, and EUS-FNA examination can be recommended as soon as possible for those with high-risk factors.

Thoughts on path of R&D and registration of innovative traditional Chinese medicine with synchronous transformation of "series prescriptions" / 中国中药杂志

Since the implementation of drug registration in China, the classification of Chinese medicine has greatly met the needs of public health and effectively guided the transformation, inheritance, and innovation of research achievements on traditional Chinese medicine(TCM). In the past 30 years, the development of new Chinese medicine has followed the registration transformation model of " one prescription for single drug". This model refers to the R&D and registration system of modern drugs, and approximates to the " law-abiding" medication method in TCM clinic, while it rarely reflects the sequential therapy of syndrome differentiation and comprehensive treatment with multiple measures. In 2017, Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices released by the General Office of the CPC Central Committee and the General Office of the State Council pointed out that it is necessary to " establish and improve the registration and technical evaluation system in line with the characteristics of Chinese medicine, and handle the relationship between the traditional advantages of Chinese medicine and the requirements of modern drug research". Therefore, based on the development law and characteristics of TCM, clinical thinking should be highlighted in the current technical requirements and registration system of research and development of Chinese medicine. Based on the current situation of registration supervision of Chinese medicine and the modern drug research in China, the present study analyzed limitations and deficiency of " one prescription for single drug" in the research and development of Chinese medicine. Additionally, a new type of " series prescriptions" was proposed, which was consistent with clinical thinking and clinical reality. This study is expected to contribute to the independent innovation and high-quality development of the TCM industry.

Category of Chinese medicine registration:historical evolution,current status,and problems / 中国中药杂志

The development of traditional Chinese medicine(TCM) has always been highly valued and supported since 1949. However, Chinese medicine industry still faces great challenges in view of the current status of the industry and registration and approval of new products in recent years. Related policies also directly influence the development of the industry. The latest version of the Provisions for Drug Registration and Requirement on Registration Classification and Application Information of Traditional Chinese Medicines have been put into practice since 2020. Registration classification is the core content of the Chinese medicine registration management system, as it is closely related to the research, development, and registration of Chinese medicine and the innovative development of the industry. This article aims to systematically review the historical evolution of the category of Chinese medicine registration and analyze the current status and problems, which is expected to provide a reference for the formulation of supporting documents according to related laws and regulations.

Early therapeutic interventions of traditional Chinese medicine in COVID-19 patients: A retrospective cohort study / 中西医结合学报

OBJECTIVE@#To observe the early interventions of traditional Chinese Medicine (TCM) on the conversion time of nucleic acid in patients with coronavirus disease 2019 (COVID-19), and find possible underlying mechanisms of action.@*METHODS@#A retrospective cohort study was conducted on 300 confirmed COVID-19 patients who were treated with TCM, at a designated hospital in China. The patients were categorized into three groups: TCM1, TCM2 and TCM3, who respectively received TCM interventions within 7, 8-14, and greater than 15 days of hospitalization. Different indicators such as the conversion time of pharyngeal swab nucleic acid, the conversion time of fecal nucleic acid, length of hospital stay, and inflammatory markers (leukocyte count, and lymphocyte count and percentage) were analyzed to observe the impact of early TCM interventions on these groups.@*RESULTS@#The median conversion times of pharyngeal swab nucleic acid in the three groups were 5.5, 7 and 16 d (P < 0.001), with TCM1 and TCM2 being statistically different from TCM3 (P < 0.01). TCM1 (P < 0.05) and TCM3 (P < 0.01) were statistically different from TCM2. The median conversion times of fecal nucleic acid in the three groups were 7, 9 and 17 d (P < 0.001). Conversion times of fecal nucleic acid in TCM1 were statistically different from TCM3 and TCM2 (P < 0.01). The median lengths of hospital stay in the three groups were 13, 16 and 21 d (P < 0.001). TCM1 and TCM2 were statistically different from TCM3 (P < 0.01); TCM1 and TCM3 were statistically different from TCM2 (P < 0.01). Both leucocyte and lymphocyte counts increased gradually with an increase in the length of hospital stay in TCM1 group patients, with a statistically significant difference observed at each time point in the group (P < 0.001). Statistically significant differences in lymphocyte count and percentage in TCM2 (P < 0.001), and in leucocyte count (P = 0.043) and lymphocyte count (P = 0.038) in TCM3 were observed. The comparison among the three groups showed a statistically significant difference in lymphocyte percentage on the third day of admission (P = 0.044).@*CONCLUSION@#In this study, it was observed that in COVID-19 patients treated with a combination of Chinese and Western medicines, TCM intervention earlier in the hospital stay correlated with faster conversion time of pharyngeal swab and fecal nucleic acid, as well as shorter length of hospital stay, thus helping promote faster recovery of the patient. The underlying mechanism of action may be related to improving inflammation in patients with COVID-19.

Expert consensus on key issues of quality control in clinical trials of new drugs of traditional Chinese medicine / 中国中药杂志

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.

Consensus on collaborative ethical review of multi-center clinical trials of new drugs of traditional Chinese medicine (version 1.0) / 中国中药杂志

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.

Development of clinical trial of new drugs of traditional Chinese medicines / 中国中药杂志

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.

Theoretical thinking on guiding research and development of new drugs of traditional Chinese medicine / 中国中药杂志

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.

Data collection, quality and evidence formation for human use experience of traditional Chinese medicine / 中国中药杂志

Collecting and summarizing human use experience(HUE) data, forming high-quality data and evidences that can be used for evaluation are the key links of HUE research on traditional Chinese medicine(TCM). The collection, collation and summary of human experience data were discussed in this paper. It is pointed out that the collection of HUE should be focus on the source of prescription of new traditional Chinese medicines, and be summarized based on dialectical thinking, experience in medication, characte-ristics of prescription and clinical application. The collected contents include prescription, process, clinical location and applicable population, efficacy data and safety data, etc. The methods include interview, clinical data summary and data mining. When the data formed based on HUE information is used as drug registration information, it is necessary to ensure that the data source is legal and compliant, and the ownership of intellectual property is clear.Data sources should meet the requirements of medical ethics. To avoid conflict of interest, data analysis should be conducted by an independent third party. It is necessary to develop the quality control measures of HUE data to ensure the data traceability, integrity, consistency and accuracy, and avoid data bias.The data of HUE should include the key data such as accurate clinical location and applicable population, recognized clinical efficacy and safety.After the formation of HUE, the statistical analysis plan of empirical data of human use should be formulated. Through strict data processing, statistical analysis and clinical interpretation, HUE can be produced for evaluation.

Analysis of a Rare Case of Cerebral Infarction Secondary to Anaphylactic Shock Caused by Nicotinic Acid Injection / 中国药房

OBJECTIVE：To provide reference for safe use of Nicotinic acid injection in the clinic. METHODS ：The clinical pharmacist introduced the occurrence and treatment of cerebral infarction secondary to anaphylactic shock caused by Nicotinic acid injection in a patient with hypertension in the cardiovascular medicine department of our hospital. By consulting the relevant drug instructions and searching the relevant literatures ，the inducement and severity of ADR were evaluated ，and the rational drug use suggestions of Nicotinic acid injection were put forward. RESULTS & CONCLUSIONS ：According to the Management Measures for ADR Reporting and Monitoring ，the correlation between anaphylactic shock and Nicotinic acid injection was analyzed and evaluated as “very likely ”. Secondary cerebral infarction was mainly associated with a variety of risk factors （hypertension， hyperlipidemia，etc.），among which there was a greater possibility of secondary cerebral infarction due to insufficient cerebral perfusion caused by anaphylactic shock and sharp drop of blood pressure. The above symptoms could be life-threatening if not rescued in time ，which was defined as “severe ADR ”. Clinical pharmacists suggest that when using Nicotinic acid injection ，the patient’s allergy history should be inquired in detail ，the use should be started from a small dose ，and the patient ’s reaction should be closely monitored in the early stage of medication. For patients with high-risk factors of cerebrovascular diseases （hypertension， hyperlipidemia，etc.），if anaphylactic shock occurs ，the effective circulating blood volume should be restored as soon as possible. After the blood pressure rises ，drugs such as improving microcirculation can be used to prevent secondary cerebral infarction. Clinical pharmacists should timely carry out medication education for such patients ，and warn patients to inform doctors of the related drugs with severe ADR in the later stage of treatment ，so as to prevent the recurrence of anaphylactic shock and severe complications. At the same time ，when antihypertensive drugs and statins are combined ，the blood pressure monitoring and the monitoring of ADR such as muscle toxicity should be strengthened，so as to ensure the medication safety of patients.

Role of mitochondrial injury in the development and progression of nonalcoholic fatty liver disease / 临床肝胆病杂志

Mitochondria are an important organelle and can regulate lipid metabolism, oxidative phosphorylation, and ATP synthesis. Disorder of mitochondria biosynthesis, loss of mitochondrial homeostasis, and even mitochondrial structural damage will lead to lipid metabolism disorders and oxidative stress. Nonalcoholic fatty liver disease (NAFLD) is a chronic liver disease characterized by lipid accumulation in hepatocytes. NAFLD is a progressive disease manifesting as the process from hepatocyte steatosis to steatohepatitis, liver fibrosis, and liver cirrhosis. It is currently believed that mitochondria play an important role in the onset of NAFLD, and thus NAFLD is also referred to as “mitochondrial disease”. This article reviews the association of mitochondrial injury, such as lipid metabolism disorders, change in reactive oxygen species, and loss of mitochondrial homeostasis, with the development and progression of NAFLD.

Clinical Efficacy of Tiandan Tongluo Capsule Against Cerebral Infarction in Convalescence Corresponding to Stoke Due to Wind-Phlegm-Static Blood Obstructing Vessels / 中国实验方剂学杂志

Objective:To evaluate the safety and effectiveness of Tiandan Tongluo capsule in the treatment of cerebral infarction （CI） in convalescence （stoke involving meridians and collaterals due to wind-phlegm-static blood obstructing vessels）， with Naoshuantong capsule as a control. Method:A total of 352 convalescent patients with CI differentiated into stoke involving meridians and collaterals due to wind-phlegm-static blood obstructing vessels in traditional Chinese medicine （TCM） were included in this multi-center， randomized， double-blind， single-simulated， Naoshuantong capsule-controlled clinical trial， which lasted from 28 December， 2016 to 12 April， 2019. After being randomized into an experimental group and a control group at a ratio of 3∶1， patients in the experimental group were provided with oral Tiandan Tongluo capsule， five capsules per time， three times per day， whereas those in the control group received both Naoshuantong capsule simulator， two capsules per time， three times per day， and Naoshuantong capsule， three capsules per time， three times per day， for 12 successive weeks. The patients were followed up until 180 days after onset. The Barthel activities of daily living （ADL） index （BI） score was used as the primary outcome， and the secondary outcomes included neurological deficit score ［assessed with National Institutes of Health Stroke Scale （NIHSS）］， modified Rankin scale （mRS）， TCM syndrome score， and proportion of patients with new vascular events. The changes in laboratory indexes and the incidence of adverse reactions during treatment were observed. Result:Among the 389 cases enrolled， 30 dropped out， with the drop-out rate being 7.71%. There were 374 cases included in the full analysis set and 377 in the safety set. The comparison with the control group revealed that the total BI score and the percentage of BI score ≥ 75 in the experimental group were increased， but the difference was not statistically significant. The percentage of mRS score ≤ 2 within 180 days after onset in the experimental group obviously elevated in contrast to that of the control group （<italic>P</italic><0.05）. As demonstrated by TCM syndrome score analysis， the markedly effective rate in the experimental group was significantly higher than that in the control group （<italic>P</italic><0.05）. During the trial， the incidence rates of new vascular events in the experimental group and the control group were 0.00% and 1.09% （one case）， respectively， exhibiting no statistically significant difference between the two groups. Conclusion:Tiandan Tongluo capsule and Naoshuantong capsule both produce definite therapeutic effects in the treatment of CI in convalescence （stoke involving meridians and collaterals due to wind-phlegm-static blood obstructing vessels）. Compared with Naoshuantong capsule， Tiandan Tongluo capsule better alleviates neurological deficit， promotes neural functional recovery， and improves TCM syndrome score， without inducing severe adverse reactions.

Clinical study on improving the strength and activity of lumbar spine with Qiang Jin exercises / 中国骨伤

OBJECTIVE@#To observe the effect of Qiang Jin exercises on the muscle strength and activity of lumbar spine in patients with lumbar disc herniation.@*METHODS@#From March 2016 to September 2017, at the Department of Orthopaedics, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, a total of 110 subjects were enrolled, and 98 eligible subjects were screened. The subjects were randomized by stratified randomization and divided into experimental group and control group, 49 cases in each group, 25 males and 24 females in the experimental group, 25 males and 24 females in the control group. The experimental group exercised with Qiang Jin exercises, one time each morning and evening, each time10 sets were made;the control group used classic rehabilitation training, training twice a week, and three months was a course of treatment. After 12 weeks of training, the muscle strength and activity of the lumbar spine were evaluated and compared with the muscle strength and activity of the lumbar spine before training.@*RESULTS@#The experimental group and the control group had different muscle strength and activity of the lumbar spine before and after treatment (@*CONCLUSION@#Qiang Jin exercises can effectively improve the muscle strength and activity of the lumbar spine and improve the daily living ability of patients.

Application of real world study and human use experience in research and development of new traditional Chinese medicine drugs / 中国中药杂志

Real world study(RWS) refers to the process of collecting real world data related to the health of research subjects in the real world environment for pre-set clinical problems and obtaining the status of drug use and potential benefits/risks through analysis. The data are derived from the hospital information system(HIS), medical insurance system, disease registration system, adverse drug reaction monitoring system, etc. Human use experience of traditional Chinese medicine(TCM) is a new concept put forward by experts after summarizing the problems existing in clinical trials of new TCM drugs. The data come partially from the real world, and more importantly, such key elements as the formulated prescriptions of new TCM drugs, principles and methods, and clinical applications should be covered. RWS is mainly used for adverse drug reaction monitoring after marketing, benefit evaluation of listed drugs, decision-making of medical treatment and medical insurance, as well as supervision and approval of special medical devices and special drugs. It is complementary to randomized controlled clinical trials. Human use experience is suitable for the research and development of Chinese medicinal compound preparations and the expansion of functions and indications. There are no special provisions for clinical indications and target population. There exists a sequential relationship between the human use experience and clinical trials. Specifi-cally, the summarization of human use experience provides good support for the design and implementation of clinical trials, which is an important segment in the research and development of new TCM drugs. The correlation between real-world data and research results and their reliability should be ensured in RWS, and the unreality should be avoided. The key to summarizing the human use experience is to identify the clinical orientation, target population, course of treatment, usage and dosage of new TCM drugs, and it should be noted that human use experience does not only mean clinical experience. Experimental clinical trial(PCT), a type of study in the real world, has been commonly employed for the summary of human use experience. RWS and human use experience are different research designs targeting different clinical questions in the research and development of new TCM drugs, which can be flexibly selected depending on the actual situation.