Exploring efficacy of Chinese medicine injection for promoting blood circulation and removing blood stasis in treatment of acute cerebral infarction based on two complex network analysis methods / 中国中药杂志

This study aims to explore the efficacy of Chinese medicine injections( CMIs) for promoting blood circulation and removing blood stasis for acute cerebral infarction from the perspectives of clinical medication and mechanism of action based on two complex network analysis methods. Firstly,the current 13 kinds of CMIs for acute cerebral infarction were obtained from 2019 List of medicines for national basic medical insurance,industrial injury insurance and maternity insurance with the method of network Meta-analysis. Secondly,with the use of network pharmacology,the mechanisms of top 2 CMIs with the highest therapeutic effect for acute cerebral infarction were explored from two levels including core target and network function enrichment. The result of network Meta-analysis showed Mailuoning Injection was superior to Danhong Injection in terms of total effectiveness rate for neurological deficit score and NIHSS score. The network pharmacology results showed that Mailuoning Injection had more core targets,interaction networks,enriched biological functions and more signaling pathways than Danhong Injection for cerebral infarction. Both two CMIs can play a role in treating cerebral infarction through core targets such as TP53 and NOS3,biological processes such as fibrinolysis,nitric oxide biosynthesis,nitric oxide-mediated signal transduction,negative regulation of apoptosis in endothelial cells and apoptosis process,as well as the signaling pathways such as PI3 K-Akt signaling pathway,HIF-1 signaling pathway and cell apoptosis signaling pathways. The results of pharmacological studies explained their differences in clinical efficacy to a certain extent. A research strategy based on curative effect should be advocated in efficacy evaluation of traditional Chinese medicine,where comparative research on clinical efficacy can be conducted firstly,and then mechanism research based on outstanding effective drugs to better provide references and basis for selection of similar competitive drugs for one disease in the clinical practice.

Semi-quantitative risk assessment of the contamination of Vibrio parahaemolyticus in oysters from Jinshan District, Shanghai / 上海预防医学

Objective To investigate the prevalence of Vibrio parahaemolyticus(VP)in oysters in Jinshan District, Shanghai and make assessment on the risks that may cause, providing the basis for prevention and control of foodborne disease. Methods Raw oyster samples with shells were randomly collected from markets, supermarkets and restaurants in Jinshan District from July to October in 2017. The content of VP in oysters was tested in accordance with the national standard methods. The semi-quantitative risk assessment for VP in oysters was made by Risk Ranger combining with the monitoring results of diet and health status of residents in Jinshan District of Shanghai in 2012-2013. Results The overall positive rate of VP in the 40 oyster samples was 80.0%(32/40). The positive rate of VP in oyster samples from farmer's markets was the highest, 85.7%(12/14), followed by those from restaurants and supermarkets. The relative risk for VP in raw oysters was 63. The probability of illness caused by VP in oysters per day per consumer of interest was 6.85×10-4, and the total predicted patients annual incidence rate in this population was 1 247.8/105. Conclusion The contamination of VP in seafood oysters in Jinshan District is serious. Eating raw oysters is at high risk; consumers are advised to reduce or avoid eating raw oysters, and processing food before eating is an effective method to decrease VP infection. Strengthening surveillance and management is imperative in this regard.

Evodiamine inhibits high-fat diet-induced colitis-associated cancer in mice through regulating the gut microbiota / 中西医结合学报

OBJECTIVE@#High-fat diet is one of the main risk factors that disrupt the balance of gut microbiota, which eventually will induce colorectal cancer (CRC). Evodiamine (EVO) is a wildly used multifunctional traditional Chinese medicine extract. In this study, we investigated the role of gut microbiota in high-fat diet-propelled CRC and the potential of EVO for CRC chemoprevention.@*METHODS@#Gut microbiota, serum d-lactic acid and endotoxin from 38 patients with colon cancer and 18 healthy subjects were detected by quantitative real-time polymerase chain reaction and enzyme-linked immunosorbent assay (ELISA). In addition, body mass index, phospho-signal transducer and activator of transcription 3 (p-STAT3) expression in cancer tissues and paracancerous tissues were detected by immunohistochemistry. A mouse intestinal inflammatory tumor model was established by azomethane/sodium dextran sulfate, followed by treatment with EVO and 5-aminosalicylic acid (ASA). Gut microbiota and inflammatory factors were detected by quantitative polymerase chain reaction, while serum d-lactic acid and endotoxin were detected by ELISA. Furthermore, cell proliferation, cell apoptosis, and interleukin (IL)-6/STAT3/P65 pathway were evaluated by 5-ethynyl-2'-deoxyuridine, terminal-deoxynucleotidyl transferase-mediated nick-end labeling, and Western blot assays.@*RESULTS@#In patients with colon cancer, the numbers of Enterococcus faecalis and Escherichia coli were increased, while those of Bifidobacterium, Campylobacter and Lactobacillus were decreased. Serum endotoxin and d-lactic acid levels and p-STAT3 levels were significantly increased. In the mouse model, both EVO and ASA inhibited tumor formation, decreased the proliferation of tumor cells, and induced apoptosis of tumor cells. Compared with the control group, the numbers of E. faecalis and E. coli were decreased, while Bifidobacterium, Campylobacter and Lactobacillus numbers were increased. In the EVO group, serum endotoxin and d-lactic acid levels and inflammatory factors were significantly decreased. Further, the IL6/STAT3/P65 signaling pathway was inhibited in the EVO group.@*CONCLUSION@#EVO may inhibit the occurrence of colon cancer by regulating gut microbiota and inhibiting intestinal inflammation. The potential mechanism involves inhibition of the IL6/STAT3/P65 signaling pathway, revealing its potential therapeutic significance in clinical applications.

Network Meta-analysis of randomized controlled trials of Chinese patent medicine for bradyarrhythmia / 中国中药杂志

To assess the clinical efficacy of Chinese patent medicine for bradyarrhythmia(BA) by using network Meta-analysis method. Relevant randomized controlled trials(RCTs) of Chinese patent medicine for BA were retrieved from China National Knowledge Infrastructure(CNKI), WanFang Database, VIP database, SinoMed, PubMed and Cochrane Library. The retrieval time ranged from the commencement of each database to February 2019. We completed the literature screening and data extraction according to the pre-determined inclusion and exclusion criteria. The quality of inclusion studies was assessed using the bias risk assessment tool recommended by the Cochrane Handbook of Systematic Review 5.3. The data were analyzed by WinBUGS, and STATA software was used for plotting. Finally, 46 RCTs were included, involving 4 Chinese patent medicines and 3 306 patients. According to the network Meta-analysis, the total effective rate in alleviating BA symptoms had 7 direct comparisons and 3 indirect comparisons. The efficacy of the 4 Chinese patent medicines combined with routine therapy was superior to that of routine therapy, with statistically significant differences. The order of the four Chinese patent medicines by efficacy was as follows: Shenxian Shengmai Oral Liquid>Shensong Yangxin Capsules>Xinbao Pills>Ningxinbao Capsules. The average heart rate had 7 direct comparisons and 3 indirect comparisons. The efficacy of Shenxian Shengmai Oral Liquid and Shensong Yangxin Capsules combined with routine therapy was superior to that of routine therapy, with statistically significant differences. The order of the four Chinese patent medicines by efficacy was as follows: Shenxian Shengmai Oral Liquid>Shensong Yangxin Capsules>Xinbao Pills>Ningxinbao Capsules. The results showed that the Chinese patent medicines combined with routine therapy were effective in the treatment of BA. Due to the differences in the quantity and quality of the included studies on different Chinese patent medicines, the sequencing results of Chinese patent medicines need to be further verified.

Risk assessment of cadmium contamination and dietary exposure in market aquatic products in one district of Shanghai / 上海预防医学

Objective To investigate the status of cadmium contamination in commercially sold aquatic products and to analyze the risk of dietary intake of cadmium among residents in one district of Shanghai. Methods Multistage sampling was used to collect 397 animal aquatic products from agricultural markets and supermarkets in 11 communities (townships), the District from 2018 to 2019.Cadmium content was tested according to national standard.The status of cadmium contamination was assessed by single factor pollution index(Pi)method.Risk of dietary intake of cadmium among residents was assessed by point evaluation method in combination with food consumption and dietary survey in 2013 and calculation of safe limits for cadmium in various aquatic diets(MOS). Results The detection rate of cadmium was 75.06% in the 397 animal aquatic products and the content of cadmium in 10 samples which crabs were totally exceeded the standard, accounting for 2.52%.The average contents of cadmium in crabs, bivalves which were higher than in shrimps(11.0 μg/kg), gastropods(7.6 μg/kg) and marine fish(3.8 μg/kg) were respectively 140.0 μg/kg and 90.0 μg/kg(χ2=186.41, P < 0.005), but no cadmium was detected in freshwater fish.The single factor pollution index(Pi) of crabs was 0.280 which meant light pollution and the Pi of other kinds of aquatic products was respectively under 0.100 that meant no cadmium contamination.The consumption of animal aquatic products was the highest in freshwater fish followed by shrimps, marine fish and crabs.The MOS of every kind of aquatic products is higher than 1 which meant cadmium intake from commercially sold animal products was an acceptable health risk for the population. Conclusion The risk level of cadmium intake by residents in the district through commercially sold animal aquatic products is relatively low, but the cadmium pollution status of commercially sold crustacean crabs should be vigilant, and the intake of crabs is advised to be reduced as far as possible.Relevant departments should also pay attention and strengthen monitoring and management in this regard.

Effect of parental factors on junior high students′ physical activity in their leisure time outside school / 上海预防医学

Objective To investigate the effects of parental support for the moderate-to-vigorous physical activity (MVPA) of their children and to promote physical activity for children and adolescents. Methods A total of 622 students were selected by stratified clustering sampling methods.Physical activity and parental support factors were assessed by self-report questionnaire survey.Logistic regression was used to analyze determinants of physical inactivity. Results Nearly 58.7% of the parents purchased sports equipment for their children and 57.6% of the parents accompanied their children to do exercise.The rate of parental explicit modeling was 22.8%.The students who received parental logistic support and explicit modeling did longer MVPA on weekends.The students with parental logistic support were prone to be in activity (OR=1.51, 95%CI:1.01-2.27). Conclusion Family-based interventions from parental logistic support and explicit modeling could promote middle-to-high-intensity activities for junior high school students.

Systematic review and trail sequential analysis of preparation of Xiakucao for Hashimoto's thyroiditis / 中国中药杂志

To systemically evaluate the clinical efficacy and safety of oral preparation of Xiakucao with levothyroxine(LT4) on Hashimoto's thyroiditis(HT), so as to provide the evidence for its clinical application in the future. All the included studies were retrieved from four Chinese databases and three English databases from their inception to December 2019. ROB assessment tool of cochrane system and the evidence classification recommended by GRADE were used to evaluate the quality of evidences in all included studies. RevMan 5.3 was used for Meta-analysis of the outcomes. Software TSA 0.9(trail sequential analysis) was used to estimate the sample size for Meta-analysis. The results showed that 11 randomized controlled trials and totaling 1 215 patients were included. Preparation of Xiakucao combined with LT4 was adopted as intervention in experimental group, while patients in control group were treated with LT4 alone. Meta-analysis results showed that as compared with control group, the rate of total efficacy in experimental group was significant improved, including improvement of thyroid function and thyroid autoantibodies, shrinkage of thyroid gland and nodule, and improvement of clinical symptoms such as fatigue and cold intolerance(RR=1.15, 95%CI[1.09, 1.21]). The experimental group significantly decreased the serum level of thyroperoxidase antibody TPO-Ab(SMD=-0.91, 95%CI[-1.40,-0.41]), and reduced the size of left thyroid lobe(MD=-1.46, 95%CI[-1.82,-1.11]), right thyroid lobe(MD=-1.45, 95%CI[-1.96,-0.94]) and isthmus of thyroid gland(MD=-1.08, 95%CI[-1.20,-0.95]). After evaluation based on GRADEpro, the results showed that the evidence quality of all included studies was low or very low. The result of TSA showed that the cumulative sample size had reached the expected value. However, the pooled results may be affected by one study with high bias risk, with not so high effect intensity of evidences. From this review, we can see that in treatment of HT, intervention of preparation of Xiakucao combined with LT4 has advantages on improvement of clinical efficiency, decreasing serum level of TPO-Ab and shrinkage of thyroid gland. However, due to the quality of evidence, more rigorously designed and high-quality trials are needed in the future to verify the clinical efficacy and safety of preparation of Xiakucao in treating HT.

Network Meta-analysis of oral Chinese patent medicine in treatment of acute cerebral infarction / 中国中药杂志

The efficacy of oral Chinese patent medicine in the treatment of acute cerebral infarction was systematically evaluated by network Meta-analysis. The literature search was conducted in three English databases(Medline, EMbase and Cochrane Library) and four Chinese databases(CNKI, VIP, WanFang and SinoMed) from inception to June 2018, and the randomized controlled trials of acute cerebral infarction were screened out according to the pre-set criteria. Two reviewers independently screened out the literature by using pre-specified eligibility criteria, and assessed the quality of included studies according to the risk of bias tool of Cochrane Handbook 5.1.0. Data analysis was conducted by using Stata 13.0 and WinBUGS 1.4.3 software. Finally, 52 RCT were included, involving 11 kinds of oral Chinese patent medicines. The results of the network Meta-analysis showed that in terms of the total effective rate, the order of efficacy was as follows: Naomaitai Capsules>Xiaoshuan Changrong Capsules>Angong Niuhuang Pills>Yangxue Qingnao Granules>Compound Danshen Dripping Pills>Naoxintong Capsules>Tongxinluo Capsules>Naoxueshu Oral Liquid>Zhuyu Tongmai Capsules>Yinxingye Tablets>Compound Danshen Tablets; in terms of neurological deficit scores, the order of efficacy was: Tongxinluo Capsules>Angong Niuhuang Pills>Compound Danshen Dripping Pills>Xiaoshuan Changrong Capsules>Yangxue Qingnao Granules>Zhuyu Tongmai Capsules>Naoxintong Capsules>Naoxueshu Oral Liquid; in terms of Barthel index score, the order of efficacy was: Xiaoshuan Changrong Capsules>Naomaitai Capsules>Naoxueshu Oral Liquid>Angong Niuhuang Pills>Tongxinluo Capsules>Zhuyu Tongmai Capsules. Although different oral Chinese patent medicines can improve these outcomes, the difference in efficacy ranking was relatively large. Because of the small number and low quality of research literature, the conclusion still needs to be proved by multi-center, large-sample, and double-blind randomized trials.

Systematic review and Meta-analysis of efficacy and safety of Xiangsha Yangwei Pills in treatment of chronic gastritis / 中国中药杂志

To systematically evaluate the efficacy and safety of Xiangsha Yangwei Pills in the treatment of chronic gastritis. Compu-ter retrieval was performed for Cochrane Library, Medline, EMbase, China Knowledge Network Database(CNKI), China Biomedical Literature Service System(SinoMed), Chongqing Weipu Chinese Science and Technology Journal Database(VIP) and WanFang Database(WanFang) randomized controlled trials about Xiangsha Yangwei Pills combined with Western medicine in the treatment of chro-nic gastritis. The retrieval time ranged from the establishment of the library to April 26, 2019. Meta-analysis was performed by RevMan 5.3 software after two independent researchers conducted literature screening, data extraction and quality evaluation according to inclusion and exclusion criteria. A total of 1 720 patients were enrolled in 18 RCT. According to the classification of chronic gastritis, they were divided into three subgroups: chronic gastritis, chronic atrophic gastritis and chronic superficial gastritis. The results of Meta-ana-lysis showed that the efficacy of Xiangsha Yangwei Pills combined with Western medicine in treating chronic gastritis was higher than that of Western medicine. As for the recurrence rate, Xiangsha Yangwei Pills combined with Western medicine was lower than Western medicine. And there was no statistical difference about helicobacter pylori(Hp) eradication rate between Xiangsha Yangwei Pills combined with Western medicine as well as Western medicine. In terms of the incidence of adverse reactions, Xiangsha Yangwei Pills combined with Western medicine was lower than Western medicine, and no serious adverse reaction was reported. The results of this systematic review showed that compared with the conventional Western medicine group, Xiangsha Yangwei Pills combined with Western medicine can significantly alleviate clinical symptoms of chronic gastritis, with fewer adverse reactions. However, due to the low methodological quality of the included studies and the reliability of the impact conclusions, high-quality multi-center, large-sample, randomized, double-blind controlled trials are needed for validation.

Analysis of status quo of RCT outcome indexes in treatment of acute ischemic stroke with traditional Chinese medicine / 中国中药杂志

The purpose of this study was to evaluate the selection situation of outcome indexes in randomized controlled trials of traditional Chinese medicine(TCM) in the treatment of acute ischemic stroke and to provide suggestions for future research. In this study, four Chinese databases and three English databases were searched from January 2017 to June 2019. The randomized controlled trials of traditional Chinese medicine in the treatment of ischemic stroke were selected according to the pre-established selection criteria. Cochrane bias risk assessment tool was used to evaluate the quality of the included studies. A total of 20 651 related articles were searched, and 11 662 ones were left after eliminating the repetitions. Finally, 42 articles were included, including 36 articles in Chinese and 6 articles in English, 40 randomized controlled trials and 2 registration schemes of randomized controlled trials. The results showed that the outcome indexes of 42 randomized controlled trials were mainly divided into seven categories, that is clinical outcome index, blood biochemical index, mental state evaluation index, cerebral hemodynamics index, index of evaluating the degree of carotid artery stenosis, safety indicators and other indicators. The blood biochemical index was the one with highest frequency, followed by the clinical outcome index. TCM syndrome score was used as an indicator of curative outcome in 17 studies. After the analysis, it was found that there were many problems in selecting the outcome indexes for the randomized controlled trials of traditional Chinese medicine in the treatment of cerebral apoplexy. For example, the end point index and hard index were rarely selected as the main outcome indicators, and the vast majority of them were intermediate alternative indexes; recognized curative effect could not be obtained; there were too many kinds of outcome indicators and excessive heterogeneity, hindering the promotion of superior treatment measures of traditional Chinese medicine in clinical practice. Therefore, we should draw lessons from the establishment method of the international core index outcome index set, construct the core index outcome index set of traditional Chinese medicine in the treatment of ischemic stroke, and develop the outcome index set which accords with the curative effect characteristics of traditional Chinese medicine treatment mea-sures to solve the problems effectively.

Meta-analysis of randomized controlled trials on effect of Tanreqing Injection combined with Western medicine on acute exacerbation of chronic bronchitis / 中国中药杂志

To systematically review the effectiveness and safety of Tanreqing Injection in treating acute exacerbation of chronic bronchitis( AECB). CNKI,Wan Fang,VIP,CBM,Medline,Cochrane Library,EMbase and Web of Science were retrieved,and randomized controlled trials for the effect of Tanreqing Injection in the treatment of acute exacerbation of chronic bronchitis were screened. The quality of the included studies was evaluated according to the Cochrane Handbook's evaluation criteria. The data was analyzed by RevMan 5.3. Totally 23 RCTs involving 1 901 patients were included,including 952 in the experimental group and 949 in the control group. The Meta-analysis demonstrated that in terms of the disappearance time of fever,the group of Tanreqing Injection combined with the conventional therapy was superior to conventional therapy group( RR =-1. 03,95%CI[-1. 45,-0. 62],P<0. 000 01); compared with the conventional therapy group,the group of Tanreqing Injection combined with conventional therapy had a higher cure rate for AECB( RR = 1. 17,95% CI[1. 13,1. 23],P < 0. 000 01). The group of Tanreqing Injection combined with levofloxacin had a higher cure rate for AECB than the levofloxacin group( RR = 1. 23,95% CI[1. 08,1. 41],P = 0. 002). The group of Tanreqing Injection combined with cefuroxime had a higher cure rate for AECB than the cefuroxime group( RR = 1. 22,95%CI[1. 05,1. 42],P = 0. 01).The group of Tanreqing Injection combined with cefoperazone sodium and sulbactam sodium had a higher cure rate for AECB than the group of cefoperazone sodium and sulbactam sodium( RR = 1. 22,95% CI[1. 04,1. 44],P = 0. 02). The outcomes of disappearance time of cough and expectoration had a huge heterogeneity,so were used for descriptive analysis. The adverse reactions mainly included skin rash,dizziness,gastrointestinal reactions. Based on the available data and the results of the analysis,the group of Tanreqing Injection combined with Western medicine has a higher cure rate for acute exacerbation of chronic bronchitis,and the effect in reducing symptoms disappearance time. In view of the limited number of included studies,small sample size and low methodological quality,the results of this study need to be confirmed with high-level clinical trials.

Editorial explanation for Expert consensus statement on Diemailing Kudiezi Injection in clinical practice / 中国中药杂志

Expert consensus statement on Diemailing Kudiezi Injection in clinical practice was approved on April 17,2019 by the Standardadization Office of the Chinese Association of Chinese Medicine. This project,which started in November 2017,has been developed and completed in accordance with the standard developing procedure. This paper will give a detailed introduction to the compilation process about the consensus. The aim is to enable readers to understand the background,purpose and basis of this consensus in a timely manner. Readers can learn about diffferent stages of develping process,including project management system,drafting,consulting,expert consensus,as well as current problems and shortcomings. Such an editorial explanation is just a dynamic follow-up of the whole consensus-making process. It also plays a good supervisory role in the whole consensus-making. It could be a guarantee for the quality of the consensus. There is no doubts that the editorial explanation is an important auxiliary document in the process of consensus-making. It is the extension and supplement of consensus content and a basis for fully understanding the technical content of this consensus. Therefore it is an indispensable document in the process of consensus-making.

Systematic review and Meta-analysis of Huoxiang Zhengqi Pills combined with Western medicine for acute gastroenteritis / 中国中药杂志

To systematically review the efficacy and safety of Huoxiang Zhengqi Pills combined with Western medicine in the treatment of acute gastroenteritis. Four Chinese databases( CNKI,VIP,Wan Fang,Sino Med) and three English databases( Cochrane Library,Medline,EMbase) were systematically and comprehensively searched from the database establishment to April 2019 to collect the randomized controlled trials( RCTs) about the treatment of acute gastroenteritis with Huoxiang Zhengqi Pills combined with Western medicine. Two investigators independently performed literature screening,data extraction and bias risk assessment. Rev Man 5. 3 software was used for data analysis. A total of 316 articles were retrieved and finally 44 studies were included in this study,involving 4153 patients. The overall quality of the included studies was generally low. Meta-analysis results showed that in the total clinical effective rate,Huoxiang Zhengqi Pills combined with conventional treatment or norfloxacin tablets was superior to conventional treatment or norfloxacin tablets alone. In terms of the time for improving clinical symptoms,Huoxiang Zhengqi Pills combined with conventional treatment or norfloxacin tablets could better relieve fever than conventional treatment or norfloxacin tablets alone. In terms of incidence of adverse reactions,there was no statistical difference between Huoxiang Zhengqi Pills combined with conventional treatment and conventional treatment alone. Other outcome measures were affected by various factors( such as inclusion of only 1 study or excessive heterogeneity among studies) and could not be concluded. Due to the limitations of the quality and quantity of included studies,this conclusion still needs to be verified by more high quality researches.

Systematic review and Meta-analysis on randomized controlled trials on effectiveness and safety of Kudiezi Injection in treatment of acute cerebral infarction / 中国中药杂志

To systematically review the effectiveness and safety of Kudiezi Injection in treating patients with acute cerebral infarction( ACI). Four Chinese databases( CNKI,VIP,Wan Fang,Sino Med),three English databases( Cochrane Library,EMbase,Medline)and Clinical Trail.gov were systematically and comprehensively retrieved. The retrieval time was from the establishment of each database to November 2017. Randomized controlled trials( RCTs) for the treatment of acute cerebral infarction with Kudiezi Injection were screened out according to pre-established inclusion criteria and exclusion criteria. The quality of the included studies was assessed using the Cochrane Risk Assessment Tool,and the included studies were put into descriptive analysis or Meta-analysis using the Rev Man 5. 3 software. A total of 932 articles were retrieved,and finally 14 studies were included. Except for 2 multi-arm trials,the total sample size was 1 244 in the experimental group and 638 in the control group. The overall quality of the included studies was not high. The results of Meta-analysis showed that Kudiezi + conventional therapy for acute cerebral infarction was superior to conventional therapy in total effective rate( RR = 0. 86,95% CI[0. 77,0. 96],P = 0. 006); Kudiezi + conventional therapy for acute cerebral infarction was superior to conventional therapy in serum inflammatory factors( MDhs-CRP=-3. 77,95% CI[-4. 17,-3. 37],P < 0. 000 01; MDIL-18=-16. 18,95% CI[-19. 26,-13. 11],P<0. 000 01); Kudiezi + conventional therapy was superior to conventional therapy in Barthel index( MD = 12. 52,95%CI[8. 93,16. 10],P<0. 000 01). Adverse reactions included in the study reports showed mild adverse reactions. Based on the results of this study,Kudiezi Injection combined with conventional therapy or other Western medicine had a certain curative effect on acute cerebral infarction,with no serious adverse reactions. However,due to the low quality of the included research methodology,the conclusions of this study were not recommended. In addition,in order to produce high-quality evidence for the clinical application of Kudiezi Injections,more randomized controlled trials with a large sample size,scientific design and strict implementation were required to study the effectiveness and safety of Kudiezi Injection in the treatment of cerebral infarction.

Efficacy and safety of Breviscapine Injection in treatment of diabetic nephropathy: systematic review and Meta-analysis of randomized controlled trials / 中国中药杂志

This study aimed to systematically evaluate the efficacy and safety of Breviscapine Injection in the treatment of diabetic nephropathy( DN). Eight electronic databases and Clinical Trials.gov were searched to collect randomized controlled trials on Breviscapine Injection in the treatment of DN. According to the Cochrane Handbook 5. 1,two independent reviewers screened out the literatures,extracted data and assessed the quality of the studies included. Rev Man5. 3 software was used for the data analysis. A total of 29 studies containing 37 trials were included,involving 2 097 patients,1 054 cases in test groups and 1 043 cases in control groups. The clinical studies included had a low overall quality. According to Meta-analysis: ①Conventional therapy plus breviscapine injection was superior to conventional therapy in total efficiency rate,24 h UTP,SCR,BUN,UEAR,ALB and m ALB during DN stage Ⅲ( RRtotal effective rate=1. 60,95%CI [1. 32,1. 93],P<0. 000 01; SMD24 h UTP=-1. 21,95%CI[-1. 56,-0. 87],P<0. 000 01; MDSCR=-6. 33,95%CI[-9. 20,-3. 46],P<0. 000 1; MDBUN=-6. 6,95%CI[-1. 10,-0. 22],P = 0. 003; MDUEAR=-20. 30,95%CI [-28. 14,-12. 46],P<0. 000 01; MDALB= 0. 47,95%CI[0. 42,0. 52],P<0. 000 01; MDmALB=-10. 03,95%CI[-10. 62,-9. 46],P<0. 000 01). ②Conventional therapy plus Breviscapine Injection was better than conventional therapy in total efficiency rate( only 1 study),24 h UTP,SCR and BUN during DN stage Ⅳ( RRtotal effective rate= 1. 57,95% CI[1. 10,2. 25],P = 0. 01; SMD24 h UTP=-0. 52,95% CI [-0. 71,-0. 33],P<0. 000 01; MDSCR=-35. 38,95%CI[-48. 57,-22. 19],P<0. 000 01; MDBUN=-1. 89,95%CI [-3. 01,-0. 77],P<0. 000 01). ③Conventional therapy plus Breviscapine Injection was better than conventional therapy in SCR( MD =-26. 35,95% CI[-47. 45,-5. 24],P= 0. 01),but with no significant difference in 24 h UTP,BUN and ALB during DN stageⅤ. ④It was impossible to obtain the specific judgment information on the adverse reactions of Breviscapine Injection in the treatment of the disease from the existing evidences. The current evidences suggest that the combination of Breviscapine Injection and conventional therapy had a certain curative effect in the treatment of DN,especially in stages Ⅲ and Ⅳ. The safety of Breviscapine Injection needs to be further explored.Because the low quality of the study impacted the accuracy of the result,more rigorous,high-quality,multi-center,randomized doubleblind controlled trials are required to increase the support of the evidences in the future.

Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica / 中国中药杂志

To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials （1.09%） reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials. At the same time, in order to improve the reporting quality of randomized controlled trials, CONSORT standards should be adopted in the preparation of research reports and submissions.

Efficacy and safety of breviscapine injection in treatment of unstable angina pectoris: systematic review and Meta-analysis / 中国中药杂志

To systematically evaluate the efficacy and safety of breviscapine injection in the treatment of unstable angina pectoris (UAP). Eight electronic databases and clinical trials registries were searched to collect randomized controlled trials on breviscapine injection in the treatment of UAP. According to the evaluation standards in Cochrane Handbook 5.1, two independent reviewers screened out the literature, extracted data and assessed the quality of the studies included. RevMan 5.3 software was used for Meta quantitative analysis and corresponding description analysis. A total of 36 studies involving 3 058 patients were included, 1 552 cases in the trial group, 1 506 cases in the control group, 1 846 males and 1 212 females. All the clinical studies showed a low quality. Meta-analysis results showed that the combination of breviscapine injection and conventional therapy was superior to conventional therapy in angina pectoris efficacy (RRangina pectoris efficacy=1.29, 95%CI[1.23,1.35],<0.000 01；RRECG1=1.25,95%CI[1.12,1.38],<0.000 1；RRECG2=1.38,95%CI[1.27,1.49],<0.000 01); descriptive analysis of a single study showed that the efficacy of combination of breviscapine injection and conventional therapy was superior to that of conventional therapy alone. In respect of hemorheology, the combination of breviscapine injection and conventional therapy was better than conventional therapy in lowering LBV and EAI (MDLBV=-1.27,95%CI[-1.55,-0.99],<0.000 01；MDEAI=-0.38,95%CI[-0.60,-0.16],=0.000 6), as well as in lowering WBV and HCT in the descriptive analysis of single study. In respect of blood lipid, the combination of breviscapine injection and conventional therapy was better than conventional therapy in lowering TC, TG and LDL-C (MDTC=-0.30,95%CI[-0.51,-0.10],=0.003；MDTG=-0.32,95%CI[-0.77,0.13],=0.16；MDLDL-C=-0.45,95%CI[-0.76,-0.14],=0.004). In reducing the frequency of angina attacks, heart rate, high sensitive C-reactive protein and improving exercise tolerance, the combination of breviscapine injection and conventional therapy was also superior to the conventional therapy alone (MDFAP=-3.30,95%CI[-4.06,-2.54],< 0.000 01；MDHR=-9.38,95%CI[-12.78,-5.98],=0.000 2；MDhs-CRP=-0.56,95%CI[-0.85,-0.27],=0.000 2；MDET=0.88,95%CI[0.41,1.35],=0.000 2). The main adverse reactions in the two groups included headache, dizziness, palpitations, nausea, abdominal distension, skin pruritus, flushes and allergic reactions in the study. The safety of breviscapine injection needs to be further studied and clarified because of the combination of drugs and the incomplete information reported in the original study. The current evidence suggested that the combination of breviscapine injection and conventional therapy had certain advantages in curative effect for the treatment of UAP. Due to the low quality of the study and its own shortcomings, it is necessary to design more rigorous, high-quality, multi-center randomized double-blind controlled trials to increase the strength of the evidence.

Effectiveness and safety of Kudiezi injection in treating coronary angina pectoris: systematic review and Meta-analysis of randomized controlled trials / 中国中药杂志

To evaluate the effectiveness and safety of Kudiezi injection in the treatment of angina pectoris of coronary heart disease. Four Chinese databases (CNKI, VIP, WanFang, and SinoMed) and three English databases (Cochrane Library, Medline, and ClinicalTrail.gov) were systematically and comprehensively searched from the establishment of each database to March 2018. Randomized controlled trials (RCTs) on the treatment of angina pectoris of coronary heart disease with Kudiezi injection (KDZ) were screened according to the pre-established inclusion criteria and exclusion criteria. The quality of the included studies was evaluated by using the ROB tool developed by the Cochrane Collaboration, and RevMan 5.3 software was used for Meta-analysis. A total of 712 articles were retrieved and finally 38 studies were included. The total sample size was 3 812 cases, 1 945 in the experimental group and 1 867 in the control group. The overall quality of the included studies was generally low. The results of Meta-analysis showed that: KDZ combined with conventional or western medicine was superior to conventional or western medicine alone in the effectiveness and electrocardiogram efficacy of angina pectoris and unstable angina. The descriptive analysis showed that KDZ combined with conventional treatment group was superior to conventional treatment group in agina pectoris associated indicators of angina pectoris and unstable angina. Other outcome measures were easily affected by various factors (such as too large heterogeneity of outcome indicators) and could not be concluded. Adverse reactions included in the study report were all mild adverse reactions and did not affect treatment. Based on the results of this study, it can be seen that Kudiezi injection had a certain effect on the treatment of angina pectoris of coronary heart disease, especially with significant positive effect on the improvement of the curative effect for angina pectoris and the effect of electrocardiogram. No serious adverse reactions occurred. However, due to the limited number of studies included, the generally low quality of the included studies, and the existence of published biases, the quality of the evidence in this study was low, so that caution should be taken to apply this conclusion. The effectiveness and safety of Kudiezi injection in the treatment of angina pectoris of coronary heart disease remained to be confirmed in the future with a well-designed and rigorous multi-center randomized controlled trials with standardized report, large sample, and enough follow-up time.

Report quality evaluation of systematic review or Meta-analysis published in China Journal of Chinese Materia Medica / 中国中药杂志

To evaluate the report quality of intervention-related systematic reviews or Meta-analysis published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia Medica webpages to collect intervention-related systematic reviews or Meta-analysis since the first issue of the magazine. A total of 40 systematic reviews or Meta-analysis reports were included, including one network Meta-analysis. According to the PRISMA statement published in 2009, the report quality of the systematic reviews or Meta-analysis was evaluated. According to the results, 3 had the low quality, 30 had the medium quality, and 7 had the high quality. The average score for all of items was 30 points (21-30.5 points for the medium quality). The 17 high-quality (31-40 points) report items were title, rationale, objectives, information sources, study selection, data collection process, data items, risk of bias in individual studies, summary measures, risk of bias across studies, study selection, study characteristics, risk of bias within studies, results of individual studies, synthesis of results, risk of bias across studies and funding; the 4 medium-quality (21-30.5 points) reporting items were eligibility criteria, search, limitations and conclusions; and the 6 low-quality (<=20.5 points) reporting items were structured summary, protocol and registration, synthesis of results, additional analysis (No.16), additional analysis (No.23) and summary of evidence. Through the analysis, it is found that the report quality of intervention-related systematic reviews or Meta-analysis published in China Journal of Chinese Materia Medica is medium, and it is necessary to improve the quality standard of the report.

Application of isothermal titration calorimetry in drug research / 中草药

Isothermal titration calorimetry (ITC) is a real-time, quantitative, on-line, and dynamic thermal analysis technique for describing reaction processes. Some thermodynamic parameters, such as association constant, dissociation constant, stoichiometry ratio, enthalpy change, and entropy change of host and guest interaction, can be obtained in ITC analysis. This technique has the advantages of high calorimetric sensitivity and accurate measurement. In this paper, the principle and application characteristics of ITC technology are described, and the application of this technique in drug research are reviewed, including the interaction between drugs and proteins, the interaction between drugs and DNA molecules, clinical drug compatibility, the application in pharmaceutical preparations and the interaction between drugs and biomembrane. Lastly, the application of this technique in the nonspecific molecular interaction is prospected.