[Three oral Chinese patent medicines for children with tic disorder: a rapid health technology assessment].

This study aims to comprehensively evaluate the clinical value of Shaoma Zhijing Granules(SZG), Changma Xifeng Tablets(CXT), and Jiuwei Xifeng Granules(JXG) in the treatment of children with tic disorder with the method of rapid health technology assessment(RHTA), which is expected to serve as a reference for medical and health decision-making and clinical rational use of drugs in children. To be specific, relevant articles were retrieved from eight databases and three clinical trial registry platforms. After the quality evaluation, rapid assessment was carried out from the dimensions of disease burden and unmet needs, technical characteristics, safety, efficacy and economy, and the results were analyzed and presented descriptively. A total of 22 articles(1 in English, 21 in Chinese) were screened out: 18 randomized controlled trials(RCTs) and 4 clinical controlled trials(CCTs). Among them, 5 were about the SZG(all RCTs) and 9 were on CXT(6 RCTs and 3 CCTs). The rest 8 focused on JXG(7 RCTs and 1 CCT). Moreover, the overall risk of bias for 94.40% RCTs was evaluated as "some concerns" and only one(5.60%) had high risk of bias. In terms of quality, the 4 CCTs scored 5-6 points(<7 points), suggesting low quality. SZG alone or in combination with tiapride has obvious advantages in improving traditional Chinese medicine syndromes and tic symptoms compared with tiapride alone, with the average daily cost of CNY 79.44-119.16. Compared with conventional western medicine or placebo, CXT alone or in combination with conventional western medicine can improve the total effective rate and alleviate tic symptoms, and the average daily cost is CNY 22.50-67.50. JXG alone or in combination with conventional western medicine can effectively relieve tic symptoms compared with conventio-nal western medicine or placebo, with the average daily cost of CNY 82.42-164.85. The adverse events related to the three Chinese patent medicines mainly occurred in the digestive, respiratory, and nervous systems, all of which were mild. In general, SZG, CXT, and JXG are effective for children with tic disorder. They have been approved to be used in this field, of which SZG was approved in 2019, with the most up-to-date research evidence and high-quality RCT in Q1 journals. However, the comparative analysis of the three was affected by many factors, which should be further clarified. Based on the large sample data available in multiple dimensions, a comprehensive comparative evaluation of the three Chinese patent medicines should be carried out, thereby highlighting the advantages and disadvantages of them and serving a reference for rational clinical use and drug supervision.

Performance Investigation and Cost-Benefit Analysis of Recycled Tire Polymer Fiber-Reinforced Cemented Paste Backfill.

To alleviate the environmental problems caused by scrap tire and tailings disposal, the performance of recycled tire polymer fiber (RTPF)-reinforced cemented paste backfill (CPB) was investigated. Ordinary CPB, commercial poly-propylene fiber (CPPF) and reinforced CPB were also investigated for comparison. Slump tests, unconfined compression tests and a cost-benefit analysis were conducted. The results indicate that the flowability of the RTPF-reinforced CPB decreased with the increasing fiber content. The failure strain, unconfined compressive strength, and toughness values were generally higher than that of ordinary CPB (i.e., CPB without any fiber reinforcement). However, the mechanical properties would not be improved continuously with increasing RTPF content. It was found that the inclusion of RTPFs achieved the best improvement effect with the best mechanical properties of CPB at the fiber content of 0.6%. The failure mode of the RTPF-reinforced CPB was safer than that of the ordinary CPB. Microscopic observations indicated that the bond between RTPFs and the CPB matrix could affect the mechanical properties of the RTPF-reinforced CPB. From the cost-benefit analysis, the inclusion of RTPFs to reinforce CPB could gain relatively high mechanical properties with a low material cost.

[Analysis of RCT outcome indicators of traditional Chinese medicine for essential hypertension in recent two years].

To find the status of outcome indicators reported in published randomized controlled trial(RCT) of traditional Chinese medicine(TCM) for essential hypertension in the past two years, we searched for relevant information from four Chinese databases, three English databases and two clinical trial registries in this study, from January 2018 to September 2019. The outcome indicators of RCT were extracted and categorized from trials and the risk of bias was assessed by ROB tools from the Cochrane Collaboration. A total of 125 RCTs and 15 RCT protocols were finally included after study screening. The results showed that the RCT outcomes mainly included efficacy and safety outcomes. Efficacy indicators mainly included blood pressure measurement, quality of life assessment, blood biochemical indicators, urine analysis, arterial ultrasound, vascular endothelial function indicators, hematocrit, hemorheology indicators and other indicators. The safety indicators mainly included general physical examination items, heart, liver and kidney function tests, blood, urine, and stool routine examinations as well as adverse drug reactions/events. The current RCTs cannot distinguish primary and secondary outcomes, and the RCT protocols didn't report efficacy criteria clearly. They both didn't report health economic indicators and the methodological qualities were relatively low. In view of the current status on outcome indicators reported in TCM RCTs, constructing a core outcome set of TCM for essential hypertension and improving the methodology quality of RCTs will help to accurately reflect the actual efficacy of TCM intervention.

[Study on establishing a methodology of comprehensive clinical evaluation for Chinese patent medicine based on health technology assessment].

At present, most of Chinese patent medicines have problems, such as weak scientific basis, unclear clinical value evaluation, etc., which lead to the lack of sufficient evidence for the entry into the essential medicine list, medical insurance catalog and other important health resource allocation tools. This has a negative impact on the development of traditional Chinese medicine. It is urgent to establish a comprehensive evaluation methodology system of Chinese patent medicine in China. There are at least three reasons including producing evidence for clinical rational use scientifically, developing an objective and transparent selecting strategy, eventuating and highlighting its clinical value. The process and method of health technology assessment(HTA) can provide reference for the establishment of comprehensive evaluation method of Chinese patent medicine. However, HTA is rarely carried out in the field of traditional Chinese medicine. The latest domestic and international research showed that HTA combined with multi-criteria decision analysis(MCDA) can increase the transparency of decision-making and improve the quality of decision-making. The combined two formed the EVIDEM framework, which is conducive to drug selection and its clinical use. In this paper, the EVIDEM framework was introduced to establish the methodology framework of the comprehensive clinical evaluation system of Chinese patent medicine. A preliminary research idea has been put forward. In the future, we can establish a set of comprehensive clinical evaluation methods for Chinese patent medicine in cooperation with relevant national drug decision-making departments and management departments. It is believed that such cooperation could promote the full implementation of the re-evaluation for Chinese patent medicine.

[Methodological quality assessment of community-acquired pneumonia clinical practice guidelines in China based on AGREE â ¡ tool].

This study is aimed to identify and assess the methodological quality of community-acquired pneumonia (CAP) clinical practice guidelines (CPG) in China by using AGREE Ⅱ tool. CNKI, SinoMed, Wanfang, and VIP Chinese databases from database establishment to March 2017 were searched by manual retrieval to collect all the clinical practice guidelines prepared by various associations or organizations, then AGREE Ⅱtool was used to assess them. Data in each CPG were analyzed in terms of six domains, including scope and purpose, participants, rigor, clarity and readability, applicability and editorial independence. A total of 4 CPGs were included. The results showed that the scope and purpose scored 45.8%; the clarity of expression scored 44.75%; the participants scored 31.9%; the rigor scored 18.98%; the applicability scored 7%; and finally the editorial independence scored 1%. It is concluded that the quality of applicability and the editorial independence should attained paid more attention in future development or updating of the guidelines. In addition to strengthening the compliance with international general principles, we should also pay attention to the characteristics of traditional Chinese medicine treatment, especially the related evidences as complementary and alternative treatment for western intervention measures.

[Characteristics of Deposited Sediment and Assessment of Heavy Metals in Typical Tributaries Bay Riparian Zone of the Three Gorges Reservoir].

In order to analyze the spatial variation characteristics of grain diameter, nutrient elements and heavy metal pollution with deposition sediment in tributaries bay of the Three Gorges Reservoir, we selected 9 typical tributaries bay, 54 deposited sediment samples were collected from the riparian zone for analyzing grain diameter distribution, capacity, organic matter, nutrient elements of TN, TP and K, heavy metal elements of Cr, Cu, Ni, Pb, and Zn. The results indicated that particle size distribution from Wujiang River in Fuling to the Modao stream in Yunyang presented a trend of fluctuation, deposited sediment at 160-165 m elevation was coarser than that at 165-175 m elevation,volume percent of sand and clay presented a moderate variation at both altitudes, while silt had small variation. Independent sample t test showed that characteristics difference between the upper and lower sediments in riparian zone was not significant. The geo-accumulation index of heavy metal pollutants in the sediment from riparian zone of the Three Gorges Reservoir tributaries bay indicated that, only Zn element in Zhenxi River, Longdong River and Long River, Pb element in the Modao Stream belonged to non-moderate pollution levels, whereas there were no pollution of all other elements in tributaries.

Urgent need to improve the quality of case report in traditional Chinese medicine: Assessment on reporting quality of 3,417 cases.

OBJECTIVE: To survey the reporting quality of traditional Chinese medicine (TCM) case reports published in recent years and understand the common problems. The assessment results would lay the foundation for the development of recommendations for case report in Chinese medicine. METHODS: This survey determined the reporting quality of cases with Chinese herbal decoction, Chinese proprietary medicine, acupuncture, moxibustion and other traditional therapies published in 20 core medical journals of China by searching the China Academic Journals Full-text Database from 2006 to 2010. Fifty survey items in 16 domains were used to determine the reporting quality. One point was assigned to each item (Yes=1 point; No=0 point), and total score was 50 points. The domain of treatment was assessed independently, ranging from 2 to 9 items for different TCM interventions. RESULTS: The total of 1,858 case reports, covering 3,417 cases were included to analyze from 13 out of 20 core medical journals of China. There were 74.8% of them did not identify the nature of study in title, while 73.9% did not comprise an abstract. Incomplete reporting was found in discussions/ comment, and only 38.9% had made recommendations or take-away messages. Figures and tables were infrequently used. Three cases cited the full names of patients, but without declaring that any consent was obtained. Over 90% reported the symptoms and signs of TCM, and characteristics on tongue and pulse, but less than 50% did mention other medical history and diagnostic rationale. More than 90% treatments of the included cases were herbal decoction, with clear reporting on the ingredients and dosages. However, the reporting rate of the dosages of each ingredient was just 48.4%. Almost none reported the quality control of crude herbs, manufacturers and lot numbers of herbal proprietary medicine. Besides, advices and precautions on diet, emotions and living were rare to be illustrated. CONCLUSION: Systematic reporting recommendations are urged to develop for improving the contents and format of case reports in TCM.

Quantitative assessment of gene expression network module-validation methods.

Validation of pluripotent modules in diverse networks holds enormous potential for systems biology and network pharmacology. An arising challenge is how to assess the accuracy of discovering all potential modules from multi-omic networks and validating their architectural characteristics based on innovative computational methods beyond function enrichment and biological validation. To display the framework progress in this domain, we systematically divided the existing Computational Validation Approaches based on Modular Architecture (CVAMA) into topology-based approaches (TBA) and statistics-based approaches (SBA). We compared the available module validation methods based on 11 gene expression datasets, and partially consistent results in the form of homogeneous models were obtained with each individual approach, whereas discrepant contradictory results were found between TBA and SBA. The TBA of the Zsummary value had a higher Validation Success Ratio (VSR) (51%) and a higher Fluctuation Ratio (FR) (80.92%), whereas the SBA of the approximately unbiased (AU) p-value had a lower VSR (12.3%) and a lower FR (45.84%). The Gray area simulated study revealed a consistent result for these two models and indicated a lower Variation Ratio (VR) (8.10%) of TBA at 6 simulated levels. Despite facing many novel challenges and evidence limitations, CVAMA may offer novel insights into modular networks.

[Cultivation strategy and path analysis on big brand Chinese medicine for small and medium-sized enterprises].

Small and medium-sized enterprises (SMEs) are important components in Chinese medicine industry. However, the lack of big brand is becoming an urgent problem which is critical to the survival of SMEs. This article discusses the concept and traits of Chinese medicine of big brand, from clinical, scientific and market value three aspects. Guided by market value, highlighting clinical value, aiming at the scientific value improvement of big brand cultivation, we put forward the key points in cultivation, aiming at obtaining branded Chinese medicine with widely recognized efficacy, good quality control system and mechanism well explained and meanwhile which can bring innovation improvement to theory of Chinese medicine. According to the characters of SMEs, we hold a view that to build multidisciplinary research union could be considered as basic path, and then, from top-level design, skill upgrading and application three stages to probe the implementation strategy.

[Research progress on standards of commodity classes of Chinese materia medica and discussion on several key problems].

Standards of commodity classes of Chinese materia medica is an important way to solve the "Lemons Problem" of traditional Chinese medicine market. Standards of commodity classes are also helpful to rebuild market mechanisms for "high price for good quality". The previous edition of commodity classes standards of Chinese materia medica was made 30 years ago. It is no longer adapted to the market demand. This article researched progress on standards of commodity classes of Chinese materia medica. It considered that biological activity is a better choice than chemical constituents for standards of commodity classes of Chinese materia medica. It is also considered that the key point to set standards of commodity classes is finding the influencing factors between "good quality" and "bad quality". The article also discussed the range of commodity classes of Chinese materia medica, and how to coordinate standards of pharmacopoeia and commodity classes. According to different demands, diversiform standards can be used in commodity classes of Chinese materia medica, but efficacy is considered the most important index of commodity standard. Decoction pieces can be included in standards of commodity classes of Chinese materia medica. The authors also formulated the standards of commodity classes of Notoginseng Radix as an example, and hope this study can make a positive and promotion effect on traditional Chinese medicine market related research.

[Assessment of the results of syndrome in clinical trials of dementia treated by Chinese herbal medicine].

Chinese medical syndrome efficacy, as a second efficacy indicator, has been widely used in clinical trials of treating dementia by Chinese herbal medicine. The syndrome assessment tool is a key point in assessing the efficacy of Chinese medical syndrome. The syndrome assessment tool for dementia used nowadays needs to be optimized in content, reliability, and validity. In this paper, the authors reviewed some problems correlated with the design of Chinese medical assessment questionnaire on the basis of Chinese medical theories by combining the common requirements for questionnaire development.

[Thinking on risk assessment and risk management of post-marketing Chinese medicine].

Drug risk assessment and management is an important measure for reducing the adverse drug reaction and enhancing medication safety of the patient. Based on the concepts of drug risk assessment and risk management, and domestic and international drug risk management situation, this paper discusses the risk management of post-marketing Chinese medicine.

[Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials].

As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.

[Interpretation of modified prescription for pharmacoeconomic analysis of New Zealand].

The Prescription for Pharmacoeconomic Analysis (PFPA) of New Zealand was firstly published in 1999. The original version was reviewed in 2004 and version 2, approved and published in 2007, is the living document. The main purpose for this guideline is to provide an overview of the methods PHARMAC (Pharmaceutical Management of Agency) uses when conducting cost-utility analysis. Compared with version 1, version 2 involved and discussed the most frequently mentioned issues in pharmacoeconomic guidelines around the world. This paper describes the distinguishes between version 1 and 2, the advantages of version 2 as well as the amendments that will be made in PHARMAC's future work, in order to provide meaningful advice for standardizing and documenting methods in China

[Application of Markov model in post-marketing pharmacoeconomic evaluation of traditional Chinese medicine].

In post-marketing study of traditional Chinese medicine (TCM), pharmacoeconomic evaluation has an important applied significance. However, the economic literatures of TCM have been unable to fully and accurately reflect the unique overall outcomes of treatment with TCM. For the special nature of TCM itself, we recommend that Markov model could be introduced into post-marketing pharmacoeconomic evaluation of TCM, and also explore the feasibility of model application. Markov model can extrapolate the study time horizon, suit with effectiveness indicators of TCM, and provide measurable comprehensive outcome. In addition, Markov model can promote the development of TCM quality of life scale and the methodology of post-marketing pharmacoeconomic evaluation.