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The quality evaluation of the blind method is to evaluate the clinical blind data obtained from clinical trials adopting the blind method and judge the effectiveness of the blind method by investigating the blind effect of different blind objects. A successful blind method can avoid the influence of subjective factors on the test results of subjects and researchers to a certain extent. The quality evaluation of the blind method can reflect not only the effectiveness of the blind method but also the accuracy and credibility of clinical trial results. In recent years， randomized controlled trials have been widely used in the evaluation of the clinical efficacy of traditional Chinese medicine （TCM）， but the quality of the implementation of blind methods is uneven， and the evaluation criteria have not yet been formed. In this paper， the data collection methods， calculation principles， advantages， and disadvantages of two quantitative quality evaluation methods of blind methods， namely James Blinding Index （JBI） and Bang Blinding Index （BBI）， were introduced. The two indexes were analyzed in a randomized controlled trial of acupuncture and moxibustion to relieve postoperative oral pain. The calculation process of the results was demonstrated by R software and visualized by forest map. At the same time， a tool table was designed to facilitate the collection of evaluation data of blind methods in TCM clinical trials at different stages. Finally， the necessity and feasibility of quality evaluation of blind method in TCM research were discussed to provide a basis for evaluating and improving the quality of blind method implementation in TCM clinical trials.
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ObjectiveTo evaluate the methodological quality of traditional Chinese medicine （TCM） diagnosis and treatment guidelines/consensus of constipation with Appraisal of Guidelines for Research and Evaluation Ⅱ （AGREE Ⅱ）tool， and to study the attention situation of the included Chinese patent medicines in China's National Reimbursement Drug List in the guidelines/consensus. MethodThe data of CNKI，VIP，Wanfang Data，SinoMed，PubMed and Cochrane from the inception of the databases to October 2021 were searched to collect the TCM diagnosis and treatment guidelines/consensus of constipation. Then，the diagnosis and treatment standards and recommended Chinese patent medicines were extracted. Two researchers assessed the methodological quality of the guidelines/consensus with AGREE Ⅱ tool independently. The quality of reports was evaluated by Reporting Items for practice Guidelines in HealThcare （RIGHT） Statement. The recommended Chinese patent medicines in the guidelines/consensus were compared with those in the National Reimbursement Drug List. ResultEleven consensus and 2 guidelines were included，involving 794 experts. The scores of AGREE II were clarity of presentation（59.0%），scope and purpose（44.0%），stakeholder involvement（23.1%），rigor of development （12.1%），applicability （11.1%），and editorial independence （8.3%） from high to low. Five articles were recommended at B level（recommended after revision） and 8 articles were at C level （not recommended）. The average scores of RIGHT Statement were as follows：basic information （93.59%），background （57.69%），evidence （18.46%），recommendations （20.88%），review and quality assurance （19.23%），funding，declaration and management of interests （0.00%）， and other information （0.00%）. The included guidelines/consensus recommended a total of 27 Chinese patent medicines，among which 20 were included in the National Reimbursement Drug List，with 4 species of Class A and 16 species of Class B， accounting for 74.1% of all recommended Chinese patent medicines. Ten purgative Chinese patent medicines in the National Reimbursement Drug List were recommended by the guidelines/consensus，accounting for 50% of all purgative drugs， and 8 were not recommended. There were prescriptions for purgation， for promoting digestion and removing food stagnation， for clearing heat and purging fire，and for warming the middle and dissipating cold，Tibetan medicine and Mongolian medicine. ConclusionBy the AGREE Ⅱ assessment，the methodological quality of the TCM diagnosis and treatment guidelines/consensus of constipation included in this study needed to be improved in the future. The report quality evaluated with RIGHT Statement was low. Most drugs included in the National Reimbursement Drug List were paid attention in the TCM diagnosis and treatment guidelines/consensus of constipation. Moreover，the drugs included in the National Reimbursement Drug List could basically fulfill the clinical needs reflexed from the guidelines/consensus recommendations. However， the reasons of some drugs failing to be included in the National Reimbursement Drug List needed to be studied in the future.
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Objective:To evaluate the clinical effectiveness and safety of Jiuwei-Zhuhuang San plus amoxilcillin sodium and sulbactam sodium in the treatment of bacterial pneumonia in children. Methods:A total of 120 patients with bacterial pneumonia in children from 1 year to 14 years old were randomly divided into the study group ( n=90) and the control group ( n=30) with ratio 3 to 1, the random sequence created by SAS software. Both groups were treated with amoxilcillin sodium for basic treatment, the observation group was treated with Jiuwei-Zhuhuang San. Both groups were treated for 1 week and followed up for 1 week. The cough frequency, clinical effective rate, symptoms and signs score, Traditonal Chinese medicine (TCM) pattern scores and adverse event rate were observed. Results:Eighteen cases were dropped and eliminated in the observation group, and 4 cases were dropped and eliminated in the control group, so 72 of observation group and 26 of control group were analyzed. After treatment, the clinical effective rate of the observation group was 27.8% (20/72), and the control group was 0% (0/26), where the difference was significant ( χ2=7.445, P=0.006). The difference of TCM syndrome score before and after treatment in the observation group (-16.8 ± 8.2 vs. -11.0 ± 5.8, t=-3.858) was lower than that of the control group ( P<0.01). There was significant difference between the two groups ( Z=-2.347, P= 0.019) in the TCM syndrome. The cough frequency of the observation group was 41.7% (30/72), and the control group was 26.9% (7/26). There wasn’t any significant differences in the cough frequency between two groups ( P>0.05). There was no statistical difference in symptoms and signs score or adverse event rate between two groups ( P>0.05). Conclusion:On the basis of amoxicillin sodium and sulbactam sodium, combined use of Jiuwei-Zhuhuang San can improve the clinical effectiveness of children with bacterial pneumonia.
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Objective To screen genes differentially expressed between dermal papilla cells from occipital and vertex scalp of patients with androgenic alopecia (AGA) through a 3D culture system.Methods Dermal papilla cells isolated from the occipital scalp tissue of patients with AGA were cultured in a 2D system for several days.Then,the third-passage dermal papilla cells were subjected to a 3D culture with the presence of dihydrotestosterone (DHT) for 72 hours (experimental group).The dermal papilla cells isolated from the vertex scalp tissue of patients with AGA,which were cultured in a 3D system with dimethyl sulfoxide,but not DHT,served as the control group.Subsequently,total RNA was extracted from the cells and reversely transcribed into cDNA followed by labeling with Cy3 and hybridization to a NimbleGen microarray.Gene ontology (GO) and pathway analysis was carried out to screen differentially expressed genes between the experimental and control group.Real time PCR was conducted to validate the results of microarray analysis.Results As the genome-wide expression profile analysis showed,there were 622 genes differentially expressed between the experimental group and control group,of which,359 were up-regulated and 263 were down-regulated in the experimental group compared with the control group.The above results were corffirmed by real time PCR.GO analysis revealed that the up-regulated genes,such as the CHEK1 and Tobl genes,were mainly involved in the inhibition of cell proliferation and promotion of cell apoptosis,while the down-regulated genes,such as the BAMBI,EFNA3,Dlx3 and UCGC genes,were associated with the acceleration of cell proliferation as well as the growth and development of epidermis.Pathway analysis showed that cell circle-controlling molecules were the most abundant molecules.Conclusions Numerous signalling molecules and pathways are involved in the development of AGA,which are mainly responsible for the modulation of cell circle,proliferation and apoptosis.