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.
Medicine, Chinese Traditional ; Nonprescription Drugs ; Consensus ; China ; Reference Standards ; Drugs, Chinese Herbal

Ischemic stroke is one of the main causes of death and long-term disability worldwide, which seriously affects the quality of life of patients and brings a heavy economic burden to families and society. Epidemiological studies have shown that stroke has become the second leading cause of death and major disabling disease in the world, with the characteristics of high morbidity, high recurrence, and high mortality. Epigenetic mechanism is the molecular process where gene expression and function in each cell are dynamically regulated and interconnected and a biological mechanism that changes genetic performance without changing the DNA sequence, including DNA methylation, histone modifications, and non-coding RNA. However, the research on epigenetics is currently focused on other diseases such as tumors. Recent studies have found that epigenetics has received extensive attention in the past few decades as a key factor involved in the pathophysiological process of ischemic stroke. The present study introduced the mediation of epigenetics in the induction of stroke, summarized the potential drug targets for these mechanisms in the treatment of stroke, and further explored the significance of traditional Chinese medicine(TCM) against cerebral ischemia injury based on TCM classification of stroke.
DNA Methylation ; Epigenesis, Genetic ; Humans ; Ischemic Stroke/genetics* ; Quality of Life ; RNA, Untranslated/metabolism* ; Stroke/genetics*

Objective: To understand the related factors of new-type drug use and recent HIV infection among men who have sex with men (MSM), and provide a reference for formulating targeted strategies for HIV/AIDS prevention and control. Methods: MSM were recruited in sentinel surveillance sites of nine cities in Shandong province from April to July 2021, with a sample size of 400 in each city. A face-to-face questionnaire was conducted to collect demographic characteristics, high-risk behaviors, acceptance of HIV intervention services, etc. Blood samples were collected for HIV and syphilis antibodies detection. Limiting-antigen avidity enzyme immunoassay (LAg-Avidity EIA) was used to detect recent HIV infection, and the rate of recent HIV infection was calculated. Results: 3 624 MSM were under study with the following characteristics as: aged (32.70±9.33) years old, the aged 30 and above (59.52%, 2 157/3 624), with high school education or below (55.99%, 2 029/3 624), being unmarried/divorced/widowed (57.70%, 2 091/3 624) and as having homosexual orientation (86.26%, 3 126/3 624) accounted for the more mainly. Of 32.95% (1 194/3 624) had same-sex unprotected anal sex in recent six months; 27.48% (993/3 613) ever used new-type drugs, and the HIV antibody positive rate was 3.12% (113/3 624). The recent HIV infection rate appeared as 2.61% (95%CI: 1.73%-3.49%). The multivariable logistic regression analysis indicated that the related factors of new-type drug use were unmarried/divorced/widowed (compared with being married/cohabitating, aOR=1.43, 95%CI: 1.22-1.69), educational level of college or above (compared with educational level of high school or below, aOR=1.47, 95%CI: 1.25-1.72), mainly through the Internet/dating software to find male sex partners (compared with mainly through bars/baths/parks and other places to find male sex partners, aOR=1.76, 95%CI: 1.41-2.19). Those who had unprotected anal sex in the last six months (compared with no unprotected anal sex, aOR=1.33, 95%CI: 1.13-1.57), had sexually transmitted diseases in the past year (compared with no sexually transmitted disease, aOR=2.77, 95%CI: 2.04-3.76) were more likely to use new-type drugs. The multinominal logistic regression showed that MSM who had unprotected anal sex in the last six months (compared with no unprotected anal sex, aOR=2.51, 95%CI: 1.25-5.01) or did not receive HIV intervention services in the past year (compared with those who received HIV intervention services, aOR=3.89, 95%CI: 1.30-11.60), were syphilis positive (compared with syphilis negative, aOR=8.18, 95%CI: 2.98-22.48), used new-type drugs (compared with those who did not use new-type drugs, aOR=4.75, 95%CI: 2.32-9.70) had a higher risk of recent HIV infection. Conclusions: New-type drugs have been widely used in MSM in Shandong province. The abuse of new-type drugs increases the risk of recent HIV infection.
Male ; Humans ; Young Adult ; Adult ; HIV Infections/epidemiology* ; Syphilis ; Homosexuality, Male ; Sexual and Gender Minorities ; Substance-Related Disorders/epidemiology* ; Acquired Immunodeficiency Syndrome

Objective: To understand the characteristics and depressive status of men who have sex with men (MSM) who self-reported HIV infection through heterosexual transmission and to provide evidence for personalized management of HIV infected people. Methods: A cross-sectional survey was carried out in Shandong province from September to December in 2019. Male HIV patients aged ≥15 years who self-reported HIV infection through heterosexual transmission were selected to verify the route of infection by one-to-one interview in Ji'nan, Qingdao, Weifang and Linyi cities of Shangdong province. According to the 1∶1 ratio, local HIV patients with age difference ≤3 years who self-reported MSM were selected as controls. A questionnaire survey was conducted, including data on demographic characteristics, behavior status, CES-D and PSSS. The related factors of the depressive symptoms and characteristics were analyzed. Results: A total of 373 male HIV patients were interviewed, and 39.7%(148/373) were confirmed as MSM after reexamination. The interviewers were: aged (40.3±12.0) years old, 41.9% (62/148) married/cohabiting. 27.0% (40/148) had been tested before HIV diagnosis, 71.6% (106/148) had homosexual partners ≥2 and 55.4% (82/148) had depressive symptom. Multivariate analysis showed that the MSM without HIV testings before diagnosis, had homosexual partners ≥2 before diagnosis, had first homosexual behavior at the age >30 years old and with depressive symptoms were more likely to conceal the true infection route. The incidence of depression among MSM who self-reported HIV infection through heterosexual transmission was related to physical health status social support and occupational stability. Conclusions: Some male HIV persons self-reported as being heterosexually transmitted were really transmitted through homosexual behavior. There were high-risk behaviors such as multiple partners and intersex among this group, and with high incidence of depression. It is necessary to encourage the reexamination program during follow-up and target on psychological and behavioral interventions, continuously.
Male ; Humans ; Adult ; Middle Aged ; Heterosexuality ; Depression/epidemiology* ; HIV Infections/epidemiology* ; Self Report ; Homosexuality, Male ; Cross-Sectional Studies ; Sexual and Gender Minorities

Objective: Comparative analyses of wild-type Clostridioides difficile 630 (Cd630) strain and pathogenicity locus (PaLoc) knockout mutant (ΔPaLoc) by using RNA-seq technology. Analysis of differential expression of Cd630 wild-type strain and ΔPaLoc mutant strain and measurement of its cellular virulence changes. Lay the foundation for the construction of an toxin-attenuated vaccine strain against Clostridioides difficile. Methods: Analysis of Cd630 and ΔPaLoc mutant strains using high-throughput sequencing (RNA-seq). Clustering differentially expressed genes and screening differentially expressed genes by DESeq software. Further analysis of differential genes using Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment. Finally, cytotoxicity assays of ΔPaLoc and Cd630 strains were performed in the African monkey kidney epithelial cell (Vero) and the human colonic cell (Caco-2) lines. Results: The transcriptome data showed that the ΔPaLoc mutant toxin genes tcdA and tcdB were not transcribed. Compared to the wild-type strain, CD630_36010, CD630_020910,CD630_02080 and cel genes upregulated 17.92,11.40,8.93 and 7.55 fold, respectively. Whereas the hom2 (high serine dehydrogenase), the CD630_15810 (spore-forming protein), CD630_23230 (zinc-binding dehydrogenase) and CD630_23240 (galactitol 1-phosphate 5-dehydrogenase) genes were down-regulated by 0.06, 0.075, 0.133 and 0.183 fold, respectively. The GO and KEGG enrichment analyses showed that the differentially transcribed genes in ΔPaLoc were enriched in the density-sensing system, ABC transport system, two-component system, phosphotransferase (PTS) system, and sugar metabolism pathway, as well as vancomycin resistance-related pathways. Cytotoxicity assays showed that the ΔPaLoc mutant strain lost its virulence to Vero and Caco-2 cells compared to the wild-type Cd630 strain. Conclusion: Transcriptional sequencing analysis of the Cd630 and ΔPaLoc mutant strains showed that the toxin genes were not transcribed. Those other differential genes could provide a reference for further studies on the physiological and biochemical properties of the ΔPaLoc mutant strain. Cytotoxicity assays confirmed that the ΔPaLoc mutant lost virulence to Vero and Caco-2 cells, thus laying the foundation for constructing an toxin-attenuated vaccine strain against C. difficile.
Bacterial Proteins/metabolism* ; Bacterial Toxins/metabolism* ; Caco-2 Cells ; Clostridioides ; Clostridioides difficile/genetics* ; Humans ; Oxidoreductases/metabolism* ; Transcriptome ; Vaccines, Attenuated

The present study explored the drying effect of new spiral vibration drying technology on Chinese medicinal pills with Liuwei Dihuang Pills, Zhuanggu Guanjie Pills, and Muxiang Shunqi Pills as model drugs. With the drying uniformity, drying time, energy consumption, pill split, dissolution time, and change of index components as evaluation indicators, the drying effect of spiral vibration drying technology on model drugs was evaluated and compared with traditional drying methods, such as hot air drying and vacuum drying in the oven. The dynamic changes of moisture in Liuwei Dihuang Pills with different drying time were investigated. Compared with the traditional drying methods in the oven(hot air drying and vacuum drying) at 80 ℃, the spiral vibration drying only took 80 min, shortened by 80%, with 10%-13% energy consumed. The results showed that the moisture of Liuwei Dihuang Pills was negatively related to the drying time. By virtue of multi-layer countercurrent drying and super resonant fluidization techniques, the new spiral vibration drying technology can significantly improve the drying quality of Chinese medicinal pills, improve the drying efficiency, and enhance the manufacturing capacity of Chinese medicinal pills. This study is expected to provide references for the innovation and development of new drying technology of Chinese medicinal pills.
China ; Desiccation ; Physical Therapy Modalities ; Technology ; Vibration

Background: Subclinical hypothyroidism (SCH) is the most common thyroid dysfunction, and its relationship with blood pressure (BP) has been controversial. The aim of the study was to analyze the association between SCH and newly-diagnosed hypertension. Methods: Based on data from the Thyroid disease, Iodine nutrition and Diabetes Epidemiology (TIDE) study, 49,433 euthyroid individuals and 7,719 SCH patients aged ≥18 years were enrolled. Patients with a history of hypertension or thyroid disease were excluded. SCH was determined by manufacturer reference range. Overall hypertension and stage 1 and 2 hypertension were diagnosed according to the guidelines issued by the American College of Cardiology/American Heart Association in 2017. Results: The prevalence of overall hypertension (48.7%), including stage 1 (28.9%) and 2 (19.8%) hypertension, increased significantly in SCH patients compared with euthyroid subjects. With elevated serum thyroid stimulating hormone (TSH) level, the hypertension prevalence also increased significantly from the euthyroid to different SCH subgroups, which was more profound in females or subjects aged <65 years. The age- and sex-specific regression analysis further demonstrated the same trends in the general population and in the 1:1 propensity matched population. Similarly, several BP components (i.e., systolic, diastolic, and mean arterial BP) were positively associated with TSH elevation, and regression analysis also confirmed that all BP components were closely related with SCH in female subjects aged <65 years. Conclusion The prevalence of hypertension increases for patients with SCH. SCH tends to be associated with hypertension and BP components in females younger than 65 years.

Background: Subclinical hypothyroidism (SCH) is the most common thyroid dysfunction, and its relationship with blood pressure (BP) has been controversial. The aim of the study was to analyze the association between SCH and newly-diagnosed hypertension. Methods: Based on data from the Thyroid disease, Iodine nutrition and Diabetes Epidemiology (TIDE) study, 49,433 euthyroid individuals and 7,719 SCH patients aged ≥18 years were enrolled. Patients with a history of hypertension or thyroid disease were excluded. SCH was determined by manufacturer reference range. Overall hypertension and stage 1 and 2 hypertension were diagnosed according to the guidelines issued by the American College of Cardiology/American Heart Association in 2017. Results: The prevalence of overall hypertension (48.7%), including stage 1 (28.9%) and 2 (19.8%) hypertension, increased significantly in SCH patients compared with euthyroid subjects. With elevated serum thyroid stimulating hormone (TSH) level, the hypertension prevalence also increased significantly from the euthyroid to different SCH subgroups, which was more profound in females or subjects aged <65 years. The age- and sex-specific regression analysis further demonstrated the same trends in the general population and in the 1:1 propensity matched population. Similarly, several BP components (i.e., systolic, diastolic, and mean arterial BP) were positively associated with TSH elevation, and regression analysis also confirmed that all BP components were closely related with SCH in female subjects aged <65 years. Conclusion The prevalence of hypertension increases for patients with SCH. SCH tends to be associated with hypertension and BP components in females younger than 65 years.

The purpose of the study is to analyze the outcomes of randomized controlled trial(RCT) of Chinese herbal medicine formula(CHMF) in the treatment of vascular cognitive impairment caused by cerebral small vessel disease(CSVD-VCI), and provide suggestions for future studies in this field. Three English databases, four Chinese databases, and two online registration websites of clinical trials were searched with use of the search strategy established in advance. Relevant RCTs published in recent ten years were screened, and necessary information was extracted to assess the risk of bias and analyze the outcomes of these RCTs. As a result, a total of 10 461 articles were retrieved, of which 8 681 were kept after de-duplication, and 41 RCTs were included after screening, with a generally higher risk of bias. The outcomes of included RCTs were classified into 9 categories, namely, clinical symptom outcomes, neuroimaging outcomes, neuroelectrophysiological outcomes, blood biochemical outcomes, hemorheology outcomes, physical signs, syndrome scores of traditional Chinese medicine(TCM), clinical effective rate, and safety outcomes. Among them, the most frequently reported outcomes of included RCTs were blood biochemical outcomes, and clinical symptom outcomes showed the highest reporting rate. Besides, 9 RCTs reported syndrome scores of TCM as the outcomes and illustrated corresponding evaluation criteria. The analysis showed that the application of RCT outcomes in this field had clinical rationality and limitations, and there were also some deficiencies in the trial design level, namely, no distinction between primary and secondary outcomes, insufficient blind methods, not detailed description of outcomes, disunity of evaluation tools, and despised endpoint outcomes. These limitations and deficiencies were negatively affecting the quality of RCTs of CHMF in the treatment of CSVD-VCI. Therefore, we suggest that future researchers should be well prepared in the top-level design stage, and actively construct the core outcome set of this field, so as to improve the quality of clinical trials.
Cerebral Small Vessel Diseases ; Cognitive Dysfunction ; Drugs, Chinese Herbal ; Humans ; Medicine, Chinese Traditional ; Phytotherapy

The expert consensus on clinical practice of Chinese patent medicines shall be regarded as the same with clinical practice guidelines,which shall be concise,readable and applicable. Therefore,a formal expert consensus is unable to contain the whole compilation process and the content of its important process documents. It is necessary to write instructions for continuation,expansion and publicity. In 2018 Standardization Department of China Association of Chinese Medicine invited methodologists with the background of evidence-based medicine drafted a series of standards for expert consensus on clinical practice of Chinese patent medicines,including the guidance for compilation the instructions. It will be useful for readers of expert consensus to understand the work behind the compilation,so as to make the compilation process more transparent and standardized. We proposed nine requirements for compilation the instructions,namely content and requirements,work overview,main technical content,compilation process,process and basis for handling major disagreements,expert consensus implementation requirements and measure suggestions,other issues need to be explained,appendix and format for instructions.
China ; Consensus ; Evidence-Based Medicine ; Medicine, Chinese Traditional ; standards ; Nonprescription Drugs ; standards