Objective To analyze the current status of clinical trial registration of common anorectal diseases in Chinese Clinical Trial Registry(ChiCTR)and the research of TCM.Methods The ChiCTR database was retrieved to collect and organize clinical trials related to hemorrhoids,anal fissures,anal fistulas,perianal abscesses,and perianal eczema.The retrieval time was from the establishment of the database to December 10,2023.Characterization of included registration trials was analyzed.Results A total of 148 registered projects were included,75 of which were TCM-related clinical trials.Among them,134 clinical trials were pre-registered and 121 passed the ethical review.Shanghai,Jiangsu,Guangdong,Beijing and Sichuan accounted for 76.35％of the total number of registrations,and the largest number of registered projects was in Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine.The top 3 funding sources were local finance,self-funding and hospital funding.The registered projects were mainly intervention studies.114 studies used randomized methods and 34 studies were blinded.Conclusion At present,the number of ChiCTR-registered clinical trials on anorectal diseases is on an increasing trend,and the treatment of anorectal diseases with TCM has obvious characteristics.However,there are cases of irregular filling of registration content and uneven regional distribution.

Objective To investigate the distribution characteristics and future trends of clinical trials related to TCM prevention and treatment of constipation by analyzing the clinical trials registered in the Chinese Clinical Trial Registry(ChiCTR).Methods The clinical trials data related to TCM prevention and treatment of constipation in the ChiCTR database were retrieved from the establishment of the database to April 15,2024.Excel 2019 was utilized for de-duplication.Subsequently,SPSS 26.0 was employed to analyze the general characteristics,research types,intervention measures,etc.of the included trials,charts were drawn,and the clinical trial characteristics were summarized.Results A total of 107 clinical trials were included,with 102 being pre-registered,involving 21 provincial-level administrative regions and 75 clinical institutions.The top five regions in terms of the number of registered clinical trials were Beijing(19.63%),Shanghai(15.89%),Guangdong(14.02%),Sichuan(10.28%)and Jiangsu(9.35%).The top three sources of funding were local finance(28.97%),self-raised funds(18.69%)and hospital-funded funds(15.89%).The research types were mostly intervention studies(92.52%),of which 41 explicitly stated the use of blinding methods,and the main research design type is randomized parallel controlled trial.Conclusion The number of clinical trials related to TCM prevention and treatment of constipation registered in ChiCTR is on an upward trend.However,there is a noticeable geographical imbalance in the distribution of these trials,and there is a need for further improvement in the quality of trial design and the standardization of registration information.

Objective To analyze the clinical trial projects of TCM treatment for psoriasis registered at the China Clinical Trial Registry(ChiCTR);To provide references for clinical research in this field.Methods Clinical trial studies on the TCM treatment for psoriasis were retrieved from the ChiCTR database from the establishment of the database to June 17,2024.Excel 2019 and GraphPad Prism 9.0 were used to organize and analyze the general characteristics included in registered clinical trials.Results Totally 65 TCM-related trials were included,of which 58(89.23%)were prospectively registered,and 55(84.62%)had undergone ethical review.The majority of trials were registered in Guangdong,Beijing and Shanghai,collectively accounting for 78.46%(n=51)of the total.The leading institution,Guangdong Provincial Hospital of Chinese Medicine,contributed 19 trials.Funding was predominantly sourced from governmental bodies,with 72.31%(n=47)supported by national or regional grants.Among the registered studies,interventional trials predominated(n=56),including 46 randomised parallel-controlled designs.Blinding was implemented in 23 trials,and biospecimen collection was reported in 48 studies.40 trials were single-centre studies,and a cumulative sample size was 17 695 participants.Common interventions included oral administration of classical TCM formulations or hospital-prepared remedies,alongside topical applications such as medicated baths and ointments.The primary outcome measure in most trials was the Psoriasis Area and Severity Index.Conclusion While the number of registered clinical trials on TCM for psoriasis in China demonstrates a fluctuating yet upward trend,the overall volume remains modest.Disparities in regional distribution,methodological variability,and incomplete trial registration details highlight areas for improvement.

Objective To analyze the clinical trial projects of TCM treatment for psoriasis registered at the China Clinical Trial Registry(ChiCTR);To provide references for clinical research in this field.Methods Clinical trial studies on the TCM treatment for psoriasis were retrieved from the ChiCTR database from the establishment of the database to June 17,2024.Excel 2019 and GraphPad Prism 9.0 were used to organize and analyze the general characteristics included in registered clinical trials.Results Totally 65 TCM-related trials were included,of which 58(89.23%)were prospectively registered,and 55(84.62%)had undergone ethical review.The majority of trials were registered in Guangdong,Beijing and Shanghai,collectively accounting for 78.46%(n=51)of the total.The leading institution,Guangdong Provincial Hospital of Chinese Medicine,contributed 19 trials.Funding was predominantly sourced from governmental bodies,with 72.31%(n=47)supported by national or regional grants.Among the registered studies,interventional trials predominated(n=56),including 46 randomised parallel-controlled designs.Blinding was implemented in 23 trials,and biospecimen collection was reported in 48 studies.40 trials were single-centre studies,and a cumulative sample size was 17 695 participants.Common interventions included oral administration of classical TCM formulations or hospital-prepared remedies,alongside topical applications such as medicated baths and ointments.The primary outcome measure in most trials was the Psoriasis Area and Severity Index.Conclusion While the number of registered clinical trials on TCM for psoriasis in China demonstrates a fluctuating yet upward trend,the overall volume remains modest.Disparities in regional distribution,methodological variability,and incomplete trial registration details highlight areas for improvement.

Objective To investigate the distribution characteristics and future trends of clinical trials related to TCM prevention and treatment of constipation by analyzing the clinical trials registered in the Chinese Clinical Trial Registry(ChiCTR).Methods The clinical trials data related to TCM prevention and treatment of constipation in the ChiCTR database were retrieved from the establishment of the database to April 15,2024.Excel 2019 was utilized for de-duplication.Subsequently,SPSS 26.0 was employed to analyze the general characteristics,research types,intervention measures,etc.of the included trials,charts were drawn,and the clinical trial characteristics were summarized.Results A total of 107 clinical trials were included,with 102 being pre-registered,involving 21 provincial-level administrative regions and 75 clinical institutions.The top five regions in terms of the number of registered clinical trials were Beijing(19.63%),Shanghai(15.89%),Guangdong(14.02%),Sichuan(10.28%)and Jiangsu(9.35%).The top three sources of funding were local finance(28.97%),self-raised funds(18.69%)and hospital-funded funds(15.89%).The research types were mostly intervention studies(92.52%),of which 41 explicitly stated the use of blinding methods,and the main research design type is randomized parallel controlled trial.Conclusion The number of clinical trials related to TCM prevention and treatment of constipation registered in ChiCTR is on an upward trend.However,there is a noticeable geographical imbalance in the distribution of these trials,and there is a need for further improvement in the quality of trial design and the standardization of registration information.

Objective To analyze the current status of clinical trial registration of common anorectal diseases in Chinese Clinical Trial Registry(ChiCTR)and the research of TCM.Methods The ChiCTR database was retrieved to collect and organize clinical trials related to hemorrhoids,anal fissures,anal fistulas,perianal abscesses,and perianal eczema.The retrieval time was from the establishment of the database to December 10,2023.Characterization of included registration trials was analyzed.Results A total of 148 registered projects were included,75 of which were TCM-related clinical trials.Among them,134 clinical trials were pre-registered and 121 passed the ethical review.Shanghai,Jiangsu,Guangdong,Beijing and Sichuan accounted for 76.35％of the total number of registrations,and the largest number of registered projects was in Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine.The top 3 funding sources were local finance,self-funding and hospital funding.The registered projects were mainly intervention studies.114 studies used randomized methods and 34 studies were blinded.Conclusion At present,the number of ChiCTR-registered clinical trials on anorectal diseases is on an increasing trend,and the treatment of anorectal diseases with TCM has obvious characteristics.However,there are cases of irregular filling of registration content and uneven regional distribution.

Objective:To investigate the protective effect of ulinastatin combined with adipose-derived stem cells (ADSCs) transplantation on renal tissue in rats with endotoxic shock.Methods:20 Sprague Dawley rats were randomly selected as normal group from 108 Sprague Dawley rats. The remaining 88 rats were treated with 2 ml lipopolysaccharide (10 mg/kg) via tail intravenous injection to establish endotoxic shock model. The established 80 model rats were randomly divided into model group, ADSCs group, ulinastatin group and combination group (ulinastatin combined with ADSCs). All the rats were treated once a day for 3 days. Three days after transplantation, the renal tissues of each group were stained with hematoxylin-eosin staining to observe the pathological changes. The distribution of CM-Dil labeled ADSCs in the kidney of rats was observed by fluorescence microscope. The levels of nitric oxide synthase (NOS), nitric oxide (NO), creatinine and urea nitrogen in rat serum were measured. The reverse transcription PCR and Western Blot were used to detect the level of Bax and Caspase-3 in rat kidney tissue. Three days after transplantation, inflammatory cell infiltration and necrosis were occasionally seen in model group. Compared with the model group, the kidney damage in the ADSCs group and the ulinastatin group was significantly reduced, and kidney damage in the combined group was the least.Results:CM-Dil-labeled positive cells were found by microscope in the ADSCs group and the combined group, while CM-Dil-labeled ADSCs were not found in the kidney tissues of the normal group, model group and ulinastatin group. Compared with the normal group, the levels of NOS, NO, creatinine and urea nitrogen in the model group were significantly increased (all P<0.05). Compared with the model group, the levels of NOS, NO, creatinine and urea nitrogen in the ADSCs group, the ulinastatin group and the combination group were significantly increased (all P<0.05), in which the combined group has a further reduction in these related protein levels than the ADSCs group and the Ulinastatin group (all P<0.05). The mRNA and protein expressions of Bax and Caspase-3 in the kidney tissues of the model group were significantly higher than those in the normal group (all P<0.05). The Bax and Caspase levels in the kidney tissues of the ADSCs group, Ulinastatin group and combination group -3 mRNA and protein expression were significantly lower than those of the model group (all P<0.05), in which the combined group has a further reduction in these related protein levels than the ADSCs group and the Ulinastatin group (all P<0.05). Conclusions:Ulinastatin combined with ADSCs transplantation has a protective effect on kidney damage caused by endotoxin shock, which may be related to alleviating renal cell injury.

Objective To investigate the effects of tea-polyphenols on diabetic nephropathy (DN) mice by regulating nuclear factor E2-related factor 2/antioxidant response element (Nrf-2/ARE) signaling pathway. Methods A total of ten male 9-week-old normal (db/m) mice were randomly and equally divided into blank control group and tea-polyphenol control group, and ten male 9-week-old homologous type 2 diabetes (db/db) mice were randomly divided into model group and tea polyphenol treatment group. The animals in the tea-polyphenol control group and the treatment group were given 50 mg/(kg·d) tea-polyphenols by oral gavage, and the animals in the blank control group and model group were given same volume of double distilled water. The administration was once a day for 8 weeks. The blood glucose and 24-hour urine protein quantization (24 h-UP) were measured and recorded at 0, 4, and 8 weeks. After 8 weeks of the treatment, the mice were sacrificed. The intraocular blood stasis samples were collected for renal function indicators (serum creatinine and urea nitrogen), and kidney tissue samples were also collected for the tests of superoxide dismutase (SOD), reactive oxygen species, and malondialdehyde. Periodic acid Schiff reaction (PAS) staining was used to observe glomerular injury and scored. Western blot was used to detect the expression of Nrf-2 and hemeoxygenase-1 (HO-1) protein. Results Compared with the blank control group, the blood glucose and 24 h-UP of the mice in the model group and the tea-polyphenol treatment group increased after 4 and 8 weeks of the treatment (all P<0.01). Compared with the blank control group, after 8 weeks of the treatment, the serum creatinine and blood urea nitrogen of the model group and the tea-polyphenol treatment group increased (all P<0.01), the content of SOD in the renal tissue decreased (all P<0.01), the content of active oxygen and malondialdehyde, the relative expression of Nrf-2 and HO-1 protein increased (all P<0.01), and the glomerular injury aggravated (all P<0.01). However, there were no significant differences in all the indexes between the tea-polyphenol control group and the blank control group (all P>0.05). Conclusions Renal tissue of DN mice will undergo significant oxidative stress injury. Tea-polyphenols may reduce the oxidative stress injury in DN mice by regulating the Nrf-2/ARE signaling pathway, and play a protective role in the kidney.

OBJECTIVETo investigate an evaluation mode FOR in-process quality control for traditional Chinese medicines by adopting quantitative fingerprint technique as the main mean.

METHODRegarding Guizhi Fuling capsules as an example, the stability and repeatability were observed by tests of quantitative fingerprint of 90% ethanol extract, aqueous extract, the final mixing extract, soft material and products during the production process.

RESULTThe fingerprint similarities of four kinds of intermediates and products from 10 batches of Guizhi Fuling capsules were in the range of 0.966-0.999, respectively. The RSD of quantitative results of marked components, which included gallic acid, paeoniflorin, benzoic acid, cinnamic acid, benzoyl paeoniflorin, cinnamic aldehyde, paeonol, etc, were less than 15% in the products.

CONCLUSIONThis method is accurate, feasible and could be an effective way to be applied to in-process quality control of traditional Chinese medicine.

BACKGROUND: With the bio-coated prosthesis implanted in the body by a complex interaction of chemo-mechanics, the cases of clinical revision increased.OBJECTIVE: To summarize the research progress of effect of interaction of chemo-mechanics on the microstructure and properties of thermal-sprayed bioactive coatings.METHODS: The relevant articles were retrieved from Elsevier with the key words of "apatite, coating, spraying" in English between January 1999 to November 2009. Meanwhile, the relevant articles were searched from database of Vip Information with the key words of "apatite, coating, spraying" in Chinese between January 1989 to November 2009. The articles that were highly related to the effect of chemo-mechanics on the microstructure and properties of thermal-sprayed bio-coatings were collected. The repetitive researching results and those with weak correlation were excluded.RESULTS AND CONCLUSION: It was shown that loading affected the dissolution of bio-coatings significantly. Tensile stress promoted the dissolution, while compressive stress inversely. In addition, the mechanical properties decreased after immersion in simulation body fluid. Moreover, the mechanical properties increased when it was implanted in bone tissue. However, there were only investigation of microstructure and properties of bio-coatings under simple loading. The coupling effect of complex loading, such as tension, torsion and fatigue, etc., and the specific chemical environment on the bio-coatings should be studied in order to ensure the integrity of its structure and properties.