To analyze all clinical trials of ankylosing spondylitis (AS) up to December 31, 2022, so as to provide information reference for clinical studies related to AS drug treatment.

The website ClinicalTrials.gov was searched, then the items of the retrieved trials were described and analyzed.

There were 392 clinical trials of AS, with 59 countries/regions participating in the world, and the top three were the United States, China, and Germany. The primary objective of the trials was treatment (n=187), followed by prevention (n=9). Nearly two-thirds of the trials excluded children, and 97% of the trials were not gender restricted. Most studies were designed to be randomized, parallel-assigned, and unblinded. The largest number of interventional trials involved biological agents (n=201), followed by chemical agents (n=65), and a small number of trials (n=3) also investigated the therapeutic effects of stem cells.

Most of the clinical trials of AS registered on ClinicalTrials.gov are randomized, parallel-assigned, unblinded interventional trials based on therapeutic purposes. The participating countries and sponsors are mostly in the United States, and a majority of the trials are funded by pharmaceutical companies. At the same time, new biological agents targeting different targets have gradually become the mainstream, bringing new opportunities for the treatment of AS.

To study the effects of cinobufagin and its main component alkaloids on the contraction of colonic smooth muscle in rats in vitro and their influence on abnormal expression of channel proteins related to diarrhea in vivo.

Normal rat colon tissue samples were put into the bath to connect with the displacement tension transducer. After the tension of the colon sample was stabilized, different doses of cinobufagin and alkaloid solution were given to the colon sample, and the changes of the contraction tension of the colon sample were recorded. The rats were given the clinically equivalent dose of cinobufagin and alkaloid solution by gavage for 7 consecutive days, and the rats were killed on the 8th day. Colon tissues were taken, and the expressions of calcium channel proteins CaV1.2, CaV1.3, sodium channel proteins NHE2, NHE3, aquaporins AQP3, AQP8 were detected by Western blot to observe the changes.

The tension of colon specimen did not change significantly when the original solution was <0.10 mg (drug content<0.09 mg); 0.10~18.74 mg stock solution (0.09~16.21 mg) increased the tension of colon specimen. If the original solution was >19.25 mg (drug content >16.64 mg), the tension of colon specimen decreased. When alkaloids was <0.06 μg, the tension of colon specimen had no obvious change; 0.06~23.41 μg alkaloid increased the tension of colon specimen. When alkaloids was >24.03 μg, the tension of colon specimen decreased. Compared with the normal group, the sodium channel proteins NHE2, NHE3 and aquaporins AQP3, AQP8 in the cinobufotalin group decreased significantly (P<0.05), while the calcium channel protein CaV1.2 increased significantly (P<0.05). Sodium channel protein NHE3 and aquaporin AQP3 were significantly decreased in the alkaloid group (P<0.05). There was no significant difference in the expression of other proteins (P>0.05).

In the study of diarrhea mechanism, the results of colon tension test in vitro showed that a certain dose of cinobufagin could promote intestinal peristalsis and increase the incidence of diarrhea, and it could inhibit intestinal peristalsis when the dosage was higher than a certain level. The detection results of diarrhea-related proteins in the colon showed that the administration of cinobufotalin and alkaloid solution would cause changes in diarrhea-related channel proteins, and the number of alkaloid solutions that had significant effects on channel proteins was less than that of the original solution, suggesting that there were other components in the purgative component besides the alkaloids.

Carboxymethyl starch sodium is the most commonly used superdisintegrant, and the degree of substitution and crosslinking density are the important quality attributes that affect its water swellability and disintegration performance. By exploring the correlation between degree of substitution, crosslinking density, and water swellability, this study aims to provide a theoretical reference for the production of disintegrant with excellent performance.

Seventeen batches of carboxymethyl starch sodium were collected. Low-field nuclear magnetic resonance technique was used to determine the crosslink density values. And the degree of substitution and water swellability value were determined by physical-chemical method. The correlation between crosslinking density, degree of substitution and water swellability was investigated by Pearson correlation.

There were significant differences in the attribute values of products from different sources. The crosslinking density was significantly negatively correlated with the degree of substitution and water swellability, and the correlation coefficients were -0.814 and -0.854. The degree of substitution was significantly positively correlated with the water swellability, and the correlation coefficient was 0.823.

The crosslinking density and the degree of substitution are the critical quality attributes that affect the disintegration of carboxymethyl starch sodium. Understanding the disintegration behavior of disintegrants is of great significance for the development of pharmaceutical solid preparations. Clarifying the relationship between the disintegration characteristics of carboxymethyl starch sodium and crosslinking density and degree of substitution will help to select the correct disintegrant for a given formulation.

To analyze the characteristics of roxadustat utilization in our hospital's renal division, promote rational use of roxadustat, and provide evidence for a post-marketing study.

A retrospective study was conducted. The clinical data of hospitalized patients treated with roxadustat from July 1st, 2021, to June 30th, 2022, in the renal division of our hospital were collected and analyzed.

A total of 208 medical records were included. Twenty-two (10.6%) acute kidney injury patients with anemia without the diagnosis of chronic kidney disease were treated with roxadustat. The average single dose of dialysis patients was significantly higher than that of non-dialysis patients (77.85 vs 67.37 mg, P=0.03). Sixty-three patients (30.3%) received statins, and 27 (13.0%) received sevelamer. There was significant difference between hemoglobin levels at baseline and discharge (84.80 vs 89.43 g·L^-1, P=0.007). No adverse events occurred in any patient.

The tolerability and safety were good in anemia patients in the renal division who were treated with roxadustat. However, there existed a few problems, such as off-label drug use, subtherapeutic dosage and drug-drug interactions. It is necessary to strengthen the intervention of clinical pharmacists and promote the rational use of roxadustat.

To study the development process, current situation and specific requirements of drug registration based on e-CTD format in the United States, and to provide some reference for the construction of e-CTD channel for drug registration in China.

A literature review was used to review the regulatory process of e-CTD implementation in the United States, and the data of e-CTD application and total electronic data application were compared and analyzed. To explore the similarities and differences between the traditional registration declaration format and e-CTD format in terms of organization, data requirements, application process and data review, the specific changes were analyzed.

In the process of e-CTD implementation, the United States improved and optimized the submission process and approval process by constantly issuing technical guidelines and paid attention to the training of technical personnel and protected data security. On the one hand, it is suggested that Chinese regulatory agencies improve the guidelines for drug registration application based on e-CTD format as soon as possible, increase policy support such as priority review and approval, and strengthen e-CTD knowledge training for registration personnel in enterprises and review centers. On the other hand, strengthen e-CTD knowledge training for registered personal of enterprises and agencies, enterprises should change their research and development ideas, carry out the QbD concept, formulate a registration operation team suitable for their own development needs, and actively participate in international drug registration to accumulate experience in order to promote the application of e-CTD in enterprises