Objective:To analyze and summarize the drug registration clinical trial for rheumatic diseases in China from January 2013 to November 2019.Methods:The website of CDE was searched to obtain the data and statistical analysis was conducted.Results:①The number of drug clinical trials for rheumatic diseases in China increased year by year and the total was 525. The registered indications mainly included diffuse connective tissue disease, spondylo arthritis, metabolic diseases and degenerative diseases, including rheumatoid arthritis (RA) (189), gout (122), osteoarthritis (OA) (89), ankylosing spondylitis (AS) (60) and systemic lupus erythematosus (SLE) (39). ② The phaseⅡ-Ⅲ clinical trials were mainly for biological disease-modifying antirheumatic drugs (bDMARDs). Most of the bioequivalence test (BE) were chemical drugs.③ The domestically developed chemicals and biological included BLyS/APRIL, CD22, JAK1, S1P1 and BTK. ④ Adalimumab and tocilizumab accounted for the largest proportion of biosimilar drugs. The indications were mainly RA. ⑤ The number of international multi-center clinical trials increased year by year, with the indications mainly for RA and SLE.Conclusion:① The overall number of drugs trials for rheumatic diseases in China has been increasing rapidly in recent years. ② The research and development of chemicals and biologics is the trend. ③ Significant achievements have been made in the research and development of biosimilars in China and it is expected to benefit more patients by broaden the indications.

Objective:To evaluate the efficacy of dural puncture epidural (DPE) combined with programmed intermittent epidural bolus (PIEB) for labor analgesia in parturients.Methods:A total of 200 primiparas of American Society of Anesthesiologists physical status Ⅰ or Ⅱ, who were at full-term with a singleton fetus in vertex presentation and requested natural childbirth and intraspinal analgesia were selected and divided into 2 groups ( n=100 each) according to a computer-generated random number table: epidural block alone+ PIEB group (group E) and DPE+ PIEB group (group D). After successful epidural puncture, epidural catheter was placed in the epidural cavity, and the depth was 3-4 cm in group E. In group D, spinal needle was used for intrathecal needle puncture after successful epidural puncture, the posterior epidural catheter was placed in the epidural cavity, and the depth was 3-4 cm.The epidural pulse pump (0.08% ropivacaine plus sufentanil 0.4 μg /ml) was connected and was set up to deliver a 5-ml bolus dose with initial dose 10 ml, a 20-min lockout interval and background infusion at a rate of 10 ml/h.The onset time of analgesia, development of the sensory block reaching S 2 within 30 min after administration, development of motor block, effective pressing times and consumption, requirement of ropivacaine for rescue analgesia, ropivacaine consumption and delivery mode were recorded.The development of hypotension, pruritus, nausea, vomiting, headache after puncture and fetal bradycardia were recorded.The Apgar scores at 1 and 5 min after delivery were recorded and the parturients were followed up on 1 day after delivery for the scores for satisfaction with analgesia. Results:Compared with group E, the onset time of analgesia was significantly shortened, the ratio of sensory block reaching S 2 was increased, analgesia pump pressing times and ropivacaine consumption were decreased ( P<0.05), and no significant change was found in the incidence of motor block, the requirement for rescue analgesic, the scores for parturients′ satisfaction with analgesia, delivery mode, Apgar scores of the neonates and the incidence of adverse reactions in group D ( P>0.05). Conclusion:DPE combined with PIEB for labor analgesia can shorten the onset time of analgesia and provide reliable efficacy and higher safety.

Objective:To compare the efficacy and safety of different dosages of new drugs in the treatment of PsA by using network meta-analysis.Methods:Three medical databases (PubMed, Web of Science, Cochrane Library) were searched for the studies that compared the efficacy and safety of 4 new drugs (secukinumab, ixekizumab, apremilast, tofacitinib) with different dosages in the treatment of PsA. Data from included studies were analyzed by Stata 15.0.Results:A total of 16 RCTs were included. The results of the network meta-analysis showed that: (1) Among the overall patients, in terms of ACR20 response rate, the larger the surface under the cumulative ranking (SUCRA), the more effective it is. Secukinumab 300 mg Q4W(96.1%) had the best efficacy, followed by ixekizumab 80 mg Q4W(79.0%), ixekizumab 80 mg Q2W(75.1%), secukinumab 150 mg Q4W(73.2%), apremilast 30 mg BID(50.6%), apremilast 20 mg BID(38.6%), tofacitinib 5 mg BID(18.1%), tofacitinib 10 mg BID(17.7%) and placebo(2.0%). (2) In terms of PASI75 response rate, the larger the area under the SUCRA curve, the more effective it is. Ixekizumab 80 mg Q4W(96.1%) had the best efficacy, followed by ixekizumab 80 mg Q2W(88.7%), secukinumab 300 mg Q4W(75.6%), secukinumab 150 mg Q4W(63.3%), apremilast 30 mg BID(44.5%), apremilast 20 mg BID(38.4%), tofacitinib 10 mg BID(30.0%), tofacitinib 5 mg BID(12.5%) and placebo(1.0%). (3) Among the overall patients, in terms of safety, the smaller the area under the SUCRA curve, the higher the safety it is. Secukinumab 300 mg Q4W (17.3%) has the best safety. (4) The results of subgroup analysis showed that in terms of ACR20 response rate, ixekizumab 80 mg Q2W(85.3%) had the best efficacy in bDMARDs-na?ve patients, while in bDMARDs-IR patients, secukinumab 300 mg Q4W(83.9%) had the best efficacy.Conclusion:Among all patients, secukinumab 300 mg Q4W is the best in terms of ACR20 response rate and safety, but ixekizumab 80 mg Q4W is more effective in improving PsA lesions comparing yo other drugs.

Objective:To analyze and summarize the key points of design and implementation of new drug clinical trials for ankylosing spondylitis.Methods:The platform for drug clinical trial registration and information published on the official website of center for drug review and evaluation of national medical products administration (CDE) was searched to obtain data and classified statistics was conducted then. The Mean±SD and M ( Q1, Q3) were used for quantitative data for statistical description, and the rate, composition or relative ratio of qualitative data were used for statistical description. Results:A total of 23 clinical trials meeting the requirements were screened, among which 19 were biological products included in nine phase Ⅲ clinical trials. Among the four chemical drugs, two were phase Ⅱ clinical trials. One of the clinical trials on AS adopted the 1966 New York classification criteria, accounting for 4%. Nineteen of the trials adopted the1984 New York classification criteria, accounting for 83%. Three other trials adopted unspecified classification criteria, accounting for 13%. In one of these clinical trials, the age of patients included was older than 16 years old, 9 trials were 18 to 65 years old, 6 were 18 years old but without upper limit. In the definition of active AS, 19 trials took BASDAI≥4 as the cut-off value for active disease, and BASDAI, total back pain, spinal pain and morning stiffness were regarded as active disease in 4.Conclusion:The number of dosestic AS clinical trial projects continnes to rise. The 1984 classification criteria is adopted as the classification criteria in clinical trials. The minimum age in the inclusion criteria is 18 years old, there is no upper limit in age for inclusion. Disease activity can be evaluated by BASDAI score, combined with comprehensive indicators such as night-time back pain, global spinal pain and morning stiffness.

Objective The occurrence of chickenpox in rapidly developing areas poses substantial seasonal risk to children.However,certain factors influencing local chickenpox outbreaks have not been studied.Here,we examined the relationship between spatial clustering,heterogeneity of chickenpox outbreaks,and socioeconomic factors in Southern China. Methods We assessed chickenpox outbreak data from Southern China between 2006 and 2021,comprising both relatively fast-growing parts and slower sub-regions,and provides a representative sample of many developing regions.We analyzed the spatial clustering attributes associated with chickenpox outbreaks using Moran's I and local indicators of spatial association and quantified their socioeconomic determinants using Geodetector q statistics. Results There were significant spatial heterogeneity in the risk of chickenpox outbreaks,with strong correlations between chickenpox risk and various factors,particularly demographics and living environment.Furthermore,interactive effects among specific are factors,such as population density and per capita residential building area,percentage of households with toilets,percentage of rental housing,exhibited q statistics of 0.28,0.25,and 0.24,respectively. Conclusion This study provides valuable insights into the spatial dynamics of chickenpox outbreaks in rapidly developing regions,revealing the socioeconomic factors affecting disease transmission.These implications extend the formulation of effective public health strategies and interventions to prevent and control chickenpox outbreaks in similar global contexts.