1.Meta-analysis of the efficacy and safety of rituximab in the treatment of primary Sjögren syndrome
Jigao LI ; Ruilin LIU ; Zihua WANG ; Hejun WANG ; Peipei SU ; Quan ZHOU
China Pharmacy 2025;36(5):619-623
OBJECTIVE To evaluate the efficacy and safety of rituximab (RTX) in the treatment of primary Sjögren syndrome (pSS). METHODS Randomized controlled trials (RCTs) on the effects of RTX (trial group) versus placebo (control group) in the treatment of pSS were searched from the Cochran Library, PubMed, Embase, Medline, Web of Science, VIP, CNKI, Wanfang, and other databases during the inception to February 2024. After literature screening and quality evaluation, meta-analysis was performed by using RevMan 5.3 software. RESULTS Seven RCTs were finally included, involving a total of 518 patients. Results of meta-analysis showed that European League Against Rheumatism Sjögren syndrome disease activity index (ESSDAI) score [MD=-1.17, 95%CI(-1.52, -0.82), P<0.000 01] and oral dryness visual analogue scale (VAS) score [MD=-3.97, 95%CI (-5.08, -2.86), P<0.000 01] in the trial group were significantly lower than the control group; unstimulated salivary flow rate [SMD=0.64, 95%CI(0.41, 0.87), P<0.000 01] and Schirmer score [MD=0.19, 95%CI(0.18, 0.20), P<0.000 01] were significantly higher than the control group. There was no statistical significance in response rate [RD=0.10, 95%CI(-0.04, 0.23), P=0.16], fatigue VAS score [MD=-12.50, 95%CI(-35.14, 10.15), P=0.28], European League Against Rheumatism Sjögren syndrome patient reported index (ESSPRI) score [MD=0.33, 95%CI(-0.53, 1.18), P=0.46], Short-form 36 health survey physical component summary (SF36-PCS) score [MD=0.90, 95%CI(-2.97, 4.78), P=0.65], SF-36 mental component summary (SF36-MCS) score [MD=0.11, 95%CI(-0.41, 0.63), P=0.68], total salivary gland ultrasound score [SMD=-1.91, 95%CI(-4.01, 0.19), P=0.07] or the incidence of adverse drug reactions [OR=1.15,95%CI(0.62,2.13),P=0.66] between 2 groups. CONCLUSIONS RTX has advantages in the improvement of ESSDAI score, unstimulated salivary flow rate, Schirmer score and oral dryness VAS score in pSS patients, and has a good safety profile. However, it did not exhibit significant improvement in fatigue VAS score, ESSPRI score, SF36-PCS score, SF36-MCS score or response rates.
2.Current Status of Stratified Diagnosis and Treatment of Sjögren's Syndrome and Reflections on It
Wenjing LIU ; Xinyao ZHOU ; Quan JIANG
Journal of Traditional Chinese Medicine 2025;66(3):244-250
Stratified diagnosis and treatment is a crucial approach in precision medicine, aiming to optimize medical care by grouping patients based on clinical manifestations, biomarkers, and pathological characteristics. Based on clinical stages, symptoms, age, gene expression, and pathology, research on Sjögren's syndrome (SS) has proposed various stratification methods, incorporating both traditional Chinese medicine (TCM) and Western medicine perspectives. These methods provide essential support for early diagnosis, risk assessment, and personalized treatment. Key strategies include moving SS intervention time forward, to leverage TCM's preventive principles, integrating TCM and Western tools to enhance precision, innovating clinical trial designs, developing multifactorial risk prediction models and digital imaging technologies, and constructing combined prognostic models for personalized follow-up and big data-driven treatment. These insights offer a comprehensive framework for advancing SS precision medicine.
3.Treating premature ejaculation combined with anxiety and depression based on the "four-dimensional integration" of the "holism of body and spirit" theory
Yi WEI ; Zhiming HONG ; Junfeng QIU ; Zilong CHEN ; Hao KUANG ; Yangling ZENG ; Quan WANG ; Wenbin ZHOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(3):418-423
Premature ejaculation refers to a sexual dysfunction in which men experience a short intravaginal ejaculation latency and a lack of control over ejaculation during sexual activity. The onset of this condition is often accompanied by anxiety and depression, which can seriously affect the quality of the patient′s sexual life and the relationship between partners. Based on the "integration of body and spirit" theory in traditional Chinese medicine, our team believes that this condition is a comorbidity of physical and spiritual factors. We propose that the core pathogenesis of this disease lies in the "loss of form and essence, impairment of spirit, and depression of the mind, "while the primary treatment principle involves "nourishing form and regulating spirit." As a result, a new diagnosis and treatment approach of "four-dimensional integration" is summarized in this study. The disease is treated through the four dimensions of shape, body, spirit, and emotion. Traditional Chinese medicine is used to adjust the shape in cases where the physical form is damaged. For individuals with depression of heart and liver qi, the treatment focuses on soothing the heart and smoothing liver qi, and the modified Wangyou Powder and Xuanzhi Decoction is used. In cases where the heart and kidney function are compromised, the treatment involves nourishing both the heart and kidney while restoring interaction between the heart and the kidney, and modified Jihuo Yansi Elixir is used. To reduce the sensitivity of the glans penis, the patient′s body is washed with a traditional Chinese medicine formula, and a delicate fumigation formula is decocted for external washing. For those who are not in tune with their god, psychological counseling can be used to regulate their spirit and advocate "self-partner" and psychotherapy. If there are issues with intimacy, partners should focus on cooperating during foreplay, sexual intercourse, and post-coital interactions. Overall, the treatment aims to harmonize the body and spirit, addressing both physical and psychological factors through a comprehensive, multi-dimensional approach. This method provides new perspectives and ideas for the clinical diagnosis and treatment of this condition.
4.Assessment of the implementation of Radiation shielding requirements for radiotherapy room—Part 4: Radiotherapy room of 252Cf neutron afterloading (GBZ/T 201.4-2015)
Yuze YANG ; Hongfang WANG ; Haoxian YANG ; Quan WU ; Mingsheng LI ; Bala HARI ; Yongzhong MA ; Zechen FENG ; Bin BAI ; Jie GAO ; Wei ZHOU ; Weixu HUANG ; Zhengjie SHI ; Hezheng ZHAI
Chinese Journal of Radiological Health 2025;34(5):660-665
Objective To track and evaluate the implementation and application of the occupational health standard Radiation shielding requirements for radiotherapy room—Part 4: Radiotherapy room of 252Cf neutron afterloading (GBZ/T 201.4-2015) by radiation health technical service agencies, medical institutions, health supervision agencies, and radiotherapy facility design units, and to provide a scientific basis for the further revision and implementation of this standard. Methods Following the Guideline for health standards tracking evaluation (WS/T 536-2017) and the project implementation plan, relevant practitioners were randomly selected for a questionnaire survey. The survey primarily focused on their awareness, standard training, application, and revision suggestions of GBZ/T 201.4-2015. The results were summarized and analyzed. Results A total of 168 evaluation questionnaires were collected from relevant practitioners in 28 provinces. Only 31.6% of the respondents reported being “well familiar” or “ familiar” with the standard, 27.4% of the respondents believed that the standard was widely used, and 45.2% of the respondents believed that the standard could meet the needs of their work. Only 14.9% of the respondents had received relevant training on the standard, more than half of the respondents had not applied the standard within the past 10 years, and 45.2% of the respondents believed that the standard "needs to be revised". Conclusion Due to the small number of californium-252 neutron afterloading radiotherapy devices in operation on the market, the overall awareness of the standard is low, suggesting that relevant authorities need to strengthen training and publicity of the standard, and that certain sections of the standard need to be revised or merged.
5.Methodological Evaluation of Advantages of Traditional Chinese Medicine Treatment of Sjögren's Syndrome
Wenjing LIU ; Shiya WU ; Ruihua LIU ; Xinyao ZHOU ; Juan JIAO ; Ying LIU ; Zeguang LI ; Zhenbin LI ; Huadong ZHANG ; Xiaopo TANG ; Quan JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(1):192-197
Screening and evaluating the diseases responding specifically to traditional Chinese medicine (TCM) will help to highlight the advantages of TCM treatment, and the evaluation method should be standardized with consideration to the unique characteristics of the diseases. The incidence of Sjögren's Syndrome (SS) is increasing year by year, while the pathogenesis of this disease remains unclear. Modern therapies for this disease include biological agents and immunosuppressants, which generally have unsatisfactory efficacy. The TCM treatment of SS focuses on the harmony of the physical and mental health. The Rheumatology Branch of the China Association of Chinese Medicine organizes experts in TCM, Western medicine, and evidence-based medicine to form working groups. Delphi method and bibliometric method were used for analysis, and SS was selected as a disease responding specifically to TCM. Furthermore, the evaluation system was established for this disease, and the consensus regarding this disease was reached after seminar discussion. This paper summarized the whole process of the evaluation of the advantages of TCM treatment of SS. First, because TCM atomization is widely used in clinical practice and enriches TCM administration methods, this therapy is included after other non-drug therapies were taken as characteristic therapies. Second, the evaluation indicators of therapeutic effect should be determined with consideration to international acceptance and the current research status. Third, the expression method should be accurate, standardized, and objective, highlight the natural advantages of TCM, and avoid arbitrary extension. This paper provides a reference for clinicians to explore other diseases responding specifically to TCM.
6.Effect of Dendrobium officinale leaf fermentation fluid on a mouse model of alcoholic hepatitis and its mechanism of action
Xingnian ZHOU ; Yuhong LIU ; Yujie QIN ; Quan ZHANG ; Mingliang CHENG ; Hong LI
Journal of Clinical Hepatology 2024;40(2):335-342
ObjectiveTo investigate the intervention mechanism of Dendrobium officinale leaf fermentation fluid in mice with alcoholic hepatitis. MethodsA total of 70 healthy male C57BL/6J mice, aged 6-8 weeks, were randomly divided into normal group, model group, liquid feed control group, silybin group, and low-, middle-, and high-dose Dendrobium officinale leaf fermentation fluid groups, with 10 mice in each group. The mice in the normal group were given normal diet, and those in the other groups were given Lieber-DeCarli classic liquid diet for 8 weeks to induce alcoholic hepatitis. During modeling, the mice in the low-, middle-, and high-dose Dendrobium officinale leaf fermentation fluid groups were given Dendrobium liquid manufactured by Warmen Pharmaceutical, and the mice in all the other groups were given pure water; the mice in the normal group, the model group, and the liquid feed control group were given normal saline by gavage, those in the silybin group were given silybin 0.25 mL/10 g by gavage, and those in the low-, middle-, and high-dose Dendrobium officinale leaf fermentation fluid groups were given Dendrobium officinale leaf fermentation fluid at a dose of 0.125 mL/10 g, 0.250 mL/10 g, and 0.375 mL/10 g, respectively, by gavage, once a day. At week 8, chloral hydrate was injected intraperitoneally for anesthesia, and blood samples were collected from the eyeball. After serum was separated, the biochemical method was used to measure the levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT); HE staining and oil red staining were used to observe liver histopathology and lipid accumulation in mice; multiplex Luminex assay was used to measure the serum levels of interleukin-6 (IL-6), interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), and CCL2; quantitative real-time PCR, Western blot, and immunofluorescence assay were used to measure the protein expression levels of NLRP3, caspase-1, caspase-11, gasdermin D (GSDMD), N-terminal gasdermin D (GSDMD-N) in liver tissue. A one-way analysis of variance was used for comparison of continuous data between multiple groups, and the least significant difference t-test was used for further comparison between two groups. ResultsCompared with the normal group, the model group had significant increases in the serum levels of AST, ALT, IL-6, IL-1β, TNF-α, and CCL2 (all P<0.05), and compared with the model group, the high-dose Dendrobium officinale leaf fermentation fluid group had significant reductions in the serum levels of AST, ALT, IL-6, IL-1β, TNF-α, and CCL2 (all P<0.05). HE staining showed that the model group had disordered structure of hepatic lobules, with a large number of steatosis vacuoles and massive cell necrosis, and compared with the model group, the high-dose Dendrobium officinale leaf fermentation fluid group had alleviation of liver histopathological injury, intact structure of most hepatic lobules, and a small amount of inflammatory cell infiltration. Oil red staining showed that the model group had accumulation of large and small lipid droplets in the liver and a significant increase in liver fat content, and compared with the model group, the high-dose Dendrobium officinale leaf fermentation fluid group had significant alleviation of hepatic steatosis, with the presence of sporadic small lipid droplets. Immunofluorescence assay of liver tissue showed that compared with the normal group, the model group had a significant increase in the ratio of GSDMD-positive staining area in hepatocyte cytoplasm (P<0.001), and compared with the model group, the high-dose Dendrobium officinale leaf fermentation fluid group had a significant reduction in such ratio in hepatocyte cytoplasm (P<0.001). Quantitative real-time PCR showed that compared with the normal group, the model group had significant increases in the protein expression levels of NLRP3, caspase-1, caspase-11, GSDMD, GSDMD-N, interleukin-18 (IL-18), and IL-1β in liver tissue (all P<0.05), and compared with the model group, the high-dose Dendrobium officinale leaf fermentation fluid group had significant reductions in the protein expression levels of NLRP3, caspase-1, caspase-11, GSDMD, GSDMD-N, IL-18, and IL-1 (all P<0.05). Compared with the model group, the high-dose Dendrobium officinale leaf fermentation fluid group had significant reductions in the protein expression levels of caspase-1 and caspase-11 (both P<0.05), with a relative expression level of caspase-1 of 1.757 (reduced by 26.6% compared with the model group) and a relative expression level of caspase-11 of 0.455 (reduced by 70.3% compared with the model group), suggesting that caspase-11 showed a greater reduction than caspase-1. ConclusionDendrobium officinale leaf fermentation fluid can alleviate alcoholic hepatitis in mice, possibly by inhibiting the non-classical cell pyroptosis pathway mediated by caspase-11.
7.A Multicenter, Randomized, Double-blind, and Placebo-parallel Controlled Trial of Tibetan Medicine Ruyi Zhenbaowan in Treatment of Knee Osteoarthritis
Chunquan SUN ; Yanming XIE ; Jinghua GAO ; Weiheng CHEN ; Lianxin WANG ; Shangquan WANG ; Xiangdong TIAN ; Zujian XU ; Yuxin ZHENG ; Mingwang ZHOU ; Chungen LI ; Zhanwang XU ; Jiayi GUO ; Shuangqing DU ; Qigang CHEN ; Quan JI ; Zhiqiang BAI ; Jing XIAO ; Wanli QI ; Weiyi YANG ; Jingxiao ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):57-67
ObjectiveThis study aimed to evaluate the clinical efficacy of Ruyi Zhenbaowan(RYZBW)in the treatment of initial and early knee osteoarthritis (KOA) through a prospective multicenter,randomized,double-blind,and placebo-parallel controlled trial. MethodFrom October 13th, 2021 to December 25th, 2021, 240 KOA subjects meeting the acceptance criteria were enrolled in 15 sub-centers including Wangjing Hospital, Chinese Academy of Chinese Medical Sciences, and they were randomly divided into observation group and control group, with 120 cases in each group. The intervention measures for the observation group were RYZBW + health education, and the intervention measures for the control group were RYZBW placebo + health education. The intervention period in both groups was four weeks, and they were followed up for four weeks after the intervention. The primary outcome measure was the total score of Western Ontario and McMaster University Osteoarthritis Index score (WOMAC score), and the secondary outcome measures were the response rate of visual scale (VAS) pain score, WOMAC sub item scores (joint pain, joint stiffness, and joint function), quality of life (SF-12) score, and traditional Chinese medicine (TCM) syndrome score. Result(1) Efficacy evaluation. The marginal model results showed that the observation group was better than the control group in improving the WOMAC total score and WOMAC pain score in the treatment of KOA with RYZBW, and the difference was statistically significant (P<0.05). There was no significant difference between the two groups in improving VAS score response rate, WOMAC function score, WOMAC stiffness score, SF12-PCS (quality of life-physical health) score, SF12-MCS (quality of life-mental health) score, and TCM syndrome score. (2) Subgroup analysis. ① In terms of VAS score response rate, the response rate of the observation group was higher than that of the control group for subjects with baseline VAS score of (4, 5], and the difference was statistically significant (P<0.05). ② In terms of TCM syndrome score, for subjects aged [56, 60] and [61, 65], the decrease in total TCM syndrome score in the observation group was better than that in the control group, and the difference was statistically significant (P<0.05). ConclusionTibetan medicine RYZBW has good clinical efficacy in improving WOMAC total score, VAS score response rate, WOMAC pain score, WOMAC function score, and TCM syndrome score for patients with initial and early KOA, which can fill the lack of Tibetan medicine RYZBW in the treatment of KOA and make a demonstration study for the inheritance and development of ethnic medicine.
8.GPR40 novel agonist SZZ15-11 regulates glucolipid metabolic disorders in spontaneous type 2 diabetic KKAy mice
Lei LEI ; Jia-yu ZHAI ; Tian ZHOU ; Quan LIU ; Shuai-nan LIU ; Cai-na LI ; Hui CAO ; Cun-yu FENG ; Min WU ; Lei-lei CHEN ; Li-ran LEI ; Xuan PAN ; Zhan-zhu LIU ; Yi HUAN ; Zhu-fang SHEN
Acta Pharmaceutica Sinica 2024;59(10):2782-2790
G protein-coupled receptor (GPR) 40, as one of GPRs family, plays a potential role in regulating glucose and lipid metabolism. To study the effect of GPR40 novel agonist SZZ15-11 on hyperglycemia and hyperlipidemia and its potential mechanism, spontaneous type 2 diabetic KKAy mice, human hepatocellular carcinoma HepG2 cells and murine mature adipocyte 3T3-L1 cells were used. KKAy mice were divided into four groups, vehicle group, TAK group, SZZ (50 mg·kg-1) group and SZZ (100 mg·kg-1) group, with oral gavage of 0.5% sodium carboxymethylcellulose (CMC), 50 mg·kg-1 TAK875, 50 and 100 mg·kg-1 SZZ15-11 respectively for 45 days. Fasting blood glucose, blood triglyceride (TG) and total cholesterol (TC), non-fasting blood glucose were tested. Oral glucose tolerance test and insulin tolerance test were executed. Blood insulin and glucagon were measured
9.Progress in delivering biotechnology drugs on microneedles
Han LIU ; Guo-zhong YANG ; Wan-ren DU ; Suo-hui ZHANG ; Ze-quan ZHOU ; Yun-hua GAO
Acta Pharmaceutica Sinica 2024;59(10):2751-2762
As a new transdermal drug delivery system, microneedles can significantly improve skin permeability, enhance drug transdermal delivery, and demonstrate unique advantages in breaking stratum corneum barrier of skin. This feature enables microneedles to demonstrate enormous potential in delivering biotechnology drugs. The traditional delivery method for biotechnology drugs is mainly injection, which brings problems such as pain and skin redness to patients, leading to poor patient compliance. In addition, the production, transportation, and storage of biotechnology drugs require strict low-temperature conditions to maintain their activity and increase cost output. Microneedles, by contrast, have many benefits, providing new avenues and solutions for biomolecular delivery. Accordingly, this review introduced the microneedle drug delivery system for delivery biotechnology drugs, and summarized the research progress of microneedle systems in biotechnology drugs.
10.Effect of type of carrier material on the in vitro properties of solid dispersions of progesterone
Jing-nan QUAN ; Yi CHENG ; Jing-yu ZHOU ; Meng LI ; Zeng-ming WANG ; Nan LIU ; Zi-ming ZHAO ; Hui ZHANG ; Ai-ping ZHENG
Acta Pharmaceutica Sinica 2024;59(3):735-742
This study investigated the effect of different carrier materials on the


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