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.Efficacy of stereotactic body radiotherapy combined with sintilimab and bevacizumab in treatment of unresectable hepatocellular carcinoma
Teng ZHANG ; Quan WANG ; Wengang LI ; Xuezhang DUAN
Journal of Clinical Hepatology 2025;41(1):69-74
ObjectiveTo investigate the efficacy and safety of stereotactic body radiotherapy (SBRT) combined with sintilimab and bevacizumab in the treatment of patients with unresectable hepatocellular carcinoma (uHCC) and related prognostic factors. MethodsA total of 42 patients with uHCC who underwent SBRT combined with sintilimab and bevacizumab in Department of Radiation Oncology, The Fifth Medical Centre of PLA General Hospital, from March to December 2022 were enrolled. The prescribed dose of planning target volume was 36 — 50 Gy in 5 — 6 fractions for continuous irradiation, followed by the regimen of sintilimab and bevacizumab. Each course of treatment was 3 weeks until the presence of tumor progression or serious adverse events. The Kaplan-Meier method was used to calculate overall survival (OS) rate and progression-free survival (PFS) rate, and the log-rank test was used for comparison between groups; the Cox proportional hazards model was used to investigate the influencing factors for prognosis. ResultsThe median follow-up time was 21.6 months, with an objective response rate of 69%, a disease control rate of 85.7%, a median PFS of 10.0 months (95% confidence interval [CI]: 6.7 — 13.0), and a median OS of 23.3 months (95%CI: 14.7 — 31.8). Most adverse events were grade 1 — 2 events, and there were no fatal adverse events. At 6 — 8 weeks after treatment, the AFP response group had a significantly better OS than the non-AFP response group (not reached vs 11.8 months, P=0.007). The multivariate analysis showed that AFP response was associated with the good prognosis of patients (hazard ratio=0.31, 95%CI: 0.13 — 0.75, P=0.009). ConclusionFor patients with uHCC, SBRT combined with sintilimab and bevacizumab can improve survival with a manageable safety profile, and a >50% reduction in AFP at 6 — 8 weeks after treatment can be used as a potential prognostic indicator.
3.Analysis of pharmaceutical clinic service in our hospital over the past five years
Li FAN ; Shuyan QUAN ; Xuan WANG ; Menglin LUO ; Fei YE ; Lang ZOU ; Feifei YU ; Min HU ; Xuelian HU ; Chenjing LUO ; Peng GU
China Pharmacy 2025;36(6):748-751
OBJECTIVE To summarize the current situation of pharmaceutical clinic service in our hospital over the past five years, and explore sustainable development strategies for service models of pharmaceutical clinics. METHODS A retrospective analysis was conducted on the consultation records of patients who registered and established files at the pharmaceutical clinic in our hospital from January 2019 to December 2023. Statistical analysis was performed on patients’ general information, medication- related problems, and types of pharmaceutical services provided by pharmacists. RESULTS A total of 963 consultation records were included, among which females aged 20-39 years accounted for the highest proportion (66.04%); obstetrics and gynecology- related consultations accounted for the largest number of cases. Additionally, 80 patients attended follow-up visits at our hospital’s pharmaceutical clinic. A total of 1 029 medication-related issues were resolved, including 538 cases of drug consultations (52.28%), 453 medication recommendations (44.02%), 22 medication restructuring(2.14%), and 16 medication education (1.55%); the most common types of medication-related problems identified were adverse drug events(70.07%). CONCLUSIONS Although the pharmaceutical clinic has achieved recognition from clinicians and patients, challenges such as low awareness among healthcare providers and the public persist. Future efforts should focus on strengthening information technology construction, enhancing pharmacist training, and establishing various forms of outpatient pharmaceutical service models.
4.Efficacy of 3% diquafosol sodium ophthalmic solution in dry eye syndrome after cataract surgery and its impact on tear film stability
Xiuting LI ; Yan QUAN ; Lili WANG
International Eye Science 2025;25(5):854-857
AIM: To evaluate the efficacy of 3% diquafosol sodium ophthalmic solution in treating dry eye syndrome following cataract surgery and its impact on tear film stability.METHODS: This prospective clinical study was conducted at Xi'an Aier Eye Hospital, Northwest University from January 2021 to January 2024. A total of 124 patients(124 eyes)who underwent cataract phacoemulsification were enrolled and randomly assigned to either the study group(62 cases, 62 eyes)or the control group(62 cases, 62 eyes)using a random number table. The study group received 3% diquafosol sodium ophthalmic solution four times daily for 1 mo, while the control group was treated with sodium hyaluronate eye drops four times daily for 1 mo. Clinical efficacy, tear film breakup time(BUT), Schirmer I test(SⅠt), corneal fluorescein staining(FL)score, inflammatory factors [interleukin-1β(IL-1β), interleukin-6(IL-6), and tumor necrosis factor-α(TNF-α)] levels in tears, and adverse reactions were compared between the two groups.RESULTS: After treatment, the effective rate was 93.5% in the study group and 87.1% in the control group, with no significant difference between the two groups(P>0.05). The study group showed significantly higher BUT, SⅠt values compared to the control group, while FL score, and inflammatory factor levels in tears were significantly lower at 1 mo after treatment(all P<0.05). The incidence of adverse reactions did not differ significantly between the two groups(P=0.198).CONCLUSION: The 3% diquafosol sodium ophthalmic solution significantly improves tear secretion and tear film stability in patients with dry eye syndrome after cataract surgery, effectively alleviating dry eye symptoms. It is a safe and effective treatment method.
5.Correlation Between Cardiovascular Events and Traditional Chinese Medicine Syndrome in Patients with Rheumatoid Arthritis:A Cross-Sectional Study
Fuyuan ZHANG ; Quan JIANG ; Jun LI ; Yuchen YANG ; Xieli MA ; Tian CHANG ; Congmin XIA ; Jian WANG ; Xun GONG
Journal of Traditional Chinese Medicine 2025;66(15):1572-1578
ObjectiveTo explore the correlation between the occurrence of cardiovascular events in rheumatoid arthritis(RA) and traditional Chinese medicine(TCM) syndrome. MethodsThe cross-sectional study selected 6713 RA patients from 122 centres nationwide, in which general information such as name, gender, age, height, body weight, and course of disease were collected by completing a questionnaire; patients were classified into eight types of syndrome according to the information of their four examinations,i.e. wind-dampness obstruction syndrome, cold-dampness obstruction syndrome, dampness-heat obstruction syndrome, phlegm-stasis obstruction syndrome, stasis-blood obstructing collateral syndrome, qi-blood deficiency syndrome, liver-kidney insufficiency syndrome, and qi-yin deficiency syndrome. According to the occurrence of cardiovascular events, they were divided into the occurrence group and the non-occurrence group, and the condition assessment data and laboratory examination indexes were recorded. The test of difference between groups was used to analyse the possible risk factors for the occurrence of RA cardiovascular events, and binary logistic regression was used to analyse the correlation between TCM syndromes and RA cardiovascular events. ResultsA total of 6713 RA patients were included, including 256 cases in occurrence group and 6457 in non-occurrence group. There was no statistically significant difference between groups in terms of height, gender, insomnia, appetite, white blood cell(WBC), hemoglobin(HGB), platelets(PLT), rheumatoid factor(RF), anti-cyclic peptide containing citrulline(CCP), alanine aminotransferase(ALT), aspartate aminotransferase(AST), γ-glutamyl transpeptidase(GGT), urea creatinine(CREA), and glucose(GLU)(P>0.05). The TCM syndromes between groups showed significant statistic differences(P<0.05). Patients in occurrence group had longer disease duration, heavier body weight, and older age; more severe conditions such as disease activity(DAS-28), number of painful joints(TJC), number of swollen joints(SJC), health questionnaire scores(HAQ), visual analog scores(VAS), restlessness, and fatigue; higher blood sedimentation rate(ESR), low-density lipoprotein(LDL-C), triglyceride(TG), total cholesterol(TC), D-Dimer, and lower high-density lipoprotein(HDL-C)(P<0.05). The distribution of syndrome types showed that dampness-heat obstruction syndrome accounted for the largest proportion of patients in both groups and was higher in RA cardiovascular events. Logistic regression analysis showed that the occurrence of RA cardiovascular events was strongly associated with dampness-heat obstruction syndrome[OR=5.937, 95%CI (4.434, 7.949), P<0.001]. ConclusionThe occurrence of RA cardiovascular events were associated with TCM syndromes, and the probability of cardiovascular events in the RA patients with dampness-heat obstruction syndrome was 5.937 times higher than patients with other TCM syndromes.
6.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.
7.Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine:Fibromyalgia Syndrome
Juan JIAO ; Jinyang TANG ; Xiujuan HOU ; Mengtao LI ; Dongfeng LIANG ; Yuhua WANG ; Weixia JING ; Guangtao LI ; Qin ZHANG ; Yongfeng ZHANG ; Guangyu LI ; Qian WANG ; Yang YANG ; Jin HUO ; Mei MO ; Jihua GUO ; Xiaoxiao ZHANG ; Quan JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(1):216-222
Fibromyalgia syndrome (FMS) is a refractory, chronic non-articular rheumatic disease characterized by widespread pain throughout the body, for which there are no satisfactory therapeutic drugs or options. There are rich Chinese medical therapies, and some non-drug therapies, such as acupuncture, Tai Chi, and Ba-Duan-Jin, have shown satisfactory efficacy and safety and definite advantages of simultaneously adjusting mind and body. FMS is taken as a disease responding specifically to traditional Chinese medicine (TCM) by the National Administration of Traditional Chinese Medicine in 2018. In order to clarify the research progress in FMS and the clinical advantages of TCM/integrated Chinese and Western medicine, the China Academy of Chinese Medicine organized a seminar for nearly 20 experts in Chinese and Western medicine, including rheumatology, psychology, acupuncture and moxibustion, and encephalopathy, with the topic of difficulties in clinical diagnosis and treatment of FMS and advantages of TCM and Western medicine. The recommendations were reached on the difficulties in early diagnosis and solutions of FMS, mitigation of common non-specific symptoms, preferential analgesic therapy, TCM pathogenesis and treatment advantages, and direction of treatment with integrated Chinese and Western medicine. FMS is currently facing the triple dilemma of low early correct diagnosis, poor patient participation, and unsatisfactory benefit from pure Western medicine treatment. To solve the above problems, this paper suggests that rheumatologists should serve as the main diagnostic force of this disease, and they should improve patient participation in treatment decision-making, implement exercise therapy, and fully utilize the holistic and multidimensional features of TCM, which is effective in alleviating pain, improving mood, and decreasing adverse events. In addition, it is suggested that FMS treatment should rely on both TCM and Western medicine and adopt multidisciplinary joint treatment, which is expected to improve the standard of diagnosis and treatment of FMS in China.
8.Pharmacological Effect of Phellodendri Chinensis Cortex and Active Components on Gout: A Review
Min LI ; Yunyun QUAN ; Ting WANG ; Li LI ; Jin ZENG ; Junning ZHAO ; Jiuzhou MAO ; Yangfan TANG ; Zhujun YIN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(1):286-298
Gout is a metabolic disease closely associated with hyperuricemia and urate deposition. Because of the complex pathogenesis, high morbidity, multiple complications, and increasingly young patients, gout has received worldwide attention. Currently, western medicine mainly treats gout by lowering the uric acid level and reducing inflammation, which, however, causes serious adverse reactions and has contraindications. Phellodendri Chinensis Cortex (PCC) is the dried bark of Phellodendron chinense, with the effects of clearing heat, drying dampness, purging fire, detoxifying, and treating sores. Studies have shown that PCC and its active components have anti-inflammatory, pain-relieving, uric acid-lowering, and anti-gout activities, with extensive sources and high safety. PCC and its active components could prevent and treat gout through multi-targets and multi-pathways, whereas the systematic review remains to be carried out. Therefore, this paper summarized the pharmacological activities and mechanisms of PCC and its active components in the treatment of gout. The available studies have shown that PCC and its active components exert the anti-gout effect by lowering the uric acid level, reducing inflammation, alleviating oxidative stress, and regulationg intestinal flora, and protecting the kidneys. Particularly, the active components represented by alkaloids contribute obviously to the therapeutic effect of of PCC. Herein, we analyzed the problems and future development of the research on PCC, aiming to provide theoretical support and a scientific basis for the research and development of new drugs against gout.
9.Drug metabolism and excretion of14Cbirociclib in Chinese male healthy subjects
Quan-Kun ZHUANG ; Hui-Rong FAN ; Shi-Qi DONG ; Bin-Ke FAN ; Ming-Ming LIU ; Ling-Mei XU ; Li WANG ; Xue-Mei LIU ; Fang HOU
The Chinese Journal of Clinical Pharmacology 2024;40(14):2118-2123
Objective To evaluate the characteristics of the mass balance and pharmacokinetics of[14 C]birociclib in Chinese male healthy volunteers after a single oral administration.Methods This study used a 14 C labeled method to investigate the mass balance and biological transformation of birociclib in human.Subjects were given a single oral dose of 360 mg/50 pCi of[14 C]birociclib suspension after meals.The blood,urine,and fecal samples were collected at specified time points/intervals after administration.The radiation levels of 14 C labeled birociclib-related compounds in the blood,plasma,urine,and feces were analyzed using liquid scintillation counting.In addition,a combination of high-performance liquid chromatography and on-line/off-line isotope detectors was used to obtain radioactive isotope metabolite spectra of plasma,urine,and fecal samples,and high-resolution mass spectrometry was used to identify the main metabolites.Results A total of 6 healthy male subjects were enrolled in this study.The median peak time of radioactive components in plasma was 5.00 h and the average terminal elimination half-life was 43.70 h after administration.The radioactive components were basically excreted and cleared from the body within 288.00 hours after administration,and average cumulative recovery rate of radioactive drugs was(94.10±8.19)%.The radioactive drugs were mainly excreted through feces,accounting for(84.60±7.10)%of the dose of radioactive drugs administered.Urine was the secondary excretory pathway,accounting for 9.41%of the dose of radioactive drugs administered.Metabolic analysis indicated that the prototype drug was the main radioactive components in plasma samples.The main metabolites in plasma were RM4(XZP-5286),RM6(XZP-3584),and RM7(XZP-5736).The drugs were mainly cleared from the body in the form of prototype drugs and metabolites.In addition to prototype drugs,a total of 9 metabolites were identified and analyzed in plasma,urine,and fecal samples,all of which were phase 1 metabolites.The main metabolic and clearance pathways of drugs in the body were deethylation,diisopropylat ion,oxidation,etc.Conclusion After a single oral administration of[14C]birociclib suspension to healthy subjects,it was mainly cleared from the body in the form of prototype drugs and metabolites,with feces as the main excretory pathway and urine as the secondary excretory pathway.Drugs mainly undergo metabolic reactions in the body,such as deethylation,diisopropylation,and oxidation.The subjects were well tolerance after administration.
10.Chinese herbal medicine for the treatment of endocrine therapy-related osteoporosis among patients with breast cancer: A systematic review and meta-analysis
Xiaomin Quan ; Hongyang Chen ; Weiyi Wang ; Yu Gao ; Xingyue Zhi ; Xun Li ; Guanhu Yang ; Donggui Wan ; Chao An
Journal of Traditional Chinese Medical Sciences 2024;11(2):148-164
Objective:
To assess the efficacy and safety of combining traditional Chinese medicine (TCM), specifically Chinese herbal medicine (CHM), with Western medicine (WM), compared to WM alone to treat breast cancer endocrine therapy-related osteoporosis (BCET-OP) by meta-analysis.
Methods:
Thirty-eight randomized controlled trials involving 2170 participants were analyzed. Eight databases were searched for articles published between inception and December 2023. Quality assessment was performed using the Risk of Bias 2 tool.
Results:
Significant increases were observed in the TCM-WM group in lumbar vertebrae bone mineral density (BMD) (P < .001, mean difference (MD) = 0.07, 95% confidence interval (CI): 0.06 to 0.08), lumbar vertebrae T-score (P = .0005, MD = 0.21, 95%CI: 0.09 to 0.33) and collum femoris BMD (P = .01, MD = 0.10, 95%CI: 0.02 to 0.19). No significant difference was observed between the groups in the collum femoris T-score and estradiol levels. Bone gla-protein levels were significantly increased in the TCM-WM group (P = .0002, MD = 0.52, 95%CI: 0.25 to 0.79). Beta-CrossLaps decreased significantly in the TCM-WM group (P = .0008, MD = −0.10, 95%CI: −0.16 to −0.04). No significant difference was observed between the TCM-WM and WM groups in alkaline phosphatase, in procollagen type I N-terminal propeptide, and in the Kupperman index. The visual analog score (VAS) was decreased in the TCM-WM group compared to the WM group (P < .001, MD = −1.40, 95%CI: −1.94 to −0.87). No significant difference in adverse events was observed between the two groups.
Conclusion
Combining CHM with WM in patients with BCET-OP significantly improved BMD, T-score, and certain bone turnover markers and reduced the VAS score, indicating potential benefits for bone health and related pain. Adverse event analysis revealed no differences between the groups, supporting the feasibility of the combination therapy. However, further research, particularly in diverse populations, is required.


Result Analysis
Print
Save
E-mail