1.Clinical trial of Morinda officinalis oligosaccharides in the continuation treatment of adults with mild and moderate depression
Shu-Zhe ZHOU ; Zu-Cheng HAN ; Xiu-Zhen WANG ; Yan-Qing CHEN ; Ya-Ling HU ; Xue-Qin YU ; Bin-Hong WANG ; Guo-Zhen FAN ; Hong SANG ; Ying HAI ; Zhi-Jie JIA ; Zhan-Min WANG ; Yan WEI ; Jian-Guo ZHU ; Xue-Qin SONG ; Zhi-Dong LIU ; Li KUANG ; Hong-Ming WANG ; Feng TIAN ; Yu-Xin LI ; Ling ZHANG ; Hai LIN ; Bin WU ; Chao-Ying WANG ; Chang LIU ; Jia-Fan SUN ; Shao-Xiao YAN ; Jun LIU ; Shou-Fu XIE ; Mao-Sheng FANG ; Wei-Feng MI ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(6):815-819
Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P<0.05).After continuation treatment,the remission rate was 54.59%(202 cases/370 cases),and the recurrence rate was 6.49%(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35%(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.
2.Recent advances in small-molecule inhibitors targeting influenza virus RNA-dependent RNA polymerase
Hui-nan JIA ; Rui-fang JIA ; Ji-wei ZHANG ; Yuan-min JIANG ; Chuan-feng LIU ; Ying ZHANG ; Xin-yong LIU ; Peng ZHAN
Acta Pharmaceutica Sinica 2024;59(1):43-60
Influenza virus causes serious threat to human life and health. Due to the inherent high variability of influenza virus, clinically resistant mutant strains of currently approved anti-influenza virus drugs have emerged. Therefore, it is urgent to develop antiviral drugs with new targets or mechanisms of action. RNA-dependent RNA polymerase is directly responsible for viral RNA transcription and replication, and plays key roles in the viral life cycle, which is considered an important target of anti-influenza drug design. From the point of view of medicinal chemistry, this review summarizes current advances in diverse small-molecule inhibitors targeting influenza virus RNA-dependent RNA polymerase, hoping to provide valuable reference for development of novel antiviral drugs.
3.Recent advances in small-molecule inhibitors targeting influenza virus glycoproteins
Yuan-min JIANG ; Ji-wei ZHANG ; Rui-fang JIA ; Hui-nan JIA ; Ying ZHANG ; Xin-yong LIU ; Peng ZHAN
Acta Pharmaceutica Sinica 2023;58(11):3254-3269
Hemagglutinin and neuraminidase, two important glycoproteins on the surface of influenza virus, play a considerable role in the entry and release stage of the viral life cycle, respectively. With in-depth investigation of influenza virus glycoproteins and the continuous innovation of drug discovery strategies, a new generation of glycoproteins inhibitors have been continuously discovered. From the point of view of medicinal chemistry, this review summarizes the current advances in seeking small-molecule inhibitors targeting influenza virus glycoproteins, hoping to provide valuable guidance for future development of novel antiviral drugs.
4.A multicenter study of the clinicopathological characteristics and a risk prediction model of early-stage breast cancer with hormone receptor-positive/human epidermal growth factor receptor 2-low expression.
Ling XIN ; Qian WU ; Chongming ZHAN ; Hongyan QIN ; Hongyu XIANG ; Min GAO ; Xuening DUAN ; Yinhua LIU ; Jingming YE
Chinese Medical Journal 2023;136(24):2967-2973
BACKGROUND:
In light of the significant clinical benefits of antibody-drug conjugates in clinical trials, the human epidermal growth factor receptor 2 (HER2)-low category in breast cancers has gained increasing attention. Therefore, we studied the clinicopathological characteristics of Chinese patients with hormone receptor (HR)-positive/HER2-low early-stage breast cancer and developed a recurrence risk prediction model.
METHODS:
Female patients with HR-positive/HER2-low early-stage breast cancer treated in 29 hospitals of the Chinese Society of Breast Surgery (CSBrS) from Jan 2015 to Dec 2016 were enrolled. Their clinicopathological data and prognostic information were collected, and machine learning methods were used to analyze the prognostic factors.
RESULTS:
In total, 25,096 patients were diagnosed with breast cancer in 29 hospitals of CSBrS from Jan 2015 to Dec 2016, and clinicopathological data for 6486 patients with HER2-low early-stage breast cancer were collected. Among them, 5629 patients (86.79%) were HR-positive. The median follow-up time was 57 months (4, 76 months); the 5-year disease-free survival (DFS) rate was 92.7%, and the 5-year overall survival (OS) rate was 97.7%. In total, 412 cases (7.31%) of metastasis were observed, and 124 (2.20%) patients died. Multivariate Cox regression analysis revealed that T stage, N stage, lymphovascular thrombosis, Ki-67 index, and prognostic stage were associated with recurrence and metastasis ( P <0.05). A recurrence risk prediction model was established using the random forest method and exhibited a sensitivity of 81.1%, specificity of 71.7%, positive predictive value of 74.1%, and negative predictive value of 79.2%.
CONCLUSION:
Most of patients with HER2-low early-stage breast cancer were HR-positive, and patients had favorable outcome; tumor N stage, lymphovascular thrombosis, Ki-67 index, and tumor prognostic stage were prognostic factors. The HR-positive/HER2-low early-stage breast cancer recurrence prediction model established based on the random forest method has a good reference value for predicting 5-year recurrence events.
REGISTRITATION
ChiCTR.org.cn, ChiCTR2100046766.
Humans
;
Female
;
Breast Neoplasms/diagnosis*
;
Ki-67 Antigen
;
Receptor, ErbB-2
;
Prognosis
;
Thrombosis
;
Receptors, Progesterone
5.Overview of systematic reviews of acupuncture for vascular cognitive impairment.
Fu-Hua HAN ; Lin-Juan SUN ; Yun-Ling ZHANG ; Zi-Xiu ZENG ; Wei SHEN ; Min ZHAN ; Ying WANG ; Jing-Zi SHI ; Xin-Yun ZENG ; Xi-Yue LU ; Xing LIAO
Chinese Acupuncture & Moxibustion 2022;42(1):109-115
OBJECTIVE:
To overview the methodological quality, report quality and evidence quality of the systematic review (SR) of acupuncture for vascular cognitive impairment ( VCI ).
METHODS:
The SRs regarding acupuncture for VCI were searched in PubMed, Cochrane Library, EMbase, CNKI, SinoMed, Wanfang and VIP databases. The retrieval period was from the establishment of the database to September 24, 2020. The report quality, methodological quality and evidence quality of the included SRs were evaluated by PRISMA statement, the AMSTAR 2 tool and the GRADE system.
RESULTS:
A total of 22 SRs were included, including 102 outcome indexes. The methodological quality was generally low, with low scores on items 2, 5, 7, 10, 14, 15 and 16. The report quality was good, with scores ranging from 19 points to 24.5 points. The problems of report quality were mainly reflected in the aspects of structural abstract, program and registration, other analysis and funding sources. The level of outcome indexes of SRs was mostly low or very low, and the main leading factor was limitation, followed by inconsistency and inaccuracy.
CONCLUSION
Acupuncture for VCI is supported by low quality evidence of evidence-based medicine, but the methodological quality and evidence body quality of relevant SRs are poor, and the standardization is needed to be improved.
Acupuncture Therapy
;
Cognitive Dysfunction/therapy*
;
Databases, Factual
;
Humans
;
Research Report
;
Systematic Reviews as Topic
6.Outcomes in randomized controlled trials of acupuncture for vascular cognitive impairment during recent five years.
Xin-Yun ZENG ; Xing LIAO ; Yun-Ling ZHANG ; Zi-Xiu ZENG ; Wei SHEN ; Min ZHAN ; Ying WANG ; Fu-Hua HAN ; Jing-Zi SHI ; Xi-Yue LU
Chinese Acupuncture & Moxibustion 2022;42(5):590-594
The existing problems in the outcomes of randomized controlled trials (RCTs) of acupuncture for vascular cognitive impairment (VCI) during recent five years are analyzed and suggestions are proposed. The RCTs of acupuncture for VCI were selected in PubMed, EMbase, Cochrane Library, Clinical Trials, CNKI database, Wanfang database, VIP database, SinoMed database and Chinese Clinical Trial Registry (ChiCTR) from January 1, 2015 to September 14, 2020. The outcomes were extracted and analyzed. As a result, 21 RCTs were included and the outcomes used were divided into 9 categories: clinical symptom/sign indexes, quality of life indexes, neuroimaging indexes, neuroelectrophysiology indexes, blood biochemical indexes, hemorheology indexes, TCM syndrome score indexes, clinical efficacy indexes, and safety indexes. Among them, the top three of the most used outcomes were clinical symptoms/signs indexes (21, 100.0%), clinical efficacy indexes (14, 66.7%) and quality of life indexes (12, 57.1%). In the RCTs of acupuncture for VCI, attention should be paid to distinguish the primary outcomes and secondary outcomes, adopt objective and standardized efficacy evaluation, and give consideration to report the outcomes of safety, health economic and TCM characteristic indexes.
Acupuncture Therapy
;
Cognitive Dysfunction/therapy*
;
Humans
;
Randomized Controlled Trials as Topic
;
Treatment Outcome
7.A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China.
Quan-Min JING ; Xin ZHAO ; Ya-Ling HAN ; Ling-Ling GAO ; Yang ZHENG ; Zhan-Quan LI ; Ping YANG ; Hong-Liang CONG ; Chuan-Yu GAO ; Tie-Min JIANG ; Hui LI ; Jun-Xia LI ; Dong-Mei WANG ; Geng WANG ; Zhan-Chun CONG ; Zhong ZHANG
Chinese Medical Journal 2020;133(8):899-908
BACKGROUND:
Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions.
METHODS:
Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (n = 113) and a BA group (n = 109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses.
RESULTS:
At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0% ± 19.0%) was -11.3% (95% confidence interval: -16.3% to -6.3%, Psuperiority <0.0001) in the intention-to-treat analysis, and similar results were recorded in the per-protocol analysis, demonstrating the superiority of PEB to BA. Late lumen loss was significantly lower in the PEB group than in the BA group (-0.06 ± 0.32 vs. 0.18 ± 0.34 mm, P < 0.0001). For intention-to-treat, there were no significant differences between PEB and BA in the 9-month percentages of MACCEs (0.9% vs. 3.7%, P = 0.16) or non-fatal myocardial infarctions (0 vs. 0.9%, P = 0.49). There were no clinical events of target lesion revascularization, target vessel revascularization, target lesion failure, all-cause death, cardiac death or target lesion thrombosis in either group.
CONCLUSIONS:
In de novo non-left main coronary artery bifurcations treated with provisional T stenting, SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov.
8.Effect of acupuncture and moxibustion on post-stroke constipation: a network Meta-analysis.
Ou-Feng TANG ; Si-Min HUANG ; Xin-Xin YE ; Qi-Xi LIU ; Ting-Ting CHEN ; Chen-Ju ZHAN
Chinese Acupuncture & Moxibustion 2020;40(9):1011-1016
OBJECTIVE:
To systematically review the therapeutic effect of acupuncture-moxibustion therapies on post-stroke constipation based on the network Meta-analysis.
METHODS:
The randomized controlled trials of acupuncture and moxibustion for post-stroke constipation were retrieved from the databases, starting from the time of establishment through to June, 2019, i.e. the PubMed, EMbase, Cochrane Library, Web of Science, SinoMed, CNKI, Wanfang and VIP. The literature was selected according to inclusion and exclusion criteria, the quality of literature was evaluated by bias risk assessment tool of Cochrane Review Manual 5.3 and the data was statistically analyzed by softwares of Stata 13.1 and R Language.
RESULTS:
A total of 28 trails were included, involving 9 intervention methods. The therapeutic effect was arranged from high to the low according to the surface under cumulative ranking area (SUCRA), i.e. acupuncture combined with medication (0.86), warm needling (0.83), electroacupuncture combined with medication (0.68), electroacupuncture (0.68), moxibustion (0.50), auricular point sticking (0.44), acupuncture (0.31), Chinese herbal medicine (0.12) and western medication (0.04).
CONCLUSION
Acupuncture- moxibustion therapies have superiority on treating post-stroke constipation, acupuncture combined with medication has the most optimum therapeutic effect and the therapeutic effect of acupuncture-moxibustion combined with medication is superior to the single treatment of medication.
9.Role of TLR4/NF-κB pathway for early change of synovial membrane in knee osteoarthritis rats.
Xue-Zong WANG ; Dao-Fang DING ; Yan XUE ; Xin-Feng GU ; Jian PANG ; Min ZHANG ; Yu-Xin ZHENG ; Yue-Long CAO ; Hong-Sheng ZHAN
China Journal of Orthopaedics and Traumatology 2019;32(1):68-71
OBJECTIVE:
To study role of TLR4/NF-κB pathway for early change of synovial membrane in knee osteoarthritis rats.
METHODS:
Eighteen male SD rats weighted (200±20) g were randomly divided into 2 groups, namely control and model group, and 9 in each group. Knee OA model group was established by using modified Hulth method in model group. Control group was not treated. Synovial tissue and serum was extracted at 4 and 21 d after operation. Expression of CD14, TLR4, IL-1β, TNF-α, ADAMTS-4, MMP-13 were detected by real-time PCR respectively. NF-κB p65 protein was detected by Western-blot; serum concentrations of haluronic acid (HA), N-propeptide of type III procollagen(PIIINP) was detected by Elisa.
RESULTS:
Expression of CD14, ADAMTS-4, and NF-κB p65 in model group were higher than that of control group at 4 and 21 days after operation, while expression of TLR4, IL-1β, TNF-α and MMP-13 were higher than that of control group at 21 days after operation(<0.01). Concentration of PIIINP and HA in model group were higher than that of control group at 4 days after operation, while there was no significant difference at 21 days after operation.
CONCLUSIONS
NF-κB pathway could mediate occurrence of KOA by early activating and triggeringg synovial increasingly secreting inflammatory secretion CD14, TLR4, IL-1β, TNF-α, ADAMTS-4, MMP-13, PIIINP and HA.
Animals
;
Male
;
NF-kappa B
;
Osteoarthritis, Knee
;
Rats
;
Rats, Sprague-Dawley
;
Signal Transduction
;
Synovial Membrane
;
Toll-Like Receptor 4
10. Treatment of complex coronary lesions by excimer laser coronary atherectomy: the experiences of single center
Yuan HAN ; Quan-min JING ; Geng WANG ; Xin ZHAO ; Xiao-zeng WANG ; Kai XU ; Jun-na SUN ; Zhan-chun CONG ; Ya-ling HAN
Chinese Journal of Practical Internal Medicine 2019;39(01):73-77
OBJECTIVE: The aim of this study was to introduce the experience in treatment of acute ST segment elevation myocardial infarction(STEMI), saphenous vein graft(SVG), Chronic total occlusion(CTO),In-stent restenosis(ISR)and diffuse calcification lesions by excimer laser coronary atherectomy(ELCA). METHODS: Twenty-two patients were enrolled through our center from November 2016 to May 2017 and ELCA was performed on 22 lesions.The clinical and procedure endpoints were recorded. RESULTS: All the lesions were successfully crossed with laser catheterand and finally were performed by ELCA. Five cases(22.7%)with STEMI, ten cases(45.5%) with SVG lesions,five cases with ISR and other cases were CTO(4.5%) and Calcification(4.5%) lesions.Seventeen patients underwent balloon dilatation and successful implantation of drug-eluting stents(DES) and one patients was treated with drug-eluting balloon(DEB).the procedual and clinical success rates were 100%. At 6.6±2.7 months follow-up, there were no major adverse cardiac events(MACEs) and ELCA relatedcomplications recorded. Conclution This limited evdiences showed that treatment of complex coronary lesions by excimer laser coronary atherectomy may be a Safe and effective choice.It can be further popularized in complex coronary artery disease.

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