1.Real-world efficacy and safety of azvudine in hospitalized older patients with COVID-19 during the omicron wave in China: A retrospective cohort study.
Yuanchao ZHU ; Fei ZHAO ; Yubing ZHU ; Xingang LI ; Deshi DONG ; Bolin ZHU ; Jianchun LI ; Xin HU ; Zinan ZHAO ; Wenfeng XU ; Yang JV ; Dandan WANG ; Yingming ZHENG ; Yiwen DONG ; Lu LI ; Shilei YANG ; Zhiyuan TENG ; Ling LU ; Jingwei ZHU ; Linzhe DU ; Yunxin LIU ; Lechuan JIA ; Qiujv ZHANG ; Hui MA ; Ana ZHAO ; Hongliu JIANG ; Xin XU ; Jinli WANG ; Xuping QIAN ; Wei ZHANG ; Tingting ZHENG ; Chunxia YANG ; Xuguang CHEN ; Kun LIU ; Huanhuan JIANG ; Dongxiang QU ; Jia SONG ; Hua CHENG ; Wenfang SUN ; Hanqiu ZHAN ; Xiao LI ; Yafeng WANG ; Aixia WANG ; Li LIU ; Lihua YANG ; Nan ZHANG ; Shumin CHEN ; Jingjing MA ; Wei LIU ; Xiaoxiang DU ; Meiqin ZHENG ; Liyan WAN ; Guangqing DU ; Hangmei LIU ; Pengfei JIN
Acta Pharmaceutica Sinica B 2025;15(1):123-132
Debates persist regarding the efficacy and safety of azvudine, particularly its real-world outcomes. This study involved patients aged ≥60 years who were admitted to 25 hospitals in mainland China with confirmed SARS-CoV-2 infection between December 1, 2022, and February 28, 2023. Efficacy outcomes were all-cause mortality during hospitalization, the proportion of patients discharged with recovery, time to nucleic acid-negative conversion (T NANC), time to symptom improvement (T SI), and time of hospital stay (T HS). Safety was also assessed. Among the 5884 participants identified, 1999 received azvudine, and 1999 matched controls were included after exclusion and propensity score matching. Azvudine recipients exhibited lower all-cause mortality compared with controls in the overall population (13.3% vs. 17.1%, RR, 0.78; 95% CI, 0.67-0.90; P = 0.001) and in the severe subgroup (25.7% vs. 33.7%; RR, 0.76; 95% CI, 0.66-0.88; P < 0.001). A higher proportion of patients discharged with recovery, and a shorter T NANC were associated with azvudine recipients, especially in the severe subgroup. The incidence of adverse events in azvudine recipients was comparable to that in the control group (2.3% vs. 1.7%, P = 0.170). In conclusion, azvudine showed efficacy and safety in older patients hospitalized with COVID-19 during the SARS-CoV-2 omicron wave in China.
2.Research progress on valgus impacted proximal humeral fractures.
Bo LI ; Shimin CHANG ; Sunjun HU ; Shouchao DU ; Wenfeng XIONG
Chinese Journal of Reparative and Reconstructive Surgery 2024;38(1):107-112
OBJECTIVE:
To review the advancement made in the understanding of valgus impacted proximal humeral fracture (PHF).
METHODS:
The domestic and foreign literature about the valgus impacted PHF was extensively reviewed and the definition, classification, pathological features, and treatment of valgus impacted PHFs were summarized.
RESULTS:
PHF with a neck shaft angle ≥160° is recognized as a valgus impacted PHF characterized by the preservation of the medial epiphyseal region of the humeral head, which contributes to maintenance of the medial periosteum's integrity after fracture and reduces the occurrence of avascular necrosis. Therefore, the valgus impacted PHF has a better prognosis when compared to other complex PHFs. The Neer classification designates it as a three- or four-part fracture, while the AO/Association for the Study of Internal Fixation (AO/ASIF) categorizes it as type C (C1.1). In the management of the valgus impacted PHF, the selection between conservative and surgical approaches is contingent upon the patient's age and the extent of fracture displacement. While conservative treatment offers the advantage of being non-invasive, it is accompanied by limitations such as the inability to achieve anatomical reduction and the potential for multiple complications. Surgical treatment includes open reduction combined with steel wire or locking plate and/or non-absorbable suture, transosseous suture technology, and shoulder replacement. Surgeons must adopt personalized treatment strategies for each patient with a valgus impacted PHF. Minimally invasive surgery helps to preserve blood supply to the humeral head, mitigate the likelihood of avascular necrosis, and reduce postoperative complications of bone and soft tissue. For elderly patients with severe comminuted and displaced fractures, osteoporosis, and unsuitable internal fixation, shoulder joint replacement is the best treatment option.
CONCLUSION
Currently, there has been some advancement in the classification, vascular supply, and management of valgus impacted PHF. Nevertheless, further research is imperative to assess the clinical safety, biomechanical stability, and indication of minimally invasive technology.
Aged
;
Humans
;
Bone Plates
;
Bone Wires
;
Fracture Fixation, Internal/adverse effects*
;
Fractures, Comminuted/surgery*
;
Humeral Fractures
;
Osteonecrosis
;
Retrospective Studies
;
Shoulder Fractures/surgery*
;
Treatment Outcome
3.XIONG Jibai's Experience in Treating Henoch-schonlein Purpura by Staged Diagnosis and Treatment with "Simultaneous Treatment of Wind and Blood"
Wenfeng XU ; Hua HU ; Yajun PENG ; Fan WU ; Wei CAI ; Zhaohong GONG ; Chao TAN
Journal of Traditional Chinese Medicine 2024;65(13):1318-1322
This article aimed to summarise the clinical experience of Professor XIONG Jibai in treating henoch-schonlein purpura (HSP) from the perspective of "simultaneous treatment of wind and blood". HSP was devided into acute phase and transitional phase in clinic. It was considered that the wind pathogen exists throughout the disease course, and the treatment is guided by the "four methods of treating blood" in TANG Rongchuan's Treatise on Blood Syndromes - Blood Vomiting (《血证论·吐血》), which are stanching bleeding, expelling stasis, tranquilising blood, and tonifying blood. In the acute phase, wind-heat damaging collateral symdrome and blood-heat frenetic flow syndrome are common, which could be treated by the method of cooling blood to dispel wind, and eliminating stasis to stop bleeding, with self-prescribed modified Ziping Xiaofeng Powder (紫萍消风散); in the transitional phase, syndrome of effulgent fire due to yin deficiency and syndrome of qi deficiency failing to control are common, which could be treated by the method of tranquilising blood and tonifying deficiency, with modified Zhibai Dihuang Decoction (知柏地黄汤) and Guipi Decoction (归脾汤). At the same time, it is believed that wind-related medicinal has the function of eliminating stasis, stanching bleeding, and cooling blood, and the wind-related medicinal should be used throughout the treatment.
4.Successful replantation of an almost-amputated nose
Meng LIU ; Wenfeng ZHAO ; Xiyue HU ; Chen ZHANG ; Jieqing WANG
Chinese Journal of Plastic Surgery 2024;40(5):555-559
There are limited reports available regarding the treatment of amputated noses. This article presented a case of an incompletely amputated nose in a 47-year-old male who was admitted to Dalian University Affiliated Xinhua Hospital in July 2023. He was characterized by an amputated right nasal tip and alar region, with an avulsion area of approximately 4 cm×4 cm. The broad pedicle was connected to the nasal base, approximately 5 mm below the remaining nasal column, and only the nasal column retained a satisfactory arterial blood supply. During the operation, the amputated tissue was implanted in situ, and clindamycin was employed to prevent infection after the operation by intravenous infusion. Bloodletting with flaps, wet application of heparin saline, and massage were employed and all the amputated tissue survived. The appearance of the nose was deemed acceptable. By reviewing relevant literature, the author discussed and summarized the methods of nasal blood supply and treatment for nasal amputated injuries, thereby providing a reference for the management of similar cases.
5.Risk factors and prevention for implant treatment in patients with periodontitis
Chinese Journal of Stomatology 2024;59(4):383-388
In patients with periodontitis, due to problems of periodontal tissue infection as well as soft and hard tissues defects, it may lead to implant infection, gingival papilla loss, soft tissue recession and poor coordination with adjacent teeth. For such patients, periodontal infection should be actively controlled before dental implant therapy. In consideration of insufficient soft and hard tissues, alveolar ridge preservation and soft tissue augmentation procedure can be used to preserve or increase soft and hard tissues as much as possible. Multi-disciplinary treatment is often needed for occlusion problems and coordination with adjacent tooth. Periodontal maintenance treatment of implants and natural teeth is also necessary after implant therapy. This paper discussed these risk factors and strategies for prevention and control, in order to provide some clinical guidances for the implant treatment of periodontitis patients.
6.Successful replantation of an almost-amputated nose
Meng LIU ; Wenfeng ZHAO ; Xiyue HU ; Chen ZHANG ; Jieqing WANG
Chinese Journal of Plastic Surgery 2024;40(5):555-559
There are limited reports available regarding the treatment of amputated noses. This article presented a case of an incompletely amputated nose in a 47-year-old male who was admitted to Dalian University Affiliated Xinhua Hospital in July 2023. He was characterized by an amputated right nasal tip and alar region, with an avulsion area of approximately 4 cm×4 cm. The broad pedicle was connected to the nasal base, approximately 5 mm below the remaining nasal column, and only the nasal column retained a satisfactory arterial blood supply. During the operation, the amputated tissue was implanted in situ, and clindamycin was employed to prevent infection after the operation by intravenous infusion. Bloodletting with flaps, wet application of heparin saline, and massage were employed and all the amputated tissue survived. The appearance of the nose was deemed acceptable. By reviewing relevant literature, the author discussed and summarized the methods of nasal blood supply and treatment for nasal amputated injuries, thereby providing a reference for the management of similar cases.
7.A multi-center, double-blind, randomized, placebo- and positive-controlled phase II clinical study of benvitimod for the treatment of atopic dermatitis.
Lin CAI ; Yan ZHAO ; Min ZHENG ; Furen ZHANG ; Qing SUN ; Quanzhong LIU ; Jin HU ; Juan SHEN ; Jianzhong ZHANG
Chinese Medical Journal 2023;136(2):251-252
8.Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial.
Chengyuan GU ; Zengjun WANG ; Tianxin LIN ; Zhiyu LIU ; Weiqing HAN ; Xuhui ZHANG ; Chao LIANG ; Hao LIU ; Yang YU ; Zhenzhou XU ; Shuang LIU ; Jingen WANG ; Linghua JIA ; Xin YAO ; Wenfeng LIAO ; Cheng FU ; Zhaohui TAN ; Guohua HE ; Guoxi ZHU ; Rui FAN ; Wenzeng YANG ; Xin CHEN ; Zhizhong LIU ; Liqiang ZHONG ; Benkang SHI ; Degang DING ; Shubo CHEN ; Junli WEI ; Xudong YAO ; Ming CHEN ; Zhanpeng LU ; Qun XIE ; Zhiquan HU ; Yinhuai WANG ; Hongqian GUO ; Tiwu FAN ; Zhaozhao LIANG ; Peng CHEN ; Wei WANG ; Tao XU ; Chunsheng LI ; Jinchun XING ; Hong LIAO ; Dalin HE ; Zhibin WU ; Jiandi YU ; Zhongwen FENG ; Mengxiang YANG ; Qifeng DOU ; Quan ZENG ; Yuanwei LI ; Xin GOU ; Guangchen ZHOU ; Xiaofeng WANG ; Rujian ZHU ; Zhonghua ZHANG ; Bo ZHANG ; Wanlong TAN ; Xueling QU ; Hongliang SUN ; Tianyi GAN ; Dingwei YE
Chinese Medical Journal 2023;136(10):1207-1215
BACKGROUND:
LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.
METHODS:
We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.
RESULTS:
On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).
CONCLUSION:
LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04563936.
Humans
;
Male
;
Antineoplastic Agents, Hormonal/therapeutic use*
;
East Asian People
;
Gonadotropin-Releasing Hormone/agonists*
;
Goserelin/therapeutic use*
;
Prostate-Specific Antigen
;
Prostatic Neoplasms/drug therapy*
;
Testosterone
9.Research progress in impurity control of ursodeoxycholic acid
Xuelin SUN ; Wenfeng XU ; Xin HU
China Pharmacy 2022;33(21):2681-2684
Ursodeoxycholic acid (UDCA)is a natural hydrophilic bile acid derived from cholesterol ,which has a low content in human body ,and can be used for the treatment of gallstones ,cholestatic liver disease ,fatty liver and so on . Due to the differences in the synthesis process ,source of active pharmaceutical ingredients (API)and impurity control standards of UDCA at home and abroad ,the author summarized the synthesis process of UDCA at home and abroad by searching relevant literature ,and analyzed the impurity sources and impurity control standards of API . The results showed that the pharmacopoeia of the United States,the United Kingdom and Europe put forward clear requirements on the synthesis route and impurity control of UDCA ,and formulated corresponding impurity control standards . However,synthesis process and impurity detection standards of UDCA were relatively simple in China . It is suggested that domestic research institutions constantly improve impurity spectrum ,promote the synthesis process ,and improve the quality detection standards of UDCA ,so as to provide a reference for pharmaceutical study and reasonable clinical application of UDCA .
10.Application value of three risk assessment models of venous thromboembolism in hospitalized stroke patients
Yueping ZHENG ; Meiling HU ; Liqian WANG ; Ailan HE ; Hongying TANG ; Wenfeng CHEN
Journal of Chinese Physician 2022;24(1):44-48
Objective:To compare the value of Caprini, Padua and Autar risk assessment models in the risk assessment of venous thromboembolism in hospitalized stroke patients.Methods:A retrospective case-control study were used to collect hospitalized stroke patients in the neurology department of Xiangya Hospital from January 1, 2018 to June 30, 2020. 75 patients with venous thromboembolism (VTE) were VTE group and 75 patients without VTE were control group. The risk of thrombosis was assessed by Caprini risk assessment model, Padua risk assessment model and Autar risk assessment model respectively. The predictive value of each model on the risk of VTE formation in stroke patients was analyzed by receiver operating characteristic (ROC) curve and area under the curve (AUC).Results:The areas under the curve of Caprini, Padua and Autar risk assessment models for predicting the risk of VTE formation in stroke patients were 0.768±0.039, 0.746±0.040 and 0.710±0.042 respectively. The sensitivity, specificity and accuracy were 81.3%, 61.3%, 71.3%(Caprini), 72.0%, 72.0%, 72.0%(Padua), 66.7%, 68.0% and 67.3%(Autar) respectively. There was no significant difference in the prediction value of the three models on the formation risk of stroke VTE (all P>0.05). The technique for order preference by similarity to ideal solution (TOPSIS) method was used to comprehensively evaluate the AUC, sensitivity, specificity and accuracy of the three risk assessment models. Padua risk assessment model was the best, followed by Caprini risk assessment model and Autar risk assessment model. Conclusions:The Caprini, Padua, and Autar risk assessment scales can well predict the risk of VTE in stroke patients. The Caprini scale has the highest sensitivity and the Padua scale has the highest specificity. There is no significant difference in the predictive value of the three scales. Comprehensive evaluation of predictive value: Padua risk assessment scale is the best.

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