2.Clinical Application of Zanubrutinib in B-Cell Lymphoma --Review.
Xiao TANG ; Wen-Rong ZOU ; Peng PENG ; Yang-Lyu BAI
Journal of Experimental Hematology 2022;30(3):965-969
Zanubrutinib is a highly selective second-generation BTK inhibitor developed in China and first approved by the U.S. Food and Drug Administration (FDA) as a novel antineoplastic drug. In recent years, with the birth of molecularly targeted drugs, the treatment of B-cell lymphoma have entered the era of targeted therapy, and immunotherapy has been widely accepted. Especially in some relapsed and refractory lymphomas, zanubrutinib has shown deep and sustained remissions and a favorable safety, which lays a foundation for precision therapy. In this review the clinical application and new progress for zanubrutinib in B-cell lymphoma was summarized briefly.
Humans
;
Lymphoma, B-Cell/drug therapy*
;
Piperidines/therapeutic use*
;
Protein Kinase Inhibitors/therapeutic use*
;
Pyrazoles/therapeutic use*
;
Pyrimidines/therapeutic use*
3.Continuation, reduction, or withdrawal of tofacitinib in patients with rheumatoid arthritis achieving sustained disease control: a multicenter, open-label, randomized controlled trial.
Mengyan WANG ; Yu XUE ; Fang DU ; Lili MA ; Liang-Jing LU ; Lindi JIANG ; Yi-Li TAO ; Chengde YANG ; Hui SHI ; Honglei LIU ; Xiaobing CHENG ; Junna YE ; Yutong SU ; Dongbao ZHAO ; Sheng-Ming DAI ; Jialin TENG ; Qiongyi HU
Chinese Medical Journal 2023;136(3):331-340
BACKGROUND:
Rheumatoid arthritis (RA), a chronic systemic autoimmune disease, is characterized by synovitis and progressive damage to the bone and cartilage of the joints, leading to disability and reduced quality of life. This study was a randomized clinical trial comparing the outcomes between withdrawal and dose reduction of tofacitinib in patients with RA who achieved sustained disease control.
METHODS:
The study was designed as a multicenter, open-label, randomized controlled trial. Eligible patients who were taking tofacitinib (5 mg twice daily) and had achieved sustained RA remission or low disease activity (disease activity score in 28 joints [DAS28] ≤3.2) for at least 3 months were enrolled at six centers in Shanghai, China. Patients were randomly assigned (1:1:1) to one of three treatment groups: continuation of tofacitinib (5 mg twice daily); reduction in tofacitinib dose (5 mg daily); and withdrawal of tofacitinib. Efficacy and safety were assessed up to 6 months.
RESULTS:
Overall, 122 eligible patients were enrolled, with 41 in the continuation group, 42 in the dose-reduction group, and 39 in the withdrawal group. After 6 months, the percentage of patients with a DAS28-erythrocyte sedimentation rate (ESR) of <3.2 was significantly lower in the withdrawal group than that in the reduction and continuation groups (20.5%, 64.3%, and 95.1%, respectively; P < 0.0001 for both comparisons). The average flare-free time was 5.8 months for the continuation group, 4.7 months for the dose reduction group, and 2.4 months for the withdrawal group.
CONCLUSION:
Withdrawal of tofacitinib in patients with RA with stable disease control resulted in a rapid and significant loss of efficacy, while standard or reduced doses of tofacitinib maintained a favorable state.
TRIAL REGISTRATION
Chictr.org, ChiCTR2000039799.
Humans
;
Quality of Life
;
China
;
Arthritis, Rheumatoid/drug therapy*
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Piperidines/therapeutic use*
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Treatment Outcome
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Antirheumatic Agents/therapeutic use*
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Pyrroles/therapeutic use*
4.Efficacy of dexmedetomidine combined with remifentanil for lower eyelid blepharoplasty.
Minghao WU ; Xiang LI ; Huiyu CHEN
Chinese Journal of Plastic Surgery 2014;30(3):183-186
OBJECTIVETo explore the feasibility and safety of dexmedetomidine combined with remifentanil for lower eyelid blepharoplasty.
METHODS50 patients undergoing lower eyelid blepharoplasty ASA I - II were randomly divided into 2 groups (25 in each group) as observation group and control group. Dexmedetomidine (0.3 microg x kg(-1) x h(-1)) and remifentanil (0.05 microg x kg(-1) x min(-1)) were used in observation group. Local anesthesia by lidocaine (1%) combined with midazolam (0.04 mg/kg) intravenous sedation were used in control group. HR, mean arterial pressure (MAP), heart rate (HR), breathing rate (RR), pulse oxygen saturation (SpO2) change were monitored and recorded before and after the administration of the drug, as well as at the beginning of operation, during the operation, at the end of the operation, and 5 minutes after the operation. Patients sedation degree was evaluated by Ramsay. Operation time, recovery time, the incidence of adverse reactions, the satisfaction of patients and doctors were also recorded.
RESULTSPatients had no obvious difference of intraoperative MAP, RR, SpO2, operation time and postoperative recovery time between the two groups (P > 0.05). Compared with control group, HR during the operation were decreased significantly [(64.2 +/- 8.2) bpm, P < 0.05] in observation group. In control group, there were 18 cases of patients with agitation, but they endured the operation anyway. In observation group, 24 cases of patients underwent operation without agitation. The satisfaction of patients and the operation doctors (96%) in observation group were markedly higher than that in control group (P < 0.05).
CONCLUSIONDexmedetomidine combined with remifentanil is practical and safe. The effect of reducing HR should be noticed.
Adult ; Blepharoplasty ; Dexmedetomidine ; therapeutic use ; Double-Blind Method ; Female ; Humans ; Hypnotics and Sedatives ; therapeutic use ; Male ; Middle Aged ; Piperidines ; therapeutic use
5.Efficacy of analgesic and sedative treatments in children with mechanical ventilation in the pediatric intensive care unit.
Xiao-Fang CAI ; Fu-Rong ZHANG ; Long ZHANG ; Ji-Min SUN ; Wen-Bin LI
Chinese Journal of Contemporary Pediatrics 2017;19(11):1138-1144
OBJECTIVETo compare the efficacy and safety of different analgesic and sedative treatments in children with mechanical ventilation in the pediatric intensive care unit (PICU).
METHODSEighty children with mechanical ventilation in the PICU who needed analgesic and sedative treatments were equally and randomly divided into midazolam group and remifentanil+midazolam group. The sedative and analgesic effects were assessed using the Ramsay Scale and the Face, Legs, Activity, Cry and Consolability (FLACC) Scale. The following indices were recorded for the two groups: vital signs, ventilator parameters, organ function, total doses of remifentanil and midazolam, duration of mechanical ventilation, length of PICU stay, PICU cost, and incidence of adverse events.
RESULTSSatisfactory sedation was achieved in the two groups, but the remifentanil+midazolam group had a significantly shorter time to analgesia and sedation than the midazolam group. The remifentanil+midazolam group had a significantly higher percentage of patients with grade 3-4 on the Ramsay Scale and a significantly lower dose of midazolam than the midazolam group (P<0.05). Both groups showed decreases in heart rate (HR), mean arterial pressure (MAP), and spontaneous breathing frequency (RRs) after treatment. However, the remifentanil+midazolam group had significantly greater decreases in HR at 3-24 hours after treatment and MAP and RRs at 3-12 hours after treatment than the midazolam group (P<0.05). Compared with the midazolam group, the remifentanil+midazolam group had significantly higher ventilator tidal volume and transcutaneous oxygen saturation at 6 and 12 hours after treatment and significantly lower end-tidal carbon dioxide partial pressure at 6 and 12 hours after treatment (P<0.05). The remifentanil+midazolam group had significantly shorter time to awake, extubation time, duration of mechanical ventilation, and length of PICU stay than the midazolam group (P<0.05). There were no significant differences in PICU cost, incidence of adverse events, and hepatic and renal functions before and after treatment between the two groups (P>0.05). Both groups showed a significant decrease in fasting blood glucose level after treatment (P<0.05).
CONCLUSIONSFor children with mechanical ventilation in the PICU, remifentanil+midazolam treatment can rapidly achieve analgesia and sedation, improve the effect of mechanical ventilation, and reduce the dose of sedative compared with midazolam alone, and is well tolerated.
Analgesics ; therapeutic use ; Blood Glucose ; analysis ; Female ; Humans ; Hypnotics and Sedatives ; therapeutic use ; Infant ; Intensive Care Units, Pediatric ; Male ; Midazolam ; therapeutic use ; Piperidines ; therapeutic use ; Respiration, Artificial
6.Current and Emerging Biologics for Ulcerative Colitis.
Sung Chul PARK ; Yoon Tae JEEN
Gut and Liver 2015;9(1):18-27
Conventional medical treatment for ulcerative colitis can have limited efficacy or severe adverse reactions requiring additional treatment or colectomy. Hence, different biological agents that target specific immunological pathways are being investigated for treating ulcerative colitis. Anti-tumor necrosis factor (TNF) agents were the first biologics to be used for treating inflammatory bowel disease. For example, infliximab and adalimumab, which are anti-TNF agents, are being used for treating ulcerative colitis. Recently, golimumab, another anti-TNF agent, and vedolizumab, an anti-adhesion therapy, have been approved for ulcerative colitis by the U.S. Food and Drug Administration. In addition, new medications such as tofacitinib, a Janus kinase inhibitor, and etrolizumab, another anti-adhesion therapy, are emerging as therapeutic agents. Therefore, there is a need for further studies to select appropriate patient groups for these biologics and to improve the outcomes of ulcerative colitis treatment through appropriate medical usage.
Antibodies, Monoclonal/therapeutic use
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Antibodies, Monoclonal, Humanized/therapeutic use
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Biological Factors/*therapeutic use
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Cell Adhesion Molecules/antagonists & inhibitors
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Colitis, Ulcerative/*drug therapy
;
Humans
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Janus Kinases/antagonists & inhibitors
;
Piperidines/therapeutic use
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Pyrimidines/therapeutic use
;
Pyrroles/therapeutic use
7.Risperidone versus haloperidol in the treatment of chronic schizophrenic patients: a parallel group double-blind comparative trial.
Sung Kil MIN ; Choong Soon RHEE ; Chul Eung KIM ; Dae Yeob KANG
Yonsei Medical Journal 1993;34(2):179-190
A parallel group double-blind comparative trial was conducted to study the efficacy and safety of risperidone compared with haloperidol. After a one-week wash-out, 35 chronic schizophrenic patients (17 males, 18 females) were randomly assigned to one of two groups for eight weeks of double-blind treatment. The patients' psychopathology was assessed by means of the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) and the Clinical Global Impression (CGI). Safety assessments included the Extrapyramidal Symptom Rating Scale (ESRS), the UKU Side Effect Rating Scale, vital signs, body weight, ECG and laboratory screening. Thirty-two patients completed the trial: there were 3 dropouts in the risperidone group. The results on the PANSS and CGI indicate that the mean changes from baseline on the total PANSS score and on the total BPRS score were comparable in both treatment groups. The number of patients where a clinical improvement at least 20% reduction in baseline score was also similar in both treatment groups. Risperidone caused less extrapyramidal symptoms and less side effects in UKU scale than haloperidol. No significant ECG changes were induced, no relevant changes in blood pressure or clinical laboratory parameters were observed. This study has demonstrated that the combined serotonin 5-HT2 and dopamine-D2 antagonist risperidone is an antipsychotic as potent as haloperidol. Risperidone causes less extrapyramidal symptoms, and is better tolerated than haloperidol.
Adolescent
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Adult
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Chronic Disease
;
Comparative Study
;
Double-Blind Method
;
Female
;
Haloperidol/*therapeutic use
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Human
;
Isoxazoles/*therapeutic use
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Male
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Middle Age
;
Piperidines/*therapeutic use
;
Risperidone
;
Schizophrenia/*drug therapy
8.Treatment of vascular dementia by Chinese herbal medicine: a systematic review of randomized controlled trials of clinical studies.
Wen-Jia JIAN ; Jing SHI ; Jin-Zhou TIAN ; Jing-Nian NI
Chinese Journal of Integrated Traditional and Western Medicine 2015;35(1):46-52
OBJECTIVEChinese herbal medicine has been extensively used in the treatment of vascular dementia (VaD), but lacked systematic review on its efficacy and safety. So we conducted a systematic review to assess the efficacy and safety of Chinese herbal medicine in treating VaD.
METHODSCNKI, CBM, PubMed, and Wiley Online Library were retrieved for randomized trials (RCTs) on Chinese herbal medicine treating VaD patients. Randomized parallel control trials by taking Chinese herbal medicine as one treatment method and placebos/cholinesterase inhibitors/Memantine hydrochloride as the control were included. Quality rating and data extraction were performed. RevMan5.2.0 Software was used for meta-analysis. Standardized mean difference (SMD) at 95% confidence interval (CI) was used to indicate effect indicators of results.
RESULTSSeven RCTs met the inclusive criteria. Totally 677 VaD patients were randomly assigned to the treatment group and the control group. Descriptive analyses were performed in inclusive trials. The cognitive function was assessed in all trials. Results showed Mini-Mental state examination (MMSE) score was better in the Chinese herbal medicine group than in the placebo group, but with no significant difference when compared with the donepezil group (P > 0.05). Adverse reactions were mainly manifested as gastrointestinal symptoms such as abdominal pain in the Chinese herbal medicine group. But they occurred more in the donepezil group than in the Chinese herbal medicine group.
CONCLUSIONSThe methodological quality of included trials was poor with less samples. Results of different trials were lack of consistency. Present evidence is not sufficient to prove or disapprove the role of Chinese herbal medicine in improving clinical symptoms and outcome indicators of VaD patients. Their clinical efficacy and safety need to be supported by more higher quality RCTs.
Complementary Therapies ; Dementia, Vascular ; drug therapy ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Indans ; therapeutic use ; Piperidines ; therapeutic use ; Randomized Controlled Trials as Topic
9.Recent research on tofacitinib in the treatment of pediatric rheumatic diseases.
Shi-Hai ZHOU ; Ya-Qun XIONG ; Ya CHEN
Chinese Journal of Contemporary Pediatrics 2022;24(4):447-453
Tofacitinib is a Janus kinase inhibitor and can block the Janus kinase-signal transducer and activator of transcription signal transduction pathway and reduce the production and release of a variety of cytokines. It has great potential in the treatment of various rheumatic diseases with a rapid onset of action and can reduce corticosteroid dependence and related adverse events. The therapeutic effect of tofacitinib in adult patients has been confirmed, and it has been increasingly used in pediatric patients in recent years. This article reviews the clinical application of tofacitinib in the treatment of pediatric autoimmune diseases.
Adult
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Child
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Humans
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Janus Kinases/metabolism*
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Piperidines/therapeutic use*
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Protein Kinase Inhibitors/therapeutic use*
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Pyrimidines/therapeutic use*
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Rheumatic Diseases/drug therapy*