2.Efficiency of Sunitinib in Chinese Patients with Advanced Progressive Pancreatic Neuroendocrine Tumor.
He-li GAO ; Hong-yan YING ; Yue-juan CHENG ; Chang-ting MENG ; Chun-mei BAI
Acta Academiae Medicinae Sinicae 2016;38(3):300-304
Objective To explore the efficiency of sunitinib in Chinese pancreatic neuroendocrine tumors (pNET) patients. Methods Advanced pNET patients who had accepted sunitinib treatment in the oncology department of PUMC Hospital from January 2009 to June 2015 after disease progression were enrolled in this study. Data collection included clinicopathological characteristics,medical therapies and outcomes. Results Eighteen pNET patients were collected. The overall response rate (ORR) was 27.7% and the disease control rate (DCR) was 83.3%. Nine patients received sunitinib as the first-line therapy and 9 as the second/post-second line. The median progression-free survival (mPFs)(12 month vs. 12 month;HR:0.92,95%CI:0.31-2.75,P=0.88),ORR (22.2% vs.33.3%;Χ(2)=0.055,P=0.98),and DCR (88.9% vs.77.8%;Χ(2)=0.4,P=0.98)showed no significant difference between first-line therapy and post-second line therapy. The mPFS of Ki-67≥10% and Ki-67<10% group patients was not significantly different (8 months vs. 13 months;HR:1.13,95% CI:0.34-3.77,P=0.845). The commonly reported adverse events included bone marrow suppression,diarrhea,roteinuria,hypertension,and rash. Conclusions First-line or second/post-second line sunitinib treatment has certain antitumor activity in Chinese patients with advanced pNET. The efficiency and commonly reported adverse events of Sunitinib are consistent with the known Western data.
Antineoplastic Agents
;
therapeutic use
;
Disease-Free Survival
;
Humans
;
Indoles
;
therapeutic use
;
Pancreatic Neoplasms
;
drug therapy
;
Pyrroles
;
therapeutic use
4.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*
;
Piperidines/therapeutic use*
;
Treatment Outcome
;
Antirheumatic Agents/therapeutic use*
;
Pyrroles/therapeutic use*
5.Resistance and treatment strategy of gastrointestinal stromal tumor target therapy.
Chinese Journal of Gastrointestinal Surgery 2012;15(3):309-312
Gastrointestinal stromal tumor(GIST) originates from interstitial cells of Cajal(ICCs). Tyrosine kinase inhibitors(TKI) such as imatinib and sunitinib, are effective agents besides surgery. However some GIST can become primarily or secondarily resistant to those drugs. The difference in gene mutation types and secondary gene mutation is the main cause. When the GIST is proved to be drug resistance, reasonable personal treatment strategies based on individualized medicine should be made to improve outcomes and quality of life.
Antineoplastic Agents
;
therapeutic use
;
Benzamides
;
therapeutic use
;
Drug Resistance, Neoplasm
;
genetics
;
Gastrointestinal Stromal Tumors
;
drug therapy
;
genetics
;
Humans
;
Imatinib Mesylate
;
Indoles
;
therapeutic use
;
Piperazines
;
therapeutic use
;
Protein Kinase Inhibitors
;
therapeutic use
;
Pyrimidines
;
therapeutic use
;
Pyrroles
;
therapeutic use
6.Analysis of clinical use of shuxuening injection in treatment of cerebral infarction based on real world.
Yan-Hua LUO ; Yan-Ming XIE ; Wei YANG ; Yong-Yan WANG ; Li YOU ; Yan ZHUANG
China Journal of Chinese Materia Medica 2014;39(18):3499-3503
To know the characteristics of Shuxuening injection used on cerebral infarction patients in clinical practice, 6 053 cases of Hospital information system (HIS) data from 20 hospitals were analyzed. Using the basic description method and association rules to analysis the data. By analysis the data we found that the average age of cerebral infarction patients who used Shuxuening injection is 67.96, 83.94% of patients were aged 46-80. The injection is administered intravenously,with most patients receiving a dosage of 15-20 mL per dose for between 1 and 14 days. It is always combined with aspirin (48.508%), cinepazide maleate injection (22.073%), atorvastatin calcium tablets (18.873%) in clinical practice. When it comes to two drug combinations, it always combined with cinepazide maleate injection and aspirin (8.178%), nicergoline capsules and aspirin (7.63%). Therefore, based on existing data, we give the conclusion that for the treatment of cerebral infarction Shuxuening injection is mainly used for older patients, and is often combination with similar pharmacological effects chemical drugs, which is complied with the guidelines. However, the wrong dose is still exist, doctors should realize the hiding risk.
Adolescent
;
Adult
;
Aged
;
Aged, 80 and over
;
Anticoagulants
;
therapeutic use
;
Aspirin
;
therapeutic use
;
Atorvastatin Calcium
;
Cerebral Infarction
;
drug therapy
;
Drugs, Chinese Herbal
;
therapeutic use
;
Female
;
Heptanoic Acids
;
therapeutic use
;
Humans
;
Male
;
Middle Aged
;
Piperazines
;
therapeutic use
;
Pyrroles
;
therapeutic use
;
Young Adult
7.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
;
Biological Factors/*therapeutic use
;
Cell Adhesion Molecules/antagonists & inhibitors
;
Colitis, Ulcerative/*drug therapy
;
Humans
;
Janus Kinases/antagonists & inhibitors
;
Piperidines/therapeutic use
;
Pyrimidines/therapeutic use
;
Pyrroles/therapeutic use
8.Efficacy and safety of various doses of hybutimibe monotherapy or in combination with atorvastatin for primary hypercholesterolemia: a multicenter, randomized, double-blind, double-dummy, parallel-controlled phase Ⅲ clinical trial.
Si Yu CAI ; Xiang GU ; Pei Jing LIU ; Rong Shan LI ; Jian Jun JIANG ; Shui Ping ZHAO ; Wei YAO ; Yi Nong JIANG ; Yue Hui YIN ; Bo YU ; Zu Yi YUAN ; Jian An WANG
Chinese Journal of Cardiology 2023;51(2):180-187
Objective: To evaluate the efficacy and safety of hybutimibe monotherapy or in combination with atorvastatin in the treatment of primary hypercholesterolemia. Methods: This was a multicenter, randomized, double-blind, double-dummy, parallel-controlled phase Ⅲ clinical trial of patients with untreated primary hypercholesterolemia from 41 centers in China between August 2015 and April 2019. Patients were randomly assigned, at a ratio of 1∶1∶1∶1∶1∶1, to the atorvastatin 10 mg group (group A), hybutimibe 20 mg group (group B), hybutimibe 20 mg plus atorvastatin 10 mg group (group C), hybutimibe 10 mg group (group D), hybutimibe 10 mg plus atorvastatin 10 mg group (group E), and placebo group (group F). After a dietary run-in period for at least 4 weeks, all patients were administered orally once a day according to their groups. The treatment period was 12 weeks after the first dose of the study drug, and efficacy and safety were evaluated at weeks 2, 4, 8, and 12. After the treatment period, patients voluntarily entered the long-term safety evaluation period and continued the assigned treatment (those in group F were randomly assigned to group B or D), with 40 weeks' observation. The primary endpoint was the percent change in low density lipoprotein cholesterol (LDL-C) from baseline at week 12. Secondary endpoints included the percent changes in high density lipoprotein cholesterol (HDL-C), triglyceride (TG), apolipoprotein B (Apo B) at week 12 and changes of the four above-mentioned lipid indicators at weeks 18, 24, 38, and 52. Safety was evaluated during the whole treatment period. Results: Totally, 727 patients were included in the treatment period with a mean age of (55.0±9.3) years old, including 253 males. No statistical differences were observed among the groups in demographics, comorbidities, and baseline blood lipid levels. At week 12, the percent changes in LDL-C were significantly different among groups A to F (all P<0.01). Compared to atorvastatin alone, hybutimibe combined with atorvastatin could further improve LDL-C, TG, and Apo B (all P<0.05). Furthermore, there was no significant difference in percent changes in LDL-C at week 12 between group C and group E (P=0.991 7). During the long-term evaluation period, there were intergroup statistical differences in changes of LDL-C, TG and Apo B at 18, 24, 38, and 52 weeks from baseline among the statins group (group A), hybutimibe group (groups B, D, and F), and combination group (groups C and E) (all P<0.01), with the best effect observed in the combination group. The incidence of adverse events was 64.2% in the statins group, 61.7% in the hybutimibe group, and 71.0% in the combination group during the long-term evaluation period. No treatment-related serious adverse events or adverse events leading to death occurred during the 52-week study period. Conclusions: Hybutimibe combined with atorvastatin showed confirmatory efficacy in patients with untreated primary hypercholesterolemia, which could further enhance the efficacy on the basis of atorvastatin monotherapy, with a good overall safety profile.
Male
;
Humans
;
Middle Aged
;
Atorvastatin/therapeutic use*
;
Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use*
;
Hypercholesterolemia/drug therapy*
;
Cholesterol, LDL/therapeutic use*
;
Anticholesteremic Agents/therapeutic use*
;
Treatment Outcome
;
Triglycerides
;
Apolipoproteins B/therapeutic use*
;
Double-Blind Method
;
Pyrroles/therapeutic use*
9.Multi-targeted tyrosine kinase inhibitor sunitinib: a novel strategy for sporadic malignant pheochromocytoma.
Fu-Kang SUN ; Hong-Chao HE ; Ting-Wei SU ; Wen-Long ZHOU ; Xin HUANG ; Jun DAI ; Zhou-Jun SHEN
Chinese Medical Journal 2012;125(12):2231-2234
Sporadic malignant pheochromocytoma, a rare disease with poor prognosis, is always difficult to treat due in part to lack of effective agents. We presented three patients with advanced malignant pheochromocytoma treated by sunitinib, which indicates that sunitinib is an effective agent for this malignancy.
Adrenal Gland Neoplasms
;
drug therapy
;
Adult
;
Female
;
Humans
;
Indoles
;
therapeutic use
;
Male
;
Middle Aged
;
Pheochromocytoma
;
drug therapy
;
Protein Kinase Inhibitors
;
therapeutic use
;
Pyrroles
;
therapeutic use
10.Use of atorvastatin in lipid disorders and cardiovascular disease in Chinese patients.
Yi-Cong YE ; Xi-Liang ZHAO ; Shu-Yang ZHANG
Chinese Medical Journal 2015;128(2):259-266
OBJECTIVEStatins are still underused for the prevention of cardiovascular disease (CVD) in China. Hence, we conducted a systemic review on the pharmacology, clinical efficacy, and adverse events of atorvastatin, as well as on patient adherence.
DATA SOURCESWe conducted a systemic search in PubMed with the following keywords: "atorvastatin" (Supplementary concept) or "atorvastatin" (All field) and ("China" [AD] or "China" [all field] or "Chinese" [All field]).
STUDY SELECTIONClinical or basic research articles on atorvastatin were included.
RESULTSAtorvastatin is a reversible and competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A reductase, decreasing the de novo cholesterol synthesis. The pharmacokinetics of atorvastatin among Chinese is similar to those in Caucasians, and several gene polymorphisms have proved to be associated with the metabolism of atorvastatin in the Chinese population. Several international multiple-center randomized control trials have demonstrated the benefit of atorvastatin for primary and secondary prevention of CVD. None of them, however, included the Chinese, and current evidence in the population is still inadequate, due to the small sample size, low study quality, short study duration, and the use of surrogate endpoints instead of clinical endpoints. The overall incidence of adverse events observed with atorvastatin did not increase in the 10-80 mg dose range, and was similar to that observed with placebo and in patients treated with other statins, which makes atorvastatin well-tolerated in the Chinese population. Moreover, high patient adherence was observed in clinical studies.
CONCLUSIONSBased on the current available evidence, there is no significant difference between Chinese and non-Chinese population in term of pharmacology and clinical efficacy/safety. High-quality evidence is still needed to support the use of atorvastatin in high-risk Chinese population.
Atorvastatin Calcium ; Cardiovascular Diseases ; drug therapy ; China ; Heptanoic Acids ; therapeutic use ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; therapeutic use ; Pyrroles ; therapeutic use