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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.
Subject(s)
Humans , Male , Antineoplastic Agents, Hormonal/therapeutic use , East Asian People , Gonadotropin-Releasing Hormone/agonists , Goserelin/therapeutic use , Prostate-Specific Antigen , Prostatic Neoplasms/drug therapy , TestosteroneABSTRACT
Objective@#To analyze the mid-term clinical efficacy of extended to C1, 2 posterior single-door laminoplasty for the treatment of ossification of the posterior longitudinal ligament combined the upper cervical spine.@*Methods@#From February 2013 to December 2015, 32 patients with cervical OPLL who were extended to C1, 2 posterior open-door laminoplasty were enrolled in our hospital (complete follow-up of 25 patients). There were 19 males and 6 females, aged 48-76 years (mean 60.1±7.0 years). Cervical spinal cord function was assessed using the Japanese Orthopaedic Association (JOA) spinal cord function score, and the rate of improvement in neurological function was calculated. The quality of life of patients was assessed using the neck disability index (NDI). Axial symptoms were assessed and indexed using the visual analog scale (VAS). The C0-2 angle of the cervical spine was measured by X-ray preoperative and at the last follow-up. The cervical curvature was evaluated by the C2-7 angle, and the cervical vertebra activity was observed by the dynamic X-ray of the cervical spine.@*Results@#25 patients were followed up for a period of 26-64 months (mean 35.9±8.1 months). At the last follow-up, the JOA score was 14.32±3.24, the NDI score was 7.61±1.23, and the VAS score was 1.42±0.78. The differences between the three scores were statistically significant compared with the preoperative scores. The neurological improvement rate at the last follow-up was 79.61%±13.23%. The preoperative C0-2 angle was 26.04°±6.28°, and the last follow-up was 24.92°±5.51°; the C2-7 angle was 19.55°±9.42° before surgery, and the C2-7 angle at last follow-up was 17.97°±8.80°. The C2-7 angle at last follow-up was slightly reduced compared with that preoperative, but the difference was not statistically significant. The preoperative cervical vertebra ROM was 35.31°±12.24°, and at the last follow-up it was 32.23°±9.65°. The ROM of cervical vertebrae at the last follow-up was slightly lower than that before surgery, but the difference was not statistically significant. Among them, the reduction of the ROM of overflexion was greater than that of the over-extension, which was the main reason for the decrease of ROM. The OPLL bone mass continued to grow at the last follow-up of 11 patients.@*Conclusion@#The extended to C1, 2 posterior single-door laminoplasty for the treatment of ossification of the posterior longitudinal ligament combined the upper cervical spine can achieve adequate spinal cord decompression, satisfactory neurological improvement, and improve the postoperative cervical curvature and activity. There was no obvious change in the curvature and activity of the cervical spine, and the axial symptoms did not increase significantly, and the clinical efficacy was positive.
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OBJECTIVE： To investigate sulfonamide allergy item annotation in drug instructions of sulfonylureas， and to provide reference for the promoting rational clinical use of the drugs. METHODS： In Oct. 2018， the drug instructions of commonly-used sulfonylureas at home and abroad were collected by MCDEX software （online version）， Drugs@FDA of the US Food and Drug Administration website， DailyMed website， European Medicines Agency website and UK electronic Medicines Compendium website. The annotation of sulfonamide allergy was analyzed statistically in respects of non-labeled sulfonamide allergy， only labeled sulfonamide allergy contraindication， only labeled sulfonylureas allergy contraindication， labeled sulfonamide and sulfonylureas allergy contraindication. The proportion of sulfonamide allergy contraindication labelling was calculated. RESULTS： Among 174 pieces of domestic drug instructions， 67 pieces of drug instructions were gliclazide， 48 were glipizide， 23 were glibenclamide， 23 were glimepiride and 13 were gliquidone. Different pharmaceutical manufacturers reached a consensus on the sulfonamide allergy of gliquidone and glibenclamide. The proportions of sulfonamide allergy contraindication labelling were 100％ and 95.65％， respectively. However， there were great differences on the sulfonamide allergy of glipizide， glimepiride and gliclazide， and the proportions of sulfonamide allergy contraindication labelling were 70.83％， 65.22％ and 49.25％， respectively. Among 13 foreign drug instructions， 4 pieces of drug instructions were glibenclamide， 3 were glipizide， 3 were glimepiride， and 3 were gliclazide， among which 7 drug instructions were sulfonamide allergy contraindication. However， there were great differences in the sulfonamide allergy annotation of drug instructions between US and Europe. CONCLUSIONS： There are great differences in the annotation for sulfonamide allergy in drug instructions of sulfonylureas at home and abroad， which indicates that there are different opinions on the clinical significance of sulfa cross-reaction in patients with sulfonamide allergy， and sulfonamide cross-allergy is a controversial issue. It is necessary to promote the research of sulfonamide cross-allergy from the perspectives of scientific researchers， medical associations， pharmaceutical manufacturers， medical staff and patients， and to clarify its mechanism and clinical significances.
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Liver-qi stagnation and spleen deficiency syndrome can be seen in a variety of clinical diseases,such as chronic hepatitis,liver cirrhosis,chronic gastritis,peptic ulcer,irritable bowel syndrome (IBS),p.sychosis and so on.Disease characteristics determine the symptom characteristic and criterion of syndrome differentiation and treatment.Therefore,different diseases with liver-qistagnation and spleen deficiency syndrome have different clinical manifestation and diagnostic criteria.This paper summarized the modern biological basis of liver-qistagnation and spleen deficiency syndrome from the nervous system,endocrine system,digestive system,circulatory system,immune system and metabolic system,in order to provide reference for researches on modern biology basis of liver-qistagnation and spleen deficiency syndrome.
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OBJECTIVE:To observe the effects of Breviscapine injection on serum copeptin,NT-proBNP and ischemia modi-fied albumin (IMA) level and hemorheology indexes in patients with acute cerebral infarction. METHODS:Data of 132 patients with acute cerebral infarction were selected and randomly divided into observation group(66 cases)and control group(66 cases). Control group received 1 Aspirin enteric-coated tablet,qd + 20 ml Muscular amino acids and nucleosides injection adding into 500 ml 0.9% Sodium chloride solution,intravenous infusion,qd + 4 ml Ozagrel injection adding into 250 ml Sodium chloride solution, intravenous infusion,qd. Observation group was additionally given 5 ml Breviscapine injection adding into 250 ml 0.9% Sodium chloride solution,intravenous infusion,qd. 7 d ag was regarded as 1 treatment course,it lasted for 2 courses. Copeptin,NT-proB-NP,IMA levels (showed by serum ACB value) and changes of related hemorheology indexes before and after treatment in 2 groups were observed. RESULTS:Before treatment,there was no significant difference in Copeptin,NT-proBNP,serum ACB val-ue,whole blood viscosity,plasma viscosity,hematocrit,ESR and fibrinogen levels in 2 groups(P>0.05);after treatment,Co-peptin,NT-proBNP,whole blood viscosity,plasma viscosity,hematocrit,ESR and fibrinogen levels in 2 groups were significant-ly lower than before,and observation group was lower than control group,while serum ACB value was significantly higher than be-fore,and observation group was significantly higher than control group,the differences were statistically significant(P<0.05). CONCLUSIONS:Based on conventional treatment,Breviscapine injection can significantly improve the copeptin,NT-proBNp and IMA levels,and improve hemorrheology.
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Objective To intestate the effect of different doses of atorvastatin on early neurological deterioration and short-term outcomes in patients with acute ischemic stroke.Methods The patients with acute ischemic stroke were enrolled prospectively.They were randomly assigned to either a standard therapy group (atorvastatin 20 mg/d) or an intensive treatment group (atorvastatin 40 mg/d).The primary outcomes were early neurological deterioration within 1 week of treatment and the good outcome of evaluation at 1 month after treatment (the modified Rankin Scale score 0-2); the secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS) score and adverse events at 1 month.Results A total of 125 patients with acute ischemic stroke were enrolled,including 62 in the standard therapy group and 63 in the intensive treatment group.The incidence of early neurological deterioration at 1 week after treatment in the standard therapy group was significantly higher than that in the intensive treatment group (16.13％ vs.4.76％;x2=4.333,P=0.038); the proportion of good outcome in the standard therapy group was significantly lower than that in the intensive treatment group at 1 month after treatment (53.23％ vs.71.43％ ;x2 =4.413,P=0.036).During the treatment,no significant liver damage,muscle toxicity and other adverse events of causing atorvastatin reduction or withdrawal occurred in the patients of both groups.Conclusions Using high-dose atorvastatin in the acute phase of ischemic stroke may decrease the incidence of early neurological deterioration compared with the conventional dose,and improve short-term clinical outcomes.
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Objective To determine the effect of the Buyang Huanwu Tang and batroxobin treating sudden deafness.Methods 90 cues(99 ears)with sudden deafness were randomly divided into two groups,the control group were treated with dextran glucose intravenous and lignstrazine,the treat group were treated with the Buyang Huanwu Tang and batroxobin.The periods were 2 weeks.Results The effect in the treat group was more remarkable compared with the control group,there was a significant difference(P＜0.05).Conclusion The Buyang Huanwu Tang and batroxobin treeing sudden deafness Can increase curative rete.
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Fructus Xanthii is commonly used in rhinology, especially used in treatment of chronic rhinitis and sinusitis. But Fructus Xanthii is toxicant, and it maybe result in poisoning when used excessively, without preparation or in inappropriate preparation. This article reviewed all poisoning cases from 1960 to 2000, its toxicology and methods for detoxification
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Objective To observe the curative effect of Rougan Granules on rats hepatocirrhosis induced by carbon tetra- chloride(CCl_4)with 10 % alcohol and high fat feed.Method The rat model was established by gastric garage of CCh (CCl_4:salad oil=1:1)1 mL/kg twice a week for two weeks,and with 10 % alcohol as drinking water,high fat feed as food.After administration of CCl_4,the rats were divided into 5 groups:the model group,high-,medium-and low-dosage of Rougan Granules groups,the eolchicine group.And normal control group was also set up.After adminis- tration for 6 weeks,hyaluronic acid,typeⅣcollagen and typeⅢprecollagen in serum were measured and liver histopathol- ogy examination was done.Result The contents of hyaluronic acid,typeⅣcollagen and typeⅢprecollagen in model rats were increased significantly,while Rougan Granules could decrease those increase significantly.Liver histopathology exami- nation showed medium or high fatty degeneration of hepatic cell,obvious hyperplasia of fibrous tissue with fibrous distance broaden and pseudolobuli formed in model group,but in Rougan Granules group the general pathological changes of liver were less.Conclusion Rougan Granules have an effect of experimental anti-hepatocirrhosis in rats.
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Objective To observe the preventive and therapeutic effect of Chinese herbal medicine film µwave irradiation on mammary hyperplasia in rats. Methods Rat models of experimental mammary hyperplasia were established by intramuscular injection of estrogen and a small quantity of progestin. Two weeks after modeling, the rats were treated with Chinese herbal medicine film µwave irradiation. Before and after the treatment, mammary diameter of the second nipples were measured, serum concentrations of estrogen (E2), progesterone (P) and prolactin (PRL) were determined by radioimmunoassay,pathological changes of mammary hyperplasia were examined under microscope,and the rate of mammary hyperplasia was measured. Results Chinese herbal medicine film markedly inhibited experimental mammary hyperplasia in rats,and the rate of mammary hyperplasia were 23.4 %in medicine film group and 20.9 %in medicine film µwave irradiation group respectively. Medicine film regulated the concentrations of estrogen and progestin,reduced the level of PRL and alleviated the pathological severity of mammary hyperplasia obviously. Conclusion Chinese herbal medicine film µwave irradiation have certain preventive and therapeutic effect on mammary hyperplasia in rats.