A prospective multicenter clinical trial study of a domestic HeartCon third-generation magnetic and hydrodynamic levitation LVAD for the treatment of 50 cases of end-stage heart failure / 中华胸心血管外科杂志

Objective:To analyze and evaluate the safety and efficacy of a Chinese domestically manufactured Heart Con-type implantable third-generation magnetic and hydrodynamic levitation left ventricular assist device(LVAD) for the treatment of end-stage heart failure(ESHF), by reporting the results of eleven-center clinical trial on 50 cases.Methods:This study was a multicenter clinical trial, designed by means of prospective, multicenter and single-group target value. 50 subjects with ESHF were competitively enrolled and treated with HeartCon as the LVAD in eleven centers. The primary efficacy measure was survival, defined as either the subjects experiencing the transition to heart transplantation(HT) or myocardial recovery assisted by the device within 90 days, or as successfully assisted by the LVAD for full 90 days after implantation. The target survival rate was 60%, other observations included implantation success rate, mortality, pump failure needing replacement or emergency heart transplantation.Results:All enrolled 50 patients received LVAD implantation successfully, 46 survived with the pump for 90 days, 1 patient transitioned to heart transplantation, and 3 patients experienced pump thrombosis, within which 2 patients underwent pump replacement and continued to live with the pump for 90 days, and the other one received emergency heart transplantation. There were no dropout subjects. The survival rate at full 90 days after HeartCon implantation was 100%. The survival rates with pump in the full set analysis and the protocol set analysis were 96.00% and 95.92% respectively, which were higher than the target value of 60%. The differences were both statistically significant( P<0.05). Conclusion:The results of the multicenter clinical trial with the largest sample size in China using domestically manufactured third-generation LVAD has demonstrated that, HeartCon is a safe and effective LVAD to treat ESHF patients.

Harmonization of laboratory results by data adjustment in multicenter clinical trials

BACKGROUND/AIMS: In multicenter clinical trials, laboratory tests are performed in the laboratory of each center, mostly using different measuring methodologies. The purpose of this study was to evaluate coefficients of variation (CVs) of laboratory results produced by various measuring methods and to determine whether mathematical data adjustment could achieve harmonization between the methods. METHODS: We chose 10 clinical laboratories, including Green Cross Laboratories (GC Labs), the central laboratory, for the measurement of total cholesterol, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), serum triglycerides, creatinine, and glucose. The serum panels made with patient samples referred to GC Labs were sent to the other laboratories. Twenty serum samples for each analyte were prepared, sent frozen, and analyzed by each participating laboratory. RESULTS: All methods used by participating laboratories for the six analytes had traceability by reference materials and methods. When the results from the nine laboratories were compared with those from GC Labs, the mean CVs for total cholesterol, HDL-C, LDL-C, and glucose analyzed using the same method were 1.7%, 3.7%, 4.3%, and 1.7%, respectively; and those for triglycerides and creatinine analyzed using two different methods were 4.5% and 4.48%, respectively. After adjusting data using Deming regression, the mean CV were 0.7%, 1.4%, 1.8%, 1.4%, 1.6%, and 0.8% for total cholesterol, HDL-C, LDL-C, triglyceride, creatinine, and glucose, respectively. CONCLUSIONS: We found that more comparable results can be produced by laboratory data harmonization using commutable samples. Therefore, harmonization efforts should be undertaken in multicenter trials for accurate data analysis (CRIS number; KCT0001235).

Multicenter clinical trial of Tiaojing Huoxue Capsules for primary dysmenorrhoea / 中草药

Objective To assess the efficacy of Tiaojing Huoxue CapsuleS for the primary dysmenorrhoea (PD). Methods A total of 300 women with PD were enrolled and randomly divided into the control and treatment group, which were administrated with placebo and Tiaojing Huoxue Capsules for three menstrual cycles, respectively. The efficacy of Tiaojing Huoxue Capsule was evaluated by visual analogue scale (VAS) and traditional Chinese medicine (TCM) syndrome scores. Results The effective rate of VAS was 62.43% in the experiment group with statistical significance when compared with the control group (P < 0.01). Similarly, the total effective rate in the treatment group was 76.30% while that in the control group was 36.67% after treatment of three menstrual cycles. Conclusion Tiaojing Huoxue Capsules can relieve the alleviating pain for women with PD.

Necessity and conduct of multicenter clinical trials / 대한산부인과학회지

Recently, multicenter clinical trials have been getting more popular inside and outside of the country. The disease pattern of our country is somewhat different from that of western countries in terms of its incidence, clinical feature. Therefore, the results of clinical studies in US or European countries cannot be properly applied without consideration of trial design features and intertrial comparisons. Therefore, the conduct of multicenter trial with our own population is necessary. Well organized multicenter trials having competitive power will make it possible to develop new treatment modalities, frame a reasonable policies for its clinical applications and ultimately contribute to improve national healthcare services.

Necessity and conduct of multicenter clinical trials / 대한산부인과학회지

Recently, multicenter clinical trials have been getting more popular inside and outside of the country. The disease pattern of our country is somewhat different from that of western countries in terms of its incidence, clinical feature. Therefore, the results of clinical studies in US or European countries cannot be properly applied without consideration of trial design features and intertrial comparisons. Therefore, the conduct of multicenter trial with our own population is necessary. Well organized multicenter trials having competitive power will make it possible to develop new treatment modalities, frame a reasonable policies for its clinical applications and ultimately contribute to improve national healthcare services.

Acute lymphoblastic leukemia in children: past, present and future / 소아과

The cure rate of acute lymphoblastic leukemia (ALL) in children dramatically improved over past 5 decades from zero to about 80%. The main cause of improvement is owing to the development of chemotherapy by multicenter clinical trial of large study groups with the understanding of leukemia biology. Recently, pediatric ALL protocols were applied to the treatment of adolescent and even adult ALL patients. For nearly 30 years, clinical factors have been used to risk-stratify therapy for children with ALL, so that the most intensive therapies are reserved for those patients at the highest risk of relapse. The risk groups of ALL are divided as standard- (low- plus intermediate-), high- and very high-risk group according to the prognostic factors, and treatment results improved by this risk based treatment. The factors used to risk-stratify therapy include age, gender, presenting leukocyte count, immunophenotype, cytogenetic aberrations including ploidy and translocations, and initial response after 1 to 2 weeks of therapy. But treatment efficacy is the most important determinant and can abolish the clinical significance of most, if at all, prognostic factors. Today, in the era of intensive, multiagent regimens, there is increasing evidence that we have reached the limits of prognostic significance of currently applied clinical risk factors in childhood ALL. As the cure rate of ALL is about 80%, introducing new prognostic factors such as new molecular prognostic markers, new methods of assessment about minimal residual disease, and pharmacogenetic study, with the development of stem cell transplantation and molecular targeted therapy are needed to cure residual 20% of childhood ALL patients without short and long term complications.

Efficacy and Safety of Olanzapine in the Treatment of Korean Patients with Schizophrenia and Schizophreniform Disorder: Open Multicenter Clinical Trial / 신경정신의학

OBJECTIVE: This multicenter clinical trial was carried out to investigate the efficacy and the safety of olanzapine for the treatment of Korean patients. METHOD: 105 patients with schizophrenia and schizophreniform disorder, visited at 10 mental or university hospitals, had received an open and non-comparative treatment with olanzapine for 8 weeks. Patients had psychotic or depressive symptoms with the severity above moderate degree or intolerable side effects to previous antipsychotics. After a wash-out period of 2-7 days, 10mg olanzapine was prescribed initially to all the patients, and then the dosage could be adjusted within the range of 5-20mg/day of olanzapine by 3-7 days. RESULTS: 90(85.7%) of 105 patients completed the 8-weeks trial and the mean modal dose of olanzapine was 16.1(+/-4.7)mg/day. At the end of the trial, 73 patients(69.5%) were classified as responder, which was defined as 40% or more improvement in BPRS(Brief Psychiatric Rating Scale) score comparing to baseline. There was a significant reduction in the scores of PANSS(Positive and Negative Syndrome Scale) and subscales including negative symptom scores and CGI. Also weekly analysis showed that the reductions in scores were kept on for the whole period of the trial. 43.8% of all the patients had depressive symptoms at the baseline and total scores of MADRS(Montgomery-sberg Depression Rating Scale) and HAM-A(Hamilton Rating Scale for Anxiety) were also reduced after the trials. Vital signs revealed no clinically significant changes but continuous weight gain was observed during the treatment with olanzapine. The scores of SAS(Simpson-Angus Scale) and AIMS(Abnormal Involuntary Movement Scale) for assessing the EPS(extrapyramidal symptoms) and tardive dyskinesia respectively were significantly decreased and only a few patients reported EPS as adverse events. Although mild and clinically non-significant elevation of ALT/SGPT was observed, most laboratory parameters including plasma prolactin level showed no significant changes during the trial. CONCLUSIONS: Although this trial had many limitations because it was a non-comparative and open study, olanzapine showed high efficacy on the positive, negative and depressive symptoms in schizophrenia and schizophreniform disorder. In addition to that, olanzapine showed a substantially favorable safety profile, such as low incidence of EPS and hyperprolactinemia.