10.3969/j.issn.1007-3969.2013.05.002

PURPOSE: Asthma affects approximately 30 million patients in China; however, tiotropium data for Chinese patients is limited. This study aimed to assess the efficacy and safety of tiotropium in Chinese patients with moderate symptomatic asthma. METHODS: A post hoc subgroup analysis was conducted on 430 Chinese patients pooled from two 24-week, replicate phase 3 trials (NCT01172808 and NCT01172821), in which they received once-daily tiotropium 2.5 µg (Tio R2.5) or 5 µg (Tio R5) (n = 106 or 109, respectively), twice-daily salmeterol 50 µg (Sal 50) (n = 110), or placebo (n = 105), while maintaining inhaled corticosteroids (ICS). The co-primary endpoints assessed in week 24 were forced expiratory volume in 1 second (FEV1) peak0–3h response, trough FEV1 response, and responder rate as assessed using the Asthma Control Questionnaire (ACQ). RESULTS: For both FEV1 peak0–3h responses and trough FEV1 responses, the mean treatment differences were greater for Tio R2.5, Tio R5, and Sal 50 compared with placebo at 0.249 L, 0.234 L, and 0.284 L, and 0.172 L, 0.180 L, and 0.164 L, respectively (P< 0.001). The ACQ responder rate in placebo, Tio R2.5, Tio R5, and Sal 50 was 58.7%, 62.3%, 59.3%, and 69.1%, respectively. Furthermore, 11 (2.6%) of 430 patients had serious adverse events (Tio R5, n = 4; Tio R2.5, n = 1; Sal 50, n = 1; and placebo, n = 5). CONCLUSIONS: Once-daily tiotropium, as add-on to medium-dose ICS, was effective and well tolerated for Chinese patients with moderate symptomatic asthma, consistent with the main analysis.
Adrenal Cortex Hormones ; Adult ; Asian Continental Ancestry Group ; Asthma ; China ; Forced Expiratory Volume ; Humans ; Salmeterol Xinafoate ; Tiotropium Bromide

OBJECTIVETo evaluate relevant prognostic factors of unrelated single unit umbilical cord blood hematopoietic stem cell transplantation (sUCBT), and to explore the correlation between cryopreservation time of cord blood and cell viability and outcome of sUCBT.

METHODSRetrospective analysis of 137 patients undergoing sUCBT with cord blood provided by Shanghai Cord Blood Bank from Mar. 15, 2007 to Dec. 26, 2013 were performed in this study. The mean cryopreservation time of 137 units cord blood was 698(96-1968) days, with mean cell viability of 87.4% after thawing.

RESULTSNo statistical difference on cell viability, hematopoietic reconstitution, graft failure, acute graft versus host disease (GVHD) and overall survival (OS) was found between patients transfused with cord blood preserved below and above 2 years. The 5-year OS of patients transfused with cord blood preserved below and above 2 years were 55.6% and 67.9%, respectively (P=0.124). OS of the UCBT at 2011 and before, and after 2011 was 48.7% and 79.6%, respectively (P=0.001). Age above 16-year-old (RR=2.830, P=0.027) and UCBT at 2011 and before (RR=0.203, P<0.001) were two risk factors of treatment related mortality.

CONCLUSIONOutcome of sUCBT in China had significant improvement in recent 2 years. Cryopreservation time of cord blood had no statistical correlation to cell viability after thawing and clinical outcome.

Cell Survival ; China ; Cord Blood Stem Cell Transplantation ; Fetal Blood ; Graft vs Host Disease ; Hematopoietic Stem Cell Transplantation ; Humans ; Retrospective Studies

OBJECTIVETo investigate the impact of cryopreservation duration of umbilical cord blood (UCB) on quality of hematopoietic stem cell and outcome of clinical transplantation.

METHODS605 units of UCB which had been used in clinical transplantation were previously cryopreserved for 820 (88-2651) days in average. UCB was detected for total nucleated cell count, CD34+ cells count, cell recovery rate, cell viability and CFU-GM after thawing.

RESULTSNo statistical correlation was found between cryopreservation duration and cell recovery rate, cell viability. CFU-GM decreased along with the extension of cryopreservation duration (P=0.011), ranging between 109.6 and 105.7/1 × 10⁵. There was no significant difference on hematopoietic reconstitution time, graft failure, acute GVHD and overall survival among groups with different cryopreservation duration.

CONCLUSIONCryopreservation duration has no significant effect on cell recovery rate, cell viability and clinical transplantation outcome. Extension of cryopreservation duration may reduce CFU-GM of stem cells with fluctaion still in normal range. UCB could maintain cell viability and function to achieve satisfactory clinical transplantation outcome even when thawed after 3 to 7 years' cryopreservation.

Cell Count ; Cell Survival ; Cryopreservation ; Fetal Blood ; Graft vs Host Disease ; Granulocyte-Macrophage Progenitor Cells ; Hematopoietic Stem Cell Transplantation ; Hematopoietic Stem Cells ; Humans ; Treatment Outcome