Background and purpose:Huachansu has been widely used to treat cancer in China.But maximum tolerated dose(MTD) of huachansu is still not well defined.The purpose of this study was to conduct a Phase Ⅰ study to determine the MTD of huachansu in the treatment of patients with hepatocellular carcinoma,non-small cell lung or pancreatic cancer.Toxic profile and efficacy of huachansu were also assessed qualitatively.Methods:Huachansu was intravenously administered to patients with stage Ⅲ/Ⅳ hepatocellular carcinoma,non-small cell lung cancer,or pancreatic cancer.Each cycle consisted of daily huachansu for 14 days with an interval of 7 days between two cycles.2 or more cycles were delivered to the patients if no severe adverse event occurred.The planned dose escalation schedule for huachansu was as follows,10,20,40,60,90 and 120 ml/(m2?d).Results:Fifteen patients(3 at each level) have been recruited to the study(11 with hepatocellular carcinoma,2 with pancreatic cancer,and 2 with lung cancer).There were no dose limiting toxicities found after dose level 5.Among all these patients,the efficacy in 14 patients could be valued,in which,6 were SD(42.9%),8 were PD(57.1%).At dose level 1,there was one patient with hepatocellular carcinoma achieving a 20% reduction in tumor mass that lasted 11 months,6 of 15(42.9%) patients with stable disease and 8 of 15(57.1%) with progress disease after the treatment.Conclusions:To date,dose limiting toxicity has not been seen with doses up to eight times higher than that typically used before.Of interest, several patients had prolonged stable disease or minor tumor shrinkage.

Objective:To monitor and investigate the long-term growth trend and nutritional status of very preterm infants (VPIs, born at gestational age between [28~31 +] weeks) with extrauterine growth restriction (EUGR) from birth to preschool period. Methods:VPIs who met with the following criteria were enrolled: infants born in Huai'an Maternity and Child Heath Care Hospital from January 1 to December 31, 2015; infants admitted to the Neonatal Medical Center and discharged alive; infants who received multi-disciplinary treatment in Child Care Division from discharge to preschool period. All of the VPIs were divided into the EUGR group and the non-EUGR group according to whether the weight at hospital discharge was below the 10 th percentile for corrected age in body weight. The weight for age Z score (WAZ), height for age Z score (HAZ), and head circumference for age Z score (HCZ) were calculated at each specified time point (at 40 weeks of age; at 1, 2, 3, 4, 5, 6 and 24 months of corrected age; and at 48 months of age). The growth trend and the nutritional status at 48 months of age were compared between the two groups. Results:1. A total of 53 VPIs were enrolled, among whom 35 cases were boys and 20 cases were with EUGR. The differences in the gestational age, birth weight, incidence of very low birth weight infants, neonatal respiratory distress syndrome (NRDS) and bronchopulmonary dysplasia (BPD) were all statistically significant between the EUGR group and the control group ( x 2= 2.306, 3.543, 10.852, 9.515, 0.001, respectively; all P<0.05). 2. The WAZ and HAZ of the EUGR group were lower at each time point. The WAZ at 40 weeks of age and the HAZ at 3 months of corrected age were significantly different between the two groups. From 40 weeks of age to 2 months of corrected age and from 6 months to 24 months of corrected age, the WAZ, HAZ and HCZ in both groups showed an increasing trend. However, the WAZ in the EUGR group and the WAZ, HAZ and HCZ in the non-EUGR group showed a declining trend from 24 months of corrected age to 48 months of age. 3. There was no significant differences in growth restriction incidence at each time point between the EUGR group and the control group. 4. The nutritional status showed no significant difference between the two groups, either ( P>0.05). Conclusions:Low gestational age, low birth weight, NRDS and BPD are the risk factors of EUGR. The growth trend of the EUGR VPIs shows an overall upward trend from hospital discharge to 24 months of corrected age but declined thereafter, while the nutritional status is good at 48 months of age. Thus, in addition to the integrated management, continuous monitoring of long-term growth and nutrient input after 24 months of age is required for VPIs.