1.
Chinese Herbal Medicine (Xiaoaiping) Injections for Chemotherapy-Induced Thrombocytopenia: A Randomized, Controlled, Multicenter Clinical Trial.
Qi, S, Li, X, Dong, Q, Lai, H, Porter, D, Tian, S, Hou, L, Chen, X, Li, X, Wang, K
Journal of alternative and complementary medicine (New York, N.Y.). 2019;(6):648-655
-
-
Free full text
-
Abstract
Objectives: The study aims to evaluate the therapeutic efficacy and safety of Chinese herbal medicine (Xiaoaiping) injections for chemotherapy-induced thrombocytopenia (CIT) in nonsmall cell lung cancer (NSCLC) and gastric cancer. Design: A randomized, controlled, multicenter study from December 2013 to August 2015. Settings/Location: All patients are from China. Subjects: One hundred forty patients with either NSCLC or gastric cancer were enrolled in this trial. Interventions: The intervention group (n = 70) was given Xiaoaiping injections (1 dose/day for 10 days) with chemotherapy, whereas the control group (n = 70) was given chemotherapy only. The follow up period was 11 days after the final injection. Outcome measures: Platelet (PLT) count was tested at day 0, 7, 14, and 21 as the primary outcome for evaluation. Safety measurements, including red blood cells (RBC), hemoglobin (HBG), white blood cells (WBC), neutrophil (NE)#, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), creatine kinase (CK), creatinine (Cr), and blood urea nitrogen (BUN) were tested at day 0 and 21 as the secondary outcomes. Results: (1) Two patients in the intervention group and four patients in the control group were lost upon follow-up. (2) PLT count: there was no significant difference in PLT count between the two groups from baseline (day 0), day 7, and day 14. At day 21, the intervention group indicated an upward trend of PLT count with a statistically significant difference than that of the control group (p < 0.05). (3) NSCLC there was significant difference in PLT count between the two groups on day 21 (p < 0.01). (4) Gastric cancer: there was no significant difference in PLT count between the two groups during this trial (p > 0.05). (5) There was no statistically significant difference between the intervention group and the control group with the safety figures (secondary outcomes) RBC, HGB, WBC, NE#, AST, ALT, LDH, CK, Cr, and BUN measured (p > 0.05). (6) Adverse events: one gastric cancer patient in the control group was diagnosed with gastrointestinal bleeding on day 3. Conclusions: In conclusion, Xiaoaiping injections may provide a safe and effective option for CIT in patients with NSCLC.
2.
[Preoperative assessment value of spectral CT quantitative parameters in lymph node metastasis of gastric cancer].
Chai, Y, Gao, J, Xing, J, Lyu, P, Liang, P, Chen, X
Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery. 2017;(3):309-314
Abstract
OBJECTIVE To investigate the preoperative assessment value of spectral CT quantitative parameters in lymph node metastasis of gastric cancer. METHODS From December 2013 to June 2015, clinical and image data of 86 patients with gastric cancer confirmed by gastroscope pathology undergoing preoperative enhanced CT were prospectively collected. Enhanced CT included nonenhanced CT of conventional 120 kVp mode, arterial phase (AP) and venous phase (VP) with GSI mode on Discover GSI CT scanner. The raw data were transferred to ADW4.6 workstation to reconstruct the monochromatic images at 70 keV and iodine-based images in AP and VP with 1.25 mm thickness. The short diameter, long diameter, ratio of short to long diameter, CT attenuation and iodine value of lymph nodes in each phase were measured and recorded. Pathology results were used as golden standard. The spectral CT quantitative parameters of positive and negative lymph nodes were compared by t test and the sensitivity and specificity analyses were performed by ROC curves. This clinical study registration number 81271573. RESULTS Among these 86 gastric cancer patients (53 male and 33 female), tumors of 28 cases were in upper part, of 12 cases in middle part, of 27 cases in distal part and of 19 cases involved two parts. Thirty-five cases were differentiated type and 51 cases were undifferentiated type. A total of 1 072 lymph nodes were found in operation, of which 412 nodes were positive and 660 were negative. Among 552 lymph nodes found in CT images, 338 nodes were positive and 214 were negative. Compared to negative lymph nodes, short diameter [(9.52±3.58) mm vs. (6.48±2.94) mm, t=4.639, P=0.000], ratio of short to long diameter (0.82±0.14 vs. 0.61±0.08, t=13.514, P=0.000), CT attenuation in precontrast [(20.44±6.77) Hu vs. (16.06±7.14) Hu, t=3.154, P=0.002], CT attenuation in AP[(61.71±11.78) Hu vs. (40.11±10.18) Hu, t=9.588, P=0.000], CT attenuation in VP[(71.34±13.03) Hu vs. (53.81±11.39) Hu, t=7.888, P=0.000], iodine value in AP [(16.17±4.22) 100 μg/cm3 vs. (8.03±3.10) 100 μg/cm3, t=9.781, P=0.000], the iodine value in VP [(20.13±6.04) 100 μg/cm3 vs. (11.58±4.13) 100 μg/cm3, t=10.147, P=0.000] of positive lymph nodes were greater. The long diameter was not significantly different between positive and negative lymph nodes [(11.71±5.63) mm vs. (10.64±3.20) mm, t=1.380, P=0.169]. The area under ROC curve of short diameter, ratio of short to long diameter, CT attenuation in precontrast, AP and VP, iodine value in AP and VP of lymph nodes was 0.600, 0.880, 0.648, 0.832, 0.755, 0.864, 0.835, respectively. Taking the ratio of short to long diameter over 0.72 as diagnosis standard, the sensitivity was 75.6% and the specificity was 93.5%. Taking the CT number in AP over 49.75 Hu, the sensitivity was 66.9% and the specificity was 88.8%. Taking the CT number in VP over 59.80 Hu, the sensitivity was 69.9% and the specificity was 77.6%. Taking the iodine value in AP over 9.65 (100 μg/cm3), the sensitivity was 80.4% and the specificity was 82.2%. Taking the iodine value in VP over 15.65 (100 μg/cm3), the sensitivity was 69.9% and the specificity was 86.9%. Combinong the ratio of short to long diameter with the iodine value in AP, the sensitivity was 95.2% and the specificity was 76.9%. CONCLUSIONS The ratio of short to long diameter, the iodine value and CT attenuation in AP and VP of lymph nodes in spectral CT are important criteria to evaluate the metastasis of gastric cancer. Combining the ratio of short to long diameter with the iodine value in AP can obviously improve the sensitivity.