PEG-rhG-CSF for prophylaxis of neutropenia after chemotherapy in patients with non-small cell lung cancer: A multicenter, prospective, randomized study.

BACKGROUND: To evaluate the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in preventing neutropenia during multiple cycles of chemotherapy in patients with non-small cell lung cancer (NSCLC). METHOD: In a multicenter, prospective, randomized trial, patients with NSCLC were randomly assigned in a 2:1 ratio to treatment group (PEG-rhG-CSF as primary prophylactic therapy) or control group. Patients in the control group were administered rhG-CSF when white blood cell count was <2.0 × 109 /L or absolute neutrophil count <1.0 × 109 /L. The primary endpoint was the incidence of grade 3/4 neutropenia. Secondary endpoints included the incidence and duration of grade 3/4 neutropenia in each cycle, the incidence of febrile neutropenia (FN), delay rate of chemotherapy, prolonged time of chemotherapy, and safety. RESULTS: Between January 2019 and July 2021, 130 patients were enrolled (treatment group: n = 87, control group: n = 43). The incidence of grade 3/4 neutropenia in the treatment group was significantly lower than that in the control group (1.15% vs. 11.63%, p < 0.05). The mean duration of grade 3/4 neutropenia for the treatment and control group was 2.00 and 3.75 days, respectively. There were no statistical differences in the incidence of FN, delay rate of chemotherapy, prolonged time of chemotherapy, and antibiotic use between the two groups (all p > 0.05). Adverse events were reported in 47.13% of patients in the treatment group and 48.84% patients in the control group. CONCLUSIONS: Primary prophylactic treatment with PEG-rhG-CSF could reduce the incidence of neutropenia in patients with NSCLC during multiple cycles of chemotherapy, with acceptable safety and tolerability.

Chinese Herbal Medicine Combined with Entecavir for HBeAg Positive Chronic Hepatitis B: Study Protocol for a Multi-Center, Double-Blind Randomized-Controlled Trial.

BACKGROUND: The domestic prevalence of chronic hepatitis B (CHB) in China is 7.18% in 2006, imposing great societal healthcare burdens. Nucleot(s)ide analogues (NUCs) anti-hepatitis B virus (HBV) therapies are widely applied despite the relatively low rate of seroconversion and high risk of drug-resistant mutation. More effective treatments for CHB deserve further explorations. Combined therapy of NUCs plus Chinese herbal medicine (CHM) is widely accepted in China, which is recognized as a prospective alternative approach. The study was primarily designed to confirm the hypothesis that Tiaogan-Yipi Granule (, TGYP) or Tiaogan-Jianpi-Jiedu Granule (, TGJPJD) plus entecavir tablet (ETV) was superior over ETV monotherapy in enhancing HBeAg loss rate. METHODS: The study was a nationwide, large-scale, multi-center, double-blind, randomized, placebo-controlled trial with a designed duration of 108 weeks. A total of 16 hospitals and 596 eligible Chinese HBeAg positive CHB patients were enrolled from November 2012 to September 2013 and randomly allocated into 2 groups in 1:1 ratio via central randomization system: experimental group (EG) and control group (CG). Subjects in EG received CM formulae (TGYP or TGJPJD, 50 g per dose, twice daily) plus ETV tablet (or ETV placebo) 0.5 mg per day in the first 24 weeks (stage 1), and CHM granule plus ETV tablet (0.5 mg per day) from week 25 to 108 (stage 2). Subjects in CG received CHM Granule placebo plus ETV tablet (0.5 mg per day) for 108 weeks throughout the trial. The assessments of primary outcomes (HBV serum markers and HBV-DNA) were conducted by a third-party College of American Pathologists (CAP) qualified laboratory. Adverse effects were observed in the hospitals of recruitment. DISCUSSION: The study was designed to compare the curative effect of CM plus ETV and ETV monotherapy in respect of HBeAg loss, which is recognized by the European Association for the Study of the Liver as "a valuable endpoint". We believe this trial could provide a reliable status for patients' "journey" towards durable responses after treatment discontinuation. The trial was registered before recruitment on Chinese Clinical trial registry (No. ChiCTR-TRC-12002784, Version 1.0, 2015/12/23).

Electronic and vibrational properties of stable isomers of (SiO)n((0,±)) (n = 2-7) clusters.

First-principles calculations based on density functional theory have been performed to explore the stable configurations, electronic structures, and vibrational spectra of neutral and charged silicon monoxide clusters (SiO)n((0,±)) (n = 2-7), which could be used as precursors in the synthesis of silicon nanowires. Our theoretical calculations provide new results on characteristic electron affinity, ionization potential, and vibrational spectroscopy, guiding future experiments in the synthesis of high-quality silicon nanowires. Specifically, as the number of SiO units n increases, IR spectra of (SiO)n(±) and Raman spectra of (SiO)n(-) show an evident blue shift, and Raman spectra of (SiO)n demonstrate a red shift. Moreover, most of the neutral silicon monoxide clusters have strong IR intensities and weak Raman activities, while most of the anionic counterparts have relatively weak IR intensities and strong Raman activities. Some other energetically competitive isomers of some (SiO)n((0,±)) species were also studied for comparison.

[Efficacy and safety of integrative medical program based on blood cooling and detoxification recipe in treating patients with hepatitis B virus related acute-on-chronic liver failure: a randomized controlled clinical study].

OBJECTIVE: To evaluate the clinical efficacy and safety of integrative medical program based on blood cooling and detoxification recipe (BCDR) in treating patients with hepatitis B virus related acute-on-chronic liver failure (HBV-ACLF) of heat-toxicity accumulation syndrome (HTAS). METHODS: Adopting randomized controlled clinical design, a total of 105 HBV-ACLF patients of HTAS were randomly assigned to the trial group (64 cases) and the control group (41 cases). Patients in the control group were treated with comprehensive Western therapy, while those in the trial group were treated with comprehensive Western therapy plus BCDR. All were treated for 8 weeks and followed up for 40 weeks. Effect and safety of the treatment were assessed, including fatality, liver functions [total bilirubin (TBIL), albumin (ALB), alanine aminotransferase (ALT), and aspartate transaminase (AST)], and prothrombin activity (PTA) after treatment and at week 48 of follow-ups. RESULTS: After 8-week treatment, there was statistical difference in the overall fatality rate (15.63% vs 34.15%), the fatality rate in the mid-term (25.0% vs 64.7%), TBIL at week 8 (64.54 +/- 79.75), AST [at week 2: (178.97 +/- 44.24) U/L vs (288.48 +/- 58.49) U/L; at week 4: (61.65 +/- 27.36) U/L vs (171.12 +/- 89.11) U/L] and PTA [at week 4: (58.30 +/- 15.29) vs (42.56 +/- 15.27); at week 6: (60.77 +/- 20.40) vs (43.08 +/- 12.79)] (all P < 0.05). At week 48 of the followup, the fatality rate of the trial group (21.88%) decreased by 17. 14% when compared with that of the control group (39.02%; P < 0.05). No obvious adverse event occurred in the two groups during the 8-week treatment period. CONCLUSION: BCDR could significantly reduce the mortality of HBV-ACLF patients.

Introgression and selection shaping the genome and adaptive loci of weedy rice in northern China.

As a weed of rice paddy fields, weedy rice has spread worldwide. In northern China, the expansion of weedy rice has been rapid over the past two decades. Its evolutionary history and adaptive mechanisms are poorly understood. Evolutionary relationships between northern weedy rice and rice cultivars were analyzed using presumed neutral markers sampled across the rice genome. Genes involved in rice domestication were evaluated for their potential roles in weedy rice adaptation. Seed longevity, a critical trait of weedy rice, was examined in an F(2) population derived from a cross between weedy rice and a rice cultivar to evaluate weedy rice adaptation and the potential effect of candidate genes. Weedy rice in northern China was not derived directly from closely related wild Oryza species or from the introgression of indica subspecies. Introgression with local cultivars, coupled with selection that maintained weedy identity, shaped the evolution of weedy rice in northern China. Weedy rice is a unique system with which to investigate how weedy plants adapt to an agricultural environment. Our finding that extensive introgression from local cultivars, combined with the continuing ability to maintain weedy genes, is characteristic of weedy rice in northern China provides a clue for the field control of weedy rice.

[Clinical feature and treatment of 69 Chinese children patients infected with influenza A (H1N1)].

OBJECTIVE: During the 2009 influenza A (H1N1) epidemic in China, children are the main group among people infected with influenza A (H1N1) virus, but few reports about children are available. The present study aimed to observe the clinical, laboratory features and to analyze therapeutic result. METHOD: The research subject were 93 children infected with influenza A (H1N1), 59 male and 34 female who were treated in Beijing Ditan Hospital from 15 May 2009 to 10 September 2009. The patients' data on symptoms, signs, chest X-ray, blood routine test, erythrocyte sedimentation rate (ESR), C reactive protein (CRP), liver function, renal function, helper T lymphocyte were collected and analyzed. The patients were treated with Oseltamivir, traditional Chinese medicine and symptomatic treatment. RESULT: The main symptoms of children infected with influenza A (H1N1) are fever (84 cases, 90.3%), cough (62 cases, 66.7%), pharyngodynia (36 cases, 38.7%) and expectoration (19 cases, 20.4%) at onset, and fever (59 cases, 63.4%), cough (52 cases, 55.9%), pharyngodynia (23 cases, 24.7%) and expectoration (9 cases, 9.7%) were the mojor symptoms and signs while the patients visited our hospital. The main signs were fervescence, pharyngeal congestion (53 cases, 57.0%), tonsilar swelling (21 cases, 22.6%), and abnormal white blood count (WBC) was found in 32 cases, abnormal ESR in 10 cases, abnormal CRP in 10 cases, abnormal CD4 T lymphocyte count in 19 cases, abnormal liver function and renal function were found in very few patients. After treatment, the febrile duration and time to virus negative in patients treated with oseltamivir alone, traditional Chinese medicine alone, combined oseltamivir and traditional Chinese medicine as well as those who were neither treated with oseltamivir nor traditional Chinese medicine were respectively 1 - 6 days (median 1 day), 3 - 13 days (median 7 days), 1 - 6 days (median 1.5 days), 4 - 11 days (median 8 days), 1 - 5 days (median 1 days), 5 - 14 days (median 8 days), 1 - 5 days (median 2 days), 4 - 13 days (median 8 days). CONCLUSION: Clinical manifestations of 93 children cases were the same as those of adults. The traditional Chinese medicine could improve symptoms of children infected with influenza A (H1N1), but other clinical therapeutic effects need further study.