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A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother's own milk for preterm infants in the NICU.
Sun, H, Cao, Y, Han, S, Cheng, R, Liu, L, Liu, J, Xia, S, Zhang, J, Li, Z, Cheng, X, et al
Trials. 2020;(1):170
Abstract
BACKGROUND Necrotizing enterocolitis (NEC) is the leading cause of death among preterm infants born at < 30 weeks' gestation. The incidence of NEC is reduced when infants are fed human milk. However, in many neonatal intensive care units (NICUs), it is standard practice to freeze and/or pasteurize human milk, which deactivates bioactive components that may offer additional protective benefits. Indeed, our pilot study showed that one feed of fresh mother's own milk per day was safe, feasible, and can reduce morbidity in preterm infants. To further evaluate the benefits of fresh human milk in the NICU, a randomized controlled trial is needed. METHODS Our prospective multicenter, double-blinded, randomized, controlled trial will include infants born at < 30 weeks' gestation and admitted to one of 29 tertiary NICUs in China. Infants in the intervention (fresh human milk) group (n = 1549) will receive at least two feeds of fresh human milk (i.e., within 4 h of expression) per day from the time of enrollment until 32 weeks' corrected age or discharge to home. Infants in the control group (n = 1549) will receive previously frozen human milk following the current standard protocols. Following informed consent, enrolled infants will be randomly allocated to the control or fresh human milk groups. The primary outcome is the composite outcome mortality or NEC ≥ stage 2 at 32 weeks' corrected age, and the secondary outcomes are mortality, NEC ≥ stage 2, NEC needing surgery, late-onset sepsis, retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), weight gain, change in weight, increase in length, increase in head circumference, time to full enteral feeds, and finally, the number and type of critical incident reports, including feeding errors. DISCUSSION Our double-blinded, randomized, controlled trial aims to examine whether fresh human milk can improve infant outcomes. The results of this study will impact both Chinese and international medical practice and feeding policy for preterm infants. In addition, data from our study will inform changes in health policy in NICUs across China, such that mothers are encouraged to enter the NICU and express fresh milk for their infants. TRIAL REGISTRATION Chinese Clinical Trial Registry; #ChiCTR1900020577; registered January 1, 2019; http://www.chictr.org.cn/showprojen.aspx?proj=34276.
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Comparative risk of new-onset diabetes mellitus for antihypertensive drugs in elderly: A Bayesian network meta-analysis.
Zhang, J, Tong, A, Dai, Y, Niu, J, Yu, F, Xu, F
Journal of clinical hypertension (Greenwich, Conn.). 2019;(8):1082-1090
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Abstract
There is no study to compare different class of antihypertensive drugs on new-onset diabetes mellitus (NOD) in elderly. We aimed to investigate the risk of antihypertensive drugs on NOD in elderly patients. The databases were retrieved in an orderly manner from the dates of their establishment to October, 2018, including Medline, Embase, Clinical Trials, and the Cochrane Database, to collect randomized controlled trials (RCTs) of different antihypertensive drugs in elderly patients (age > 60 years). Then, a network meta-analysis was conducted using R and Stata 12.0 softwares. A total of 14 RCTs involving 74 042 patients were included. The relative risk of NOD mellitus associated with six classes of antihypertensive drugs was analyzed, including placebo, angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), calcium channel blockers (CCBs), diuretics, and β blockers. Patients with ACEIs or ARBs appeared to have significantly reduced risk of NOD compare with placebo: ACEIs (OR = 0.49, 95% CrI 0.28-0.85), ARBs (OR = 0.37, 95% CrI 0.26-0.52), while CCBs, diuretics, and β blockers appeared to have not significantly reduced risk of NOD mellitus compare with placebo: CCBs (OR = 1.10, 95% CrI 0.85-1.60), diuretics (OR = 1.40, 95% CrI 0.92-2.50), β blockers (OR = 1.40, 95% CrI 0.93-2.10). The SUCRA of placebo, ACEIs, ARBs, CCBs, diuretics, and β blockers was, respectively, 65.3%, 69.3%, 92.3%, 44.1%, 12.1%, and 16.5%. According to the evidence, ARBs have an advantage over the other treatments in reducing the risk of NOD in elderly patients.
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Comparison of Xilei-san, a Chinese herbal medicine, and dexamethasone in mild/moderate ulcerative proctitis: a double-blind randomized clinical trial.
Zhang, F, Li, Y, Xu, F, Chu, Y, Zhao, W
Journal of alternative and complementary medicine (New York, N.Y.). 2013;(10):838-42
Abstract
BACKGROUND Xilei-san is a traditional Chinese herbal medicine that has proven to be of possible use in the treatment of ulcerative proctitis (UP) in a pilot study. OBJECTIVES This study was intended to compare Xilei-san with dexamethasone enemas in subjects with mild-to-moderate active UP. METHODS A double-blind randomized study was performed in 35 subjects. During the initial 8 weeks, the subjects received an enema of Xilei-san or dexamethasone at bedtime, then discontinued the treatment and were followed for 12 weeks. All of the subjects received 3 g/day oral mesalazine during the entire study. The disease activity was assessed at inclusion and at weeks 4, 8, and 20. RESULTS Both treatments showed significant improvement in clinical, endoscopic, and histological grades in comparison with the baseline. CONCLUSIONS Xilei-san enemas are comparable to dexamethasone enemas in this study. This medicine is safe, well accepted, and may be an alternative drug in the treatment of mild-to-moderate active UP.
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[A 32P application device for the treatment of condyloma acuminatum in the rectum].
Ma, YB, Liu, YW, Gu, AC, Xu, F, Liu, PA, Yuan, SF, Zhai, CT
Zhonghua nan ke xue = National journal of andrology. 2011;(1):47-51
Abstract
OBJECTIVE To investigate the use of a 32P application device (AD) in the treatment of condyloma acuminatum (CA) in the rectum, and to compare its clinical effect with that of the microwave therapy. METHODS This study included 107 cases of CA in the rectum, 99 males and 8 females, aged 21-58 (33.6 +/- 9.4) years. Forty-six of the patients (the AD group) were treated with a self-made 32P application device, which, as a tube-shaped carrier of radionuclide 32P colloid, was fixed in the rectum at the diseased part for medication at 4.9-8.2 Gy for 3-5 hours once and 1-2 times a week. The other 61 (the microwave group) were treated by microwave burning under local anesthesia. Both groups of patients were followed up for over 3 months for comparison of the therapeutic results and observation of the stability and reliability of the 32P application device. RESULTS The rates of cure, reoccurrence and adverse reaction were 84, 8%, 13.0% and 8.7% in the AD group, compared with 40.3%, 55.7% and 75.4% in the microwave group, with statistically significant differences between the two groups (P < 0.01). CONCLUSION The 32P application device, with its advantages of low cost, easy operation, good effect, high safety and reliability, low recurrence, fewer adverse events and good acceptability, is highly valuable for the treatment of CA in the rectum.