Abstract: Objective To investigate the clinical effect of using zerobalanced ultrafiltration on postoperative lung function of coronary artery bypass grafting (CABG) patients under cardiopulmonary bypass (CPB). Methods Forty coronary artery bypass grafting patients in the First Affiliated Hospital of China Medical University from June 2006 to December 2008 were enrolled in this study, and were divided into two groups based on different ultrafiltration procedures. Patients in the experimental group (n=20), 14 males and 6 females, with an age of 65.43±8.31 years, underwent zerobalanced ultrafiltration and conventional ultrafiltration after CPB was carried out. Patients in the control group (n=20), 15 males and 5 females, with an age of 66.51±7.62 years, only underwent conventional ultrafiltration after temperature restoration. Preoperative pulmonary function and arterial blood gas were tested routinely. Airway resistance (Raw), oxygenation index (OI) and alveolar arterial oxygen difference ［P(Aa)O2］ were measured at the following points: before CPB, at the end of CPB, 6 hours, and 12 hours after operation. Postoperative mechanical ventilation time was also recorded. Results There was no significantly statistical difference between the two groups of patients in pulmonary function and arterial blood gas indexes before operation, and Raw, OI and P(Aa)O2 before CPB (Pgt;0.05). Nevertheless, at the points of 6 hours and 12 hours after operation, Raw ［2.22±0.31 cm H2O/(L·s) vs. 2.94±0.42 cm H2O/(L·s), F=0.061, Plt;0.05; 1.89±0.51 cm H2O/(L·s) vs. 2.52±0.29 cm H2O/(L·s), F=0.096, Plt;0.05］ and P(Aa)O2 (86.74±7.63 mm Hg vs. 111.66±7.49 mm Hg, F=0.036, Plt;0.05; 74.82±5.67 mm Hg vs. 95.23±6.78 mm Hg, F=0.059, Plt;0.05) of patients in the experimental group were significantly lower than those of patients in the control group. At the same points, OI of patients in the experimental group was significantly higher than that of patients in the control group (384.33±30.67 vs. 324.63±31.22, F=0.033, Plt;0.05; 342.24±23.43 vs. 293.67±25.44, F=0.047, Plt;005). Ventilator support time of the experimental group was shorter than the control group (15.44±3.93 h vs. 20.68±5.77 h,Plt;0.05). Conclusion Zerobalanced ultrafiltration can improve pulmonary function after coronary artery bypass grafting and shorten postoperative mechanical ventilation time.
ObjectiveTo overview the systematic reviews on efficacy and safety of hyperbaric oxygen in treatment of diabetic foot.MethodsCNKI, CBM, VIP, WanFang Data, The Cochrane Library, PubMed and EMbase databases were searched to collect systematic reviews or meta-analyses on the efficacy and safety of hyperbaric oxygen therapy for diabetic foot from inception to November 17th, 2019. Two researchers independently screened literature and extracted data. Then, AMSTAR 2 tool and PRISMA statement were used to evaluate the methodological quality and reporting quality of included systematic reviews, and the outcome indicators were comprehensively analyzed.ResultsA total of 10 systematic reviews were included. The results of AMSTAR 2 suggested that 6 systematic reviews were of extremely low quality, 3 of low quality, and 1 of high quality. The PRISMA score ranged from 16.5 to 27. The results of the included systematic reviews showed that hyperbaric oxygen therapy might be superior to other interventions in ulcer healing rate and large amputation rate without increasing the risk of adverse events. ConclusionsThe existing systematic reviews/meta-analysis evidence shows that hyperbaric oxygen therapy may have certain curative effect on diabetic foot, however, its methodology and report quality evaluation are insufficient.
Objective To explore the difference between the hemorheology levels and the expression of hypoxia inducible factor 1α/2α (HIF-1α/2α) in the peripheral blood mononuclear cells of the Tibetan and Han patients with obstructive sleep apnea hypopnea syndrome (OSAHS). Methods This research recruited 30 high-risk Tibetan and Han patients with OSAHS, and 30 Tibetan and Han healthy volunteers at the same period. The whole blood viscometer was used to detect the high shear rate of whole blood viscosity, low shear rate of whole blood viscosity, plasma viscosity ratio, red blood cell aggregation index, and hematocrit in each group. RT-qPCR and Western blot assays were used to detect the mRNA and protein levels of phosphoinositide 3-kinase (PI3K), serine/threonine kinase (AKT), nuclear factor-κB (NF-κB) p65, HIF-1α and HIF-2α in peripheral blood mononuclear cells. Results The hemorheology level of Tibetan OSAHS patients was significantly higher than that of healthy Tibetans and Han OSAHS patients (P<0.05), and the hemorheology level of Han OSAHS patients was significantly higher than that of Han healthy people (P<0.05) . The mRNA and protein levels of PI3K, AKT, NF-κB p65 and HIF-1α in the peripheral blood mononuclear cells of Tibetan OSAHS patients were significantly higher than those of the healthy Tibetans or Han people, and these indexes of the Han OSAHS patients were significantly higher than those of the Han healthy people (all P<0.05), while HIF-2α mRNA and protein levels were significantly lower than those of healthy Han people (all P<0.05). Conclusion The upregulation of HIF-1α level and downregulation of HIF-2α expression in peripheral blood mononuclear cells of OSAHS patients depend on the activation of the PI3K/AKT/NF-κB p65 signaling pathway, and the hemorheological level of Tibetan OSAHS patients is higher than that of Han OSAHS patients.
Objective To investigate the effects of Neuritin on the regeneration of the neural axons after acute spinal cord injury (SCI) in rats. Methods The model of acute SCI at T10 was establ ished in 54 adult healthy Wistar rats (half males and half females) weighing 250-300 g by using the improved Allen’s weight-drop method. The rats were randomly dividedinto 3 groups. 100 μL (6 μg) Neuritin and His protein was injected into group A (n=24) and group B (n=24), respectively,through subarachnoid catheter. Six rats from each group were killed 3, 7, 14, and 28 days after injury to receive Basso, Beattie and Bresnahan (BBB) locomotor rating scal ing, HE staining observation, and immunohistochemistry staining observation for neurofilament 200 (NF-200) and growth associated protein 43 (GAP-43). Group C (n=6) served as sham-operated group receiving laminectomy without spinal injury and with an empty catheter in the subarachnoid space and received the above observations 7 days after injury. Results BBB scale: after operation, the scale of groups A and B was increased over time; group A was significantly higher than group B from 14 days (P lt; 0.05); group C was higher than groups A and B at different time points after operation (P lt; 0.05). HE staining: in group C, the injured spinal tissue was normal after operation; from 7 days after operation, group A presented deeper-stained nissl body, less physal iferous cells, and more nerve synapses when compared with group B. NF-200 and GAP-43 immunohistochemistry observation: in group C, there was just l ittle positive expression; while in groups A and B, positive expression of NF-200 and GAP-43 was evident in the spinal cord from 7 days after operation. Mean density integral absorbency (IA) value of NF-200 and GAP-43: group A was higher than group B at each time point (P lt; 0.05) and group C was lower than groups A and B at each time point (P lt; 0.05). Conclusion Local application of exogenous Neuritin can promote the axonal regeneration after acute SCI in rats and the recovery of the locomotion function of hind-limbs in rats.
Big data technology is an inevitable result of the information age, which not only promotes the development of biomedical science, but also opens up new paths for the development of traditional Chinese medicine (TCM). This paper introduced the application status of big data technology in the field of TCM in recent years, and put forward some thinkings and prospects so as to provide new insights and methods for the future development direction of TCM.
Objectives To discuss the methodology of evaluation of traditional Chinese medicine (TCM) placebo simulation effects and the problems of blind implementation and so as to improve the quality of double-blind clinical trials of TCM. Methods Focusing on case of placebo preparation of TCM investigational new drug, simulation effects of the placebo were evaluated in terms of shape, color, taste and smell. The possibility of placebo be a drug and the similarity between placebo and drug were tested. Results There was no significant difference between placebo and investigational new drug to be judged as a drug (P>0.05). As for the similarity between placebo and drug, there was no significantly difference of the shape (P>0.05), for which the similarity was 100%. The color, taste and smell were significant different between placebo and drug (P<0.05), for which the similarity were 50%, 10% and 15% respectively. Conclusions It is very difficult to simulate TCM based on its certain color, taste or smell. Therefore, the subjects and the investigators’ compliance should be kept to avoid breaking the blind intentionally in the process of the trial and the influence of unblinding should be estimated at the end of the trial.
ObjectiveTo systematically review the methodological quality of Chinese clinical practice guidelines (CPGs) for diagnosis and management of diabetic foot.MethodsCNKI, WanFang Data, VIP, CBM, Yimaitong databases, website of Diabetes Branch of Chinese Medical Association, website of Chinese Integrative Medicine Association and website of Peripheral Vascular Disease Professional Committee of Chinese Society of Microcirculation were electronically searched to collect relevant CPGs from inception to May, 2020. Four researchers independently evaluated the CPGs methodological quality by using AGREEⅡ tool.ResultsA total of 10 Chinese CPGs for diabetes foot were included. The standardized mean scores for various fields were 75.74% for scope and purpose, 36.58% for stakeholder involvement, 28.61% for rigor of development, 86.30% for clarity and presentation, 43.47% for applicability, and 9.44% for editorial independence. ConclusionsThere are merely a small quantity of diabetic foot guidelines in China, and the methodological quality is insufficient. Therefore, more attention should be focused on the establishment of guidelines in the future, so as to further improve the quality of Chinese diabetic foot guidelines.
ObjectiveTo explore the associations between estrogen receptor α (ESR1) gene intron 1 PvuⅡ (−397 T/C, rs2334693), XbaⅠ (−351 A/G, rs9340799) polymorphisms and premature ovarian failure (POF).MethodsLiterature published before February 2021 were retrieved in PubMed, Web of Science, China National Knowledge Infrastructure, Wanfang, and CQVIP databases, according to the inclusion and exclusion criteria developed before. Odds ratio (OR) and 95% confidence interval (CI) were used for data analysis, the Q test and I2 statistic were used for heterogeneity analysis. Random-effect model or fixed-effect model was used according to I2 value. All analyses were performed by RevMan 5.3 software.ResultsSix case-control studies were included in this meta-analysis. For the associations between ESR1 gene intron 1 PvuⅡ polymorphisms and POF, there was no statistical difference in TT vs. CC model [OR=0.72, 95%CI (0.31, 1.70), P=0.46], TC vs. CC model [OR=1.09, 95%CI (0.83, 1.43), P=0.54], recessive model [OR=1.08, 95%CI (0.68, 1.70), P=0.74], or dominant model [OR=0.77, 95%CI (0.42, 1.42), P=0.41]. For the associations between ESR1 gene intron 1 XbaⅠ polymorphisms and POF, there was no statistical difference in AA vs. GG model [OR=0.88, 95%CI (0.44, 1.75), P=0.72], AG vs. GG model [OR=1.23, 95%CI (0.84, 1.79), P=0.29], recessive model [OR=1.14, 95%CI (0.81, 1.61), P=0.44], or dominant model [OR=0.75, 95%CI (0.41, 1.35), P=0.34], either. No statistical difference was found in the ethno-based subgroup analyses (P>0.05). Most models had obvious heterogeneities.ConclusionsCurrent evidence can’t confirm the associations between ESR1 gene PvuⅡ, XbaⅠ polymorphisms and POF. High-quality, multi-central and large-sample studies are still necessary to support this conclusion.
Randomization was the basis for the design and conduct of clinical trials. However, the traditional randomized controlled trials (RCTs) were often randomized in a fixed manner with unbalanced potential covariates, which spured researchers to develop a more flexible and practical randomization method. Thus, the adaptive randomization emerged as the time needed. In this paper, the application of adaptive randomization in clinical trials was introduced, and its key points of implementation, advantages and disadvantages were summarized. The development space of the adaptive randomization in clinical applications was also discussed, and it provided evidence for the development of the drug clinical trials in China.
Objective To evaluate the efficacy and safety of Niuhuangjiangya tablets (NT) on mild to moderate primary hypertension (overabundant liver-fire) in comparison with Niuhuangjiangya pills (NP). Method The double-dummy and randomized controlled method was adapted to assess 240 patients (overabundant liver-fire) who were divided into the treatment group (n =120, treated with NT 2 tablets, twice a day) and the control group (n =120, treated with NP 1 pill, twice a day).The duration of treatment for both groups was 4 weeks. Results Blood pressure began to decline in the first week of treatment. After 4 weeks, the mean diastolic and systolic blood pressure dropped 7.51 and 12.16 mmHg, respectively, in the treatment group; 7.53 and 12.45 mmHg dropped respectively in the control group. For diastolic blood pressure, the total efficacy rates of the two groups were 50.8% and 54.9% (Pgt;0.05), respectively. For TCM syndromes, the total efficacy rates of the two groups were 45.6% and 42.34% (Pgt;0.05), respectively. The two drugs were equivalent by the equivalent test (Plt;0.05). No adverse effect was found in the study. Conclusions Niuhuangjiangya tablets have confirmed that the effects on mild to moderate hypertension has few side effects. The efficacy of the two drugs is equivalent by the equivalence test. placebo=controlled trials are required.