Association between Genetic Variants and Characteristic Symptoms of Type 2 Diabetes: A Matched Case-Control Study

Objective

To examine the association of genetic variants with characteristic symptoms of type 2 diabetes mellitus (T2DM).

Methods

A matched case-control study was performed to investigate the association between common variants in four genes (CDKAL1, GLIS3, GRK5, and TCF7L2) and symptoms of T2DM. Symptoms were examined with questionnaire for 710 subjects. Genomic DNA was extracted from peripheral blood mononuclear cell by salting-out procedure. Genotyping was carried out by direct sequencing of the unpurified polymerase chain reaction products.

Result

Most of the T2DM patients pressented characteristic symptoms, such as feeling weak in limbs (P =0.0057), hand tremor (P =0.0208), bradymasesis (P =0.0234), and polyuria (P =0.0051). Some of the T2DM patients shared characteristic symptoms, such as desire for cold drinks (P =0.0304), polyphagia (P =0.0051), and furred tongue (P =0.028). The impaired glucose regulation (IGR) cases took only one characteristic symptom of frequent micturition (P =0.0422). GLIS3 rs7034200 and GRK5 rs10886471 were significantly associated with increased T2DM risk (GLIS3 rs7034200 under dominant model: P=0.0307; GRK5 rs10886471 under recessive model: P=0.0092). However, only the rs10886471 polymorphism in GRK5 showed a significant effect on both differentiated symptoms and T2DM risk. The C-allele was involved in both dampness-heat encumbering Pi (Spleen) syndrome (P =0.047) and qi-yin deficiency syndrome (P =0.002) via increased GRK5 expression.

Conclusions

Both T2DM and IGR exhibited its corresponding characteristic symptoms. The variants of GRK5 were involved with both qi-yin deficiency syndrome and dampness-heat encumbering Pi syndrome.

     

Association of Platelet-Activating Factor Receptor Gene rs5938 (G/T) and rs313152 (T/C) Polymorphisms with Coronary Heart Disease and Blood Stasis Syndrome in A Chinese Han Population

Objective

To explore the association of the platelet-activating factor receptor (PAFR) gene rs5938, rs313152 and rs76744145 polymorphisms with coronary heart disease (CHD) and blood stasis syndrome (BSS) of CHD in Chinese Han population.

Methods

A total of 570 CHD patients (299 with BSS and 271 with non-BSS) and 317 controls were enrolled. The PAFR gene rs5938, rs313152 and rs76744145 polymorphisms were genotyped using the multiplex SNaPshot technology. The statistical analysis was conducted using a multiple variable logistic regression model.

Results

Significant differences were detected in the genotypes frequency distributions of the rs5938 (P<0.01), but not the rs313152 (P>0.05), between the controls and CHD patients. Individuals with an rs5938 or rs313152 mutated allele had a low risk for CHD [adjusted odds ratio (aOR)=0.35, 95% confidence interval (CI): 0.23 to 0.56, P<0.01; aOR=0.65, 95% CI: 0.46 to 0.91, P<0.05, respectively]. After the CHD patients were stratified as BSS or non-BSS according to their Chinese medicine patterns, the rs5938 polymorphism mutated alleles had a significant association with a low risk for BSS of CHD (aOR=0.32, 95% CI: 0.18 to 0.57, P<0.01) and non-BSS of CHD (aOR=0.31, 95% CI: 0.17 to 0.55, P<0.01). The rs313152 polymorphism was associated with a low risk for BSS (aOR=0.51, 95% CI: 0.33 to 0.79, P<0.01), but not for non-BSS (aOR=1.22, 95% CI: 0.81 to 1.85, P<0.05). Furthermore, the interaction effect of the rs5938 and rs313152 polymorphisms for BSS of CHD was significantly based on an aOR value associated with the combination of the rs5938 GT genotype with the rs313152 TC genotype of 0.27 (95% CI: 0.1 to 0.7, P<0.01).

Conclusion

The PAFR gene rs5938 or rs313152 polymorphisms might be a potential biomarker for susceptibility to CHD, especially to BSS of CHD in Chinese Han population.

     

Xinfeng Capsule(新风胶囊)for the Treatment of Rheumatoid Arthritis Patients with Decreased Pulmonary Function—A Randomized Controlled Clinical Trial

Objective:To determine the effectiveness and safety of Xinfeng Capsules(新风胶囊,XFC) for the treatment of rheumatoid arthritis(RA) patients with decreased pulmonary function.Methods:This was a randomized controlled clinical trial of 80 RA patients.Participants were assigned to the trial group(40 cases) and the control group(40 cases) by block randomization.The trial group was treated with XFC,three pills each time three times daily for 2 months.The control group was treated with tripterygium glycoside(TPT),two pills each time three times daily for 2 months.Both groups were followed up after 2 months.The clinical effects,changes in joint and pulmonary function,and quality of life before and after treatment were observed;safety indices were also evaluated.Results:Pain,swelling,tenderness,and duration of morning stiffness of joints were obviously decreased after treatment in both the trial and the control groups compared with baseline(P0.01).Compared with before treatment,hand grip strength increased significantly after treatment in the trial group(P=0.0000);pulmonary function parameters such as forced expiratory volume in the first second of expiration/forced vital capacity(FEV_1/FVC),50%of the expiratory flow of forced vital capacity(FEF_(50)),carbon monoxide diffusing capacity(DLco) were increased(P0.01 or P0.05);measures of quality of life such as role-physical,body pain,vitality and mental health were also improved after treatment in the trial group(all P0.05).Joint swelling in the trial group decreased compared with the control group(P=0.0043),while hand grip strength was increased after treatment(P=0.0000).The increase in FEF_(50),DLco,and the dimensions of quality of life such as vitality and mental health were all significantly greater in the trial group than the control group(P0.05 or P0.01).Conclusions:XFC not only relieved joint pain in RA patients,but also significantly improved the ventilation and diffusion function of the lungs.Therefore,XFC could improve the whole body function and enhance the quality of life of RA patients.     

Clinical Presentation and Treatment Strategies for Ulcerative Colitis: A Retrospective Study of 247 Inpatients

Objective

Complementary and alternative medicine, particularly herbal therapy, is widely used by patients with ulcerative colitis (UC), but controlled data are limited. To describe the clinical presentation and treatment strategies for UC in inpatients from Shanghai, China and to improve the therapeutic outcomes for patients with UC.

Methods

Medical records from 247 patients with UC who were admitted to Longhua Hospital Affifiliated to Shanghai University of Traditional Chinese Medicine between January 2008 and June 2013 were analyzed for gender, age, course of the disease, clinical type, extent and severity of the disease, treatment strategies, and therapeutic outcomes.

Results

Gender ratios and disease onset of inpatients with UC in the Shanghai area were consistent with other reports in the literature. In contrast to previous studies, most patients exhibited disease of the left colon, over half of the patients had problems of the rectum or sigmoid colon, and most patients had either mild or moderate UC. Comparison of Sutherland Disease Actirity Index scores for patients treated with Chinese medicine (CM) and those treated with integrated CM and Western medicine revealed signifificant reductions in scores for both groups after treatment (P<0.01), with no signifificant difference in therapeutic effects between groups (P=0.938).

Conclusions

Herbal medicine has been widely used in patients with mild to moderate disease and as adjunct therapy in patients with moderate to severe disease. Therefore, the strategy was proposed for the treatment of UC with CM therapy based on 2 steps according to the stage of the disease, even in the clinical setting.

     

Effects of Senegenin against Hypoxia/Reoxygenation-Induced Injury in PC12 Cells

Objective:To investigate the effect and the potential mechanism of Senegenin(Sen) against injury induced by hypoxia/reoxygenation(H/R) in highly differentiated PC12 cells.Methods:The cultured PC12 cells were treated with H/R in the presence or absence of Sen(60 μmol/L).Four groups were included in the experiment:control group,H/R group,H/R+Sen group and Sen group.Cell viability of each group and the level of lactate dehydrogenase(LDH) in culture medium were detected for the pharmacological effect of Sen.Hoechst 33258 staining and annexin V/propidium iodide double staining were used to analyze the apoptosis rate.Moreover,mitochondrial membrane potential(△Ψm),reactive oxygen species(ROS) and intracellular free calcium([Ca~(2+)]i) were measured by fluorescent staining and flow cytometry.Cleaved caspase-3and activity of NADPH oxidase(NOX) were determined by colorimetric protease assay and enzyme linked immunosorbent assay,respectively.Results:Sen significantly elevated cell viability(P0.05),decreased the leakage of LDH(P0.05) and apoptosis rate(P0.05) in H/R-injured PC12 cells.Sen maintained the value of△Ψm(P0.05) and suppressed the activity of caspase-3(P0.05).Moreover,Sen reduced ROS accumulation(P0.05) and[Ca~(2+)]i increment(P0.05) by inhibiting the activity of NOX(P0.05).Conclusion:Sen may exert cytoprotection against H/R injury by decreasing the levels of intracellular ROS and[Ca~(2+)]_i,thereby suppressing the mitochondrial pathway of cellular apoptosis.     

In Vivo and In Vitro Anti-inflammatory Effects of Ethanol Fraction from Periploca forrestii Schltr.

Objective: To determine the anti-inflammatory effects of an ethanol fraction of Periploca forrestii Schltr. (EFPF) and to investigate the potential mechanisms underlying in vivo and in vitro models. Methods: The anti-inflammatory effects of EFPF were evaluated using the xylene-induced mouse ear edema and carrageenan-induced rat paw edema models in vivo. In vitro, RAW264.7 cells were exposed to 0–800 μg/mL EFPF and the cell viability was determined by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay. Then cells were treated with different concentrations of EFPF (100–400 μg/mL) and stimulated with lipopolysaccharide (LPS, 1 μg/mL) for 24 h. The supernatant was analyzed for nitric oxide (NO) using the Griess reagent, and the levels of inflammatory mediators and cytokines were determined using enzyme-linked immunosorbent assays for prostaglandin E2 (PGE2), tumor necrosis factor α (TNF-α), interleukin (IL) 6, and IL-10. The protein expressions of inducible NO synthase (iNOS), cyclooxygenase-2 (COX-2), nuclear factor κB (NF-κB), and mitogen-activated protein kinases (MAPKs) including extracellular signal-regulated kinase (ERK), c-Jun N-terminal kinase (JNK), and p38 MAPK were examined by Western blot. Results: Compared with the control group, EFPF significantly reduced mouse ear edema and rat paw edema rate (P<0.05 or P<0.01). Compared with the LPS group, EFPF significantly inhibited the LPS-stimulated production of NO, PGE2, TNF-α and IL-6 (P<0.05 or P<0.01), and increased the IL-10 production (P<0.05). EFPF also significantly inhibited LPS-induced protein expressions of iNOS and COX-2, suppressed the phosphorylation and degradation of inhibitor of NF-κB-α, decreased p65 level, and inhibited the phosphorylation of p38, ERK1/2 and JNK (P<0.05 or P<0.01). Conclusion: EFPF exerted anti-inflammatory effect by reducing protein expressions of iNOS and COX-2 and the production of the inflammation factors, including TNF-α, IL-6, NO and PGE2, mainly through inhibition of LPS-mediated stimulation of NF-κB and MAPK signaling pathways.     

Synchronous Dynamic Research on Respiratory and Intestinal Microflora of Chronic Bronchitis Rat Model

Objectives

To investigate the mechanism of the Chinese medicine theory that Fei (Lung) and Dachang (Large Intestine) are exteriorly and interiorly related via synchronous observation on the dynamic changes of the respiratory and intestinal microflora.

Methods

Forty specific pathogen free Sprague-Dawley rats were selected and randomly divided into blank (10 rats) and chronic bronchitis model groups (30 rats). The blank group rats were put into the smoke-free environment and the model group rats were put into the smoke environment in order to establish pulmonary disease (chronic bronchitis) model. Then the corresponding changes of the respiratory and intestinal microflflora of the model on 20th, 50th and 70th days were synchronously observed.

Results

The respiratory tract microflflora showed an increase in the total aerobic and Staphylococcus aureus and reduced anaerobic amount signifificantly on 20th day in the respiratory tract microflflora (P<0.05 or 0.01). On 50th day, total aerobic, total anaerobic amount and bififidobacterium signifificantly increased (P<0.05). On 70th day, Staphylococcus aureus reduced and lactobacillus increased signifificantly (P<0.01). The intestinal microflflora showed an increase in the total aerobic, Clostridium perfringens, enterobacter and enterococcus significantly increased on 20th day (P<0.05 or 0.01). Staphylococcus aureus on 50th day increased significantly (P<0.05). Total aerobic and enterococcus increased, total anaerobic and Clostridium perfringens reduced signifificantly on 70th day (P<0.05 or 0.01).

Conclusion

The microecosystem of respiratory tract and intestine of rat model during the pathological process showed a dynamic disorder, indicating an interaction between the lung and large intestine which may be one of the connotations as they exteriorly and interiorly related.

     

Chinese Medicine for Idiopathic Parkinson's Disease: A Meta Analysis of Randomized Controlled Trials

Objective:To evaluate the efficacy of Chinese medicine(CM) adjunct to conventional medications for idiopathic Parkinson's disease(PD).Methods:Electronic English and Chinese databases including PubMed,Cochrane Library,Web of Science,Chinese Medical Current Contents,China National Knowledge Infrastructure,China Science and Technology Journal Database,Wanfang Med Database,and Traditional Chinese Medical Database System were used for key words searching in a highly sensitive search strategy.The extracted data was analyzed by the Review Manager 5.0.Results:Twelve trials involving 869 participants were included in the meta-analysis.Unified PD Rating Scale(UPDRS) I,Ⅱ,Ⅲ,Ⅳ scores and UPDRS Ⅰ-Ⅳ total scores were used to be the primary outcomes,Parkinson Disease Question-39(PDQ-39) and Scores of Chinese Medical Symptoms were the secondary outcomes.CM adjunct therapy had greater improvement in UPDRS Ⅰ[2 trials;standardized mean difference(SMD)-0.40,95%confidence interval(CI)-0.71 to-0.09;Z=2.49(P=0.01)],Ⅱ[5 trials;SMD-0.47,95%CI-0.69 to-0.25;Z=4.20(P0.01)],Ⅲ[5 trials;SMD-0.35,95%CI-0.57 to-0.13;Z=3.16(P=0.002)],Ⅳ scores[3 trials;SMD-0.32,95%CI-0.60 to-0.03;Z=2.17(P=0.03)],UPDRS Ⅰ-Ⅳ total scores[7 trials;SMD-0.36,95%CI-0.53 to-0.20;Z=4.24(P0.05)].PDQ-39 and Chinese medical symptoms compared to the conventional medication only.Conclusion:CM adjunct therapy has potential therapeutic benefits by decreasing UPDRS scores and reducing adverse effect.     

Comparative Effect of Propolis of Honey Bee and Some Herbal Extracts on Candida Albicans

Objective: To determine the effect of propolis on Candida albicans and to compare it with the effects of some other herbal extracts and antibiotics on this pathogenic fungi. Methods: The extracts of propolis, Thymus vulgaris, Caryophillium aromaticus, Echinophora platyloba, Allium cepa and Cinnamomum zeylanicum were prepared and the antifungi effects of the extracts were examined on Candida albicans ATCC10231 using disc-diffusion assay and micro-broth dilution. The minimum fungicidal concentration (MFC) and minimum inhibitory concentrations (MIC) as well as inhibition zone were evaluated and the anti fungi effects of herbal extracts were compared with amphotricin B and nystatin at the times of 24, 48 and 72 h. Data analysis was performed using t test. Results: Obtained results showed that propolis extract with MIC90 and MFC equal to 39 and 65 μg/mL, respectively, possess the highest antifungal activity when compared with other studied extracts. The extracts of Allium cepa and Thymus vulgaris, with MFC of 169 and 137 μg/mL, respectively, showed the lowest effects on the fungi. Also nystatin and amphotricin B yielded better effects on the tested fungi compared with the effects of all studied extracts on Candida albicans. Conclusions: Propolis extract is effective in controlling Candida albicans. However, the issue requires further investigation on samples in animals and performing toxicological examinations.     

Shen-Fu Injection(参附注射液) Alleviates Post-resuscitation Myocardial Dysfunction by Up-regulating Expression of Sarcoplasmic Reticulum Ca2~+ -ATPase

Objective: To compare the effect of Shen-Fu Injection(SFI) and epinephrine on the expression of sarcoplasmic reticulum Ca2~+ ATPase 2a(SERCA2a) in a pig model with post-resuscitation myocardial dysfunction. Methods: Ventricular fibrillation(VF) was electrically induced in Wu-zhi-shan miniature pigs. After 8 min of untreated VF and 2 min of cardiopulmonary resuscitation(CPR), all animals were randomly administered a bolus injection of saline placebo(SA group, n=10), SFI(0.8 mg/kg, SFI group, n=10) or epinephrine(20 μg/kg, EPI group, n=10). After 4 min of CPR, a 100-J shock was delivered. If the defibrillation attempt failed to attain restoration of spontaneous circulation(ROSC), manual chest compressions were rapidly resumed for a further 2 min followed by a second defibrillation attempt. Hemodynamic variables were recorded, and plasma concentrations of catecholamines were measured. Adenylate cyclase(AC), cyclic adenosine monophosphate(c AMP) and the expressions of β1-adrenoceptor(AR) and SERCA 2a were determined. Results: Cardiac output, left ventricular dp/dt_(max) and negative dp/dt_(max) were significantly higher in the SFI group than in the SA and EPI groups at 4 and 6 h after ROSC. The expression of β1-AR and SERCA2 a at 24 h after ROSC were significantly higher in the SFI group than in the SA and EPI groups(P0.05 or P0.01). Conclusions: The administration of epinephrine during CPR decreased the expression of SERCA2 a and aggravated postresuscitation myocardial function(P0.01). SFI attenuated post-resuscitation myocardial dysfunction, and the mechanism might be related to the up-regulation of SERCA2 a expression.     

Protective Effect of Hydroxysafflor Yellow A on Bleomycin-Induced Pulmonary Inflammation and Fibrosis in Rats

Objective: To observe the effect of hydroxysafflor yellow A(HSYA), an active ingredient of a traditional Chinese herbal medicine Carthamus tinctorius L., on lung inflammation and pulmonary fibrosis induced by bleomycin(BLM) in rats. Methods: Animals were divided into 6 groups including normal group, model group, three HSYA groups and dexamethasone(DXM) group. Three doses of HSYA(35.6, 53.3, and 80.0 mg·kg~(–1)·day~(–1)) were intraperitoneally(i.p.) injected in rats for 3 weeks after BLM administration and DXM was used as the positive control(n=8 or 12). Arterial blood gas was assayed and morphological changes were observed. Lung mRNA expressions of tumor necrosis factor(TNF)-α, interleukin(IL)-1β, IL-6 and some cytokines in lung tissue were detected by real-time polymerase chain reaction. Nuclear factor-κB p65 or α-smooth muscle actin(α-SMA) protein distribution in rat lung tissue was observed by immunohistochemistry. Results: On the 7 th day after BLM administration, lung tissue showed serious inflammation. Treatment with HSYA or DXM ameliorated lung inflammation. After treatment with HSYA or DXM, oxygen partial pressure(PaO_2) increased(HSYA 80.0 mg·kg~(–1), P0.01) and CO_2 partial pressure(PaCO_2) decreased(HSYA 53.3, 80.0 mg·kg~(–1), P0.05). Moreover, the mRNA expression of TNF-α, IL-1β, and IL-6; and the number of NF-κB p65 positive cells was lower in HSYA 53.3 and 80.0 mg·kg~(–1) groups than those in the model group(all P0.05). Twenty-one days after BLM administration, HSYA or DXM treatment ameliorated fibrosis, increased PaO_2(HSYA 53.3, 80.0 mg·kg~(–1), P0.01), and decreased PaCO_2(53.3 and 80.0 mg·kg~(–1), P0.05). Further, the mRNA expression of TGF-β1, α-SMA, and collagen Ⅰ as well as the number of α-SMA positive cells increased in the model group and HSYA can attenuate these changes(53.3, 80.0 mg·kg~(–1), P0.05). Hematoxylin and eosin and Masson's trichrome staining indicated that the fibrosis and collagen deposition were ameliorated in HSYA groups(53.3, 80.0 mg·kg~(–1), P0.05). Conclusion: HSYA could alleviate acute lung inflammation and chronic pulmonary fibrosis induced by BLM in rats.     

Effects of Shenfu Injection (参附注射液) on Cerebral Metabolism in A Porcine Model of Cardiac Arrest

Objective:To investigate the effects of Shenfu Injection(参附注射液,SFI) on cerebral metabolism in a porcine model of cardiac arrest(CA).Methods:Thirty Wuzhishan minipigs were randomly assigned to the control group(n=6),epinephrine group(EP group,n=12) and SFI group(n=12).After8 min of untreated ventricular fibrillation(VF),pigs in the EP group or SFI group were administered with either EP(0.02 mg/kg) or SFI(1.0 mL/kg),respectively.After successful resuscitation,cerebrospinal fluid(CSF) levels of glucose,pyruvate,lactate,glutamate and glycerol were measured at 1,6,12 and 24 h after recover from spontaneous circulation(ROSC).In addition,neurologic deficit score(NDS) was calculated at 24 h after ROSC.Surviving pigs were killed at 24 h after ROSC,and the brain tissue was obtained for ultra-microstructure examination.Results:Compared with the EP group,CSF glucose and pyruvate levels were higher(all P0.01),and lactate levels were lower in the SFI group(P0.01).Meanwhile,CSF glutamate and glycerol levels in the SFI group were lower in comparison to the EP group(all P0.05).In addition,SFI decreased NDS at 24 h after ROSC(P0.01),and alleviated the histopathological damage of the brain.Conclusions:SFI could alleviate brain injury after CA,which may be associated with improving cerebral metabolism.     

Effect of Health Education Based on Integrative Therapy of Chinese and Western Medicine for Adult Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Study

Objective: To investigate the effects of health education based on integrative therapy of Chinese and Western medicine for type 2 diabetes mellitus(T2DM) from the aspects of knowledge, attitude and practice(KAP), health-related quality of life(HRQo L), body mass index(BMI) and glucose control. Methods: Patients were individually randomized into intervention group(receiving integrative education, n=120) and control group(receiving usual education, n=120). The primary outcome was the changes in glycosylated hemoglobin A1c(HbA1c) levels after 3, 6, 9 and 12 months from baseline. Hierarchical linear models(HLMs) were used to assess within-group changes in outcomes over time and between-group differences in patterns of change. Secondary outcomes were KAP scores, HRQo L scores and BMI after 6 and 12 months, paired-sample t test was used to assess within-group changes in outcomes in 6 and 12 months, independent-sample t test was used to assess between-group differences in patterns of change. Results: HbA1c decreased statistically from baseline to 3 months, from 3 to 6 months, from 6 to 9 months and from 9 to 12 months in the intervention group(all P0.01); and decreased significantly from baseline to 3 months, and from 3 to 6 months in the control group(P0.01). There were significant between-group differences from baseline to 3 months(P=0.044), from 6 to 9 months(P0.01) and from 9 to 12 months(P0.01). Significant improvements in the intervention group along with significant between-group differences were found in KAP and HRQo L scores respectively(all P0.05). The number in the intervention group of normal weight increased from 56 at baseline to 81(6 months), 94(12 months), the number in the control group were 63(baseline), 69(6 months), 70(12 months), the χ~2 of hierarchical analysis of BMI were 6.93(P=0.075), 10.31(P=0.016), 15.53(P0.01), respectively. Conclusion: Health education based on integrative therapy of Chinese and Western medicine is beneficial to the control of T2DM and should be recommended for T2DM.     

Efficacy of Xuebijing Injection (血必净注射液) on Cardiopulmonary Bypass-Associated Pulmonary Injury: A Prospective, Single-center, Double Blinded, Randomized Controlled Trial

Objective: To evaluate the efficacy of Xuebijing Injection (血必净注射液, XBJ) on the lung injury induced by cardiopulmonary bypass (CPB). Methods: Fifty patients undergoing CPB were randomized to either the saline group or XBJ group according to a random number table (25 cases in each group). The patients in the saline group received saline and patients in XBJ group received XBJ at 12 h prior to the operation, at the beginning of the operation, and at 12 h after the second injection. The PaO2/FiO2 at extubation 3 days post-operation, duration of ventilation in the intensive care unit (ICU), and lengths of stay in the ICU and hospital were recorded. The levels of inflammatory mediators including interleukin (IL)-1β, IL-8, IL-10, and C-reactive protein (CRP) in bronchoalveolar lavage fluid (BALF) and plasma were measured. The neutrophil count and elastase neutrophil elastase in BALF were also measured. In addition, adverse events were monitored. Results: The PaO2/FiO2 in the XBJ group was higher than that in the saline group from 12 to 72 h post-operation (all P<0.05). The blood levels of IL-1β, IL-8, and CRP in the XBJ group from 12 to 72 h were all significantly lower than those in the saline group (all P<0.05). In contrast, the level of the anti-inflammatory cytokine IL-10 was significantly higher in the XBJ group than in the saline group (P<0.05). In addition, 4 patients presented with atelectasis in the saline group and none in the XBJ group. Ten patients experienced mild acute respiratory distress syndrome (ARDS) during hospitalization, and 5 patients with mild ARDS were in the XBJ group (P<0.05). Conclusion: XBJ shows protective potential against lung injury in patients who undergo CPB surgery, possibly through the downregulation of inflammatory mediators, reduction in neutrophil infiltration, and upregulation of IL-10 (Trial registry: ChiCTR-TRC-14004628).     

Hot Compress with Chinese Herbal Salt Packets Reducing PICC Catheter Complications: A Randomized Controlled Trial

Objective: To explore the preventive effect of applying hot compress with Chinese herbal salt packets(CHSP) to puncture vessels under aseptic conditions during peripherally inserted central catheter(PICC) on postoperative phlebitis. Methods: A total of 720 hospitalized patients undergoing first PICC were assigned to treatment and control groups(360 cases each group) according to a random number table. The control group received conventional catheterization and nursing care. The treatment group was first given hot compress with CHSP(which consisted of honeysuckle 30 g, Semen brassicae 30 g, Salvia miltiorrhiza 30 g, Angelica dahurica 30 g, Semen raphani 30 g, Evodia rutaecarpa 30 g, and coarse salt 20 g) on the punctured vessel under aseptic conditions for 5–10 min before conventional catheterization. The main efficacy indices were the vessel diameters before and during catheterization and the success rate of a single catheter, and the secondary efficacy indiex was the incidence of superficial phlebitis within 1 week after catheterization. Results: The vessel diameter during catheterization of the treatment group was remarkably increased compared with the control group [(7.96±0.42) mm vs.(4.39±0.54) mm, P0.01]. The success rate of the single catheter of the treatment group was significantly higher than that of the control group [94.00%(329/350) vs. 73.72%(244/329), P0.01]. The incidence of superficial phlebitis within 1 week after catheterization in the treatment group was lower than that in the control group(P=0.007). There was no adverse event with CHSP. Conclusion: Hot compress with CHSP during PICC is applicable as it can effectively improve the success rate of a single catheter and reduce the incidence of superficial phlebitis after catheterization(Trial registration No. ChiCTR-ONC-17010498).     

Gefitinib plus Fuzheng Kang'ai Formula(扶正抗癌方) in Patients with Advanced Non-Small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation:A Randomized Controlled Trial

Objective: To evaluate the effect of Fuzheng Kang'ai Formula(扶正抗癌方, FZKA) plus gefitinib in patients with advanced non-small cell lung cancer with epidermal growth factor receptor(EGFR) mutations. Methods: A randomized controlled trial was conducted from 2009 to 2012 in South China. Seventy chemotherapynaive patients diagnosed with stage ⅢB/Ⅳ non-small cell lung cancer with EGFR mutations were randomly assigned to GF group [gefitinib(250 mg/day orally) plus FZKA(250 m L, twice per day, orally); 35 cases] or G group(gefitinib 250 mg/day orally; 35 cases) according to the random number table and received treatment until progression of the disease, or development of unacceptable toxicities. The primary endpoint [progression-free survival(PFS)] and secondary endpoints [median survival time(MST), objective response rate(ORR), disease control rate(DCR) and safety] were observed. Results: No patient was excluded after randomization. GF group had significantly longer PFS and MST compared with the G group, with median PFS of 12.5 months(95% CI 3.30–21.69) vs. 8.4 months(95% CI 6.30–10.50; log-rank P0.01), MST of 21.5 months(95% CI 17.28–25.73) vs. 18.3 months(95% CI 17.97–18.63; log-rank P0.01). ORR and DCR in GF group and G group were 65.7% vs. 57.1%, 94.3% vs. 80.0%, respectively(P0.05). The most common toxic effects in the GF group and G group were rash or acne(42.8% vs. 57.1%, P0.05), diarrhea(11.5% vs. 31.4%, P0.05), and stomatitis(2.9% vs. 8.7%, P0.05). Conclusion: Patients with advanced non-small cell lung cancer selected by EGFR mutations have longer PFS, MST with less toxicity treated with gefitinib plus FZKA than gefitinib alone.     

Effect of Kuanxiong Aerosol(宽胸气雾剂)on Patients with Angina Pectoris:A Non-inferiority Multi-center Randomized Controlled Trial

Objective: To evaluate the effect and safety of Kuanxiong Aerosol(宽胸气雾剂, KA) on patients with angina pectoris. Methods: Block randomization was performed to randomly allocate 750 patients into KA(376 cases) and control groups(374 cases). During an angina attack, the KA group received 3 consecutive sublingual sprays of KA(0.6 m L per spray). The control group received 1 sublingual nitroglycerin tablet(NT, 0.5 mg/tablet). Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment(1, 2, 3, 4, 5, and 5 min). Logistic regression analysis was performed to observe the factors influencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society(CCS) classes of angina. Results: The 5-min remission rates in the KA and control groups were not significantly different(94.41% vs. 90.64%, P0.05). The angina CCS class significantly influenced the rate of remission (95% confidence interval = 0.483–0.740, P0.01). In the CCS subgroup analysis, the 3-and 5-min remission rates for KA and NT were similar in the CCSⅠ and Ⅳ subgroups(P0.05), while they were significantly better for KA in the CCSⅡ and Ⅲ subgroups(P0.05 or P0.01). Furthermore, the incidence of adverse reactions was significantly lower in the KA group than in the control group for the CCSⅡ and Ⅲ subgroups(9.29% vs. 26.22%, 10.13% vs. 20.88%, P0.05 or P0.01). Conclusions: KA is not inferior to NT in the remission of angina. Furthermore, in CCSⅡ and Ⅲ patients, KA is superior to NT, with a lower incidence of adverse reactions.