ObjectiveTo evaluate the clinical efficacy and safety of Xiaozhen Formula （消疹方） in preventing skin toxicity induced by epidermal growth factor receptor inhibitors （EGFRIs） in patients with EGFR-mutant non-small cell lung cancer （NSCLC）. MethodsA randomized， double-blind， placebo-controlled， multicenter clinical study was conducted. A total of 120 patients with EGFR-mutant NSCLC from seven centers were enrolled and randomly assigned to a treatment group （60 cases） or a control group （60 cases）. On the basis of EGFRI-targeted therapy， patients in the treatment group received Xiaozhen Formula granules， whereas those in the control group received Xiaozhen Formula placebo granules， both at 10 g twice daily for 4 consecutive weeks. The primary outcomes were the grading of skin toxicity evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events （NCI-CTCAE） version 5.0 and the incidence of rash. Secondary outcomes included the time to onset and time to resolution of the highest-grade rash， the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 （EORTC QLQ-C30） scores， the Hospital Anxiety and Depression Scale （HADS） scores， and disease control rate， together with safety assessments. ResultsBased on the full analysis set （FAS）， the incidence of skin toxicity in the treatment group was 18.33% （11/60）， significantly lower than 45.00% （27/60） in the control group （P＜0.01）， with the highest severity of skin toxicity in both groups was grade 2. Among patients who developed rash， the resolution rate in the treatment group was 90.91% （10/11）， higher than that 33.33% （9/27） in the control group. The median time to resolution was 15 days （95%CI： 8-17 days） in the treatment group and it was not reached in the control group； the distribution of time to resolution differed significantly between groups （P＜0.001）. After treatment， the treatment group had higher EORTC QLQ-C30 functional scale and global health status/quality-of-life scores， and lower symptom scale， single-item scores， as well as HADS-A， and HADS-D scores than the control group （P＜0.05）. In the FAS analysis， the disease control rate （DCR） was 85.0% （51/60） in the treatment group， lower than 100.0% （60/60） in the control group （P=0.003）， whereas no significant between-group difference was observed in the per-protocol set （PPS） analysis （P=0.464）. The incidence of adverse events did not differ significantly between the two groups （P＞0.05）， and no definite safety signals related to the investigational drug were observed. ConclusionXiaozhen Formula can reduce the incidence of EGFRI-induced skin toxicity， and improve the outcome of rash regression， the patients' quality of life and psychological status in EGFR-mutant NSCLC patients.

ObjectiveTo investigate the acute effects of compound air pollution on children’s respiratory function. MethodsUsing panel group study design， 223 students in five classes of grade 4 from two primary schools （a， b） in Xuhui and Hongkou districts of Shanghai were randomly selected to measure pulmonary function and exhaled nitric oxide （FeNO）. The first three tests were carried out from May to June in 2020， and the fourth test was carried out from September to December in 2021. At the same time， the daily and hourly mean values of PM_2.5， PM₁₀， SO₂， NO₂， O₃ and CO was collected from the nearby air quality monitoring points of the two schools during the same period ， as well as meteorological monitoring data （temperature， humidity， wind speed and atmospheric pressure）. The linear mixed effect model was used to analyze the effects of air pollution on pulmonary function and respiratory inflammation in the summer. ResultsThe results of single pollutant model showed that PM_2.5， PM_10， SO₂ and NO₂ were positively correlated with FeNO， and the effect was reflected in lag0， lag1 and lag3 （P<0.05）. PM_2.5， PM₁₀ and NO₂ were negatively correlated with the changes of lung function FEF_25%， FEF_50%， FEF_75%， FeF_25%-75%， PEF， FVC， FEV1 and FEV1/FVC， and the effect was reflected in lag0 to lag3 days （P<0.05）. The results of the dual pollutant model showed that the concentration changes of SO₂ and NO₂ were significantly correlated with the decrease of FEV1 when combined with O₃ or PM_2.5 （P<0.01）， and the concentration changes of PM_2.5 was significantly correlated with the increase of FeNO when O₃， SO₂ and NO₂ were combined respectively （P<0.01）. The effects of the dual pollutant model were greater than the effect of PM_2.5 single pollutant model. ConclusionThe health effects of different air pollutants on children’s respiratory tract function indexes in summer are different. The combined effects of two pollutants on the lung function of children increased to different degrees. Although air pollution is light in summer， it still has an impact on children’s respiratory tract function index and inflammation index， and the combined effect of dual pollutants is more significant than that of single pollutant.

Proximal gastrectomy, the surgical treatment of gastric upper adenocarcinoma or early esophagogastric junction adenocarcinoma, has received more and more attention. However, pathophysiological changes after proximal gastrectomy lead to a high risk of severe gastroesophageal reflux or reflux esophagitis, such as loss of mechanical anti-regurgitation barrier and receptive relaxation, decrease of peristalsis of remnant, incoordinate contraction, pylorus spasm, which limit its widespread use. Dozens of digestive tract reconstruction methods with different anti-reflux design have been reported in recent years. These strategies could be divided into 3 categories: buffer zone method, reconstruction of mechanical anti-regurgitation barrier, speeding up gastric emptying. The authors analyze the pathophysiological changes related with gastroesophageal reflux after proximal gastrectomy from the perspective of anatomy and phy-siology, summarize the advantages and disadvantages of anti-regurgitation methods, and look forward to the development trends in the future.

Objective To compare the outcome of combined and staged approach on concomitant carotid and coronary severe stenosis.Methods From March 2013 to May 2015,27 patients with concomitant carotid and coronary severe stenosis were treated by carotid endarterectomy and coronary artery bypass grafting,15 cases received one-stage operation and 12 staged.The basic characteristics,details during surgery,complications,quality of life score,hospital stay and cost were compared.Results 27 patients received carotid endarterectomy and off-pump coronary artery bypass grafting under general anesthesia.Revascularization were performed on 27 carotid and 82 coronary artery.The characteristics of patients were similar between two groups,reflected with WIC,combined approach subgroup was (5.27 ± 0.88) and staged subgroup was (4.92 ± 1.24).The operation time was significantly decreased in the synchronous group [(295.33 ± 49.73)min vs (390.83 ± 73.45) min,P ＜ 0.001].Hospital stay days was also reduced [(30.20 ± 12.91) days vs(44.67 ± 6.34) days,P =0.002],the medical cost was lower in combined approach group,but no significant statistical difference.The complications including 1 case TIA,1 recurrent nerve injury in one-stage group and 1 case myocardial infarction,1 mediastinal bleeding post-operation and 1 pulmonary infection in stage group.No cerebral infarction and death.Quality of life scores(SF-36) of the two groups was 5.53 ± 1.30 and 5.75 ± 1.36 respectively,no significant difference.Conclusion The efficacy and safety of treatment for concomitant carotid and coronary severe stenosis patients with combined or staged approach was similar.But the combined approach program can reduce the hospital stay time and cost in some degree.

BACKGROUND:No uniform standard for constructing the animal model of exercise-induced myocardial ischemia injury results in the incomparability among research results and impedes the development of sport medicine especial y in the cardiovascular field;thereby, it is imperative to reach an agreement in constructing criteria.
OBJECTIVE:To explore the method of establishing the rat model of myocardial ischemia induced by running.
METHODS:Total y 96 female Sprague-Dawley rats were randomly divided into rest control group, isoprenaline group and 10 exercise groups (1-and 3-time moderate-intensity exercise groups, 1-, 2-and 3-week moderate-intensity exercise groups, 1-and 3-time high-intensity exercise groups, 1-, 2-and 3-week high-intensity exercise groups). After exhaustive exercise, myocardium was col ected for morphological observation by hematoxylin-eosin staining, serum levels of myocardial enzymes and cardiac troponin I were detected, and the expressions of Bcl-2 and Bax were detected by real-time PCR.
RESULTS AND CONCLUSION:(1) Hematoxylin-eosin staining showed that the damage degree was more severe with the time of exercise, and the high-intensity exercise groups were more severe than those in the moderate-intensity exercise groups. (2) The activity of serum glutamic-oxaloacetic transaminase and lactic dehydrogenase was significantly increased after 1-week moderate-intensity exhaustive exercise (P<0.05 or P<0.01). From the beginning of the 3-time high-intensity exhaustive exercise, the activity of glutamic-oxaloacetic transaminase and lactic dehydrogenase was significantly increased (P<0.05 or P<0.01). (3) Cardiac troponin I content change trend was basical y the same as glutamic-oxaloacetic transaminase and lactic dehydrogenase changes, but cardiac troponin I content in the moderate-intensity exhaustive exercise groups was significantly higher than that in the rest control group until 2 weeks. The Bcl-2/Bax ratios in al exercise groups were significantly lower than that in the rest control group (P<0.05 or P<0.01);those in the 1-and 3-time high-intensity exercise groups were significantly higher than in the isoprenaline group (P<0.05 or P<0.01);and those in moderate-intensity groups were higher than in the isoprenaline group (P<0.05 or P<0.01). (4) In conclusion, 2-week high-intensity and 3-week moderate-intensity exhaustive exercise can induce myocardial ischemia injury, and pathological analysis, serum levels of myocardial enzymes and cardiac troponin I can be used as the evaluation indexes, while apoptosis regulation genes just as the reference index.

Laparoscopic surgery develops fast in China in recent years,and it is widely applied in different fields in the digestive surgery and satisfactory results are achieved.However,uniformed training,technique standard and quality control standard are missing in the education of laparoscopic surgery in China.Fundamentals of laparoscopic surgery (FLS) program is developed by the Society of American Gastrointestinal and Endoscopic Surgeons in 2004.It is composed of congenital assessment and manual skills assessment.Twelve surgeons from China have taken FLS examination in April of 2014,and they introduced the content,features of FLS examination,some thoughts and inspirations on the training of laparoscopic surgery in China in this article.

Objective To investigate the predictive value of cardiovascular risk factors in coronary atherosclerotic heart disease.Methods A total of 400 patients who underwent coronary angiography (CAG) in our hospital was divided into multiple vascular lesion group,single vascular lesions group,and non-CAD group according to the result of CAG and their clinical data were analyzed retrospectively.The correlation between cardiovascular risk factors and coronary artery lesions was analyzed,and the independent risk factor of CAD was screened by multi-factorial logistic regression analysis.Results There was significant difference in total cholesterol (TC),triglycerides (TG),high density lipoprotein cholesterol (HDLC),fasting blood glucose (FBG),inflammatory cells,carotid artery plaque,brachial-ankle pulse wave velocity (baPWV),high-sensitivity C-reactive protein (Hs-CRP) between the CAD group and the non-CAD group (P ＜ 0.05 or P ＜ 0.01).The number of coronary artery lesion branch was increased significantly when risk factors,such as age,body mass index(BMI),hypertension,diabetes mellitas,smoking,carotid artery plaque,TG,TC,low density lipoprotein cholesterol (LDL-C),FBG,WBC,monocytes (M),neutrophils (N),neutrophils/lymphocytes (N/L),baPWV,and Hs-CRP.Other risk factors including TC,HDL-C,L were decreased with a statistically significant difference (P ＜ 0.05).There was no significant relation among,and left ventricular ejection fraction (LVEF)％.The most significant risk factor was carotid artery plaque that was independently associated with coronary heart disease (b =1.264,P ＜ 0.01),followed by smoking (b =1.204,P ＜0.01),HDL-C (b =1.104,P ＜0.01),TC (b =1.082,P ＜0.01) diabetes mellitus (b =0.956,P ＜0.01),baPWV increased (b =0.741,P ＜0.01),WBC (b=0.721,P ＜0.01),hypertension (b =0.602,P ＜0.01),the age (b =0.538,P ＜0.01),and HsCRP(b =0.421,P ＜ 0.01).Conclusions The results suggest that the hypertension,hyperlipidemia,smoking,age,baPWV,inflammatory cells,Hs-CRP,and carotid artery plaque was a significant independent CHD risk factors.

Objective To evaluate a therapeutic strategy using aromatase inhibitors and TAM in postmenopausal Luminal B breast cancer patients. Methods The clinical data of 733 primary breast cancer cases receiving postoperative endocrine thempy from July 2002 to Mar 2005 in Tianjin Cancer Hospital were retrospectively analyzed.Diagnosis was confirmed by pathology in all the cases.All patients were post-menopausal and ER-positive.501 patients were given tamoxifen(TAM 2.5 mg qd,po),232 patients were given aromatase inhibitors(Letrozole 10 mg bid,po).The follow-up time ranged from 36 to 90 months.Median follow-up time was 46 months.Results The disease-free-survival(DFS)rate of Luminal B breast cancer patients in aromatase inhibitors(AIS)group was higherthan that in TAM group(90.6% vs.88.6%,P=0.038).In TAM group,subgroup analysis showed 3-year DFS of node-positive with HER2(+)is lower than that of node-positive with Her-2-negative(88.2% vs.90.4%,P=0.037);3-year DFS of ER+/PR+ group in HER2(+) patients was higher than that of ER+/PR-group(90.8% vs.89.5%.P=0.032).In AIs group,in spite of the axillary lymph node status,there was no significant difference of 3-year DFS between HER2(+)patients and HER2(-)ones(P>0.05).3-year DFS of ER+/PR+with HER2(+) patients was higher than that of ER+/PR-ones with HER2(+)(91.9% vs.90.5%,P=0.029).Hot flush,vaginal bleeding and thromboembolics in AIS group is less frequent,but muscle pain and bone fracture is more common than that in TAM group(P<0.05).Conclusion Compared to TAM, AIs is more effective and safer with postmenopausal Luminal B patients,and the effect is independent on node stams.

Objective To compare the clinical results of endovenous laser treatment(EVLT),radiofrequency endovenous occlusion(RFO)and conventional stripping combined with transilluminated powered phlebectomy(TIPP)for lower extremity varicose vein.Methods From Jun 2004 to Jan 2007,200 cases(232 limbs)were treated by EVLT with TIPP,80 cases(88 limbs)by RFO with TIPP,and 180 cases(202 limbs)by conventional stripping with TIPP.Operation time,number of the incision made,intraoperative bleeding,postoperative hospital stay,complications,and one-year recurrence rate were compared with each other. Results Operation time was longer(41±8)min in RFO group than that in other two groups.Postoperative hospital stay was shorter in EVLT group(1.2±0.4 d)and RFO group (2.1±0.8 d)than that in stripping and TIPP group(P＜0.05).Patients in stripping group also suffered from more intra-operative bleeding more often incidental nervus saphenus injury and more incision numbers when compared with other two groups(P＜0.05).There was no significant difierence in one-year recurrence rate among patients in the three groups. Conclusions The clinical efficacy is almost the same among the three groups in terms of eradication of the varicose veins.EVLT and RFO are safe and minimal invasive for the treatment of lower extremity varicose vein.

Objective To explore the effects of estrogen,sport walking with weight and estrogen plus sport walk on serum lipid,bone metabolism and bone mineral density(BMD) in postmenopausal women.Methods 52 postmenopausal women were divided into the hormone replacement therapy(HRT) group(n=12),sport walking with weight group(Sp group,n=14),HRT + Sp group(n=12) and control group(n=14).HRT group took compound nylestriol,Sp group took sport walking with 5 kg weight and exercise intensity was from 60% to 80% VO2max,HRT+Sp group received two treatments as HRT group and Sp group.The experimental duration consisted of six months.Results The total cholesterol(TC),TC/high density lipoprotein cholesterol(HDL-C),alkaline phosphatase(APL) and urine calcium(Ca)/creatinine(Cr) were markedly lower in three experimental groups than the control group and before experiment(P<0.05 or P<0.01),HDL-C in Sp and HRT+Sp groups were markedly higher than the control group and before experiment(P<0.05),BMD of spine(L2～L4) and left trochanter in three experimental groups were markedly higher than the control group(P<0.01) and before experiment(P<0.0).Conclusion Both estrogen replacement therapy and sport walking with weight effectively improve serum lipid,prevent and reverse osteoporosis induced by menopause in women.