OBJECTIVE: To evaluate the efficacy and safety of Chinese medicine (CM) improving pregnancy outcomes after surgery for endometriosis-associated infertility. METHODS: A multicenter, randomized, double-blind placebo parallel controlled clinical trial was designed. A total of 202 patients who had laparoscopy for endometriosis-associated infertility with qi stagnation and blood stasis syndrome were included and randomly divided into the CM treatment group and placebo control group at a ratio of 1:1 using a central block randomization from May 2014 to September 2017, 101 patients in each group. The two groups received continuous intervention at 1-5 days after surgery, for 6 menstrual cycles. Before ovulation, the CM group was treated Huoxue Xiaoyi Granule (); after ovulation, Bushen Zhuyun Granule ( was involved. The control group was treated with placebo. Transvaginal ultrasonography was performed every menstrual cycle during the treatment, and female hormone levels in the follicular and luteal phases were measured during the 1st, 3rd and 6th menstrual cycles. The analysis was continued until pregnancy. The primary outcomes were clinical pregnancy rate and pregnancy outcome, and the secondary outcomes were follicular development and endometrial receptivity. Safety evaluations were performed before and after treatment. RESULTS: (1) Clinical pregnancy and live birth rates: the clinical pregnancy and live birth rates of the CM group were significantly higher than those of the placebo group [44.6% (45/101) vs. 29.7% (30/101), 34.7% (35/101) vs. 20.8% (21/101), both P<0.05]. (2) Follicle development: the incidence of dominant follicles, rate of cumulative cycle ovulation, and rate of cumulative cycle mature follicle ovulation were significantly higher in the CM group than those in the placebo group [93.8% (350/373) vs. 89.5% (341/381), 80.4% (275/342) vs. 69.1% (253/366), 65.8% (181/275) vs 56.1% (142/253), P<0.05 or P<0.01]). The incidence of cumulative cycle luteinized unruptured follicle syndrome was significantly lower in the CM group than in the placebo group [11.7% (40/342) vs. 17.8% (65/366), P<0.05). (3) Endometrial receptivity: after treatment, both endometrial types and endometrial blood flow types in the CM group were mainly types A and B, while those in the placebo group were mainly types B and C, with a significant difference between the two groups (both P<0.05). (4) Adverse events: the incidence of adverse events between the two groups was not significantly different (P>0.05). CONCLUSION Strategies for activating blood circulation-regulating Gan (Liver)-tonifying Shen (Kidney) sequential therapy can effectively improve the clinical pregnancy rate and live birth rate of endometriosis-associated infertility with qi stagnation and blood stasis after laparoscopy, improve follicular development, promote ovulation, improve endometrial receptivity, while being a safe treatment option. (Trial registration No. NCT02676713).

OBJECTIVE: To investigate the efficacy and safety of arsenic trioxide combined with ATRA and chemo- therapy for treatment of relapsed acute promyelocytic leukemia (APL) patients. METHODS: The clinic data of 25 patients with relapse APL treated in our hospital from 1996 to 2013 were collected and analyzed. Among the 25 patients, 15 patients suffered first-time hematological relapse (HR), and the other 10 patients showed first-time molecular relapse (MR). The patients with first-time replase were treated with ATO+ATRA+Anthracycline re-induction chemotherapy. The clinical features, complete remission (CR) rate, overall survival (OS), disease-free survival (DFS) and adverse events after re-induction therapy were analyzed. RESULTS: Fourteen of 15 hematological relapsed patients achieved the second-time hematological complete remission (CR2) after re-induction therapy except one patient died of bleeding complication during the re-induction. 8 of 14 patient showed molecular complete remission (CRm) after two cycles of therapy with this regimen. Totally, eleven out of the 14 HR patients were alive without disease till the last follow-up, and 3 of the 14 HR patients died because of bleeding complications. All of the 10 molecular relapsed patients received the second CRm after treated by the regimen. Among these 10 patients, 6 patients suffered only once relapse and continued with the molecular CR2 status, and for the other 4 patients with more than two-relapses, only 1 survived untill 89.3 months after achieved second-time CRm, and other 3 patients died because of bleeding complications. CONCLUSION For relapsed APL patients, the treatment with ATO+ATRA+chemotherapy regimen after relapse still shows encouraging efficacy, no matter whether or not the application of ATO in the previous regimens. In addition, patients with more than two molecular relapses show a poor prognosis.

BACKGROUND: Early investigation suggested patients' level of awareness regarding clinical trials was related with willingness to participation. This study was intended to evaluate the level of awareness of cancer patients regarding clinical trials and related influencing factors, and to compare the differences of awareness between patients who attended clinical trials before and not. METHODS: From Jun, 2018 to April, 2019, standardized question-naires were gathered from cancer patients (attended clinical trials vs not attended clinical trials) in our hospital regarding basic information and 10 other questions about awareness. The level of awareness was evaluated and patients were classified into "low cognition" and "high cognition" groups. Logistic regression analysis was performed to determine whether certain characteristics would predict for awareness. RESULTS: Of the 617 participants, 38.6% have attended clinical trials before. 338 (54.6%) patients had a correct overall understanding of clinical trials, while 44 (7.1%) patients still thought participants were the victim of scientific research. Except for the compensation of medical expenses (51.5% vs 48.7%) and related laws of clinical trials (52.3% vs 45.5%), other parts of understanding were elevated in patients attended clinical trials before comparing with patients who didn't, including significance (86.2% vs 77.6%), risk disclosure (91.2% vs 71.6%), confidentiality (73.2% vs 59.7%), voluntariness (95.8% vs 76.3%), withdrawal (86.6% vs 68.2%) and expenses (62.8% vs 39.2%). The proportion of participants who understand these components did not increase even in 239 patients who had attended clinical trials before. Participants who attended clinical trials before (OR=1.83, 95%CI: 1.11-3.00), unmarried/divorced (OR=5.04, 95%CI: 1.73-14.66), retired (OR=2.53, 95%CI: 1.16-5.50) had a higher level of awareness, while patients who had bad impression with doctors (OR=0.43, 95%CI: 0.26-0.72) had lower awareness. CONCLUSIONS The current level of awareness for clinical trials of cancer patients in our hospital was relatively low, even in patients who had attended clinical trials before. It's necessary to improve patients' awareness of clinical trial by promoting harmony relationship between patients and doctors, as well as by enhancing related propagation. Strengthening the adequacy and efficacy of informed consent in clinical trials also needs to be achieved in the future.

The current document is based on a consensus reached by a panel of experts from the Chinese Society of Allergy and the Chinese Society of Otorhinolaryngology-Head and Neck Surgery, Rhinology Group. Chronic rhinosinusitis (CRS) affects approximately 8% of Chinese adults. The inflammatory and remodeling mechanisms of CRS in the Chinese population differ from those observed in the populations of European descent. Recently, precision medicine has been used to treat inflammation by targeting key biomarkers that are involved in the process. However, there are no CRS guidelines or a consensus available from China that can be shared with the international academia. The guidelines presented in this paper cover the epidemiology, economic burden, genetics and epigenetics, mechanisms, phenotypes and endotypes, diagnosis and differential diagnosis, management, and the current status of CRS in China. These guidelines—with a focus on China—will improve the abilities of clinical and medical staff during the treatment of CRS. Additionally, they will help international agencies in improving the verification of CRS endotypes, mapping of eosinophilic shifts, the identification of suitable biomarkers for endotyping, and predicting responses to therapies. In conclusion, these guidelines will help select therapies, such as pharmacotherapy, surgical approaches and innovative biotherapeutics, which are tailored to each of the individual CRS endotypes.
Adult ; Asian Continental Ancestry Group ; Biomarkers ; China ; Consensus ; Diagnosis ; Diagnosis, Differential ; Drug Therapy ; Eosinophils ; Epidemiology ; Epigenomics ; Genetics ; Humans ; Hypersensitivity ; Inflammation ; International Agencies ; Medical Staff ; Neck ; Phenotype ; Precision Medicine

Objective To evaluate the effect of serum chromium on oral cancer after adjusting the covarite between groups based on propensity score matching (PSM). Methods We performed a case-control study in 395 cases of newly diagnosed primary oral cancer from the First Affiliated Hospital of Fujian Medical University and 1 240 controls from the same community from January 2010 to February 2018. Using the PSM to select 309 controls randomly which were matched with the cases by 1 ∶1 matching. Conditional Logistic regression model was used to explore the association between chromium and oral cancer. Results The level of serum chromium was 178.91 (121.83-284.19) μg/L in the case group, which was lower than 324.27 (264.82-397.69) μg/L in control group, the difference was statistically significant (P＜0.001). Dose-response analysis showed that the risk of oral cancer gradually decreased with the increase of serum chromium, which presented a negative correlation. There was a negative correlation between serum chromium level and the risk for oral cancer by conditional Logistic regression,the aOR of serum chromium in the Q2, Q3 and Q4 compared with the Q1 were 0.14 (0.08-0.26), 0.15 (0.08-0.28) and 0.10 (0.05-0.20),with significant trend (Ptrend＜0.001). Stratified analysis showed the negative correlation between serum chromium and oral cancer by smoking, drinking tea, not drinking alcohol status and fish, fruits and green vegetables intake frequencies. Conclusions The high level of serum chromium is a protective factor for the incidence of oral cancer, and the higher of serum chromium, the lower risk of developing oral cancer.

Objective: To study the role of alternative complement pathway overactivation in malignant nephrosclerosis. Methods: (1) Fifty patients with confirmed malignant nephrosclerosis by renal needle biopsy were enrolled. Meanwhile, twenty-five cases of time-zero renal needle biopsy were enrolled as control subjects. Enzyme linked immunosorbent assay (ELISA) was used to detect alternative complement pathway of the complement initiation factor B, positive regulation factor P, negative regulation factor H, and the complement end products C3a and C5a in the plasma and urine. (2) Immunohistochemistry was used to detect the deposition of the complement end product C5b-9, C4d and mannan binding lectin (MBL) of lectin pathway in the renal biopsies. Double immunofluorescence labeling method was used to assay the deposition of C5b-9 and CD34 (endothelial cell marker) in the arteriolar endothelium and glomerular capillary endothelium. Results: (1) The plasma and urine levels of complement factor B, factor P, C3a and C5a in malignant nephrosclerosis patients were significantly higher than those in control subjects (all P<0.05), while the plasma and urine levels of complement factor H in malignant nephrosclerosis patients were lower than those in control subjects (all P<0.05). (2) The plasma level of factor P was positively correlated with 24 h urine protein (r_s=0.465, P=0.001). Urinary factor B/urinary creatinine, urinary factor P/urinary creatinine and urinary C3a/urinary creatinine were positively correlated with serum creatinine in malignant nephrosclerosis patients (r_s=0.483, P<0.001; r_s=0.352, P=0.012; r_s=0.319, P=0.024), while urinary factor H/urinary creatinine was negatively correlated with serum creatinine and 24 h urine protein (r_s=-0.299, P=0.035; r_s=-0.342, P=0.015). Urinary C5a/urinary creatinine was positively correlated with serum creatinine and 24 h urine protein (r_s=0.525, P<0.001; r_s=0.496, P<0.001). (3) Immunohistochemical results showed that there were C5b-9 deposited in the arterioles and glomerular capillary wall in malignant nephrosclerosis patients, and no deposition in control renal tissues. Meanwhile, the semi-quantitative scores showed that C5b-9 deposition intensity was positively correlated with serum creatinine and 24 h urine protein (r_s=0.791, P<0.001; r_s=0.345, P=0.014). The double immunofluorescence labeling analysis showed that the C5b-9 and CD34 deposited in the arteriolar endothelium and glomerular capillary endothelium. (4) Plasma level of factor B in malignant nephrosclerosis patients was positively correlated with plasma C3a level (r=0.331, P=0.022). Plasma level of factor P was positively correlated with C5b-9 score (r_s=0.300, P=0.034). Urinary B was positively correlated with urinary C3a, C5a and C5b-9 score (r_s=0.311, P=0.028; r_s=0.465, P=0.001; r_s=0.428, P=0.002). Urinary factor P was also positively correlated with urinary C3a and C5a (r_s=0.307, P=0.030; r_s=0.442, P=0.001). Immunohistochemical result showed that there were C4d deposited in the arterioles and glomerular, and no deposition of MBL. Conclusion Complement activation via the alternative pathway may be involved in malignant nephrosclerosis and related to the severity of the disease.

Objective: To investigate the risk factors for susceptibility of abnormal liver function in patients with gout. Methods: A total of 5 044 cases of male gout patients in remission were selected and divided into normal liver function group with 3 693 patients and abnormal liver function group with 1 351 patients. The clinical information was collected and relevant biochemical indices were detected. Serum uric acid(SUA) was divided into quartiles, and its associations with elevated ALT were evaluated. Results: There were significant differences in the history of drinking, family history, combining with hyperlipidemia, fatty liver, and coronary heart disease between the abnormal liver function group and normal function group(P<0.05 or P<0.01). There were significant statistical differences in age, disease duration, body mass index, waist circumference, diastolic blood pressure, serum cholesterol and triglyceride, uric acid, and creatinine clearance rate between 2 groups(P<0.01), while without significant difference in history of smoking, regular exercise, combining hypertension and diabetes, the means of systolic blood pressure, and fasting blood glucose(all P>0.05). Further logistic regression analysis indicated that body mass, waist circumference, combining fatty liver, higher SUA level, higher cholesterol and triglyceride were risk factors of the early onset of abnormal liver function. ALT and the proportion of abnormal liver function were increased with the increase of UA. After adjustment for BMI, TG, TC and fatty liver, the ALT level and the proportion of abnormal liver function decreased significantly while still showed an upward trend. Conclusion Patients with obesity, high level of uric acid, high blood lipids and fatty liver were more likely to develop abnormal liver function, SUA was independently associated with elevated ALT.

Objective: To screen gene mutation information of gout pedigree through whole genome sequencing and to carry out preliminary analysis. Methods: One typical gout pedigree was selected as the study subjects. The clinical data and the peripheral blood samples were collected and constructed charts of the pedigree. DNAs were extracted from peripheral blood and analyzed by the whole genome sequencing, and by the software analysis and comparison, screening out the pathogenic genes and related mutations. Then the verifications were conducted in the family members and the controls. Bioinformatics software was applied to predict the effect of mutation on gene expression. Results: Based on the sequencing results, advanced informational analysis was performed to screen out the mutations 1040-8 A> G near the 5 ′end near the exon 8 of the PLAA gene. The results showed that all the gout patients in the family had 1040 -8 A> G sites, and none of the mutants were found in the non-gout group and 200 controls; bioinformatics analysis suggested that the mutation could affect PLAA gene expression, but not affecting PLAA mRNA structure. Conclusion PLAA gene 1040-8 A> G mutation is separated from patients in the gout pedigree, and the newly discovered PLAA gene may act as a gout pathogenic gene.

Objective: To explore the risk factors of deep venous thrombosis(DVT) in lower limbs of orthopedic inpatients, and provide reference for clinical nursing and prevention of thrombosis. Methods: A retrospective case-control approach was used in this study. A total of 148 orthopedic inpatients diagnosed with DVT in the First Affiliated Hospital of Soochow University from February 2014 to October 2018 were selected as the case group. At the same time, 148 orthopaedic inpatients with undiagnosed DVT in the same Department were randomly selected as the control group. The electronic medical history data and related laboratory examination indexes of the two groups of patients during hospitalization in Orthopedics Department were analyzed retrospectively. Gender, age, seven indicators of blood coagulation, as well as history of hypertension, diabetes, history of DVT and other common risk factors of DVT in the two groups were statistically analyzed. Results: In the case group, 63 patients (42.5%) DVT developed in the right lower extremity. The differences in the clinical symptoms and characteristics of fever, pulmonary infection, cough, expectoration, chest distress and shortness of breath, pleural effusion and constipation between the two groups were statistically significant (χ² value was 5.688-12.312, P<0.01 or 0.05). Single factor analysis of related risk factors showed the differences of age, type of injury, lower limb joint replacement, a plaster cast, hypertension, history of DVT, central venous catheter, D-dimer and preoperative albumin levels, fibrinogen degradation products, and red blood cell count between the two groups were statistically significant (t value was-7.275-3.998, χ² value was 4.889-13.305, Z value was-3.500--3.454, P < 0.01). Multivariate Logistic regression analysis showed that lower limb joint replacement(OR=0.383, 95%CI0.190-0.773), cough (OR=0.085, 95%CI0.010-0.731), chest distress and shortness of breath (OR=0.240, 95%CI0.077-0.745), constipation (OR=0.312, 95%CI0.135-0.718), red blood cell count (OR=3.314, 95%CI 2.105-5.216), hypertension (OR=0.534, 95%CI0.292-0.976) were independent risk factors for DVT formation in orthopedic inpatients (P<0.01 or 0.05). Conclusions DVT in orthopedic inpatients is a common result of multiple factors, among which, lower limb joint replacement, cough, chest distress and shortness of breath, constipation, red blood cell count and hypertension are independent risk factor, which should be monitored and given preventive care.

Objective To summary the risk factors,clinical characteristics and treatment of acute colonic pseudo-obstruction (ACPO) after cesarean section(CS).Methods The case group enrolled 11 patients who were diagnosed with ACPO after cesarean section in the First Affiliated Hospital of University of Science and Technology of China from January 2006 to January 2018.Another 55 patients without ACPO after CS,performed within two weeks' difference from the case group,were randomly selected as the control group.Clinical data of all subjects were analyzed retrospectively.Potential clinical risk factors were statistically analyzed.T test,Chi-square test and logistic regression analysis were used for statistical analysis.Results In the case group,the abdominal distension presented on 2 d (n=1),3 d (n=7),4 d (n=2) and 17 d (n=1) respectively after CS,and all cases experienced abdominal pain and nausea.Vomiting was reported in some cases.Plain abdominal X-ray images revealed pneumocolon with colon pouch.The maximum diameter of cecum was 6 to 12 cm.Air-liquid levels were observed in two patients.All patients underwent fasting,gastrointestinal decompression,intravenous fluid infusion,correction of electrolyte imbalance,hypertonic saline enema and prophylactic antibiotic treatment.The disease condition lasted two to six days in these patients.Conservative treatment was successful in eight patients and failed in the other three who later went for operations.The maximum cecal diameters in the three patients who underwent surgery were all ≥ 9 cm,among whom one case progressed quickly and laparotomy was tempted to rule out mechanical intestinal obstruction.In this case,the pressure was successfully reduced by placing a thoracic catheter through the anus after the failure of intestinal puncture trying to release the gases.One patient underwent colostomy due to positive signs of peritoneal irritation after a failure of four-day conservative treatment.One patient suffered a relapse after having been treated conservatively for five days,and then underwent surgeries of resection of ileocecum,distal closure of the colon ascendens plus terminal ileostomy due to intestinal perforation.Multivariate logistic regression analysis showed that higher postoperative leukocyte count (OR=1.38,95％CI:1.12-1.71,P=0.003) and postoperative body temperature ＞38 ℃ (OR=6.47,95％CI:1.06-39.61,P=0.044) were the risk factors for ACPO after CS.Conclusions Elevated leukocyte count and body temperature ＞38 ℃ were two high-risk factors for ACPO after CS.ACPO is characterized by acute onset,and the first choice is conservative management.Active surgical treatment would be required if conservative treatment fails,especially when the maximum diameter of the cecum is ≥ 9 cm,which may increase the incidence of intestinal necrosis or perforation.