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OBJECTIVE To understand the safety of Ilaprazole sodium for injection in clinical practice. METHODS From Jan. 1st 2019 to Feb. 29th 2020， the data of 3 926 valid hospitalized patients receiving Ilaprazole sodium for injection were collected prospectively from 5 third-level hospitals through CHPS， and the post-marketing safety analysis was performed by using retrospective multicenter single cohort study. At the same time， a nested case-control study （the ratio of trial group and control group was 1∶4） was used to confirm the baseline stability of this study cohort and the correlation between adverse reactions and Ilaprazole sodium for injection. RESULTS Among 3 926 patients， 3 patients experienced 5 adverse drug events after using Ilaprazole sodium for injection， with the incidence of 0.076%. There was no serious adverse event， and the occurrence time was 2 days after medication； adverse drug events mainly include elevated liver function indicators （alanine transaminase， aspartate transaminase， total bilirubin）， which were mild and untreated， and all adverse drug events were improved. The results of the nested case-control study showed that the trial group and the control group belonged to the same background baseline， and the occurrence of adverse drug events was more closely related to Ilaprazole sodium for injection. CONCLUSIONS The overall safety of Ilaprazole sodium for injection is relatively high， and the occurrence of adverse events is more related to it.
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Objective To evaluate the efficacy and safety of ilaprazole sodium for injection in the treatment of peptic ulcer bleeding.Methods It was designed as a multi-center,stratified randomized,double-blind,positive drug parallel controlled and non-inferiority study.From October 2014 to April 2015,at 40 hospitals,patients with peptic ulcer hemorrhage confirmed by gastroendoscopy were enrolled and divided into the ilaprazde sodium group (10 mg ilaprazole sodium for injection every 24 h,the first dose doubled) and the positive control group (40 mg of omeprazole sodium for injection every 12 h).The course of both treatment was 72 h.The hemostasis rate of overall group at 72 h,the clinical rebleeding rate at four to seven days,the blood transfusion rate,the incidence of switching to other treatments and the incidence of adverse reactions were compared between the two groups.A chi-square test or Fisher's exact probability method were performed for statistical analysis.Results A total of 533 patients with peptic ulcer bleeding were enrolled,355 patients in the ilaprazole sodium group and 178 patients in the positive control group.The hemostasis rates of ilaprazole sodium group and positive control group at 72 h were 97.69 ％ (339/347) and 97.14 ％ (170/175),respectively,and the difference was not statistically significant (P＞0.05).There were no rebleeding patients in both groups at four to seven days.The blood transfusion rates of ilaprazole sodium group and positive control group were 5.07 ％ (18/355) and 3.37 ％ (6/178).The incidence of switching to other treatments was 0.56％ (2/355) and 0.56％ (1/178),respectively,and the differences were not statistically significant (both P＞ 0.05).The incidence of adverse reactions in the ilaprazole sodium group was 3.94％ (14/355),which was lower than that of positive control group (8.43％,15/178).And the difference was statistically significant (Fisher's exact probability method,P=0.042).Conclusions The efficacy of ilaprazole sodium for injection in the treatment of peptic ulcer bleeding is similar to that of omeprazole sodium for injection.Moreover,the smaller the dose,the lower the frequency of administration and the better the safety.
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<p><b>OBJECTIVE</b>To explore the value of baseline serum alkaline phosphatase (ALP) for predicting 2-year fracture in patients with chronic kidney disease (CKD) on maintenance dialysis.</p><p><b>METHODS</b>A total of 139 patients with CKD undergoing maintenance dialysis in our hospital were enrolled in this study. According to the median serum ALP level, the patients were divided into high ALP and low ALP groups. The demographic and clinical data of the patients including dialysis duration, serum calcium level, serum phosphorus level, and serum intact parathyroid hormone level were recorded, and their bone mineral density of the femur and the lumbar spine was measured using dual energy X-ray absorptiometry. The patients were followed up for 2 years and fracture events were recorded. The risk factors of fracture were analyzed using logistic regression analysis, and their predictive value for fracture was analyzed using receiver-operating characteristic (ROC) curve.</p><p><b>RESULTS</b>The mean baseline serum ALP level was 132.55±167.68 U/L in these patients, significantly higher than that in the normal population (=2.816, =0.006). Baseline serum ALP level was negatively correlated with the bone mineral density of the lumbar spine (=-0.203, =0.006) and the femur (=-0.196, =0.021). Fractures occurred in 21 (15.1%) of the patients during the 2-year follow-up, and the fracture rate was significantly higher in patients with high ALP levels. Logistic regression analysis identified serum ALP level as an independent risk factor of fracture (OR: 1.010, =0.001, 95%CI: 1.004-1.016). The areas under the ROC curve were 0.900 and 0.768 for serum ALP level and intact parathyroid hormone level in predicting 2-year fractures, respectively.</p><p><b>CONCLUSIONS</b>Serum ALP may serve as a good indicator for predicting 2-year fractures in patients with CKD on maintenance dialysis.</p>
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Objective To explore the role and mechanism of microRNA-15b in the regulation of epithelial-mesenchymal transition (EMT) of human peritoneal mesothelial cells (HPMCs).Methods PCR assay was used to determine the expression of microRNA-15b in the HMrSV5 induced by 138mmol/L high glucose for 24 h.MicmRNA-15b mimic or inhibitor was transfected into human peritoneal mesothelial cells (HMrSV5) to over-express or down-regulate microRNA-15b.The cells were then incubated with 138 mmol/L high glucose for 24 h,and the expressions of E-cadherin(E-Cad),Vimentin (VIM),Fibronectin(FN) and Smad7 were detected by real-time PCR and Western blotting respectively.Results microRNA-15b in the HMrSV5 ceils was over-expressed and down-regulated.Increased level of microRNA-15b was obtained in HMrSV5 cells treated with high glucose.In vitro,high glucose led to the up-regulation of vimentin as well as fibronectin and the down-regulation of E-cadherin in HMrSV5 cells (all P ＜ 0.05),which indicated EMT and fibrosis.Suppression of microRNA-15b by transfection with microRNA-15b inhibitor partially reversed the EMT and fibrosis changes (P ＜ 0.05),while over-expression of microRNA-15b by transfection with microRNA-15b mimic obviously enhanced the EMT and fibrosis changes (P ＜ 0.05).Conclusions MicroRNA-15b mediates high glucose induced EMT in human peritoneal mesothelial cells by the inhibition of Smad7 possibly.MicroRNA-15b maybe a new target for the prevention and treatment of peritoneal fibrosis during peritoneal dialysis (PD).
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OBJECTIVE:To evaluate the economic value of Shenqi fuzheng injection combined with chemotherapy vs. chemo-therapy alone for non-small lung cancer(NSCLC),and to provide reference for drug payment and clinical treatment. METHODS:By prospective cohort design,516 patients with non-small cell lung cancer from 11 hospitals were selected as subjects according to the sale distribution of Shenqi fuzheng injection in district and hospital;267 cases of Shenqi fuzheng injection combined with che-motherapy and 249 cases of chemotherapy alone formed naturally according the clinical therapy plan. The cost-effectiveness and cost-utility analysis were conducted using FACT-L score,KPS score and ZPS score as effect index,QALYs as effectiveness index observation period of 21 d. RESULTS:5 dimensions FACT-L score:the patients of Shenqi fuzheng injection combined with chemo-therapy group could be effectively improved,and the cost-effectiveness ratio was lower than chemotherapy alone group;KPS score:the cost-effectiveness ratio of Shenqi fuzheng injection combined with chemotherapy group was lower than chemotherapy alone group (1 632.44 vs. 11 145.30),and incremental cost-effectiveness ratio was 448.69. ZPS score:Shenqi fuzheng injection combined with chemotherapy group was lower than chemotherapy alone(-17 398.77 vs. 384 513.00). Shenqi fuzheng injection combined with chemotherapy group was lower than chemotherapy alone group in average cost per 1 QALYs(1 313 326 yuan vs. 13 374 365 yuan). CONCLUSIONS:Compared with chemotherapy alone group,Shenqi fuzheng injection combined with chemo-therapy can effectively improve the quality of life,and it is worth of spending more money on Shenqi fuzheng injection from the perspective of the pharmacoeconomics.
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Objective To evaluate the synergy effect of Meropenem and Sulbactam combination against Meropenem-resistant and Meropenem-susceptible A.baumannii in vitro and optimize combination ratio of Meropenem and Sulbactam to achieve best synergy effect.Methods Evaluating the synergy effect of Meropenem and Sulbaetam combination through microdilution checkerboard method against Meropenemresistant and Meropenem-susceptible A.baumannii,isolated from inpatients of Chinese hospitals.Assessing the synergy effect of combination in different ratios of Meropenem to Sulbactam.Results The checkerboard method with the combination of Meropenem and Sulbactam demonstrated 25.0％ ( 10/40 ) synergism,67.5％ (28/40) partial synergism,7.5％ (3/40) additive,no indifference and antagonism in Meropenemsusceptible isolates,and 27.5％ (11/40) synergism,40.0％ (16/40) partial synergism,25.0％(10/40) additive,no indifference and antagonism in Meropenem-resistant isolates.Eleven Meropenemresistant isolates which showed synergism in synergy test were tested for MICs of combination of Meropenem and Sulbactam,using ratios of 4∶ 1,2∶ 1,1∶1 and 1∶2,and the MIC90 were 64∶ 16,64∶ 32,32∶32,32∶64 μg/ml,respectively.Conclusions Meropenem and Sulbactam combination show synergism or partial synergism against most A.baumannii isolates.The optimal ration of combination for clinical use may be 1∶ 1.
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Objective To evaluate the effect of ilaprazole enteric tablets on intragastric pH in duodenal ulcer patients. Methods A randomized, double blind, positive controlled clinical trial was carried out. A total of forty-two patients with duodenal ulcer were randomized into low dose ilaprazole group (5 mg/d), medium dose ilaprazole group (10 mg/d), high dose ilaprazole group(20 mg/d) and omeprazole group(20 mg/d). An ambulatory 24 hour intragastric pH study was performed at the fifth treatment day. Fraction time pH above 3, 4 or 5, median values of 24 hour diurnal pH and 12 hour nocturnal pH, the percentage of patients with total time pH above 3, 4 or 5 at least for 18 hours were evaluated. Results There were no significant differences of fraction time pH above 3 or 4, median values of 24 hour diurnal pH and 12 hour nocturnal pH and the percentage of patients with total time pH above 3, 4 or 5 at least for 18 hours among all the groups with different doses of ilaprazole and the omeprazole group. The fraction time pH above 5 in medium and high dose ilaprazole groups were (87.96 ± 12. 29)% and (89.86±15. 18)% respectively, which was higher than that in low dose ilaprazole group [(67. 17± 30. 16)%] and omeprazole group[(76. 14 ± 16. 75)%], P <0. 05. Conclusion Ilaprazole has a strong effect on intragastric acid control with a dose dependent trend.
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Objective To evaluate the efficacy and safety of two kinds of dosage of 5-aminosalicylic acid zinc enteric-coated capsule in treatment of active ulcerative colitis (UC). Methods The muhicentre, double blind, dosage reaction and contrast trial was conducted in six hospitals during March 2004 to Sep. 2004. One hundred and eight patients with UC were randomly allocated into the high dosage (n= 36, 1 g, bid) and the low dosage (n = 36, 0.5 g, bid) of 5-aminosalicylic acid zinc enteric-coated capsule groups, and the Olsalazine sodium group (n = 36, 1 g, tid) with a 8-week treatment. The efficacy and adverse events of 5-aminosalicylic acid zinc enteric-coated capsule were evaluated based on the clinical presentations and endoscopic findings. Results The clinical efficacy was 68.97% in high dosage group, 45. 45% in low dosage group and 62.86% in Olsalazine sodium group with no significant difference (P>0. 05). The endoscopic examination showed that the healing rate of UC in high dosage group and low dosage group was 51.72% and 21.21%, respectively, whereas the efficacy rate was 82.76% and 69.70% respectively. The results showed that high dosage was more effective than low dosage (P=0.023), but was similar to Olsalazine sodium (healing rate of 34.29% and effective rate of 88.57% ,P>0. 05). Diarrhea was main adverse event, which was accounted for 2.8% (1/36) in high dosage group and 2.8% (1/36) in the Olsalazine sodium group. There was no adverse event in low dosage group. Conclusions 5-aminosalicylic acid zinc enteric-coated capsule is an effective agent in treatment of UC, especially in high dosage. It is similar to Olsalazine sodium in treatment of UC, and has advantages in reducing medication times.
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OBJECTIVE: To report the current situation of dialysis and transplantation in Foshan City. METHODS: A total of 18 hospitals performed dialysis filled the registration forms, which comprised situations of hospital, staff establishment, blood purification developing, blood purification equipments, hemodialysis patients, peritoneal dialysis patients, and acute renal failure patients. The registration time was form the beginning to ending of 2007, and the information was statistical analyzed.RESULTS: Totally 18 hospitals in Foshan district performed hemodialysis and 6 of them offered peritoneal dialysis simultaneously. There were 155 hemodialysis machines, 6 CRRT machines, and 15 dialyser reuse devices. Totally 1 718 patients received dialysis in 2007 year, including 93.60% hemodialysis patients and 6.40% peritoneal dialysis patients. Until the end of 2007, 1011 patients were received dialysis treatment, including 90.60% hemodialysis and 9.40% peritoneal dialysis. Glomerulonephritis (47.1%) was still the first primary disease of dialysis, then diabetic nephropathy (28%), third arteriosclerosis nephropathy (9.7%), fourth obstructive nephropathy (3.2%). Totally 743 hemodialysis patients stopped treating for reasons of death, improvement or recovery, changed to peritoneal dialysis, kidney transplantation, transfer, economics and lost follow-up, accounted for 20.3%, 20.1%, 7.2%, 4.1%, 21.5%, 20.2% and 6.6%, respectively. Cerebrovascular disease, cardiovascular disease, infection, dystrophy, synthetic factors and other were the main reasons for death, which accounted for 16.6%, 28%, 17.2%, 3.2%, 18.4% and 16.6%. A total of 16 patients stopped peritoneal dialysis for death (68.7%), improvement or recovery (18.7%), changed to hemodialysis (7.1%), or lost follow-up (6.3%). The causes of death were cerebrovascular disease (21.4%), cardiovascular disease (7.1%), infection (28.6%) and others (42.9%).CONCLUSION: There are 18 hospitals can perform dialysis treatment in Foshan district. Glomerulonephritis, diabetic nephropathy, arteriosclerosis nephropathy and obstructive nephropathy are the first four primary diseases of dialysis. Cerebrovascular disease and infection are the main causes of death.