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Objective:To evaluate the safety of discontinuing nucleoside/nucleoside analogue (NAs) therapy in patients with compensated hepatitis B cirrhosis after HBsAg negative conversion.Methods:A total of 3 783 patients with hepatitis B cirrhosis in compensated stage were treated with NAs at Taizhou Hospital, Taizhou Municipal Hospital and Taizhou Enze Hospital from January 2008 to December 2020. The clinical data and laboratory tests results of 85 patients with HBsAg negative conversion were retrospectively analyzed, including 36 cases discontinued the drug, and 49 continued to use drug. Chi-square test and rank-sum test were used for data analysis.Results:During the 24 and 48 months of follow-up, the ALT levels were within the normal range in both groups. There were no significant differences in positive rates of anti-HBs and HBeAg ( χ2=0.75, 0.39 and 0.90, P=0.78 0.84 and 0.34; χ2=0.40, 0.00 and 0.00, P=0.84, 1.00 and 1.00) between two groups. After 48 months of follow-up, 2 cases of primary liver cancer occurred in the discontinuation group and no primary liver cancer occurred in the continuation group ( χ2=0.89, P=0.34). Throughout the follow-up, HBsAg remained negative and HBV DNA load was below the lower limit of detection in both groups. Conclusions:Discontinuation of NAs can be considered after the HBsAg negative conversion in patients with compensated hepatitis B cirrhosis.
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We report a patient with severe acne who developed facial paralysis after two months of treatment with oral isotretinoin. Drug withdrawal resulted in a complete clinical recovery. Our case and a review of the literature indicate that oral isotretinoin might be capable of causing a dysfunction of predominantly sensory nerve fibers in some individuals. Clinicians should be aware of possible neurological sensorial symptoms during isotretinoin therapy
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Objective@#To observe the changes of liver function, virology and serology and the safety of drug withdrawal in pregnant women who are chronic hepatitis B virus (HBV) carriers.@*Methods@#A prospective clinical cohort was established to enroll pregnant women who are chronic HBV carriers and they were divided into the nucleoside/nucleotide analogs (NAs) intervention group and the non-NAs intervention group according to patients' wishes. Liver function, HBV DNA and HBV serological markers were detected at gestation, postpartum 6 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks.@*Results@#351 patients were enrolled, 320 in the NAs intervention group and 31 in the non-NAs intervention group. The proportion of postpartum hepatitis flares in both groups was higher than that in pregnancy (39.4% vs 12.5%, P < 0.001; 38.7% vs 3.2%, P = 0.001). Six weeks postpartum was the peak period of hepatitis flares, and 96.0% (121/126) of the hepatitis flares occurred within 24 weeks postpartum. At 6 weeks postpartum, there were 6 cases of alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN) in the NAs intervention group. The rate of the hepatitis flare after drug withdrawal was 16.7% (34/203).@*Conclusion@#Regardless of the presence or absence of NAs intervention, pregnant women who are chronic HBV carriers have a certain proportion of hepatitis flares during pregnancy and postpartum, and the hepatitis flare even have a tendency to be severe. Therefore, drug withdrawal after delivery is not always safe, which requires close observation and classification. At 6 weeks postpartum, the incidence of hepatitis flares was high, and those who meet the treatment indications can get better therapeutic effects if given appropriate treatment. The vast majority (96%) of postpartum hepatitis flares occur within 24 weeks, so it is recommended to follow up to at least 24 weeks postpartum after discontinuation.
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Drug withdrawal has always been a tough challenge in drug quality management for the pharmacist. In order to optimize the drug withdrawal process, the hospital has introduced an inpatient pharmacy IT system. This system can efficiently minimize the drug withdrawal rate of major departments and withdrawal counts due to substandard quality problems, thus sizably avoiding human resource wastes in the conventional withdrawal process, reducing drug quality problem, enhancing management efficiency and efficiency of nursing staff and pharmacists, and ensuring clinical drug use safety.
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Objective To observe the effects of acupuncture therapy on sleep quality after drug withdrawal symptoms and long-term recurrence in patients with depression. Methods A total of 70 depression patients were retrospectively analyzed, according to the withdrawal method is divided into two groups, each group of 35 cases. The incidence of drug withdrawal syndrome in the two groups was observed and the success rate of drug withdrawal was calculated. The recurrence rate of depression in the two groups within one year after drug withdrawal, and the sleep quality were observed. The degree of depressive symptoms were assessed. Results The incidence of drug withdrawal syndrome were 11.4% in the observation group and 31.4% in the control group, which the difference was statistically significant (χ2=4.158, P=0.041). The rate of recurrence of depression was 9.7% in the observation group and 41.7% in the control group, which the observation group was significantly lower than the control group (χ2=7.669, P=0.006). After 1 year the drug was stopped, the sleep quality, sleep time, sleep efficiency, sleep disorder, daytime function and hypnotic drug score and total scores of PSQI of the observation group were significantly increased (P<0.01). And the PSQI at different time frames were significantly lower than those of the control group (t value were 2.888, 2.329, 2.092, 2.535, 9.951, P<0.05 or P<0.01). The HAMD score of the observation group 1 week after drug withdrawal and 1 year after drug withdrawal was significantly lower than those of the control group (t value were 9.271, 14.238, P<0.05). Conclusions The acupuncture therapy can improve the sleep quality of patients with mild and moderate depression after drug withdrawal, and reduce the incidence of drug withdrawal syndrome, and the risk of long-term recurrence.
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Objective To observe the condition changes in patients with chronic hepatitis B (CHB) following medication withdraw of nucleoside/nucleotide analogues (NAs) treatment and to analyze the factors related to disease relapse.Methods Eighty-five CHB patients who discontinued medication of nucleoside/nucleotide analogues for antiviral therapy in Nanjing Second Municipal Hospital from January 2002 to December 2017 were enrolled in the study, among whom 22 cases met the withdrawal criteria (standard withdrawal group ) and 63 cases did not meet the withdraw criteria ( non-standard withdrawal group).The correlation of condition changes (abnormal liver function, positive rate of HBV DNA, hepatic failure with the drug withdrawal , the course of medication, serological transformation of HBeAg during drug withdrawal, HBsAg level, and liver cirrhosis during drug administration was analyzed.Results In standard withdraw group, the medication lasted for ＞3 years, only 1 case had HBV DNA positive conversion , abnormal ALT and TBil, and liver failure.In non-standard withdraw group, 50 cases (79.4%) had HBV DNA positive conversion, 36 (57.1%) had abnormal ALT, 25 ( 39.7%) had abnormal TBil and 14 (22.2%) had liver failure.There were 19 cases with HBsAg ＞1 000 IU/mL and 3 cases with HBsAg ≤1 000 IU/mL, and 1 case with HBsAg＞1 000 IU/mL (5.3%) had HBV DNA positive conversion , ALT, TBil abnormality and liver failure.In non-standard withdraw group, there were 52 cases with HBsAg ＞1000 IU/mL, among whom 45 cases (86.5%) had positive HBV DNA conversion , 31 (59.6%) had ALT abnormalities, 25 (48.1%) had TBil abnormalities, and 13 (25.0%) had liver failure; there were 11 patients with HBsAg ≤1 000 IU/mL, among whom 6 cases (54.5%) had HBV DNA positive conversion , 5 (45.4%) had ALT abnormalities, and no TBil abnormalities or liver failure occurred.There were 5 cases of liver cirrhosis in the standard withdraw group , only 1 case had HBV DNA positive conversion , ALT, TBil abnormality and liver failure.None of the 17 patients with non-cirrhosis had HBV DNA positive conversion , ALT, TBil abnormality and liver failure.There were 29 patients with liver cirrhosis in non-standard withdraw group showed positive HBV DNA conversion , 28 (96.6%) had ALT abnormalities, 22 (75.8%) had TBil abnormalities, and 11 (37.9%) had liver failure; among 34 non-cirrhosis patients, 21 (61.8%) had positive HBV DNA conversion, 8 (23.5%) had ALT abnormalities, 3 (8.8%) had TBil abnormalities, and 2 (5.9%) had liver failure.According to the standard discontinuation , 12 patients (16.7%) had positive HBV DNA transformation after HBeAg serological conversion , and no ALT abnormality, TBil abnormality and liver failure occurred.In non-standard withdraw group, only 17 cases without HBeAg serological conversion , 10 cases (58.8%) had positive HBV DNA conversion , 5 cases (29.4%) had ALT abnormalities, 2 cases (11.8%) had TBil abnormalities and liver failure did not occur.Conclusion CHB patients with medication of NAs should be discontinued according to the withdrawal criteria .and the course of medication, the immune index and the liver cirrhosis should be taken into account.
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OBJECTIVE:To control the drug quality risk in drug withdrawal links of hospital pharmacy,and provide reference for the application of quality risk management(QRM)in hospital pharmacy. METHODS:Drug QRM was developed in drug with-drawal links through risk identification,risk assessment,risk control,risk assessment and other steps. Using the incidence of risk factors and reusable rate of withdrawal drug as indexes,related data of before(Jul.-Dec. 2015)and after(Jan.-Jun. 2016)devel-oping QRM in our hospital were compared to evaluate the effect of drug QRM. RESULTS:Determining whether specific storage drugs kept the required storage conditions,whether the numbers of withdrawal drugs counted to minimal packaging and other 5 fac-tors were high-risk factors(the risk score of each factor>4 points);control measures were taken separately for high risk factors, then high-risk factors were reduced to acceptable levels(risk score<4 points). After developing QRM,the incidence of risk factors were reduced than before(reduce 1.35%-6.19%),reusable rate of withdrawal drug was increased(98.64% vs. 86.32%)(all P<0.05). CONCLUSIONS:Developing QRM in drug withdrawal links of hospital pharmacy can reduce the drug quality risk.
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Objective To explore the recurrence of chronic hepatitis B(CHB) after stopping nucleoside (acid) analogue(NAs) and the impact of residual amount of serum hepatitis B virus(HBV) DNA on recurrence. Methods Seventy-nine CHB patients, who received treatment of NAs and achieved standard withdrawal were enrolled in this study. According to lab examination, there were 47 hepatitis B e antigens (HBeAg)-positive patients and 32 HBeAg-negative patients. Meanwhile, 33 CHB patients received lamivudine treatment (LAM group), 27 CHB patients received adefovir treatment (ADV group), and 19 CHB patients received entecavir treatment (ETV group). The biochemical and virological indicators of CHB patients′recurrence would be recorded after 48 weeks. Results There were 43 CHB patients (54.4%), whose indicators of HBV DNA turned positive after discontinuity of treatment with NAs of 48 weeks. There were 27 CHB patients (55.3%), the HBV DNA of whom turned positive among 47 HBeAg-positive patients, and 17 patients(53.1%) among 32 HBeAg-negative patients, and there was no significant difference (P>0.05). In addition, the positive conversion rate after stopping treatment with NAs of 48 weeks in LAM group, ADV group and ETV group had no significant difference:54.5%(18/33), 51.9%(14/27), 11/19, P > 0.05. Moreover, there were 36 patients (45.6%) whose index of alanine aminotransferase(ALT) increased again after discontinuity of treatment with NAs of 48 weeks . There were 20 CHB patients (42.6%) in HBeAg-positive patients, and 16 patients (50.0%) in HBeAg-negative patients, and there was no significant difference (P>0.05). The rate of ALT increase again in LAM group, ADV group and ETV group had no significant difference: 48.5%(16/33), 40.7%(11/27), and 9/19, P >0.05. According to the results of serum samples of 79 CHB patients with Roche reagent when stopping using NAs, in 35 CHB patients (44.3%) serum HBV DNA>12 × 103 U/L was detected. However, serum HBV DNA>5 × 105 U/L was detected in 25 CHB patients (71.4%)among 35 patients with serum HBV DNA > 12 × 103 U/L after 48 weeks, and merely in 18 CHB patients (40.9%) among 44 patients with serum HBV DNA < 12 × 103 U/L, and there was significant difference (P < 0.01). Conclusions The CHB patients with standard withdrawal still have high recurrence rate after stopping treating, whatever medicine was used. Then, residual amount of serum HBV DNA is an important indicator for predicting relapse of CHB. Meanwhile, the retreatment of these patients should be researched further.
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Zolpidem is a hypnotic drug with rapid -onset and short duration of action. It is popularly used for the induction and maintenance of sleep in adults suffering from insomnia. It supersedes benzodiazepines with better tolerability and has fewer side effects such as less residual sedation and the potential for rebound insomnia and dependence is also less. Adverse neuropsychiatric reactions such as visual hallucinations, amnesia, sleepwalking and nocturnal eating are known to occur with zolpidem. Literature suggests higher incidence of visual hallucinations with zolpidem when used along with selective serotonin reuptake inhibitors. Furthermore, visual hallucinations are one of the causes for drug withdrawal. We are reporting a case of zolpidem induced visual hallucinations when used alone and also which disappeared with proper assurance to the patient in subsequent use.
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OBJECTIVE:To study the persistence of the effects of nucleoside (acid) analogues in the treatment of chronic hepatitis B (CHB) after drug withdrawal. METHODS:150 cases of CHB were selected and received nucleoside (acid) ana-logues for one year at least. They were divided into the standard group(n=56)and non standard group(n=87)according to the drug withdrawal standard stated in Guidelines for Prevention and Treatment of CHB,and followed up for one year except 7 cas-es of drug withdrawal who were followed up less than one year. HBV serum markers HBVM and HBV-DNA were detected quan-titatively in 2 groups. CHB recurrence,HBsAg disappearance and the change of HBV in serum were observed in 2 groups after drug withdrawal. RESULTS:The recurrence rate of CHB patients with HBeAg (+) in standard group and non standard group were lower than those with HBeAg(-),with statistical significance(P0.05);the total recurrence rate of standard group was lower than that of non standard group,with statistical sig-nificance(P0.05). Among sustained responders,HBsAg of 3 patients disappeared in standard group,including 2 cases of HBsAg seroconversion,1 case of no HBsAg seroconversion. Among patients with recurrent CHB,2 patients suffered from HBeAg(+)again in standard group,and 1 patient with HBeAg(-)developed liver cancer;5 patients suffered from HBeAg(+)again in non standard group,including 1 patient died and 1 patient with HBeAg(-)devel-oped liver cancer. CONCLUSIONS:Taking Guidelines for Prevention and Treatment of CHB as drug withdrawal standard,there still is a high recurrence rate after stopping nucleoside(acid)analogues;the recurrence rate of patients with HBeAg(-)is high-er than those with HBeAg(+),and that of patients in non standard group is higher than in standard group. The types of nucleo-side(acid)analogues do not influence recurrence rate after drug withdrawal.
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Objective To discuss the optimal occasions for CsA withdrawal after kidney transplantation. Methods Thirty-eight cases of kidney transplantations in out-clinic were included in this study. CsA was withdrawn in their immunosuppressive regimen owing to different reasons after operation.All patients were followed up at least 2 years after operation, and followed up more than 12 months after CsA withdrawal. All patients were divided to two groups: Group A (18 cases), control group; group B (20cases), the CsA withdrawal owing its side effects. Acute rejection rate, SCr, uromicroprotein and side effects were analyzed in order to find the optimal occasions for CsA withdrawal Results CsA was re-administered in 9 cases (50 0/4) owing to different reasons in Group A. In group B, CsA was withdrawn due to gradually increased Scr and proteinuria in 12 cases, CsA related acute toxidty in 2 cases, hepatic injury in 8 cases and other reasons in 2 cases, After withdrawal of CsA, renal function was improved and hepatic injuries were recovered. Conclusion The suitable opportunity for CsA withdrawal for long-term survival patients should be at the beginning of gradually increased Scr and/or proteinuria. For the patients with normal and stable renal function and having no CsA related side effects, small dosage (1.5-2. 0 mg/kg)of CsA was the choice for the maintenance therapy.
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Previous studies have proved that the effect of statins in both primary and secondary prevention of ischemic stroke, however, whether acute ischemic stroke needs to be treated with statins and the effect of statins pretreatment on acute ischemic stroke remain unclear. This article reviews the recent representative studies in this field, and analyzes the effects of the application of statins in the treatment of acute ischemic stroke on prognosis.
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[Objective]To analyze the characteristics of outpatient prescription drug withdrawal,reduce out-patient drug withdrawal to ensure the safety of patients with medication.[Method]Make statistics on outpatients from January to September of 2007,1292 prescription drug withdrawals,drug withdrawal rate accordingly,drug dosage forms,drug types,the cause of drug withdrawal classification.[Result]There're many pediatric drug withdrawal,injection drug withdrawal,retreat antibiotic drugs,drug withdrawal and the main reason is unreasonable adverse drug reaction.[Conclusion] Analyzing the characteristics of drug withdrawal to strengthen rational drug use can reduce the greatest degree of adverse drug reaction,reducing out-patient drug withdrawal to ensure the drug safe,effective,rational and economic.
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OBJECTIVE: To evaluate the effect of intervention measures enforced by clinical pharmacists on reducing dosage of benzodiazepines. METHODS: Clinical pharmacists described benzodiazepine withdrawal scheme for adult patients who were treated with repeated benzodiazepine prescription more than 3 months. 10% of benzodiazepines dose was reduced every two weeks and single blind drug withdrawal was carried out. RESULTS: Consumption of benzodiazepine was reduced significantly by 70.50% after intervening by pharmacists. CONCLUSION: Clinical pharmacists play an important role in benzodiazepine withdrawal, whose intervention is rapid and useful method for physicians reducing dosage of benzodiazepines.
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Objective To explore the mechanism of the reversibility of chronic cyclosporine (CsA) nephrotoxicity in rats after long-term drug withdrawal. Methods Chronic CsA nephrotoxicity was induced in Sprague-Dawley rats by administering CsA(15 mg . kg-1. d-1) for 5 weeks,and then the effect of drug withdraw for 5 and 10 weeks was observed. Body weight,systolic blood pressure,and renal function were monitored. In addition,renal histopathology(arteriolopathy,ED-1-positive cells,and tubulointerstitial fibrosis) and expression of osteopontin(OPN) and transforming growth factor(TGF) -?1 mRNA was examined. Results Compared with the control rats,CsA-treated rats showed loss of body weight,deterioration in renal function and development of typical histopathology. All of these above parameters were significantly reversed,meanwhile,the upregulation of OPN and TGF-?1 mRNA expression decreased significantly at 5th and 10th week after CsA withdrawal. Of note,the decreased OPN and TGF-?1 mRNA expression was positively correlated with the reduction in the tubulointerstitial fibrosis score. Conclusion The established chronic CsA nephrotoxicity is reversible after long-term CsA discontinuation,and the mechanism may be associated with the down-regulation of OPN and TGF-?1 mRNA expression.