某院药物不良反应报告分析

目的分析药物不良反应的发生特点、处理方法、临床表现和治疗,为临床合理用药提供依据。方法抽取笔者所在医院2010年度药物不良反应报告128份,借助统计学方法进行归纳和分析。结果药物不良反应涉及药品86种,其中抗感染药物30种,占药品总数34．9％,占病例总数的44．5％;中药制剂8种,占药物品种数9．3％,占病例总数的6．3％;给药途径以静脉滴注为主,占75％;常见不良反应为皮肤及其附件损伤;严重药物不良反应占6％。结论药物不良反应发生与多种因素有关,老年患者更易发生药物不良反应;加强药物不良反应监测工作有助于减少药物不良反应发生。     

肾移植后不同免疫抑制方案的效果及不良反应的临床分析

目的 总结肾移植后使用不同免疫抑制方案的效果和不良反应,以提高人/肾的长期存活率.方法 对单中心3102例肾移植受者的临床资料进行回顾性分析,所采用的免疫抑制方案有环孢素A(CsA)+硫唑嘌呤(Aza)+泼尼松(Pred)、低剂量CsA+吗替麦考酚酯(MMF)+Pred、低剂量他克莫司(Tac)+MMF+Pred、低剂量CsA(或Tac)+西罗莫司(SRL)+Pred等方案,分析各方案的效果和不良反应.结果 低剂量CsA+MMF+Pred方案的人/肾1、5、10年存活率均高于CsA+Aza+Pred方案,而高血压、震颤、高尿酸、肝肾毒性、白细胞下降等的发生率显著低于CsA+Aza+Pred方案(P＜0.05),腹泻发生率显著高于CsA+Aza+Pred方案(P＜0.05).低剂量Tac+MMF+Pred方案的高血糖发生率显著高于低剂量CsA+MMF+Pred方案(P＜0.05),多毛症发生率显著低于低剂量CsA+MMF+Pred方案(P＜0.05);低剂量CsA(或Tac)+SRL+Pred方案的腹泻、高尿酸血症、肝肾毒性和多毛症等的发生率显著低于低剂量CsA(或Tac)+MMF+Pred方案(P＜0.05),但高血脂发生率显著高于后者(P＜0.05).以低剂量Tac为基础的方案者高血糖发生率显著应用低剂量CsA者.结论 低剂量CsA(或Tac)+MMF+Pred方案改善了肾移植受者和移植肾的存活,降低了不良反应发生率,尤以低剂量Tac+MMF+Pred方案为优;调整免疫抑制方案或剂量,改善饮食习惯,加强锻炼,优化降血压、降血脂、控制血糖的治疗措施对预防和控制不良反应尤为重要.

Abstract：

Objective To summarize the incidence and treatment experience of the effectiveness and adverse reactions of the different immunosuppressive protocols and to increase the long-term survival rate in kidney recipients. Methods Single-center retrospective analysis was performed on 3102 cases of kidney transplant recipients in effectiveness and adverse reactions of different immunosuppressive protocols. The immunosuppressive protocols were as follows: CsA + Aza + Pred,low dose CsA + MMF + Pred, low dose Tac + MMF + Pred, low dose CsA + SRL + Pred, and low dose Tac+ SRL+ Pred. Results The 1-, 5-, 10-year survival rate of patients/kidney in low dose CsA + MMF + Pred protocol was higher than that in CsA + Aza + Pred protocol. The incidence of adverse reactions, such as hypertension, hyperuricemia, kidney and liver toxicity, and leukopenia was significantly lower, but the incidence of diarrhea was significantly higher in CsA + MMF + Pred protocol than in CsA + Aza + Pred protocol (all P＜0. 01). The incidence of hyperglycemia was significantly higher (P＜0. 05), and that of hairy and gingival hyperplsia was significantly lower (P＜0. 05) in low dose Tac+ MMF+ Pred than in low dose CsA+ MMF+ Pred protocol. The incidence of hyperlipidemia in low dose CsA (or Tac)+ SRL + Pred was significantly higher than in CsA (or Tac)+ MMF+ Pred protocol (P＜0. 05). The incidence of hirsutism in low dose Tac + SRL + Pred was significantly lower than that in CsA + SRL + Pred protocol (P ＜ 0. 05). The incidence of hyperglycemia in low dose Tac + SRL + Pred was significantly higher than that in low dose CsA + SRL + Pred protocol. Conclusion The triple drug protocol with a low dose of CsA (or Tac)+ MMF+ Pred significantly improved the survival of renal transplant recipients and graft, and reduced the incidence of adverse reactions, especially Tae + MMF + Pred protocol. Adjustment of the immunosuppressant dosage and protocol, improvement of eating habits, exercise, reduction of blood pressure, reduction of blood lipid, and control of blood glucose were particularly important in preventing and controlling adverse reactions during kidney transplantation.     

肝移植后因药物不良反应暂停及转换钙调磷酸酶抑制剂的单中心经验

目的 研究肝移植术后暂停及转换钙调磷酸酶抑制剂(CNI)对控制感染和改善受损肾功能的作用.方法 回顾性分析单中心施行的947例原位肝移植的资料,分为2个阶段,第1阶段(2002年1月至2007年12月)有234例肝移植术后发生感染的患者,第2阶段(2008年1月至2010年12月)有101例.2个阶段共有329例受者因CNI肾毒性而造成肾功能损害,其中将CNI转换为SRL者40例(转换组),其余289例采取CNI减量+吗替麦考酚酯(MMF)加量方案(减量组).结果 肝移植术后存活超过1、3和5年者CNI的应用率分别为95.8%、95.3%和97.5%.第2阶段共有17例受者短期停用免疫抑制剂,停药的主要原因是细菌(部分合并真菌)感染(88.2%);2个阶段共有48例患者将CNI转换为SRL,换药主要原因是肾功能损害(83.3%).第2阶段感染患者中短期暂停CNI者15例,占14.9%(15/101),CNI暂停后感染控制的有效率为73.3%(11/15),排斥反应发生率为6.7%(1/15).第2阶段感染患者的累积存活率明显高于第1阶段(P＜0.05).转换组CNI转换前肾小球滤过率为(0.82±0.24)ml/s,CNI转换后6周时为(1.28±0.31)ml/s,6个月时为(1.36±0.32)ml/s,转换后6周和6个月时高于转换前(P＜0.05).CNI调整后6个月时,转换组患者存活率为85.0%,减量组为83.7%(P＞0.05).结论 肝移植术后患者发生感染及肾功能损害时可采取CNI减量甚至短时间停用CNI,或转换使用SRL,此方案是安全、有效的.

Abstract：

Objective To report the results of a single-center, retrospective study on the effect of calcineurin inhibitors (CNI) withdraw for controlling infections and conversion to sirolimus (SRL)for ameliorating renal dysfunction. Methods A total of 947 liver transplant cases from 2002 to 2010were divided into two eras (Jan. 2002 to Dec. 2007 and Jan. 2008 to Dec. 2010). There were 234cases of infections after liver transplantation (LT) in the first era and 101 cases in the second era. And of 329 cases of CNI-related renal dysfunction after LT in two eras, 40 cases (converting group) had converted CNI to SRL, while 289 cases (reducing group) adopted protocol of CNI reducing and mycophenolate mofetil (MMF) raising. Results CNI-based IS took up 95.8 %, 95. 3 %, 97. 5 % of the IS protocols with recipient survival time longer than 1, 3, and 5 years. The primary cause for CNI withdraw was infection (88. 2 %, 15/17) in the second era, and renal dysfunction for conversion to SRL in the two eras (83. 3 %, 40/48). In the second era, 14. 9% (15/101) of the cases of infections after LT experienced CNI withdraw. Of the 15 patients, 11 had effectively controlled the infection (77. 3 %) while rejection rate was 6. 7 % (1/15). The cumulative survival rate of the second era was significantly higher than the first era (P＜0. 05). The glomerular filtration rate (GFR) of converting group at 6th week and 6th month was statistically elevated as compared with that before conversion,respectively (1.28 ± 0. 31, 1.36 ± 0. 32 mL/s vs. 0. 82 ± 0. 24 mL/s, P＜0. 05). Six months after CNI adjustments, survival rate of converting group and reducing group was 85. 0% and 83. 7 %,respectively (P＞0. 05). Conclusion Reducing or even short-term withdraw of CNI may allow the better control of infections after LT, and the conversion from CNI to SRL can ameliorate the CNIrelated nephrotoxicity. These individually tailored IS protocols will benefit the long term survival for LT.     

中药注射剂的风险及防范

对中药注射剂安全性问题进行文献调研,查阅相关资料,进行分析总结,从而阐述中药注射剂不良反应发生的原因及表现,讨论预防不良反应发生的对策,应从加强中药注射剂生产、流通,使用过程监督管理入手,加强中药注射剂不良反应上报工作,善于积累和共享不良反应的资料,为临床合理安全使用中药注射剂,规避风险,提供科学依据。     

Postmarketing safety of biologics and biological devices

Background contextRegardless of study design, the approval process of biologics and biological devices cannot identify every possible safety concern. Postmarketing safety surveillance can provide information based on real-world use of medical products in heterogeneous populations and is critical for identifying potentially serious adverse events, events that are too rare to be detected during premarketing studies, late complications, and events involving individuals or uses that were not evaluated in clinical trials.PurposeTo review why adverse event reporting is important and how the information is used, with emphasis on the points that are most applicable for surgeons and other spine professionals.MethodsThis is an overview of postmarketing safety surveillance.ResultsReview of adverse event reports has resulted in safety notifications, label changes, and publications regarding the safety of biologics and biological devices, such as the risk of airway compromise after the use of recombinant human bone morphogenetic protein in cervical spine fusion, the occurrence of a fatal air embolism after the use of a fibrin sealant that had been applied with a spray device, and infections after allograft transplantation of human tissues.ConclusionsIn light of the rapid development of new biologics, postmarketing surveillance is imperative for ensuring that these products are as safe as possible. By reporting adverse events, surgeons and other health care professionals play a key role in improving and refining our understanding of the safety of biologics.     

Prospective analysis of adverse events in surgical treatment of degenerative spondylolisthesis

Background contextSurgical adverse event (AE) monitoring is imprecise, of uncertain validity, and tends toward underreporting. Reports focus on specific procedures rather than outcomes in the context of presenting diagnosis. Specific intraoperative (intraop) or postoperative (postop) AEs that may be independently associated with degenerative spondylolisthesis (DS) have never been reported.PurposeThe primary purpose was to assess the AE profile of surgically treated patients with L4–L5 DS. The secondary goal was to identify potential risk factors that correlate with those AEs.Study design/settingProspective cohort and academic quaternary spine center.Patient sampleNinety-two patients with L4–L5 DS were treated surgically, discharged from Vancouver General Hospital between January 1, 2009 and December 31, 2010.Outcome measuresIncidence rates and odds ratios.MethodsProspective AE data were analyzed using univariate analyses, forward selection regression models, and Spearman correlation coefficients. Results were compared with outcomes reported in the Spine Patient Outcomes Research Trial.ResultsNo AEs were seen in 57.6% of patients, one AE in 17.4%, and two or more AEs in 17.4%. Dural tears (6.5%) and intraop bone-implant interface failure requiring revision (3.3%) were the most common intraop AEs. Postoperatively, the most frequent AEs were urinary tract infection (10.9%), delirium (5.4%), neuropathic pain (4.4%), deep wound infection (3.3%), and superficial wound infection (3.3%). The odds of an intraop AE increased by 9% (95% confidence interval [CI] 1–18) per year of age at admission. Adjusted Charlson comorbidity index (CCI) did not correlate with number of AEs experienced. The odds of postop delirium correlated with CCI (odds ratio [OR] 3.39, 95% CI 1.12–10.24) and dural tear (OR 35.84, 95% CI 1.72–747.45). Length of stay was statistically significant and was influenced by two or more AEs, CCI, postop loss of correction, cerebrospinal fluid leak, deep wound infection, noninfected wound drainage, and gender.ConclusionsRisk of intraop AEs, but not postop AEs, increased with increasing age. Having multiple comorbidities does not predispose to more AEs. Infections predominate among the postop AEs. Patients at increased risk of delirium or of having an increased length of hospital stay may more easily be predicted. Studies specifically designed to prospectively assess AEs have the potential to more accurately identify postop AE rates.     

Single shot spinal anesthesia with very low hyperbaric bupivacaine dose (3.75 mg) for hip fracture repair surgery in the elderly. A randomized,double blinded study

PurposeSingle shot spinal anesthesia is used worldwide for hip fracture repair surgery in the elderly. Arterial hypotension is a frequent adverse effect. We hypothesized that lowering local anesthetics dose could decrease the incidence of arterial hypotension, while maintaining quality of surgical anesthesia.MethodsIn a randomized double blinded study, 66 patients over the age of 65 years, with hip fracture needing surgical repair, were assigned to B0.5 group 7.5 mg hyperbaric bupivacaine 5 mg/ml (control group), and B0.25 group 3.75 mg hyperbaric bupivacaine 2.5 mg/ml (study group). Sensory and motor block level, and hemodynamic parameters including blood presure, heart rate and vasopressor dose administration were registered, along with rescue anesthesia needs, the feasibility of surgery, its duration, and regression time of sensory anesthesia to T12.ResultsAfter exclusions, 61 patients were included in the final analysis. Arterial hypotension incidence was lower in the B0.25 group (at the 5, 10, and 15 min determinations), and a lower amount of vasopressor drugs was needed (mean accumulated ephedrine dose 1.6 mg vs. 8.7 mg in the B0.5 group, p < 0.002). Sensory block regression time to T12 was shorter in the B0.25 group, mean 78.6 ± 23.6 (95% CI 51.7–110.2) min vs. 125.5 ± 37.9 (95% CI 101.7–169.4) min in the B0.5 group, p = 0.033. All but one patient in the B0.25 group were operated on under the anesthetic procedure first intended. No rescue anesthesia was needed.ConclusionLowering bupivacaine dose for single shot spinal anesthesia for hip fracture repair surgery in elderly patients was effective in decreasing the occurrence of arterial hypotension and vasopressor use, while intraoperative quality remained.     

What about doctors? The impact of medical errors

Medical error is a distressing event to the patient and the health care providers. The impact of such events has been well studied on patients but poorly on health professionals. These events are still considered as a taboo in the medical culture and hence missed as great learning opportunities. They have negative impact on doctors' emotional wellbeing, general quality of life, and their professional practice and conduct. Medical errors and adverse events also affect the quality and cost of the health service. Health service administrations should provide healthcare professionals involved in such events with professional support and counselling services, and should consider and treat them as second victims.