Search

Establishing Medical Risk Monitoring and Early Warning System for Quality Improvement and Patient Safety

腫瘤醫院門診患者的安全隱患分析與管理對策

目的　探討腫瘤專科醫院門診患者就診中的安全隱患和防范措施。 方法　從2009年1月起，通過采取加強各個環節的安全管理，制訂應急預案，增強醫務人員的安全意識教育和急救能力培訓等措施，全面防范門診突發安全事件的發生。 結果　投訴糾紛和意外發生率由2006年－2008年的48起、0.028 2%下降到2009年－2011年的33起、發生率分別下降至0.026 5%、0.017 8%、0.010 9%，安全防范管理效果明顯。 結論　實施對門診患者的安全管理，可減少醫療糾紛，降低患者風險，提升門診服務質量和社會形象。

Patients for Patient Safety: A Systematic Review

Objective　To systematically review the abroad studies on patients for patient safety, and compare them with the current status of domestic studies, so as to provide suggestions for evidence-based strategic decision about how to conduct the education of patients for patient safety and improve the medical quality. Methods　The databases of MEDLINE, EMbase and Chinese Biomedical Literature Database (CBM) were searched to identify the relevant studies and their references. Literatures were screened with data extraction in accordance with the predefined inclusive and exclusive criteria. The quality of literatures was assessed with the standard of Cochrane Handbook 5.0 and Critical Appraisal Skills Programme, and the data were comprehensively analyzed with qualitative research methods.Results　Among 28 included studies, 5 were Chinese literatures, 1 was RCT, and the others were cross-sectional studies. The results showed that: a) Generally, the patients at home and abroad were poor in the awareness of patient safety, but they were eager to participate in the patient safety; b) Factors affecting patients’ participation were their characteristics, disease-related, and emotional feelings; c) Three studies reported the methods of involving patients in patient safety from the aspects of infection, malpractice, and medication; d) Some studies showed that patients’ participation could effectively promote the standardized operation of medical staffs, prevent unsafe events, and reduce damages; and e) The research contents of the included Chinese literatures were just related to the patients’ awareness of patient safety, attitude to participation, and influencing factors. Conclusion　The limited studies relevant to patients for patient safety are short of high-quality RCTs for proving the effectiveness of patient participation methods, so it indicates that the stress should be laid on evaluating the effectiveness of patients for patient safety in future research.

Implementation of Emergency Security Plan of West China Hospital during Medical Rescue after Wenchuan Earthquake

During the medical rescue after the earthquake, the Security Department of West China Hospital understood those factors affecting the hospital safety in the earthquake disaster, established emergent communication platform and information release channel, and opened up special areas and passages for the wounded, so as to ensure smooth passages for the rescue work, security of disaster-relief materials as well as an orderly, safe and stable medical environment.

Safety Evaluation of Intra-Abdominal Implantation of Sustained-Releasing 5-Fluorouracil in Gastrointestinal Malignant Tumor

Objective To explore the postoperative influence of intra-abdominal implantation of sustained-releasing 5fluorouracil on the hepato-renal function, immune function, nutritional state and complications in patients with gastric and colorectal cancer. Methods Sixty-five patients with gastric or colorectal cancer were included into this study from January to June 2009. The patients (35 cases of gastric cancer, 18 cases of colon cancer and 12 cases of rectal cancer) were randomly divided into experimental group (n=25) and control group (n=40). In experimental group, 400 mg sustained-releasing 5-fluorouracil was used. Blood samples were gained before operation, the second day and the seventh day after operation to examine the indexes of hepato-renal function, immune function and nutritional state. Complications， venting time and length of stay after operation were also recorded. Results There was no statistical significance for distribution of tumor stages and patients’ gender between experimental group and control group (Pgt;0.05). Preoperative indexes of hepato-renal function, immune function and nutritional state were also not reached statistical significance between two groups (Pgt;0.05). Compared with control group, the indexes of total protein and transferrin were decreased and urea nitrogen and IgM were increased in the second day after operation in experimental group (Plt;0.05). The number of lymphocyte was increased, while CD4, Alb, total protein and IgA were decreased in the seventh day after operation in experimental group, respectively. The time of passage of gas of experimental group was longer than that of control group (Plt;0.05).Conclusion Intra-abdominal implantation of sustained-releasing 5-fluorouracil is safe and feasible, which does not increase the complications and the time of length stay after operation. However, there is a little influence on immune function and gastrointestinal function after operation for intra-abdominal implantation of sustained-releasing 5-fluorouracil.

The Efficacy and Safety of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ: IgG Fc Fusion Protein for Treatment of Rheumatoid Arthritis

ObjectiveTo investigate the efficacy and safety of recombinant human tumor necrosis factor-α receptor Ⅱ:IgG Fc fusion protein (rhTNFR:Fc) for treatment of active rheumatoid arthritis (RA). MethodsThis study included 86 patients with active rheumatoid arthritis treated between September 2011 and January 2013. They were divided into two groups randomly. Forty-three patients in the treatment group received rhTNFR:Fc (25 mg, twice a week) by subcutaneous injection and methotrexate (MTX) (10 mg, orally once a week), and the other 43 patients in the contrast group received MTX (10 mg, orally once a week), hydroxychloroquine (100 mg, orally twice daily), and leflunomide (10 mg, orally once daily). The clinical efficacy of the treatments 12 weeks later were compared between the two groups. American College of Rheumatology (ACR) 20, 50, and 70 evaluation criteria were used for efficacy evaluation. ResultsThe ACR 20, 50 and 70 effective rates in 4, 8 and 12 weeks after the treatment in the treatment group were significantly higher than those in the control group (P<0.05). The seven indicators including the duration of morning stiffness, joint tenderness index, joint swelling index, erythrocyte sedimentation rate, C-reactive protein, platelets and rheumatoid factors within 12 weeks after treatment were significantly improved in both the two groups, and the improvements in the treatment group were more significant (P<0.05). There was no significant difference in the incidence of adverse drug reactions between the two groups (P>0.05). ConclusionRhTNFR:Fc is effecive and safe in treating active RA.

Clinical Efficacy of Middle and Lower Rectum Carcinoma with Intestinal Obstruction Undergoing One-Stage Anastomosis

Objective To compare the clinical effects of one-stage anastomosis on patients with middle and lower rectum carcinoma and intestinal obstruction and the ones without intestinal obstruction, and to evaluate the safety and feasibility of patients with middle and lower rectum carcinoma and intestinal obstruction undergoing one-stage anastomosis. Methods The data of patients diagnosed definitely by pathology as middle and lower rectum carcinoma underwent one-stage anastomosis in West China Hospital of Sichuan University between January 2007 and December 2008 was retrospectively analyzed. The clinical effects were compared between intestinal obstruction group and non-intestinal obstruction group. Results During this period, 525 patients were included into intestinal obstruction group (n=87) and non-intestinal obstruction group (n=438). Among the patients included, there were 307 males and 218 females. Ages were from 25 to 85 years, and the average age was 60 years old. According to tumor histology, there were 487 cases of adenocarcinoma, 29 of mucinous adenocarcinoma and 9 of other types. According to the degree of tumor differentiation, there were 140 cases of low differentiation, 372 of middle differentiation and 13 of high differentiation. According to TNM stage, there were 4 cases of stage 0, 93 of stageⅠ, 189 of stage Ⅱ, 202 of stage Ⅲ and 37 of stage Ⅳ. Constituent ratio of gender, distributions of distances from tumor to anus, TNM stages and differentiation degrees of tumor were significantly different between intestinal obstruction group and non-intestinal obstruction group (Plt;0.05); and there was no statistical difference in the age, pathological types， significant internal medical complications and operative types between the two groups (Pgt;0.05). There was no statistical diffe rence in operative duration and intraoperative blood loss between the two groups (Pgt;0.05). There was no statistical difference in postoperative time of first defecation, first out-of-bed activity and first oral feeding, and postoperative hospital stay between the two groups (Pgt;0.05); while time of first aerofluxus was earlier in intestinal obstruction group than that in non-intestinal obstruction group (Plt;0.05). There was no statistical significance in the disease incidence of postoperative complications between the two groups (Pgt;0.05). Conclusions Comparing with patients with non-intestinal obstruction, there is no significant evidence shows that one-stage anastomosis will affect the rehabilitation and increase the risk of complications in patients with middle and lower rectum carcinoma and intestinal obstruction. It is considered that it would be safe and feasible for patients with middle and lower rectum carcinoma and intestinal obstruction to have one-stage anastomosis; however, it is necessary for us to have more researches to evaluate the long-term clinical effect.

The effects of levetiracetam on neonatal safety during early pregnancy: a meta analysis

ObjectivesUsing systematic literature review to analyze the effects of levetiracetam (LEV) on neonatal safety during early pregnancy.MethodsThe scope of the literature must be English literature, published from 1997 to 2018. Meta-analysis was performed by random effects models.ResultsSeven literatures were included. A total of 672 cases exposed to LEV in treatment group and 772 234 cases in control groups were selected for meta-analysis. There was no significant difference in neonatal malignancy between treatment group and control group［OR=1.05, 95% CI (0.54, 2.02), P=0.37］. Further, we evaluated the effect of LEV monotherapy and polytherapy on neonatal safety, a total of 464 monotherapy cases and 632 polytherapy cases respectively were selected for meta-analysis. The results showed that there was no significant difference between these two therapies in neonatal malignancy ［OR=0.54, 95% CI(0.31, 0.96), P=0.32］.ConclusionsAs the papers we included, levetiracetam in the treatment of epilepsy during pregnancy is relatively safe for newborn.

藥物安全與藥品不良反應監測

　　人類應用藥品治療疾病已有幾千年的歷史，遠古時代人們為了生存從生活經驗中得知某些天然物質可以治療疾病與傷痛，隨著醫藥學科學的發展，到目前已有鎮痛藥、抗生素、抗腫瘤藥、心血管系統藥、呼吸系統藥、神經系統藥等類別繁多，數量龐大的藥品，為解除病痛、挽救生命發揮了極其重要的作用。但是藥品猶如一把雙刃劍，人類通過藥品征服疾病帶來的痛苦的同時，也因此付出了慘痛的代價。醫藥史發展上，屢屢發生如含汞藥物與肢端疼痛病、磺胺酏劑與腎功能衰竭、孕激素與女嬰外生殖器男性化等致死、致殘的藥害事件。經歷了一系列藥物危害事件，尤其是20世紀60年代初發生的震驚世界的“反應停”事件后，藥品不良反應（adverse drug reaction，ADR）受到世界的廣泛關注。　　1　藥品不良反應的定義　　WHO的定義為：“使用正常劑量的藥物進行治療時出現的非預期有害反應，稱作ADR”[1]。　　我國是WHO國際藥物監測合作計劃的成員國，在ADR監測工作中同樣遵循著WHO所規定的ADR定義。因而，我國衛生部、國家食品藥品監督管理局發布的《藥品不良反應報告和監測辦法》規定：“藥品不良反應是指合格藥品在正常用法用量下出現的與用藥目的無關的或意外的有害反應。”包括：藥物的副作用、毒性作用、繼發反應、撤藥反應、后遺反應、藥物依賴、過敏反應、特異質反應、致癌作用、致畸作用、致突變作用等類型。　　2　藥品不良反應監測建立的背景　　20世紀30年代的“磺胺酏劑事件”引發美國政府對其聯邦食品藥品法規的修訂，強調藥品上市前必須進行毒理研究，藥品生產者必須把安全性資料報告食品及藥物管理局（Food and Drug Administration，FDA）進行審批，由此全球開始關注藥品安全性問題[2]。　　20世紀60年代的“反應停事件”引發了新一輪對藥品安全性的關注和研究，促使各國紛紛進一步完善藥品管理法規，并加快了對ADR信息收集系統的建立。為了避免再次發生類似“反應停”的災難，一些國家率先建立了醫務人員志愿報告ADR的監測體制：1963年西德和荷蘭建立了ADR鑒別報告制度；1964年英國建立黃卡制度；澳大利亞建立藍卡制度；法國、西班牙、日本、比利時、捷克等國，也紛紛建立了現代意義上的藥品不良反應報告制度。為在藥品安全性、有效性方面有經常性的交流信息，一旦發現新的、嚴重的藥品不良反應，可迅速采取措施避免危害的擴大，避免同樣藥物的同樣不良反應在不同時間、不同地點重復發生，防止藥品不良反應的流行，保護各國人民的用藥安全，1962年，世界衛生大會責成WHO衛生總干事研究防治藥物災難性事件的有效措施，并“確保將藥物新的嚴重不良反應迅速通報到各國衛生行政機構”。1968年WHO制訂了國際藥品監測合作計劃，在美國成立藥物不良反應合作監測的國際組織，并在已建立報告制度的10個國家試點。1970年WHO正式設立國際藥品監測合作中心作為具體執行WHO藥品不良反應監測合作計劃的常設機構，1971年在瑞士日內瓦建立了全球ADR數據庫，1978年搬遷到瑞典的Uppsala（烏普薩拉）市，1997年WHO國際藥物監測合作中心更名為烏普沙拉監測中心（Uppsala Monitoring Certre，UMC）我國于1998年3月正式加入了WHO國際藥品監測合作中心并成為第68個成員國。到目前世界衛生組織（WHO）國際藥物監測計劃的正式成員國達到了100個[3]。　　3　藥品上市后監測的必要性3.1　動物實驗的局限性　　動物與人類的種屬差異：動物在遺傳、新陳代謝、體內酶系統等與人類有巨大的種屬差異；許多藥品不良反應在動物實驗中難以證實。3.2　臨床試驗的局限性　　臨床試驗的病例數少、試驗時間短、試驗對象的局限性、用藥條件控制嚴格（too homogeneous）。有特殊情況的排除、目的單純。觀察指標只限于試驗所規定的內容。因此臨床試驗ne;臨床應用，罕見但嚴重的 ADR、特殊人群用藥、連續用藥、長潛伏期、藥品相互作用、注射液配伍禁忌等信息缺乏或不全，獲得新藥證書上市時，用藥不足5 000人，只能發現更常見的ADR。　　因而上市后的不良反應監測是繼續對藥品的安全性考察，能正確指導合理用藥，有效的避免或減輕潛在的ADR，減輕患者經濟負擔。　　4　我國藥品不良反應監測的發展　　早在20世紀50年代后期，我國就曾經建立了部分地區的青霉素不良反應報告制度。1983年，衛生部組織專家和有關單位起草了《藥品毒副反應報告制度》，后改為《藥品不良反應監測報告制度》，為我國藥品不良反應報告和監測工作邁出第一步。1984年，我國藥品管理法頒布，規定藥品管理部門、藥品生產企業、藥品經營企業和醫療單位要經常考察并組織調查藥品質量、療效和不良反應。第一次將藥品不良反應報告和監測工作列為藥品生產、經營、使用單位和監督管理部門的法定責任。20世紀80年代末期衛生部藥政局組織了藥品不良反應報告制度的試點，1989年11月，成立衛生部藥物不良反應監察中心。1998年4月，國家藥品監督管理局（SDA）成立以后，1999年，衛生部藥品不良反應監察中心并入國家藥品監督管理局藥品評價中心，更名為“國家藥品不良反應監測中心”同年頒布《藥品不良反應監測管理辦法（試行）》，標志我國正式實施藥品不良反應報告制度。　　2001年11月，國家藥品不良反應信息通報制度和各地藥品不良反應病例報告情況通報制度建立。截止到目前，全國各級藥品不良反應監測機構技術體系框架已基本建成。其間，2001年建成覆蓋全國的國家ADR監測信息網絡系統，為中國的ADR監測工作提供了現代化的管理手段。　　2001年新修訂的藥品管理法第71條明確規定“國家實行藥品不良反應報告制度”；2004年以衛生部和國家食品藥品監督管理局（SFDA）聯合令的形式發布了法規性文件《藥品不良反應報告與監測管理辦法》，確定了藥品使用單位法定報告和監測責任，將ADR監測工作已納入法制化管理軌道，推動了我國藥物警戒的發展和藥品不良反應突發事件預警機制的建立。2011年7月1日開始實施的新修訂的《藥品不良反應報告和監測管理辦法》進一步提出加強藥品不良反應監測體系建設、加強藥品不良反應報告的收集和上報，并深入開展藥品不良反應分析評價的要求。　　5　藥物警戒　　WHO對藥物警戒的定義為：發現、評估、理解和預防不良作用或者一些其他藥物有關問題的科學和活動[4]。　　WHO指出：在藥品的整個生命周期（自批準前階段到患者使用），都保持警惕，對藥物存有的風險和帶來的益處進行評估[1]。　　因此，藥物警戒已不僅僅是上市后的監測，而是包括了所有其他提供用藥安全保障的工作，它不僅涉及藥品不良反應，還涉及與藥物相關的其他問題，如不合格藥品、藥物治療錯誤、缺乏有效性的報告、對沒有充分科學根據而不被認可的適應證的用藥、急慢性中毒的病例報告、與藥物相關的病死率的評價、藥物的濫用與錯用、藥物與化學藥物、其他藥物和食品的不良相互作用。其最終目標為提高醫療質量及與藥品應用相關的安全性；提高公眾的健康及與藥品應用相關的安全性；有利于與藥品的收益、危害、效果及風險的評估，鼓勵安全、合理和更有效（包括經濟）地使用藥品；促進對藥物警戒的理解、教育和臨床培訓以及與公眾的有效交流[4]。　　2006年以來國內發生的“齊二藥”、“欣弗”、“上海華聯（甲氨蝶呤）”等一系列藥害事件，都是從藥品不良反應監測系統上報的，因此，我們的藥品不良反應監測系統已經擴展為藥物警戒，即為控制藥品安全性問題提供預警。　　　……　　（查看完整版請下載PDF）

Continuous Quality Administrations of the Safety of Vein Detained Needles for Inpatients in the Department of Neurology

目的　探討神經科住院患者留置針安全的持續質量管理。 方法　選擇2011年8月－10月100例神經科住院患者，按入院時間先后排序分為對照組和試驗組，每組50例。對照組運用靜脈留置針的常規護理方法進行護理，試驗組在給予常規護理方法的同時實施一系列持續質量管理的措施，包括安排護理業務查房、組織操作示范、應用留置安全健康宣傳小卡片對患者進行宣教、定期不定期的留置質量檢查、將留置針安全作為一項交班內容、強調優質護理指針。留置針留置第3天對兩組患者使用同一自制量表調查留置期間的安全問題及患者對護理的評價，并對兩組調查結果進行統計分析。 結果　試驗組留置期間不良事件發生率為6.0%，對照組為34.0%，兩組差異有統計學意義（χ2=12.250，P=0.000）；試驗組對留置針留置安全知識的4個方面知曉情況均優于對照組（P=0.000）；試驗組對護理滿意度較對照組好（P=0.000）。 結論　持續質量管理增加了神經科住院患者留置針留置安全、增進了患者對相關健康知識的掌握，提高了患者對護理的滿意，值得臨床推廣。