1、透析器復(fù)用經(jīng)驗交流Dialyser reuse1提要Contents 透析器復(fù)用Reason, disputes, methods of reuse 復(fù)用的原因和爭議及現(xiàn)狀 復(fù)用的方法部分B.Braun客戶使用、復(fù)用Diacap Polysulfone的經(jīng)驗experience of our customer復(fù)用中的可能問題Potential problems 2透析器復(fù)用1 復(fù)用的原因和爭議及現(xiàn)狀Reason, disputes a.復(fù)用的支持和反對意見Pros and cons b.復(fù)用現(xiàn)狀Whats on 2 復(fù)用的方法Methods a.自動復(fù)用Automatic b.手工復(fù)用Manu

2、al c.兩者的比較Comparison31.復(fù)用的原因和爭議及現(xiàn)狀 Reason, disputes a 復(fù)用的支持意見pros降低使用成本，減輕病人經(jīng)濟負擔economical consideration CTS, 1991改善生物相容性，減少相應(yīng)的免疫反應(yīng)increase biocompatibility Daugirdas and Ing,1988; Hakim and Lowrie, 1980 減少透析器首次使用綜合癥reduce 1st use syndrome Bok et al, 1980有利于環(huán)保environmental friendly4 透析器的性能受到的可能影響pos

3、sible influence of the dialyser Gotch , 1986; Cheung, 1999; Pizziconi, 1990消毒不嚴格帶來的可能后果malpractice of disinfection殘余消毒劑帶來的不利影響adverse reaction of disinfectant血液交叉感染/對濾器處理人員的危險cross infectiona 可能的不利因素cons5National Kidney Foundation report on dialyzer reuse. Task Force on Reuse of Dialyzers, Council o

4、n Dialysis, National Kidney Foundation. Am J Kidney Dis. 1997 美國腎病基金會報告The National Kidney Foundation takes no position for or against dialyzer reuse. The principal reason for the practice of reuse is economical. 經(jīng)濟原因決定復(fù)用In view of the uncertainties related to the safety and biological impact of reu

5、se procedures, the task force recommends that a full discussion of the issue of reuse and its potential beneficial and detrimental effects be undertaken with each patient. 復(fù)用的考慮應(yīng)個體化Dialyzers should not be reprocessed from patients who have tested positive for hepatitis B surface antigen. HBV陽性不應(yīng)復(fù)用Gi

6、ven the significant fall in dialyzer efficiency for urea removal that can occur after repeated uses of a dialyzer, dialysis prescriptions in units practicing reuse should be designed to deliver a Kt/V or URR value that exceeds the dose used for patients treated with single-use dialyzers to make allo

7、wance for any possible reuse-induced reduction in dialyzer efficiency. 治療劑量的調(diào)整The effects of reprocessing high-flux dialyzers on beta2-microglobulin clearance are dependent on the reprocessing technique, the number of reuses, and the nature of the dialyzer membrane used.復(fù)用技術(shù)對后續(xù)使用有很大影響 6The effect of

8、 dialyzer reuse on dialysis delivery.Sherman RA,Cody RP,Rogers ME,Solanchick JC Sherman Department of Medicine, UMDNJ-Robert Wood Johnson Medical School, New Brunswick Am J Kidney Dis. 1994 Dec;24(6):924-6.濾器復(fù)用對治療的效應(yīng)Prospective 436-patient, 34-center study. All patients underwent formal urea kinetic

9、 modeling monthly, usually for 3 sequential months. Dialyzers were reprocessed and reused in the usual manner for each unit. Kt/V urea for the treatment using the dialyzer with the most reuses (mean, 13.8) was compared with that with the treatment using the dialyzer with the fewest reuses (mean, 3.8

10、). The mean Kt/V delivered for high reuse treatments was significantly lower than that for low reuse treatments (1.05 v 1.10, P = 0.002). 復(fù)用對清除產(chǎn)生明顯負面的影響Of the 23 centers using formalin-based reprocessing, an average difference of or = 0.12 (mean, 0.17) in Kt/V between high and low reuse treatments w

11、as seen in 10 centers. Dialyzer reprocessing significantly impairs dialysis delivery, an effect that may be related to the methods and procedures in individual dialysis centers.復(fù)用過程對治療效果有極大影響7b.復(fù)用現(xiàn)狀whats on US Reuse of dialyzers and clinical outcomes: fact or fiction. Agodoa L, Wolfe RA, Port FK Am

12、J Kidney Dis 6:S88-S92, 1998 Since its introduction in the United States more than two decades ago, the practice of dialyzer reuse has continued to grow. In recent years, it appears to have been based mainly on economic, rather than medical, considerations. demographic, comorbidity, laboratory, trea

13、tment, socioeconomic, and insurance data on a large random sample of approximately 20,000 of the US dialysis patient population over a 3-year period, using the dialysis records. Data were collected 20,000 個病人納入研究The results show that there has been a significant increase in the practice of dialyzer

14、reuse in the United States. 濾器復(fù)用在增加Large regional differences exist, and reuse is greatest in freestanding for-profit (FSFP) units (87%) and freestanding nonprofit (FSNP) units (77%) and least in hospital units (49%).復(fù)用的分布情況與醫(yī)療機構(gòu)性質(zhì)有關(guān) 8b.復(fù)用現(xiàn)狀whats on HEMODIALYZER REUSE: CONSIDERATIONS OF SAFETY AND C

15、OSTS. Montreal: CTS, 1991. 65 復(fù)用的使用及經(jīng)濟學(xué)分析Since dialyser reuse was first described in 1969, it has been employed with increasing frequency in the United States of America where the percentage of patients who reuse their hemodialysers has increased from 18% in 1976 to 72% in 1988. In Europe, the gener

16、al level of reuse is lower average 10% in 1988. Differences between European countries are however, considerable, for example; Belgium 19%, United Kingdom 16%, Denmark 12%, France 8%, Sweden, Norway, Holland and Ireland all below 1%. In Canada, in 1987, 13% of dialysis centres practised reutilizatio

17、n. 歐洲的情況Economic consequences of reutilisation in QuebecTo gain some idea of the possible savings which might be achieved in Quebec, a study was made of the difference in direct cost between single use and multiple reuse 6 to 11 times of hemodialysers. It was estimated that 5 reuses might generate e

18、conomies of approximately $3,245 dollars per patient per year $2,700 to $3,800. The saving associated with 10 reutilisations would be of the order of $3,500 per year.十次復(fù)用可達的每年經(jīng)濟效應(yīng)Further estimations can be made on the assumption that only in units in excess of 30 patients would it be economically fe

19、asible to purchase automated reconditioning equipment. If all such units practised 10 reutilisations for each patient in whom there were no contraindications, the total saving would be between 2 and 2.7 million dollars per year.復(fù)用規(guī)模效應(yīng) In the U.S.A., companies are available to collect, recondition an

20、d re-distribute hemodialysers at a cost of approximately of $6 per use. 專業(yè)化經(jīng)營 9BACKGROUND AND AIM: Dialyser reuse treatments in Korea were first practised at a facility in 1985. Until 1999, there was only one facility practising dialyser reuse treatments, but the reuse practice has gradually increas

21、ed since 1999. The purpose of this study was to gather and analyse the current (April 2002) dialyser reuse treatment data in Korea. METHOD AND RESULTS: Data was collected via a questionnaire sent to the each hospital that reuses the dialyser, and we received a response from 26 out of 29 facilities (

22、89.7%). Twenty-nine facilities comprised 7.7% (29 of 376) of the total nationwide haemodialysis facilities in Korea. The percentage of patients on dialyser reuse treatments was 6.2% (1234 of 20,010). All facilities used an automated reuse processing technique for dialyser reuse and 22 facilities use

23、d a peracetic acid mixture (PAM) without hypochlorite. There was one facility that used the heated citric acid method. Eighty per cent of facilities used only high flux membranes (Kuf or = 20 mL/h per mmHg) and 12% of the facilities used both high and low flux membranes. The average number of the re

24、use treatments was 15-fold (range 10-22) and the average of the maximum number of reuse treatments was 20-fold (range 10-50). CONCLUSION: Although dialyser reuse treatments are not a common practice in Korea, the reuse programs are steadily increasing. Strict quality control and further regulations

25、regarding the reuse program should be promptly enacted to provide a better quality of haemodialysis treatment for patients in Korea.復(fù)用率不高；復(fù)用次數(shù)大于中國；尚無嚴格法規(guī)Status of dialyser reuse in Korea.Cho HKCho HK,Shin GT,Kim H Nephrology (Carlton). 2004 Aug;9(4):212-6. Department of Nephrology, Ajou University S

26、chool of Medicine, Suwon, Korea.韓國的復(fù)用10中國China中國大陸范圍約七成為復(fù)用市場70% reuse經(jīng)濟原因?qū)?fù)用有直接關(guān)系，有一些地方有強制非復(fù)用規(guī)定economical reason is the motivation自動，手工復(fù)用同時存在，以后者為主；復(fù)用質(zhì)量有待提高both manual and automatic112.復(fù)用方法methodsa.自動復(fù)用automatic reuse標記labeling自動沖洗rinse自動安全測試safety test自動消毒液灌注disinfection科學(xué)化管理（條碼識別）management12b.手工復(fù)

27、用過程概述manual method標記 labeling 下機后沖洗 cleaning after use安全檢測 safety check消毒和保存 disinfection and store 使用前沖洗 rinsing 目的是為沖去殘余消毒劑，避免不良反應(yīng)的發(fā)生。預(yù)充及循環(huán)管路 rinsing, circulation 循環(huán)管路是為了最大限度降低濾器中消毒劑濃度，防止透析中不良反應(yīng)的發(fā)生，也有觀點認為循環(huán)管路時加做超濾會有益于抗凝。13c.兩者的比較comparison自動復(fù)用automatic對沖洗水壓，水流控制更好，更穩(wěn)定；避免了不良反應(yīng)的發(fā)生stable control, les

28、s complication避免了處理時的個體差異universal in practice節(jié)約了人力和時間用于病員護理saving of manpower保證復(fù)用質(zhì)量better QC手工復(fù)用manual 節(jié)約成本，機動靈活cost effective for small scale practice, flexible14B.Braun客戶使用Polysulfone的經(jīng)驗1 上海華山醫(yī)院血透中心2 上海浦東新區(qū)人民醫(yī)院腎臟科3 上海南匯區(qū)人民醫(yī)院腎臟科4 四川大學(xué)華西醫(yī)院血透中心5 中山大學(xué)附屬一院6 深圳紅會醫(yī)院血透中心7 馬來西亞用戶經(jīng)驗15上海華山醫(yī)院血透中心目前有血透機40臺貝朗機

29、器12 臺，其中Advance6臺，HDF online機4臺，Dialog+2臺固定透析病員數(shù)約150人161.下機后沖洗rinsing使用反滲水沖洗, 水壓一般介于0.1-0.2Mpa/cm2間。在氣溫較低時，用溫水沖洗，低溫水會促使血液凝結(jié)，使凝塊更難沖洗。沖洗時逆血流方向進行，即濾器內(nèi)由靜脈端向動脈端沖，還應(yīng)包括正向（超濾）及反向（反超濾）沖洗。如血凝塊存在，使用0.2%過氧乙酸浸泡，直至目測洗出液變清。將過氧乙酸注入透析液室及血室，依靠彌散來發(fā)生作用。（低濃度溶液使血塊溶解，高濃度溶液使血塊凝結(jié)。）應(yīng)對所用消毒劑的濃度進行檢查，明確是否使用了適當?shù)臐舛?。再次沖洗直至洗出液清亮172.

30、安全檢測safety test血室容積試驗，血室容積不小于原值80%(TCV test) 血室容積下降反映透析室內(nèi)有可能的微小血塊或蛋白殘留，將對下次的透析產(chǎn)生影響破膜試驗(Membrane Rupture Test) 將血路一端堵死，使用250-270mmHg的壓力在另一端進行檢測，沒有泄漏為準不能通過兩項試驗者應(yīng)棄去。(Discard for those can not pass the test)183.消毒和保存disinfection and storage灌入消毒劑之前應(yīng)確定水分已完全排除，避免消毒劑被水份稀釋，無法達成消毒效果。灌入相當三倍血室容積的消毒劑使用0.4%過氧乙酸溶液

31、進行封管消毒，持續(xù)至少12小時后備用，有效7天。將血室及透析液室均灌滿消毒劑后，封口，置于冷藏室中194.使用前沖洗rinsing首先將透析器內(nèi)消毒劑放空使用至少1000ml0.9%生理鹽水沖洗，將此水放空而不應(yīng)同時用于循環(huán)管路。 205.預(yù)充及循環(huán)管路priming and circulation預(yù)充血泵速度為150ml/min。過快的預(yù)充速度會在管路中導(dǎo)致湍流，產(chǎn)生小氣泡，對以后的凝血起重要的促進作用。預(yù)充時仔細檢查，確認管路中沒有氣泡的殘留。0.9%NS500ml循環(huán)管路,血泵速 300ml/min，循環(huán)20min, 循環(huán)末期回路中加入20mg左右的肝素循環(huán)，使管路及濾器上可以吸附部分肝

32、素。216.抗凝劑的使用anticoagulation首劑0.4mg/kg, 維持量0.080.16mg/kg/h; 使用單次追加法的時候首劑量較持續(xù)推注維持法時可能要大。首劑肝素510min后開始引血， 低分子肝素使用，常規(guī)情況在開始前使用一劑可滿足治療需要?，F(xiàn)常用以下種類，于血透開始前動脈端注入： 速避凝 (Fraxiparine)0.4ml吉派林 5000法安明 (Fragmin) 5000 22上海浦東新區(qū)人民醫(yī)院腎臟科Peoples Hospital,Pu Dong New Area, Shanghai 血透機20臺Dialog advance 單泵 6臺，雙泵2臺，plus 4 臺

33、，Secura 2臺透析病員數(shù)約85人23反滲水沖洗，正向反向共10min，水壓0.1Mpa，直至洗出液清晰3.5%Renalin灌注消毒一晚備用二次使用前，管路連接完畢后用500ml鹽水沖洗管路；500ml循環(huán)管路加用超濾900ml/h，其中并加入肝素30mg；首劑肝素量30mg,引血前710min加入，追加5mg/h,低分子肝素一劑給完（復(fù)用血路管，同樣用Renalin消毒）復(fù)用至三次為止24下機后反滲水沖洗，正向反向，水壓0.1Mpa，直至洗出液清晰除蛋白：2%次氯酸鈉 浸泡一晚（已廢除）消毒處理： 3.5% Renalin 灌注， 可放置21天上機前先沖去消毒劑；血泵速 300ml/m

34、in, 循環(huán)15min加入 20mg Heparin 肝素：首劑2025mg, 追加 810mg/h，按公斤體重調(diào)整復(fù)用五次上海南匯區(qū)人民醫(yī)院腎臟科 Peoples Hospital, Nan Hui District, Shanghai2538臺透析機28臺B.Braun機器90個病人四川大學(xué)華西醫(yī)院血透中心Western China Hospital, Sichuan University26四川大學(xué)華西醫(yī)院血透中心Western China Hospital, Sichuan University反滲水沖洗至目測洗出液清晰1%次氯酸鈉透析器膜內(nèi)短時灌注兩次，除蛋白，去除沉積物 過氧乙酸浸

35、泡消毒，濃度至少0.5%以上,0.8%兩小時可復(fù)用27四川大學(xué)華西醫(yī)院血透中心 Western China Hospital, Sichuan University0.9%NS1000ml沖洗殘余消毒液肝素20mg加入鹽水500ml循環(huán)管路，約1020min首劑肝素2530mg,810mg/h追加高低通復(fù)用方法一致，復(fù)用八次28中山大學(xué)附屬一院No.1 Affiliated Hospital,Zhong Shan University 60余血透機器固定透析病人200余人透析器復(fù)用35次29兩袋鹽水(每袋1000ml)預(yù)沖管路,在預(yù)沖第二袋開始循管,循管量為500ml在循管加肝素,劑量為18-

36、22mg,加用超濾病人治療前體內(nèi)肝素化,劑量為18mg左右,治療中維持量為6-10mg/h 中山大學(xué)附屬一院No.1 Affiliated Hospital,Zhong Shan University 30深圳紅會醫(yī)院血透中心Hong Hui Hospital, Shengzhen血透機12臺貝朗機器9臺透析病員數(shù)約60人31深圳紅會醫(yī)院血透中心 Hong Hui Hospital, Shengzhen反滲水沖洗,直至洗出液清晰1%次氯酸鈉浸泡 ，膜內(nèi)膜外保持15min34%甲醛封管消毒四瓶鹽水(每瓶500ml)預(yù)沖,在預(yù)沖完1000ml(兩瓶)后,第三瓶循管,并開始加肝素,一般劑量為16-2

37、2mg，在此階段將機器設(shè)置到循管超濾模式 病人在治療前體內(nèi)肝素化,加入劑量為12-16mg。治療開紿后,肝素維持劑量為6-8mg/h。 32馬來西亞用戶使用方法Malaysian Experience40% 人工復(fù)用, 60% 自動復(fù)用 反滲水(RO)沖洗，水壓2大氣壓,直至洗出液清晰人工復(fù)用用2%過氧乙酸/3.54.5%福爾馬林消毒 ； 自動復(fù)用用3.5%Renalin消毒1L 鹽水用于使用前沖洗沖洗完成后使用試紙檢測殘余Renalin濃度肝素: 2000 IU 首劑, 1000 IU 追加 /3 hrs 可隨病人體重調(diào)整 33復(fù)用中的可能問題potential problems 1 復(fù)用次

38、數(shù)不夠fewer reuse times2 復(fù)用后破膜membrane rupture3 殘余消毒液反應(yīng)disinfectant reaction4 感染反應(yīng)infection34不適當?shù)氖褂孟緞?dǎo)致透析膜的損傷，在膜上形成毛糙面，有利于蛋白及血細胞的沉積，并進而導(dǎo)致凝血。Improper use of disinfectants推薦使用3.5%Renalin，在美國被50%以上的透析中心使用，證明了它的有效和安全性；次氯酸鈉及雙氧水的強大氧化作用對膜可能產(chǎn)生巨大的傷害。The effect of bleach35Dialyzer-dependent changes in solute and water permeability with bleach reprocessing.Scott MK,Mueller BA,Sowinski KM, Clark WR Am J Kidney Dis. 1999 Jan;33(1):87-96.（漂白劑對復(fù)用濾器清除率影響）We compared the effects of automated bleach/formaldehyde reprocessing on solute and hydraulic permeability for cellulose triacetate (CT190) and polysulfone