Prospective randomized comparison of oral sodium phosphate and polyethylene glycol lavage for colono Prospective randomized comparison of oral sodium phosphate and polyethylene glycol lavage for colono

Prospective randomized comparison of oral sodium phosphate and polyethylene glycol lavage for colono

  • 期刊名字:世界胃肠病学杂志(英文版)
  • 文件大小:430kb
  • 论文作者:Kai-Lin Hwang,William Tzu-Lian
  • 作者单位:Department of Public Health, Center for Clinical Trials,Division of Colorectal Surgery at ChangHua Christian Hospital
  • 更新时间:2020-12-22
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论文简介

PO Box 2345, Beijing 100023, ChinaWorld I Gastroenterol 2005;11(47:7486-7493www.wjgnet.comWorld Journal of Gastroenterology ISSN 1007-9327wjg@wignet.comELSEVIER◎2005 The wjG Press and Elsevier Inc. All rights reserved.●CLINTCAL RESEARCH●Prospective rando mized comparison of oral sodiumphosphate and polyethylene glycol lavage for colonoscopypreparationKai-in Hwang, Wlliam Tzu-Liang Chen, Koung-Hong Hsiao, Hong-Chang Chen, Ting-Ming Huang, Chien-Ming Chiu,Ger-Haur HsuKai-Lin Hwang, Department of Public Health, Chung Shantransverse (94.6% vs 74.4%, P = 0.025) colon. lightlyMedical University, Taichung 402, Taiwan; Center for Clinicalmore patients graded the taste of NaP as "good" or "veryTrials, ChangHua Christian Hospital, Changhua 500, Taiwan,good" compared to the PEG patients (32.5% Vs 12.5%;ChinaP = 0.059). Patients' willingness to take the same prepa-William Tzu-Liang Chen, Koung-Hong Hsiao, Hong-Changration in the future was 68.4% in the NaP compared toChen, Ting-Ming Huang, Chien-Ming Chiu, Ger-Haur Hsu,75% in the PEG group (P = 0.617). There was a signif-Division of Colorectal Surgery at ChangHua Christian Hospital,cant increase in serum sodium and a significant decreaseChanghua 500, Taiwan, ChinaThis study was conducted at the Division of Colorectal Surgery atin phosphate and chloride levels in NaP group on the dayfollowing the colonoscopy without any dlinical sequelae.ChangHua Christian Hospital, Changhua 500, Taiwan, ChinaCorrespondence to: Dir. William Tzu-Liang Chen, Division ofProlonged (>24 h) hemodynamic changes were also ob-Colorectal Surgery, ChangHua Christian Hospital, 135 Nanhsiaoserved in 20-35% subjects of either group.Street, Changhua, 500, Taiwan, China. 37599@cch.org.twTelephone: +886- 4-7238595 Fax: +886-4-7227945CONCLUSION: Both bowel cleansing agents provedReceived: 2005-04-07Accepted: 2005-07-08to be similar in safety and effectiveness, while NaP ap-peared to be more cost-effective. After identifying andexcluding patients with potential risk factors, sodiumphosphate should become an alternative preparation forAbstractpatients undergoing elective colonoscopy in the Taiwan-AIM: To compare the effectiveness, patient acceptability,ese population. ,and physical tolerability of two oral lavage solutions priorG 2005 The W)G Press and Elsevier Inc. AIl rights reserved.to colonoscopy in a Taiwanese population.METHODS: Eighty consecutive patients were random-Key words: Colonoscopy; Bowel preparation; Sodiumized to receive either standard 4 L of polyethylene glycolphosphate; Polyethylene glycol(PEG) or 90 mL of sodium phosphate (NaP) in a splitHwang KL, Chen WTL, Hsiao KH, Chen HC, Huang TM,regimen of two 45 mL doses separated by 12 h, prior toChiu CM, Hsu GH. A prospective randomized comparisoncolonoscopic evaluation. The primary endpoint was theof oral sodium phosphate and polyethylene glycol lavagepercent of subjects who had completed the preparation.for colonoscopy preparation. World J Gastroentero/ 2005;Secondary endpoints included colonic dleansing evalu-11(47): 7486-7493ated with' an overall assessment and segmental evalua-http://www.wjgnet.com/1007-9327/11/7486.asption, the tolerance and acceptability assessed by a self-administered structured questionnaire, and a safety pro-file such as any unexpected adverse events, electrolytetests, physical exams, vital signs, and body weights.INTRODUCTIONRESULTS: A significantly higher completion rate wasColonoscopy has become an essential procedure for thefound in the NaP group compared to the PEG groupdetection and treatment of colonic lesions; therefore,(84.2% vs 27.5%, P<0.001). The amount of fluid SuC-cleansing the bowel for adequate visualization of thetioned was significantly less in patients taking NaP VSmucosa during colonoscopic examination isPEG (50.13+54.8 cc vs 121.13+115.4 c, P<0.001),important. In the past two decades, various boweleven after controlling for completion of the oral solutionpreparation methods have been proposed including castor(P = 0.031). The two groups showed a comparabledinhenulmathanes, phenolphthalein,overall assessment of bowel preparation with a rate of"good" or "excellent" in 78.9% of patients in the NaPand中国煤化工tion with a low residuegroup and 82.5% in PEG group (P = 0.778). Patientsdiet'TYH.CNMHGansing agents, cleansingenembowel preparations .taking NaP tended to have significantly better colonicThe introduction of polyethylene glycol (PEG) in 1980,segmental cleansing relative to stool amount observedin the descending (94.7% Vs 70%, P = 0.007) andan osmotically balanced solution, gradually replaced the7487Hwang KL et al. NaP vs PEG for colonoscopic bowel preparationrigorous traditional 2 d preparation of enemas, a。MATERIALS AND METHODSliquid diet, and laxatives in various combinationsPatients and methodsAlthough PEG provided safe and effective bowel cleansing,From August 2003 to December 2003, 80 consecutivethe patient was required to take 3-4 Lof a salty tastingpatients who underwent elective colonoscopy weresolution within a short period of time'e61. As repotted,enolled in this study. Eligible patients who had given5-15% of patients were unable to finish the prescribedwritten informed consent were randomized to receivedosagelhio, potenialy resuling in a pootly cleansed coloneither the standard 4 L of PEG (Klean Prep solution;and inadequate colonoscopic assessment'Helsinn Birex Pharmaceuticals Ltd, UK) or 90 mL of NaPOral sodium phosphate (NaP), a highly osmotic(Fleet' Phospho soda*; C.B. Fleet Company, Inc, USA),cathattic containing monobasic and dibasic sodiumin a split regimen of two 45 mL doses separated by 12 h,phosphate, was first evaluated by Vanner et al' in 1990prior to the colonoscopic evaluation. Colonoscopy wasby comparing it with PEG solutions. The mechanism ofscheduled after 8:00 a.m. for all the subiects, and studyNaP is through the osmotic effect of phosphate. Thissubjects werc asked to report to the endoscopy room bydraws large amounts of water into the bowe, creating a8:00 a.m. on the day of examination. Both groups wereflushing action and a laxative effect within 30 min afterinstructed to strt the preparation around 6:00-7:0 p.m.ingestion and lasting an average of 2-3 hle . Severalthe day before the colonoscopy. One sachet of Kleanstudies have been conducted to compare both NaP andPrep should be diluted in 1 L of water (repcat for all fourPEG solutions, the majority of which have suggested asachet) and one glassful (250 mL) of the solution wouldsuperiority or ecquivalence of NaP for adequate mechanicalbe taken every 10-15 min until the entire solution wasbowel preparation and sfty1-1r21.2. Moreover, NaPconsumned. The first 45 mL dose of Flee Phospho-sodawas provennotrecost-ffective and has since been used”(diluted with a cold clear liquid or water by 1:16) wasworldwide'With few studies being conductedtaken at 6:00-7:00 p.m. on the previous evening, and thein Singapore and Hong Kong24-20, the effectivenesssecond dose was taken at 6:00-7:00 a.m. on the day ofand safety of NaP for bowel preparation has not beenthe colonoscopy. A clear liquid dict was allowed duringprospectively asessed within the confines of a trial inthe bowel preparation. This study was approved by boththe Taiwanese population. Due to the National Healththe Health Department of Taiwan and the InstitutionalInsurance (NHI) policy in Taiwan, only one bottleReview Board of ChangHua Christian Hospital, Traiwan.of magnesium citrate solution (MagVac, Pfizer Inc,Exclusion criteria included symptomatic congestiveUSA) combined with six tablets of Bisacodyl (Durolaxheart failure, myocardial infarction, serum creatinine,, Boehringer-ingelheim GmbH, Ingelheim, Germany)greater than 1.5 mg/dL, abnormal live function definedare covered by NHI for bowel preparation; however, theas glutamic- oxaloacetic transaminase (GOT)/ glutamic-results of bowel cleansing are oftenI unsatisfactory. Otherpyruvic transaminasc (GPT) greater thanagents such as Klean Prep (Helsinn Birex Pharmaceuticalselectrolyte abnormalirties, gastrointestinal obstruction,Ltd, UK), a PEG solution, and Fleet' Phospho-sodagastric retention, bowel perforation, obstructive or。(C.B. Fleet Company, Inc., Lynchbutg, VA, USA), aparalytic ileus, uncntolled hypertension, unstable anginaNaP solution licensed after this trial, may be availablepetoris, pregnancy or breast feeding, and severe chronicat patients' own expense, if the hospitals carry suchconstipation.products. Most of the elective colonoscopic evaluationsDemographic characteristics such as age, gender, priorwere performed at outpatient practicc in Taiwan. Patientsbowel preparation experience, indication for colonoscopy,were scheduled for the examination on the day of consent,and medical history were obtained for all the patients.and bowel preparation agents were dispensed off on theLaboratory assessment including blood urea nittogensame day along with both written and or(BUN), GOT, GPT, sodium Na), potassium (K), chloridePatients were advised to start the preparation at home on(CI), calcium (Ca), and phosphate (P), were done for allthe evening before the day of colonoscopy and only clearpatients at baseline (the day of screening and consent,liquids were alowed after the procedure. The price ofwithin 15 d prior to colonoscopy) and on the day followingregular use of Klean Prep is NTS800 (about US$25) forcolonoscopy. In addition, a pregnancy test was performedfour sachets (to be diluted to 4 L solution for use), while aon all the female patients and an clctrocardiogram was90 mL Fleet Phospho- soda costs NT$380 (aboutperformed on all the patients if no data were availableUS$12). Since Fleete Phospho soda had not been licensedwithin the priot 6 mo, during the initial screening visit.by the Department of Health (IDOH), Taiwan, until theBody weight and troutine vital signs, including pulse rate,results of this bridging study were available, and most ofblood pressure, and temperature were obtained at baseline,the doctors here do not have muchexperience with it,on the day of colonoscopy, and on the following day.it becomes essential to provide effectiveness and safetyBlood pressure and pulse rate were mcasured with thedata in this population along with cost-effective concerns.patieresting for 5 min) andThis study was undertaken to prospectively comparestand中国煤化工sositons.the effectiveness, patients' accptability, and physicalTHC N M H Ged qustionnaire wastolerability berween the NaP and PEG in the Taiwanese... pauuito assess the tolerance,population.acceptability, and palatability of the bowel preparation7488ISSN 1007-9327CN 14-1219/ RWorld J Gastroenterol December 21, 2005 Volume 11 Number 47Table 1 Grades of bowel cleansingTable 3 Consumption rate of oral solutionScore Stool amountPercent wall Overall assessmentNaP(n-38)PEG(m- 40)consistencyvisualizedVariablesN%pNone≥90%Consumption rate (%)1SmallClear lavage 75 89% Excellent (small100%84.211275<0.001volume of clear liquid)1537.52 Moderate Liquid stool 50-74% Good (large volume ofclear liquid)<75%Large ;Particulate≤49% Fair (some semisolidMeantSD'97.216.973.4+21.1stool that could beMedian (range)100 (75-100)75 (25-100)suctioned or washed'Mantel-Haenszel x2 test and t-test when appropriate. "SD: standardSemi-solidPoor (seni-solid stooldeviation.stoolaway)Solid stoolStatistical analysisThe Mantel-Haenszel x test and Fisher's exact test wereTable 2 Demographic characteristics and prior bowel preparationused to compare the ordinal scores of the global andexperiencesegmental asssment of bowel cleansing and patient indexNaP(n-40) PEG (n= 40)of experience, preference, and acceptability between thetwo groups. The Cochran-Mantel-Haenszel x was usedGender0.178to compare these categorical variables between the twoMale1845.0 2562.5groups, controlling for the completion of oral solution.Female2255.037.General linear regression analysis was conducted by SASProc GLM procedure (SAS v.8.12, SAS Institute Inc, Cary,52.2+13.652.4+12.6NC, USA) for the comparison of continuous variables51.9 (25.6-75.60) 54.2 (23.1-773)between the two groups, contolling for the completionFrame size0.571of oral solution. Changes ftom baseline of the laboratorySmall (BM1<21)615.0tests and vital signs were analyzed across the treatmentMedium (BM1:21-24)75.065.0groups by the paired -test. With a one-sided test, type ILarge (BMI>24)10.020.0ertor rate of 0.05, power of 80% and a drop out rate ofConcomitant edlication1012.51.007.5%, 40 patients for each group are needed to distinguishAnti-hypertensive2Othersthe difference of completion rate between a 62% forPrevious bowel preparation1.000 .Klean Prep and 87% for Fleet" Phospho-soda' 8 Solution.1332.535.0Fisher's exact test or 2-sample Student's t-test, when appropriate. 'SD:RESULTSstandard deviation.and completed the study, 'two NaP subjects were excludedmethod. The taste of the oral solutions was graded as veryfrom effectiveness analysis due to invalid laboratory testspoor, poor, fair, good, and excellent. The ease of takingat screening visit. The demographic characteristics andor swallowing, convenience, and the entire preparationprior bowel preparation experience of all the 80 patientsprocess were graded as very difficult, difficult, tolerable,are summarized in Table 2. No significant differences ineasy, and very easy. The occurrence and severity ofany of these variables were observed between the twoseveral adverse events commonly associated with bowelgroups. The major indications for colonoscopic evaluationpreparation, the percentage of the solution ingested, andwere change in bowel habits (34/80; 42.5%), history ofwillingness to repeat the assigned preparation in the futurepolyps (11/80; 13.8%), bleeding (11/80; 13.8%), familywere also addressed in the questionnaire. Patients werehistory of colorectal cancer (10/ 80; 12.5%), and cancerinstructed to complete and return the questionnaire priorsureillance (9/ 80; 11.3%). There were four patients (threeto the colonoscopy.from NaP, and one from PEG group) in whom the cecumA single surgeon who was blinded to the type ofwas not reached due to a surgical history of colorectalpreparation performed all of the colonoscopies. The timecancer. None of the baseline variables for the laboratoryto reach the cecum, the scope of insertion and removalassessment/vital sign measurements were significantlytime, the volume of fluid irrigated and suctioned, anddifferent between the two groups. However, the NaPthe level of the colon reached were recorded: Colonicgroup had a significantly higher preparation completioncleansing was evaluated as to the amount and consistencyrate than the PEG group (84.2% vs 27 .5%, respectively;of stool and the estimated percentage of the bowel wallP<0.中国煤化工visualized at the level of the rectum, descending colon,transverse colon, ascending colon, and cecum, as wellAsse|YHCNMH Gas the overall assessment rated by the colonoscopist andThe amount of fluid suctioned was significantly lessscored according to the scale shown in Table 1.in patients taking NaP than those taking PEG (50.13土Hwang KL et al. NaP VS PEG for colonoscopic bowel preparation7489Table 4 Overall assessment of preparation by the colonoscopist and stratified by completion of solutionGroupExcellent (%)Good (%)Fair(%)Poor (%)xmHPGood/excellent (%)POverallNaP (n=38)22 (57.9)8 (21.1)8(21.1)0 (0.0)0.64830 (78.9)0.778'PEG (n - 40)22 (55.0) .11 (27.5)3(7.5)4 (10.0)33 (82.5)Complete1000.584"0.3212NaP (n = 32)19 (59.4)7(21.9)6 (18.8)0(0.0)26 (81.)PEG (n-11) .8(72.72(18.2)1 (9.1)10 (90.9)Incomplete0-99NaP (n= 6)3 (50.0)1 (16.7)2 (3.3)466.)PEG (n= 29)14 (48.3)9 (31.0)2 (6.9)4 (13.8)23 (79.3)'Fisher's exact test. Cochran-Mantel-Haenszel x2 test contolling for completion of oral solution.Table 5 Colonic segmental assessment of preparationStool amount (none/small) N(%)Stool consistency (none/clear lavage) N (%)% Colonic wall visualized (≥75%)N(%)NaP(N=38) PEG(N- 40)NaP (N=38) PEG (N= 40)FNaP(N-38) PEG (N= 40)Rectum37 (974)0.05731 (81.)32 (80.0)1.00037 (97.4)37 (925)Descending36 (94刀)28 (70.0)0.00732 (84.2)33 (825)38 (100)35 (87.5)0.055Transverse'35 (94.6)29 (74.)0.02531 (83.8)34 (87.2)75237 (100)037 (94.9)0.494Ascending'35 (100)35 (89.7)0.11724 (68.6)31 (79.5).30238 (974)Cecum223 (65.刀)0.2020.495'One patient in NaP group and 1 in PEG group did not have this data. "Three patients in NaP group and 1 in PEG group did not have this data.54.8 cm’vs 121.13+115.4 cm', respectively; P<0.001),respectively; P = 0.059). No differences were observedeven after controlling for the completion of oral solutionrelative to ease of taking or swallowing, convenience,(P = 0.031). The two groups showed a comparable overalland ease of the entire preparation process, althoughassessment of bowel preparation with a grade of“good”slightly more patients in our study taking PEG rated theseor "excellent" in 78.9% in the NaP and 82.5% in the PEGvariables as“good/casy"” or“very good/easy". Whengroup (P = 0.778) (Table 4). Patients taking NaP tendedasked whether the patient would take the same preparationto have significantly better colonic segmental clcansingin the future, 26 (68.4%) in the NaP group and 30 (75%)as assessed by the colonoscopist in the amount of stoolin the PEG group replied“yes”(P = 0.617). Amongobserved in the descending (P = 0.007) and transversethe patients who had previous experience with bowel(P = 0.025) colon, even after controlling for the completionpreparation, 8 (66.7%) of the 12 teceiving NaP and 11of oral solution (P = 0.006 for descending and P = 0.048(78.6%) of the 14 receiving PEG would have the samefor transverse colon). Twenty -two (57.9%) patients in thepreparation in the future (P = 0.665).NaP gtoup had the stool amount graded as“none”for thedescending and 22 (59.5%) for the transverse colon, whileAdverse eventsonly 11 (27.5%) and 16 (41%) patients in the PEG groupA total of 33 patients had 117 adverse events in the NaPhad perfect visibility in the descending and transversegroup and 33 had 91 adverse events in the PEG group.colon, respectively. Furthermore, more patients in the NaPThese are summarized in Table 6. Although patients whogroup had a grade of“none”in terms of stool consistencyreceived NaP had a slightly higher incidence than thoseand≥90% of the colonic wall visualized throughout thewho received PEG, no significant differences betweenentire colon, although this difference was not statisticallythe two groups were observed. One 32-year-old femalesignifcant. A slightly better grade in the rectum (P = 0.057)patient in the NaP group who had a history of allergiesrelative to stool amount and in the descending colon forto seafood was taking Lorazepan (Ativan, Wyeth, USA)percent of wall visualized (P = 0.055) was also obscrved infor insomnia during the study period. Consequently, thethe NaP group (Table 5).patient experienced severe nausea, dizziness, and chillsafter taking the entire NaP solution. The patient's follow-Patient acceptabllity and preferenceu中elctrolytes were normal and all the symptoms subsidedWhen assessing for the taste of the bowel preparation,on the day following the colonoscopy.four patients disliked the NaP and did not wish to have中国煤化工this preparation again, while slightly more patients enjoyedSeruthe taste and rated it as“good" or“very good”comparedComYHC N M H Golonoscopy laboratoryto patients taking PEG (13/40, 32.5% us 5/40, 12.5%,assessment revealed a signiticantly elevated Na, while CI7490ISSN 1007-9327CN 14-1219/ RWorld J Gastroenterol December 21, 2005 Volume 11 Number 47Table 6 Cccurrence and severity of anticipated adverse eventsNaP(n=40)PEG (n =40)Mild Moderate SevereOCcurrencee (%)'MildModerate SevereOccurrence (%)'pNausea118 (45)1401.000Vomitin;10 (25)549 (25)1212 (30)0.248Abdominal pain16 (40)1111 (27.5)0.344Anal iritation100.482 .Dizziness4 (10)3 (7.5)Hunger pains7 (17.5)7(17.5)Headache6(15)Insomnia'5(128)2(5)0.263otal91tOcurrence rate was calculated by "frequency of occurrence/ total number of subject". Fisher's exact test for occurrence frequency of adverse events. 'Onepatient in NaP group was taking Lorazepan (Ativan, Wyeth, USA) for insomnia during the bowel preparation, therefore this event was not assessable for thispatient.Table 7 ElectrolytesNaP (n = 40)PEG (n -40)Overall2-SampleBaselineFollow-up Change'Follow-up Change' Baseline Follow-upChange'l-testMeantSD' MeantSD' MeantSD2 MeantSD MeantSD* MeantSD° MeantSD' MeantSD' MeantSD'Na(meq/L) 138.832.15 140.40+242 1.58+2.57* 138.85+215 10.+237 2.03+1.8383 138842.14 140.64+2.39 1.80+2350.370K (meq/L)3.99+0.34 3.86+0.39 -0.13t0.43 4.02+0.40 4.10+0.50 0.0940.40 4.00+0.37 3.98+0.46 -0.02+0.430.022"a (meq/L)104.93+2.75 101.48+277 -3.45+284° 105.20+2.85 101.43+2.38 -3.7842.71 105.06+2.78 101.45+2.57-3.61+2.76*0.602Ca (mg/dL)9.17+0.359.1740.39 -0.010.490.07+0.460.129P (mg/dL)3.4240.832.71+0.50 -0.71+0.76 3.2540.57 3.10+0.51 -0.160.57 3.340.712.90+0.54-0.43+0.73*<0.0016*P<0.05; 'P<0.01. 'Change: value obtained at follow -up visit - value obtained at baseline visit. 'SD: standard deviation. 'The change from baseline (change) wascompared between the two groups by independent 2-sample t-test.Table 8 Hemodynamic profileDay of colonoscopy change' fromFollow-up visit change' frombaselineNaPPEGPulse (beats/ min) meantSD'76.4+11.272.9+12.46.7+12.61.7+10.90.6+13.0Elevation in pulse rate +10 beats/min (n %13 (32.5%)8 (20%)9 225%)Elevation in pulse rate +20 beats/ min (n %)5(125%)4 (10%)3(7.5%)SBP' (mmHg) meantSD*128.0+16.4130.4+16.0-6.8+12.5-1.7+10.8.3+10.7-1.4+13.6Drop in SBP≥10 mmHg (n %)11 (27.5%)14 (35%7 (17.5%)Drop inSBP≥20 mmHg (n %)0 (0.0%)2(5%)'Change: value obtained at the visit - value obtained at baseline visit. SD: standard deviation. 'SBP: systolic blood pressure.and P were decreased in both groups (P<0.001; Table27.5- 32.5% subjects from each group on the day of7). The changes from baseline for both K and P werecolonoscopy after the preparation, and were seen insignificantly different (P<0.05), while the changes of Na,17.5-35% subjects on the day following the colonoscopicCl, and Ca were comparable between the two groups. Mostevaluation, though only <10% of the subjects had aof the laboratory values remained within the normal rangechange of > 20 beats/ min (mmHg) at the follow-up visit.and none of the patients complained of any discomfortFollowing the colonoscopy, after rest and resumption ofduring the follow-up period.a normal diet, most of the average values of vital signs,中国煤化工ody weight, and pulseHemodynamic profile and body weightrateFexcept blood pressureHemodynamic profile is summatized in Table 8. Change(chaMYHC N M H G all subjects: -2.8+12.3,tom baseline in pulse rate ( > 10 beats/ min) and systolicP = 0.042; diastolic BP: -3.5士7.9, P<0.001). None ofblood pressure (SBP≥10 mmHg) were observed inthese hemodynamic fuctuations were clinically significantHwang KL et al. NaP VS PEG for colonoscopic bowel preparation7491and no patients reported a syncopal episode or postural our data show that significantly more fluid was suctioneddizziness.in patients who took PEG than those taking NaP, while theamount of irrigation did not differ between the two groups.More fuid in the colon may result in missed colonic lesionsDISCUSSIONor tumors while the use of suction may cause more mucosalA“clean”colon is essential in colonoscopic examination forinjurythe early diagnosis of colonic neoplasia. A higher complianceThere were four patients who disliked the NaP and didrate for a bowel preparation agent will help to achieve thisnot wish to have this preparation again. The same situationgoal. In this study, 84% of the patients who received NaPwas mentioned by some studie , although some patientscompleted the entire bowel preparation regimen comparedreported discomfort with the NaP solution due to its saltywith only 27.5% of the PEG group (P<0.001). All fourand unpalatable taste, still found it easier to complete thanpatients in the PEG group who reported a“poor”grade forthe PEG solution due to the smaller volumes. Although theoverall assessment were associated with poor compliance.4 L required for the PEG solution is much grcater than thatConsistently more patients in the NaP group had perfectrequired for NaP, none of the patients in the PEG groupcleanliness in terms of the stool amount, stool consistency,complained about taking or swallowing the large amount ofand percent of colonic wall visualized in the majority of thesolution. Furthermore, none of them rated the conveniencecolonic segments compared to those paticnts in the PEGof taking or ease of the entire preparation as“very poor",gtoup. In out study, although significantly better performancethough the completion rate was also much lowet thanwas found in some of the colonic segmental evaluations,expected. In contrast to most of the other studies, slightlyNaP did not demonstrate a dramatio superiority over PEG inmore patients in our study taking PEG rated the ease ofterms of the overall assessment. Our results differ from thosetaking or swallowing, convenience of taking, and ease ofof previous studies that have repotted a 10-40% differencethe preparation as“good/easy" or“very good/easy", andin favor of NaPl61T71921. 4 . In addition to these studies, twoanswered "yes”to the question "would you take the sameAsian studies conducted in Singapore and Hong Kongpreparation in the future" compared with the NaP group,also indicated a significantly higher proportion of patientsalthough these differences were not statistically significant.reporting good or excellent grades with the NaP compared toThe majority of our patient population lived in rural areasthe PEG solutions (22% and 20% difference, respectively forand tended to unquestionably follow physician's instructionseach study; P<0.05). However, this study did not demonstratemore than their urban counterparts, which may explain theany statistically significant diffcrence between patientshigh satisfaction rates with the PEG preparation.receiving PEG who were gradcd as“good" or“excellent”The patients in our study reported a consistently higherin terms of overall assessment by the physician, comparedincidence of several anticipated adverse events than citedto those who took NaP (82.5% vs 78.9%, respectively;by other studis, although there was no significantP= 0.78). Although some of the studies used less amount, i.e.,difference between the two gtoups. Nevertheless, the NaP3 or 2L, instead of 4 L for PEG preparation'group had a slightly higher overall occurrence of thesethe trials adopted a standard amount of 4 L recommended bysymptoms than did the PEG gtoup. The majority of thethe manufacturer for a better cleansing result. The Hintertuxadverse events were graded as mild- to-moderate and hadstudy group even demonstrated that the 4 L PEG group wassubsided by the day following the colonoscopy. One patientsignifcantly superior to the 3 L PEG group. However, a in the NaP group who suffered from severe nausea, dizziness,remarkably low completion rate of PEG solution (27.5%)and chills was taking Lorazepan (Ativan, Wyeth, USA) forwas observed in this study. Using 75% as the cut-off for theinsomnia during the bowel preparation, This observationcompletion rate, i.e, 3 L of PEG solution, there were stillmight be just a coincidence or a result from multiple factors,14 (35%) subjects who failed to complete the PEGi.e., the concomitant use of NaP and Lorazepan alongpreparation in this study, which indicated a cultural differenccwith the patient's history of alrgy, which will need furtherin terms of the practice of bowel preparation. Insteadinvestigations. A transient hypophosphatemia was observed inof getting admitted to the hospital the day prior to the the NaP group the day following the colonoscopy, comparedcolonoscopic evaluation as did in some other trialsl9so, allto bascline. Hyperphosphatemia is a recognized consequenceof our subjects initiated the preparation at home withoutof sodium phosphate. According to the teports by Koltsassistance. With the large amount (4 L) of the solution,et al!E 4 and Huynh et al'", serum phosphate rose significantlysome subjects tended to stop drinking PEG when they felt2 h after NaP consumption, but subsequently returned tothat they were already clean. Others stated that they werenormal within 26 h. Since the preparation was done at theafraid of having the needs to go to the restroom on a bus orsubjects' residence, instead of continuous monitoring thea train to the hospital and therefore stopped taking the restelecttolytes during the preparation, only the value on the dayof the solution after going to bed in the night before theafter the colonoscopy was obtained to compare the baselinecolonoscopy. This kind of stress and inconvenience are less level, and therefore we failed to observe the elevation phaselikely to happen to inpatients, subjects who have their ownofs中国煤化工ly the dectease phase atvehicles or those who live close to the hospital. Contrary tomoreThe same pattern wasthe results reported by Cohen et al!" ”in which significantlyYHC N M H Gwhich serum phosphatemore fluid was suctioned ftom the colon after NaP, while of seven patents in Nar group elevated ftom 3.7+0.2 mg/dLmore irrigation was necessary to cleanse the bowel after PEG,on the day of admission to 7.2+0.6 mg/ dL at 8:00 a.m. on the7492ISSN 1007-9327CN 14-1219/ RWorld J GastroenterolDecember 21, 2005 Volume 11 Number 47day of colonoscopy, then dropped to 3.7+0.3 mg/dL at 4:00to concomitant medications. Although not clinicallyp.m. in the evening and to 3.1+0.3 mg/dL at 8:00 a.m. on thesignificant, some hemodynamic and electrolyte changesfollowing day. Consistent with known effect of oral sodiumwere prolonged more than 24 h. After identifying andphosphate solution, scrum sodium levels remained higherexcluding patients with potential risk factors, NaP shouldand potassium levels were lower than baseline on the daybecome an alternative bowel preparation for patientsfollowing the colonoscopy. Although different ftom baseline,undergoing colonoscopy in the Taiwanese population.most of the values were still within normal ranges and noneof the subjects developed any clinically relevant adverseREFERENCESevents that accompanied these metabolic changes after thecessation of the preparation.1 Yang HC, Sheu MH, Wang JH, Chang CY. Bowel preparationContraindications to the use of NaP have beenof outpatients for intravenous urography: efficacy of castor oilemphasized, and serious electrolyte disturbances havezversus bisacodyl. Kaohsiung I Med Sci 2005; 21: 153-158Chen cC, Ng ww, Chang FY, Lee SD. Magnesium citate-bi-been reported in individual patients taking oral sodiumsacodyl regimen proves better than castor oil for colonoscopicphosphate0-32. Some studies have indicated that NaP shouldpreparation. J Gastroenterol Hepatol 1999; 14: 1219-1222not be used in women who are pregnant or breast-feeding,Strates BS, Hofmann LM. A randomized study of two prepa-or patients with renal failure, congestive heart failure, ascites,rationsfor large bowel radiology. Phrarterapeute 1987; 5:57-61or congenital megacolonP4.35. Furthermore, hypokalemiaDelegge M, Kaplan R. Efficacy of bowel preparation with theresulting from the ingestion of NaP can increase the riskuse of a prepackaged, low fibre diet with a low sodium, mag-of cardiac arrhythmias in patients who are taking diureticsnesium citrate cathartic vs. a clear liquid diet with a standardor digialso,s 0. The proportion of subjects (27.5-32.5%)sodium phosphate cathartic. Aliment Pharmacol Ther 2005; 21:with a hemodynamic change greater than 10 beats/min in1491-1495Zmora 0, Pikarsky AJ, Wexner SD. Bowel preparation forpulse rate or 10 mmHg in systolic blood pressure on thecolorectal surgery. Dis Colon Rectum 2001; 44: 1537-1549morning of colonoscopy compared to baseline levels areDonovan IA, Arabi Y, Keighley MR, Alexander-Williams J.slightly higher than reported studies, i.e, 14-28% of oralModification of the physiological disturbances produced bysodium phosphate solution recipients with decreases inwhole gut irigation by preliminary mannitol administration.SBP >1.33 Kpa and 15-30% with changes in postural pulseBr I Surg 1980; 67: 138-139Minervini s, Alexander-Williams ], Donovan IA, Bentley s,≥10 beats/ min from baselinel9.30.3 ". Without taking anyKeighley MR. Comparison of three methods of whole bowelsolid food since the previous afternoon, suffering from theirrigation. Am J Surg 1980; 140: 400 402preparation process and insufficient sleep, along with an eatly eGrundel K, Schwenk W, Bohm B, Muller JM. Improvementscommute to the hospital (some had a commute longer thanin mechanical bowel preparation for elective colorectal sur-30 min), most of the subjects appeared weak on arrival atgery. Dis Colon Rectum 1997; 40: 1348-1352Davis GR, Santa Ana CA, Morawski sG, Fordtran JS. Devel-the endoscopic station. It might explain why the outpatientsubjects had a larger hemodynamic change on the day ofopment ofitofalavasolution associated with minimal waterand electrolyte absorption or secretion. Gastroenterology 19colonoscopy. compared with those who were admitted to78: 991-995the hospital on the previous dayl. One study repotted that10 DiPalma JA, Brady cE 3rd, Stewart DL, Karlin DA, McKinney12% NaP patients had changes in SBP> 20 mmHg", whichMK, Clement D], Coleman Tw, Pierson WP. 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