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Studies on Hospital Pharmaceutical Manufacturing. (VII). The Revision of Package Insert of 1%Methylene Blue Injection on the Basis of Clinical Need. 医院药品生产研究。(七)根据临床需要修改1%亚甲蓝注射液说明书。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.454
Moemi Saito, Machiko Watanabe, H. Ogata, K. Edo
One percentage Methylene Blue (MB) injection prepared in our hospital pharmacy has been used at concentrations of 0.05% and 0.25% for the treatment for methemoglobinemia and septic shock. In order to provide more information on “the package insert” which we have been making since 1996, we performed a pH variation test using a 1% MB injection and a stability test for 0.05% and 0.25% MB injections.The changes in MB absorbance were monitored by the UV spectrometry method. No significant changes in MB absorbance were observed either at room temperature and 40°C at 1000 Lux fluorescent light or in darkness for 48 hours, under 0.05% or 0.25% MB injection conditions. Based on these results, we were able to increase the amount of information regarding the pH variation tests and stability tests on our package insert.
我院药房配制的1%亚甲基蓝(MB)注射液,浓度分别为0.05%和0.25%,用于治疗高铁血红蛋白血症和感染性休克。为了提供更多关于我们自1996年以来一直在制作的“包装说明书”的信息,我们使用1% MB注射剂进行了pH变化测试,并使用0.05%和0.25% MB注射剂进行了稳定性测试。紫外分光光度法监测MB吸光度的变化。在室温和40°C 1000 Lux荧光灯下,在0.05%或0.25% MB注射条件下,在黑暗中48小时,均未观察到MB吸光度的显著变化。基于这些结果,我们能够在包装说明书上增加有关pH变化测试和稳定性测试的信息量。
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引用次数: 2
Investigation of the Physicochemical Properties of Medicine in the Ground Tablets and the Evaluation for Dispensing Characteristics of Ground Tablets. 粉剂中药物理化性质的研究及制剂特性评价。
Pub Date : 2000-01-01 DOI: 10.5649/jjphcs1975.26.532
T. Hanawa, K. Kawata, Rie Ueda, A. Ito, M. Ohkuma, S. Nakajima
The effect of grinding of the carbamazepine (CBZ) tablets (Tegretol® tablet; Teg-tab.) on the physicochemical properties of carbamazepine was investigated using X-ray diffraction, differential scanning calorimetric and fourier transform infrared spectrophotometric measurements. The ground samples were prepared by grinding Teg-tab. using an electrical tablet grinder or an agate mortar and pestle. There were no changes in the crystallinity of CBZ before and after grinding. In the infrared spectra of the ground sample prepared by the electrical tablet grinder, a peak shift suggesting a molecular interaction between CBZ and its excipients were observed. The dissolution rates of CBZ from the ground samples prepared by using an electrical tablet grinder were faster than those of Tegretol® fine granules or the ground samples prepared using the agate mortar and pestle. According to the measurements of the mean diameters of the ground samples, the differences in the dissolution behavior of the ground samples were due to the mean diameter of the ground samples, namely, the smaller the mean diameter by the elongation of the grinding time, the faster the CBZ dissolved. Furthermore, the dispensing characteristics of the ground samples were evaluated. As a result, the dispensing characteristics of the ground samples were observed to possibly greatly depend upon the micromeritical properties of the ground samples, such as the bulk density, compressibility and uniformity.
卡马西平(CBZ)片(Tegretol®片;采用x射线衍射、差示扫描量热法和傅里叶变换红外分光光度法对卡马西平的理化性质进行了研究。采用Teg-tab研磨法制备研磨样品。使用电动磨片机或玛瑙研钵和杵。研磨前后CBZ的结晶度没有变化。在电子磨片机制备的地面样品的红外光谱中,观察到一个峰移,表明CBZ与其辅料之间存在分子相互作用。与Tegretol®细颗粒或玛瑙臼杵研磨样品相比,电子研磨机研磨样品中CBZ的溶出速度更快。通过对磨样平均直径的测量,发现磨样溶解行为的差异是由于磨样的平均直径不同,即磨时间延长,磨样的平均直径越小,CBZ溶解越快。此外,还对地面样品的分配特性进行了评价。因此,我们观察到,地面样品的点胶特性可能在很大程度上取决于地面样品的微观特性,如体积密度、可压缩性和均匀性。
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引用次数: 0
Pharmacokinetics and Adverse Reaction in Methotrexate Therapy of Osteosarcoma. 甲氨蝶呤治疗骨肉瘤的药代动力学及不良反应。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.116
H. Ikeda, T. Sugita, K. Miyake, E. Sato, Y. Kimura, T. Kitaura, H. Fukuchi, Y. Ikuta, K. Kihira
The effect of the dosage of methotrexate (MTX) on pharmacokinetic parameters in renal, hepatic and hematological functions were investigated. Twenty osteosarcoma patients (age: 13-53 years) received MTX infusions (dosage: 3.3-11.2g/m2) for 6 hrs. The serum MTX concentrations at 6h, 12h and 24h increased almost proportionally with the infused dose. The total serum MTX clearance and half-lives were almost constant in all the dosing ranges examined.To evaluate the relationship between the dosage and laboratory values, the patients were divided into three groups based on the MTX dosage and consisting of: low-dose (dosage: 3.3-5.2g/m2), middle-dose (dosage: 5.4-8.3g/m2), and high-dose (dosage: 9.0-11.2g/m2) groups. There was no significant difference between the renal and hematological functions before MTX infusion. In the high-dose group, significantly increased GOT and GPT values were observed on days 2 and 7, which indicate a decreased in hepatic function.In spite of the linear pharmacokinetics of MIX, a high-dose may cause remarkably nonlinear increased GOT and GPT values compared to those with low-and middle-doses.To avoid a severe adverse reaction of MTX therapy in the high-dosage group, careful monitoring of both the serum concentration of MTX and the liver functions is considered to be important after infusion.
研究了甲氨蝶呤(MTX)剂量对大鼠肾、肝及血液功能药动学参数的影响。20例骨肉瘤患者(年龄13 ~ 53岁)接受MTX输注,剂量3.3 ~ 11.2g/m2,持续6小时。血清MTX浓度在6h、12h和24h几乎与注射剂量成正比增加。血清总MTX清除率和半衰期在所有剂量范围内几乎不变。为评价剂量与实验室检测值的关系,根据甲氨蝶呤剂量将患者分为低剂量组(3.3 ~ 5.2g/m2)、中剂量组(5.4 ~ 8.3g/m2)、高剂量组(9.0 ~ 11.2g/m2)。注射甲氨蝶呤前两组患者的肾功能和血液学功能无明显差异。高剂量组在第2天、第7天血清GOT、GPT值显著升高,提示肝功能下降。尽管MIX的药代动力学是线性的,但与中、低剂量相比,高剂量可能导致GOT和GPT值的显著非线性增加。为避免MTX治疗在高剂量组出现严重不良反应,输注后仔细监测MTX的血药浓度和肝功能是重要的。
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引用次数: 2
A Case Report of Docetaxel-Induced Recall Reaction. 多西他赛诱发回忆反应1例报告。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.642
T. Yae, Yumiko Tanaka, Emiko Yae, Shiori Kishita, S. Beppu, Motoki Kamura, Keigo Sakou, M. Kimura, K. Uemura
The patient was a 68-year-old woman who developed metastic lymphangitic carcinomatosis in the lung due to primary lung cancer. She was given docetaxel at a dose of 10 mg intravenously every 7 days. At cycle 9 of the chemotherapy, a small-volume extravasation of docetaxel occurred during an infusion through a percutaneously inserted peripheral intravenous line in her left hand.Thereafter, she developed edema and pain at the injection point, which almost completely resolved within 3 days. The 10 th cycle of the docetaxel was administered through the right antecubital vein without incident. However from 15-24 hours after the administration of docetaxel, edema, pain, erythema and piecing pain occurred at the site of the previous extravasation on the back of the left hand. These symptoms gradually progressed, and were more serious and extensive than previous phenomena. During the 2-month follow-up period, the symptoms have been decreasing slowly.“R adiation recall” reactions induced by docetaxel have been previously reported. However, no such “ recall” reaction after systemic re-exposure to docetaxel has ever been reported previously. Those involved in the administration of docetaxel should thus be aware of the possibility of this agent causing a “ recall” reaction at a previous extravasation site.
患者是一名68岁的女性,因原发性肺癌而发展为肺转移性淋巴管癌。每7天静脉给予多西紫杉醇10mg。化疗第9周期,患者左手经皮外周静脉输注多西紫杉醇时发生小体积外渗。此后,患者出现注射点水肿和疼痛,3天内几乎完全消退。第10个周期多西紫杉醇经右肘前静脉给药,无意外。然而,多西紫杉醇给药后15-24小时,左手背先前外渗部位出现水肿、疼痛、红斑和刺痛。这些症状逐渐加重,并且比以前的现象更加严重和广泛。随访2个月,症状逐渐减轻。多西紫杉醇引起的“R辐射召回”反应已有报道。然而,在系统再暴露于多西紫杉醇后,从未报道过这种“召回”反应。因此,那些参与多西紫杉醇给药的人应该意识到这种药物在以前的外渗部位引起“召回”反应的可能性。
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引用次数: 1
Quantitative Analysis of Injection-Mixing Services in the Ward by Pharmacists. (1). A Case of the Aseptic Ward for Bone Marrow Transplantation. 药师在病房配药服务的定量分析。(1)骨髓移植无菌病房一例。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.555
Reiko Omura, T. Aoyama, M. Sugiura, S. Hotoda, Mizuki Ito, H. Yokoyama, Y. Yamamura, K. Nakajima, Hitoshi Nakamura, Kouichi Nakamura, Hitoshi Sato, T. Iga
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引用次数: 1
Influence of the Product Liability Law on the Pharmacy Service for Hospital Pharmaceutical Preparations. 产品责任法对医院制剂药学服务的影响。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.188
Yasuaki Ohtsubo, T. Ishimitsu, Kaori Tsubone, H. Yoshida, A. Kamiya
Various pharmaceutical preparations are prepared in hospital pharmacies on a daily basis. The Product Liability (PL) Law has been in effect since July 1995 in Japan. To clarity the influence of the PL Law on the pharmacy service for hospital preparations, the frequency of preparation requests, preparation quantities, and the total preparation time of each hospital preparation were investigated retrospectively for 5 fiscal years (April to next March) from April 1993 to March 1998 at Yamaguchi University Hospital. Hospital preparations were classified into three categories based on the raw materials used. The category I preparations were prepared from the medicines listed in the National Health Insurance price standard for medicine, and were used according to the Pharmaceutical Affairs Law. The category 2 preparations were prepared from the medicine listed on the standard price lists and were used outside the jurisdiction of the Pharmaceutical Affairs Law. The category 3 preparations were prepared from chemical agents not listed in the standard price lists. It is necessary to get the approval of the Institutional Review Board at our hospital before category 2 and 3 preparations can be used. The request frequency and preparation quantity of category 1 preparations gradually decreased during the investigation period, while category 2 preparations remained almost constant. On the other hand, those of category 3 preparations steadily increased from 1993 to 1997. In addition, the total preparation time of the hospital preparations gradually increased year by year, and the preparation times for 1997 reached 110 percent of that for 1993. These results indicate that the pharmacists in our hospital have adequately understood the importance of the hospital preparations and have been adhering to the special preparation orders from each physician. As a result, it appears that the PL Law has not substantially affected the pharmacy service for pharmaceutical preparations in our hospital.
医院药房每天都要配制各种药物制剂。《产品责任法》自1995年7月起在日本生效。为了明确《药剂法》对医院制剂药学服务的影响,对山口大学医院1993年4月至1998年3月5个会计年度(4月至次年3月)的制剂请求频率、制剂数量和每种医院制剂的总制剂时间进行了回顾性调查。医院制剂根据使用的原料分为三类。第一类制剂采用《国家医疗保险药品价格标准》所列药品配制,并按《药事法》规定使用。第2类制剂由标准价目表上列出的药品制备,并在《药事法》管辖范围之外使用。第3类制剂是由标准价目表中未列出的化学制剂制备的。第2类和第3类制剂在使用前必须获得我院机构审查委员会的批准。调查期间,第一类制剂的请求频率和制剂数量逐渐减少,而第二类制剂基本保持不变。另一方面,1993年至1997年,第3类筹备工作稳步增加。此外,医院制剂的总配制时间逐年增加,1997年的配制次数达到1993年的110%。这些结果表明,我院药师充分认识到医院制剂的重要性,并一直坚持每位医师的特殊制剂指令。由此看来,《物权法》并未对我院制剂的药学服务产生实质性影响。
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引用次数: 1
Investigation of Outpatients' Compliance with Medication After Meal and Analysis of Factors on their Noncompliance. 门诊患者餐后用药依从性调查及不依从性因素分析。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.79
Noriko Umemoto, Manami Yamaoka, T. Seino, Y. Yamamura, T. Aoyama, Hitoshi Nakamura, Hitoshi Sato, T. Iga
We investigated the outpatients' understanding and compliance with taking “medication after meals”, a typical timing of medication, and examined the factors influencing patients' noncompliance. The subjects (35 men and 69 women, aged 56±8) were randomly chosen from the outpatients at Tokyo University Hospital, to whom a drug listed in our active guidance system as “ medication required after meal” had been prescribed at a community pharmacy. The patients were interviewed at the outpatient counter to examine the following points: 1) whether they understood and actually took the medications after meals, 2) whether or not they routinely having breakfast, 3) when and why some patients cannot comply with taking medications after meals, and 4) whether or not they had received drug compliance instructions at community pharmacies and if so what instructions were received. As a result, almost all patients (97%) understood that they have to take particular medicines “within 30 min after meals”, but approximately 30% of the patients failed to do so, indicating a discrepancy between the patients' understanding and actual compliance. The occurrence of noncompliance was as high as 47% after lunch and 21% after breakfast, and the major reason for the former case was time restrictions due to work or going out, thus suggesting the need to consider the patients' life style when pharmacists give instructions. 61 % of the patients answered that they have not received compliance instructions at community pharmacies; the ratio of those who have not received compliance instructions at community pharmacies was 52% among the patients who corrected took the drugs after meals, but 71% among the patients who sometimes failed to take the drugs correctly (one-sided P<0.05;χ2 test), thus suggesting the importance of giving compliance instruction at community pharmacies. In conclusion, our study suggested that pharmacists need to make greeter efforts to instruct patients, such as a more individualized instructions based on the lifestyle of each patient, in order to improve patients' compliance with medication after meals and thus to promote the rationaluse of medicine.
调查门诊患者对“餐后用药”这一典型用药时间的理解和依从性,并探讨影响患者不依从性的因素。受试者(男35名,女69名,年龄56±8岁)随机从东京大学医院门诊患者中选取,这些患者在社区药房开了一种在我们的主动引导系统中被列为“餐后用药”的药物。在门诊柜台对患者进行访谈,检查以下几点:1)饭后是否理解并实际服用药物,2)是否常规吃早餐,3)何时以及为什么有些患者不能饭后服药,4)他们是否在社区药房接受了药物依从性指导,如果接受了指导,接受了什么指导。因此,几乎所有的患者(97%)都理解他们必须在“餐后30分钟内”服用某些药物,但约有30%的患者没有做到这一点,这表明患者的理解与实际依从性存在差异。午餐后服药不遵医嘱的发生率高达47%,早餐后服药不遵医嘱的发生率高达21%,早餐后服药不遵医嘱的主要原因是工作或外出等时间限制,提示药师指导时需考虑患者的生活方式。61%的患者回答说,他们没有在社区药房得到合规指导;在纠正餐后服药的患者中,未在社区药房接受遵医嘱的比例为52%,但有时不能正确服药的比例为71%(单侧P<0.05;χ2检验),说明在社区药房进行遵医嘱的重要性。综上所述,我们的研究建议药师在指导患者时应更加友好,如根据每个患者的生活方式进行更加个性化的指导,以提高患者餐后用药的依从性,从而促进药物的合理使用。
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引用次数: 1
Influence of Anti-Hyperlipidemic Agents on Renal Functions of Patients Having Normal Kidney. 抗高脂血药对肾脏正常患者肾功能的影响。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.443
M. Saito, Yoshihiro Ishida, H. Yoshida, Yuka Irie, N. Terakawa, A. Iwai
Acute coronary syndrome (ACS) was recently revealed to occur when a fragile plaque in a fibrous capsule breaks off and a thrombus produced at the broken site obstructs the vascular cavity. Anti-hyperlipidemic agents have been reported to be effective in preventing this onset of ACS through its stabilizing effect on these plaques, thereby leading to its extensive application. However, no reports have yet comparatively examined the influence of two combined antihyperlipidemic agents of different species on the renal functions including blood urea nitrogen (BUN) and serum creatinine (Scr) in patients whose kidneys function normally. Therefore, BUN, total cholesterol (TC), neutral triglyceride (TG), high density lipoprotein (HDL), and low density lipoprotein (LDL) were comparatively analyzed before and one year after treatment with single pravastatin (CS), single bezafibrate (BF) or CS-F BF combination in patients first diagnosed to have hyperlipidemia at our hospital. While TC and LDL significantly decreased in the CS group, TG significantly decreased and HDL significantly increased in the BF group. In the CS-FBF combination group, TC, TG and LDL significantly decreased while HDL significantly increased. In the three groups, no significant increase was detected for BUN or Scr. As mentioned above, the administration of CS and BF to patients with normal renal functions therefore appears to be safe since no renal disturbances were observed.
急性冠状动脉综合征(ACS)最近被发现是当纤维囊内脆弱的斑块破裂并在破裂部位产生血栓阻塞血管腔时发生的。据报道,抗高脂血症药物通过对这些斑块的稳定作用有效地预防ACS的发生,从而导致其广泛应用。然而,两种不同种类的联合抗高脂血药对肾功能正常患者血尿素氮(BUN)和血清肌酐(Scr)的影响尚未见比较报道。因此,比较分析我院首次诊断为高脂血症患者单药普伐他汀(CS)、单药贝扎贝特(BF)或CS- f BF联合治疗前后1年的BUN、总胆固醇(TC)、中性甘油三酯(TG)、高密度脂蛋白(HDL)、低密度脂蛋白(LDL)。CS组TC和LDL显著降低,BF组TG显著降低,HDL显著升高。CS-FBF联合组TC、TG、LDL显著降低,HDL显著升高。在三组中,BUN或Scr均未显著升高。如上所述,由于未观察到肾脏紊乱,因此对肾功能正常的患者给予CS和BF似乎是安全的。
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引用次数: 0
The Individual Medication Counseling to the Outpatient with Diabetes Mellitus by the Stuff of Faculty of Pharmaceutical Sciences and Clinical Training for the Students. 药学院工作人员对门诊糖尿病患者的个体化用药咨询及学生临床培训。
Pub Date : 2000-01-01 DOI: 10.5649/JJPHCS1975.26.17
H. Araki, H. Kawasaki, M. Izushi, K. Futagami, K. Shikata, J. Wada, H. Sugimoto, M. Kushiro, H. Makino, Y. Gomita
Individual medication counseling for outpatient with diabetes mellitus was carried out by an instructor who was a faculty staff member of the department of pharmaceutical sciences (DPS) as a part of pharmaceutical clinical training of pharmacy students. The team instructor from the faculty of DPS and a hospital pharmacist investigated the chart of the patient with diabetes mellitus based on a request from a doctor, and according to the counseling policy, it counseled the patient after first discussing the details with the doctor. Pharmaceutical students observed this process as part of their training. Although the drug specifies had already been explained to the patient by the doctor, for ther details regarding the pharmacological contents of the dosing drug, the drug efficacy at the application, dose, side effects, especially hypoglycemia, etc. were explained to the patient. As some patients have other diseases besides diabetes mellitus, the effects of drugs for other diseases were also explained. The report was made after finishing all counseling, and was submitted to the doctor. The participation of faculty members from the DPS in clinical training is an effective method for educating students. In addition, it is also important to increase the numbers of opportunities for hospital pharmacists to share clinical experience with the faculty member of the DPS. It is therefore necessary to increase the mutual cooperation between the faculty staff members of the DPS and hospital pharmacists to improve the overall education of pharmacy students.
作为药学专业学生临床药学培训的一部分,由药学系教职员指导对门诊糖尿病患者进行个体化用药咨询。DPS学院的团队指导老师和医院药剂师根据医生的要求对糖尿病患者的病历进行了调查,并根据咨询政策,先与医生讨论细节后对患者进行了咨询。药学专业的学生观察这个过程是他们训练的一部分。虽然医生已经向患者解释了药物说明书,但对于给药药物的药理成分、用药时的疗效、剂量、副作用,特别是低血糖等细节,还是要向患者解释清楚。由于部分患者除糖尿病外还伴有其他疾病,故对其他疾病的药物作用也作了说明。报告是在完成所有的咨询后制作的,并提交给医生。DPS教师参与临床培训是一种有效的教育学生的方法。此外,增加医院药剂师与DPS教员分享临床经验的机会也很重要。因此,有必要加强DPS教职员工与医院药剂师之间的相互合作,以提高药学学生的整体教育水平。
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引用次数: 0
A Case Report of Hemodialysis Patient with Successful Determination of Pilsicainide and Digoxin Dosage by Therapeutic Drug Monitoring. 治疗药物监测成功测定血液透析患者匹西奈德和地高辛用量1例。
Pub Date : 2000-01-01 DOI: 10.5649/jjphcs1975.26.398
Megumi Morii, K. Ueno, Kana Matsumoto, M. Takada, Y. Nojima, F. Sakamaki, N. Nakanishi, M. Shibakawa
( Received October 7,1999 Accepted March 27, 2000 ) A 67-year-old man who had been receiving hemodialysis (HD) was administered pilsicainide and digoxin for the treatment of paroxysmal atrial fibrillation. Thereafter, when undergoing HD, ventricular fibrillation and flutter frequently appeared, and he was therefore admitted to National Cardiovascular Center. After being admitted, the administration of pilsicainide and digoxin was immediately stopped due to a widening QRS on ECG. After that the terminal half-time (t1/2) of pilsicainide and digoxin were calculated and these drugs were restarted base on his calculated t1/2. Subsequently a good control of arrhythmia without any side effects was obtained at this dosage. The above findings suggested that although the dose of digoxin in this case ranged from onesixth to one-third of the normal dose when the renal function was normal, the dose of pilsicainide was only about one-tenth that of a normal dose, and a remarkable difference was observed between the dose of digoxin and pilsicainide. This case suggests that drugs, which are mainly eliminated in the kidney, especially pilsicainide, should thus be carefully monitored regarding their influence on the renal function in HD patients, since such therapy could lead to renal function failure.
一名接受血液透析(HD)的67岁男性患者接受匹西卡因和地高辛治疗阵发性心房颤动。此后,在接受HD手术时,经常出现心室颤动和扑动,因此被送入国家心血管中心。入院后,由于心电图QRS变宽,立即停用匹西奈德和地高辛。计算匹西奈德和地高辛的终末半衰期(t1/2),并根据计算的t1/2重新开始用药。在此剂量下,心律失常得到良好控制,无任何副作用。上述结果提示,虽然本例中地高辛的剂量在肾功能正常时为正常剂量的六分之一至三分之一,但匹西卡因的剂量仅为正常剂量的十分之一左右,地高辛与匹西卡因的剂量有显著差异。本病例提示,主要在肾脏中消除的药物,特别是匹西奈德,对HD患者肾功能的影响应密切监测,因为这种治疗可能导致肾功能衰竭。
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引用次数: 0
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Japanese Journal of Hospital Pharmacy
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