Cisplatin is a platinum compound used in solid tumor treatment. A dose limiting factor in cisplatin treatment is renal function disorder. Hydration is performed as a precaution at the time of cisplatin dosage. However, a most appropriate hydration method has yet to be established. Therefore, we investigated the serum creatinine rise in patients after cisplatin therapy to clarify an effective hydration method and risk factors of renal function disorder. We administered the treatment of 266 cycles in 111 patients who had received chemotherapy including more than 60 mg/m² cisplatin in the past. We investigated the infusion solution used for hydration, various patient criteria factors and serum creatinine changes before and after cisplatin dosage. As a result, no significant difference was recognized in age, sex, diuretic dosage, and treatment cycles. However, a significant difference in the ratio of the patients was seen in those whose serum creatinine level increased at an Na load less than 371 mEq (odds ratio: 3.141, 95% confidence interval: 1.174-8.407, p=0.017), whose serum creatinine before the treatment was at more than 85.5% of the normal range upper limit value (4.481, 1.310-15.317, 0.012) and whose cisplatin dose was more than 60.1 mg/m² (3.565, 1.117-12.493, 0.041). We infer that these are risk factors for a serum creatinine rise with the cisplatin treatment. Providing Na in excess of 371 mEq in hydration seems to be an effective precaution of the renal function disorder.

抄録全体を表示

The aim of the present study was to compare contamination by 5-FU between a conventional mixing method of a portable disposable infuser pump using an ampule form of 5-FU and a mixing method of an infuser pump using a vial form of 5-FU. The pharmacist handled 5-FU on the stainless steel tray in the biological safety cabinet. Wipe samples of the stainless steel tray and glove samples from the pharmacist were collected. Then the mixing operation was timed by stop-watch.
When the pharmacist prepared the infuser pump with ample form of 5-FU, the median 5-FU concentration from wipe samples was 33 μg. When the pharmacist prepared the infuser pump with the vial form of 5-FU, the median 5-FU contamination from wipe samples was lower than the quantification limit. Use of the vial form of 5-FU significantly reduced the surface contamination from wipe samples (p=0.003, Mann-Whitney's U-test). The median mixing operation time was also significantly reduced by using the vial form of 5-FU (347 sec and 169 sec, p<0.001, Mann-Whitney's U-test). Based on these results, we concluded that the vial form of 5-FU can reduce contamination in a hospital work environment, and increase the efficiency of mixing operation.

抄録全体を表示

For oral medicines, the dosage form influences patient compliance and the resulting effectiveness. In recent years, dry syrups (DSs) have come to be used as a common dosage form for adult patients. In order to clarify the usefulness of DSs, comparative investigation between DS (n=1,196), 250 mg tablets (n=1,433) and 500 mg tablets (n=2,290) of L-Carbocisteine (MUCODYNE^Ⓡ) was conducted in adult patients. Both 250 mg tablets and DS were evaluated as being easy to swallow by approximately 74% of patients, which was superior to that for the 500 mg tablets. It is of note that DS was evaluated as being easy to swallow by men or those aged 65 and over. Many patients responded that good taste was the reason why the DS was easy to swallow. For the 500 mg tablets, many patients (significantly more women than men) responded that the tablet size was large. In patients who agreed to take the 500 mg tablets in an ongoing manner, the rate of patients who responded that it was difficult to swallow was higher than that for the DS and the 250 mg tablets. In contrast, in patients who agreed to take the DS in an ongoing manner, the majority responded that it was easy to swallow.
The aforementioned results indicate that DS is very useful as a dosage form for adult patients. The results also revealed that convenience (including handling), influences the palatability of tablets.

抄録全体を表示

Translational research is important for applying the outcomes of basic researches to practical medical treatments. In exploratory clinical trials in the early-phase for an innovative therapy, researchers should often manufacture investigational agents by themselves. To supply investigational agents with safety and high quality in clinical studies, appropriate production management and quality control are essential. In the Department of Pharmacy of Kyoto University Hospital, a manufacturing facility for sterile drugs was established, independent of existing manufacturing facilities. Fifteen manuals about the production management and quality control were enacted. Staff organization based on the enacted manuals was also designated. The facility, manuals and staff organization were evaluated according to good manufacturing practice (GMP) for investigational new drugs (INDs). They were revealed to conform to GMP for INDs except for some clauses. Furthermore, the management of microparticles and microorganisms in the sterile room, referring to the Japanese Pharmacopeia, was determined, and the cleanness was evaluated. A manufacturing facility complying with GMP for INDs was established for supplying high-quality sterile drugs in clinical studies. These achievements can contribute to the safety of patients and reliability in clinical studies.

抄録全体を表示

In cancer chemotherapy, much more information regarding patients' background and treatment regimens is required compared with other pharmacotherapies. Such information is important for patients to assure effective and safe chemotherapy treatment and avoid further serious adverse events and mortality. When prescriptions of chemotherapy for outpatient are handled in a community pharmacy, full information should be transferred from the hospital because an outpatient usually receives oral anticancer agents in a pharmacy and injections in a hospital. For such patient, information sharing among the hospital and the pharmacy is especially important, so we developed a new tool for information sharing using the quick response (QR) cord that is printed on a prescription. As an example, we suppose a patient who receives S-1+CDDP chemotherapy for stomach cancer, and the processes to convert the patients' information about regimens, laboratory evidence and contents of injections into the QR cords were compiled and verified. The developed tool using QR cords has the advantage that it can transfer patients' information easily and precisely, and would be useful for information sharing and consequently contribute to a good partnership between hospital pharmacy and community pharmacy.

抄録全体を表示

Combination therapy of platinum and gemcitabine (GEM) is a standard regimen for non-small cell lung cancer (NSCLC). However, the treatment plan of this combination therapy might need to be changed due to blood toxicity and other side effect symptoms. There are many reports on the side effects of cancer chemotherapy, but there are few reports that examine gender differences. In this study, we carried out a retrospective analysis of the relationship between gender difference and hematological toxicity in combination therapy of platinum and GEM in 34 patients (22 males and 12 females).
There were no differences in age groups between BMI and each drug dose. On the eighth day of treatment, the incident rates of leucopenia (p=0.013) and neutropenia (p=0.039) were significantly higher in women than in men. As a result, the rate of GEM canceled on the eighth day of treatment was significantly higher in women than in men. (p=0.039)
These results suggest that gender difference is a potentially useful factor for predicting hematotoxicity due to combination therapy of platinum and GEM. These findings suggest the necessity of dosage adjustment considering gender in GEM-containing chemotherapy for NSCLC.

抄録全体を表示

Despite the increased awareness of the risk of adverse health effects for medical personnel with occupational exposure to anticancer drugs, proper safety controls have not yet been implemented in Japan.The immediate need is to establish appropriate conditions for mixing of anticancer drugs.This study examined the procedures currently used for mixing of anticancer drugs in Japanese hospitals. Two thousand hospitals were randomly selected, and asked to complete a questionnaire about the facilities, equipment and techniques used to mix anticancer drugs. We obtained 1,073 valid responses (among them, 360 hospitals prepared anticancer drug injections and 713 did not).We found that the availability of a biological-safety cabinet for mixing of anticancer drug injections was related to the number of prescriptions issued per day; a cabinet was available in 97.1% of hospitals that issued more than 10 prescriptions per day, 86.3% of hospitals that issued more than 1 and less than 10 prescriptions a day, and 38.4% of hospitals that issued less than 1 prescription per day.Hospitals that issued more than 10 prescriptions per day tended to have safer conditions for mixing anticancer drugs, but conditions in some hospitals were dangerous (e.g., use/non-use of clean benches). Some hospitals commented that equipment for safe mixing of anticancer drugs was too expensive to purchase.There appears to be an urgent need to modify the present system of mixing of anticancer drugs to ensure the safety of hospital personnel.This problem should be tackled by not only pharmacists, but also other staff including managers.

抄録全体を表示

The dosing regimen of teicoplanin (TEIC) is primarily determined by a patient's renal function. Currently, CockcroftGault (CG) equation is widely used to evaluate renal function; however, a new equation for estimation of the glometer filtration rate (eGFR) was reported by the Japanese Society of Nephrology in 2008. Accumulated evidence-from recent studies suggests that correction of the serum creatinine (SCr) and physical constitutions of the pyknic body type (body mass index (BMI) ≥ 25) provides a better predictive outcome for setting the initial dosing of vancomycin. We investigated the influence of gender and age and the effect of correcting the SCr and physical constitutions parameters on the initial dosing of TEIC in conjunction with either the eGFR equation or the CG equation. As a result of this analysis, for patients under age 65 and for women, the prediction error (PE) of the eGFR equation was found to be significantly improved compared with the PE of the CG equation. By correction of the SCr, the PE of both the CG and eGFR equations was significantly improved, and by correction of the physical constitutions, the PE of the eGFR equation was significantly improved. Therefore, these results suggest that the eGFR equation would be more useful for determining the initial dose of TEIC for patients under age 65 and for female patients, and moreover, further improvements could be obtained by correction of the SCr and the physical constitutions of the pyknic body type (BMI≥25) with the eGFR equation to determine the initial dosing of TEIC.

抄録全体を表示