Maalox^® dry suspension granule (MLX-G), a granular preparation of Maalox^®, an antacid widely used all over the world, is suspended in water immediately before use. In this study, we investigated the effect of concomitant use of MLX-G and antibacterial drugs on clinical isolates of Helicobacter pylori under the acidic conditions. The result showed that the MIC of clarithromycin (CAM) tended to be decreased by MLX-G. This tendency was especially remarkable for CAM-resistant organisms, and the MIC of OTR 10, one of the strains, decreased from 32μg/ml to 0.5μg/ml. MBC of amoxicillin (AMPC) was also decreased by MLX-G. The enhanced effect of antibacterial drugs observed in this experiment was considered to be mainly attributable to the increase in pH due to the addition of MLX-G. However, the enhanced effect when used concomitantly use with AMPC appeared to be related to other factors as well.

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We investigated the antimicrobial activity of a cephem (cefpirome [CPR]) and two carbapenems meropenem [MEPM] and imipenem [IPM] against Pseudomonas aeruginosa (20 clinically isolated strains, ATCC 27853, and PAO-1) in vitro. At constant concentrations, the carbapenems, especially IPM, displayed strong bactericidal activity and a postantibiotic effect (PAE), and enhancement of bactericidal activity and suppression of bacterial growth at sub-MICe after previous exposure to above-MIC (during the PAE-phase). In contrast, CPR failed to display any PAE or enhancement of the sub-MIC effect after pre-exposure. When human serum concentrations were simulated by using an auto-simulation system, carbapenems showed strong bactericidal activity and long suppression of growth after time above-MIC. These findings suggest that differences between the antimicrobial activity of cephems and carbapenems are one of the important factors to be considered in the dosage and duration of β-lactam therapy for P. aeruginosa infections.

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A dose-comparison trial to establish the optimal dose of the new quinolone synthetic antibacterial agent grepafloxacin (GPFX, OPC-17116) in the treatment of respiratory infections was conducted in patients with chronic respiratory tract infection, using ofloxacin (OFLX) as the control drug. The efficacy, safety, and usefulness of GPFX 200mg q. d.(Group L) were compared with GPFX 300mg q. d.(Group H) by the double-blindmethod, and each dose of GPFX was compared with open-label treatment with OFLX 200mg t. i. d.(Group O). As a rule, treatment was continued for 14 days. It was judged that 121 of the 127 patients enrolled (37 in Group L, 41 in Group H, 43 in Group O) were capable of being evaluated for efficacy.
1. Clinical efficacy:
The clinical efficacy rate was 89.2%(33/37), 97.6%(40/41), and 88.4%(38/43) in Groups L, H, and O, respectively. No statistically significant differences were observed among the 3 groups.
2. Bacteriological efficacy:
The bacterial eradication rate was 75.0%(15/20), 93.3%(14/15), and 85.7%(18/21) in Groups L, H, and O, respectively. No statistically significant differences were observed in the 3 groups.
3. Safety assessments:
In Groups L, H and O, the incidence of adverse reactions was 2.6%(1/39), 7.3%(3/41) and 9.1%(4/44), respectively, and the incidence of abnormal laboratory findings was 5.1%(2/39), 5.1%(2/39), and 4.9%(2/41), respectively. There were no statistically significant differences in the incidence of adverse reactions or abnormal laboratory findings in the 3 groups.
4. Usefulness:
The usefulness rate was 86.5%(32/37), 94.9%(37/39), and 85.4%(35/41) in Groups L, H, and O, respectively. No statistically significant differences were observed in the 3 groups.
These findings demonstrated that 300mg q. d. is the appropriate clinical dose of GPFX for the treatment of respiratory infections.

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The clinical efficacy, safbty, and u8efUlness of a new quinolone synthetic antibacterial agent, grepafloxacin (GPFIX), in the treatment of pneumonia were evaluated in a double-blind study using ofloxacin (OFLX) as the control drug. GPFX and OFLX were admini8tered by the oral route at a daily dose of 300mg q. d. and 200mg t. i. d., respectively, for 14 successive days, in principle.
1. The clinical efficacy rate of GPFX and OFLXin the 225 efficacy-evaluable patients among the 256 patients enrolled in the study was 96.4%(108/112) and 92.9%(105/113), respectively.The difference between the two groups was not statistically significant, and the 90% confidence interval of-1.4% to 8.4% demonstrated the clinical equivalency of the two drugs.
2. The bacterial eradication rate was 96.4%(27/28) in the GPFX group and 97.0%(32/33) in the OFLX group. The rates were not significantly different.
3. Adverse reactions were observed in 2.4%(3/125) of the patients in the GPFX group and 5.0%(6/120) of the patients in the OFLX group. Abnormal clinical laboratory values were observed in 15.8%(19/120) of the patients in the GPFX group and 11.4%(13/114) of the patients in the OFLX group. The differences between the two groups were not statistically significant. The safety rates were 81.8%(98/121) in the GPFX group and 83.5%(96/115) in the OFLX group. The rates were not significantly different.
4. The usefulness rates were 94.5%(104/110) in the GPFX group and 91.0%(101/111) in the OFLX group. The difference between the two groups was not statistically significant, and the 90% confidence interval of-2.2% to 9.3% demonstrated clinical equivalency of the two drugs.
The above findings demonstrate that GPFX at 300mg q.d. is equivalent to OFLX at 200mg t.i.d. in clinical usefulness in the treatment of pneumonia.

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The clinical efficacy, safety, and usefulness of a new quinolone antibacterial agent, greparfloxacin (GPFX), in the treatment of chronic respiratory tract infections were evaluated in a double-blind study using ofloxacin (OFLX) as the control drug. GPFX and OFLX were administered by the oral route in a daily dose of 300mg q. d. and 200mg t. i. d., respectively, for 14 successive days, in principle.
1. The clinical efficacy rates of GPFX and OFLX in the 190 efficacy-evaluable patients among the 203 patients enrolled in the study were 90.3%(84/93) and 90.7%(88/97), respectively. The difference was not statistically significant, between the two groups, and the 90% confidence interval was-7.3% to 6.5%, demonstrating the clinical equivalency of both drugs.
2. The bacterial eradication rate was 72.9%(35/48) in the GPFX group, and 84.2%(32/38) in the OFLX group. The difference in rates between the two groups was not significant.
3. Adverse reactions were observed in 8.3%(8/96) of the patients in the GPFX group and 4.1%(4/98) of the patients in the OFLX group. Abnormal clinical laboratory values were observed in 12.2%(11/90) of the patients in the GPFX group and 6.7%(6/89) of the patients in the OFLX group. There were no significant differences in the occurrence of adverse reactions in the two groups. The safety rate was 79.3%(73/92) in the GPFX group and 88.8%(79/89) in the OFLX group. The rates were not significantly different.
4. The usefulness rate was 86.8%(79/91) in the GPFX group and 87.5%(77/88) in the OFLX group. The difference between the two groups was not statistically significant and the 90% confidence interval of-9.0% to 7.6% demonstrated the clinical equivalency of both drugs.
The above results demonstrated that GPFX 300mg q. d. is equivalent in clinical usefulness to OFLX 200mg t. i. d. in the treatment of chronic respiratory tract infections.

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