拉坦前列素/马来酸噻吗心安合剂与溴莫尼定、拉坦前列素联合治疗的有效性、安全性对比

Aims. To evaluate the efficacy and safety of latanoprost/timolol maleate fixed combination (LTFC) given once daily vs the concomitant therapy of brimonidine t wice daily and latanoprost once daily in primary open angle glaucoma or ocular hypertensive subjects. Methods. A prospective, double masked, active controlle d comparison in which qualified subjects had all glaucoma medicines discontinued for 1 month and then were randomized to either LTFC or brimonidine and latanopr ost concomitant therapy for 6 weeks. They were then switched to the other treatm ent regimen. The intraocular pressure (IOP) was measured at 0800, 1200, and 1600 h at baseline and at the end of Periods 1 and Period 2. Results. In 32 subjects , the diurnal curve of the untreated IOP of 26.0±3.4 decreased to 17.8±2.5 on LTFC and 17.2±2.8 mmHg on brimonidine and latanoprost (P=0.31). At 0800 and 160 0 h, the IOPs were statistically similar between the groups (P > 0.05). At 1200 h the latanoprost and brimonidine treatment IOP was statistically lower (16.2±3 .2) than LTFC (18.0±2.8 mmHg). However, the reduced IOP from untreated baseline was not statistically different at each time point and for the diurnal curve fo r each therapy (P < 0.05). Safety was similar between groups for both solicited and unsolicited side effects (P > 0.05). Conclusion. This study suggests that LT FC and concomitant therapy of brimonidine and latanoprost provide statistically similar diurnal IOP reduction from an untreated baseline.

ACHIEVING POWERFUL IOP CONTROL IN CLINICAL PRACTICE

The timolol maleate 0.5% /dorzolamide 2% fixed combination (Cosopt) was commercially released in 1998 and is dosed twice daily. Boyle and associates and Clineschmidt and cowork-ers have demonstrated that Cosopt provided greater intraocular pressure control than timolol maleate 0.5% twice daily, or dorzolamide 2% three times daily, each given alone. Further,

Long-term cost and efficacy analysis of latanoprost versus timolol in glaucoma patients in Germany

AIM: To evaluate 5-year effectiveness and cos between latanoprost or timolol monotherapy in a pilot trial.METHODS: A retrospective, multi-center trial performed at 6 sites in Germany of patients who had a diagnosis of primary open-angle or pigmentary glaucoma, in at least one eye, initiated on monotherapy with latanoprost or timolol maleate. Qualified consecutive charts were reviewed in which 5-year efficacy, safety and cost data was abstracted.RESULTS: Seventy-seven latanoprost and 49 timolo patients were included, at the final visit no difference existed between the two groups in disc parameters including: rim area, rim area/disc area ratio, cup volume or vertical cup/disc ratio (P 】0.05). There was no difference in intraocular pressure (IOP) between the initial latanoprost (17.4 ±2.6) and timolol (16.3 ±2.8mmHg) groups. There was less change in medicines over the follow-up period (0.1 vs 0.8) and fewer medications at the final visit (1.2 vs 1.8) with latanoprost compared to timolol. No patient treated with latanoprost discontinued therapy during follow-up, while 12% discontinued timolol mostly due to inadequate IOP control. Cost/year was less with initial timolol ($458±236) as compared to latanoprost ($552±202). CONCLUSION: Patients begun on latanoprost o timolol and followed over 5 years may have similar clinical outcomes. However, timolol patients may require more medicines and medicine changes to control IOP for long-term, but at a lower cost.

调查高眼压症及青光眼患者眼压治疗满意度的临床意义

Purpose:To provide initial validation of the Treatment Satisfaction Survey-Intraocular Pressure(TSS-IOP)quality-of-life survey that analyses specific issues related to side effects,patient satisfaction,and compliance.Methods:A prospective,observational cohort of 250 consecutive patients with primary open-angle glaucoma or ocular hypertension was administered the TSS-IOP survey.Results:Factors that correlated with patient satisfaction included perceived effectiveness of the medicine(F=7.47,P< 0.001),ocular irritation(F=6.06,P< 0.001),conjunctival hyperaemia(F=4.40,P< 0.001),ease of use(F=8.52,P< 0.001),and convenience of use(F=6.90,P < 0.001).Patient compliance,acceptance of their illness,and knowledge of glaucoma were also related to perceived effectiveness of the medicine(P < 0.001),ease of use(P < 0.05)and convenience(P < 0.001).Physician ratings of patient pressure control,side effects,and instillation problems also were significantly correlated to patient satisfaction(R=0.13=0.26,P=0.05-0.001).The physician ratings of patient compliance,however,were not significantly related to any dimension of patient satisfaction(P > 0.05).Among monotherapy prostaglandin treatments,latanoprost demonstrated statistically greater satisfaction than bimatoprost or travoprost regarding conjunctival hyperaemia(P < 0.05)and eye irritation(P < 0.01).Conclusions:This study provides initial evidence that patient satisfaction may be related to compliance,perceived effectiveness of treatment,adverse side effects,ease and convenience of use,acceptance of illness,and knowledge of glaucoma.

拉坦前列素-噻吗心安联合用药与单用拉坦前列素24h眼压控制效果比较

Objective: To evaluate the 24- hour efficacy and safety of the latanoprost-timolol maleate-fixed combination vs latanoprost therapy in patients with primary open-angle glaucoma. Methods: A prospective, observer-masked, crossover, activecontrolled, randomized comparison in which after a 6- week medicine-free period, patients were randomized to either latanoprost-timolol-fixed combination therapy or latanoprost therapy, both dosed once each evening, alone for 8 weeks. Patients were then switched to the opposite treatment for 8 weeks. At the end of the washout and treatment periods, a 24- hour diurnal curve was performed. Results: The baseline untreated mean± SD diurnal curve in 37 patients who completed the study was 24.2± 2.0 mm Hg. The mean diurnal curve was 19.2± 2.6 mm Hg for those who received latanoprost therapy alone and 16.7 ± 2.1 mm Hg for those who received the fixed combination therapy (P<.001). The fixed combination therapy also provided a lower absolute intraocular pressure level (1.5- 2.9 mm Hg, P<.001) and a greater intraocular pressure reduction from the untreated baseline (P<.001). Stinging was statistically lower with latanoprost therapy alone (P=.04), but itching was statistically increased compared with the fixed combination therapy (P=.04). Conclusion: The result of this study suggests that the latanoprost-timolol-fixed combination compared with latanoprost therapy alone provides improved intraocular pressure reduction over the 24- hour diurnal curve and for each individual time point in patients with primary open-angle glaucoma.

原发性开角型青光眼晨用及夜用曲伏前列腺素24h眼压控制效果的比较

Purpose: To evaluate the quality of 24- hour intraocular pressure (IOP) control between morning-and evening-dosed travoprost in primary open-angle glaucoma patients. Design: Prospective, crossover, double-masked comparison. Methods: After a 6- week medicine-free period, 33 patients were randomized to receive travoprost dosed in the morning or evening. After 8 weeks of treatment, a 24- hour IOP curve was performed at 6 am, 10 am, 2 pm, 6 pm, 10 pm, and 2 am. Patients were then treated with the opposite dosing regimen for another 8 weeks, after which the 24- hour IOP curve was repeated. MainOutcome Measures: Twenty-four-hour IOP. Results: The untreated mean 24- hour IOP was 23.6± 2.0 mmHg. There were no differences for mean 24- hour IOP between the morning (17.5± 1.9mmHg)-and evening (17.3± 1.9 mmHg) dosings (P=0.7). At 10 am, the evening dosing provided a statistically lower IOP (17.2± 2.1 mmHg) than the morning dosing (19.1± 2.5mmHg) (P=0.02). Evening dosing demonstrated a statistically lower 24- hour fluctuation of IOP (3.2± 1.0 mmHg) than morning dosing (4.0± 1.5 mmHg) (P=0.01). Safety was similar, with conjunctival hyperemia being the most common adverse event (n=9 [27% for morning dosing] and n=11 [33% for evening dosing], P=0.6). Conclusions: This study suggests that both morning and evening dosings of travoprost provide effective 24- hour IOP reduction. However, the evening dosing of travoprost demonstrates slightly greater daytime efficacy, with a narrower range of 24- hour pressure.

溴莫尼定或多佐胺加入拉坦前列素对原发性开角型青光眼患者24h眼压的影响

Objective: To evaluate the 24-hour efficacy of brimonidine purite versus dorz olamide, each added to latanoprost. Design: Double-masked, 2-center, prospecti ve, crossover comparison. Participants: Primary open-angle glaucoma (POAG) subj ects. Methods: Subjects were randomized to brimonidine purite or dorzolamide, ea ch given twice daily, for the first 6-week treatment period after a 6-week lat anoprost run-in. Subjects began the opposite treatment for the second 6-week p eriod after a 6-week latanoprost-only treatment between periods. Intraocular p ressure (IOP) was measured at 8 am, 12 pm, 4 pm, 8 pm, 12 am, 4 am, and 8 am at each baseline and at the end of each treatment period. This study provided an 80 %power that a 1.5-mmHg difference could be excluded between groups if 27 subje cts completed the study. A standard deviation (SD) of 2.8 mmHg was assumed. Main Outcome Measures: Twentyfour-hour efficacy of intraocular pressures of brimoni dine purite versus dorzolamide, each added to latanoprost. Results: In 31 comple ted subjects, the baseline mean diurnal 24-hour IOP (±SD) was 19.0±1.7 mmHg f or brimonidine purite and 19.0±1.6 mmHg for dorzolamide (P=0.52). The 8 am IOP after 6 weeks of therapy was 18.4±2.1 mmHg for brimonidine purite and 18.9±1.9 mmHg for dorzolamide (P=0.40). The mean diurnal IOP was 16.9±1.5 mmHg for brim onidine purite and 16.8±1.5 mmHg for dorzolamide (P=0.66). Dorzolamide caused a more bitter taste (P=0.01) than brimonidine purite. Conclusions: This study sug gests that brimonidine purite and dorzolamide, added to latanoprost, have simila r efficacy and safety in POAG or ocular hypertensive subjects.

0.005%拉坦前列素与0.03%比马前列素治疗原发性开角型青光眼的疗效评比

Objective: To evaluate latanoprost versus bimatoprost given each evening over the 24- hour diurnal curve. Design: Double- masked, 2- center, crossover comparison. Participants: Forty- two of 44 patients with primary open- angle glaucoma (POAG) completed the study. Methods: Consecutive patients were not treated during a baseline 24- hour curve after a glaucoma medicine- free period. They then were randomized to either latanoprost or bimatoprost for a 7- week treatment period. Diurnal curve intraocular pressures (IOPs) were measured at treatment period end at 2 AM, 6 AM, 10 AM, 2 PM, 6 PM, and 10 PM. After the first treatment period, patients were changed to the opposite medicine without a medicine- free period. Diurnal curve measurements were performed again at the end of the second 7- week treatment period. Main Outcome Measure: The 24- hour diurnal IOP. Results: On the last day of treatment, mean 24- hour IOPs were 17.3± 2.8 mmHg for latanoprost and 16.7± 2.4 mmHg for bimatoprost (P=0.01). The 6 PM individual time point for IOP was statistically lower for bimatoprost after a Bonferroni correction (P=0.008). The largest IOP difference at any time point was 0.9 mmHg at 6 PM. The most common side effect was conjunctival hyperemia, which occurred less with latanoprost (n=6) than with bimatoprost (n= 15) (P=0.004). Two patients had their treatments discontinued while on bimatoprost, one due to conjunctival hyperemia and the other due to ocular intolerance. Conclusion: This study indicates that the 24- hour diurnal IOP is statistically lower in POAG with bimatoprost, compared with latanoprost, among patients who tolerated bimatoprost. However, the IOP difference between groups was small and may not be clinically meaningful. In contrast, conjunctival hyperemia seems statistically greater with bimatoprost. The exact clinical importance of conjunctival hyperemia, if any, needs to be clarified further.

0.2%溴莫尼定、0.15%乌诺前列酮分别加入0.5%马来酸噻吗洛尔眼液2次/d治疗原发性开角型青光眼或高眼压症

Purpose. To compare the efficacy and safety of brimonidine 0.2% vs unoprostone 0.15% , both added to timolol maleate 0.5% each given twice daily. Methods. In this prospective, multi-centred, double-masked, crossover comparison, patients were randomized to one treatment group for a 6- week treatment period, and then crossed over to the opposite treatment. Measurements were performed at 0800, 1000, 1600, 1800, and 2000 h at baseline and at the end of each treatment period. Results. In all,33 patients entered this trial and 29 completed. The baseline trough intraocular pressure (IOP) was 23.3± 2.4 and the diurnal curve IOP was 22.0± 1.3mmHg. For the brimonidine and timolol maleate treatment group, the trough IOP was 21.6± 3.3 and the diurnal curve IOPwas 19.8± 2.1mmHg,while the timolol and unoprostone treatment showed a trough IOP of 20.9± 3.8 and a diurnal curve IOP of 19.3± 2.4 mmHg. There was no significant difference between treatment groups at any time point for the diurnal curve,or in the reduction from baseline (P >0.05). Both treatments failed to statistically reduce the IOP from baseline at 1800h. There was no difference between treatment groups regarding ocular and systemic unsolicited adverse events, but patients admitted to more dryness (P=0.02) and burning upon instillation (P< 0.0001) with unoprostone by survey. Conclusion. Brimonidine 0.2% or unoprostone 0.15% added to timolol maleate 0.5% provide similar efficacy and safety throughout the daytime diurnal curve.