Belcaro G, Cesarone M R, Bucci M, Iacobitti P, Dugall M
Angiology and Vasc. Surgery, Clinical Trials Unit, Pierangeli Clinic, Pescara.
Minerva Cardioangiol. 1998 Oct;46(10 Suppl 1):55-8.
Morbidity and mortality were evaluated in three groups of vascular patients: one group was treated with PGE1 alpha-ciclodestrina according to the short term protocol; the second group was treated with PGE1 alpha-ciclodestrina and subcutaneous calcium heparin (SCH; 0.5 ml once daily, in the evening) while a third group was a historical reference group.
All included patients had a follow up of at least 12 months. The historical reference group had been managed without PGE1 alpha-ciclodestrina or SCH while in the two PGE1 alpha-ciclodestrina groups included patients who had been treated with at least four PGE1 alpha-ciclodestrina short-term treatment cycles per year. The 3 groups were comparable for sex and age distribution. In the PGE1 alpha-ciclodestrina group 142 patients (64 +/- 17; M:F = 84:58) had been treated (47 for intermittent claudication and 95 for critical ischemia). The historical reference group included 157 patients (65 +/- 18: M:F = 91:66); 53 with intermittent claudication and 104 with critical ischemia). The group treated with PGE1 alpha-ciclodestrina and SCH included 74 patients (27 with claudication and 47 with critical ischemia).
In claudicants yearly cardiovascular morbidity was reduced from 15.5% in the reference group to 10.2% in patients treated with PGE1 alpha-ciclodestrina and to 7.9% in those treated with PGE1 alpha-ciclodestrina and SCH. Mortality decreased from 11.3% in the reference group to 6% in the PGE1 alpha-ciclodestrina group and to 5.1% in the PGE1 alpha-ciclodestrina + SCH group. In patients with critical limb ischemia morbidity decreased from 28.6% in the reference group to 23.2% in PGE1 alpha-ciclodestrina-group and to 19.4% in the PGE1 alpha-ciclodestrina + SCH group. Mortality also decreased from 16% (reference group) to 13% in the PGE1 alpha-ciclodestrinagroup, to 10.3% in the PGE1 alpha-ciclodestrina + SCH group.
Cyclic treatment with PGE1 alpha-ciclodestrina produces an important decrease in cardiovascular morbidity and mortality which could be further reduced by the chronic use of subcutaneous calcium heparin.
对三组血管疾病患者的发病率和死亡率进行了评估：一组按照短期方案接受前列地尔α - 环糊精治疗；第二组接受前列地尔α - 环糊精和皮下注射钙肝素（SCH；每晚0.5 ml，每日一次）治疗，而第三组为历史参照组。
所有纳入患者均进行了至少12个月的随访。历史参照组未接受前列地尔α - 环糊精或SCH治疗，而在两个前列地尔α - 环糊精组中，患者每年至少接受四个前列地尔α - 环糊精短期治疗周期。三组在性别和年龄分布上具有可比性。在前列地尔α - 环糊精组中，142例患者（64±17岁；男:女 = 84:58）接受了治疗（47例为间歇性跛行，95例为严重肢体缺血）。历史参照组包括157例患者（65±18岁；男:女 = 91:66）；53例为间歇性跛行，104例为严重肢体缺血）。接受前列地尔α - 环糊精和SCH治疗的组包括74例患者（27例为间歇性跛行，47例为严重肢体缺血）。
在间歇性跛行患者中，每年心血管发病率从参照组的15.5%降至接受前列地尔α - 环糊精治疗患者的10.2%，以及接受前列地尔α - 环糊精和SCH治疗患者的7.9%。死亡率从参照组的11.3%降至前列地尔α - 环糊精组的6%和前列地尔α - 环糊精 + SCH组的5.1%。在严重肢体缺血患者中，发病率从参照组的28.6%降至前列地尔α - 环糊精组的23.2%和前列地尔α - 环糊精 + SCH组的19.4%。死亡率也从（参照组）的16%降至前列地尔α - 环糊精组的13%，前列地尔α - 环糊精 + SCH组的10.3%。
前列地尔α - 环糊精的周期性治疗可显著降低心血管发病率和死亡率，长期使用皮下注射钙肝素可进一步降低。
