Società Italiana Farmacia Clinica (SIFAC), Cagliari, Italy.
Department of Medical Science and Public Health - University of Cagliari, Cagliari, Italy.
Acta Biomed. 2021 Feb 4;92(1):e2021029. doi: 10.23750/abm.v92i1.11309.
A rectal ointment containing 3% of sucralfate and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile), became available in Italy in 2019 for the treatment of symptoms associated with haemorrhoidal disease. This survey evaluated the effect of the mentioned sucralfate ointment, on quality of life (QoL) and symptom frequency in participants seeking treatment for haemorrhoidal disease from community pharmacies in Italy.
EMOCARE was a multicentre prospective survey conducted at community pharmacies in Italy. Eligible participants (≥18 years) were those with haemorrhoidal symptoms in the last 7 days and were willing to initiate a treatment with the sucralfate ointment and herbal extracts (calendula, witch hazel leaf (hamamelis), chamomile). A survey was administered by the investigating pharmacists at the beginning and end (~14 days) of treatment. The primary endpoint was the change in HEMO-FISS-QoL scores.
Of the 290 (mean age 53.1 years old; 58.3% female) enrolled, 287 attended the follow-up visit. After a mean duration of 13 days, the sucralfate ointment significantly improved total HEMO-FISS-QoL scores (mean change from baseline: -10.41; 95%CI -11.95, -8.86; P<0.001) and mean scores for all domains of the HEMO-FISS-QoL scale (-11.13 [95%CI -12.95, -9.30] for physical disorders, -6.14 [95%CI -7.42, -4.85] for psychology, -18.79 [95% CI -21.67, -15.90] for defaecation, and -6.46 [95%CI -8.40, -4.51] for sexuality; all P<0.001 versus baseline). At the end of treatment, 39.4% of participants reported that they no longer had haemorrhoidal symptoms and the frequency of all assessed symptoms were reduced significantly from baseline (all P<0.05).
After a mean 13 days of treatment the sucralfate ointment with herbal extracts improved HEMO-FISS-QoL scores and reduced symptoms in people with haemorrhoidal disease.
一种含有 3%蔗糖硫酸酯和草药提取物（金盏花、榛叶（金缕梅）、甘菊）的直肠软膏于 2019 年在意大利上市，用于治疗与痔病相关的症状。本研究评估了该蔗糖硫酸酯软膏对意大利社区药房痔病患者的生活质量（QoL）和症状频率的影响。
EMOCARE 是一项在意大利社区药房进行的多中心前瞻性研究。符合条件的参与者（≥18 岁）为过去 7 天内有痔病症状且愿意开始使用蔗糖硫酸酯软膏和草药提取物（金盏花、榛叶（金缕梅）、甘菊）治疗的患者。在治疗开始和结束时（约 14 天），由调查药剂师进行调查。主要终点是 HEMO-FISS-QoL 评分的变化。
在 290 名（平均年龄 53.1 岁；58.3%为女性）入组的患者中，287 名患者参加了随访。在平均 13 天的治疗后，蔗糖硫酸酯软膏显著改善了 HEMO-FISS-QoL 总分（与基线相比的平均变化：-10.41；95%CI-11.95，-8.86；P<0.001）和 HEMO-FISS-QoL 量表所有领域的平均评分（-11.13 [95%CI-12.95，-9.30] 用于身体障碍，-6.14 [95%CI-7.42，-4.85] 用于心理，-18.79 [95%CI-21.67，-15.90] 用于排便，-6.46 [95%CI-8.40，-4.51] 用于性行为；均 P<0.001 与基线相比）。治疗结束时，39.4%的患者报告不再有痔病症状，所有评估症状的频率均显著低于基线（均 P<0.05）。
在平均 13 天的治疗后，含有草药提取物的蔗糖硫酸酯软膏改善了痔病患者的 HEMO-FISS-QoL 评分并减轻了症状。
