Kaushal V, Verma K, Manocha S, Hooda H S, Das B P
Department of Radiotherapy, 35/9J Medical Enclave, Pt. B.D. Sharma Postgraduate Institute of Medical Sciences, Rohtak, PIN-124001 Haryana, India.
Int J Tissue React. 2001;23(3):105-10.
To evaluate human placental extract in the treatment of radiation mucositis involving the oral/oropharyngeal region, a prospective randomized study was carried out in 120 patients with squamous cell carcinoma of the head and neck from August 1997 to March 1999. The study was conducted in patients receiving radical external radiation therapy, planned for = > 60 Gy/30 F/6 weeks, who developed grade 2 radiation mucositis (patchy mucositis) during radiation treatment. The patients were randomized in two groups of 60 patients each to receive either placentrex treatment (placentrex group) or conventional treatment (control group). Placentrex treatment was given as Inj Placentrex 2 ml by deep intramuscular injection 5 days a week for 15 injections. Conventional treatment given in the control group was disprin gargles and betamethasone oral drops. A subjective decrease in pain was observed in 48/60 (80%) of patients in the placentrex group compared with 22/60 (36.7%) in the control group. The progression to grade 3 radiation mucositis was 24/60 (40%) in the placentrex group compared with 52/60 (86.7%) in the control group. The subjective improvement in difficulty in swallowing was seen in 56/60 (93%) of patients in the placentrex group compared with 9/60 (15%) of patients in the control group. Only one patient in the placentrex group compared with three in the control group required interruption of radiation therapy because of severe radiation reactions. Human placental extract appears to be effective in the management of radiation-induced oral/oropharyngeal mucositis and especially in controlling subjective symptoms.
为评估人胎盘提取物治疗口腔/口咽区域放射性粘膜炎的效果，1997年8月至1999年3月，对120例头颈部鳞状细胞癌患者进行了一项前瞻性随机研究。该研究针对接受根治性外照射放疗（计划剂量≥60 Gy/30次/6周）且在放疗期间出现2级放射性粘膜炎（斑片状粘膜炎）的患者开展。患者被随机分为两组，每组60例，分别接受胎盘组织液治疗（胎盘组织液组）或传统治疗（对照组）。胎盘组织液治疗为每周5天，深部肌肉注射2 ml胎盘组织液，共注射15次。对照组的传统治疗为使用阿司匹林漱口水和倍他米松口服滴剂。胎盘组织液组60例患者中有48例（80%）主观疼痛减轻，而对照组60例患者中只有22例（36.7%）。胎盘组织液组有24例（40%）进展为3级放射性粘膜炎，而对照组为52例（86.7%）。胎盘组织液组60例患者中有56例（93%）吞咽困难主观症状改善，而对照组60例患者中只有9例（15%）。胎盘组织液组只有1例患者因严重放疗反应需要中断放疗，而对照组有3例。人胎盘提取物似乎对放射性口腔/口咽粘膜炎的治疗有效，尤其在控制主观症状方面。
