女仕口服液联合悦宁胶囊对女性阴虚体质伴失眠症的疗效与安全性评价

Efficacy and Safety Evaluation of Nvshi Oral Liquid Combined Yuening Capsules in Treating Feminine Yin Deficiency Symptom Accompanied with Primary Insomnia

目的:客观评价女仕口服液联合悦宁胶囊对女性阴虚体质伴失眠症的疗效与安全性。方法:采用随机、双盲、安慰剂对照方法将120例女性阴虚体质伴失眠受试者按1∶1随机分为实验组和安慰剂组各60例。实验组给予女仕口服液10 m L/次和悦宁胶囊2粒/次,2次/d,口服;安慰剂组给予女仕口服液模拟药和悦宁胶囊模拟药口服,用法用量同实验组。两组疗程均为8周。观察受试者阴虚质及症状改善情况、进行匹兹堡睡眠质量指数量表(PSQI)评分。结果:干预中、干预后实验组阴虚质总转化分低于安慰剂组(P<0.05,P<0.01),两组干预前后阴虚质总转化分变化值差异有统计学意义,实验组多于安慰剂组(P<0.01);干预后实验组手心发热、皮肤或口唇干燥、口唇色红、眼睛干涩、便秘、口干欲饮评分均低于安慰剂组(P<0.05,P<0.01);干预中、干预后实验组PSQI评分低于安慰剂组(P<0.01);实验组干预前后积分差值多于安慰剂组(P<0.01);干预后实验组睡眠质量、入睡时间、睡眠时间、睡眠效率、睡眠紊乱、日间紊乱评分低于安慰剂组(P<0.01);两组在实验期间均未发生不良反应,心、肝、肾功能等安全性指标未见明显异常。结论:女仕口服液联合悦宁胶囊能有效改善女性阴虚体质及睡眠质量,且安全性好。

Objective： To objectively evaluate the curative efficacy and safety of Nvshi oral liquid combined Yuening capsules in treating feminine yin deficiency symptom （FYDS） accompanied with primary insomnia （PI）. Method： One hundred and twenty FYDS patients with PI were randomly divided into the experiment group （60 cases） and the placebo group （60 cases） by a multicenter, randomized, double blind and placebo-controlled method. Patients in the experiment group received 10 mL Nvshi oral liquids, and 1 Yuening capsule twice daily. Patients in the placebo group received placebo of sham liquids and capsules, the same usage and dosage as the experiment group. All patients in two groups received 8 weeks of treatment. The melioration of patients＇ FYDS was graded by Pittsburgh sleep quality index （PSQI）. Result： The total transformational scores of FYDS in the experiment group were lower than those in the placebo group during and after the interferential treatment （P 〈 0.05, P 〈 0.01 ） , and there was statistical significance for the difference between two groups. The results of the experiment group were better than those of the placebo-controlled group （P 〈 0.01 ）. Scores of palm fever, dry skin and oral lips, oral color red, dry eyes, constipation and dry mouth to drink were lower （P 〈 0.05, P 〈 0.01 ）, score of PSQI was lower （P 〈 0.01 ）, integral calculus value was higher （P 〈 0.01 ） in the experiment group than those in the placebo group. After interferential treatment, scores of sleep quality, sleep latency, sleep time, sleep efficiency, sleep disorders and daytime dysfunction were less than those in the placebo group （P 〈 0.01 ）. No obvious abnormal safety indicators in heart, liver and kidney function were found. Conclusion： Nvshi oral liquids combined Yuening capsules could ameliorate treating patients eminine FYDS and sleep quality, and it has good safety in