| 盛少琴;董沈怡;范梦梦;万闻婧;刘佳俐;金雪静;徐 晶.坤安乐汤联合芬吗通治疗围绝经期女性睡眠障碍随机对照研究[J].,2024,44(1):25-30 |
| 坤安乐汤联合芬吗通治疗围绝经期女性睡眠障碍随机对照研究 |
| Efficacy of Kun'anle Decoction Combined with Femoston in the Treatment of Perimenopausal Women with Sleep Disorder：A Randomized Controlled Trial SHENG Shao-qin1，2，3， DONG Shen-yi3，4， |
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| DOI：10.7661/j.cjim.20230923.286 |
| 中文关键词: 围绝经期 睡眠障碍 坤安乐汤 芬吗通 中药复方 中西医结合 |
| 英文关键词:perimenopausal period sleep disorder Kun'anle Decoction Femoston Chinese herbal compound integrative medicine |
| 基金项目:浙江省中医药科技计划项目（No.2022ZB155） |
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| 中文摘要: |
| 目的 观察坤安乐汤联合芬吗通治疗围绝经期女性睡眠障碍的临床疗效。方法 267例均为在浙江中医药大学附属第二医院、杭州市妇产科医院更年期门诊就诊伴有睡眠障碍的围绝经期女性患者，符合纳入标准150例，按随机数字表法分为3组（中医组、西医组、中西医组），每组50例，中医组予坤安乐汤口服，西医组予芬吗通口服，中西医组予坤安乐汤+芬吗通口服。治疗3个月后观察3组患者匹兹堡睡眠质量指数（PSQI）、改良Kupperman评分、血糖、肝功能[谷丙转氨酶（ALT）、谷草转氨酶（AST）]、肾功能[肌酐（Cr）]、血脂[甘油三酯（TG）、总胆固醇（TC）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）]、性激素[卵泡刺激素（FSH）、黄体生成素（LH）、雌二醇（E2）]等变化。结果 142例患者完成随访，其中中医组46例，西医组48例，中西医组48例。治疗3个月后，3组患者的PSQI较治疗前均降低，与其余两组比较，中西医组入睡加快、早醒延迟、夜间苏醒次数减少、总睡眠时间延长（P＜0.05）；3组患者的改良Kupperman评分中各项症状评分及总分较治疗前均有降低，中西医组的潮热出汗、失眠、易激动、疲乏症状评分较其余两组降低更为显著（P＜0.05）；3组患者治疗后，血糖、TC下降，中医组、中西医组HDL-C升高（P＜0.05）；各组患者的FSH、LH下降，E2上升（P＜0.05），治疗后组间比较，差异无统计学意义（P>0.05）。结论 坤安乐汤联合芬吗通治疗有效缓解女性围绝经期睡眠障碍。 |
| 英文摘要: |
| Objective To evaluate the efficacy of Kun'anle Decoction （KD） combined with Femoston for perimenopausal patients with sleep disorder. Methods A total of 267 perimenopausal outpatients with sleep disorder at Climacteric Clinic，Second Affiliated Hospital of Zhejiang Chinese Medical University and Hangzhou Women's Hospital were enrolled in the study. And 150 patients met the inclusion criteria and were assigned to 3 groups （Chinese medicine group， Western medicine group， integrative medicine group） using random number table， 50 cases in each group. Patients in Chinese medicine group took KD. Those in Western medicine group took Femoston. Those in integrative medicine group took both KD and Femoston simultaneously. After 3 months of treatment，Pittsburgh Sleep Quality Index （PSQI），modified Kupperman index，blood glucose， liver function [alanine aminotransferase （ALT） and aspartate aminotransferase （AST）]， renal function （creatinine， Cr）， blood lipids [triglyceride （TG）， total cholesterol （TC）， high density lipoprotein-cholesterol （HDL-C）， low density lipoprotein-cholesterol （LDL-C）]， and sex hormone levels [follicle stimulating hormone （FSH）， luteinizing hormone （LH）， estradiol （E2）] were compared among 3 groups. Results Totally 142 patients completed follow-ups， including 46 in Chinese medicine group， 48 in Western medicine group， and 48 in integrative medicine group. After 3 months of treatment the PSQI decreased in the 3 groups. Compared with the other 2 groups， patients in integrative medicine group slept faster， awoke later， had less nighttime awakenings and longer total sleep time （P＜0.05）. Each symptom score and total scores in modified Kupperman index were lower than those before treatment. The scores of hectic fever， insomnia， irritability， and fatigue decreased more in integrative medicine group （P＜0.05）. Blood glucose and TC decreased in the 3 groups （P＜0.05）. But HDL-C level increased significantly in Chinese medicine group and integrative medicine group with statistical difference （P＜0.05）. Levels of FSH and LH decreased and E2 level increased （P＜0.05）， but with no significant differences among the 3 groups （P>0.05）. Conclusion The treatment of KD combined with Femoston effectively relieved discomfortable perimenopausal sleep disorders. |
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