补肾活血汤联合黄体酮治疗黄体功能不全性不孕临床研究_陈虹宇.pdf

新中医2023年2月第55卷第4期NEW CHINESE MEDICINEFebruary 2023 Vol.55 No.4收稿日期 2022-03-09修回日期 2022-11-19作者简介陈虹宇（1987-），女，主管药师，E-mail：。补肾活血汤联合黄体酮治疗黄体功能不全性不孕临床研究陈虹宇1，姚奏英2，吴振波11.丽水市中心医院药学部，浙江 丽水 323000；2.丽水市中心医院中医内科，浙江 丽水 323000摘要 目的：观察补肾活血汤联合黄体酮治疗黄体功能不全（LPD）性不孕的临床疗效。方法：选择LPD 性不孕患者 78 例，按随机数字表法分为治疗组 40 例与对照组 38 例。对照组给予黄体酮胶囊治疗，治疗组在对照组的基础上给予补肾活血汤治疗。治疗 3 个月经周期后，比较 2 组临床疗效、中医证候积分、子宫内膜容受性及血清雌激素水平；并随访 6 个月，比较 2 组妊娠情况。结果：治疗组总有效率为 87.50%，高于对照组 68.42%，组间比较，差异有统计学意义（P0.05）。治疗前，2 组中医证候积分比较，差异无统计学意义（P0.05）；治疗后，2 组中医证候积分均较治疗前降低（P0.05），且治疗组中医证候积分低于对照组（P0.05）。治疗前，2 组子宫内膜厚度、子宫动脉搏动指数（PI）及阻力指数（RI）比较，差异无统计学意义（P0.05）。治疗后，2 组子宫内膜厚度较治疗前增加（P0.05），PI、RI 值较治疗前下降（P0.05）；且治疗组子宫内膜厚度大于对照组（P0.05），PI、RI 值低于对照组（P0.05）。治疗前，2 组血清孕酮（P）、雌二醇（E2）水平比较，差异无统计学意义（P0.05）；治疗后，2 组 P、E2水平均较治疗前明显上升（P0.05），且治疗组 P、E2水平高于对照组（P0.05）。随访 6 个月，治疗组受孕率为 42.5%，高于对照组 15.79%，组间比较，差异有统计学意义（P0.05）。结论：补肾活血汤加减联合黄体酮治疗 LPD 性不孕，有利于改善子宫内膜容受性及临床症状，提高受孕率，疗效优于单纯西药治疗。关键词不孕症；黄体功能不全；补肾活血汤；黄体酮胶囊；子宫内膜容受性；雌激素中图分类号R711.6文献标志码A文章编号0256-7415（2023）04-0112-05DOI：10.13457/ki.jncm.2023.04.025ClinicalStudyonBushenHuoxueDecoctionCombinedwithProgesteroneforInfertility Caused by Luteal Phase DefectCHEN Hongyu，YAO Zouying，WU ZhenboAbstract：Objective：To observe the clinical effect of Bushen Huoxue Decoction on infertility causedby luteal phase defect(LPD).Methods：A total of 78 cases with infertility caused by LPD were selected anddivided into the treatment group and the control group by random number table method，with 40 and38 cases in each group respectively.The control group was given Progesterone Capsules，and thetreatment group was treated with Bushen Huoxue Decoction based on the treatment of the control group.After treatment for 3 menstrual cycles，the clinical effects，traditional Chinese medicine(TCM)syndromescores，endometrial receptivity and levels of serum estrogen in both groups were compared；the patientswere followed up for 6 months and the pregnancy between the two groups were compared.Results：Thetotal effective rate was 87.50%in the treatment group，higher than that of 68.42%in the control group，the difference being significant(P0.05).Before treatment，there was no significant difference being 112新中医2023年2月第55卷第4期NEW CHINESE MEDICINEFebruary 2023 Vol.55 No.4黄体功能不全（LPD）性不孕属于临床妇科常见疾病，主要指黄体发育异常引起体内孕酮水平及亲和力降低，使子宫内膜分泌反应性降低，孕卵种植与早期发育难以维持所致的不孕1。中医学根据 LPD 的临床症状及体征，多将其归属于月经不调、无子等范畴，认为肾虚血瘀是主要病机，治疗多以补肾活血为主要原则，辨证用药治疗疗效肯定2-3。笔者应用补肾活血汤联合黄体酮治疗肾虚血瘀证 LPD 性不孕症，取得较好疗效，结果报道如下。1临床资料1.1诊断标准符合中华妇产科学4中 LPD 性不孕相关诊断标准。患者婚后未避孕，性生活正常，婚后 2 年未妊娠；多伴有月经失调、反复生化妊娠表现。1.2辨证标准符合 中药新药临床研究指导原则（试行）5有关月经不调相关肾虚血瘀证标准。主症：月经先期量少，经色暗淡或紫黑，有血块，经期延长，腰膝酸软；次症：经行小腹疼痛、拒按，排出血块后疼痛减轻，阴毛或腋毛稀疏脱落，或阴中干涩，面色黧黑，头晕耳鸣，性欲减退，健忘恍惚；舌脉：舌淡苔少，有紫色斑点，脉细涩。1.3纳入标准符合上述诊断及辨证标准；年龄2040 岁；近 3 个月内未曾接受相关治疗；对本次研究相关药物无过敏反应；自愿参与并签署知情同意书。1.4排除标准因绝经、卵巢早衰、输卵管阻塞、子宫内膜异位症、生殖系统先天性生理缺陷等因素所致不孕者；超声检查提示伴有生殖器官器质性病变者；有甲状腺、肾上腺功能减退疾病者；有精神疾病、认知障碍等无法正常沟通者。1.5一般资料选择 2018 年 1 月2020 年 6 月丽水市中心医院中医内科收治的 LPD 性不孕患者78 例，按随机数字表法分为治疗组 40 例和对照组38 例。治 疗 组 年 龄 2239 岁，平 均（27.855.93）岁；病程 112 年，平均（6.562.10）年；不孕类型：原发性 26 例，继发性 14 例。对照组年龄found in the comparison of the TCM scores in the two groups(P0.05)；after treatment，the TCM scoresin both groups were decreased when compared with those before treatment(P0.05)，and the TCMscores in the treatment group were lower than those in the control group(P0.05).Before treatment，there was no significant difference being found in the comparisons of endometrial thickness，and pulsatilityindex(PI)and resistance index(RI)of uterine artery between the two groups(P0.05).After treatment，theendometrial thickness in both groups was increased when compared with that before treatment(P0.05)，and the PI and RI were decreased(P0.05)；the endometrial thickness in the treatment group was higher(P0.05)，and the levels of PI and RI were lower compared with those in the control group(P0.05).Before treatment，there was no significant difference being found in the comparisons of levels ofprogesterone(P)and estradiol(E2)between the two groups(P0.05)；after treatment，the levels of P andE2in both groups were significantly increased when compared with those before treatment(P0.05)；theabove two levels in the treatment group were lower than those in the control group(P0.05).After6 months of follow-up，the conception rate was 42.50%in the treatment group，higher than that of15.79%in the control group，the difference being significant(P0.05).Conclusion：Modified BushenHuoxue Decoction combined with progesterone for LPD infertility can significantly improve the endometrialreceptivity and the clinical symptoms of patients and increase the conception rate，which has a betterclinical effect than that of simple western medicine.Keywords：Infertility；Luteal phase defect；Bushen Huoxue Decoction；Progesterone Capsules；Endometrial receptivity；Estrogen 113新中医2023年2月第55卷第4期NEW CHINESE MEDICINEFebruary 2023 Vol.55 No.42340 岁，平均（27.926.14）岁；病程 111 年，平均（6.272.04）年；不孕类型：原发性 25 例，继发性13 例。2 组一般资料比较，差异无统计学意义（P0.05），具有可比性。2治疗方法2.1对照组给予黄体酮胶囊（浙江仙琚制药股份有限公司，国药准字 H20041902）口服，每次 100 mg，每天 2 次，经 B 超监测有排卵后服用 14 d。2.2治疗组在对照组的基础上给予补肾活血汤口服。处方：熟地黄、紫河