天王补心丹合交泰丸加减治疗围绝经期高血压伴失眠的临床研究

Clinical Study of Modified Treatment with Tianwang Buxin Pills Plus Jiaotai Pills for Perimenopausal Hypertension Accompanied by Insomnia

【目的】评价天王补心丹合交泰丸加减治疗围绝经期高血压伴失眠(心肾不交型)的临床疗效。【方法】将60例围绝经期高血压伴失眠(心肾不交型)患者随机分为对照组和观察组,每组各30例。对照组给予西医常规治疗,观察组在对照组基础上给予天王补心丹合交泰丸加减治疗,疗程为4周。观察2组患者治疗前后24 h动态血压、匹兹堡睡眠质量指数(PSQI)评分、更年期综合征自我评定量表Kupperman评分和性激素指标的变化情况,比较2组患者的睡眠疗效、中医证候疗效、不良反应和症状反复发生率。【结果】(1)研究过程中,观察组和对照组各有1例患者脱落,最终各纳入29例。(2)治疗4周后,观察组的睡眠疗效和中医证候疗效的总有效率分别为86.21%(25/29)和89.66%(26/29),对照组分别为75.86%(22/29)和72.41%(21/29),观察组的睡眠疗效和中医证候疗效均优于对照组(P<0.05)。(3)治疗后,2组患者的24 h动态血压(收缩压和舒张压)及PSQI评分均较治疗前明显改善(P<0.01),且观察组对PSQI评分的改善作用明显优于对照组(P<0.05);而2组24 h动态血压差值比较,差异均无统计学意义(P>0.05)。(4)治疗后,2组患者的Kupperman积分均较治疗前明显降低(P<0.01),且观察组对Kupperman积分的降低作用明显优于对照组(P<0.05)。(5)治疗后,2组患者血清卵泡刺激素(FSH)、黄体生成素(LH)水平均较治疗前明显降低(P<0.01),血清雌二醇(E2)水平均较治疗前明显升高(P<0.01),且观察组对血清FSH水平的降低作用及对血清E2水平的升高作用均明显优于对照组(P<0.05)。(6)观察组的不良反应发生率为17.24%(5/29),明显低于对照组的44.82%(13/29),差异有统计学意义(P<0.05)。(7)观察组的症状反复发生率为10.34%(3/29),低于对照组的31.03%(9/29),但差异无统计学意义(P>0.05)。【结论】天王补心丹合交泰丸加减治疗围绝经期高血压伴失眠(心肾不交型)患者疗效确切,可显著改善患者临床症状、体征和激素水平,减少不良反应,具有较高的安全性。

Objective To evaluate the clinical efficacy of modified treatment with Tianwang Buxin Pills plus Jiaotai Pills for perimenopausal hypertension accompanied by insomnia and differentiated as incoordination between heart and kidney syndrome. Methods Sixty patients with perimenopausal hypertension accompanied by insomnia and differentiated as incoordination between heart and kidney syndrome were randomly divided into control group and observation group, with 30 cases in each group. The control group was given conventional western medicine treatment,and the observation group was given modified treatment with Tianwang Buxin Pills plus Jiaotai Pills on the basis of treatment for the control group,the treatment lasting 4 weeks. The changes of24-hour dynamic blood pressure,Pittsburgh sleep quality index(PSQI)scores,self-rating menopausal syndrome Kupperman scores and sex hormone levels in the tow groups were observed before and after treatment. The sleep efficacy,traditional Chinese medicine(TCM)syndrome efficacy,incidence of adverse reactions and symptom recurrence were compared between the tow groups. Results(1)During the trial,there was one patient in each group falling off,and 29 patients in each group were eventually included.(2)After 4 weeks of treatment,the total effective rate for sleep efficacy and TCM syndrome efficacy in the observation group were 86.21%(25/29)and89.66%(26/29) respectively, and those in the control group were 75.86%(22/29) and 72.41%(21/29)respectively. The sleep efficacy and TCM syndrome efficacy in the observation group were superior to those in the control group(P<0.05).(3)After treatment,the 24-hour dynamic blood pressure(including systolic pressure and diastolic pressure)and PSQI scores in the tow groups were significantly improved compared with those before treatment(P<0.01),and the observation group had stronger effect on improving the PSQI scores than the control group(P<0.05). There was no statistical significance in the difference of 24-hour dynamic blood pressure between the two groups(P>0.05).(4)After treatment,the Kupperman scores in both groups were significantly lower than those before treatment(P<0.01),and the effect on decreasing Kupperman scores in the observation group was significantly superior to that in the control group(P<0.05).(5)After treatment, the serum levels of follicle stimulating hormone(FSH)and luteinizing hormone(LH)in the tow groups were significantly lower than those before treatment(P<0.01), and the serum level of estradiol(E2)was significantly higher than that before treatment(P<0.01). The effect on decreasing serum FSH level and increasing serum E2 level in the observation group was significantly superior to that in the control group(P<0.05).(6)The incidence of adverse reaction in the observation group was 17.24%(5/29), which was significantly lower than that in the control group(44.82%,13/29),and the difference was significant(P<0.05).(7)The incidence of recurrent symptoms in the observation group was 10.34%(3/29), which was lower than that in the control group(31.03%, 9/29), whereas the difference was not statistically significant(P>0.05). Conclusion The modified treatment with Tianwang Buxin Pills plus Jiaotai Pills has a certain effect for patients with perimenopausal hypertension accompanied by insomnia and differentiated as incoordination between heart and kidney syndrome. The combined therapy is effective on significantly improving the clinical symptoms and signs as well as the hormone levels of the patients,and reducing adverse reactions with high safety.