| Uterine adenomyosis (AM) has become a common disease and frequently occurring disease of department of gynecology, recently the incidence of which has two trends:one is the rising incidence, the second is more younger onset age。Due to UAM pathogenesis is not clear, there is no ideal conservative treatment at home and abroad.The adenomyosis patients suffer physiologically and psychologically from its clinical symptoms, which seriously affect patient’s quality of life(QOL). Chinese medicine has certain advantages in the treatment of this disease and can mitigate the clinical symptoms well by literature reported. According to the etiology and pathogenesis of this disease Professor Xu Runsan founded Yi Kun Nei Yi pills, which can significantly alleviate pain symptoms of patients with adenomyosis dysmenorrhea and improve the QOL of patients. Assessed by QOL Scale, QOL can show comprehensive health status of the patients. SF-36scale is a widely recognized and commonly used scale in the QOL scale, more clinically used in burden and efficacy evaluation research of a variety of chronic disease. Therefore, the purpose of the suevey of QOL in UAM patients by SF-36scale is to reflect the overall health status of UAM patients and to evaluate and select the drug efficacy for the treatment of UAM. Objective:1.The present study used the SF-36scale to assess the quality of life in patients with UAM.2.To evaluate the clinical efficacy and the QOL in UAM by taking Yi Kun Nei Yi pills treatment;3.To study the relationship between QOL and blood stasis and kidney deficiency syndrome in order to provide a basis for the future relationship between the Chinese medicine diagnosis and treatment of disease and quality of life assessment of disease. Methods: The present study is a randomized, open-label, non-blinded clinical study, forward looking research based, supplemented by a retrospective study.The research object is patients with adenomyosis dysmenorrhea which is belong to blood stasis and kidney deficiency syndrome. Treatment group,54cases, completed data for38cases and they do the before-after study. The patients were assessed by dysmenorrhea score, SF-36scale、TCM syndrome Integra at randomization and2months after randomization; B ultrasound and serum CA-125were assessed at randomization and2months after randomization. And there were retrospective52cases. Healthy control group of90patients are assessed by SF-36scale once.Results:1. Yi Kun Nei Yi pills treatment outcomesClinical total effective rate of the treatment group is64.4%. The dysmenorrhea score, VAS score, kidney deficiency and blood stasis syndrome score and total syndrome scores are improved significantly after the treatment. Although B ultrasound and CA-125values lower but there was no significant difference.2. SF-36scale outcomesSF-36scale results show that:compared with healthy controls, the treatment group have significant difference in the GH(P＜0.001), PF(P=0.008), RP(P=0.001), SF(P＜0.001),BP(P＜0.001). From physical health (P＜0.001), and mental health (P＜0.028) to compare the two aspects also have significant differences. The treatment group have significant difference in the GH(P=0.044), SF(P=0.001),BP(P=0.003) and MH(P=0.009) before and after the treatment. From physical health (P＜0.001), and mental health (P＜0.028) to compare the two aspects also have significant differences. Dysmenorrhea score, VAS score,kidney deficiency and blood stasis syndrome score mpact on quality of life, mainly affecting GH,BP,SF. Among the kidney deficiency and blood stasis syndrome, non-menstrual abdominal pain, intercourse pain, weakness in waist and knees are closely related to HRQOLConclusion:1. Yi Kun Nei Yi pills can reduce the patient’s symptoms of dysmenorrhea, and its clinical side effect is small. While it can improving patient accompanied by other symptoms, such as non-menstrual abdominal pain, sexual pain.2.Yi Kun Nei Yi pills can improve the quality of life in patients with adenomyosis dysmenorrhea. Some of the symptoms can be improved by Invigorating the circulation of blood and invigorating kidney qi to improve the patient’s physical health status and thus improve the patient’s mental health.3. Kidney deficiency and blood stasis is closely related to HRQOL. The TCM syndrome correlates closely with HRQOL:more severely impaired TCM syndrome suggests poorer HRQOL 4. Among the kidney deficiency and blood stasis syndrome, non-menstrual abdominal pain, the fall anal pain, weakness in waist and knees are closely related to HRQOL, which are the important factors that affect HRQOL.5. SF-36scale can be used as a guide to evaluating the effect of treatment of dysmenorrhea. |
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