Objective To observe the therapeutic effect and safety of Fu-Ke-Zai-Zao Pill on patients with dysmenorrhea of deficiency cold type.Methods A total of 240 patients with dysmenorrhea of deficiency cold type were distributed with digital cards ranging from 1 to 240,with odd number as the observation group and even number as the control group,each with 120 cases.The observation group was treated with Fu-Ke-Zai-Zao Pill and desogestrel and ethinylestradio tablets(trade name:Marvelon),and the control group was treated with Marvelon alone.The efficacy,occurrence of adverse reactions,traditional Chinese medicine syndrome score,pain intensity,serological indexes[prostaglandin E2(PGE2),prostaglandin F2a(PGF2a)]before and after treatment were compared between the two groups.Results The total effective rate of the observation group was 96.67%,which was higher than 81.67%of the control group,and the difference was significant(P<0.05).After treatment,the scores of lower abdominal pain,anal distension,limb chills,and lumbosacral pain in both groups were lower than those before treatment;in the observation group,the scores of lower abdominal pain,anal distension,limb chills and lumbosacral pain were(0.53±0.13),(0.64±0.13),(0.53±0.14)and(0.63±0.21)points,which were lower than(1.32±0.23),(1.64±0.51),(1.12±0.26)and(1.22±0.24)points in the control group;the difference was significant(P<0.05).After treatment,the visual analogue scale(VAS)score and PGF2a in both groups were lower than those before treatment,and PGE2 was higher than that before treatment;the observation group had VAS score of(1.12±0.52)points and PGF2a of(29.03±3.14)pg/ml,which were lower than(2.83±0.57)points and(34.20±3.57)pg/ml in the control group;the observation group had higher PGE2 of(28.57±3.85)pg/ml than(25.24±3.64)pg/ml in the control group;the difference was significant(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion The application of Fu-Ke-Zai-Zao Pill in the treatment of dysmenorrhea of deficiency cold type can promote the improvement of traditional Chinese medicine syndromes and serological indexes,relieve pain,and it is safe and effective.
关键词
妇科再造丸/虚寒性痛经/中医证候/疼痛/不良反应
Key words
Fu-Ke-Zai-Zao Pill/Dysmenorrhea of deficiency cold type/Traditional Chinese medicine syndrome/Pain/Adverse reactions
维普
万方数据