| ObjectiveTo evaluate the efficiency and safety of JinFeng pill in treating LPD with kidney deficiency,compared with QiNing capsule as positive control medicine.Methodsthis is a randomized, positive parallel controled study,35patients were selected in2013June to2014March, with LPD diagnosis, TCM belongs to kidney deficiency type.35cases were randomly divided into experimental group and positive control group,20cases in treatment group,15cases in the control group. The treatment group received JinFeng pill,while the control group received QiNing capsule. Observe the primary efficacy index: menstrual cycle,menstrual days, follicular size before ovulation and the blood progesterone (P) value7days after ovulation. Observe the secondary efficacy index:BBT change and clinical symptom score. And observe the changes of laboratory tests and adverse reaction. All data was analysised by SPSS17.0statistical software, by x2test,when P<0.05was considered statistically significant.Result1.before the treatment, the experimental group and the control group menstrualperiod (day)(5.90±1.45,5.47±0.74), menstrual cycle (day)(27.25±2.30,27.67±2.23),follicular size before ovulation(cm)(1.49±0.22,1.55±0.67), blood progesterone (P) value7days after ovulation (ng/ml)(8.14±2.38,8.11±0.91),BBThigh temperature phase days (day)(11.60±0.75,11.20±0.68), BBT transitional days (day)(2.30±0.73,2,27±0.70) BBT, high and low temperature difference (℃)(0.28±0.07,0.29±0.07) and clinical symptom score(6.00±1.30,6.40±1.18) have no significant difference (P>0.05).2. the experiment group-and the control group after the first course of treatment comprehensive efficiency were75%,73.33%, after the second course of comprehensive efficiency is respectively85%,86.67%.3. the primary efficacy(1) Experimental group and control group before and after treatment the menstruation (days)(5.90±1.45vs5.05±0.95,5.47±0.74vs4.93±0.80),the menstrual cycle (days)(27.25±2.29vs29.85±3.87,27.67±2.23vs28.87±1.68),the follicular size before ovulation (cm)(1.49±0.22vs1.80±0.21,1.55±0.07vs1.69±0.06) and the blood progesterone (P) value7days after ovulation (ng/ml)(8.14±2.38vs13.77±4.80,8.11±0.91vs12.17±2.78) compared to a significant improvement(P<0.05); (2) The efficiency of menstrual symptoms and BBT in experimental group and control group showed no statistically significant difference (P>0.05).But the follicle size before ovulation in experimental group improved significantly compared with the controlgroup (P<0.05).4.secondary efficacy(1)Experimental group and control group before and after the treatment the BBT high temperature phase days (day)(10.45±1.28vs12.55±1.00,(10.00±0.29vsl2.33±0.49), BBT transitional period (day)(2.50±0.51vsl.30±0.73,2.33±0.72vs0.67±0.72), high and low temperature (℃)(0.29±0.07vs0.39±0.08,0.29±0.07vs0.38±0.06) and the efficiency in experimental group of clinical symptom score(5.85±1.23,2.15±1.35), improved significantly (P<0.05);(2) The efficiency in the two group of the high and low temperature difference of BBT and high temperature phase has no significant difference (P>0.05). And the efficiency in control group of BBT transitional days was higher than that in experimental group (P<0.05). While the efficiency in experimental group of clinical symptom was higher than that in control groupConclusion1. QiNing capsule and JinFeng pill can effectively improve the kidney deficiency of luteal phase defect patients with menstrual symptoms, prolong high temperature phase time of BBT, increase temperture of high temperature phase ofBBT,shorten the BBT low-high temperature shift days and increased blood progesterone seven days after ovulation.2.The efficiency in QiNing capsule of shorten the BBT low-high shift day was higher, but JinFeng pill can more effectively promote the growth of follicles and improve the clinical symptoms of patients.3. in the course of the study, no adverse reaction, so JinFeng pill is safe and reliable, and is worthy of popularization and application. |
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