| [Objective]We observed the efficacy, the timing of treating, the medication safety of TCM prescription on treating none-breaking-Lochia after caesarean section, in order to provid data supportting and scientific evidences for clinical use of this TCM formula.[Methods]In strict accordance with the inclusion criteria, exclusion criteria listed in 《Chinese Medicine’s New Drug Guidelines for clinical research》 which is published by State Drug Administration, we screened the patients in clinic and inpatient department of Hubei Province Chinese Medicine Hospital Garden Hill District.All these65patients’Chinese medicine diagnosis were none-breaking-Lochia, syndrome type of Qi and Blood. The Western medicine diagnosis were late postpartum hemorrhage, subinvolution.All65patients were involved in the treating team, which were taken the boiled-free granules from the first day, three times a day. One treating course lasts seven days.We spyed all the patients’improvement of signs and symptoms before and after one treating course.As well as the three conventional test, Liver and kidney function test, ECG, Pelvic B ultrasound testing the Uterine three-diameter.[Result]1. Clinical effects compare:All these65patients,21cured,36effective,8invalid. The total effective rate in clinial is87.69%.2. Chinese medicine symptom efficacy:Accordig to Chinese medicine symptom efficacy standards, there were15cases cured,27cases markedly effective,18cases effective,5cases ineffective. The total effective rate was92.31%. Compare the Syndrome score before and after the treatment, before20.74±4.55, after5.72±3.46, P=0.000<0.01, there was significant difference.3. Assisted check index change:Uterine three-diameter, before23.09±2.61cm, after18.74±1.90cm, P=0.000. the treatment of uterine diameter narrowing, there are significant differences. after treatment, RBC, HGB, PLT have improved, but not statistically significant.4. Analysis of Factors Influencing Efficacy:65patients were divided into three groups according to age, the effective rates were:20-24years efficacy rate were94.74%,25-29years efficacy rate were83.33%,30-35years efficacy rate were86.36%. Compared three teams, P>0.05, there are significant differences. Then,65patients were divided into three groups according to Course of disease, the effective rates were:10-19days efficacy rate were96.15%,21-30days efficacy rate were95.00%,31days and above efficacy rate were68.42%. Compared the first and second team, P=0.974>0.05. Compared the second and third team, P=0.028>0.05. Compared the first and third team, P=0.010>0.05. It can be tell that the first team was as effective as the second team, and both more effective than the third team.5. Safety evaluation:Neither were there markable change after the treatment in the general test, the othe two conventional tests, Liver and kidney function test, ECG, ect. Nor adverse reactions directly related to the medication is safe in the treatment process. These medicine were safe and non-toxic effects.[Concludes]Chinese medicine qi circulation formula can treat the Qi and Blood type none-breaking-Lochia after caesarean section effectively.All the signs and symptoms like vaginal bleeding, abdominal pain, looking Koushi white, shenpi fatigue and shortness of breath were improved.This Chinese medicine was effective in promoting uterine involution, improved Anemia in some degree. After all, this medicine were safe and non-toxic effects in clinical. |
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