| ObjectiveThis research adopts randomized clinical trials, TCM syndrome score table and pruritus score tabl for evaluation, and combined with the results of laboratory biochemical indicators, to observ the clinical efficacy of Yinzhihuang oral liquid for intrahepatic cholestasis of pregnancy(ICP), for its further clinical application and promotion provide the basis.MethodThis study used a prospective randomized controlled clinical trials,60 cases patients who mee the inclusion criteria of hepatobiliary damp heat type in intrahepatic cholestasis of pregnancy were divided into the control group (UDCA), treatment group (Yinzhihuang oral liquid) of the 30 cases, to observe the change of skin itching, serum total bile acid (TBA), alanine aminotransferase (ALT), obstetrics complication rate, scores of TCM symptoms.ResultIn this study, the treatment group used Yinzhihuang oral solution, control group application of ursodeoxycholic acid in the treatment of ICP, the baseline data of two groups’patients was processed by statistical, there are no significant difference(P>0.05). After 7 days’,14days’,21days’treatment in two groups, The value of TBA recovery of treatment group condition is better than that of the control group. The TBA value of treatment group (5.937±2.4459 mol/L)was less than that of the control group(10.677±4.4980 mol/L),the difference was statistically significant(P<0.05);The treatment group were better than those of control group in improving the ALT value, but for that of 7days’,14 days’treatment, the value of ALT had no statistical difference (P> 0.05). After 21 days treatment the value of ALT in treatment group (6.13± 1.717U/L)was better than those of the control group (7.67±1.900U/L), the difference was statistically significant (P<0.05).The TBA value of treatment group before treatment (20.497±8.7901mol/L)was greater than those after treatment (5.937±2.4459mol/L), the difference was statistically significant(P<0.05);the ALT value of treatment group before treatment (14.37 ±5.599 U/L)was greater than those after treatment(7.67±1.900 U/L),the difference was statistically significant(P<0.05);As control group, after treatment the TBA, ALT values were significantly improved compared with before treatment, the difference has statistical significance(P<0.05).The effect was statistically significant of both groups comparing before treatment and 21 days treatment in TCM syndrome score (p<0.05). what’s more, TCM syndrome scores of the treatment group (1.83±0.592) were lower than the control group (2.20 ±0.714) after 21 days treatment and the comparison was significantly significant(p<0.05). Compared two groups of patients comprehensive curative effect, the total effective rate of treatment group 86.6% was higher than control group 73.3%, the difference was statistically significant (P<0.05). The probability of fetal abnormality during delivery and neonatal morbidity after delivery were 23.3%(treatment group) and 36.6%(control group) respectively and there was no significant difference after both groups comparing. (p<0.05). ConclusionIn this study, two kinds of drugs for the recovery of biochemical indicators of patients with ICP, the remission of symptoms and improving the quality of life of pregnancy are certainly helpful. The treatment group was better than the control group in recovery of biochemical indicators.but the difference for improvement of ALT was statistically significant after 21 days treatment for the treatment group compared with the control group. The effect of both groups was significantly different comparing before and after treatment inclinical symptoms and symptoms of TCM, and the treatment group was better than the control group. In addition, the treatment group was superior to the control group in the treatment of the comprehensive effect. And there was on difference for the two drugs in the improvement of the abnormal fetal during delivery and the incidence of jaundice and the rate of asphyxia after delivery. In summary, Yinzhihuang oral liquid can effectively reduce serum total bile acid and ALT values of intrahepatic cholestasis patients in pregnancy, relieve clinical symptoms, improve the TCM symptom scores; and it is no significant adverse reactions. In a word, it is worth of clinical application. |
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