To observe the curative effect of“Zaoshu Granule”in treating sexually precocious girls of phlegm heat pattern. Methods: The clinical effect of “Zaoshu Granule” was investigated in a multi center, randomized, single blind clinical trial with the control of No.2 prescription. Among the 140 cases, seventy patients in the treatment group were given ”Zaoshu Granule” and 70 patients in the control group were treated by No.2 prescription. The course lasted for 12 weeks. Every four weeks, the clinical symptoms, sign, height, weight, growth rate, diameter of nodule in breast and evaluation for TCM syndrome grade were detected in two groups respectively. Intrauterine volume, ovarian volume, bone age, levels of FSH, LH and E2 were detected at primary screening of enrollment and after 12 weeks treatment to evaluate the clinical effects. Safety evaluation was monitored by levels of ALT, BUN and Cr. Results: 1)The total effective rate was 96% in treatment group and 100% in control group without significant difference(P>0.05). 2)Within both of the groups, there was significant difference in diameter of nodule in breast before and after treatment(P<0.05), but no significant difference was found between the two groups(P>0.05). 3)Within both of the groups, there was no significant difference in intrauterine volume and ovarian volume before and after treatment(P>0.05), and also no significant difference between the two groups(P>0.05). 4)Within both of the groups, there was significant difference in serum levels of LH and E2 before and after treatment(P<0.05), but after treatment, no significant difference was found in all the indexes between the two groups(P>0.05). 5)Within both of the groups, there was significant difference in evaluation for TCM syndrome grade before and after treatment(P<0.001), but no significant difference was found between the two groups(P>0.05). 6)Within both of the groups, levels of ALT, BUN and Cr before and after treatment were within normal range. Conclusion: “Zaoshu Granule”has positive effect on sexually precocious girls of phlegm heat pattern and it can obviously improve TCM syndrome grade, reduce the nodule in breast diameter, and decrease the levels of LH and E2. While it has no significant effect on FSH, intrauterine volume and ovarian volume. “Zaoshu Granule” has equivalent clinical effect of No.2 prescription in treating sexually precocious girls of phlegm heat pattern. |