早熟方治疗痰热型女童性早熟140例临床研究
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摘要
目的:验证早熟方治疗女童痰热互结型性早熟的临床疗效。方法:本课题采用多中心、单盲、随机对照方法,研究早熟方对女童性早熟痰热互结型的临床疗效,并与抗早2号方进行阳性对照。临床收集140例痰热互结型性早熟女童病例,随机分为治疗组70例和对照组70例,2组分别予早熟方、抗早2号方治疗,疗程均为12周;每4周随访观察临床症状、体征、身高、体质量、生长速率,乳核直径,并进行中医证候评分。入组初筛及治疗12周后分别检查子宫容积、卵巢容积、骨龄的变化情况及血清促卵泡生成素(FSH)、促黄体生成素(LH)、雌二醇(E2)水平,评价临床疗效,监测ALT、BUN、Cr进行安全性评价。结果:1)治疗组与对照组总有效率分别为96%、100%;2组间临床疗效比较无统计学意义(P>0.05)。2)治疗组与对照组乳核直径治疗前后自身比较有统计学意义(P<0.05);2组间比较无统计学意义(P>0.05)。3)治疗组及对照组子宫、卵巢容积治疗前后自身比较无统计学意义(P>0.05);治疗后组间比较亦无统计学意义(P>0.05)。4)2组血清LH、E2治疗前后自身比较有统计学意义(P<0.05);治疗后组间比较无统计学意义(P>0.05)。5)治疗组与对照组治疗前后中医证候评分比较,差异有统计学意义(P<0.001);治疗后2组间比较,差异无统计学意义(P>0.05)。6)治疗前后ALT、BUN、Cr测定数值均在正常范围。结论:早熟方能有效治疗儿童痰热互结型性早熟,能明显改善中医症候积分,缩小乳核直径,降低LH、E2水平,但对FSH无明显影响,对子宫、卵巢容积无明显影响。临床疗效与抗早2号方相当。
Objective: 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.
Objective: 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.
引文
[1]杨章萍,郑晓萍,张旭慧,等.女童性早熟的影响因素分析[J].中国学校卫生,2014,35(1):133-135.
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[8]王春林,梁黎,留佩宁,等.促性腺激素释放激素类似物联合重组人生长激素对中枢性性早熟女童身高的影响[J].中国当代儿科杂志,2014,16(1):25-30.
[9]金献江,罗越,吴慧平,等.促性腺激素释放激素类似物治疗不同年龄中枢性性早熟女孩的剩余生长能力评价[J].Chiese Gernal Practice,2014,17(25):2965-2968.
[10]程敏,叶小弟,缪云萍,等.大补阴丸治疗雌性大鼠真性性早熟的实验研究[J].中国中药杂志,2013,38(3):386.
[11]黄蓉,汪永红,俞建,等.中医治疗儿童性早熟辨证用药规律探析[J].中华中医药杂志,2011,26(2):347-349.
[12]赵鋆,虞坚尔,朱敏华,等.抗早2号方治疗女童真性性早熟150例临床观察[J].上海中医药大学学报,2005,19(1):15-17.
[13]尤箫萌,单川,沈秀华,等.儿童肥胖与性早熟的研究进展[J].上海交通大学学报:医学版,2012:32(7):949-951.
[14]赵鋆,朱敏华,卓跃红,等.抗早2号方对青春期雌性大鼠下丘脑-垂体-性腺轴的影响[J].上海中医药杂志,2006,40(5):44-45.
[15]姚泰.生理学[M].北京:人民卫生出版社,2010:530.
[2]中华医学会儿科学分会内分泌遗传代谢学组.中枢性(真性)性早熟诊断和治疗的建议[S].中华儿科杂志,2003,42(4):272-273.
[3]汪受传,俞景茂.中医儿科临床研究[M].北京:人民卫生出版社,2009:362.
[4]吴瑞萍,胡亚美,江载芳.诸福堂实用儿科学[M].北京:人民卫生出版社,1997:1930.
[5]徐迪华,徐剑秋.中医量化诊断[M].南京:江苏科学技术出版社,1997:99-103,112-137.
[6]上海市卫生局.上海市中医病证诊疗常规[S].上海:上海中医药大学出版社,2003:257.
[7]吴静,吕瑞丽,何春风,等.不同治疗方法对特发性中枢性性早熟女童初潮年龄及成年终身高的影响[J].中国妇幼保健,2014,29(36):6032-6034.
[8]王春林,梁黎,留佩宁,等.促性腺激素释放激素类似物联合重组人生长激素对中枢性性早熟女童身高的影响[J].中国当代儿科杂志,2014,16(1):25-30.
[9]金献江,罗越,吴慧平,等.促性腺激素释放激素类似物治疗不同年龄中枢性性早熟女孩的剩余生长能力评价[J].Chiese Gernal Practice,2014,17(25):2965-2968.
[10]程敏,叶小弟,缪云萍,等.大补阴丸治疗雌性大鼠真性性早熟的实验研究[J].中国中药杂志,2013,38(3):386.
[11]黄蓉,汪永红,俞建,等.中医治疗儿童性早熟辨证用药规律探析[J].中华中医药杂志,2011,26(2):347-349.
[12]赵鋆,虞坚尔,朱敏华,等.抗早2号方治疗女童真性性早熟150例临床观察[J].上海中医药大学学报,2005,19(1):15-17.
[13]尤箫萌,单川,沈秀华,等.儿童肥胖与性早熟的研究进展[J].上海交通大学学报:医学版,2012:32(7):949-951.
[14]赵鋆,朱敏华,卓跃红,等.抗早2号方对青春期雌性大鼠下丘脑-垂体-性腺轴的影响[J].上海中医药杂志,2006,40(5):44-45.
[15]姚泰.生理学[M].北京:人民卫生出版社,2010:530.