针药并用改善多囊卵巢综合征患者胰岛素抵抗的临床研究
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摘要
研究背景：
多囊卵巢综合征(polycystic ovary syndrome, PCOS)是以持续性无排卵、高雄激素或胰岛素抵抗为特征的内分泌紊乱的症候群,发病率高达5%-10%。近年来大量研究表明,PCOS患者不论肥胖与否,都存在不同程度的胰岛素抵抗(insulin resistance, IR),其发生率可达70%,并且认为IR可能是PCOS病情的始动因素和中心环节。西医目前治疗PCOS合并IR首选二甲双胍,但因二甲双胍单一用药恢复月经与促排卵疗效欠佳,易出现消化道副作用,且对胚胎安全性尚未明确,故临床应用受到一定的限制。
广东省名老中医李丽芸教授创立的灵术颗粒剂通过前期实验及临床研究证实其治疗PCOS并IR疗效确切。研究表明穴位埋线可通过减轻体重指数改善PCOS患者临床症状。为探寻一种治疗PCOS并IR有效的、副作用少的治疗方法,本研究将灵术颗粒与穴位埋线联合用于治疗PCOS并IR,以评价其有效性及安全性,希望能为本病的治疗提供一种新方法及新思路。
研究目的：
本研究旨在通过比较经验方灵术颗粒与目前西医治疗PCOS合并IR的最常用药物二甲双胍,单纯穴位埋线以及经验方灵术颗粒联合穴位埋线治疗多囊卵巢综合征并IR的临床疗效及安全性,通过观察患者体重指数、胰岛素抵抗、月经及排卵情况、生殖内分泌、血脂等的改善情况,对灵术颗粒联合穴位埋线治疗多囊卵巢综合征并IR的临床疗效作出客观评价,探讨其可能的作用机制。为临床提供一种治疗PCOS合并胰岛素抵抗有效的、副作用少的治疗方法奠定理论基础。
研究方法：
本研究采用前瞻性临床对照试验研究,选择2009年12月至2011年12月广东省中医院妇科门诊就诊的符合诊断和纳入标准的PCOS合并IR的患者175例,设立灵术颗粒组、穴位埋线组、二甲双胍组、针药并用组。其中灵术颗粒组44例,采用经验方灵术颗粒(广东省中医院院内制剂,批号：08102305)治疗,穴位埋线组43例,二甲双胍组44例,采用二甲双胍(格华止,上海施贵宝药业公司)治疗,针药并用组44例,采用经验方灵术颗粒联合穴位埋线治疗。每组均治疗3个月为一疗程。评价治疗前后体重、BMI、WHR,月经及排卵情况,中医症状量化评分,多毛、痤疮评分、BBT、性激素、空腹血糖、空腹胰岛素、胰岛素抵抗指数、血脂等疗效判定指标的改善情况。以及治疗前后检测一般安全性项目,及记录不良反应的发生。
研究结果：
1.四组治疗均可改善PCOS患者体重指数、腰臀比。本研究结果显示四组治疗后PCOS患者体重、BMI、腰臀比水平均较治疗前明显下降,治疗前后比较,差异均有统计学意义(P<0.05)；经组间疗效差异比较,针药并用组在降低体重指数方面优于灵术颗粒组、穴位埋线组及二甲双胍组,组间比较,差异均有统计学意义(P<0.05)。
2.四组治疗均可改善PCOS患者IR,本研究结果显示四组治疗后PCOS患者空腹INS.HOMA-IR水平均较治疗前改善,治疗后针药并用组在改善HOMA-IR方面优于灵术颗粒组、穴位埋线组,组间比较,差异有统计学意义(P<0.05)；针药并用组与二甲双胍组治疗后HOMA-IR组间比较,差异无统计学意义(P>0.05),说明针药并用组与二甲双胍组在改善HOMA-IR方面的疗效相当。
3.本研究结果证实：灵术颗粒联合穴位埋线、二甲双胍是治疗PCOS合并IR患者的有效治疗方法。根据组间疗效差异比较,我们认为针药并用在治疗PCOS并IR患者疗效优于单纯灵术颗粒或单纯穴位埋线；针药并用与二甲双胍治疗IR组间比较,差异无统计学意义,说明两种治疗方法疗效相当,但针药并用组解决了二甲双胍胃肠道不适的不良反应和安全性不明确问题,对于有生育要求的患者针药并用治疗无疑是首选治疗方法,便于临床推广应用。
4.四组治疗均可改善PCOS患者中医症状量化评分,针药并用组在改善中医症状量化评分方面疗效优于其它三组。
5.针药并用组在改善PCOS患者血脂情况方面,疗效优于其它三组。
6.通过本课题研究,我们认为灵术颗粒联合穴位埋线可以通过降低体重指数,改善胰岛素抵抗,改善内分泌水平及血脂代谢情况,在治疗PCOS同时,可降低PCOS患者发生远期并发症的风险。
研究结论：
灵术颗粒联合穴位埋线治疗PCOS合并IR疗效肯定,考虑其可能通过降低患者体重指数、腰臀比,从而改善胰岛素抵抗,其疗效优于单纯灵术颗粒或单纯穴位埋线治疗,与二甲双胍组比较疗效相当,但灵术颗粒联合穴位埋线解决了二甲双胍副作用明显且安全性不明确的问题,故对于不能耐受二甲双胍副作用,或有生育要求的女性,灵术颗粒联合穴位埋线可作为其首选的治疗方法,值得临床推广应用。
Background
Polycystic ovarian syndrome(PCOS) is a persistent anovulation, hyperandrogenism or insulin resistance syndrome is characterized by endocrine disorders, the incidence rate as high as5%-10%. In recent years, a large number of studies have shown that PCOS, whether obese or not, there are varying degrees of insulin resistance (insulin resistance, IR), an incidence of up to70%, and that the IR may be the initiating factor and the central link of the PCOS condition. Western medicine treatment of PCOS with IR preferred metformin, but metformin single medication to restore menstruation and ovulation efficacy poor, prone to gastrointestinal side effects, and embryonic security is not yet clear, clinical application is subject to certain restrictions.
The famous professor Li LiYun of GuangDong Province Hospital of Traditional Chinese Medicine, created Ling-Zhu granule, early experimental and clinical studies confirmed that is very effective to treat the patient of PCOS and insulin resistance. Studies show that acupoint catgut embedding can improve the clinical symptoms of patients with polycystic ovary syndrome by reducing the body mass index. Hence, in order to explore and find an effective treatment method for PCOS and IR with fewer side effects, in this study, joint Ling-Zhu granule with acupoint catgut embedding for treatment of polycystic ovary syndrome and insulin resistance, in order to evaluate the efficacy and safety, hoping to disease-oriented treatment to provide a new approach and new ideas.
Objectives
Through comparing the clinical healing effect difference for PCOS between the Ling-Zhu granule from Professor Li Liyun, acupoint catgut embedding, the most common medicine metformin for curing PCOS with IR in Western Medicine and the Ling-Zhu granule and acupoint catgut embedding combined treatment as well as observing improvement of menstruation, ovulation, body mass, reproductive endocrinology, insulin resistance, lipids, etc, this study is aiming at making objective evaluation to the clinical healing effects of Ling-Zhu granule and acupoint catgut embedding combined treatment for PCOS and exploring the possible action mechanism in order to lay the foundation for the treatment method which has high efficiency and less side for curing PCOS and can also excellently prevent its long future complication.
Method
This study adopts prospective clinical controlled trial, chooses175PCOS and IR patients who went to Guangdong TCM Hospital to see gynecologic doctors during the time from December2009to December2011and are conforming to the diagnosis and adopting standard and divides them into four groups, Ling-Zhu granule group, acupoint catgut embedding group, metformin group and Ling-Zhu granule and acupoint catgut embedding combined group. Ling-Zhu granule group has44patients and they are treated with the experienced prescription Ling-Zhu granule group (domestic preparation, batch number:08102305). acupoint catgut embedding group has43patients and they are treated with acupoint catgut embedding therapy. Metformin group has44patients and they are treated with metformin (made in Shanghai). Ling-Zhu granule and acupoint catgut embedding combined group has44patients and they are treated with Ling-Zhu granule and acupoint catgut embedding combined therapy, three months for each treatment period. This study evaluates the improvement situation of clinical symptoms and signs before and after the treatment, as well as the improvement situation of weight, BMI, waistline, hipline, WHR, hirsutism, acne scores, BBT, sex hormones before and after treatment, GLU, INS, HOMA-IR, TG, Tc, HDL-C, LDL-C, ApoA, ApoB and other indicators to determine efficacy, examines the general safety items before and after the treatment and records the occurrence of adverse reactions.
Results
1. Four groups of patients with body mass index, waist-hip ratio have improved. After treatment, the body weight, BMI, and waist-hip ratio levels than before treatment was significantly decreased, the differences were statistically significant(P<0.05); Ling-Zhu granule and acupoint catgut embedding combined group was better than Ling-Zhu granule group, acupoint catgut embedding group and metformin group in decreasing body mass index, the differences were statistically significant(P<0.05).
2. Four groups of patients with IR have improved. After treatment, the INS and HOMA-IR levels have improved than before treatment. Ling-Zhu granule and acupoint catgut embedding combined group was better than Ling-Zhu granule group and acupoint catgut embedding group in improveing HOMA-IR, the differences were statistically significant(P<0.05); The difference between Ling-Zhu granule and acupoint catgut embedding combined group and metformin group was not statistically significant (P>0.05), We believe that the efficacy is similar between Ling-Zhu granule and acupoint catgut embedding combined group and metformin group in improving HOMA-IR.
3. Results of this study confirmed:Ling-Zhu granule and acupoint catgut embedding combined treatment is an effective treatment method for curing PCOS and IR. Ling-Zhu granule and acupoint catgut embedding combined solved the problem of gastrointestinal discomfort and unsafely in using metformin, we believe that Ling-Zhu granule and acupoint catgut embedding combined is the preferred treatment method for fertility patients.
4. The treatment of all of the four groups can improve the quantitative scores of TCM symptoms of PCOS patients. Ling-Zhu granule and acupoint catgut embedding combined group improve the quantitative scores of TCM symptoms better than the other three groups.
5. Blood lipids status can be improved in Ling-Zhu granule and acupoint catgut embedding combined group. Its effect is better than the other three groups.
6. According to the objective findings, we believe that the Necromancy Particle and acupoint catgut embedding combined treatment, through lowering the body mass, improving the insulin resistance and improving the blood fat metabolism status, can lower in a way the risk of PCOS long future complications.
Conclusion
Ling-Zhu granule and acupoint catgut embedding combined treatment of PCOS with IR is effective. IR had improved maybe by reducing body mass index and waist-hip ratio. The efficacy of Ling-Zhu granule and acupoint catgut embedding combined treatment was equivalent to metformin, and it was better than Ling-Zhu granule or acupoint catgut embedding. But Ling-Zhu granule and acupoint catgut embedding combined treatment has no side effects, its security is clear, so it is suitable for the patients who has fertility requirements or can not tolerate metformin side effects.
多囊卵巢综合征(polycystic ovary syndrome, PCOS)是以持续性无排卵、高雄激素或胰岛素抵抗为特征的内分泌紊乱的症候群,发病率高达5%-10%。近年来大量研究表明,PCOS患者不论肥胖与否,都存在不同程度的胰岛素抵抗(insulin resistance, IR),其发生率可达70%,并且认为IR可能是PCOS病情的始动因素和中心环节。西医目前治疗PCOS合并IR首选二甲双胍,但因二甲双胍单一用药恢复月经与促排卵疗效欠佳,易出现消化道副作用,且对胚胎安全性尚未明确,故临床应用受到一定的限制。
广东省名老中医李丽芸教授创立的灵术颗粒剂通过前期实验及临床研究证实其治疗PCOS并IR疗效确切。研究表明穴位埋线可通过减轻体重指数改善PCOS患者临床症状。为探寻一种治疗PCOS并IR有效的、副作用少的治疗方法,本研究将灵术颗粒与穴位埋线联合用于治疗PCOS并IR,以评价其有效性及安全性,希望能为本病的治疗提供一种新方法及新思路。
研究目的：
本研究旨在通过比较经验方灵术颗粒与目前西医治疗PCOS合并IR的最常用药物二甲双胍,单纯穴位埋线以及经验方灵术颗粒联合穴位埋线治疗多囊卵巢综合征并IR的临床疗效及安全性,通过观察患者体重指数、胰岛素抵抗、月经及排卵情况、生殖内分泌、血脂等的改善情况,对灵术颗粒联合穴位埋线治疗多囊卵巢综合征并IR的临床疗效作出客观评价,探讨其可能的作用机制。为临床提供一种治疗PCOS合并胰岛素抵抗有效的、副作用少的治疗方法奠定理论基础。
研究方法：
本研究采用前瞻性临床对照试验研究,选择2009年12月至2011年12月广东省中医院妇科门诊就诊的符合诊断和纳入标准的PCOS合并IR的患者175例,设立灵术颗粒组、穴位埋线组、二甲双胍组、针药并用组。其中灵术颗粒组44例,采用经验方灵术颗粒(广东省中医院院内制剂,批号：08102305)治疗,穴位埋线组43例,二甲双胍组44例,采用二甲双胍(格华止,上海施贵宝药业公司)治疗,针药并用组44例,采用经验方灵术颗粒联合穴位埋线治疗。每组均治疗3个月为一疗程。评价治疗前后体重、BMI、WHR,月经及排卵情况,中医症状量化评分,多毛、痤疮评分、BBT、性激素、空腹血糖、空腹胰岛素、胰岛素抵抗指数、血脂等疗效判定指标的改善情况。以及治疗前后检测一般安全性项目,及记录不良反应的发生。
研究结果：
1.四组治疗均可改善PCOS患者体重指数、腰臀比。本研究结果显示四组治疗后PCOS患者体重、BMI、腰臀比水平均较治疗前明显下降,治疗前后比较,差异均有统计学意义(P<0.05)；经组间疗效差异比较,针药并用组在降低体重指数方面优于灵术颗粒组、穴位埋线组及二甲双胍组,组间比较,差异均有统计学意义(P<0.05)。
2.四组治疗均可改善PCOS患者IR,本研究结果显示四组治疗后PCOS患者空腹INS.HOMA-IR水平均较治疗前改善,治疗后针药并用组在改善HOMA-IR方面优于灵术颗粒组、穴位埋线组,组间比较,差异有统计学意义(P<0.05)；针药并用组与二甲双胍组治疗后HOMA-IR组间比较,差异无统计学意义(P>0.05),说明针药并用组与二甲双胍组在改善HOMA-IR方面的疗效相当。
3.本研究结果证实：灵术颗粒联合穴位埋线、二甲双胍是治疗PCOS合并IR患者的有效治疗方法。根据组间疗效差异比较,我们认为针药并用在治疗PCOS并IR患者疗效优于单纯灵术颗粒或单纯穴位埋线；针药并用与二甲双胍治疗IR组间比较,差异无统计学意义,说明两种治疗方法疗效相当,但针药并用组解决了二甲双胍胃肠道不适的不良反应和安全性不明确问题,对于有生育要求的患者针药并用治疗无疑是首选治疗方法,便于临床推广应用。
4.四组治疗均可改善PCOS患者中医症状量化评分,针药并用组在改善中医症状量化评分方面疗效优于其它三组。
5.针药并用组在改善PCOS患者血脂情况方面,疗效优于其它三组。
6.通过本课题研究,我们认为灵术颗粒联合穴位埋线可以通过降低体重指数,改善胰岛素抵抗,改善内分泌水平及血脂代谢情况,在治疗PCOS同时,可降低PCOS患者发生远期并发症的风险。
研究结论：
灵术颗粒联合穴位埋线治疗PCOS合并IR疗效肯定,考虑其可能通过降低患者体重指数、腰臀比,从而改善胰岛素抵抗,其疗效优于单纯灵术颗粒或单纯穴位埋线治疗,与二甲双胍组比较疗效相当,但灵术颗粒联合穴位埋线解决了二甲双胍副作用明显且安全性不明确的问题,故对于不能耐受二甲双胍副作用,或有生育要求的女性,灵术颗粒联合穴位埋线可作为其首选的治疗方法,值得临床推广应用。
Background
Polycystic ovarian syndrome(PCOS) is a persistent anovulation, hyperandrogenism or insulin resistance syndrome is characterized by endocrine disorders, the incidence rate as high as5%-10%. In recent years, a large number of studies have shown that PCOS, whether obese or not, there are varying degrees of insulin resistance (insulin resistance, IR), an incidence of up to70%, and that the IR may be the initiating factor and the central link of the PCOS condition. Western medicine treatment of PCOS with IR preferred metformin, but metformin single medication to restore menstruation and ovulation efficacy poor, prone to gastrointestinal side effects, and embryonic security is not yet clear, clinical application is subject to certain restrictions.
The famous professor Li LiYun of GuangDong Province Hospital of Traditional Chinese Medicine, created Ling-Zhu granule, early experimental and clinical studies confirmed that is very effective to treat the patient of PCOS and insulin resistance. Studies show that acupoint catgut embedding can improve the clinical symptoms of patients with polycystic ovary syndrome by reducing the body mass index. Hence, in order to explore and find an effective treatment method for PCOS and IR with fewer side effects, in this study, joint Ling-Zhu granule with acupoint catgut embedding for treatment of polycystic ovary syndrome and insulin resistance, in order to evaluate the efficacy and safety, hoping to disease-oriented treatment to provide a new approach and new ideas.
Objectives
Through comparing the clinical healing effect difference for PCOS between the Ling-Zhu granule from Professor Li Liyun, acupoint catgut embedding, the most common medicine metformin for curing PCOS with IR in Western Medicine and the Ling-Zhu granule and acupoint catgut embedding combined treatment as well as observing improvement of menstruation, ovulation, body mass, reproductive endocrinology, insulin resistance, lipids, etc, this study is aiming at making objective evaluation to the clinical healing effects of Ling-Zhu granule and acupoint catgut embedding combined treatment for PCOS and exploring the possible action mechanism in order to lay the foundation for the treatment method which has high efficiency and less side for curing PCOS and can also excellently prevent its long future complication.
Method
This study adopts prospective clinical controlled trial, chooses175PCOS and IR patients who went to Guangdong TCM Hospital to see gynecologic doctors during the time from December2009to December2011and are conforming to the diagnosis and adopting standard and divides them into four groups, Ling-Zhu granule group, acupoint catgut embedding group, metformin group and Ling-Zhu granule and acupoint catgut embedding combined group. Ling-Zhu granule group has44patients and they are treated with the experienced prescription Ling-Zhu granule group (domestic preparation, batch number:08102305). acupoint catgut embedding group has43patients and they are treated with acupoint catgut embedding therapy. Metformin group has44patients and they are treated with metformin (made in Shanghai). Ling-Zhu granule and acupoint catgut embedding combined group has44patients and they are treated with Ling-Zhu granule and acupoint catgut embedding combined therapy, three months for each treatment period. This study evaluates the improvement situation of clinical symptoms and signs before and after the treatment, as well as the improvement situation of weight, BMI, waistline, hipline, WHR, hirsutism, acne scores, BBT, sex hormones before and after treatment, GLU, INS, HOMA-IR, TG, Tc, HDL-C, LDL-C, ApoA, ApoB and other indicators to determine efficacy, examines the general safety items before and after the treatment and records the occurrence of adverse reactions.
Results
1. Four groups of patients with body mass index, waist-hip ratio have improved. After treatment, the body weight, BMI, and waist-hip ratio levels than before treatment was significantly decreased, the differences were statistically significant(P<0.05); Ling-Zhu granule and acupoint catgut embedding combined group was better than Ling-Zhu granule group, acupoint catgut embedding group and metformin group in decreasing body mass index, the differences were statistically significant(P<0.05).
2. Four groups of patients with IR have improved. After treatment, the INS and HOMA-IR levels have improved than before treatment. Ling-Zhu granule and acupoint catgut embedding combined group was better than Ling-Zhu granule group and acupoint catgut embedding group in improveing HOMA-IR, the differences were statistically significant(P<0.05); The difference between Ling-Zhu granule and acupoint catgut embedding combined group and metformin group was not statistically significant (P>0.05), We believe that the efficacy is similar between Ling-Zhu granule and acupoint catgut embedding combined group and metformin group in improving HOMA-IR.
3. Results of this study confirmed:Ling-Zhu granule and acupoint catgut embedding combined treatment is an effective treatment method for curing PCOS and IR. Ling-Zhu granule and acupoint catgut embedding combined solved the problem of gastrointestinal discomfort and unsafely in using metformin, we believe that Ling-Zhu granule and acupoint catgut embedding combined is the preferred treatment method for fertility patients.
4. The treatment of all of the four groups can improve the quantitative scores of TCM symptoms of PCOS patients. Ling-Zhu granule and acupoint catgut embedding combined group improve the quantitative scores of TCM symptoms better than the other three groups.
5. Blood lipids status can be improved in Ling-Zhu granule and acupoint catgut embedding combined group. Its effect is better than the other three groups.
6. According to the objective findings, we believe that the Necromancy Particle and acupoint catgut embedding combined treatment, through lowering the body mass, improving the insulin resistance and improving the blood fat metabolism status, can lower in a way the risk of PCOS long future complications.
Conclusion
Ling-Zhu granule and acupoint catgut embedding combined treatment of PCOS with IR is effective. IR had improved maybe by reducing body mass index and waist-hip ratio. The efficacy of Ling-Zhu granule and acupoint catgut embedding combined treatment was equivalent to metformin, and it was better than Ling-Zhu granule or acupoint catgut embedding. But Ling-Zhu granule and acupoint catgut embedding combined treatment has no side effects, its security is clear, so it is suitable for the patients who has fertility requirements or can not tolerate metformin side effects.
引文
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