Randomized controlled study of Banxia Tiaozhong Granules combined with Yangyuan Tongluo Acupuncture in the treatment of diabetic gastroparesis with mixed cold and heat syndrome
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摘要: 目的 观察半夏调中颗粒联合养元通络针法对寒热错杂型糖尿病胃轻瘫(DGP)的临床疗效。方法 64例寒热错杂型DGP患者按随机数字表法分为研究组(32例)和对照组(32例)，研究组予半夏调中颗粒和养元通络针法治疗，对照组予枸橼酸莫沙必利片治疗，两组疗程均为4周。观察两组患者治疗前后中医证候评分、胃轻瘫主要症状的标准调查表(GCSI)评分、胃排空率、胃肠激素及胃电图指标变化情况，并评价两组患者的临床疗效和安全性。结果 治疗过程中脱落4例，最终两组各有32例患者完成研究。研究组的临床疗效总有效率为93.8%(30/32)，高于对照组的75.0%(24/32)，差异有统计学意义(P < 0.05)；两组患者的各项中医证候评分、GCSI症状评分均较治疗前明显下降，且研究组优于对照组，差异有统计学意义(P < 0.05)；两组患者的血清胃泌素及胃动素水平均较治疗前下降，且研究组较对照组下降明显，差异有统计学意义(P < 0.05)；两组患者的胃排空率均较治疗前升高，且研究组较对照组升高明显，差异有统计学意义(P < 0.05)；两组患者的胃电图胃平均收缩波频率和收缩波振幅增高，胃电节律紊乱百分比下降，均较治疗前改善，差异有统计学意义(P < 0.05)，且研究组的改善情况优于对照组，差异有统计学意义(P < 0.05)。结论 半夏调中颗粒联合养元通络针法可显著缓解寒热错杂型DGP患者的消化道临床症状，能有效调节胃肠激素水平，改善胃电节律和胃肠动力。Abstract: Objective To observe the effect of compound Banxia Tiaozhong Granule combined with Yangyuan Tongluo Acupuncture for treatment of diabetic gastroparesis with mixed cold and heat syndrome.Methods Sixty-four cases of diabetic gastroparesis with mixed cold and heat syndrome were randomly divided into trial group(34 cases) and control group(34 cases). The cases in trial group were administered with Banxia Tiaozhong Granule and Yangyuan Tongluo Acupuncture, and the cases in control group were administred with mosapride tablets. The overall effective rate was compared between the two groups after 4 weeks of treatment; the changes in main symptom scores, gastrointestinal hormones, gastrointestinal dynamics and electrogastrogram. After treatment, the clinical efficacy and safety of the two groups were also evaluated.Results During the trial, 4 cases fell off during the treatment, and 32 cases were lost in each group. The total effective rate of the trial group was 93.8%(30/32) higher than that of the control group 75.0%(24/32)(P < 0.05). the scores of various Traditional Chinese Medicine syndrome scores and gastroparesis cardinal symptom index(GCSI) symptom scores of both groups were significantly decreased compared with before treatment, and the trial group was better than the control group(P < 0.05). Serum gastrin and motilin in 2 groups were lower than before treatment, and the levels in the trial group were significantly lower than those in the control group(P < 0.05). The gastric emptying rate of the two groups was higher than that before treatment, and the trial group was significantly higher than the control group(P < 0.05). The mean frequency of contraction and amplitude contraction of the 2 groups were increased, and the percentage of gastroelectric rhythm disturbance was decreased, both of which were improved compared with before treatment(P < 0.05), and the improvement in the trial group was better than that in the control group(P < 0.05).Conclusion Compound treatment of diabetic gastroparesis with mixed cold and heat syndrome significantly and improve the gastric emptying, regulate gastrointestinal hormone level effectively, improve gastric electric rhythm and gastrointestinal motility.
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表 1 两组患者的临床资料比较
例(%)，X±S 临床资料 对照组(n=32) 研究组(n=32) t/χ2 P 性别 男 18(56.25) 15(46.88) 0.563 0.453 女 14(43.75) 17(53.12) 年龄/岁 51.70±7.62 52.80±7.39 0.424 0.652 糖尿病病程/年 10.80±3.36 11.30±3.12 0.332 0.723 DGP病程/月 14.10±4.09 13.40±3.81 0.489 0.609 BMI 24.64±1.31 23.92±1.25 0.509 0.598 空腹血糖/(mmol·L-1) 6.59±0.63 6.83±0.71 0.301 0.817 餐后2 h血糖/(mmol·L-1) 9.54±0.82 10.02±0.91 0.532 0.571 糖化血清蛋白/(mmol·L-1) 6.03±0.61 6.26±0.54 0.318 0.783 合并症 高血压 11(34.38) 8(25.00) 糖尿病肾病 5(15.63) 3(9.38) 1.326 0.713 神经病变 12(37.50) 14(43.75) 高血脂 6(18.75) 8(25.00) GCSI评分/分a) 31.20±7.62 32.30±6.89 0.726 0.415 中医证候评分/分 10.46±2.48 10.57±2.37 0.679 0.509 胃排空率/% 36.10±8.62 34.90±9.06 1.049 0.295 注：a)GCSI为胃轻瘫主要症状的标准调查表。 
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表 2 两组患者的临床疗效比较
例(%) 组别 例数 临床痊愈 显效 有效 无效 总有效 研究组 32 0 16(50.0) 14(43.8) 2(6.2) 30(93.8) 对照组 32 0 14(43.8) 10(31.2) 8(25.0) 24(75.0) P 0.616 0.292 0.039 0.039
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表 3 两组患者的中医证候评分和临床症状评分比较
分，X±S 指标 对照组(n=32) 研究组(n=32) t P 治疗前 治疗后 治疗前 治疗后 胃脘胀满 2.09±0.52 1.21±0.391) 2.20±0.58 0.67±0.311)2) 3.237 0.003 食欲不振 1.94±0.55 1.02±0.371) 1.86±0.61 0.59±0.231)2) 2.163 0.016 恶心呕吐 2.03±0.51 1.25±0.331) 2.11±0.56 0.71±0.211)2) 3.959 < 0.001 早饱 2.26±0.48 1.09±0.361) 2.18±0.57 0.62±0.241)2) 2.426 0.007 嗳气 2.14±0.53 1.34±0.411) 2.21±0.47 0.76±0.261)2) 3.634 < 0.001 中医证候总评分 10.46±2.48 5.91±1.881) 10.57±2.37 3.37±1.241)2) 6.137 < 0.001 GCSI评分 31.20±7.12 16.80±4.211) 32.60±6.79 12.10±3.471)2) 4.841 < 0.001 与治疗前比较，1)P < 0.05；与对照组治疗后比较，2)P < 0.05。
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表 4 两组患者的胃泌素、胃动素含量及胃排空率比较
X±S 组别 例数 胃泌素/(ng·mL-1) 胃动素/(ng·mL-1) 胃排空率/% 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 对照组 32 160.38±14.49 131.12±11.721) 509.00±80.63 412.00±62.411) 40.60±7.29 69.10±11.981) 研究组 32 166.50±13.61 109.47±8.561)2) 516.00±76.31 329.00±51.921)2) 38.90±7.87 82.50±12.711)2) t 0.657 5.992 0.497 8.795 0.284 3.376 P 0.513 < 0.001 0.605 < 0.001 0.782 0.001 与治疗前比较，1)P < 0.05；与对照组治疗后比较，2)P < 0.05。
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表 5 两组患者的胃电图指标比较
X±S 组别 例数 MFC/(次·min-1) AC/μV 胃电节律紊乱/% 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 对照组 32 餐前 2.41±0.26 2.81±0.291) 109.30±10.79 118.80±11.211) 25.78±3.78 23.53±2.291) 餐后 2.94±0.27 3.21±0.251) 126.20±11.46 141.20±13.011) 22.75±3.51 20.48±2.431) 研究组 32 餐前 2.52±0.27 2.92±0.261) 111.60±10.63 123.80±11.461) 25.02±3.87 22.25±2.18 餐后 2.89±0.25 3.52±0.241)2) 124.90±10.721) 165.30±14.211)2) 22.39±3.34 18.39±2.031)2) 与治疗前比较，1)P < 0.05；与对照组治疗后比较，2)P < 0.05。
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表 6 两组患者的复发情况比较
例(%) 组别 例数 随访1个月 随访3个月 随访6个月 研究组 30 2(6.6) 8(26.7) 19(63.3) 对照组 24 4(16.6) 14(58.3) 20(83.3) χ2 1.556 4.243 2.658 P 0.212 0.039 0.171
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