观察基于“治未病”理论的中医体质调理对早期无症状型糖尿病周围神经病变（diabetic peripheral neuropathy， DPN）的影响及安全性。【方法】 将87例早期无症状型DPN患者随机分为对照组43例和试验组44例，对照组仅予糖尿病的规 范饮食、运动及药物治疗，试验组在对照组的基础上，根据患者的主要体质类型给予相应的中医体质调养方案进行调理， 疗程为 48 周。观察 2 组患者干预前后中医体质转化情况、体质量指数（BMI）、收缩压（SBP）、舒张压（DBP）、空腹血糖 （FPG）、糖化血红蛋白（HbA1c）、总胆固醇（TC）、甘油三酯（TG）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇 （LDL-C）水平以及神经传导速度（NCV）的变化情况，并评价2组患者的安全性。【结果】（1）干预结束后，试验组有17例患者 转化为平和质，而对照组仅有5例患者转化为平和质，2组患者的中医体质分布比较，差异有统计学意义（P＜0.05）。（2）干预 前，2组患者的BMI、SBP、DBP、FPG、HbA1c、TC、TG、HDL-C、LDL-C水平比较，差异均无统计学意义（P＞0.05），具 有可比性。干预后，2组患者的BMI、SBP、DBP水平以及试验组的HbA1c、TC、TG、LDL-C水平均较干预前下降（P＜0.05 或 P＜0.01），对照组的 FPG、HDL-C 水平则较干预前升高（P＜0.05 或 P＜0.01）；组间比较，试验组的 FPG、HbA1c、TG、 LDL-C水平均较对照组明显降低，差异均有统计学意义（P＜0.05或P＜0.01）。（3）干预结束后，对照组有10例出现DPN临床 典型症状，试验组仅有6例出现DPN临床症状。干预前，2组患者的双侧胫神经及腓总神经运动传导速度（MNCV）、双侧腓 肠神经及腓浅神经感觉传导速度（SNCV）比较，差异均无统计学意义（P＞0.05），具有可比性。干预后，对照组的双侧胫神经 及腓总神经MNCV、双侧腓肠神经及腓浅神经SNCV均较干预前减慢（P＜0.01），而试验组的以上神经传导速度虽较干预前有轻微上升，但与干预前比较差异均无统计学意义（P＞0.05）；组间比较，试验组的双侧胫神经MNCV、双侧腓肠神经及腓浅 神经SNCV均较对照组高，差异均有统计学意义（P＜0.05）。（4） 干预过程中，2组患者均未出现明显不良反应，具有较高的 安全性。【结论】 中医体质调理可以调整早期无症状型DPN患者的失衡体质，同时对患者的糖脂代谢、胫神经运动传导速度、 双侧腓肠神经及腓浅神经的感觉传导速度具有一定的保护作用。

To observe the clinical efficacy and safety of traditional Chinese medicine（TCM）constitution correction based on the theory of preventive treatment of disease on the patients with early asymptomatic diabetic peripheral neuropathy （DPN）. Methods A total of 87 patients with early asymptomatic DPN were randomly divided into the control group with 43 cases and the trial group with 44 cases. The control group was required to have standard diet，do exercises and take medicines for diabetes. On the basis of treatment for the control group，the trial group was given the corresponding TCM constitution correction regimen according to the predominated constitution types of the patients. The course of treatment for the two groups lasted for 48 weeks. Before and after intervention，the two groups were observed in the alteration of TCM constitution types，and the changes of body mass index （BMI）， systolic blood pressure （SBP）， diastolic blood pressure （DBP）， fasting plasma glucose （FPG），glycosylated hemoglobin（HbA1c），total cholesterol（TC），triglyceride （TG），high-density lipoprotein cholesterol（HDL-C）， low-density lipoprotein cholesterol（LDL-C） and nerve conduction velocity（NCV）. Moreover， the safety of the two groups was evaluated. Results （1） After the intervention， the constitution of 17 patients in the trial group was transformed into the balanced constitution，while only the constitution of 5 patients in the control group was transformed into balanced constitution. There was a statistically significant difference in the distribution of TCM constitution between the two groups（P＜0.05）. （2）Before intervention， there were no significant differences in the levels of BMI，SBP，DBP，FPG，HbA1c，TC，TG，HDL-C and LDL-C between the two groups （P＞0.05）. After intervention，the levels of BMI，SBP and DBP in the two groups and the levels of HbA1c，TC，TG and LDL-C in the trial group were lower than those before intervention （P＜0.05 or P＜0.01）， while the levels of FPG and HDL-C in the control group were higher than those before intervention （P＜0.05 or P＜ 0.01）. The intergroup comparison showed that the levels of FPG，HbA1c，TG and LDL-C in the trial group were significantly lower than those in the control group （P＜0.05 or P＜0.01）.（3）After the intervention，10 cases in the control group had typical clinical symptoms of DPN，while only 6 cases in the trial group had the clinical symptoms of DPN. Before intervention，there was no significant difference in the motor nerve conduction velocity （MNCV） of bilateral tibial nerve and common peroneal nerve and in the sensory nerve conduction velocity （SNCV） of bilateral sural nerve and superficial peroneal nerve between the two groups （P＞0.05）. After intervention，the MNCV of bilateral tibial nerve and common peroneal nerve and the SNCV of bilateral sural nerve and superficial peroneal nerve in the control group were slower than those before intervention （P＜0.05），while the above indicators of nerve conduction velocity in the trial group were mildly increased compared with those before intervention，but the differences were not significant（P＞0.05）. The intergroup comparison showed that the MNCV of bilateral tibial nerve and SNCV of bilateral sural nerve and superficial peroneal nerve in the trial group were higher than those in the control group， and the differences were statistically significant（P＜0.05）.（4）During the intervention， no obvious adverse reactions occurred in the two groups，with high safety. Conclusion The TCM constitution correction can adjust the biased constitution of patients with early asymptomatic DPN，and has certain protective effect on the glucose and lipid metabolism，MNCV of tibial nerve，and SNCV of bilateral sural nerve and superficial peroneal nerve.

R259.872

广东省中医药局科研项目（编号：20201313）